Records released by the U.S. Senate Permanent Subcommittee on Investigations chronicle FDA scientists' attempts to surface masking-affected safety signals in COVID-19 vaccine adverse event data, the agency's responses, and the Subcommittee's oversight.
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ANALYSIS·
Niu emails Anderson about a meeting with Szarfman to discuss new methods for data mining.
Manette Niu, an official at FDA's Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Pharmacovigilance (OBPV), emails Steven Anderson, the Director of that office, to inform him that she has a meeting the next day with Ana Szarfman to "discuss [Szarfman's] proposal on instituting new methods to improve data mining."PSI-HHS-000004585100. Until 2022, The Office of Biostatistics and Pharmacovigilance was named the Office of Biostatistics and Epidemiology. For purposes of this document, the office will be referred to by its current name. See National Science Foundation, NI Protocol, FDA CBER Reorg & More—March '22 Pharma News, Mar. 1, 2022, available at.PSI-HHS-000004585100Read PDF (page 38) →View as text →See also: external source → Szarfman, a medical officer and safety data mining developer, works in FDA's Center for Drug Evaluation and Research (CDER), Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN). It is unclear what specific "new methods" Szarfman wanted to discuss and whether the meeting occurred.
Citations:
PSI-HHS-000004585100. Until 2022, The Office of Biostatistics and Pharmacovigilance was named the Office of Biostatistics and Epidemiology. For purposes of this document, the office will be referred to by its current name. See National Science Foundation, NI Protocol, FDA CBER Reorg & More—March '22 Pharma News, Mar. 1, 2022, available at.
FDA issues an EUA for the Pfizer-BioNTech COVID-19 mRNA vaccine for individuals ages 16 and older.
FDA issues an Emergency Use Authorization (EUA) for the Pfizer COVID-19 mRNA vaccine for individuals ages 16 and older.COVID-19 Timeline, Centers for Disease Control and Prevention.External source →
Citations:
COVID-19 Timeline, Centers for Disease Control and Prevention.
Szarfman organizes a virtual meeting on a new safety data mining methodology designed by DuMouchel.
Szarfman organizes a virtual meeting to discuss proposals for a new safety data mining methodology designed by Oracle Chief Statistician William DuMouchel, the architect of FDA's existing data mining system.PSICOVID_00014194.PSICOVID_00014194Read PDF (page 93) →View as text → Meeting invitees include Richard Forshee, Associate Director for Research at CBER OBPV/Acting Deputy Director for CBER OBPV; Narayan Nair, a CBER OBPV official; and Norman Stockbridge, an official at CDER OCHEN.PSICOVID_00014194; PSI-HHS-000002185990-91. Szarfman's Dec. 23, 2020 email thanking Forshee for attending the presentation notes that she has attached an updated version of the slides. One such update appears to be a slide including DuMouchel's background as the inventor of MGPS. See PSI-HHS-000002293255.PSICOVID_00014194; PSI-HHS-000002185990-91; PSI-HHS-000002293255Read PDF (page 93) →View as text →
In her introductory remarks, Szarfman notes that among other problems with current data mining practices "safety signals may remain hidden."PSICOVID_00014198.PSICOVID_00014198Read PDF (page 97) →View as text →
PSICOVID_00014194; PSI-HHS-000002185990-91. Szarfman's Dec. 23, 2020 email thanking Forshee for attending the presentation notes that she has attached an updated version of the slides. One such update appears to be a slide including DuMouchel's background as the inventor of MGPS. See PSI-HHS-000002293255.
Menschik and Baer exchange about classic data mining references written by Szarfman and DuMouchel.
As FDA officials discussed the use of empirical Bayesian (EB) data mining to detect safety signals for adverse events associated with COVID-19 vaccines, David Menschik and Bethany Baer, two officials at CBER OBPV, communicate about "a few classic data mining references" written by Szarfman and DuMouchel.PSI-HHS-000008254390.PSI-HHS-000008254390Read PDF (page 148) →View as text → Baer notes that FDA's current EB data mining system uses the Multi-item Gamma Poisson Shrinker (MGPS), which is the algorithm DuMouchel invented.Id.; PSI-HHS-000002293255.PSI-HHS-000002293255Read PDF (page 178) →View as text →
CDC releases its VAERS Standard Operating Procedures assigning FDA responsibility for EB data mining.
The CDC releases its Standard Operating Procedures (SOP) for the Vaccine Adverse Event Reporting System (VAERS).Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19, Centers for Disease Control and Prevention, Jan. 29, 2021.External source → The SOP identifies the "analyses for COVID-19 vaccine safety signals," noting that FDA will be responsible for "using empirical Bayesian data mining to identify [adverse events] reported more frequently than expected following vaccination with COVID-19 vaccines."Id. at 16-17.External source →
Citations:
Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19, Centers for Disease Control and Prevention, Jan. 29, 2021.
Szarfman raises COVID-19 vaccine safety monitoring concerns with CBER Director Marks.
Szarfman raises concerns to CBER Director Peter Marks regarding COVID-19 vaccine safety monitoring issues with FDA's current practices and asks "if you want Bill DuMouchel and I to discuss our proposal for more effective monitoring, including the need to use an updated algorithm by DuMouchel for data mining spontaneous reports at [FDA.]"PSI-HHS-000002213369.PSI-HHS-000002213369Read PDF (page 13) →View as text → Marks arranges a time to meet with her in the following weeks.Id.PSI-HHS-000002213369Read PDF (page 13) →View as text →
FDA approves an EUA for Johnson & Johnson's COVID-19 vaccine for ages 18 and older.
FDA approves an EUA for Johnson & Johnson's COVID-19 vaccine for all people ages 18 years and older.COVID-19 Timeline, Centers for Disease Control and Prevention.External source →
Citations:
COVID-19 Timeline, Centers for Disease Control and Prevention.
Szarfman presents RGPS to Marks and other CBER officials, calling MGPS not state of the art.
Szarfman meets with CBER Director Peter Marks, along with Forshee, Anderson, and others at CBER, to discuss confounding issues with MGPS, particularly data masking, a known limitation that can lead to missed or reduced signals in data mining.PSI-HHS-000004783471-72; PSI-HHS-000002134656.PSI-HHS-000004783471-72; PSI-HHS-000002134656Read document → Szarfman showcases "the superior performance" of DuMouchel's Regression-Adjusted Gamma Poisson Shrinker (RGPS), an "updated algorithm" for data mining that DuMouchel first outlined in a 2012 white paper.PSI-HHS-000004783471-72; PSI-HHS-000008259555; William DuMouchel and Rave Harpaz, Regression-Adjusted GPS Algorithm (RGPS), Oracle, Nov. 2012.PSI-HHS-000004783471-72; PSI-HHS-000008259555Read document →See also: external source → Szarfman states that "[t]he MGPS data mining method currently in use at [FDA]" is "not the state of the art."PSI-HHS-000008259561.PSI-HHS-000008259561Read PDF (page 183) →View as text → In contrast, she emphasizes, "RGPS is the state of the art," noting that the new method can "better adjust for both, masking (false negatives) and confounding (false positives)."Id. (emphasis in original); PSI-HHS-000002134652 (emphasis added).PSI-HHS-000002134652Read PDF (page 118) →View as text →
Marks thanks Szarfman "for taking the time to go over everything so carefully with us."PSI-HHS-000004783470-71.PSI-HHS-000004783470-71Read document → He writes, "[w]e will work through the issues that you presented."Id.PSI-HHS-000004783470-71Read document → Afterwards, Marks schedules a meeting with Forshee and Anderson to discuss "how to proceed" on the issues raised by Szarfman and DuMouchel's updated data mining algorithm.PSI-HHS-000004584613.PSI-HHS-000004584613Read PDF (page 34) →View as text → It is unclear whether this meeting occurred.
Szarfman confirms she has access to VAERS data through Oracle's Empirica.
Szarfman confirms that she has access to VAERS data through Oracle's Empirica, a tool for detecting and analyzing vaccine safety signals.PSI-HHS-000008257240-41.PSI-HHS-000008257240-41Read PDF (page 164) →View as text → Other CBER officials, including Anderson, were aware of and did not object to Szarfman's access, even though she works in CDER.PSI-HHS-000008257239.PSI-HHS-000008257239Read PDF (page 163) →View as text →
Zinderman tells Baer he has no issue with Szarfman's VAERS access through Empirica.
