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URLhttps://factcheck.afp.com/doc.afp.com.36ZP8RH
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First Indexed2025-03-13 19:11:12 (1 year ago)
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Meta TitlePosts falsely claim Pfizer published list of Covid-19 vaccine side effects | Fact Check
Meta DescriptionPfizer's Covid-19 vaccine is considered by healthcare authorities to be safe and effective, with data gathered from billions of shots delivered around the world. In February 2025, social media users started sharing what they claimed was a list released by Pfizer showing the vaccine’s dangerous side effects. But this is false; the conditions and illnesses in the list differ from the noted possible side effects compiled by regulators. European medicines agencies told AFP Fact Check that the vaccine’s safety is constantly monitored and information is regularly updated with expert findings. Pfizer denied releasing the list and said it did not reflect the vaccine’s established efficacy and safety.
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“Pfizer has just released its list of side effects of its ‘Covid-19 vaccine’,” reads an X post published on February 7, 2025. Among the purported side effects listed are several life-threatening conditions and diseases such as heart failure, liver damage and stroke. Screenshot of the false X post, taken on March 5, 2025 The claim appeared on Facebook and elsewhere on X, including in a post by Stella Immanuel, a Houston-based physician born in Cameroon who championed discredited treatments for Covid-19 throughout the pandemic. However, AFP Fact Check found no evidence that Pfizer publicly released any such list of vaccine side effects. Additionally, the purported Pfizer list does not match the official schedule of possible side effects compiled by health authorities worldwide. AFP Fact Check first  debunked the claim in Croatian. Fabricated list Limiting an internet search to Pfizer's website returned an August 2024 press release — a year after the World Health Organization  announced the pandemic was over.  The company wrote that the US Food and Drug Administration (FDA) had authorised the use of its Cominarty vaccine adapted specifically for the Omicron KP.2 variant (archived here ). Some of the false posts link to this statement as proof of their claims. The most recent press release on Pfizer's website mentioning the Comirnaty vaccine was posted on September 20, 2024, and it reports that the Committee for Medicinal Products for Human Use (CHMP) gave a  positive opinion for the Omicron KP.2-adapted Covid-19 vaccine in the European Union (archived here ) Only three side effects are common to official records and the false posts: facial paralysis (“rare”, according to the European Medicines Agency or EMA), and myocarditis and pericarditis (both considered “very rare” by health authorities) (archived here ). The false posts, on the other hand, claim there are several fatal and serious side effects, including cardiac arrest, sudden death, neonatal death, stroke, diabetes and epileptic psychosis — none of which have been certified by regulatory bodies. Up to date The Agency for Medicinal Products and Medical Devices of Croatia ( HALMED ) told AFP Fact Check on February 21, 2025, that drug manufacturers generally do not publish a “list of side effects”. Rather, they inform the regulatory agencies of any new information regarding approved medicines. “Marketing authorisation holders have a legal obligation to continuously monitor the safety profile of a medicine, including vaccines, for as long as the medicine or vaccine is on the market,” a HALMED spokesman said. “Accordingly, they are required to submit all new information and findings related to the medicine’s safety to the competent regulatory authorities for review and evaluation. In addition, regulatory authorities also receive reports of suspected side effects directly from patients and healthcare professionals.” HALMED noted that drug manufacturers are also compelled to periodically submit all collected data on the safety of medicines and vaccines in the so-called PSUR, or Periodic Safety Update Report. The most recent PSUR for Comirnaty – the brand name for Pfizer’s Covid vaccine – covered the second half of 2023, and the EMA issued its recommendations based on this document in July 2024 (archived  here ). EMA found that the risk-benefit balance remained unchanged and kept the authorisation for the vaccine. The next PSUR review procedure is expected to start this month. The EMA press office told AFP Fact Check that the most recent safety update to the product information took place in November 2024 , to include further information on the safety of vaccines in infants born to people vaccinated during pregnancy and immunocompromised participants (archived here ). The update added data from three scientific studies that found no new dangers or side effects. The EMA also noted that the agency, together with national healthcare authorities and manufacturers, is responsible for detecting and managing safety signals , which is any information on possible side effects that warrants further investigation (archived here ).  