Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
hearts inflamed; bleeds more; joint pain; she got sick; This is a spontaneous report received from a Physician from medical information team. A 44-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDITIS (medically significant), outcome "unknown", described as "hearts inflamed"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "bleeds more"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; ILLNESS (non-serious), outcome "unknown", described as "she got sick ". Clinical course: The patient asked if the data reports of the menstrual irregularities were released or known in Mar2022 to the public, physicians, or patients. She was upset about how everything played out, not having enough data, and being forced into taking the vaccine. She stated that Pfizer should be held liable for the damages her body was going through. She learned a big lesson and realized that she would never take a vaccine that wasn't FDA approved, as it came out too quickly and no one knew the safety or post marketing results. As a physician, she was not recommending the Pfizer covid vaccine to anyone until all of the safety data was out and then they will talk about it. She spoke to Pfizer MI previously and received an email from Medical Information with an attachment regarding the side effects of the Pfizer Covid vaccine. She had read the information and sent it to the doctor that was in charge of her medical exemption, in which the doctor provided that they didn't know about the information that was sent. The patient asked if Pfizer had released a meta-analysis in 2021 to providers, public or anyone, or if it most likely post marketing collection data. The information that HCP was previously sent included reports of menstrual irregularities and CONS. She was specifically speaking upon reports of menstrual irregularities. She saw the data collected in Sep2021 and Sep2022 and onwards, in which she was trying to get the vaccine around Mar2022. She was compliant with the 1st and 2nd shot and there were case reports of vaccines causing things such as bleeding, heart problems, joint pain, and other things. The patient stated that she took the vaccine, she bled more, had joint pain, her heart was inflamed, and her body was getting damaged because of the vaccine but it's not a severe reaction. She stated that she got sick from the Pfizer Covid-19. It was very frightening and everyone continued to say, "take it, take it, take it". The patient asked who was compensating patients for their body getting damaged by the vaccine and if the CICP was a program from Pfizer or if it's a federal program. She was also querying if it was considered fully vaccinated if you take the 1st and 2nd dose, then why does the booster need to be administered.; Sender's Comments: There is not a reasonable possibility that the reported events heart inflammation, menstrual bleeding, arthralgia, and illness were related to the suspect product events most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.