Craig Zinderman, a CBER official, affirms to Baer that he has no issue granting Szarfman access to VAERS data through Empirica.PSI-HHS-000008257238-39.PSI-HHS-000008257238-39Read PDF (page 162) →View as text → Baer responds writing "we will leave Ana's account as is with a CBER login."PSI-HHS-000008257238.PSI-HHS-000008257238Read PDF (page 162) →View as text →
Baer questions Szarfman's COVID vaccine data mining; Zinderman cautions against blocking access.
A day after affirming her access, Baer takes issue with Szarfman having access to a database controlled by CBER, an office that Szarfman is not a part of, saying that on calls with the contractor supporting Empirica and FDA's data mining, Commonwealth Informatics ("Commonwealth"), Szarfman "has twice now expressed interest in COVID vaccine data mining and made some broad statements that I don't think [the Division of Pharmacovigilance] would agree with[.]"Id. At the time of Baer's email the Division of Pharmacovigilance was known as the Division of Epidemiology.PSI-HHS-000008257238Read PDF (page 162) →View as text → Baer also questions who at CBER will be coordinating with Szarfman and interpreting her results.Id.PSI-HHS-000008257238Read PDF (page 162) →View as text → Baer recognizes Szarfman's expertise, writing, "I know Ana [Szarfman] worked to develop the data mining system and this might be a special circumstance due to her knowledge and experience."Id. (emphasis added).PSI-HHS-000008257238Read PDF (page 162) →View as text →
Zinderman replies that "[r]efusing her access just for vaccines seems a little disingenuous," but adds it "[s]eems reasonable to try to understand why [Szarfman] wants to use VAERS data instead of [CDER's] data, and to caution her that while its [sic] fine for her to do methodological work, we aren't interested in additional data mining studies of COVID data outside of CBER's usual processes."PSI-HHS-000008257237-38 (emphasis added).PSI-HHS-000008257237-38Read PDF (page 161) →View as text →
Citations:
Id. At the time of Baer's email the Division of Pharmacovigilance was known as the Division of Epidemiology.
Baer acknowledges Szarfman knows more about data mining but characterizes her comments as atypical.
Responding to Zinderman, Baer acknowledges that "[Szarfman] knows a lot more about data mining than I do[.]"PSI-HHS-000008257237.PSI-HHS-000008257237Read PDF (page 161) →View as text → However, Baer reiterates her earlier concerns about Szarfman's apparent comments during a regularly scheduled call between officials at CBER, CDER, and Commonwealth.Id.PSI-HHS-000008257237Read PDF (page 161) →View as text → Baer characterizes Szarfman's comments as atypical and speculates that Szarfman may have been "just brainstorming and theorizing," which was "unusual compared to the typical topics covered on the call."Id.PSI-HHS-000008257237Read PDF (page 161) →View as text →
Niu writes Baer that she and Zinderman will meet with Szarfman about her VAERS objectives.
Niu writes to Baer that she and Zinderman have decided to schedule a meeting with Szarfman to discuss her "VAERS objectives/rationale."Id.PSI-HHS-000008257237Read PDF (page 161) →View as text →
Menschik requests a special MGPS run apparently adjusting for masking with COVID-19 vaccines.
Menschik emails Brian Hendrix, a contractor at Commonwealth, and Baer to request a "'special project' run" of MGPS that will apparently adjust for masking with COVID-19 vaccines, though he does not use that specific term.PSICOVID_00017214.PSICOVID_00017214Read PDF (page 183) →View as text → He notes that he observed a "muting trend" for adverse events, which he attributes to the volume of COVID-19 vaccine reports.Id.PSICOVID_00017214Read PDF (page 183) →View as text → Menschik specifies that the viewers of this potential data analysis should be limited to himself, Baer, and the contractor.Id.PSICOVID_00017214Read PDF (page 183) →View as text →
The "'special run'" was completed, but the results do not appear in the records reviewed to date.PSICOVID_00017210.PSICOVID_00017210Read PDF (page 179) →View as text →
Szarfman shares DuMouchel's RGPS analysis showing 49 examples of extreme masking with senior FDA officials.
After speaking with Zinderman, Niu, and Baer earlier that day, Szarfman sends them, as well as Menschik and Stockbridge, an earlier email and spreadsheet from DuMouchel that includes his RGPS analysis showing "49 examples of extreme masking," with over twenty of those examples of adverse events now showing a statistically significant safety signal when adjusted for masking.PSI-HHS-000008263190-91 (emphasis added).PSI-HHS-000008263190-91Read PDF (page 61) →View as text → Some of the statistically significant safety signals associated with the COVID-19 vaccines that were not previously detected through MGPS include sudden cardiac death, Bell's palsy, and pulmonary infarction.PSI-HHS-000008257443-44 (with attachment).PSI-HHS-000008257443-44Read document → Szarfman also attaches her March 1 presentation she gave to Marks and other FDA officials.Id.PSI-HHS-000008257443-44Read document →
Szarfman notes that the "comparisons between RGPS and MGPS were generated by Bill DuMouchel using the VAERS public domain data incorporated into Empirica Signal." Szarfman explains that she and DuMouchel "extensively studied the increased value of RGPS over MGPS for reducing false positives and negative signals."Id.PSI-HHS-000008257443-44Read document →
Menschik circulates safety signal list and a draft presentation on MGPS limitations to FDA and CDC officials.
Menschik circulates a list of adverse events with safety signals identified by FDA's data mining methodology to FDA senior officials, as well as several officials at CDC, including John Su and Tom Shimabukuro.PSI-HHS-000001187885 (with attachment); PSI-HHS-000001187886-88.PSI-HHS-000001187885; PSI-HHS-000001187886-88Read document → Menschik also attaches a draft presentation detailing limitations with the FDA's current MGPS data mining system.Id.PSI-HHS-000001187885; PSI-HHS-000001187886-88Read document → Some of the limitations highlighted in the draft, such as "confounding" and "false alerts from statistical interaction," appear similar to the concerns Szarfman previously raised about MGPS.PSI-HHS-000001187888.PSI-HHS-000001187888Read PDF (page 23) →View as text → It is unclear how the senior CDC and FDA officials responded.
DuMouchel sends analysis adjusting for the fact that 99% of 2021 VAERS reports are for COVID-19 vaccines.
DuMouchel sends additional data to Szarfman and others that appears to analyze VAERS reports while adjusting for the fact that "99% of all reports" for the year 2021 are for the COVID-19 vaccines.PSI-HHS-000008251981-82; PSI-HHS-000008258306-07 (with attachment).PSI-HHS-000008251981-82; PSI-HHS-000008258306-07Read document → DuMouchel's analysis appears to adjust for the masking effect.Id.PSI-HHS-000008251981-82; PSI-HHS-000008258306-07Read document → He notes, "[o]nly if you mix in more non-covid reports within each stratum can you get enough diversity to allow larger disproportionalities."PSI-HHS-000008251982.PSI-HHS-000008251982Read PDF (page 130) →View as text →
Szarfman forwards the email to Niu and other FDA officials, flagging the "[i]mportant analysis by DuMouchel," and writes, "I think that we need to invite [DuMouchel] to talk with us about the effect of adjustment factors, given the data, so we can all learn from his knowledge."PSI-HHS-000008251981-82.PSI-HHS-000008251981-82Read PDF (page 129) →View as text →
Niu asks whether DuMouchel's findings affect 2021 data mining results; Szarfman confirms they do.
Two days after Szarfman flags DuMouchel's "[i]mportant analysis," Niu replies in a separate chain asking, "Does this effect the data mining results we are receiving in 2021?"PSI-HHS-000008251981.PSI-HHS-000008251981Read PDF (page 129) →View as text → Szarfman responds the next day, saying, "Exactly. As DuMouchel pinpointed, there is a need to extend the stratification brackets by the fact that 99% of the results for FY2021 are for COVID-19 vaccines this indeed affects the results."PSI-HHS-000008251980-81.PSI-HHS-000008251980-81Read PDF (page 128) →View as text →
Niu forwards DuMouchel's analysis to Zinderman without Szarfman; Zinderman flags it as worth considering.
Niu forwards the emails containing DuMouchel's writeup of his analysis and Szarfman's comments to Zinderman (removing Szarfman from the email chain), but does not appear to share DuMouchel's data mining results at this time.Id.PSI-HHS-000008251980-81Read PDF (page 128) →View as text → Zinderman in turn sends DuMouchel's writeup and Szarfman's comments to Menschik and Baer, with Niu copied.Id.PSI-HHS-000008251980-81Read PDF (page 128) →View as text → Zinderman questions whether DuMouchel's apparent adjustment for masking "[m]ight be worth considering[.]"PSI-HHS-000008251980.PSI-HHS-000008251980Read PDF (page 128) →View as text → He adds, "I don't pretend to understand it, but sounds like they are suggesting an analysis not stratified by year."Id.PSI-HHS-000008251980Read PDF (page 128) →View as text →
Baer welcomes DuMouchel's input; Menschik pushes back on reaching out to Szarfman directly.