Once a signal is investigated, the Pharmacovigilance Risk Assessment Committee (PRAC) issues a recommendation on what to do if it suspects it might be a side effect (archived here and here ). All signals are publicly available (archived here ), and the process of recognising new side effects, as was the case with myocarditis and pericarditis, can be tracked in the table. According to the EMA, and as evidenced in the available data, the most recent safety signal reviewed was “postmenopausal haemorrhage”, which was considered in March 2024, but PRAC did not find sufficient evidence that it was linked to the Cominarty vaccine (archived here ). The most recent safety information on Covid-19 vaccines, including Comirnaty, states that all vaccines authorised for use in the EU are safe and effective (archived here ).  “Since December 2020, people in the EU and EEA received almost 1 billion doses of Covid-19 vaccines, making it the largest vaccination programme in history,” the EMA says on its website. “Regulators have an unprecedented amount of data to confirm the safety and efficacy of Covid-19 vaccines.” Pfizer also denied publishing the list circulating on social media. “Pfizer did not publish this list, which does not reflect the established efficacy and safety profile of the vaccine,” a spokesperson for the company told AFP Fact Check in an email. “With billions of doses of the vaccine administered around the world, the safety profile for the vaccine for all authorised groups continues to be favourable.” Misinterpreted adverse effects The purported side effects found in the false Facebook posts do correspond to a list from a 2021 Pfizer document (archived here ).  The document listed all adverse effects reported and recorded after vaccination in addition to a list of pre-specified medical problems that could theoretically be attributed to the vaccination. This list of adverse effects has previously been misinterpreted to be a list of confirmed side effects, which AFP Fact Check has already debunked  here in Croatian and here in Serbian. In September 2023, HALMED told AFP Fact Check that any incident following a vaccination does not necessarily mean it was caused by the jab. “Information about reports of suspected side effects does not mean that the medicine or active substance causes the observed effect or that it is unsafe for use,” the agency said. “Only a thorough review and scientific assessment of all available data allows for conclusions to be drawn about the benefits and risks of a medicine.” More AFP fact checks on the topic of vaccines can be found here , and on Covid-19 can be found here . March 14, 2025 Updated with link to Committee for Medicinal Products for Human Use and its positive opinion for Omicron KP.2-adapted Covid-19 vaccine in the EU
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[Skip to main content](https://factcheck.afp.com/doc.afp.com.36ZP8RH#main-content) [![Home](https://factcheck.afp.com/themes/custom/factuel/afp-logo-light.svg)](https://factcheck.afp.com/ "Home") [Fact Check](https://factcheck.afp.com/ "Home") - Search - [Contact](https://factcheck.afp.com/contact) Dark mode ##### Navigation principale - [Home](https://factcheck.afp.com/) - [About AFP](https://factcheck.afp.com/about-afp) - [How we work](https://factcheck.afp.com/How-we-work) - [Editorial & ethical standards](https://factcheck.afp.com/AFPs-editorial-and-ethical-standards) - [Fact-Checking Stylebook](https://factcheck.afp.com/afp-fact-checking-stylebook) - [Meet the team](https://factcheck.afp.com/Meet-team) - [Training](https://digitalcourses.afp.com/) - [Subscribe](https://www.afp.com/en/products/afp-fact-check?utm_source=AFP_Factuel&utm_medium=referral&utm_campaign=ALL-PDT-202303-Factcheck&utm_content=Banner) - [Contact](https://factcheck.afp.com/Contact) - [Corrections](https://factcheck.afp.com/corrections) - [FactCRICIS](https://factcheck.afp.com/FactCRICIS) Choose language - Search - [Contact](https://factcheck.afp.com/contact) ## Primary tabs - [View](https://factcheck.afp.com/doc.afp.com.36ZP8RH) [Toggle tabs as a