PSI-HHS-000004783470-73 attachment
PSI-HHS-000004783470-73
Cover Page
| Case Count | 294 | |
| Selection Criteria | ||
| Product - Product Name: | ASTRAZENECA COVID-19 VACCINE | |
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| Outcome Serious?: | ||
| Outcome Death: | ||
| Outcome Hospitalization | ||
| Outcome Life Threatening: | ||
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| Outcome Congenital: | ||
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| Suspect/Concomitant: | Suspect | |
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| Patient - Race: | All | |
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| Event List | Event List Details | Event Type |
| Product List | Product List Details | Product Type |
| Sender Mfr Org List | Sender Mfr Org List Details | Sender Manufacturer Type |
Line Listing of Cases
| Total Number of Cases: 294 | |||||||||||||||||||||
| FAERS Case # | Version Number | Initial FDA Received Date | Latest FDA Received date | ALL Suspect Product Names | Primary Suspect (PS) | PS Dose-Route-Frequency | All Outcomes | PTs | Age in Years | Age/Unit | Sex | Narrative | Indication | Concomitant(s) | Country | Report Source | MFR Ctrl # | Case Type | Image | Attach | |
| REDACTED | 1 | 2/3/2021 | 2/3/2021 | ASTRAZENECA COVID-19 VACCINE:METHOTREXATE SODIUM(PS) | METHOTREXATE SODIUM | OT | DRUG INTERACTION:PYREXIA | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Rheumatoid arthritis | GBR | O | GB-PFIZER INC-2021068022 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/6/2021 | 2/6/2021 | ASTRAZENECA COVID-19 VACCINE:GLIMEPIRIDE(PS) | GLIMEPIRIDE | 1 MG PO | LT,OT | BLOOD GLUCOSE DECREASED:COUGH:DISCOMFORT:DIZZINESS:FATIGUE:FEELING COLD:HYPOGLYCAEMIA:NAUSEA:PALPITATIONS:RESTLESSNESS:SKIN DISCOLOURATION:VOMITING | 64 | 64 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Type 2 diabetes mellitus | GBR | O | GB-ACCORD-216481 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/8/2021 | 2/8/2021 | ASTRAZENECA COVID-19 VACCINE:OMEPRAZOLE(PS) | OMEPRAZOLE | PO | ARTHRALGIA:CHILLS:FATIGUE:FEELING COLD:HYPERHIDROSIS:PAIN IN EXTREMITY:PYREXIA | MALE | REDACTED | REDACTED | ASPIRIN:INSULIN:VITAMIN D | USA | O | US-ASTRAZENECA-2021A023068 | Non- Expedited | ||||||
| REDACTED | 1 | 2/9/2021 | 2/9/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE:COCODAMOL:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:CHILLS:NUCHAL RIGIDITY | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005098 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/12/2021 | 2/12/2021 | ASTRAZENECA COVID-19 VACCINE:PREDNISOLONE(PS) | PREDNISOLONE | PO | OT | ARTHRALGIA | NULL | REDACTED | REDACTED | GBR | O | GB-ADVANZ PHARMA-202102000967 | Expedited (15-Day) | ||||||
| REDACTED | 1 | 2/12/2021 | 2/12/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE:COCODAMOL:IBUPROFEN(PS) | IBUPROFEN | OT | ARTHRALGIA:CHILLS:NUCHAL RIGIDITY | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1008755 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/12/2021 | 2/12/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | ABDOMINAL PAIN:CHEST DISCOMFORT:CHILLS:CONSTIPATION:DIARRHOEA:DIZZINESS POSTURAL:DYSPNOEA:FATIGUE:HEADACHE:MYALGIA:NAUSEA:PARAESTHESIA:PAROSMIA:PERIPHERAL COLDNESS:TREMOR:VOMITING:WHEEZING | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS:INVITA D3 | GBR | O | GB-MYLANLABS-2021M1008833 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/12/2021 | 2/12/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | 400 MG | OT | CHILLS:DIZZINESS:FATIGUE:HEADACHE:MYALGIA:PYREXIA | 65 | 65 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | BENDROFLUMETHIAZIDE:ENALAPRIL MALEATE:SIMVASTATIN | GBR | O | GB-MYLANLABS-2021M1008769 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/12/2021 | 2/12/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | DS,OT | SEIZURE:TREMOR | 28 | 28 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-VIIV HEALTHCARE LIMITED-GB2021030308 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/12/2021 | 2/12/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | DS,OT | SEIZURE:TREMOR | 28 | 28 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-GLAXOSMITHKLINE-GB2021030308 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/12/2021 | 2/12/2021 | ASTRAZENECA COVID-19 VACCINE:LAMOTRIGINE(PS) | LAMOTRIGINE | 400 MG PO | OT | MEDICATION ERROR:PYREXIA | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Epilepsy | LAMOTRIGIN | GBR | O | GB-MYLANLABS-2021M1008463 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/12/2021 | 2/12/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | PYREXIA | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | PENICILLIN | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005856 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/13/2021 | 2/13/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | OT | BLOOD PRESSURE DECREASED:CHEST PAIN:DIZZINESS:MYALGIA:NAUSEA:PYREXIA | 41 | 41 YR | FEMALE | REDACTED | REDACTED | Bladder cancer | GBR | O | GB-009507513-2102GBR004099 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/13/2021 | 2/13/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | OT | HYPERHIDROSIS:HYPOGLYCAEMIA | 49 | 49 YR | MALE | REDACTED | REDACTED | Bladder cancer;Prophylaxis | GBR | O | GB-009507513-2102GBR004203 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/13/2021 | 2/13/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | OT | CHILLS:FATIGUE:HYPOAESTHESIA | 49 | 49 YR | FEMALE | REDACTED | REDACTED | Bladder cancer;Prophylaxis | LEVOTHYROXINE SODIUM | GBR | O | GB-009507513-2102GBR004209 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/13/2021 | 2/13/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | HO | TRANSIENT ISCHAEMIC ATTACK | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Bladder cancer;Prophylaxis | INFLUENZA VIRUS | GBR | O | GB-009507513-2102GBR004217 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | CHILLS:DIZZINESS:FATIGUE:HEADACHE:MYALGIA:PYREXIA | 65 | 65 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | BENDROFLUMETHIAZIDE:ENALAPRIL MALEATE:SIMVASTATIN | GBR | O | GB-JNJFOC-20210216553 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | DYSPNOEA:PYREXIA | 20 | 20 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216595 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | PYREXIA | 30 | 30 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216596 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | DS | DIZZINESS:DIZZINESS POSTURAL:HYPERTENSION | 79 | 79 YR | FEMALE | REDACTED | REDACTED | Bladder cancer | FELODIPINE:MIRTAZAPINE:WARFARIN | GBR | O | GB-009507513-2102GBR004963 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | HEADACHE:MALAISE | 80 | 80 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210217482 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:TRAMADOL(PS) | TRAMADOL | DS | ABDOMINAL PAIN UPPER:ARTHRALGIA:CHEST DISCOMFORT:CHILLS:CRYING:DEPRESSED LEVEL OF CONSCIOUSNESS:DIARRHOEA:DIZZINESS:DYSPHONIA:EAR PAIN:FATIGUE:FEELING ABNORMAL:HEADACHE:HYPERHIDROSIS:MYALGIA:NAUSEA:OROPHARYNGEAL PAIN:PAIN:PHOTOPHOBIA:PYREXIA:SOMNOLENCE:TINNITUS:VOMITING | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | ATORVASTATIN:BUTEC:DULOXETINE | GBR | O | GB-MYLANLABS-2021M1008738 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:EQUINE THYMOCYTE IMMUNE GLOBULIN:IBUPROFEN(PS):OMEGA-3-ACID ETHYL ESTERS | IBUPROFEN | OT | FATIGUE:GOUT | 71 | 71 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1008790 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:NAPROXEN(PS) | NAPROXEN | OT | ARTHRALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1008799 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ASTRAZENECA COVID-19 VACCINE:NAPROXEN(PS) | NAPROXEN | UNK | OT | ABDOMINAL DISCOMFORT:FATIGUE:INFLUENZA LIKE ILLNESS:NAUSEA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Atenolol:Bendrofluazide:Doxazosin teva:Folic acid:Methotrexate:Ramipril:Vitamin d3 | GBR | O | GB-AUROBINDO-AUR-APL-2021-005626 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:HEADACHE:HOT FLUSH:MIGRAINE:NECK PAIN:OROPHARYNGEAL PAIN | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Mercaptopurine | GBR | O | GB-AUROBINDO-AUR-APL-2021-005624 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:INFLUENZA LIKE ILLNESS:PYREXIA:RENAL PAIN:RHINORRHOEA | 53 | 53 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-005621 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | HEADACHE:MALAISE | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS | GBR | O | GB-MYLANLABS-2021M1008891 | Expedited (15-Day) | |||||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | CHILLS:HEADACHE:PYREXIA | 69 | 69 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS:ZOLEDRONATE | GBR | O | GB-MYLANLABS-2021M1008892 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | FEELING COLD:HEADACHE:INSOMNIA:MYALGIA:NERVOUSNESS:THIRST | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1008893 | Expedited (15-Day) | ||||||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | NECK PAIN | 31 | 31 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1008906 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:DECREASED APPETITE:DIZZINESS:FATIGUE:HEADACHE:MALAISE:MYALGIA:TENDERNESS | 52 | 52 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS:OESTROGEL | GBR | O | GB-JNJFOC-20210216618 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ANXIETY:CHILLS:EYE PAIN:HEADACHE:PYREXIA:STRESS | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CORTISOL [CORTISONE ACETATE] | GBR | O | GB-JNJFOC-20210216617 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FEELING COLD:TREMOR | 74 | 74 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CANDESARTAN:SINVASTATIN | GBR | O | GB-JNJFOC-20210216610 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | 1 G PO | OT | ABDOMINAL PAIN:NAUSEA:PYREXIA:SYNCOPE:VOMITING | 28 | 28 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | ESCITALOPRAM:PROPRANOLOL | GBR | O | GB-JNJFOC-20210216609 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:COCODAMOL:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:CHILLS:NUCHAL RIGIDITY | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006445 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:HEADACHE:PYREXIA | 61 | 61 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006299 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DIZZINESS:DIZZINESS POSTURAL:PAIN IN EXTREMITY:PYREXIA | 37 | 37 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Sertraline | GBR | O | GB-AUROBINDO-AUR-APL-2021-006275 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BACK PAIN:FATIGUE:HEADACHE:PYREXIA | 21 | 21 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Amoxicillin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006227 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:ILLNESS | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006196 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:CODEINE PHOSPHATE | ACETAMINOPHEN | UNK | OT | BACK PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS:PYREXIA | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Roaccutane | GBR | O | GB-AUROBINDO-AUR-APL-2021-006169 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:NAPROXEN(PS) | NAPROXEN | UNK | OT | ARTHRALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006166 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHEST PAIN:CHILLS:HEADACHE:MUSCLE FATIGUE | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006098 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FEELING COLD:TREMOR | 74 | 74 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006095 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:INJECTION RELATED REACTION:MALAISE | 66 | 66 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006280 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:NAUSEA:NIGHTMARE:PYREXIA:TINNITUS | 62 | 62 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006293 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:INFLUENZA LIKE ILLNESS:PYREXIA:RENAL PAIN:RHINORRHOEA | 53 | 53 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210211744 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/15/2021 | 2/15/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE | ACETAMINOPHEN | UNK | DS | SEIZURE:TREMOR | 28 | 28 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210211743 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/15/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PAIN IN EXTREMITY:PYREXIA | 36 | 36 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CYANOCOBALAMIN:FERROUS FUMARATE:LEVOTHYROXINE:SERTRALINE | GBR | O | GB-JNJFOC-20210217469 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | OT | DYSPNOEA:FATIGUE:HYPOPNOEA:INFLUENZA LIKE ILLNESS:PAIN IN EXTREMITY:PULMONARY PAIN:PYREXIA | 26 | 26 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | PARACETAMOL | GBR | O | GB-MYLANLABS-2021M1008932 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ASTRAZENECA COVID-19 VACCINE:COCODAMOL:TRAMADOL(PS) | TRAMADOL | 100 MG | OT | BACK PAIN:CHILLS:FEELING ABNORMAL | 31 | 31 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1008971 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ASTRAZENECA COVID-19 VACCINE:NAPROSYN(PS) | NAPROSYN | UNK | OT | ARTHRALGIA:INFLUENZA LIKE ILLNESS | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication | PARACETAMOL | GBR | O | GB-CANTON LABORATORIES, LLC-2106827 | Expedited (15-Day) | A2 | |
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHEST PAIN:CHILLS:HEADACHE:MUSCLE FATIGUE | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210217500 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:MIGRAINE:NAUSEA:PAIN:PAIN IN EXTREMITY:PYREXIA:SWEATING FEVER | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Generalised aching | CLARITHROMYCIN:CLENIL MODULITE:SALBUTAMOL | GBR | O | GB-JNJFOC-20210217480 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS | ABDOMINAL PAIN UPPER:BACK PAIN:CHEST PAIN:INSOMNIA:LYMPHADENOPATHY:NAUSEA:PAIN:PYREXIA | 27 | 27 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | PROPRANOLOL | GBR | O | GB-JNJFOC-20210217476 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | INFLUENZA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210217342 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA:TREMOR | 19 | 19 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CETIRIZINE:VENTOLIN [SALBUTAMOL] | GBR | O | GB-JNJFOC-20210217319 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:FREQUENT BOWEL MOVEMENTS:INFLUENZA:NIGHT SWEATS:PAIN IN EXTREMITY:TREMOR | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210217316 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DECREASED APPETITE:DIZZINESS:HEADACHE:INFLUENZA LIKE ILLNESS:LETHARGY:VISION BLURRED | 74 | 74 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210217312 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:COCODAMOL | ACETAMINOPHEN | UNK | DS | ANXIETY:ARTHRALGIA:BACK PAIN:CHILLS:DIZZINESS:MYALGIA:PYREXIA | 30 | 30 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210216672 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BACK PAIN:CHILLS:HEADACHE:PYREXIA | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | ATORVASTATIN | GBR | O | GB-JNJFOC-20210216665 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHEST PAIN:HEADACHE | 58 | 58 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216662 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN:ABDOMINAL PAIN UPPER:DIZZINESS:NAUSEA:PYREXIA:TACHYCARDIA | 70 | 70 YR | NULL | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216658 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DRY MOUTH:HEADACHE:INFLUENZA:NAUSEA:PAIN | 35 | 35 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216641 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:HEADACHE:NAUSEA:PYREXIA:SINUS HEADACHE:TREMOR | 60 | 60 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216626 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:NAUSEA:SWEATING FEVER | 62 | 62 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216613 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:HEADACHE:PYREXIA | 61 | 61 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216605 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:ILLNESS | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216592 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | INFLUENZA | .16667 | 2 MTH | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | OMEPRAZOLE | GBR | O | GB-JNJFOC-20210216590 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ASTHENIA:COUGH:FOOD AVERSION:INFLUENZA | 90 | 90 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | ADCAL [CALCIUM CARBONATE]:BISODOL:ISOSORBIDE:LEVOTHYROXINE | GBR | O | GB-JNJFOC-20210216586 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:CODEINE | ACETAMINOPHEN | UNK | OT | BACK PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS:PYREXIA | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | ROACCUTANE | GBR | O | GB-JNJFOC-20210216576 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ASTHENIA:BODY TEMPERATURE:DIZZINESS:FATIGUE:MIGRAINE:MYALGIA | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | FLUOXETINE:MONTELUKAST | GBR | O | GB-JNJFOC-20210216575 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA:TREMOR | 73 | 73 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216565 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ASTHENIA:CHILLS:DIZZINESS POSTURAL:MAGNETIC RESONANCE IMAGING BRAIN:MALAISE:MUSCLE SPASMS:PARAESTHESIA:PYREXIA | 41 | 41 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | FOSTAIR:MONTELUKAST | GBR | O | GB-JNJFOC-20210216554 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:ASTHENIA:CLUSTER HEADACHE:DEPRESSED MOOD:FATIGUE:INFLUENZA LIKE ILLNESS:PYREXIA | 74 | 74 YR | FEMALE | REDACTED | REDACTED | COVID-19 vaccination;Drug use for unknown indication | RAMIPRIL | GBR | O | GB-JNJFOC-20210219554 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:FEELING COLD:HEADACHE:MYALGIA | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216551 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BODY TEMPERATURE FLUCTUATION:FATIGUE:MALAISE | 70 | 70 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | ATORVASTATIN | GBR | O | GB-JNJFOC-20210216545 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ASTHENIA:CHILLS:DIZZINESS POSTURAL:MAGNETIC RESONANCE IMAGING BRAIN:MALAISE:MUSCLE SPASMS:PARAESTHESIA:PYREXIA | 41 | 41 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Fostair:Montelukast | GBR | O | GB-AUROBINDO-AUR-APL-2021-006099 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DIZZINESS:DIZZINESS POSTURAL:PAIN IN EXTREMITY:PYREXIA | 37 | 37 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | SERTRALINE | GBR | O | GB-JNJFOC-20210216539 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:HEADACHE:MALAISE:MYALGIA:NAUSEA | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210215534 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:EQUINE THYMOCYTE IMMUNE GLOBULIN | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA:TREMOR | 50 | 50 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210215531 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | INFLUENZA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006261 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS VACCINE ADSORBED NOS | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:HEADACHE:NAUSEA:PYREXIA:SINUS HEADACHE:TREMOR | 60 | 60 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006289 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:MALAISE | 66 | 66 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210215498 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:TETANUS AND DIPHTHERIA TOXOIDS ADSORBED (VACCINE) | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:MYALGIA:PYREXIA | 25 | 25 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | OMEPRAZOLE:OMEPRAZOLE:SERTRALINE | GBR | O | GB-JNJFOC-20210215520 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:DECREASED APPETITE:DIZZINESS:FATIGUE:HEADACHE:MALAISE:MYALGIA:TENDERNESS | 52 | 52 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus:Oestrogel | GBR | O | GB-AUROBINDO-AUR-APL-2021-006294 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:HEADACHE:PAIN IN EXTREMITY:PYREXIA | 52 | 52 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Leflunomide:Methotrexate | GBR | O | GB-AUROBINDO-AUR-APL-2021-006297 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:NAUSEA:NIGHTMARE:PYREXIA:TINNITUS | 62 | 62 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210215493 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN:ABDOMINAL PAIN UPPER:DIZZINESS:NAUSEA:PYREXIA:TACHYCARDIA | 70 | 70 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006314 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ASTHMA:HEADACHE:PYREXIA | .16667 | 2 MTH | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210218955 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS | ABDOMINAL PAIN UPPER:BACK PAIN:CHEST PAIN:DECREASED APPETITE:ILLNESS:INSOMNIA:LYMPHADENOPATHY:NAUSEA:PAIN:PYREXIA:SINUSITIS:THIRST | 27 | 27 YR | FEMALE | REDACTED | REDACTED | COVID-19 immunisation;Product used for unknown indication | Propranolol | GBR | O | GB-AUROBINDO-AUR-APL-2021-006317 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | LYMPHADENOPATHY | 50 | 50 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210215471 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:MYALGIA:VOMITING | 57 | 57 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | THYROXINE | GBR | O | GB-JNJFOC-20210218969 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:FEELING ABNORMAL:HEADACHE:HYPERHIDROSIS:ILLNESS:SOMNOLENCE | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | BENDROFLUMETHIAZIDE:BETAHISTINE:CANDESARTAN:DULOXETINE:OXYCODONE:ROPINIROLE HYDROCHLORIDE | GBR | O | GB-JNJFOC-20210218958 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | INSOMNIA:MIGRAINE:PYREXIA:VOMITING | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210217467 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ADMINISTRATION SITE PAIN:CHILLS:DRY MOUTH:HEADACHE:INFLUENZA:NAUSEA:PAIN | 35 | 35 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006447 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PAIN IN EXTREMITY:PYREXIA | 36 | 36 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Cyanocobalamin:Ferrous fumarate:Levothyroxine:Sertraline | GBR | O | GB-AUROBINDO-AUR-APL-2021-006475 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | MYALGIA | 72 | 72 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006472 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACYCLOVIR(PS):ASTRAZENECA COVID-19 VACCINE | ACYCLOVIR | UNK | OT | HERPES ZOSTER:NIGHT SWEATS | 54 | 54 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006361 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:MYALGIA:VOMITING | 57 | 57 YR | FEMALE | REDACTED | REDACTED | COVID-19 immunisation;Product used for unknown indication | Thyroxine | GBR | O | GB-AUROBINDO-AUR-APL-2021-006358 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | CHILLS:HEADACHE:PYREXIA | 69 | 69 YR | NULL | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS:ZOLEDRONATE | GBR | O | GB-JNJFOC-20210217456 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/16/2021 | 2/16/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | ABDOMINAL PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1008986 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE:COCODAMOL:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:CHILLS:NUCHAL RIGIDITY | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216663 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:VENTOLIN(PS):VITAMIN D3 | VENTOLIN | UNK | OT | BURNING SENSATION:ERYTHEMA:LOSS OF CONSCIOUSNESS:MALAISE | 76 | 76 YR | FEMALE | REDACTED | REDACTED | Vaccination;Product used for unknown indication;Product used for unknown indication | DAPAGLIFLOZIN:INSUMAN RAPID:LANTUS:Levothyroxine sodium:PARACETAMOL:Seretide | GBR | O | GB-GLAXOSMITHKLINE-GB2021035940 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:CIPROFLOXACIN(PS):ENOXAPARIN SODIUM | CIPROFLOXACIN | OT | ABDOMINAL PAIN:INFECTION | 84 | 84 YR | MALE | REDACTED | REDACTED | AMOXICILLIN:CLAVULANIC ACID:CO-CODAMOL | GBR | O | GB-BAYER-2021-059176 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | DS | HYPERTENSION:PYREXIA | 81 | 81 YR | FEMALE | REDACTED | REDACTED | AMLODIPINE:ATENOLOL:OMEPRAZOLE:RAMIPRIL:REPAGLINIDE:ZOLPIDEM | GBR | O | GB-009507513-2102GBR005847 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:NAPROXEN(PS) | NAPROXEN | OT | ARTHRALGIA:CLUSTER HEADACHE:MALAISE:OSTEOARTHRITIS | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1009467 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:ONCOTICE(PS) | ONCOTICE | OT | FLUSHING:RASH | 53 | 53 YR | FEMALE | REDACTED | REDACTED | GBR | O | GB-009507513-2102GBR004757 | Expedited (15-Day) | |||||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:IBUPROFEN | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:PYREXIA | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | CALCICHEW D3:LYMECYCLINE:TOLTERODINE | GBR | O | GB-JNJFOC-20210217334 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | NECK PAIN | 31 | 31 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210218971 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS):LAMIVUDINE | IBUPROFEN | UNK | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | PROPRANOLOL:SERTRALINE | GBR | O | GB-JNJFOC-20210219611 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ABDOMINAL PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK007386 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS):LAMIVUDINE | IBUPROFEN | UNK | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | PROPRANOLOL:SERTRALINE | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK007441 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | CHILLS:HEADACHE:PALLOR:PYREXIA:Q FEVER:TREMOR | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Vaccination | AMITRIPTYLINE | GBR | O | GB-VIIV HEALTHCARE LIMITED-GB2021035956 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | PROPRANOLOL:SERTRALINE | GBR | O | GB-VIIV HEALTHCARE LIMITED-GB2021035912 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | PROPRANOLOL:SERTRALINE | GBR | O | GB-GLAXOSMITHKLINE-GB2021035912 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | CHILLS:HEADACHE:PALLOR:PYREXIA:Q FEVER:TREMOR | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Vaccination | AMITRIPTYLINE | GBR | O | GB-GLAXOSMITHKLINE-GB2021035956 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:COCODAMOL:METHOTREXATE SODIUM(PS) | METHOTREXATE SODIUM | OT | ARTHRITIS:CHROMATURIA:HEADACHE:LIMB DISCOMFORT:PYREXIA | 30 | 30 YR | FEMALE | REDACTED | REDACTED | CETIRIZINE:CODEINE:COSENTYX:DICLOFENAC:FOLIC ACID:LANSOPRAZOLE:METHOTREXATE:PARACETAMOL:RAMIPRIL:SERTRALINE | GBR | O | GB-PFIZER INC-2021131170 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210217445 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABNORMAL DREAMS:CHILLS:HEADACHE:HYPERHIDROSIS:MYALGIA:PYREXIA:SWEATING FEVER | 23 | 23 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210217434 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | AGEUSIA:ANOSMIA:ARTHRALGIA:ASTHENIA:BONE PAIN:DEHYDRATION:HEADACHE:PYREXIA:TREMOR | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210221039 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | COLD SWEAT:MUSCULOSKELETAL STIFFNESS:PYREXIA | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210217426 | Expedited (15-Day) | |||||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DRY SKIN:EAR PAIN:HEADACHE:NAUSEA:NEURALGIA:PYREXIA | 56 | 56 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | BETAHISTINE DIHYDROCHLORIDE:OMEPRAZOLE | GBR | O | GB-JNJFOC-20210221037 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DIZZINESS:HEADACHE:INFLUENZA | 29 | 29 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210219612 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIARRHOEA:ILLNESS:PYREXIA:SYNCOPE:TREMOR | 63 | 63 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210219602 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN UPPER:CHILLS:COUGH:HEADACHE:HOT FLUSH | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210219590 | Expedited (15-Day) | |||||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ADVERSE DRUG REACTION:HEADACHE | .16667 | 2 MTH | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006220 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHEST PAIN:HEADACHE | 58 | 58 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006584 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BACK PAIN:CHILLS:HEADACHE:PYREXIA | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Atorvastatin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006605 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:FEELING COLD:HEADACHE:MYALGIA | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006610 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA | 20 | 20 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006676 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN:NAUSEA:PYREXIA:SYNCOPE:VOMITING | 28 | 28 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Escitalopram:Propranolol | GBR | O | GB-AUROBINDO-AUR-APL-2021-006686 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:FEELING ABNORMAL:HEADACHE:HYPERHIDROSIS:ILLNESS:SOMNOLENCE | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Bendroflumethiazide:Betahistine:Candesartan:Duloxetine:Oxycodone:Spiroco | GBR | O | GB-AUROBINDO-AUR-APL-2021-006334 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006335 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:HYPERPYREXIA:TREMOR | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006716 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:MYALGIA:NAUSEA:VOMITING | 29 | 29 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210219597 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:TRAMADOL(PS) | TRAMADOL | UNK | DS,OT | ABDOMINAL PAIN UPPER:ARTHRALGIA:CHEST DISCOMFORT:CHILLS:CRYING:DEPRESSED LEVEL OF CONSCIOUSNESS:DIARRHOEA:DIZZINESS:DYSPHONIA:EAR PAIN:FATIGUE:FEELING ABNORMAL:HEADACHE:HYPERHIDROSIS:MYALGIA:NAUSEA:OROPHARYNGEAL PAIN:PAIN:PHOTOPHOBIA:PYREXIA:SOMNOLENCE:TINNITUS:VOMITING | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Atorvastatin:Butec:Duloxetine | GBR | O | GB-AUROBINDO-AUR-APL-2021-006443 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:INJECTION RELATED REACTION:NAUSEA:SWEATING FEVER | 62 | 62 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006585 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:HYPERPYREXIA:TREMOR | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210217436 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:FREQUENT BOWEL MOVEMENTS:INFLUENZA:INJECTION RELATED REACTION:NIGHT SWEATS:PAIN IN EXTREMITY:TREMOR | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006589 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN UPPER:ADVERSE DRUG REACTION:DIZZINESS:NAUSEA | 6 | 6 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006612 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ASTHENIA:BODY TEMPERATURE:DIZZINESS:FATIGUE:MIGRAINE:MYALGIA | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Fluoxetine:Montelukast | GBR | O | GB-AUROBINDO-AUR-APL-2021-006704 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | PYREXIA | 30 | 30 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006714 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:COCODAMOL | ACETAMINOPHEN | UNK | DS | ANXIETY:ARTHRALGIA:BACK PAIN:CHILLS:DIZZINESS:MYALGIA:PYREXIA:VACCINATION SITE JOINT PAIN | 30 | 30 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006645 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN UPPER:FATIGUE:HEADACHE:PYREXIA | 42 | 42 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006579 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ANXIETY:CHILLS:EYE PAIN:HEADACHE:PYREXIA:STRESS | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Cortisol | GBR | O | GB-AUROBINDO-AUR-APL-2021-006675 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:NAUSEA | 69 | 69 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210216653 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA:TREMOR | 73 | 73 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006719 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA:TREMOR | 19 | 19 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Cetirizine:Ventolin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006708 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:CONFUSIONAL STATE:DIZZINESS:FREEZING PHENOMENON:HEADACHE:HYPOAESTHESIA:MUSCULAR WEAKNESS:MYALGIA:PAIN IN EXTREMITY:PYREXIA:SLOW SPEECH:TREMOR | 29 | 29 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CO-CODAMOL | GBR | O | GB-JNJFOC-20210219574 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:HYPERHIDROSIS:LIP SWELLING:PYREXIA | 29 | 29 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210219563 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS,OT | ARTHRALGIA:BACK PAIN:CHILLS:COLD SWEAT:DECREASED APPETITE:DIZZINESS:FATIGUE:HAEMATOCRIT:HEADACHE:HYPERHIDROSIS:MYALGIA:NAUSEA:PAIN:PYREXIA:THIRST | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | HYDROXYCHLOROQUINE SULFATE | GBR | O | GB-JNJFOC-20210218961 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:MALAISE:RASH ERYTHEMATOUS | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210217461 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:HYPERHIDROSIS:LIP SWELLING:PYREXIA | 29 | 29 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006330 