Baer responds, stating, "I think we should welcome any expert input," acknowledging that she and Menschik "are concerned about the effect of so many COVID reports on the standard system [FDA] use[s]."Id.PSI-HHS-000008251980Read PDF (page 128) →View as text → She asks if there is any way to have DuMouchel more involved in FDA's "data mining process and interpretation during this unprecedented reporting time?"Id.PSI-HHS-000008251980Read PDF (page 128) →View as text →
Niu answers stating she will send them DuMouchel's data mining results and that "[t]he best person to ask would be Ana [Szarfman] as she has close ties with Bill DuMouchel."PSI-HHS-000008251979-80.PSI-HHS-000008251979-80Read PDF (page 127) →View as text →
A few minutes later, Menschik removes Niu from the email chain and replies only to Zinderman and Baer, pushing back on immediately speaking with Szarfman: "Before we potentially reach out to Ana [Szarfman], we should meet internally – many considerations not suited to email…"PSI-HHS-000008251979 (emphasis added) (ellipses in original).PSI-HHS-000008251979Read PDF (page 127) →View as text → It is unclear if Menschik, Zinderman, and Baer met.
Szarfman shares DuMouchel's RGPS analysis revealing six new statistically significant safety signals.
Szarfman forwards Niu an analysis that DuMouchel compiled the day before using his new data mining method (RGPS), which revealed six statistically significant safety signals for adverse events not previously detected by FDA's current system.PSI-HHS-000008258202-03. Records show that FDA's threshold for determining a statistically significant safety signal was when the lower bound of the reporting estimate (EB05) exceeded 2.0. See PSI's March 25, 2026 document release on EB data mining at 166.PSI-HHS-000008258202-03Read PDF (page 5) →View as text →See also: external source → DuMouchel's analysis uncovered statistically significant safety signals, currently masked by MGPS, including Bell's palsy associated with the Pfizer vaccine and thrombosis associated with the Moderna vaccine.PSI-HHS-000008258203.PSI-HHS-000008258203Read PDF (page 6) →View as text →
Two days later, Niu forwards Szarfman's email containing DuMouchel's analysis to Zinderman, Baer, and Menschik.PSI-HHS-000008258202.PSI-HHS-000008258202Read PDF (page 5) →View as text →
Citations:
PSI-HHS-000008258202-03. Records show that FDA's threshold for determining a statistically significant safety signal was when the lower bound of the reporting estimate (EB05) exceeded 2.0. See PSI's March 25, 2026 document release on EB data mining at 166.
Baer reports to colleagues that Szarfman offered to show Commonwealth her VAERS analysis; Niu distances herself.
After receiving Szarfman's distribution of DuMouchel's analysis, Baer informs Menschik, Zinderman, and Niu that during a call that day with Commonwealth officials, Szarfman "offered to show individuals the interesting VAERS analysis she has been doing with Manette. A couple of the Commonwealth folks expressed interest in meeting with her to see it."Id.PSI-HHS-000008258202Read PDF (page 5) →View as text →
Niu responds, distancing herself from Szarfman, writing, "I have not been working with Ana directly, although she has sent me data mining runs that I've forwarded to this group. I will speak to her about this."Id.PSI-HHS-000008258202Read PDF (page 5) →View as text →
Szarfman resends DuMouchel's analysis to Niu and includes several additional FDA officials.PSI-HHS-000008258271.PSI-HHS-000008258271Read PDF (page 7) →View as text → In the email, Szarfman reiterates that she is sending all of DuMouchel's analysis to Niu.Id.PSI-HHS-000008258271Read PDF (page 7) →View as text → She writes that DuMouchel's new method (RGPS) "is better at removing false positives and negatives than MGPS. Note the safety signals for cardiac events with the Pfizer and Moderna vaccines, now in the news, that are better identified by RGPS than by MGPS."Id. (emphasis added).PSI-HHS-000008258271Read PDF (page 7) →View as text →
Niu separately asks Zinderman for advice on how to respond to Szarfman, who had apparently described Niu as her collaborator on Szarfman's data mining work to FDA's data mining contractors.PSI HHS-000008260150.PSI HHS-000008260150Read PDF (page 15) →View as text → In response, Zinderman sends Niu draft language to respond to Szarfman, telling Niu that asking Szarfman to stop sending data mining results "would create a bigger problem for us I think."Id.PSI HHS-000008260150Read PDF (page 15) →View as text →
Niu responds to Szarfman's earlier email, writing, "[w]hile we are aware that CDER is using the vaccine data to explore new calculations and various deviations of analysis parameters in disproportionality analysis, I haven't been, and are unable to, work as a collaborator with you on this project due to our higher priority work, and because this sort of statistical development work falls outside of my area of expertise."PSI-HHS-000008258271.PSI-HHS-000008258271Read PDF (page 7) →View as text → Niu's email contains similar language to the draft response Zinderman sent her earlier that day.PSI HHS-000008260150.PSI HHS-000008260150Read PDF (page 15) →View as text →
Szarfman responds to Niu that she understands but will keep her up to date with her findings.PSI-HHS-000008258271.PSI-HHS-000008258271Read PDF (page 7) →View as text →
During a meeting, NIH Director Collins responds "Senator, people die" when Sen. Johnson raises VAERS reports of more than 2,900 deaths within 30 days of vaccination.
During a meeting with then-National Institutes of Health (NIH) Director Dr. Francis Collins, Sen. Johnson asks him about the alarming number of adverse event reports in VAERS, particularly the more than 2,900 deaths worldwide reported within 30 days of vaccination. Collins responds, "Senator, people die."Available at at 2.External source →
Szarfman shares an EB data mining analysis; Niu confirms to Menschik she is not collaborating.
Szarfman shares with Niu and other FDA officials an analysis of EB data mining issues unrelated to DuMouchel's new data mining method.PSI-HHS-000008258153-54; PSICOVID_00017031; PSICOVID_00017032-33; PSICOVID_00017034-81.PSI-HHS-000008258153-54; PSICOVID_00017031; PSICOVID_00017032-33; PSICOVID_00017034-81Read PDF (page 1) →View as text → Niu forwards Szarfman's analysis to Zinderman, Baer, and Menschik.PSI-HHS-000008258153.PSI-HHS-000008258153Read PDF (page 1) →View as text → In response, Menschik asks, "[d]id you request this or anything else (COVID vaccine data mining related) from Ana and/or are you working with Ana on any data mining projects? (if so, please specify)[.]"Id.PSI-HHS-000008258153Read PDF (page 1) →View as text →
Niu responds to Menschik in two separate emails, writing first, "[n]o, I haven't requested anything from Ana. I am only passively passing on her data mining runs when she sends them to me."Id.PSI-HHS-000008258153Read PDF (page 1) →View as text → She quickly sends a second email stating that she is "not working on anything with [Szarfman]."PSI-HHS-000008258190.PSI-HHS-000008258190Read PDF (page 3) →View as text →
The same day, Niu also sends Menschik her previous conversation with Szarfman, in which Niu told Szarfman that she cannot collaborate with her.PSI-HHS-000008258271.PSI-HHS-000008258271Read PDF (page 7) →View as text →
Szarfman circulates analysis showing MGPS undervalued acute myocardial infarction signals for Pfizer and Moderna.
Szarfman circulates an analysis run by DuMouchel to Norman Stockbridge and another CDER official, showing that MGPS had undervalued the safety signals for acute myocardial infarction for both the Pfizer and Moderna COVID-19 vaccines.PSI-HHS-000002208944-45.PSI-HHS-000002208944-45Read PDF (page 3) →View as text → DuMouchel's RGPS method appeared to yield much higher signals compared to FDA's MGPS method.Id. (using the RGPS methodology, ER05 notification signals were significantly higher than the previously running EB05 of MGPS).PSI-HHS-000002208944-45Read PDF (page 3) →View as text →
Zinderman directs Szarfman to hold off on creating COVID-19 vaccine data mining reports and analyses.