menu](https://factcheck.afp.com/doc.afp.com.36ZP8RH) - [Revisions](https://factcheck.afp.com/node/65313/revisions) [Covid-19](https://factcheck.afp.com/list/Covid-19) [Vaccines](https://factcheck.afp.com/list/Vaccines) Share: ![](https://factcheck.afp.com/sites/default/files/medias/factchecking/g2/2025-03/71db6f308054ca0e5d377382f3b09d76-en.jpeg) # Posts falsely claim Pfizer published list of Covid-19 vaccine side effects - This article is more than one year old. - Published on March 11, 2025 at 16:23 - Updated on March 14, 2025 at 10:55 - 5 min read - By [Ivan FISCHER](https://factcheck.afp.com/ivan-fischer), [AFP Croatia](https://factcheck.afp.com/afp-croatia) - Translation and adaptation [Oluseyi AWOJULUGBE](https://factcheck.afp.com/oluseyi-awojulugbe), [AFP Nigeria](https://factcheck.afp.com/afp-nigeria) Pfizer's Covid-19 vaccine is considered by healthcare authorities to be safe and effective, with data gathered from billions of shots delivered around the world. In February 2025, social media users started sharing what they claimed was a list released by Pfizer showing the vaccine’s dangerous side effects. But this is false; the conditions and illnesses in the list differ from the noted possible side effects compiled by regulators. European medicines agencies told AFP Fact Check that the vaccine’s safety is constantly monitored and information is regularly updated with expert findings. Pfizer denied releasing the list and said it did not reflect the vaccine’s established efficacy and safety. “Pfizer has just released its list of side effects of its ‘Covid-19 vaccine’,” reads an X [post](https://perma.cc/39WQ-DUCJ) published on February 7, 2025. Among the purported side effects listed are several life-threatening conditions and diseases such as heart failure, liver damage and stroke. Image ![](https://factcheck.afp.com/sites/default/files/styles/image_in_article/public/medias/factchecking/g2/2025-03/2fa2b02c273bb14e84bf6d0b81b42013-en.jpeg?itok=Xy8w_bh3) Screenshot of the false X post, taken on March 5, 2025 The claim appeared on [Facebook](https://mvau.lt/media/5a2d9bbe-456f-4952-97a3-fc3d58641f81) and elsewhere on X, including in [a post](https://perma.cc/6WZS-46UW) by Stella Immanuel, a Houston-based physician born in Cameroon who championed [discredited](https://factcheck.afp.com/misleading-claims-resurface-online-about-hydroxychloroquines-efficacy-against-covid-19) treatments for Covid-19 throughout the pandemic. However, AFP Fact Check found no evidence that Pfizer publicly released any such list of vaccine side effects. Additionally, the purported Pfizer list does not match the official schedule of possible side effects compiled by health authorities worldwide. AFP Fact Check first [debunked](https://provjeracinjenica.afp.com/doc.afp.com.36YM67Y) the claim in Croatian. ### **Fabricated list** Limiting an internet search to Pfizer's website returned an August 2024 press release — a year after the World Health Organization [announced](https://www.pfizer.com/news/announcements/global-and-us-agencies-declare-end-covid-19-emergency) the pandemic was over. The company wrote that the US [Food and Drug Administration](https://www.fda.gov/) (FDA) had [authorised](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-authorization) the use of its Cominarty vaccine adapted specifically for the Omicron KP.2 variant (archived [here](https://web.archive.org/web/20240822210357/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-authorization)). Some of the false posts [link](https://perma.cc/Z269-CF23) to this statement as proof of their claims. The most recent press release on Pfizer's website mentioning the Comirnaty vaccine was [posted](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-positive-chmp-opinion-omicron-4) on September 20, 2024, and it reports that the Committee for Medicinal Products for Human Use (CHMP) gave a [positive opinion](https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp) for the Omicron KP.2-adapted Covid-19 vaccine in the European Union (archived [here](https://web.archive.org/web/20250118164755/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-positive-chmp-opinion-omicron-4)) Only three side effects are common to [official records](https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf#page=8) and the false posts: facial paralysis (“rare”, according to the European Medicines Agency or EMA), and myocarditis and pericarditis (both considered “very rare” by health authorities) (archived [here](https://perma.cc/NFL3-ESFG)). The false posts, on the other hand, claim there are several fatal and serious side effects, including cardiac arrest, sudden death, neonatal death, stroke, diabetes and epileptic psychosis — none of which have