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABNORMAL DREAMS:CHILLS:HEADACHE:HYPERHIDROSIS:MYALGIA:PYREXIA:SWEATING FEVER | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006566 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | PYREXIA | 30 | 30 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1008828 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | ARTHRALGIA:HEADACHE | 71 | 71 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1009477 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | DYSPNOEA:PYREXIA | 20 | 20 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005021 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | HYPERHIDROSIS:HYPERTENSION:LYMPHADENOPATHY | 57 | 57 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | AMLODIPIN:CIPRALEX:CODEINE:ETANERCEPT:LANSOPRAZOLE:LOSARTAN | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK007623 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:HEADACHE | 71 | 71 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210223705 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | DYSPNOEA:FATIGUE:HYPOPNOEA:INFLUENZA LIKE ILLNESS:PAIN IN EXTREMITY:PULMONARY PAIN:PYREXIA | 26 | 26 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | PARACETAMOL | GBR | O | GB-VIIV HEALTHCARE LIMITED-GB2021GSK046855 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | ASTHMA:CHILLS:CONFUSIONAL STATE:COUGH:DECREASED APPETITE:DIZZINESS:EXPOSURE DURING PREGNANCY:HEADACHE:INSOMNIA:MUSCLE SPASMS:MYALGIA:NAUSEA:PYREXIA | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | AMLODIPIN:Beclometasone Dipropionate:DECAPEPTYL SR:Levothyroxine:Ramipril:SERTRALINE:Ventolin | GBR | O | GB-VIIV HEALTHCARE LIMITED-GB2021037395 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ABDOMINAL PAIN:CHEST DISCOMFORT:CHILLS:CONSTIPATION:DIARRHOEA:DIZZINESS POSTURAL:DYSPNOEA:FATIGUE:HEADACHE:MYALGIA:NAUSEA:PARAESTHESIA:PAROSMIA:PERIPHERAL COLDNESS:TREMOR:VOMITING:WHEEZING | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | InVita D3:Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006591 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BODY TEMPERATURE FLUCTUATION:FATIGUE:MALAISE | 70 | 70 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Atorvastatin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006602 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:HEADACHE:MALAISE:MYALGIA:NAUSEA | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006606 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:MIGRAINE | 33 | 33 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus:Omeprazole:Pregabalin:Teva quetiapine:Vensir | GBR | O | GB-AUROBINDO-AUR-APL-2021-006613 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | ASTHMA:CHILLS:CONFUSIONAL STATE:COUGH:DECREASED APPETITE:DIZZINESS:EXPOSURE DURING PREGNANCY:HEADACHE:INSOMNIA:MUSCLE SPASMS:MYALGIA:NAUSEA:PYREXIA | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | AMLODIPIN:Beclometasone Dipropionate:DECAPEPTYL SR:Levothyroxine:Ramipril:SERTRALINE:Ventolin | GBR | O | GB-GLAXOSMITHKLINE-GB2021037395 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | DYSPNOEA:FATIGUE:HYPOPNOEA:INFLUENZA LIKE ILLNESS:PAIN IN EXTREMITY:PULMONARY PAIN:PYREXIA | 26 | 26 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | PARACETAMOL | GBR | O | GB-GLAXOSMITHKLINE-GB2021GSK046855 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:NAUSEA:PAIN IN EXTREMITY:PYREXIA | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006333 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | HEADACHE:MALAISE | 80 | 80 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006336 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ASTHMA:HEADACHE:PYREXIA | .16667 | 2 MTH | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006349 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:ASTHENIA:CLUSTER HEADACHE:DEPRESSED MOOD:FATIGUE:INFLUENZA LIKE ILLNESS:PYREXIA | 74 | 74 YR | FEMALE | REDACTED | REDACTED | COVID-19 immunisation;Product used for unknown indication | Ramipril | GBR | O | GB-AUROBINDO-AUR-APL-2021-006444 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS,OT | ARTHRALGIA:BACK PAIN:CHILLS:COLD SWEAT:DECREASED APPETITE:DIZZINESS:FATIGUE:HAEMATOCRIT:HEADACHE:HYPERHIDROSIS:MYALGIA:NAUSEA:PAIN:PYREXIA:THIRST | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Hydroxychloroquine sulfate | GBR | O | GB-AUROBINDO-AUR-APL-2021-006386 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:CONFUSIONAL STATE:DIZZINESS:FREEZING PHENOMENON:HEADACHE:HYPOAESTHESIA:MUSCULAR WEAKNESS:MYALGIA:PAIN IN EXTREMITY:PYREXIA:SLOW SPEECH:TREMOR | 29 | 29 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Co-codamol | GBR | O | GB-AUROBINDO-AUR-APL-2021-006563 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | ARTHRALGIA:ASTHENIA:CLUSTER HEADACHE:DEPRESSED MOOD:FATIGUE:INFLUENZA LIKE ILLNESS:PYREXIA | 74 | 74 YR | FEMALE | REDACTED | REDACTED | COVID-19 immunisation;Abdominal discomfort | RAMIPRIL | GBR | O | GB-MYLANLABS-2021M1008826 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | MUSCLE FATIGUE | 65 | 65 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210224325 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:FLUOROURACIL(PS) | FLUOROURACIL | OT | CHILLS:PALPITATIONS | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-ACCORD-217430 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | OT | CHILLS:HEADACHE:PALLOR:PYREXIA:Q FEVER:TREMOR | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | AMITRIPTYLINE | GBR | O | GB-MYLANLABS-2021M1008967 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN:LAMIVUDINE(PS) | LAMIVUDINE | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | PROPRANOLOL:SERTRALINE | GBR | O | GB-MYLANLABS-2021M1008972 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN:ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | DEAFNESS:DECREASED APPETITE:DIZZINESS POSTURAL:FATIGUE:HEADACHE:MYALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210224895 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ABDOMINAL PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210221042 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | OT | ASTHMA:CHILLS:CONFUSIONAL STATE:COUGH:DECREASED APPETITE:DIZZINESS:HEADACHE:INSOMNIA:MUSCLE SPASMS:MYALGIA:NAUSEA:PYREXIA | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | AMLODIPIN /00972401/:BECLOMETASONE DIPROPIONATE:LEVOTHYROXINE:RAMIPRIL:SERTRALINE:VENTOLIN /00139502/ | GBR | O | GB-MYLANLABS-2021M1009498 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BACK PAIN:HYPERHIDROSIS | 67 | 67 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006322 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:NAUSEA | 69 | 69 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006647 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIARRHOEA:ILLNESS:PYREXIA:SYNCOPE:TREMOR | 63 | 63 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006868 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:MYALGIA:NAUSEA:VOMITING | 29 | 29 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006865 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN UPPER:CHILLS:COUGH:HEADACHE:HOT FLUSH | 4 | 4 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006867 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:MALAISE:MYALGIA:NAUSEA:PAIN OF SKIN:PYREXIA:TREMOR | 35 | 35 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006818 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FEELING COLD:TREMOR | 72 | 72 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006802 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HERPES ZOSTER | 87 | 87 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Amlodipin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006890 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FEELING COLD:HEADACHE:PYREXIA | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006992 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA | 27 | 27 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006790 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS):LAMIVUDINE\ZIDOVUDINE | IBUPROFEN | UNK | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Propranolol:Sertraline | GBR | O | GB-AUROBINDO-AUR-APL-2021-006815 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:TREMOR | 72 | 72 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006930 | Expedited (15-Day) | |||
| REDACTED | 2 | 2/20/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:MYALGIA:TREMOR:VOMITING | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006985 | Expedited (15-Day) | |||||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PYREXIA | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006785 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DRY SKIN:EAR PAIN:HEADACHE:NAUSEA:NEURALGIA:PYREXIA | 56 | 56 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Betahistine dihydrochloride:Omeprazole | GBR | O | GB-AUROBINDO-AUR-APL-2021-006816 | Expedited (15-Day) | ||
| REDACTED | 2 | 2/20/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | 200 MG UNK BID | OT | ARTHRALGIA:HEADACHE | 71 | 71 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006942 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:FATIGUE:HEADACHE:ILLNESS:MYALGIA:PYREXIA:RASH ERYTHEMATOUS:RASH MACULAR | 29 | 29 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Migraine | GBR | O | GB-AUROBINDO-AUR-APL-2021-006876 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:INJECTION RELATED REACTION:MYALGIA | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Atorvastatin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006787 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ILLNESS | 70 | 70 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Simvastatin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006801 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:EQUINE THYMOCYTE IMMUNE GLOBULIN:IBUPROFEN(PS):OMEGA-3-ACID ETHYL ESTERS | IBUPROFEN | OT | FATIGUE:GOUT | 71 | 71 YR | NULL | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-DRREDDYS-GER/UKI/21/0132025 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE:COCODAMOL:IBUPROFEN(PS) | IBUPROFEN | OT | ARTHRALGIA:CHILLS:NUCHAL RIGIDITY | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-DRREDDYS-GER/UKI/21/0132034 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | CHILLS:DIZZINESS:FATIGUE:HEADACHE:MYALGIA:PYREXIA | 65 | 65 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | BENDROFLUMETHIAZIDE:ENALAPRIL MALEATE:SIMVASTATIN | GBR | O | GB-DRREDDYS-GER/UKI/21/0132039 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:NAPROSYN(PS) | NAPROSYN | UNK | OT | ARTHRALGIA:CLUSTER HEADACHE:MALAISE:OSTEOARTHRITIS | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication | GBR | O | GB-CANTON LABORATORIES, LLC-2107058 | Expedited (15-Day) | A2 | ||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ABDOMINAL PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006881 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:COCODAMOL:TRAMADOL(PS) | TRAMADOL | UNK | OT | BACK PAIN:CHILLS:FEELING ABNORMAL | 31 | 31 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006884 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | AGEUSIA:ANOSMIA:ARTHRALGIA:ASTHENIA:BONE PAIN:DEHYDRATION:HEADACHE:PYREXIA:TREMOR | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006897 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | EPISTAXIS:HEADACHE:PAIN IN EXTREMITY:PYREXIA | 57 | 57 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006993 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | ASTHMA:CHILLS:CONFUSIONAL STATE:COUGH:DECREASED APPETITE:DIZZINESS:HEADACHE:INSOMNIA:MUSCLE SPASMS:MYALGIA:NAUSEA:PYREXIA | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Amlodipine:Beclometasone dipropionate:Decapeptyl:Levothyroxine:Ramipril:Sertraline:Ventolin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006919 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DECREASED APPETITE:FEELING COLD:PYREXIA | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006924 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | MALAISE | 74 | 74 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006931 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:INJECTION SITE PAIN:NAUSEA:PAIN | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Amlodipine:Azithromycin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006952 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:NAPROXEN(PS) | NAPROXEN | UNK | OT | ARTHRALGIA:CLUSTER HEADACHE:MALAISE:OSTEOARTHRITIS | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-006955 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:EQUINE THYMOCYTE IMMUNE GLOBULIN:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | HYPERHIDROSIS:HYPERTENSION:LYMPHADENOPATHY | 57 | 57 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Amlodipine:Cipralex:Codeine:Etanercept:Lansoprazole:Losartan | GBR | O | GB-AUROBINDO-AUR-APL-2021-006958 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS,OT | INFLUENZA:INFLUENZA LIKE ILLNESS:LETHARGY:NAUSEA | 46 | 46 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Ventolin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006863 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | ASTHMA:HEADACHE:PYREXIA | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-DRREDDYS-GER/UKI/21/0132077 | Expedited (15-Day) | ||||||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | NECK PAIN | 31 | 31 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-DRREDDYS-GER/UKI/21/0132067 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:FLUOROURACIL(PS) | FLUOROURACIL | OT | ARTHRALGIA:BODY TEMPERATURE INCREASED:DECREASED APPETITE:HEADACHE:HYPERSENSITIVITY:NAUSEA:RASH | 65 | 65 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-ACCORD-217549 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PROCEDURAL VOMITING | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210219569 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:NAUSEA:PAIN IN EXTREMITY:PYREXIA | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210218966 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | MUSCLE FATIGUE | 65 | 65 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-007137 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PAIN IN EXTREMITY | 54 | 54 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Metoprolol:Rivaroxaban | GBR | O | GB-AUROBINDO-AUR-APL-2021-007151 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:DIZZINESS POSTURAL:VACCINATION SITE PAIN | 27 | 27 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | 5 fu | GBR | O | GB-AUROBINDO-AUR-APL-2021-007170 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:CETIRIZINE(PS):PREDNISOLONE | CETIRIZINE | UNK | OT | URTICARIA | 56 | 56 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Influenza | GBR | O | GB-AUROBINDO-AUR-APL-2021-007184 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:MYALGIA:PYREXIA:TREMOR | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Pyrexia | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-007216 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:FATIGUE:HEADACHE:ILLNESS:MYALGIA:PYREXIA:RASH ERYTHEMATOUS:RASH MACULAR | 29 | 29 YR | NULL | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210222106 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PYREXIA | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210222056 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ILLNESS | 70 | 70 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | SIMVASTATIN | GBR | O | GB-JNJFOC-20210222002 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS,OT | INFLUENZA:INFLUENZA LIKE ILLNESS:LETHARGY:NAUSEA | 46 | 46 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | VENTOLIN [SALBUTAMOL] | GBR | O | GB-JNJFOC-20210221987 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:HEART RATE INCREASED | 72 | 72 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | ANASTROZOLE:ATORVASTATIN:INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210221049 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:INJECTED LIMB MOBILITY DECREASED:MALAISE:MYALGIA:PAIN:POOR QUALITY SLEEP:PYREXIA | 45 | 45 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | COLECALCIFEROL:INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210221043 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:INFLUENZA LIKE ILLNESS:MUSCLE SPASMS:NAUSEA:NERVOUSNESS:TREMOR | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | BISOPROLOL FUMARATE:CANDESARTANCILEXETIL/HCTZ:INFLUENZA VIRUS VACCINE | GBR | O | GB-JNJFOC-20210221040 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HERPES ZOSTER | 87 | 87 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | AMLODIPINE | GBR | O | GB-JNJFOC-20210219592 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | ARTHRALGIA:ASTHENIA:CLUSTER HEADACHE:DEPRESSED MOOD:FATIGUE:INFLUENZA LIKE ILLNESS:PYREXIA | 74 | 74 YR | FEMALE | REDACTED | REDACTED | COVID-19 vaccination;Drug use for unknown indication | RAMIPRIL | GBR | O | GB-DRREDDYS-GER/UKI/21/0132074 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | ABDOMINAL PAIN:CHEST DISCOMFORT:CHILLS:CONSTIPATION:DIARRHOEA:DIZZINESS POSTURAL:DYSPNOEA:FATIGUE:HEADACHE:MYALGIA:NAUSEA:PARAESTHESIA:PAROSMIA:PERIPHERAL COLDNESS:TREMOR:VOMITING:WHEEZING | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | BOOTS VITAMIN C:INFLUENZA VIRUS:INVITA-D3 | GBR | O | GB-DRREDDYS-GER/UKI/21/0132013 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:TREMOR | 72 | 72 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210224291 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:PYREXIA | 23 | 23 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210224279 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DECREASED APPETITE:FEELING COLD:PYREXIA | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210224285 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | MALAISE | 74 | 74 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210223718 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:HEADACHE:HYPERHIDROSIS:NAUSEA | 5 | 5 YR | NULL | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210223719 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | INFLUENZA:MYALGIA:PYREXIA | 69 | 69 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210223706 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:MYALGIA:TREMOR:VOMITING | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210223702 | Expedited (15-Day) | |||||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210224905 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | TREMOR | 58 | 58 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GABAPENTIN | GBR | O | GB-JNJFOC-20210224904 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:PYREXIA:TENDERNESS | 69 | 69 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | LINAGLIPTIN | GBR | O | GB-JNJFOC-20210224902 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:MYALGIA:NAUSEA | 31 | 31 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210224901 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:EAR PAIN:NAUSEA:PAIN | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210224894 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PAIN IN EXTREMITY | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | METOPROLOL:RIVAROXABAN | GBR | O | GB-JNJFOC-20210224892 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PYREXIA:TREMOR | 37 | 37 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210224889 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DYSPNOEA:FATIGUE:HEADACHE:HYPERSENSITIVITY:NAUSEA:OROPHARYNGEAL PAIN:PERIORBITAL SWELLING:SNEEZING | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210224888 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FEELING COLD:HEADACHE:OROPHARYNGEAL PAIN:TREMOR | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | AMITRIPTYLINE:AMLODIPINE:ANUSOL:RABEPRAZOLE | GBR | O | GB-JNJFOC-20210224331 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:RASH | 71 | 71 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210224328 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN:CHILLS:FATIGUE:HEADACHE:PARAESTHESIA:RENAL PAIN | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CLENIL MODULITE:INFLUENZA VIRUS:RAMIPRIL:VENTOLIN [SALBUTAMOL] | GBR | O | GB-JNJFOC-20210224310 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA | 76 | 76 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-JNJFOC-20210222358 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:PYREXIA:TENDERNESS | 69 | 69 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Linagliptin | GBR | O | GB-AUROBINDO-AUR-APL-2021-007189 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:HEART RATE INCREASED | 72 | 72 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication | Anastrozole:Atorvastatin:Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006800 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA | 76 | 76 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-007572 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | ARTHRALGIA:HEADACHE | 71 | 71 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-DRREDDYS-GER/UKI/21/0132130 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:LANSOPRAZOLE(PS) | LANSOPRAZOLE | 30 MG QD | OT | CHILLS:GASTRIC HAEMORRHAGE:VOMITING | 72 | 72 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Reflux gastritis | INFLUENZA VIRUS | GBR | O | GB-MYLANLABS-2021M1008979 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:CETIRIZINE(PS):PREDNISOLONE | CETIRIZINE | OT | URTICARIA | 56 | 56 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS | GBR | O | GB-MYLANLABS-2021M1009450 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | MUSCLE FATIGUE | 65 | 65 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-MYLANLABS-2021M1009486 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN:ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | DEAFNESS:DECREASED APPETITE:DIZZINESS POSTURAL:FATIGUE:HEADACHE:MYALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS | GBR | O | GB-MYLANLABS-2021M1009815 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | 2 DF UNK | OT | CHILLS:DIZZINESS:FATIGUE:HEADACHE:MYALGIA:PYREXIA | 65 | 65 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | BENDROFLUMETHIAZIDE:ENALAPRIL MALEATE:SIMVASTATIN | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005064 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS):ICOSAPENT | IBUPROFEN | UNK | OT | FATIGUE:GOUT | 71 | 71 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005149 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/23/2021 | 2/23/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | .5 DF UNK | OT | ABDOMINAL PAIN:ANORECTAL DISCOMFORT:ARTHRALGIA:GENITAL DISCOMFORT:HEAD DISCOMFORT:HEADACHE:PAIN IN EXTREMITY:URINE ODOUR ABNORMAL | 63 | 63 YR | FEMALE | REDACTED | REDACTED | COVID-19 immunisation;Arthritic pains | ASACOL:LEVOTHYROXINE | GBR | O | GB-JNJFOC-20210232827 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DYSPNOEA:FATIGUE:HEADACHE:HYPERSENSITIVITY:NAUSEA:OROPHARYNGEAL PAIN:PERIORBITAL SWELLING:SNEEZING | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-007155 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE | 70 | 70 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-AUROBINDO-AUR-APL-2021-007158 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN:ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | DEAFNESS:DECREASED APPETITE:DIZZINESS POSTURAL:FATIGUE:HEADACHE:MYALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-007168 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | TREMOR | 58 | 58 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Gabapentin | GBR | O | GB-AUROBINDO-AUR-APL-2021-007188 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/23/2021 | 2/23/2021 | ASTRAZENECA COVID-19 VACCINE:EQUINE THYMOCYTE IMMUNE GLOBULIN:IBUPROFEN(PS) | IBUPROFEN | OT | HYPERHIDROSIS:HYPERTENSION:LYMPHADENOPATHY | 57 | 57 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | Amlodipine:CIPRALEX:CODEINE:ETANERCEPT:LANSOPRAZOLE:LOSARTAN | GBR | O | GB-DRREDDYS-GER/UKI/21/0132146 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/23/2021 | 2/23/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS):LAMIVUDINE | IBUPROFEN | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | PROPRANOLOL:Sertraline | GBR | O | GB-DRREDDYS-GER/UKI/21/0132104 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/23/2021 | 2/23/2021 | ASTRAZENECA COVID-19 VACCINE:FLUOROURACIL(PS) | FLUOROURACIL | OT | ARTHRALGIA:DECREASED APPETITE:FATIGUE:HYPERSOMNIA | 75 | 75 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | AMLODIPINE | GBR | O | GB-ACCORD-217693 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/23/2021 | 2/23/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:CODEINE(PS) | CODEINE | UNK | OT | BACK PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS:PYREXIA | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | ROACCUTANE | GBR | O | GB-SUN PHARMACEUTICAL INDUSTRIES LTD-2021RR-282235 | Expedited (15-Day) | A2 | |
| REDACTED | 1 | 2/23/2021 | 2/23/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | CHILLS:HEADACHE:PYREXIA | 24 | 24 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | CALCICHEW D3:LYMECYCLINE:TOLTERODINE | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005152 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/23/2021 | 2/23/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN:CHILLS:FATIGUE:HEADACHE:PARAESTHESIA:RENAL PAIN | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Clenil Modulite:Influenza virus:Ramipril:Ventolin | GBR | O | GB-AUROBINDO-AUR-APL-2021-007213 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/24/2021 | 2/24/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | MUSCLE FATIGUE | 65 | 65 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-DRREDDYS-GER/UKI/21/0132154 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/25/2021 | 2/25/2021 | ASTRAZENECA COVID-19 VACCINE:LANSOPRAZOLE(PS) | LANSOPRAZOLE | UNK | OT | CHILLS:GASTRIC HAEMORRHAGE:VOMITING | 72 | 72 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS | GBR | O | GB-SUN PHARMACEUTICAL INDUSTRIES LTD-2021RR-282595 | Expedited (15-Day) | A2 | |
| REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASTRAZENECA COVID-19 VACCINE(PS):EQUINE THYMOCYTE IMMUNE GLOBULIN | ASTRAZENECA COVID-19 VACCINE | IM | OT | ABDOMINAL PAIN:ABDOMINAL PAIN UPPER:ANXIETY:DIZZINESS:FEELING OF DESPAIR:HEADACHE:NAUSEA:PALPITATIONS:PARAESTHESIA:PARANOIA:SUICIDAL IDEATION:VOMITING | 49 | 49 YR | FEMALE | REDACTED | REDACTED | LAXIDO:NAPROXEN:OMEPRAZOLE:ORAMORPH:RELVAR ELLIPTA:ROPINIROLE:SERTRALINE:VENTOLIN | GBR | O | GB-ASTRAZENECA-2021A038558 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/25/2021 | 2/25/2021 | ASTRAZENECA COVID-19 VACCINE:DIGOXIN(PS):RIVAROXABAN | DIGOXIN | OT | HEART RATE INCREASED | NULL | REDACTED | REDACTED | Atrial fibrillation;Atrial fibrillation | GBR | O | GB-ADVANZ PHARMA-202102001235 | Expedited (15-Day) | ||||||
| REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:ASTHENIA:CLUSTER HEADACHE:DEPRESSED MOOD:FATIGUE:INFLUENZA LIKE ILLNESS:PYREXIA | 74 | 74 YR | FEMALE | REDACTED | REDACTED | COVID-19 vaccination;Product used for unknown indication | RAMIPRIL | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK009036 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | 2 DF UNK | OT | HEADACHE:MALAISE | 80 | 80 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS ANTIGEN | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK008986 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ASTHMA:HEADACHE:PYREXIA | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK008989 | Expedited (15-Day) | |||||
| REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | NECK PAIN | 31 | 31 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK009008 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | CHILLS:HEADACHE:PYREXIA | 69 | 69 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS ANTIGEN:ZOLEDRONATE | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK009023 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/25/2021 | 2/25/2021 | ASTRAZENECA COVID-19 VACCINE:FLUOROURACIL(PS) | FLUOROURACIL | OT | EYE PAIN:EYE SWELLING:HEADACHE:PHOTOPHOBIA:SWELLING FACE | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-ACCORD-217801 | Expedited (15-Day) | ||||
| REDACTED | 1 | 2/25/2021 | 2/25/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PYREXIA:TREMOR | 55 | 55 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-FRESENIUS KABI-FK202101661 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/25/2021 | 2/25/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA | 76 | 76 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GBR | O | GB-FRESENIUS KABI-FK202101761 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/25/2021 | 2/25/2021 | ACYCLOVIR(PS):ASTRAZENECA COVID-19 VACCINE | ACYCLOVIR | UNK | OT | LIP SWELLING:ORAL HERPES:PYREXIA | 80 | 80 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | BISOPROLOL:EDOXABAN | GBR | O | GB-BAUSCH-BL-2021-005538 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/26/2021 | 2/26/2021 | ACETAMINOPHEN:ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | OT | DEAFNESS:DECREASED APPETITE:DIZZINESS POSTURAL:FATIGUE:HEADACHE:MYALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-DRREDDYS-GER/UKI/21/0132163 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/26/2021 | 2/26/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | 200 MG UNK | OT | ARTHRALGIA:HEADACHE | 71 | 71 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK009619 | Expedited (15-Day) | |||
| REDACTED | 1 | 2/26/2021 | 2/26/2021 | ACETAMINOPHEN(PS):ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN | ACETAMINOPHEN | UNK | OT | DEAFNESS:DECREASED APPETITE:DIZZINESS POSTURAL:FATIGUE:HEADACHE:MYALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS ANTIGEN | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK009711 | Expedited (15-Day) | ||
| REDACTED | 1 | 2/26/2021 | 2/26/2021 | ACYCLOVIR(PS):ASTRAZENECA COVID-19 VACCINE | ACYCLOVIR | UNK | OT | LIP SWELLING:ORAL HERPES:PYREXIA | 80 | 80 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | BISOPROLOL:EDOXABAN | GBR | O | GB-GLAXOSMITHKLINE-XI2021039252 | Expedited (15-Day) |
Legend
| Logic | Abbreviations/Definitions | |||
| ALL HLTs ALL HLGTs ALL SOCs | Displays only the HLTs, HLGTs and SOCs for the first 12 PTs in the case. NOTE: If there are more than 12 PTs in the case, the SOCs for PTs which have a display number of more than 12 will NOT be displayed. | All Outcomes | Displays a concatenated list of codes. DE=Death HO=Hospitalization LT=Life Threatening DS=Disability CA=Congenital Anamoly OT=Other Serious Outome RI=Required Intervention | |
| Application # | Populated with Validated Application #; if null, use verbatim application #. | |||
| Attachment | Additional Esub case documents (e.g., Literature reports, Death certificates, Hospital records, etc. | |||
| Medical History/ Medical History Comments | Medical History = Patient=>Med History=>Other Diseases/Diagnosis=> ”Diagnosis” field (Concatenated list of data, if available); Medical History Comments = Patient=>Med History=> ”Medical History Comment” field (Available data is Concatenated together with/after list of Diagnosis, if any) | |||
| Combination product | Y=Combination Suspect Product in Case Null=Suspect product not marked as Combination Product NOTE: The FDA Office of Combination Products (OCP) was established on Dec. 24, 2002, as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The law gives the Office broad responsibilities covering the regulatory life cycle of drug-device, drug-biologic, and device-biologic combination products. | |||
| Medication Errors HLGT (PTs) | Populated with PTs from the Medication Errors HLGT if listed in case Events. | |||
| Compounded Product | Y=Compounded Suspect Product in Case Null=No Suspect product maked as Compounded Product | |||
| Therapy Duration (Days) | Displays whole number value of Therapy End Date minus Therapy Start Date (e.g., 2) | Data Entry Completion Date | Date Case was routed to SE(READY) status | |
| Dechallenge | Y=Positive dechallenge N=Negative dechallenge U=Unknown D=Does not apply | |||
| Therapy Duration (Verbatim) | Displays contents of Duration field and (Duration) Units field (Concatenated) | |||
| Image | Scanned MedWatch Paper Cases (e.g., 3500, 3500A, 3500B, CIOMS, and additional documents submitted with case, etc.) | |||
| Product Role | PS=Primary Suspect SS=Secondary Suspect C=Comcomitant | |||
| Rechallenge | Y=Positive rechallenge N=Negative rechallenge U=Unknown D=Does not apply | |||
| Reporter Information | All Reporter Information comes from the First (Primary) Reporter | |||
| Report Source | Displays a concatenated list of codes. FGN=Foreign SDY=Study LIT=Literature CSM=Consumer HP=Health Professional UF=User Facility CR=Company Representative DT=Distributor OTH=Other | |||
Plain text view