Following Szarfman's multi-month efforts advocating for FDA to change its data mining system in order to unmask statistically significant safety signals associated with the COVID-19 vaccines, Menschik, Nair, and Zinderman draft a lengthy email to Szarfman.PSICOVID_00017246; PSI-HHS-000008251530; PSI-HHS-000008251912-13; PSI-HHS-000001195617-19; PSI_HHS-000008253450-51; PSI-HHS-000001175745-47; PSI-HHS-000001148712-14.PSICOVID_00017246; PSI-HHS-000008251530; PSI-HHS-000008251912-13; PSI-HHS-000001195617-19; PSI_HHS-000008253450-51; PSI-HHS-000001175745-47; PSI-HHS-000001148712-14Read PDF (page 186) →View as text →
The final draft, which Zinderman sends to Szarfman that same day, directs her to "please hold off on creating and sending data mining reports and analyses using COVID-19 vaccine [adverse event] data."PSICOVID_00017246-47.PSICOVID_00017246-47Read PDF (page 186) →View as text →
The email states that, "we are already screening and reviewing reports, such as [acute myocardial infarction], [thrombocytopenia syndrome], Thromboembolic events, and other forms of coagulopathy."Id.PSICOVID_00017246-47Read PDF (page 186) →View as text → It concludes by reiterating the directive to Szarfman to "hold off" on continuing her efforts.Id.PSICOVID_00017246-47Read PDF (page 186) →View as text →
Szarfman replies to Zinderman that from now on, "I will only deliver analyses when I am specifically requested to do so[.]"PSICOVID_00017245.PSICOVID_00017245Read PDF (page 185) →View as text → She reiterates, "[w]e are testing a new data mining methodology, and given the circumstances, it will be good for all to understand its performance with such important data. This is a method that also strongly reduces confounding, so it may be helpful in certain future circumstances."Id. (emphasis added).PSICOVID_00017245Read PDF (page 185) →View as text →
PSICOVID_00017246; PSI-HHS-000008251530; PSI-HHS-000008251912-13; PSI-HHS-000001195617-19; PSI_HHS-000008253450-51; PSI-HHS-000001175745-47; PSI-HHS-000001148712-14Read PDF (page 186) →View as text →
Szarfman receives clearance from Stockbridge to publish her paper on masking and RGPS.
Szarfman receives clearance from Stockbridge to publish a paper she co-authored with DuMouchel and others at Oracle, entitled "Masking Associated with Early COVID-19 Vaccine Safety Surveillance."PSI-HHS-000001640809; PSI-HHS-000001622854-55.PSI-HHS-000001640809; PSI-HHS-000001622854-55Read PDF (page 96) →View as text → Szarfman encloses a draft version of her paper that "demonstrates the potential utility of a new signal detection methodology called RGPS that can address masking and confounding effects that cannot be properly controlled by conventional signaling methodologies."PSI-HHS-000001622854; PSI-HHS-000001639129-34 at 33.PSI-HHS-000001622854; PSI-HHS-000001639129-34Read PDF (page 96) →View as text →
Szarfman resends RGPS analysis on acute myocardial infarction and invites Forshee to collaborate.
Following apparent conversations between the CDC and FDA regarding "myocardial events and the lack of signals in VAERS[,]" Szarfman writes to her FDA colleagues, resending DuMouchel's analysis from one month earlier that uncovered statistically significant safety signals for acute myocardial infarction.PSI-HHS-000002208944-45.PSI-HHS-000002208944-45Read PDF (page 3) →View as text → Referring to the FDA and CDC's discussion on myocardial events, Szarfman writes, "I am not astonished that MGPS was unable to detect these signals."PSI-HHS-000002208944.PSI-HHS-000002208944Read PDF (page 3) →View as text → She reiterates that one month ago, "we documented that RGPS signals [acute myocardial infarction]."Id.PSI-HHS-000002208944Read PDF (page 3) →View as text →
Szarfman alerts Forshee, a high-ranking CBER official, about her findings on statistically significant safety signals for acute myocardial infarction and invites him to collaborate with her on her upcoming paper about masking.Id.PSI-HHS-000002208944Read PDF (page 3) →View as text → It is unclear whether Forshee responds.Id.PSI-HHS-000002208944Read PDF (page 3) →View as text →
Sens. Johnson and Lee write to CDC Director Walensky and FDA Acting Commissioner Woodcock raising concerns about reports of adverse events following COVID-19 vaccination.
Sen. Johnson and Sen. Mike Lee send a letter to CDC Director Dr. Rochelle Walensky and FDA Acting Commissioner Dr. Janet Woodcock raising concerns about several hundred individuals who reported experiencing an adverse event after receiving a COVID-19 vaccine.External source →
Szarfman writes Forshee that RGPS shows statistically significant mortality signals for Pfizer and Moderna vaccines.
Following her July 9 phone call, Szarfman writes Forshee, "As we talked over the phone, I became aware last Fri[day] that scientists from Cornell are concerned of an increased mortality signal with the COVID-19 vaccines."PSI-HHS-000004592364-65 (with attachment).PSI-HHS-000004592364-65Read document → Szarfman encloses DuMouchel's earlier RGPS analysis, showing statistically significant safety signals for "death and sudden death" associated with the Pfizer and Moderna COVID-19 vaccines.Id. (emphasis added).PSI-HHS-000004592364-65Read document → She writes that the method DuMouchel used "automatically unmask[s] signals that remain hidden by other data mining methodologies, including MGPS[,]" FDA's current data mining methodology.Id. That same day, Forshee forwards Szarfman's email and DuMouchel's analysis to Anderson. PSI-HHS-000004590546-47 (with attachment).PSI-HHS-000004590546-47Read document →
Forshee forwards Szarfman's mortality findings to Marks, expressing concern about her interpretation.
Forshee documents his contact with Szarfman and forwards her email and DuMouchel's analysis to Marks, noting that "she and Bill DuMouchel had found an increased risk of mortality following COVID-19 vaccination using data mining methods."PSI-HHS-000004588545-46 (with attachment); PSI-HHS-000004592364-65 (with attachment).PSI-HHS-000004588545-46; PSI-HHS-000004592364-65Read document → Forshee writes that he is "very concerned" with how Szarfman and DuMouchel may be interpreting their findings.PSI-HHS-000004588545-46.PSI-HHS-000004588545-46Read PDF (page 39) →View as text → Marks thanks Forshee for "documenting this" and tells Forshee that he "will follow up appropriately."PSI-HHS-000002199145.PSI-HHS-000002199145Read PDF (page 1) →View as text →
Sen. Johnson writes to Collins, Walensky, and Woodcock about vaccine safety monitoring systems described in the October 2020 VRBAC meeting.
Sen. Johnson sends a letter to NIH Director Dr. Francis Collins, CDC Director Dr. Rochelle Walensky, and FDA Acting Commissioner Dr. Janet Woodcock regarding vaccine safety monitoring systems described in the October 2020 VRBAC meeting. Sen. Johnson writes, "Unfortunately, your agencies' lack of response to congressional oversight letters, combined with my discussions with agency officials and individuals who believe they have experienced vaccine injuries, leads me to believe the preauthorization safety surveillance hype does not appear to match the agencies' actual performance."External source →
Menschik informs CDC officials that FDA will limit distribution of its data mining reports for data security reasons.
Menschik informs CDC officials that FDA will limit its distribution of its data mining reports "largely for data security reasons."PSI-HHS-000005524064.PSI-HHS-000005524064Read PDF (page 122) →View as text →
Szarfman tells Commonwealth contractor that the 20-year-old MGPS model could potentially mask signals.
Szarfman attends a call with Commonwealth, the contractor that runs FDA's data mining system, and raises concerns about the current methodology.PSICOVID_00017545.PSICOVID_00017545Read PDF (page 188) →View as text → Szarfman reportedly tells the contractor that "'the 20-year-old MGPS model could potentially mask signals.'"Id.PSICOVID_00017545Read PDF (page 188) →View as text → Baer, who participated on the call, reports Szarfman's comments to Zinderman and Menschik and informs them that she told Szarfman that Zinderman and Menschik are aware of her considerations.Id.PSICOVID_00017545Read PDF (page 188) →View as text →
FDA approves the BLA for Pfizer's Comirnaty COVID-19 vaccine for ages 16 and older.
FDA approves the Biologics License Application (BLA) for Pfizer's Comirnaty COVID-19 vaccine for ages 16 and older.BLA approval, Food and Drug Admin., Aug. 23, 2021; COVID-19 Timeline, Centers for Disease Control and Prevention, https://www.cdc.gov/museum/timeline/covid19.html.External source →
Citations:
BLA approval, Food and Drug Admin., Aug. 23, 2021; COVID-19 Timeline, Centers for Disease Control and Prevention, https://www.cdc.gov/museum/timeline/covid19.html.