been certified by regulatory bodies. ### **Up to date** The Agency for Medicinal Products and Medical Devices of Croatia ([HALMED](https://www.halmed.hr/)) told AFP Fact Check on February 21, 2025, that drug manufacturers generally do not publish a “list of side effects”. Rather, they inform the regulatory agencies of any new information regarding approved medicines. “Marketing authorisation holders have a legal obligation to continuously monitor the safety profile of a medicine, including vaccines, for as long as the medicine or vaccine is on the market,” a HALMED spokesman said. “Accordingly, they are required to submit all new information and findings related to the medicine’s safety to the competent regulatory authorities for review and evaluation. In addition, regulatory authorities also receive reports of suspected side effects directly from patients and healthcare professionals.” HALMED noted that drug manufacturers are also compelled to periodically submit all collected data on the safety of medicines and vaccines in the so-called PSUR, or Periodic Safety Update Report. The [most recent PSUR](https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/comirnaty-periodic-safety-update-report-assessment-19-june-2023-18-december-2023_en.pdf) for Comirnaty – the brand name for Pfizer’s Covid vaccine – covered the second half of 2023, and the EMA issued its recommendations based on this document in July 2024 (archived [here](https://perma.cc/2EHB-YPWE)). EMA found that the risk-benefit balance remained unchanged and kept the authorisation for the vaccine. The next PSUR review procedure is expected to start this month. The EMA press office told AFP Fact Check that the most recent safety update to the product information took place [in November 2024](https://www.ema.europa.eu/en/documents/variation-report/comirnaty-vr-0000224683-epar-assessment-report_en.pdf), to include further information on the safety of vaccines in infants born to people vaccinated during pregnancy and immunocompromised participants (archived [here](https://perma.cc/WJJ8-TU5R)). The update added data from three scientific studies that found no new dangers or side effects. The EMA also noted that the agency, together with national healthcare authorities and manufacturers, is responsible for detecting and managing [safety signals](https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management), which is any information on possible side effects that warrants further investigation (archived [here](https://perma.cc/D84K-NWG4)). Once a signal is investigated, the [Pharmacovigilance Risk Assessment Committee](https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac) (PRAC) issues [a recommendation](https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals) on what to do if it suspects it might be a side effect (archived [here](https://perma.cc/5MJA-CAN5) and [here](https://perma.cc/HS25-MVYE)). All signals are [publicly available](https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fother%2Flist-signals-discussed-prac-september-2012_en.xlsx&wdOrigin=BROWSELINK) (archived [here](https://perma.cc/GBL2-PKCL)), and the process of recognising new side effects, as was the case with myocarditis and pericarditis, can be tracked in the table. According to the EMA, and as evidenced in the available data, [the most recent safety signal](https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-4-7-march-2024_en.pdf#page=17) reviewed was “postmenopausal haemorrhage”, which was considered in March 2024, but PRAC did not find sufficient evidence that it was linked to the Cominarty vaccine (archived [here](https://perma.cc/BS5S-YFTV)). The [most recent safety information](https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/safety-covid-19-vaccines) on Covid-19 vaccines, including Comirnaty, states that all vaccines authorised for use in the EU are safe and effective (archived [here](https://perma.cc/Z35F-5W2T)). “Since December 2020, people in the EU and EEA received almost 1 billion doses of Covid-19 vaccines, making it the largest vaccination programme in history,” the EMA says on its website. “Regulators have an unprecedented amount of data to confirm the safety and efficacy of Covid-19 vaccines.” Pfizer also denied publishing the list circulating on social media. “Pfizer did not publish this list, which does not reflect the established efficacy and safety profile of the vaccine,” a spokesperson for the company told AFP Fact Check in an email. “With billions of doses of the vaccine administered around the world, the safety profile for the vaccine for all authorised groups continues to be favourable.” ### **Misinterpreted adverse effects** The