Claim: A Twitter user claims that the Pfizer vaccine has 1,291 side effects.
Our findings and the document referenced in the article only contains the list of Adverse Events of Special Interest (AESI) Pfizer considered during its pharmacovigilance activities, not the side effects of the vaccine.
A Twitter user Deez (@Deezeytop) shared the link to a story that claims the Pfizer vaccine has 1,291 side effects.
He made this claim while responding to a Tweet by DUBAWA that Nicki Minaj’s claim on COVID-19 vaccine side effects is false and misleading.
Deez requested that the tweet by DUBAWA be removed as it was spreading misinformation claiming the U.S. Food and Drug Administration (FDA) has confirmed these side effects.
“You’re spreading misinformation, please remove this tweet. It has been confirmed via the FDA” the Tweet read.
We looked at the story by The Rio Times attached to the Tweet and found the document that revealed the said side effects linked in the report.
Studying the document, we first observed that this document titled “cumulative analysis of post-authorization adverse reports of PF-07302048 (BNT162B2)” was a 2021 document.
The document showed that there were a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events.
“Cumulatively, through 28 February 2021, there were a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Most cases (34,762) were received from United States (13,739), United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866) and Spain (756); the remaining 7,324 were distributed among 56 other countries.”
The document also contained the list of Adverse Events of Special Interest (AESI). This is found under Appendix 1, page 30-38 of the document. It includes events of interest due to their association with severe COVID-19 and events of interest for vaccines in general.
This list which includes a wide range of conditions is not the list of side effects of the Pfizer vaccine but the different possible effects considered in its pharmacovigilance activities (the collection and assessment of safety related information to determine the benefit/risk impact).
“The company’s AESI list takes into consideration the lists of AESIs from the following expert groups and regulatory authorities: Brighton Collaboration (SPEAC), ACCESS protocol, US CDC (preliminary list of AESI for VAERS surveillance), MHRA (unpublished guideline).
“The AESI terms are incorporated into a TME list and include events of interest due to their association with severe COVID-19 and events of interest for vaccines in general. The AESI list comprises MedDRA PTs, HLTs, HLGTs or MedDRA SMQs and can be changed as appropriate based on the evolving safety profile of the vaccine,”the document read.
From the document’s discussion, its data did not reveal any new safety concerns and the only safety concern identified is the risk of anaphylaxis (a severe and potentially life threatening allergic reaction).
“The data do not reveal any novel safety concerns or risks requiring label changes and support a favourable benefit risk profile of the BNT162b2 vaccine. Review of the available data for this cumulative PM experience, confirms a favourable benefit: risk balance for BNT162b2.”
The document assures that Pfizer will continue routine pharmacovigilance activities on behalf of BioNTech according to the Pharmacovigilance agreement in place, in order to assure patient safety and will inform the Agency if an evaluation of the safety data yields significant new information for BNT162b2.
Since the Twitter user claims this was confirmed by the FDA, we checked out FDA’s reports. We found a report on Monday, January 03, 2022, which amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to expand its eligibility to include the use of a single booster dose in individuals 12 and older at least 5 months after primary vaccination.
The FDA had given approval for the Pfizer-BioNTech COVID-19 Vaccine, for the prevention of COVID-19 in individuals 16 years of age and older in August, 2021.
The approval and subsequent update of its EUA shows the FDA still recommends the Pfizer vaccine as safe and effective.
We also looked at the Centre for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) published in March, 2022. The report shows two doses of the Pfizer-BioNTech vaccine protect against COVID-19–associated emergency department and urgent care encounters among children and adolescents.
It, however, revealed that vaccine effectiveness (VE) was lower during Omicron predominance and decreased with time since vaccination.
The centre still advises that all eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations, including a booster dose for those aged 12–17 years.
The World Health Organisation report on the Pfizer vaccine, which was last updated January 2022, did not point to any 1,291 side effects. It only addressed anaphylaxis as the only cause to discontinue the vaccine.
A keyword search led to the same report by The Rio Times, The South African and other similar reports.
We also found a fact-check by TechArp which noted that the claim that the Pfizer vaccine has 1,291 side effects is based on the list of adverse events of special interest on the document.
So far the known side effects identified by the CDC, WHO, and the National Health Service (NHS), include; pain, redness or swelling in the arm where the shot was given and tiredness, headache, muscle pain, chills, fever, and nausea throughout the rest of your body.
We also reached out to the FDA via email for more information, but were referred to different online resources.
Our findings, documents by relevant health organisations and details of the document linked to the Rio Times report does not show 1,291 side effects of the Pfizer vaccine. The only list contained in the document is that of Adverse Events of Special Interest (AESI) Pfizer considered during its pharmacovigilance activities. This makes the claim false.