Szarfman clarifies masking concerns to Commonwealth and reiterates RGPS advantages over MGPS.
Commonwealth employees Brian Hendrix and James Sydnor follow up with Szarfman from an earlier conversation, informing her that for questions regarding data mining runs, she needs to speak with Menschik or Baer directly.PSI-HHS-000008254473-74.PSI-HHS-000008254473-74Read PDF (page 157) →View as text → Szarfman clarifies her masking concerns with the contractors, writing, "[t]herefore the background will only be for covid-19 vaccines, instead of for other vaccines. Therefore, masking covid-19 vaccine signals that are common with these vaccines, but not common across other types of vaccines."PSI-HHS-000008254472 (emphasis added).PSI-HHS-000008254472Read PDF (page 156) →View as text →
Hendrix responds to Szarfman, adding Menschik and Baer to the email chain for their awareness.Id.PSI-HHS-000008254472Read PDF (page 156) →View as text → Szarfman replies directly to Menschik, reiterating the advantages of RGPS compared to MGPS.PSI-HHS-000008254471.PSI-HHS-000008254471Read PDF (page 155) →View as text → She explicitly writes, "RGPS is much, much better at unmasking signals than MGPS. It automatically identifies and corrects for confounders. This is an important function to have, given the pandemic situation."Id. (emphasis added).PSI-HHS-000008254471Read PDF (page 155) →View as text →
Menschik tells Szarfman that VAERS data mining is CBER's responsibility and discussions must stay in chain of command.
Menschik and Zinderman draft a response to Szarfman's previous email, which Menschik sends to her.PSI-HHS-000008253098; PSI-HHS-000008253959; PSI-HHS-000008252951; PSI-HHS-000008253958; PSI-HHS-000008267103; PSI-HHS-000008254470.PSI-HHS-000008253098; PSI-HHS-000008253959; PSI-HHS-000008252951; PSI-HHS-000008253958; PSI-HHS-000008267103; PSI-HHS-000008254470Read PDF (page 136) →View as text → In his email, Menschik underscores that VAERS data mining is CBER's responsibility and must be only conducted through that office (Szarfman is a CDER employee, not a CBER employee).PSI-HHS-000008254470.PSI-HHS-000008254470Read PDF (page 154) →View as text → Menschik acknowledges a limited issue with MGPS, separate from masking, that he plans to review further within CBER.Id.PSI-HHS-000008254470Read PDF (page 154) →View as text → He also writes, "[a]ny further discussion on VAERS data mining methods/findings outside my chain of command will have to be offline and in general terms, as well as without reference to any specific VAERS [adverse events]."Id. (emphasis added).PSI-HHS-000008254470Read PDF (page 154) →View as text →
PSI-HHS-000008253098; PSI-HHS-000008253959; PSI-HHS-000008252951; PSI-HHS-000008253958; PSI-HHS-000008267103; PSI-HHS-000008254470Read PDF (page 136) →View as text →
Anderson asks Marks that Szarfman refrain from using FDA email or communicating findings using CBER VAERS data.
Anderson and Nair draft an email regarding Szarfman's data mining activities that Anderson eventually sends to Marks.PSICOVID_00014054-55; PSI-HHS-000002213753-54.PSICOVID_00014054-55; PSI-HHS-000002213753-54Read PDF (page 91) →View as text →
In the email, Anderson takes issue with Szarfman's efforts and access to CBER data "given that she is a CDER employee."PSI-HHS-000002213753-54.PSI-HHS-000002213753-54Read PDF (page 26) →View as text → He notes, "we have concerns about her communicating data mining findings using CBER VAERS data to CBER and non-CBER personnel."Id.PSI-HHS-000002213753-54Read PDF (page 26) →View as text → Anderson requests that Szarfman "refrain[s] from using her FDA email or communicating data mining findings using CBER VAERS data[.]"Id.PSI-HHS-000002213753-54Read PDF (page 26) →View as text →
Anderson appears to acknowledge the masking issue Szarfman has previously raised.Id.PSI-HHS-000002213753-54Read PDF (page 26) →View as text → Rather than take immediate steps to adjust FDA's system to address Szarfman's concerns, Anderson suggests taking a "retrospective approach" to determine if safety signals were missed only after receiving reports of adverse events through active surveillance systems.Id.PSI-HHS-000002213753-54Read PDF (page 26) →View as text → Given that FDA failed to detect the safety signal for myocarditis months earlier, it is unclear what further evidence was needed to trigger a reevaluation of FDA's current data mining system.See Chairman Ron Johnson, Failure to Warn: How Federal Health Agencies Downplayed the Risk of Myocarditis and Other Adverse Events Following COVID-19 Vaccination, Permanent Subcomm. on Investigations, May 21, 2025.External source →
See Chairman Ron Johnson, Failure to Warn: How Federal Health Agencies Downplayed the Risk of Myocarditis and Other Adverse Events Following COVID-19 Vaccination, Permanent Subcomm. on Investigations, May 21, 2025.
Marks tells Cavazzoni that Szarfman has been asked to cease and desist on her vaccine analysis.
Marks forwards Anderson's write-up about Szarfman's data mining efforts to CDER Director Patrizia Cavazzoni, to whom Szarfman reports, and writes, "I really am sorry to bother you with this, but issue is [sic] become a major distraction. . . . Ana Szarfman[] has decided on her own to do vaccine analysis using VAERS as part of her work at FDA. She is, however, not doing this in collaboration with our CBER statisticians, and quite to the contrary, has been asked to cease and desist, because the strategy that she is using could create erroneous conflicts that feed in to anti-vaccination rhetoric."PSI-HHS-000002213753 (emphasis added).PSI-HHS-000002213753Read PDF (page 26) →View as text →
CDER Office of New Drugs Director Peter Stein replies to Marks, "[T]hanks for flagging this – we've made it clear to her that she should not be discussing or providing internal analyses externally, and needs to focus on her assigned work." He closes his email, "Hopefully, you won't have further surprises…."PSI-HHS-000002213752-53 (ellipses in original).PSI-HHS-000002213752-53Read PDF (page 25) →View as text →
Menschik shares draft article language with CDC's Su that echoes Szarfman's masking concerns without crediting her.
Menschik writes to John Su, a CDC official and member of the Vaccine Safety Team and Vaccine Safety Technical Work Group, and identifies limitations within FDA's data mining system.PSI-HHS-000008268909.PSI-HHS-000008268909Read PDF (page 90) →View as text → Menschik describes the masking effect, the exact data limitation that Szarfman had been raising for months at FDA.Id.PSI-HHS-000008268909Read PDF (page 90) →View as text → Although Menschik does not credit Szarfman, he echoes her concerns in draft language he shares with Su for an article reviewing the safety of the COVID-19 vaccines.Id.PSI-HHS-000008268909Read PDF (page 90) →View as text →
Menschik's draft language notes that FDA's current data mining system "has multiple limitations," including that, "disproportionately scores . . . can be muted by COVID-19 vaccine reports contributing substantially to the comparator group, particularly if both mRNA COVID-19 vaccines are associated with the same adverse event."Id. (emphasis added).PSI-HHS-000008268909Read PDF (page 90) →View as text → Menschik tells Su he is "happy" to discuss further by phone.Id.PSI-HHS-000008268909Read PDF (page 90) →View as text →
Su acknowledges the concern in a response email, noting that signal detection with VAERS data "has always been tricky business" and that those who work with VAERS frequently are "mindful of those limitations[.]"Id.PSI-HHS-000008268909Read PDF (page 90) →View as text →
Sen. Johnson writes to Collins, Walensky, Woodcock, Marks, and Shimabukuro about federal safety surveillance systems and reports of adverse events following COVID-19 vaccination.
Sen. Johnson sends a letter to NIH Director Dr. Francis Collins, CDC Director Dr. Rochelle Walensky, FDA Acting Commissioner Dr. Janet Woodcock, Dr. Peter Marks (Director of the Center for Biologics Evaluation and Research at FDA), and Dr. Tom Shimabukuro (Deputy Director of the Immunization Safety Office at CDC) regarding federal health agencies' safety surveillance systems and reports of adverse events following COVID-19 vaccination.External source →
FDA expands EUA for the Pfizer COVID-19 vaccine for children ages 5-11.
FDA expands EUA for the Pfizer COVID-19 vaccine for children ages 5-11.FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age, Food and Drug Admin., Oct. 29, 2021.External source →
Citations:
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age, Food and Drug Admin., Oct. 29, 2021.