purported side effects found in the false Facebook posts do correspond to a list from a [2021 Pfizer document](https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf) (archived [here](https://perma.cc/CJ7V-PREP)). The document listed all adverse effects reported and recorded after vaccination in addition to a list of pre-specified medical problems that could theoretically be attributed to the vaccination. This list of adverse effects has previously been misinterpreted to be a list of confirmed side effects, which AFP Fact Check has already debunked [here](https://provjeracinjenica.afp.com/doc.afp.com.33XM3WX) in Croatian and [here](https://cinjenice.afp.com/doc.afp.com.326L4TP) in Serbian. In September 2023, HALMED told AFP Fact Check that any incident following a vaccination does not necessarily mean it was caused by the jab. “Information about reports of suspected side effects does not mean that the medicine or active substance causes the observed effect or that it is unsafe for use,” the agency said. “Only a thorough review and scientific assessment of all available data allows for conclusions to be drawn about the benefits and risks of a medicine.” More AFP fact checks on the topic of vaccines can be found [here](https://factcheck.afp.com/list/Vaccines), and on Covid-19 can be found [here](https://factcheck.afp.com/list/Covid-19). March 14, 2025 Updated with link to Committee for Medicinal Products for Human Use and its positive opinion for Omicron KP.2-adapted Covid-19 vaccine in the EU ``` March 14, 2025 Updated with link to Committee for Medicinal Products for Human Use and its positive opinion for Omicron KP.2-adapted Covid-19 vaccine in the EU ``` **Copyright © AFP 2017-2026.** Any commercial use of this content requires a subscription. Click [here](https://www.afp.com/en/products/afp-fact-check?utm_source=AFP_Factuel&utm_medium=referral&utm_campaign=ALL-PDT-202303-Factcheck&utm_content=Banner) to find out more. Share: Is there content that you would like AFP to fact-check? Get in touch. Contact us - [E-mail](https://factcheck.afp.com/contact-0) [Next article](https://factcheck.afp.com/doc.afp.com.36ZT723) [Previous article](https://factcheck.afp.com/doc.afp.com.36YY9RH) ## Related stories [Image ![](https://factcheck.afp.com/sites/default/files/styles/header_article/public/medias/factchecking/g2/2026-03/c3c6f35e387d2d4a6c3cc2ff8d92afdf-en.jpeg?itok=CqO_vXkN) Published on 13/03/2026 Posts falsely link email in Epstein files to Covid conspiracy](https://factcheck.afp.com/doc.afp.com.98LC7NQ "Posts falsely link email in Epstein files to Covid conspiracy") [Image ![](https://factcheck.afp.com/sites/default/files/styles/header_article/public/medias/factchecking/g2/2026-02/1942ed07e86d4f4c07d0b0bafef613e8-en.jpeg?itok=SxVVpKJD) Published on 27/02/2026 Covid-19 vaccine falsely linked to tuberculosis spike in Malaysia](https://factcheck.afp.com/doc.afp.com.98V79T6 "Covid-19 vaccine falsely linked to tuberculosis spike in Malaysia") [Image ![](https://factcheck.afp.com/sites/default/files/styles/header_article/public/medias/factchecking/g2/2026-01/fd7e068a49e300a361ba1fd2734190c4-en.jpeg?itok=jhTQYP9_) Published on 09/01/2026 White House misleads on vaccine schedule as CDC changes US recommendations](https://factcheck.afp.com/doc.afp.com.89UA2G4 "White House misleads on vaccine schedule as CDC changes US recommendations") [Image ![](https://factcheck.afp.com/sites/default/files/styles/header_article/public/medias/factchecking/g2/2025-12/82104791fd3b52d36e13f7a626fbd160-en.jpeg?itok=d44RMRk-) Published on 18/12/2025 Catching measles does not protect against cancer](https://factcheck.afp.com/doc.afp.com.88CK8NT "Catching measles does not protect against cancer") [![Digital courses](https://factcheck.afp.com/sites/default/files/inline-images/600x200-en.png)](https://digitalcourses.afp.com/?utm_source=AFP_Factuel&utm_medium=Banner&utm_campaign=ALL-AWA-202202-PDT-_Google-launch&utm_content=Undefined) Fact Check [![](https://factcheck.afp.com/themes/custom/factuel/images/badgemaldita.png)](http://poynter.org/ifcn/) [![](https://factcheck.afp.com/themes/custom/factuel/images/badgeefcsn.png)](https://efcsn.com/) Contact us - [Contact](https://factcheck.afp.com/Contact) Follow us - [FaceBook](https://www.facebook.com/AFPFactCheck/) - [Twitter](https://twitter.com/AFPFactCheck) - [Instagram](https://www.instagram.com/afpfactcheck/) - [Terms of use](https://www.afp.com/en/terms-use) - [Privacy policy](https://www.afp.com/en/privacy-policy "Privacy policy") - [Legal information](https://www.afp.com/en/legal-information "Legal information") - [Cookie settings](https://factcheck.afp.com/Cookie-settings) **Copyright © AFP 2017-2026. 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Readable Markdown