Sheet: Cover Page | | Case Count | 294 | Selection Criteria | | Product - Product Name: | ASTRAZENECA COVID-19 VACCINE | Product - Product Active Ingredient: | | Product - Active Ingredient: | | Product - Active Moiety: | | Product – Product Active Moiety: | | Product - Product Verbatim: | | Product - Product List: | | Product - OTC?: | | Product - NDA #: | | Product - ANDA #: | | Product - User Assignment Product Lists: | | Product - Product Type: | | Product - Marketing Category: | | Event PT: | | Event HLT: | | Event HLGT: | | Event SOC: | | Event SMQ: | | Event SMQ Algorithm: | | Event List: | | Date - Initial FDA Rcvd. Date From: | | Date - Initial FDA Rcvd. Date To: | | Date - Completed Date From: | | Date - Completed Date To: | | Completed Date - Days Before | | Outcome Serious?: | | Outcome Death: | | Outcome Hospitalization | | Outcome Life Threatening: | | Outcome Disability: | | Outcome Congenital: | | Outcome Other Serious: | | Case #: | | MCN: | | CTU #: | | Legacy AERS ISR #: | | Image #: | | Microfilm ID #: | | Country (Derived): | | Case Type: | | Suspect/Concomitant: | Suspect | BLA #: | | Lot #: | | Sender Mfr Organization: | | Compounding Outsourcing Facility 503B?: | | Sender Mfr Org List: | | Indication: | | Administration route: | | Date - Date Of Event From: | | Date - Date Of Event To: | | Age in Years From: | | Age in Years To: | | Patient Sex: | | Patient - Race: | All | Reporter Narrative: | | | | Event List | Event List Details | Event Type | | | | Product List | Product List Details | Product Type | | | | Sender Mfr Org List | Sender Mfr Org List Details | Sender Manufacturer Type | | | | Sheet: Line Listing of Cases | | | | | | | | | | | | | | | | | | | | | Total Number of Cases: 294 | | | | | | | | | | | | | | | | | | | | | FAERS Case # | Version Number | Initial FDA Received Date | Latest FDA Received date | ALL Suspect Product Names | Primary Suspect (PS) | PS Dose-Route-Frequency | All Outcomes | PTs | Age in Years | Age/Unit | Sex | Narrative | | Indication | Concomitant(s) | Country | Report Source | MFR Ctrl # | Case Type | Image | Attach REDACTED | 1 | 2/3/2021 | 2/3/2021 | ASTRAZENECA COVID-19 VACCINE:METHOTREXATE SODIUM(PS) | METHOTREXATE SODIUM | | OT | DRUG INTERACTION:PYREXIA | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Rheumatoid arthritis | | GBR | O | GB-PFIZER INC-2021068022 | Expedited (15-Day) | | REDACTED | 1 | 2/6/2021 | 2/6/2021 | ASTRAZENECA COVID-19 VACCINE:GLIMEPIRIDE(PS) | GLIMEPIRIDE | 1 MG PO | LT,OT | BLOOD GLUCOSE DECREASED:COUGH:DISCOMFORT:DIZZINESS:FATIGUE:FEELING COLD:HYPOGLYCAEMIA:NAUSEA:PALPITATIONS:RESTLESSNESS:SKIN DISCOLOURATION:VOMITING | 64 | 64 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Type 2 diabetes mellitus | | GBR | O | GB-ACCORD-216481 | Expedited (15-Day) | | REDACTED | 1 | 2/8/2021 | 2/8/2021 | ASTRAZENECA COVID-19 VACCINE:OMEPRAZOLE(PS) | OMEPRAZOLE | PO | | ARTHRALGIA:CHILLS:FATIGUE:FEELING COLD:HYPERHIDROSIS:PAIN IN EXTREMITY:PYREXIA | | | MALE | REDACTED | REDACTED | | ASPIRIN:INSULIN:VITAMIN D | USA | O | US-ASTRAZENECA-2021A023068 | Non- Expedited | | REDACTED | 1 | 2/9/2021 | 2/9/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE:COCODAMOL:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:CHILLS:NUCHAL RIGIDITY | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005098 | Expedited (15-Day) | | REDACTED | 1 | 2/12/2021 | 2/12/2021 | ASTRAZENECA COVID-19 VACCINE:PREDNISOLONE(PS) | PREDNISOLONE | PO | OT | ARTHRALGIA | | | NULL | REDACTED | REDACTED | | | GBR | O | GB-ADVANZ PHARMA-202102000967 | Expedited (15-Day) | | REDACTED | 1 | 2/12/2021 | 2/12/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE:COCODAMOL:IBUPROFEN(PS) | IBUPROFEN | | OT | ARTHRALGIA:CHILLS:NUCHAL RIGIDITY | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1008755 | Expedited (15-Day) | | REDACTED | 1 | 2/12/2021 | 2/12/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | ABDOMINAL PAIN:CHEST DISCOMFORT:CHILLS:CONSTIPATION:DIARRHOEA:DIZZINESS POSTURAL:DYSPNOEA:FATIGUE:HEADACHE:MYALGIA:NAUSEA:PARAESTHESIA:PAROSMIA:PERIPHERAL COLDNESS:TREMOR:VOMITING:WHEEZING | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS:INVITA D3 | GBR | O | GB-MYLANLABS-2021M1008833 | Expedited (15-Day) | | REDACTED | 1 | 2/12/2021 | 2/12/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | 400 MG | OT | CHILLS:DIZZINESS:FATIGUE:HEADACHE:MYALGIA:PYREXIA | 65 | 65 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | BENDROFLUMETHIAZIDE:ENALAPRIL MALEATE:SIMVASTATIN | GBR | O | GB-MYLANLABS-2021M1008769 | Expedited (15-Day) | | REDACTED | 1 | 2/12/2021 | 2/12/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | DS,OT | SEIZURE:TREMOR | 28 | 28 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-VIIV HEALTHCARE LIMITED-GB2021030308 | Expedited (15-Day) | | REDACTED | 1 | 2/12/2021 | 2/12/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | DS,OT | SEIZURE:TREMOR | 28 | 28 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-GLAXOSMITHKLINE-GB2021030308 | Expedited (15-Day) | | REDACTED | 1 | 2/12/2021 | 2/12/2021 | ASTRAZENECA COVID-19 VACCINE:LAMOTRIGINE(PS) | LAMOTRIGINE | 400 MG PO | OT | MEDICATION ERROR:PYREXIA | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Epilepsy | LAMOTRIGIN | GBR | O | GB-MYLANLABS-2021M1008463 | Expedited (15-Day) | | REDACTED | 1 | 2/12/2021 | 2/12/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | PYREXIA | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | PENICILLIN | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005856 | Expedited (15-Day) | | REDACTED | 1 | 2/13/2021 | 2/13/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | | OT | BLOOD PRESSURE DECREASED:CHEST PAIN:DIZZINESS:MYALGIA:NAUSEA:PYREXIA | 41 | 41 YR | FEMALE | REDACTED | REDACTED | Bladder cancer | | GBR | O | GB-009507513-2102GBR004099 | Expedited (15-Day) | | REDACTED | 1 | 2/13/2021 | 2/13/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | | OT | HYPERHIDROSIS:HYPOGLYCAEMIA | 49 | 49 YR | MALE | REDACTED | REDACTED | Bladder cancer;Prophylaxis | | GBR | O | GB-009507513-2102GBR004203 | Expedited (15-Day) | | REDACTED | 1 | 2/13/2021 | 2/13/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | | OT | CHILLS:FATIGUE:HYPOAESTHESIA | 49 | 49 YR | FEMALE | REDACTED | REDACTED | Bladder cancer;Prophylaxis | LEVOTHYROXINE SODIUM | GBR | O | GB-009507513-2102GBR004209 | Expedited (15-Day) | | REDACTED | 1 | 2/13/2021 | 2/13/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | | HO | TRANSIENT ISCHAEMIC ATTACK | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Bladder cancer;Prophylaxis | INFLUENZA VIRUS | GBR | O | GB-009507513-2102GBR004217 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | CHILLS:DIZZINESS:FATIGUE:HEADACHE:MYALGIA:PYREXIA | 65 | 65 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | BENDROFLUMETHIAZIDE:ENALAPRIL MALEATE:SIMVASTATIN | GBR | O | GB-JNJFOC-20210216553 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | DYSPNOEA:PYREXIA | 20 | 20 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216595 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | PYREXIA | 30 | 30 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216596 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | | DS | DIZZINESS:DIZZINESS POSTURAL:HYPERTENSION | 79 | 79 YR | FEMALE | REDACTED | REDACTED | Bladder cancer | FELODIPINE:MIRTAZAPINE:WARFARIN | GBR | O | GB-009507513-2102GBR004963 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | HEADACHE:MALAISE | 80 | 80 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210217482 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:TRAMADOL(PS) | TRAMADOL | | DS | ABDOMINAL PAIN UPPER:ARTHRALGIA:CHEST DISCOMFORT:CHILLS:CRYING:DEPRESSED LEVEL OF CONSCIOUSNESS:DIARRHOEA:DIZZINESS:DYSPHONIA:EAR PAIN:FATIGUE:FEELING ABNORMAL:HEADACHE:HYPERHIDROSIS:MYALGIA:NAUSEA:OROPHARYNGEAL PAIN:PAIN:PHOTOPHOBIA:PYREXIA:SOMNOLENCE:TINNITUS:VOMITING | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | ATORVASTATIN:BUTEC:DULOXETINE | GBR | O | GB-MYLANLABS-2021M1008738 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:EQUINE THYMOCYTE IMMUNE GLOBULIN:IBUPROFEN(PS):OMEGA-3-ACID ETHYL ESTERS | IBUPROFEN | | OT | FATIGUE:GOUT | 71 | 71 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1008790 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:NAPROXEN(PS) | NAPROXEN | | OT | ARTHRALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1008799 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ASTRAZENECA COVID-19 VACCINE:NAPROXEN(PS) | NAPROXEN | UNK | OT | ABDOMINAL DISCOMFORT:FATIGUE:INFLUENZA LIKE ILLNESS:NAUSEA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Atenolol:Bendrofluazide:Doxazosin teva:Folic acid:Methotrexate:Ramipril:Vitamin d3 | GBR | O | GB-AUROBINDO-AUR-APL-2021-005626 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:HEADACHE:HOT FLUSH:MIGRAINE:NECK PAIN:OROPHARYNGEAL PAIN | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Mercaptopurine | GBR | O | GB-AUROBINDO-AUR-APL-2021-005624 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:INFLUENZA LIKE ILLNESS:PYREXIA:RENAL PAIN:RHINORRHOEA | 53 | 53 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-005621 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | HEADACHE:MALAISE | | | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS | GBR | O | GB-MYLANLABS-2021M1008891 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | CHILLS:HEADACHE:PYREXIA | 69 | 69 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS:ZOLEDRONATE | GBR | O | GB-MYLANLABS-2021M1008892 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | FEELING COLD:HEADACHE:INSOMNIA:MYALGIA:NERVOUSNESS:THIRST | | | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1008893 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | NECK PAIN | 31 | 31 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1008906 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:DECREASED APPETITE:DIZZINESS:FATIGUE:HEADACHE:MALAISE:MYALGIA:TENDERNESS | 52 | 52 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS:OESTROGEL | GBR | O | GB-JNJFOC-20210216618 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ANXIETY:CHILLS:EYE PAIN:HEADACHE:PYREXIA:STRESS | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CORTISOL [CORTISONE ACETATE] | GBR | O | GB-JNJFOC-20210216617 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FEELING COLD:TREMOR | 74 | 74 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CANDESARTAN:SINVASTATIN | GBR | O | GB-JNJFOC-20210216610 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | 1 G PO | OT | ABDOMINAL PAIN:NAUSEA:PYREXIA:SYNCOPE:VOMITING | 28 | 28 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | ESCITALOPRAM:PROPRANOLOL | GBR | O | GB-JNJFOC-20210216609 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:COCODAMOL:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:CHILLS:NUCHAL RIGIDITY | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006445 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:HEADACHE:PYREXIA | 61 | 61 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006299 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DIZZINESS:DIZZINESS POSTURAL:PAIN IN EXTREMITY:PYREXIA | 37 | 37 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Sertraline | GBR | O | GB-AUROBINDO-AUR-APL-2021-006275 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BACK PAIN:FATIGUE:HEADACHE:PYREXIA | 21 | 21 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Amoxicillin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006227 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:ILLNESS | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006196 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:CODEINE PHOSPHATE | ACETAMINOPHEN | UNK | OT | BACK PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS:PYREXIA | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Roaccutane | GBR | O | GB-AUROBINDO-AUR-APL-2021-006169 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:NAPROXEN(PS) | NAPROXEN | UNK | OT | ARTHRALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006166 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHEST PAIN:CHILLS:HEADACHE:MUSCLE FATIGUE | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006098 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FEELING COLD:TREMOR | 74 | 74 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006095 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:INJECTION RELATED REACTION:MALAISE | 66 | 66 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006280 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:NAUSEA:NIGHTMARE:PYREXIA:TINNITUS | 62 | 62 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006293 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:INFLUENZA LIKE ILLNESS:PYREXIA:RENAL PAIN:RHINORRHOEA | 53 | 53 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210211744 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/15/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE | ACETAMINOPHEN | UNK | DS | SEIZURE:TREMOR | 28 | 28 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210211743 | Expedited (15-Day) | | REDACTED | 1 | 2/15/2021 | 2/16/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PAIN IN EXTREMITY:PYREXIA | 36 | 36 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CYANOCOBALAMIN:FERROUS FUMARATE:LEVOTHYROXINE:SERTRALINE | GBR | O | GB-JNJFOC-20210217469 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | | OT | DYSPNOEA:FATIGUE:HYPOPNOEA:INFLUENZA LIKE ILLNESS:PAIN IN EXTREMITY:PULMONARY PAIN:PYREXIA | 26 | 26 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | PARACETAMOL | GBR | O | GB-MYLANLABS-2021M1008932 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ASTRAZENECA COVID-19 VACCINE:COCODAMOL:TRAMADOL(PS) | TRAMADOL | 100 MG | OT | BACK PAIN:CHILLS:FEELING ABNORMAL | 31 | 31 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1008971 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ASTRAZENECA COVID-19 VACCINE:NAPROSYN(PS) | NAPROSYN | UNK | OT | ARTHRALGIA:INFLUENZA LIKE ILLNESS | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication | PARACETAMOL | GBR | O | GB-CANTON LABORATORIES, LLC-2106827 | Expedited (15-Day) | | A2 REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHEST PAIN:CHILLS:HEADACHE:MUSCLE FATIGUE | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210217500 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:MIGRAINE:NAUSEA:PAIN:PAIN IN EXTREMITY:PYREXIA:SWEATING FEVER | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Generalised aching | CLARITHROMYCIN:CLENIL MODULITE:SALBUTAMOL | GBR | O | GB-JNJFOC-20210217480 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS | ABDOMINAL PAIN UPPER:BACK PAIN:CHEST PAIN:INSOMNIA:LYMPHADENOPATHY:NAUSEA:PAIN:PYREXIA | 27 | 27 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | PROPRANOLOL | GBR | O | GB-JNJFOC-20210217476 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | INFLUENZA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210217342 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA:TREMOR | 19 | 19 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CETIRIZINE:VENTOLIN [SALBUTAMOL] | GBR | O | GB-JNJFOC-20210217319 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:FREQUENT BOWEL MOVEMENTS:INFLUENZA:NIGHT SWEATS:PAIN IN EXTREMITY:TREMOR | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210217316 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DECREASED APPETITE:DIZZINESS:HEADACHE:INFLUENZA LIKE ILLNESS:LETHARGY:VISION BLURRED | 74 | 74 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210217312 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:COCODAMOL | ACETAMINOPHEN | UNK | DS | ANXIETY:ARTHRALGIA:BACK PAIN:CHILLS:DIZZINESS:MYALGIA:PYREXIA | 30 | 30 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210216672 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BACK PAIN:CHILLS:HEADACHE:PYREXIA | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | ATORVASTATIN | GBR | O | GB-JNJFOC-20210216665 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHEST PAIN:HEADACHE | 58 | 58 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216662 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN:ABDOMINAL PAIN UPPER:DIZZINESS:NAUSEA:PYREXIA:TACHYCARDIA | 70 | 70 YR | NULL | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216658 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DRY MOUTH:HEADACHE:INFLUENZA:NAUSEA:PAIN | 35 | 35 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216641 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:HEADACHE:NAUSEA:PYREXIA:SINUS HEADACHE:TREMOR | 60 | 60 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216626 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:NAUSEA:SWEATING FEVER | 62 | 62 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216613 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:HEADACHE:PYREXIA | 61 | 61 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216605 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:ILLNESS | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216592 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | INFLUENZA | .16667 | 2 MTH | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | OMEPRAZOLE | GBR | O | GB-JNJFOC-20210216590 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ASTHENIA:COUGH:FOOD AVERSION:INFLUENZA | 90 | 90 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | ADCAL [CALCIUM CARBONATE]:BISODOL:ISOSORBIDE:LEVOTHYROXINE | GBR | O | GB-JNJFOC-20210216586 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:CODEINE | ACETAMINOPHEN | UNK | OT | BACK PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS:PYREXIA | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | ROACCUTANE | GBR | O | GB-JNJFOC-20210216576 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ASTHENIA:BODY TEMPERATURE:DIZZINESS:FATIGUE:MIGRAINE:MYALGIA | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | FLUOXETINE:MONTELUKAST | GBR | O | GB-JNJFOC-20210216575 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA:TREMOR | 73 | 73 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216565 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ASTHENIA:CHILLS:DIZZINESS POSTURAL:MAGNETIC RESONANCE IMAGING BRAIN:MALAISE:MUSCLE SPASMS:PARAESTHESIA:PYREXIA | 41 | 41 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | FOSTAIR:MONTELUKAST | GBR | O | GB-JNJFOC-20210216554 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:ASTHENIA:CLUSTER HEADACHE:DEPRESSED MOOD:FATIGUE:INFLUENZA LIKE ILLNESS:PYREXIA | 74 | 74 YR | FEMALE | REDACTED | REDACTED | COVID-19 vaccination;Drug use for unknown indication | RAMIPRIL | GBR | O | GB-JNJFOC-20210219554 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:FEELING COLD:HEADACHE:MYALGIA | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216551 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BODY TEMPERATURE FLUCTUATION:FATIGUE:MALAISE | 70 | 70 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | ATORVASTATIN | GBR | O | GB-JNJFOC-20210216545 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ASTHENIA:CHILLS:DIZZINESS POSTURAL:MAGNETIC RESONANCE IMAGING BRAIN:MALAISE:MUSCLE SPASMS:PARAESTHESIA:PYREXIA | 41 | 41 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Fostair:Montelukast | GBR | O | GB-AUROBINDO-AUR-APL-2021-006099 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DIZZINESS:DIZZINESS POSTURAL:PAIN IN EXTREMITY:PYREXIA | 37 | 37 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | SERTRALINE | GBR | O | GB-JNJFOC-20210216539 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:HEADACHE:MALAISE:MYALGIA:NAUSEA | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210215534 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:EQUINE THYMOCYTE IMMUNE GLOBULIN | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA:TREMOR | 50 | 50 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210215531 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | INFLUENZA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006261 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS VACCINE ADSORBED NOS | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:HEADACHE:NAUSEA:PYREXIA:SINUS HEADACHE:TREMOR | 60 | 60 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006289 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:MALAISE | 66 | 66 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210215498 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:TETANUS AND DIPHTHERIA TOXOIDS ADSORBED (VACCINE) | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:MYALGIA:PYREXIA | 25 | 25 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | OMEPRAZOLE:OMEPRAZOLE:SERTRALINE | GBR | O | GB-JNJFOC-20210215520 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:DECREASED APPETITE:DIZZINESS:FATIGUE:HEADACHE:MALAISE:MYALGIA:TENDERNESS | 52 | 52 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus:Oestrogel | GBR | O | GB-AUROBINDO-AUR-APL-2021-006294 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:HEADACHE:PAIN IN EXTREMITY:PYREXIA | 52 | 52 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Leflunomide:Methotrexate | GBR | O | GB-AUROBINDO-AUR-APL-2021-006297 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:NAUSEA:NIGHTMARE:PYREXIA:TINNITUS | 62 | 62 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210215493 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN:ABDOMINAL PAIN UPPER:DIZZINESS:NAUSEA:PYREXIA:TACHYCARDIA | 70 | 70 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006314 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ASTHMA:HEADACHE:PYREXIA | .16667 | 2 MTH | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210218955 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS | ABDOMINAL PAIN UPPER:BACK PAIN:CHEST PAIN:DECREASED APPETITE:ILLNESS:INSOMNIA:LYMPHADENOPATHY:NAUSEA:PAIN:PYREXIA:SINUSITIS:THIRST | 27 | 27 YR | FEMALE | REDACTED | REDACTED | COVID-19 immunisation;Product used for unknown indication | Propranolol | GBR | O | GB-AUROBINDO-AUR-APL-2021-006317 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | LYMPHADENOPATHY | 50 | 50 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210215471 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:MYALGIA:VOMITING | 57 | 57 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | THYROXINE | GBR | O | GB-JNJFOC-20210218969 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:FEELING ABNORMAL:HEADACHE:HYPERHIDROSIS:ILLNESS:SOMNOLENCE | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | BENDROFLUMETHIAZIDE:BETAHISTINE:CANDESARTAN:DULOXETINE:OXYCODONE:ROPINIROLE HYDROCHLORIDE | GBR | O | GB-JNJFOC-20210218958 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | INSOMNIA:MIGRAINE:PYREXIA:VOMITING | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210217467 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ADMINISTRATION SITE PAIN:CHILLS:DRY MOUTH:HEADACHE:INFLUENZA:NAUSEA:PAIN | 35 | 35 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006447 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PAIN IN EXTREMITY:PYREXIA | 36 | 36 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Cyanocobalamin:Ferrous fumarate:Levothyroxine:Sertraline | GBR | O | GB-AUROBINDO-AUR-APL-2021-006475 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | MYALGIA | 72 | 72 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006472 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACYCLOVIR(PS):ASTRAZENECA COVID-19 VACCINE | ACYCLOVIR | UNK | OT | HERPES ZOSTER:NIGHT SWEATS | 54 | 54 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006361 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:MYALGIA:VOMITING | 57 | 57 YR | FEMALE | REDACTED | REDACTED | COVID-19 immunisation;Product used for unknown indication | Thyroxine | GBR | O | GB-AUROBINDO-AUR-APL-2021-006358 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | CHILLS:HEADACHE:PYREXIA | 69 | 69 YR | NULL | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS:ZOLEDRONATE | GBR | O | GB-JNJFOC-20210217456 | Expedited (15-Day) | | REDACTED | 1 | 2/16/2021 | 2/16/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | ABDOMINAL PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1008986 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE:COCODAMOL:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:CHILLS:NUCHAL RIGIDITY | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216663 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:VENTOLIN(PS):VITAMIN D3 | VENTOLIN | UNK | OT | BURNING SENSATION:ERYTHEMA:LOSS OF CONSCIOUSNESS:MALAISE | 76 | 76 YR | FEMALE | REDACTED | REDACTED | Vaccination;Product used for unknown indication;Product used for unknown indication | DAPAGLIFLOZIN:INSUMAN RAPID:LANTUS:Levothyroxine sodium:PARACETAMOL:Seretide | GBR | O | GB-GLAXOSMITHKLINE-GB2021035940 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:CIPROFLOXACIN(PS):ENOXAPARIN SODIUM | CIPROFLOXACIN | | OT | ABDOMINAL PAIN:INFECTION | 84 | 84 YR | MALE | REDACTED | REDACTED | | AMOXICILLIN:CLAVULANIC ACID:CO-CODAMOL | GBR | O | GB-BAYER-2021-059176 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:BCG LIVE(PS) | BCG LIVE | | DS | HYPERTENSION:PYREXIA | 81 | 81 YR | FEMALE | REDACTED | REDACTED | | AMLODIPINE:ATENOLOL:OMEPRAZOLE:RAMIPRIL:REPAGLINIDE:ZOLPIDEM | GBR | O | GB-009507513-2102GBR005847 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:NAPROXEN(PS) | NAPROXEN | | OT | ARTHRALGIA:CLUSTER HEADACHE:MALAISE:OSTEOARTHRITIS | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1009467 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:ONCOTICE(PS) | ONCOTICE | | OT | FLUSHING:RASH | 53 | 53 YR | FEMALE | REDACTED | REDACTED | | | GBR | O | GB-009507513-2102GBR004757 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:IBUPROFEN | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:PYREXIA | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | CALCICHEW D3:LYMECYCLINE:TOLTERODINE | GBR | O | GB-JNJFOC-20210217334 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | NECK PAIN | 31 | 31 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210218971 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS):LAMIVUDINE | IBUPROFEN | UNK | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | PROPRANOLOL:SERTRALINE | GBR | O | GB-JNJFOC-20210219611 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ABDOMINAL PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK007386 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS):LAMIVUDINE | IBUPROFEN | UNK | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | PROPRANOLOL:SERTRALINE | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK007441 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | CHILLS:HEADACHE:PALLOR:PYREXIA:Q FEVER:TREMOR | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Vaccination | AMITRIPTYLINE | GBR | O | GB-VIIV HEALTHCARE LIMITED-GB2021035956 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | PROPRANOLOL:SERTRALINE | GBR | O | GB-VIIV HEALTHCARE LIMITED-GB2021035912 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | PROPRANOLOL:SERTRALINE | GBR | O | GB-GLAXOSMITHKLINE-GB2021035912 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | CHILLS:HEADACHE:PALLOR:PYREXIA:Q FEVER:TREMOR | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Vaccination | AMITRIPTYLINE | GBR | O | GB-GLAXOSMITHKLINE-GB2021035956 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:COCODAMOL:METHOTREXATE SODIUM(PS) | METHOTREXATE SODIUM | | OT | ARTHRITIS:CHROMATURIA:HEADACHE:LIMB DISCOMFORT:PYREXIA | 30 | 30 YR | FEMALE | REDACTED | REDACTED | | CETIRIZINE:CODEINE:COSENTYX:DICLOFENAC:FOLIC ACID:LANSOPRAZOLE:METHOTREXATE:PARACETAMOL:RAMIPRIL:SERTRALINE | GBR | O | GB-PFIZER INC-2021131170 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210217445 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABNORMAL DREAMS:CHILLS:HEADACHE:HYPERHIDROSIS:MYALGIA:PYREXIA:SWEATING FEVER | 23 | 23 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210217434 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | AGEUSIA:ANOSMIA:ARTHRALGIA:ASTHENIA:BONE PAIN:DEHYDRATION:HEADACHE:PYREXIA:TREMOR | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210221039 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | COLD SWEAT:MUSCULOSKELETAL STIFFNESS:PYREXIA | | | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210217426 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DRY SKIN:EAR PAIN:HEADACHE:NAUSEA:NEURALGIA:PYREXIA | 56 | 56 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | BETAHISTINE DIHYDROCHLORIDE:OMEPRAZOLE | GBR | O | GB-JNJFOC-20210221037 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DIZZINESS:HEADACHE:INFLUENZA | 29 | 29 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210219612 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIARRHOEA:ILLNESS:PYREXIA:SYNCOPE:TREMOR | 63 | 63 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210219602 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN UPPER:CHILLS:COUGH:HEADACHE:HOT FLUSH | | | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210219590 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ADVERSE DRUG REACTION:HEADACHE | .16667 | 2 MTH | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006220 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHEST PAIN:HEADACHE | 58 | 58 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006584 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BACK PAIN:CHILLS:HEADACHE:PYREXIA | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Atorvastatin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006605 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:FEELING COLD:HEADACHE:MYALGIA | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006610 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA | 20 | 20 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006676 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN:NAUSEA:PYREXIA:SYNCOPE:VOMITING | 28 | 28 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Escitalopram:Propranolol | GBR | O | GB-AUROBINDO-AUR-APL-2021-006686 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:FEELING ABNORMAL:HEADACHE:HYPERHIDROSIS:ILLNESS:SOMNOLENCE | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Bendroflumethiazide:Betahistine:Candesartan:Duloxetine:Oxycodone:Spiroco | GBR | O | GB-AUROBINDO-AUR-APL-2021-006334 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006335 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:HYPERPYREXIA:TREMOR | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006716 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:MYALGIA:NAUSEA:VOMITING | 29 | 29 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210219597 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:TRAMADOL(PS) | TRAMADOL | UNK | DS,OT | ABDOMINAL PAIN UPPER:ARTHRALGIA:CHEST DISCOMFORT:CHILLS:CRYING:DEPRESSED LEVEL OF CONSCIOUSNESS:DIARRHOEA:DIZZINESS:DYSPHONIA:EAR PAIN:FATIGUE:FEELING ABNORMAL:HEADACHE:HYPERHIDROSIS:MYALGIA:NAUSEA:OROPHARYNGEAL PAIN:PAIN:PHOTOPHOBIA:PYREXIA:SOMNOLENCE:TINNITUS:VOMITING | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Atorvastatin:Butec:Duloxetine | GBR | O | GB-AUROBINDO-AUR-APL-2021-006443 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:INJECTION RELATED REACTION:NAUSEA:SWEATING FEVER | 62 | 62 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006585 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:HYPERPYREXIA:TREMOR | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210217436 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:FREQUENT BOWEL MOVEMENTS:INFLUENZA:INJECTION RELATED REACTION:NIGHT SWEATS:PAIN IN EXTREMITY:TREMOR | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006589 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN UPPER:ADVERSE DRUG REACTION:DIZZINESS:NAUSEA | 6 | 6 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006612 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ASTHENIA:BODY TEMPERATURE:DIZZINESS:FATIGUE:MIGRAINE:MYALGIA | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Fluoxetine:Montelukast | GBR | O | GB-AUROBINDO-AUR-APL-2021-006704 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | PYREXIA | 30 | 30 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006714 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE:COCODAMOL | ACETAMINOPHEN | UNK | DS | ANXIETY:ARTHRALGIA:BACK PAIN:CHILLS:DIZZINESS:MYALGIA:PYREXIA:VACCINATION SITE JOINT PAIN | 30 | 30 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006645 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN UPPER:FATIGUE:HEADACHE:PYREXIA | 42 | 42 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006579 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ANXIETY:CHILLS:EYE PAIN:HEADACHE:PYREXIA:STRESS | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Cortisol | GBR | O | GB-AUROBINDO-AUR-APL-2021-006675 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:NAUSEA | 69 | 69 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210216653 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA:TREMOR | 73 | 73 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006719 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA:TREMOR | 19 | 19 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Cetirizine:Ventolin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006708 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:CONFUSIONAL STATE:DIZZINESS:FREEZING PHENOMENON:HEADACHE:HYPOAESTHESIA:MUSCULAR WEAKNESS:MYALGIA:PAIN IN EXTREMITY:PYREXIA:SLOW SPEECH:TREMOR | 29 | 29 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CO-CODAMOL | GBR | O | GB-JNJFOC-20210219574 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:HYPERHIDROSIS:LIP SWELLING:PYREXIA | 29 | 29 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210219563 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS,OT | ARTHRALGIA:BACK PAIN:CHILLS:COLD SWEAT:DECREASED APPETITE:DIZZINESS:FATIGUE:HAEMATOCRIT:HEADACHE:HYPERHIDROSIS:MYALGIA:NAUSEA:PAIN:PYREXIA:THIRST | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | HYDROXYCHLOROQUINE SULFATE | GBR | O | GB-JNJFOC-20210218961 | Expedited (15-Day) | | REDACTED | 1 | 2/17/2021 | 2/17/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:MALAISE:RASH ERYTHEMATOUS | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210217461 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:HYPERHIDROSIS:LIP SWELLING:PYREXIA | 29 | 29 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006330 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABNORMAL DREAMS:CHILLS:HEADACHE:HYPERHIDROSIS:MYALGIA:PYREXIA:SWEATING FEVER | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006566 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | PYREXIA | 30 | 30 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1008828 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | ARTHRALGIA:HEADACHE | 71 | 71 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1009477 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | DYSPNOEA:PYREXIA | 20 | 20 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005021 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | HYPERHIDROSIS:HYPERTENSION:LYMPHADENOPATHY | 57 | 57 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | AMLODIPIN:CIPRALEX:CODEINE:ETANERCEPT:LANSOPRAZOLE:LOSARTAN | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK007623 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:HEADACHE | 71 | 71 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210223705 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | DYSPNOEA:FATIGUE:HYPOPNOEA:INFLUENZA LIKE ILLNESS:PAIN IN EXTREMITY:PULMONARY PAIN:PYREXIA | 26 | 26 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | PARACETAMOL | GBR | O | GB-VIIV HEALTHCARE LIMITED-GB2021GSK046855 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | ASTHMA:CHILLS:CONFUSIONAL STATE:COUGH:DECREASED APPETITE:DIZZINESS:EXPOSURE DURING PREGNANCY:HEADACHE:INSOMNIA:MUSCLE SPASMS:MYALGIA:NAUSEA:PYREXIA | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | AMLODIPIN:Beclometasone Dipropionate:DECAPEPTYL SR:Levothyroxine:Ramipril:SERTRALINE:Ventolin | GBR | O | GB-VIIV HEALTHCARE LIMITED-GB2021037395 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ABDOMINAL PAIN:CHEST DISCOMFORT:CHILLS:CONSTIPATION:DIARRHOEA:DIZZINESS POSTURAL:DYSPNOEA:FATIGUE:HEADACHE:MYALGIA:NAUSEA:PARAESTHESIA:PAROSMIA:PERIPHERAL COLDNESS:TREMOR:VOMITING:WHEEZING | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | InVita D3:Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006591 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BODY TEMPERATURE FLUCTUATION:FATIGUE:MALAISE | 70 | 70 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Atorvastatin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006602 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FATIGUE:HEADACHE:MALAISE:MYALGIA:NAUSEA | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006606 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:MIGRAINE | 33 | 33 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus:Omeprazole:Pregabalin:Teva quetiapine:Vensir | GBR | O | GB-AUROBINDO-AUR-APL-2021-006613 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | ASTHMA:CHILLS:CONFUSIONAL STATE:COUGH:DECREASED APPETITE:DIZZINESS:EXPOSURE DURING PREGNANCY:HEADACHE:INSOMNIA:MUSCLE SPASMS:MYALGIA:NAUSEA:PYREXIA | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | AMLODIPIN:Beclometasone Dipropionate:DECAPEPTYL SR:Levothyroxine:Ramipril:SERTRALINE:Ventolin | GBR | O | GB-GLAXOSMITHKLINE-GB2021037395 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | DYSPNOEA:FATIGUE:HYPOPNOEA:INFLUENZA LIKE ILLNESS:PAIN IN EXTREMITY:PULMONARY PAIN:PYREXIA | 26 | 26 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | PARACETAMOL | GBR | O | GB-GLAXOSMITHKLINE-GB2021GSK046855 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:NAUSEA:PAIN IN EXTREMITY:PYREXIA | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006333 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | HEADACHE:MALAISE | 80 | 80 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006336 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ASTHMA:HEADACHE:PYREXIA | .16667 | 2 MTH | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006349 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:ASTHENIA:CLUSTER HEADACHE:DEPRESSED MOOD:FATIGUE:INFLUENZA LIKE ILLNESS:PYREXIA | 74 | 74 YR | FEMALE | REDACTED | REDACTED | COVID-19 immunisation;Product used for unknown indication | Ramipril | GBR | O | GB-AUROBINDO-AUR-APL-2021-006444 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS,OT | ARTHRALGIA:BACK PAIN:CHILLS:COLD SWEAT:DECREASED APPETITE:DIZZINESS:FATIGUE:HAEMATOCRIT:HEADACHE:HYPERHIDROSIS:MYALGIA:NAUSEA:PAIN:PYREXIA:THIRST | 32 | 32 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Hydroxychloroquine sulfate | GBR | O | GB-AUROBINDO-AUR-APL-2021-006386 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:CONFUSIONAL STATE:DIZZINESS:FREEZING PHENOMENON:HEADACHE:HYPOAESTHESIA:MUSCULAR WEAKNESS:MYALGIA:PAIN IN EXTREMITY:PYREXIA:SLOW SPEECH:TREMOR | 29 | 29 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Co-codamol | GBR | O | GB-AUROBINDO-AUR-APL-2021-006563 | Expedited (15-Day) | | REDACTED | 1 | 2/18/2021 | 2/18/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | ARTHRALGIA:ASTHENIA:CLUSTER HEADACHE:DEPRESSED MOOD:FATIGUE:INFLUENZA LIKE ILLNESS:PYREXIA | 74 | 74 YR | FEMALE | REDACTED | REDACTED | COVID-19 immunisation;Abdominal discomfort | RAMIPRIL | GBR | O | GB-MYLANLABS-2021M1008826 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | MUSCLE FATIGUE | 65 | 65 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210224325 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:FLUOROURACIL(PS) | FLUOROURACIL | | OT | CHILLS:PALPITATIONS | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-ACCORD-217430 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | | OT | CHILLS:HEADACHE:PALLOR:PYREXIA:Q FEVER:TREMOR | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | AMITRIPTYLINE | GBR | O | GB-MYLANLABS-2021M1008967 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN:LAMIVUDINE(PS) | LAMIVUDINE | | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | PROPRANOLOL:SERTRALINE | GBR | O | GB-MYLANLABS-2021M1008972 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ACETAMINOPHEN:ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | DEAFNESS:DECREASED APPETITE:DIZZINESS POSTURAL:FATIGUE:HEADACHE:MYALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210224895 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ABDOMINAL PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210221042 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | | OT | ASTHMA:CHILLS:CONFUSIONAL STATE:COUGH:DECREASED APPETITE:DIZZINESS:HEADACHE:INSOMNIA:MUSCLE SPASMS:MYALGIA:NAUSEA:PYREXIA | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | AMLODIPIN /00972401/:BECLOMETASONE DIPROPIONATE:LEVOTHYROXINE:RAMIPRIL:SERTRALINE:VENTOLIN /00139502/ | GBR | O | GB-MYLANLABS-2021M1009498 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | BACK PAIN:HYPERHIDROSIS | 67 | 67 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006322 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:NAUSEA | 69 | 69 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006647 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIARRHOEA:ILLNESS:PYREXIA:SYNCOPE:TREMOR | 63 | 63 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006868 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:MYALGIA:NAUSEA:VOMITING | 29 | 29 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006865 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN UPPER:CHILLS:COUGH:HEADACHE:HOT FLUSH | 4 | 4 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006867 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:MALAISE:MYALGIA:NAUSEA:PAIN OF SKIN:PYREXIA:TREMOR | 35 | 35 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006818 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FEELING COLD:TREMOR | 72 | 72 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006802 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HERPES ZOSTER | 87 | 87 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Amlodipin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006890 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FEELING COLD:HEADACHE:PYREXIA | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006992 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA | 27 | 27 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006790 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS):LAMIVUDINE\ZIDOVUDINE | IBUPROFEN | UNK | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Propranolol:Sertraline | GBR | O | GB-AUROBINDO-AUR-APL-2021-006815 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:TREMOR | 72 | 72 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006930 | Expedited (15-Day) | | REDACTED | 2 | 2/20/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:MYALGIA:TREMOR:VOMITING | | | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006985 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PYREXIA | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006785 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:DRY SKIN:EAR PAIN:HEADACHE:NAUSEA:NEURALGIA:PYREXIA | 56 | 56 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Betahistine dihydrochloride:Omeprazole | GBR | O | GB-AUROBINDO-AUR-APL-2021-006816 | Expedited (15-Day) | | REDACTED | 2 | 2/20/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | 200 MG UNK BID | OT | ARTHRALGIA:HEADACHE | 71 | 71 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006942 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:FATIGUE:HEADACHE:ILLNESS:MYALGIA:PYREXIA:RASH ERYTHEMATOUS:RASH MACULAR | 29 | 29 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Migraine | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006876 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:INJECTION RELATED REACTION:MYALGIA | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Atorvastatin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006787 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ILLNESS | 70 | 70 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Simvastatin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006801 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:EQUINE THYMOCYTE IMMUNE GLOBULIN:IBUPROFEN(PS):OMEGA-3-ACID ETHYL ESTERS | IBUPROFEN | | OT | FATIGUE:GOUT | 71 | 71 YR | NULL | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-DRREDDYS-GER/UKI/21/0132025 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:ASTRAZENECA COVID-19 VACCINE:COCODAMOL:IBUPROFEN(PS) | IBUPROFEN | | OT | ARTHRALGIA:CHILLS:NUCHAL RIGIDITY | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-DRREDDYS-GER/UKI/21/0132034 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | CHILLS:DIZZINESS:FATIGUE:HEADACHE:MYALGIA:PYREXIA | 65 | 65 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | BENDROFLUMETHIAZIDE:ENALAPRIL MALEATE:SIMVASTATIN | GBR | O | GB-DRREDDYS-GER/UKI/21/0132039 | Expedited (15-Day) | | REDACTED | 1 | 2/19/2021 | 2/19/2021 | ASTRAZENECA COVID-19 VACCINE:NAPROSYN(PS) | NAPROSYN | UNK | OT | ARTHRALGIA:CLUSTER HEADACHE:MALAISE:OSTEOARTHRITIS | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication | | GBR | O | GB-CANTON LABORATORIES, LLC-2107058 | Expedited (15-Day) | | A2 REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ABDOMINAL PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS | 38 | 38 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006881 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:COCODAMOL:TRAMADOL(PS) | TRAMADOL | UNK | OT | BACK PAIN:CHILLS:FEELING ABNORMAL | 31 | 31 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006884 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | AGEUSIA:ANOSMIA:ARTHRALGIA:ASTHENIA:BONE PAIN:DEHYDRATION:HEADACHE:PYREXIA:TREMOR | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006897 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | EPISTAXIS:HEADACHE:PAIN IN EXTREMITY:PYREXIA | 57 | 57 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006993 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:LAMIVUDINE(PS) | LAMIVUDINE | UNK | OT | ASTHMA:CHILLS:CONFUSIONAL STATE:COUGH:DECREASED APPETITE:DIZZINESS:HEADACHE:INSOMNIA:MUSCLE SPASMS:MYALGIA:NAUSEA:PYREXIA | 40 | 40 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Amlodipine:Beclometasone dipropionate:Decapeptyl:Levothyroxine:Ramipril:Sertraline:Ventolin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006919 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DECREASED APPETITE:FEELING COLD:PYREXIA | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006924 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | MALAISE | 74 | 74 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006931 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:INJECTION SITE PAIN:NAUSEA:PAIN | 78 | 78 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Amlodipine:Azithromycin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006952 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:NAPROXEN(PS) | NAPROXEN | UNK | OT | ARTHRALGIA:CLUSTER HEADACHE:MALAISE:OSTEOARTHRITIS | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-006955 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:EQUINE THYMOCYTE IMMUNE GLOBULIN:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | HYPERHIDROSIS:HYPERTENSION:LYMPHADENOPATHY | 57 | 57 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Amlodipine:Cipralex:Codeine:Etanercept:Lansoprazole:Losartan | GBR | O | GB-AUROBINDO-AUR-APL-2021-006958 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS,OT | INFLUENZA:INFLUENZA LIKE ILLNESS:LETHARGY:NAUSEA | 46 | 46 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Ventolin | GBR | O | GB-AUROBINDO-AUR-APL-2021-006863 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | ASTHMA:HEADACHE:PYREXIA | | | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-DRREDDYS-GER/UKI/21/0132077 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | NECK PAIN | 31 | 31 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-DRREDDYS-GER/UKI/21/0132067 | Expedited (15-Day) | | REDACTED | 1 | 2/20/2021 | 2/20/2021 | ASTRAZENECA COVID-19 VACCINE:FLUOROURACIL(PS) | FLUOROURACIL | | OT | ARTHRALGIA:BODY TEMPERATURE INCREASED:DECREASED APPETITE:HEADACHE:HYPERSENSITIVITY:NAUSEA:RASH | 65 | 65 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-ACCORD-217549 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PROCEDURAL VOMITING | 71 | 71 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210219569 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:NAUSEA:PAIN IN EXTREMITY:PYREXIA | 69 | 69 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210218966 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | MUSCLE FATIGUE | 65 | 65 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-007137 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PAIN IN EXTREMITY | 54 | 54 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Metoprolol:Rivaroxaban | GBR | O | GB-AUROBINDO-AUR-APL-2021-007151 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:DIZZINESS POSTURAL:VACCINATION SITE PAIN | 27 | 27 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | 5 fu | GBR | O | GB-AUROBINDO-AUR-APL-2021-007170 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:CETIRIZINE(PS):PREDNISOLONE | CETIRIZINE | UNK | OT | URTICARIA | 56 | 56 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Influenza | GBR | O | GB-AUROBINDO-AUR-APL-2021-007184 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:MYALGIA:PYREXIA:TREMOR | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Pyrexia | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-007216 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:FATIGUE:HEADACHE:ILLNESS:MYALGIA:PYREXIA:RASH ERYTHEMATOUS:RASH MACULAR | 29 | 29 YR | NULL | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210222106 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PYREXIA | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210222056 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ILLNESS | 70 | 70 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | SIMVASTATIN | GBR | O | GB-JNJFOC-20210222002 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | DS,OT | INFLUENZA:INFLUENZA LIKE ILLNESS:LETHARGY:NAUSEA | 46 | 46 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | VENTOLIN [SALBUTAMOL] | GBR | O | GB-JNJFOC-20210221987 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:HEART RATE INCREASED | 72 | 72 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | ANASTROZOLE:ATORVASTATIN:INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210221049 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:INJECTED LIMB MOBILITY DECREASED:MALAISE:MYALGIA:PAIN:POOR QUALITY SLEEP:PYREXIA | 45 | 45 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | COLECALCIFEROL:INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210221043 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:CHILLS:INFLUENZA LIKE ILLNESS:MUSCLE SPASMS:NAUSEA:NERVOUSNESS:TREMOR | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | BISOPROLOL FUMARATE:CANDESARTANCILEXETIL/HCTZ:INFLUENZA VIRUS VACCINE | GBR | O | GB-JNJFOC-20210221040 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HERPES ZOSTER | 87 | 87 