Sen. Johnson writes to Woodcock and Walensky about specific "hot lots" of COVID-19 vaccines associated with increased reports of adverse events.
Sen. Johnson sends a letter to FDA Acting Commissioner Dr. Janet Woodcock and CDC Director Dr. Rochelle Walensky regarding specific "hot lots" of COVID-19 vaccines associated with increased reports of adverse events.External source →
FDA grants EUA for Pfizer boosters for children 12-15 and a third dose for immunocompromised 5-11.
FDA grants EUA for Pfizer COVID-19 boosters for children ages 12-15 and a third primary series dose for children ages 5-11 who are immunocompromised.COVID-19 Timeline, Centers for Disease Control and Prevention.External source →
Citations:
COVID-19 Timeline, Centers for Disease Control and Prevention.
Sen. Johnson leads a roundtable, "COVID-19: A Second Opinion," documenting 1.05 million adverse events and 22,000 deaths connected to the COVID-19 vaccines.
Sen. Johnson leads a roundtable entitled, "COVID-19: A Second Opinion." At the event, Sen. Johnson documents 1.05 million adverse events, and 22,000 deaths connected to the COVID-19 vaccines.External source →
Walinsky circulates Szarfman's preprint to FDA officials weighing Moderna's pediatric COVID-19 vaccine appeal.
Following FDA's apparent decision "not to reconsider authorization" of Moderna's COVID-19 vaccine EUA for adolescents ages 12-17, FDA official Sarah Walinsky sends an invitation for a virtual meeting to Marks and other FDA officials to discuss how to respond to Moderna's appeal.PSI-HHS-000001617192-93; PSI-HHS-000001626344-45; PSI-HHS-000001626448-49.PSI-HHS-000001617192-93; PSI-HHS-000001626344-45; PSI-HHS-000001626448-49Read PDF (page 34) →View as text → Walinsky attaches several items to the meeting invitation, including a recent email between FDA officials discussing how to respond to Moderna and whether FDA should push Moderna "towards a BLA submission instead of an EUA submission."PSI-HHS-000001626344-45.PSI-HHS-000001626344-45Read PDF (page 36) →View as text → One FDA official notes that FDA's current draft response to Moderna appears to justify its decision not to authorize the vaccine because "there is not an emergency need for the Moderna vaccine for this pediatric population, especially given the data suggesting an increased myocarditis risk compared to the currently available vaccine for this population (Pfizer)."Id.PSI-HHS-000001626344-45Read PDF (page 36) →View as text →
Walinsky also attaches a preprint version of Szarfman's forthcoming paper, "Signaling COVID-19 Vaccine Adverse Events" (the finalized version of the earlier draft titled "Masking Associated with Early COVID-19 Vaccine Safety Surveillance"), which discusses the increased detection of the myocarditis signal for the COVID-19 vaccines when using the RGPS method.PSI-HHS-000001627327-77.PSI-HHS-000001627327-77Read PDF (page 44) →View as text → It is unclear why Walinsky circulated the preprint and whether the meeting took place.
Sen. Johnson writes to Walensky reiterating outstanding requests for COVID-19 information including data on adverse events and vaccine lot variation.
Sen. Johnson sends a letter to CDC Director Dr. Rochelle Walensky reiterating outstanding requests for information on COVID-19 including data on adverse events and vaccine lot variation data.External source →
Sen. Johnson writes to HHS Secretary Becerra, FDA Commissioner Califf, NIAID Director Fauci, and CDC Director Walensky highlighting more than 1 million VAERS reports of adverse events.
Sen. Johnson sends a letter to HHS Secretary Xavier Becerra, FDA Commissioner Dr. Robert Califf, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, and CDC Director Dr. Rochelle Walensky highlighting the over 1 million reports of adverse events on VAERS and what steps are being taken to address these reports. Sen. Johnson writes, "As of March 18, 2022, VAERS has received 1,183,495 worldwide reports of adverse events and 25,641 death reports. Of those deaths, 7,382 (28.8%) occurred on day 0, 1, or 2 following vaccination."External source →
FDA issues EUAs for Moderna and Pfizer COVID-19 vaccines down to 6 months of age.
FDA issues EUAs for the Moderna COVID-19 vaccines to all children as young as 6 months old and the Pfizer COVID-19 vaccines to children ages 6 months to 4 years old.Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age, Food and Drug Admin., June 17, 2022.External source →
Citations:
Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age, Food and Drug Admin., June 17, 2022.
Sen. Johnson writes to Walensky requesting CDC produce vaccine safety data, including any EB data mining analyses created as part of its monitoring efforts.
Sen. Johnson sends a letter to CDC Director Dr. Rochelle Walensky requesting CDC provide vaccine safety data, including any EB data mining analyses, created as part of its vaccine safety monitoring efforts.External source →
Szarfman, DuMouchel, and co-authors publish 'Signaling COVID-19 Vaccine Adverse Events' in Drug Safety.
Authors including Szarfman and DuMouchel publish their paper on masking, titled "Signaling COVID-19 Vaccine Adverse Events," in the journal Drug Safety.Rave Harpaz et al., Signaling COVID-19 Vaccine Adverse Events, Drug Safety (2022).External source →
Citations:
Rave Harpaz et al., Signaling COVID-19 Vaccine Adverse Events, Drug Safety (2022).
FDA approves supplemental BLA for the Pfizer COVID-19 vaccine for children ages 12 to 15.
FDA approves supplemental BLA for the Pfizer COVID-19 vaccine, authorizing its use for children ages 12 to 15 years old.COVID-19 Timeline, Centers for Disease Control and Prevention; Supplement BLA approval, Food and Drug Admin., July 8, 2022, https://www.fda.gov/media/159727/download?attachment.External source →
Citations:
COVID-19 Timeline, Centers for Disease Control and Prevention; Supplement BLA approval, Food and Drug Admin., July 8, 2022, https://www.fda.gov/media/159727/download?attachment.
Zinderman sends what records suggest is FDA's final weekly COVID-19 vaccine data mining report.
Zinderman sends a weekly data mining report to his colleagues at FDA, including Menschik and Nair, and to a limited number of senior CDC officials, including Tom Shimabukuro and John Su.PSI-HHS-000001217046 (with attachment).PSI-HHS-000001217046Read document → Based on records reviewed by the Subcommittee, this appears to be the final weekly data mining report FDA distributes for the COVID-19 vaccines.
Szarfman emails her unmasking paper to Commissioner Califf, who replies, 'Thanks. These are good.'
Szarfman emails her paper "Signaling COVID-19 Vaccine Adverse Events" to then-FDA Commissioner Robert Califf, noting that it describes "advances in the data mining (DM) methodology, especially the capacity to unmask hidden signals due to previously unaccountable confounders[.]"PSI-HHS-000004461747-48.PSI-HHS-000004461747-48Read PDF (page 28) →View as text → Upon receipt of this and another article, Califf replies, "Thanks. These are good."Id.PSI-HHS-000004461747-48Read PDF (page 28) →View as text →
Sen. Johnson writes to Walensky reiterating his June 23, 2022 request for vaccine safety data, including EB data mining analyses.
Sen. Johnson sends a letter to CDC Director Dr. Rochelle Walensky reiterating his request for the June 23, 2022 vaccine safety data, including EB data mining analyses.External source →
Menschik confirms FDA is no longer routinely sending COVID-19 vaccine data mining to CDC.
In response to an FDA official's question about sending COVID-19 vaccine data mining to CDC, Menschik confirms to his FDA colleagues, "[W]e are no longer routinely sending COVID data mining to CDC[.]"PSI-HHS-000008266854.PSI-HHS-000008266854Read PDF (page 81) →View as text → Menschik notes that Nair had previously discussed this decision with CDC official Shimabukuro.Id. After Menschik informs his colleagues that FDA is no longer routinely sending the data mining to CDC, one FDA official responds, "I was also hoping we would stop doing that at some point!" Id.PSI-HHS-000008266854Read PDF (page 81) →View as text →
Id. After Menschik informs his colleagues that FDA is no longer routinely sending the data mining to CDC, one FDA official responds, "I was also hoping we would stop doing that at some point!" Id.
Forshee notifies Marks and Anderson that FDA officials are addressing issues with Szarfman's published paper.