“Pfizer has just released its list of side effects of its ‘Covid-19 vaccine’,” reads an X [post](https://perma.cc/39WQ-DUCJ) published on February 7, 2025. Among the purported side effects listed are several life-threatening conditions and diseases such as heart failure, liver damage and stroke. Screenshot of the false X post, taken on March 5, 2025 The claim appeared on [Facebook](https://mvau.lt/media/5a2d9bbe-456f-4952-97a3-fc3d58641f81) and elsewhere on X, including in [a post](https://perma.cc/6WZS-46UW) by Stella Immanuel, a Houston-based physician born in Cameroon who championed [discredited](https://factcheck.afp.com/misleading-claims-resurface-online-about-hydroxychloroquines-efficacy-against-covid-19) treatments for Covid-19 throughout the pandemic. However, AFP Fact Check found no evidence that Pfizer publicly released any such list of vaccine side effects. Additionally, the purported Pfizer list does not match the official schedule of possible side effects compiled by health authorities worldwide. AFP Fact Check first [debunked](https://provjeracinjenica.afp.com/doc.afp.com.36YM67Y) the claim in Croatian. ### **Fabricated list** Limiting an internet search to Pfizer's website returned an August 2024 press release — a year after the World Health Organization [announced](https://www.pfizer.com/news/announcements/global-and-us-agencies-declare-end-covid-19-emergency) the pandemic was over. The company wrote that the US [Food and Drug Administration](https://www.fda.gov/) (FDA) had [authorised](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-authorization) the use of its Cominarty vaccine adapted specifically for the Omicron KP.2 variant (archived [here](https://web.archive.org/web/20240822210357/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-authorization)). Some of the false posts [link](https://perma.cc/Z269-CF23) to this statement as proof of their claims. The most recent press release on Pfizer's website mentioning the Comirnaty vaccine was [posted](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-positive-chmp-opinion-omicron-4) on September 20, 2024, and it reports that the Committee for Medicinal Products for Human Use (CHMP) gave a [positive opinion](https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp) for the Omicron KP.2-adapted Covid-19 vaccine in the European Union (archived [here](https://web.archive.org/web/20250118164755/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-positive-chmp-opinion-omicron-4)) Only three side effects are common to [official records](https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf#page=8) and the false posts: facial paralysis (“rare”, according to the European Medicines Agency or EMA), and myocarditis and pericarditis (both considered “very rare” by health authorities) (archived [here](https://perma.cc/NFL3-ESFG)). The false posts, on the other hand, claim there are several fatal and serious side effects, including cardiac arrest, sudden death, neonatal death, stroke, diabetes and epileptic psychosis — none of which have been certified by regulatory bodies. ### **Up to date** The Agency for Medicinal Products and Medical Devices of Croatia ([HALMED](https://www.halmed.hr/)) told AFP Fact Check on February 21, 2025, that drug manufacturers generally do not publish a “list of side effects”. Rather, they inform the regulatory agencies of any new information regarding approved medicines. “Marketing authorisation holders have a legal obligation to continuously monitor the safety profile of a medicine, including vaccines, for as long as the medicine or vaccine is on the market,” a HALMED spokesman said. “Accordingly, they are required to submit all new information and findings related to the medicine’s safety to the competent regulatory authorities for review and evaluation. In addition, regulatory authorities also receive reports of suspected side effects directly from patients and healthcare professionals.” HALMED noted that drug manufacturers are also compelled to periodically submit all collected data on the safety of medicines and vaccines in the so-called PSUR, or Periodic Safety Update Report. The [most recent PSUR](https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/comirnaty-periodic-safety-update-report-assessment-19-june-2023-18-december-2023_en.pdf) for Comirnaty – the brand name for Pfizer’s Covid vaccine – covered the second half of 2023, and the EMA issued its recommendations based on this document in July 2024 (archived [here](https://perma.cc/2EHB-YPWE)). EMA found that the risk-benefit balance remained unchanged and kept the authorisation for the