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | AMLODIPINE | GBR | O | GB-JNJFOC-20210219592 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | ARTHRALGIA:ASTHENIA:CLUSTER HEADACHE:DEPRESSED MOOD:FATIGUE:INFLUENZA LIKE ILLNESS:PYREXIA | 74 | 74 YR | FEMALE | REDACTED | REDACTED | COVID-19 vaccination;Drug use for unknown indication | RAMIPRIL | GBR | O | GB-DRREDDYS-GER/UKI/21/0132074 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | ABDOMINAL PAIN:CHEST DISCOMFORT:CHILLS:CONSTIPATION:DIARRHOEA:DIZZINESS POSTURAL:DYSPNOEA:FATIGUE:HEADACHE:MYALGIA:NAUSEA:PARAESTHESIA:PAROSMIA:PERIPHERAL COLDNESS:TREMOR:VOMITING:WHEEZING | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | BOOTS VITAMIN C:INFLUENZA VIRUS:INVITA-D3 | GBR | O | GB-DRREDDYS-GER/UKI/21/0132013 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:TREMOR | 72 | 72 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210224291 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:PYREXIA | 23 | 23 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210224279 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DECREASED APPETITE:FEELING COLD:PYREXIA | 68 | 68 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210224285 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | MALAISE | 74 | 74 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210223718 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:HEADACHE:HYPERHIDROSIS:NAUSEA | 5 | 5 YR | NULL | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210223719 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | INFLUENZA:MYALGIA:PYREXIA | 69 | 69 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-JNJFOC-20210223706 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:MYALGIA:TREMOR:VOMITING | | | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210223702 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210224905 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | TREMOR | 58 | 58 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | GABAPENTIN | GBR | O | GB-JNJFOC-20210224904 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:PYREXIA:TENDERNESS | 69 | 69 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | LINAGLIPTIN | GBR | O | GB-JNJFOC-20210224902 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ARTHRALGIA:MYALGIA:NAUSEA | 31 | 31 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210224901 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DIZZINESS:EAR PAIN:NAUSEA:PAIN | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210224894 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PAIN IN EXTREMITY | 54 | 54 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | METOPROLOL:RIVAROXABAN | GBR | O | GB-JNJFOC-20210224892 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PYREXIA:TREMOR | 37 | 37 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210224889 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DYSPNOEA:FATIGUE:HEADACHE:HYPERSENSITIVITY:NAUSEA:OROPHARYNGEAL PAIN:PERIORBITAL SWELLING:SNEEZING | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210224888 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:FEELING COLD:HEADACHE:OROPHARYNGEAL PAIN:TREMOR | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | AMITRIPTYLINE:AMLODIPINE:ANUSOL:RABEPRAZOLE | GBR | O | GB-JNJFOC-20210224331 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:RASH | 71 | 71 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210224328 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN:CHILLS:FATIGUE:HEADACHE:PARAESTHESIA:RENAL PAIN | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | CLENIL MODULITE:INFLUENZA VIRUS:RAMIPRIL:VENTOLIN [SALBUTAMOL] | GBR | O | GB-JNJFOC-20210224310 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA | 76 | 76 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-JNJFOC-20210222358 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | FATIGUE:HEADACHE:PYREXIA:TENDERNESS | 69 | 69 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Linagliptin | GBR | O | GB-AUROBINDO-AUR-APL-2021-007189 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE:HEART RATE INCREASED | 72 | 72 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication | Anastrozole:Atorvastatin:Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-006800 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA | 76 | 76 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-007572 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | ARTHRALGIA:HEADACHE | 71 | 71 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-DRREDDYS-GER/UKI/21/0132130 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:LANSOPRAZOLE(PS) | LANSOPRAZOLE | 30 MG QD | OT | CHILLS:GASTRIC HAEMORRHAGE:VOMITING | 72 | 72 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Reflux gastritis | INFLUENZA VIRUS | GBR | O | GB-MYLANLABS-2021M1008979 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:CETIRIZINE(PS):PREDNISOLONE | CETIRIZINE | | OT | URTICARIA | 56 | 56 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS | GBR | O | GB-MYLANLABS-2021M1009450 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | MUSCLE FATIGUE | 65 | 65 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-MYLANLABS-2021M1009486 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN:ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | DEAFNESS:DECREASED APPETITE:DIZZINESS POSTURAL:FATIGUE:HEADACHE:MYALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS | GBR | O | GB-MYLANLABS-2021M1009815 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | 2 DF UNK | OT | CHILLS:DIZZINESS:FATIGUE:HEADACHE:MYALGIA:PYREXIA | 65 | 65 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | BENDROFLUMETHIAZIDE:ENALAPRIL MALEATE:SIMVASTATIN | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005064 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS):ICOSAPENT | IBUPROFEN | UNK | OT | FATIGUE:GOUT | 71 | 71 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005149 | Expedited (15-Day) | | REDACTED | 1 | 2/23/2021 | 2/23/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | .5 DF UNK | OT | ABDOMINAL PAIN:ANORECTAL DISCOMFORT:ARTHRALGIA:GENITAL DISCOMFORT:HEAD DISCOMFORT:HEADACHE:PAIN IN EXTREMITY:URINE ODOUR ABNORMAL | 63 | 63 YR | FEMALE | REDACTED | REDACTED | COVID-19 immunisation;Arthritic pains | ASACOL:LEVOTHYROXINE | GBR | O | GB-JNJFOC-20210232827 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | DYSPNOEA:FATIGUE:HEADACHE:HYPERSENSITIVITY:NAUSEA:OROPHARYNGEAL PAIN:PERIORBITAL SWELLING:SNEEZING | 70 | 70 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-007155 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | CHILLS:HEADACHE | 70 | 70 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-AUROBINDO-AUR-APL-2021-007158 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN:ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | DEAFNESS:DECREASED APPETITE:DIZZINESS POSTURAL:FATIGUE:HEADACHE:MYALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | Influenza virus | GBR | O | GB-AUROBINDO-AUR-APL-2021-007168 | Expedited (15-Day) | | REDACTED | 1 | 2/22/2021 | 2/22/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | TREMOR | 58 | 58 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Gabapentin | GBR | O | GB-AUROBINDO-AUR-APL-2021-007188 | Expedited (15-Day) | | REDACTED | 1 | 2/23/2021 | 2/23/2021 | ASTRAZENECA COVID-19 VACCINE:EQUINE THYMOCYTE IMMUNE GLOBULIN:IBUPROFEN(PS) | IBUPROFEN | | OT | HYPERHIDROSIS:HYPERTENSION:LYMPHADENOPATHY | 57 | 57 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | Amlodipine:CIPRALEX:CODEINE:ETANERCEPT:LANSOPRAZOLE:LOSARTAN | GBR | O | GB-DRREDDYS-GER/UKI/21/0132146 | Expedited (15-Day) | | REDACTED | 1 | 2/23/2021 | 2/23/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS):LAMIVUDINE | IBUPROFEN | | OT | MYALGIA:PYREXIA:TREMOR | 23 | 23 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | PROPRANOLOL:Sertraline | GBR | O | GB-DRREDDYS-GER/UKI/21/0132104 | Expedited (15-Day) | | REDACTED | 1 | 2/23/2021 | 2/23/2021 | ASTRAZENECA COVID-19 VACCINE:FLUOROURACIL(PS) | FLUOROURACIL | | OT | ARTHRALGIA:DECREASED APPETITE:FATIGUE:HYPERSOMNIA | 75 | 75 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | AMLODIPINE | GBR | O | GB-ACCORD-217693 | Expedited (15-Day) | | REDACTED | 1 | 2/23/2021 | 2/23/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:CODEINE(PS) | CODEINE | UNK | OT | BACK PAIN:CHILLS:HEADACHE:INFLUENZA LIKE ILLNESS:PYREXIA | 24 | 24 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | ROACCUTANE | GBR | O | GB-SUN PHARMACEUTICAL INDUSTRIES LTD-2021RR-282235 | Expedited (15-Day) | | A2 REDACTED | 1 | 2/23/2021 | 2/23/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | CHILLS:HEADACHE:PYREXIA | 24 | 24 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | CALCICHEW D3:LYMECYCLINE:TOLTERODINE | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021005152 | Expedited (15-Day) | | REDACTED | 1 | 2/23/2021 | 2/23/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | ABDOMINAL PAIN:CHILLS:FATIGUE:HEADACHE:PARAESTHESIA:RENAL PAIN | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | Clenil Modulite:Influenza virus:Ramipril:Ventolin | GBR | O | GB-AUROBINDO-AUR-APL-2021-007213 | Expedited (15-Day) | | REDACTED | 1 | 2/24/2021 | 2/24/2021 | ACETAMINOPHEN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | MUSCLE FATIGUE | 65 | 65 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-DRREDDYS-GER/UKI/21/0132154 | Expedited (15-Day) | | REDACTED | 1 | 2/25/2021 | 2/25/2021 | ASTRAZENECA COVID-19 VACCINE:LANSOPRAZOLE(PS) | LANSOPRAZOLE | UNK | OT | CHILLS:GASTRIC HAEMORRHAGE:VOMITING | 72 | 72 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS | GBR | O | GB-SUN PHARMACEUTICAL INDUSTRIES LTD-2021RR-282595 | Expedited (15-Day) | | A2 REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASTRAZENECA COVID-19 VACCINE(PS):EQUINE THYMOCYTE IMMUNE GLOBULIN | ASTRAZENECA COVID-19 VACCINE | IM | OT | ABDOMINAL PAIN:ABDOMINAL PAIN UPPER:ANXIETY:DIZZINESS:FEELING OF DESPAIR:HEADACHE:NAUSEA:PALPITATIONS:PARAESTHESIA:PARANOIA:SUICIDAL IDEATION:VOMITING | 49 | 49 YR | FEMALE | REDACTED | REDACTED | | LAXIDO:NAPROXEN:OMEPRAZOLE:ORAMORPH:RELVAR ELLIPTA:ROPINIROLE:SERTRALINE:VENTOLIN | GBR | O | GB-ASTRAZENECA-2021A038558 | Expedited (15-Day) | | REDACTED | 1 | 2/25/2021 | 2/25/2021 | ASTRAZENECA COVID-19 VACCINE:DIGOXIN(PS):RIVAROXABAN | DIGOXIN | | OT | HEART RATE INCREASED | | | NULL | REDACTED | REDACTED | Atrial fibrillation;Atrial fibrillation | | GBR | O | GB-ADVANZ PHARMA-202102001235 | Expedited (15-Day) | | REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ARTHRALGIA:ASTHENIA:CLUSTER HEADACHE:DEPRESSED MOOD:FATIGUE:INFLUENZA LIKE ILLNESS:PYREXIA | 74 | 74 YR | FEMALE | REDACTED | REDACTED | COVID-19 vaccination;Product used for unknown indication | RAMIPRIL | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK009036 | Expedited (15-Day) | | REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | 2 DF UNK | OT | HEADACHE:MALAISE | 80 | 80 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS ANTIGEN | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK008986 | Expedited (15-Day) | | REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | ASTHMA:HEADACHE:PYREXIA | | | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK008989 | Expedited (15-Day) | | REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | NECK PAIN | 31 | 31 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK009008 | Expedited (15-Day) | | REDACTED | 1 | 2/24/2021 | 2/24/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | UNK | OT | CHILLS:HEADACHE:PYREXIA | 69 | 69 YR | NULL | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS ANTIGEN:ZOLEDRONATE | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK009023 | Expedited (15-Day) | | REDACTED | 1 | 2/25/2021 | 2/25/2021 | ASTRAZENECA COVID-19 VACCINE:FLUOROURACIL(PS) | FLUOROURACIL | | OT | EYE PAIN:EYE SWELLING:HEADACHE:PHOTOPHOBIA:SWELLING FACE | 51 | 51 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-ACCORD-217801 | Expedited (15-Day) | | REDACTED | 1 | 2/25/2021 | 2/25/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | PYREXIA:TREMOR | 55 | 55 YR | MALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-FRESENIUS KABI-FK202101661 | Expedited (15-Day) | | REDACTED | 1 | 2/25/2021 | 2/25/2021 | ACETAMINOPHEN(PS):ASTRAZENECA COVID-19 VACCINE | ACETAMINOPHEN | UNK | OT | HEADACHE:PYREXIA | 76 | 76 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication | | GBR | O | GB-FRESENIUS KABI-FK202101761 | Expedited (15-Day) | | REDACTED | 1 | 2/25/2021 | 2/25/2021 | ACYCLOVIR(PS):ASTRAZENECA COVID-19 VACCINE | ACYCLOVIR | UNK | OT | LIP SWELLING:ORAL HERPES:PYREXIA | 80 | 80 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | BISOPROLOL:EDOXABAN | GBR | O | GB-BAUSCH-BL-2021-005538 | Expedited (15-Day) | | REDACTED | 1 | 2/26/2021 | 2/26/2021 | ACETAMINOPHEN:ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | | OT | DEAFNESS:DECREASED APPETITE:DIZZINESS POSTURAL:FATIGUE:HEADACHE:MYALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication;Drug use for unknown indication | INFLUENZA VIRUS | GBR | O | GB-DRREDDYS-GER/UKI/21/0132163 | Expedited (15-Day) | | REDACTED | 1 | 2/26/2021 | 2/26/2021 | ASTRAZENECA COVID-19 VACCINE:IBUPROFEN(PS) | IBUPROFEN | 200 MG UNK | OT | ARTHRALGIA:HEADACHE | 71 | 71 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK009619 | Expedited (15-Day) | | REDACTED | 1 | 2/26/2021 | 2/26/2021 | ACETAMINOPHEN(PS):ASPIRIN:ASTRAZENECA COVID-19 VACCINE:IBUPROFEN | ACETAMINOPHEN | UNK | OT | DEAFNESS:DECREASED APPETITE:DIZZINESS POSTURAL:FATIGUE:HEADACHE:MYALGIA | 73 | 73 YR | FEMALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication;Product used for unknown indication;Product used for unknown indication | INFLUENZA VIRUS ANTIGEN | GBR | O | GB-GLAXOSMITHKLINE-GBCH2021GSK009711 | Expedited (15-Day) | | REDACTED | 1 | 2/26/2021 | 2/26/2021 | ACYCLOVIR(PS):ASTRAZENECA COVID-19 VACCINE | ACYCLOVIR | UNK | OT | LIP SWELLING:ORAL HERPES:PYREXIA | 80 | 80 YR | MALE | REDACTED | REDACTED | Product used for unknown indication;Product used for unknown indication | BISOPROLOL:EDOXABAN | GBR | O | GB-GLAXOSMITHKLINE-XI2021039252 | Expedited (15-Day) | | Sheet: Legend | | | | Logic | | | Abbreviations/Definitions | ALL HLTs ALL HLGTs ALL SOCs | Displays only the HLTs, HLGTs and SOCs for the first 12 PTs in the case. NOTE: If there are more than 12 PTs in the case, the SOCs for PTs which have a display number of more than 12 will NOT be displayed. | | All Outcomes | Displays a concatenated list of codes. DE=Death HO=Hospitalization LT=Life Threatening DS=Disability CA=Congenital Anamoly OT=Other Serious Outome RI=Required Intervention Application # | Populated with Validated Application #; if null, use verbatim application #. | | | | | | Attachment | Additional Esub case documents (e.g., Literature reports, Death certificates, Hospital records, etc. Medical History/ Medical History Comments | Medical History = Patient=>Med History=>Other Diseases/Diagnosis=> ”Diagnosis” field (Concatenated list of data, if available); Medical History Comments = Patient=>Med History=> ”Medical History Comment” field (Available data is Concatenated together with/after list of Diagnosis, if any) | | | | | | Combination product | Y=Combination Suspect Product in Case Null=Suspect product not marked as Combination Product NOTE: The FDA Office of Combination Products (OCP) was established on Dec. 24, 2002, as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The law gives the Office broad responsibilities covering the regulatory life cycle of drug-device, drug-biologic, and device-biologic combination products. Medication Errors HLGT (PTs) | Populated with PTs from the Medication Errors HLGT if listed in case Events. | | | | | | Compounded Product | Y=Compounded Suspect Product in Case Null=No Suspect product maked as Compounded Product Therapy Duration (Days) | Displays whole number value of Therapy End Date minus Therapy Start Date (e.g., 2) | | Data Entry Completion Date | Date Case was routed to SE(READY) status | | | Dechallenge | Y=Positive dechallenge N=Negative dechallenge U=Unknown D=Does not apply Therapy Duration (Verbatim) | Displays contents of Duration field and (Duration) Units field (Concatenated) | | | | | | Image | Scanned MedWatch Paper Cases (e.g., 3500, 3500A, 3500B, CIOMS, and additional documents submitted with case, etc.) | | | | | | | Product Role | PS=Primary Suspect SS=Secondary Suspect C=Comcomitant | | | Rechallenge | Y=Positive rechallenge N=Negative rechallenge U=Unknown D=Does not apply | | | Reporter Information | All Reporter Information comes from the First (Primary) Reporter | | | Report Source | Displays a concatenated list of codes. FGN=Foreign SDY=Study LIT=Literature CSM=Consumer HP=Health Professional UF=User Facility CR=Company Representative DT=Distributor OTH=Other | | | |