Forshee writes to Marks and Anderson, notifying them that Szarfman is a co-author on "Signaling COVID-19 Vaccine Adverse Events."PSI-HHS-000004594929; Forshee attaches Marks' September 2021 email to Szarfman's supervisors Cavazzoni and Stein. PSI-HHS-000004604858-59.PSI-HHS-000004594929; PSI-HHS-000004604858-59Read PDF (page 43) →View as text → He references that they are discussing best ways to address "a number of issues with the paper and its findings[.]"PSI-HHS-000004594929.PSI-HHS-000004594929Read PDF (page 43) →View as text → Forshee references Szarfman's earlier efforts in 2021 raising concerns about FDA's current data mining system.Id.; PSI-HHS-000004604858-59.PSI-HHS-000004604858-59Read PDF (page 44) →View as text →
Citations:
PSI-HHS-000004594929; Forshee attaches Marks' September 2021 email to Szarfman's supervisors Cavazzoni and Stein. PSI-HHS-000004604858-59.
Sen. Johnson writes to Walensky in response to CDC producing only public Proportional Reporting Ratio analyses and failing to respond to requests for EB data mining analyses.
Sen. Johnson sends a letter to CDC Director Dr. Rochelle Walensky in response to CDC producing only public Proportional Reporting Ratio analyses and failing to respond to requests for EB data mining analyses.External source →
Nair tells colleagues he suggested CDC discontinue the routine weekly data mining emails.
Nair writes to his FDA colleagues that he suggested to CDC earlier that summer that "we discontinue the routine regular [weekly data mining] emails."PSI-HHS-000001160286.PSI-HHS-000001160286Read PDF (page 13) →View as text → Nair adds, "[t]his was intended as a timesaving measure and to reduce email traffic."Id.PSI-HHS-000001160286Read PDF (page 13) →View as text → He informs colleagues that FDA decided to end the weekly reporting email because "it had been some time that we had had a data mining alert that required further evaluation, CDC agreed with this approach."Id.PSI-HHS-000001160286Read PDF (page 13) →View as text → Nair noted, however, that "FDA is still regularly conducting data mining for all approved/authorized vaccines."Id.; Per Chairman Johnson's March 23, 2026 highlighting the FDA's detection of ischemic stroke following COVID-19 vaccination, it appears FDA did regularly conduct data mining runs. Letter from Sen. Ron Johnson, Permanent Subcomm. on Investigations to Robert Kennedy, Secretary, Dep't of Health and Human Services, March 23, 2026.External source →
Id.; Per Chairman Johnson's March 23, 2026 highlighting the FDA's detection of ischemic stroke following COVID-19 vaccination, it appears FDA did regularly conduct data mining runs. Letter from Sen. Ron Johnson, Permanent Subcomm. on Investigations to Robert Kennedy, Secretary, Dep't of Health and Human Services, March 23, 2026.
CDC officials discuss the end of weekly FDA reports; one notes CDC may have asked FDA to stop because of FOIAs.
CDC officials discuss how they no longer receive weekly data mining reports from FDA.PSI-HHS-000002480132.PSI-HHS-000002480132Read PDF (page 32) →View as text → One official notes, "I think that because of the FOIAs [Freedom of Information Act requests] we may have asked FDA to stop sending these weekly data mining outputs."Id. (emphasis added).PSI-HHS-000002480132Read PDF (page 32) →View as text → A CDC official eventually writes to Menschik requesting the most recent data mining report.PSICOVID_00015642-43.PSICOVID_00015642-43Read PDF (page 125) →View as text →
Menschik argues against sharing FDA data mining output with CDC, citing concerns about misuse and over-reliance.
Menschik emails Nair about how to respond to CDC's request.Id.PSICOVID_00015642-43Read PDF (page 125) →View as text → Menschik notes that FDA has "concerns about sharing our data mining output externally given history including over reliance on data mining output[.]"Id. (emphasis added).PSICOVID_00015642-43Read PDF (page 125) →View as text →
Menschik warns that data mining results may be "misconstrued" because the detection of "signals," or lack thereof, could lead to a false conclusion.Id.PSICOVID_00015642-43Read PDF (page 125) →View as text → In addition to the masking limitations, Menschik argues against sharing the data CDC requested and states that FDA's "standard practice" relies on "assigned reviewers" to evaluate potential safety findings "in the context of other available data" prior to sharing any safety signal information.Id.PSICOVID_00015642-43Read PDF (page 125) →View as text →
Nair responds to CDC framing data mining as hypothesis-generating and not, by itself, evidence of causation.
Nair responds to the CDC official, incorporating many of Menschik's points that appear to downplay FDA's reliance on EB data mining.PSICOVID_00014435.PSICOVID_00014435Read PDF (page 123) →View as text → Nair writes, "Results from data mining are considered hypothesis generating and do not, by themselves, demonstrate causal associations."Id.PSICOVID_00014435Read PDF (page 123) →View as text → He adds that little can be attained from the presence or absence of a safety signal, and notes that even the use of the terms "signal and/or safety signal have certain connotations and may trigger actions so we try not [sic] conflate data mining alerts with signals."Id.PSICOVID_00014435Read PDF (page 123) →View as text →
Sen. Johnson leads a roundtable, "COVID-19 Vaccines: What They are, How they Work, and Possible Causes of Injuries," documenting 1.47 million adverse events and 32,000 deaths.
Sen. Johnson leads a roundtable entitled, "COVID-19 Vaccines: What They are, How they Work, and Possible Causes of Injuries." At the event, Sen. Johnson documents 1.47 million adverse events, and 32,000 deaths connected to the COVID-19 vaccines.External source →
Sen. Johnson writes to Walensky reiterating requests for EB data mining analyses and other vaccine safety data first requested in June 2022.
Sen. Johnson sends a letter to CDC Director Dr. Rochelle Walensky reiterating requests for EB data mining analyses and other vaccine safety data first requested in June 2022.External source →
Sen. Johnson writes to Becerra and HRSA Administrator Carole Johnson regarding Countermeasures Injury Compensation Program claims by individuals for COVID-19 vaccine injuries.
Sen. Johnson sends a letter to HHS Secretary Xavier Becerra and Carole Johnson, Administrator of the Health Resources and Services Administration, regarding Countermeasures Injury Compensation Program claims by individuals for COVID-19 vaccine injuries.External source →
Sen. Johnson writes to FDA Commissioner Califf requesting FDA produce all EB data mining analyses related to the COVID-19 vaccines.
Sen. Johnson sends a letter to FDA Commissioner Dr. Robert Califf requesting FDA produce all EB data mining analyses related to the COVID-19 vaccines.External source → On the same day, Sen. Johnson also sends a letter to HHS Secretary Xavier Becerra reiterating requests for information on CICP claims by individuals reporting vaccine injuries following a COVID-19 vaccine.External source →
Sen. Johnson writes to Califf, Becerra, CDC Director Cohen, and NIH Acting Director Tabak reiterating earlier requests and seeking information on myocarditis and pericarditis after vaccination.
Sen. Johnson sends a letter to FDA Commissioner Dr. Robert Califf, HHS Secretary Xavier Becerra, CDC Director Dr. Mandy Cohen, and NIH Acting Director Dr. Lawrence Tabak reiterating earlier requests for vaccine safety information and requesting additional vaccine safety information, including information on myocarditis and pericarditis after vaccination.External source →
Nair tells Harvard's Maro that FDA was aware of the masking limitation before and during the pandemic.
Nair responds to concerns about masking in FDA's data mining system raised by Judy Maro, a Harvard professor working with FDA and CDC officials.PSI-HHS-000001136460-64.PSI-HHS-000001136460-64Read PDF (page 3) →View as text → In his response, he writes:
We were aware of this limitation before and during the pandemic. There are many data mining tools and there was some discussion about utilizing a novel tool to adjust for this. However, we thought it would be problematic to use a brand new, possibly unvalidated tool in the context of an EUA. We ended up using the same EBGM [Empirical Bayes Geometric Mean] data mining we use for all vaccines and has a long history of use rather than take an experimental approach.PSI-HHS-000001136460 (emphasis added).PSI-HHS-000001136460Read PDF (page 3) →View as text →
Sen. Johnson writes to Becerra, Califf, and Cohen highlighting that deaths per million doses of COVID-19 vaccines are approximately 55 times greater than for flu vaccines and requesting all PRR and EB data mining analyses.
Sen. Johnson sends a letter to HHS Secretary Xavier Becerra, FDA Commissioner Dr. Robert Califf, and CDC Director Dr. Mandy Cohen highlighting that the deaths per million doses of COVID-19 vaccines are approximately 55 times greater than for deaths per million doses of flu vaccines and requesting all Proportional Reporting Ratio and EB data mining analyses for the COVID-19 vaccines.External source →
Sen. Johnson writes to Califf and Cohen highlighting higher rates of adverse events connected to specific manufacture lots of COVID-19 vaccine and reiterating December requests for EB data mining.