vaccine. The next PSUR review procedure is expected to start this month. The EMA press office told AFP Fact Check that the most recent safety update to the product information took place [in November 2024](https://www.ema.europa.eu/en/documents/variation-report/comirnaty-vr-0000224683-epar-assessment-report_en.pdf), to include further information on the safety of vaccines in infants born to people vaccinated during pregnancy and immunocompromised participants (archived [here](https://perma.cc/WJJ8-TU5R)). The update added data from three scientific studies that found no new dangers or side effects. The EMA also noted that the agency, together with national healthcare authorities and manufacturers, is responsible for detecting and managing [safety signals](https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management), which is any information on possible side effects that warrants further investigation (archived [here](https://perma.cc/D84K-NWG4)). Once a signal is investigated, the [Pharmacovigilance Risk Assessment Committee](https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac) (PRAC) issues [a recommendation](https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals) on what to do if it suspects it might be a side effect (archived [here](https://perma.cc/5MJA-CAN5) and [here](https://perma.cc/HS25-MVYE)). All signals are [publicly available](https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fother%2Flist-signals-discussed-prac-september-2012_en.xlsx&wdOrigin=BROWSELINK) (archived [here](https://perma.cc/GBL2-PKCL)), and the process of recognising new side effects, as was the case with myocarditis and pericarditis, can be tracked in the table. According to the EMA, and as evidenced in the available data, [the most recent safety signal](https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-4-7-march-2024_en.pdf#page=17) reviewed was “postmenopausal haemorrhage”, which was considered in March 2024, but PRAC did not find sufficient evidence that it was linked to the Cominarty vaccine (archived [here](https://perma.cc/BS5S-YFTV)). The [most recent safety information](https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/safety-covid-19-vaccines) on Covid-19 vaccines, including Comirnaty, states that all vaccines authorised for use in the EU are safe and effective (archived [here](https://perma.cc/Z35F-5W2T)). “Since December 2020, people in the EU and EEA received almost 1 billion doses of Covid-19 vaccines, making it the largest vaccination programme in history,” the EMA says on its website. “Regulators have an unprecedented amount of data to confirm the safety and efficacy of Covid-19 vaccines.” Pfizer also denied publishing the list circulating on social media. “Pfizer did not publish this list, which does not reflect the established efficacy and safety profile of the vaccine,” a spokesperson for the company told AFP Fact Check in an email. “With billions of doses of the vaccine administered around the world, the safety profile for the vaccine for all authorised groups continues to be favourable.” ### **Misinterpreted adverse effects** The purported side effects found in the false Facebook posts do correspond to a list from a [2021 Pfizer document](https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf) (archived [here](https://perma.cc/CJ7V-PREP)). The document listed all adverse effects reported and recorded after vaccination in addition to a list of pre-specified medical problems that could theoretically be attributed to the vaccination. This list of adverse effects has previously been misinterpreted to be a list of confirmed side effects, which AFP Fact Check has already debunked [here](https://provjeracinjenica.afp.com/doc.afp.com.33XM3WX) in Croatian and [here](https://cinjenice.afp.com/doc.afp.com.326L4TP) in Serbian. In September 2023, HALMED told AFP Fact Check that any incident following a vaccination does not necessarily mean it was caused by the jab. “Information about reports of suspected side effects does not mean that the medicine or active substance causes the observed effect or that it is unsafe for use,” the agency said. “Only a thorough review and scientific assessment of all available data allows for conclusions to be drawn about the benefits and risks of a medicine.” More AFP fact checks on the topic of vaccines can be found [here](https://factcheck.afp.com/list/Vaccines), and on Covid-19 can be found [here](https://factcheck.afp.com/list/Covid-19). March 14, 2025 Updated with link to Committee for Medicinal Products for Human Use and its positive opinion for Omicron KP.2-adapted Covid-19 vaccine in the EU
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