Sen. Johnson sends a letter to FDA Commissioner Dr. Robert Califf and CDC Director Dr. Mandy Cohen highlighting the issue of higher rates of adverse events connected to specific manufacture lots of COVID-19 vaccine and reiterating requests from December, including the request for all EB data mining analysis on COVID-19 vaccines.External source →
FDA officials discuss the masking effect three years after Szarfman raised it; Baer points to her published paper.
Approximately three years after Szarfman raised concerns about the masking limitation in FDA's data mining system, FDA officials including Nair, Menschik, and Zinderman discuss the masking effect.PSI-HHS-000008261793-94.PSI-HHS-000008261793-94Read PDF (page 18) →View as text → Nair writes, "I know in the past we have discussed one of the possible limitations of data mining currently is the vast number of VAERS reports from the COVID vaccines may limit our ability to detect statistical alerts because disproportionality scores may be driven towards the null."Id.PSI-HHS-000008261793-94Read PDF (page 18) →View as text → Nair asks his colleagues if they know of any publications discussing the masking limitation of data mining.Id.PSI-HHS-000008261793-94Read PDF (page 18) →View as text →
In response to Nair, Zinderman writes, "I recall Anna [sic] talking about masking in the few interactions we had with her, but I don't remember there being references."PSI-HHS-000008261793.PSI-HHS-000008261793Read PDF (page 18) →View as text →
Following Zinderman's email, Baer writes to Menschik only and attaches the "Signaling COVID-19 Vaccine Adverse Events" paper coauthored by Szarfman and DuMouchel.PSI-HHS-000008263353.PSI-HHS-000008263353Read PDF (page 63) →View as text → She attaches the paper for Menschik's consideration because she believes it could be relevant to Nair's request for public references to the masking limitation.Id.; PSI-HHS-000008261793.PSI-HHS-000008261793Read PDF (page 18) →View as text → She follows up later that day providing two specific examples of articles cited in Szarfman's and DuMouchel's paper but defers to Menschik on whether to share with Nair.PSI-HHS-000008261793.PSI-HHS-000008261793Read PDF (page 18) →View as text →
Later, Menschik responds to Nair's original email and recalls providing the CDC with language addressing the masking issue for a draft safety article, but "it now appears that they took it out before publication."PSI-HHS-000001152913.PSI-HHS-000001152913Read PDF (page 11) →View as text → This is likely a reference to the draft language Menschik previously shared with CDC official Su on Sept. 22, 2021.PSI-HHS-000008268909.PSI-HHS-000008268909Read PDF (page 90) →View as text → It is unclear whether Menschik provides the articles Baer sent to him.
Sen. Johnson writes to Califf and Cohen about a study finding increased all-cause mortality after Moderna mRNA COVID-19 vaccination and requests mortality data.
Sen. Johnson sends a letter to FDA Commissioner Dr. Robert Califf and CDC Director Dr. Mandy Cohen regarding a study finding increased all-cause mortality following receipt of the Moderna mRNA COVID-19 vaccine and requesting mortality data related to COVID-19 vaccines from federal health agencies.External source →
Baer tells Menschik RGPS yields significantly higher signals than MGPS; Menschik concurs but prefers to keep MGPS.
Following a discussion about data mining with Oracle contractors, Baer writes to Menschik about the RGPS algorithm.PSI-HHS-000008253424.PSI-HHS-000008253424Read PDF (page 142) →View as text → Baer notes that when she compared results of the RGPS and MGPS models for the Gardasil vaccine, the RGPS model yielded "significantly higher" numbers than the MGPS model for certain adverse events.Id. It is unclear what adverse events Baer reviewed that were associated with the Gardasil vaccine.PSI-HHS-000008253424Read PDF (page 142) →View as text → She also found that the RGPS numbers were higher than MGPS numbers for certain adverse events associated with the Pfizer COVID-19 bivalent vaccine.Id. It is also unclear what adverse events Baer reviewed that were associated with the Pfizer COVID-19 bivalent vaccine.PSI-HHS-000008253424Read PDF (page 142) →View as text →
Baer mentions Szarfman's 2022 paper on the masking limitation and acknowledges that the lower numbers from the MGPS model were a result of masking.Id.PSI-HHS-000008253424Read PDF (page 142) →View as text → She writes, "I understand the theory behind masking and trying to adjust for it, but I feel that comprehending the details of the approach and, importantly, which approach is 'better,' is beyond my training and experience. I think someone with more data mining expertise would have to be involved in that decision."Id.PSI-HHS-000008253424Read PDF (page 142) →View as text →
In response, Menschik concurs with Baer's finding, writing that "in general the [RGPS model] appears way more sensitive in that its scores are generally higher than corresponding [MGPS model] scores when sampling different [adverse events]."Id.PSI-HHS-000008253424Read PDF (page 142) →View as text → Despite acknowledging that RGPS addresses the masking limitation of MGPS, Menschik expresses a preference for continuing to use MGPS.Id.PSI-HHS-000008253424Read PDF (page 142) →View as text →
Sen. Johnson writes to Becerra, Califf, and Cohen about heavily redacted FOIA records on myocarditis and pericarditis after mRNA COVID-19 vaccination, requesting unredacted copies.
Sen. Johnson sends a letter to HHS Secretary Xavier Becerra, FDA Commissioner Dr. Robert Califf, and CDC Director Dr. Mandy Cohen highlighting heavily redacted records released through the Freedom of Information Act (FOIA) connected to federal health agencies' knowledge of the risks of myocarditis and pericarditis following an mRNA COVID-19 vaccine and requesting unredacted copies of these records.External source →
Sen. Johnson writes to Becerra, Califf, and Cohen about additional heavily redacted FOIA records on myocarditis and pericarditis, requesting unredacted copies.
Sen. Johnson sends a letter to HHS Secretary Xavier Becerra, FDA Commissioner Dr. Robert Califf, and CDC Director Dr. Mandy Cohen highlighting additional heavily redacted FOIA records connected to federal health agencies' knowledge of the risks of myocarditis and pericarditis following an mRNA COVID-19 vaccine and requesting unredacted copies of these records.External source →
PSI releases its prior interim report "Failure to Warn," detailing how federal health officials knew about myocarditis and pericarditis risks after mRNA COVID-19 vaccination and failed to alert the public.
PSI releases its interim report titled, "Failure to Warn: How Federal Health Agencies Downplayed the Risk of Myocarditis and Other Adverse Events Following COVID-19 Vaccination," detailing how federal health officials knew about the risks of myocarditis and pericarditis after an mRNA COVID-19 vaccine and failed to properly alert the public to those risks.External source →
Sen. Johnson writes to HHS Secretary Kennedy regarding Dr. Vinay Prasad's memorandum on deaths of children following a COVID-19 vaccine.
Sen. Johnson sends a letter to Secretary of HHS Robert F. Kennedy, Jr. regarding Dr. Vinay Prasad's, the Director of the Center for Biologics Evaluation and Research, memorandum on deaths of children following a COVID-19 vaccine.External source →
Sen. Johnson writes to HHS Secretary Kennedy detailing findings that federal health officials in late 2022 identified, then ignored and downplayed, a risk of ischemic stroke in seniors who received the Pfizer bivalent booster, and raising concerns about masking in EB data mining.
Sen. Johnson sends a letter to Secretary of HHS Robert F. Kennedy, Jr. detailing findings that in late 2022, federal health officials identified, and subsequently ignored and downplayed, a risk of ischemic stroke in individuals age 65 years and older who received the Pfizer COVID-19 bivalent booster and raising concerns about masking in EB data mining used to monitor COVID-19 vaccine safety.External source →
The Permanent Subcommittee on Investigations holds its public hearing, "Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals," with testimony from David Wiseman, Karl Jablonowski, and Maria Young.
The U.S. Senate Permanent Subcommittee on Investigations, chaired by Sen. Ron Johnson, holds a public hearing titled "Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals." The hearing examines federal officials' awareness of, and response to, masking in FDA's Empirical Bayes data mining of VAERS during the COVID-19 vaccine rollout. Witnesses include David Wiseman, PhD, MRPharmS, an independent medical researcher whose September 2025 preprint identified masking and other limitations in EB data mining; Karl Jablonowski, PhD, a Senior Research Scientist at Children's Health Defense who testified on systemic pharmacovigilance failures during the COVID-19 era; and Maria Young, a COVID-19 ARDS and ECMO survivor and patient advocate who shared her experience and continued support for vaccination.
