Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
Increased menstrual cycle bleeding like a lot of bleeding constantly; Increased menstrual cycle bleeding like a lot of bleeding constantly; body swelling/ body felt bigger; gained weight; hands and fingers were puffier; wasn't eating more; 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 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious) all with onset Jan2022, outcome "unknown" and all described as "Increased menstrual cycle bleeding like a lot of bleeding constantly"; SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "body swelling/ body felt bigger"; WEIGHT INCREASED (non-serious) with onset Jan2022, outcome "unknown", described as "gained weight"; PERIPHERAL SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "hands and fingers were puffier"; EATING DISORDER (non-serious) with onset Jan2022, outcome "unknown", described as "wasn't eating more". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was calling to report side effects from the Pfizer Covid-19 vaccine and to see if the side effects she experienced are known with the covid vaccine. Caller stated that she received the 2nd dose series of the Pfizer BioNTech Covid-19 vaccine, 12 years and up in Nov2021. Caller stated "2 months after receiving the vaccine, she experienced a lot of vaginal bleeding and had normal menstrual cycles, but she was bleeding for 4-5 months." Caller stated that she "gained weight, her hands and fingers were puffier and her body felt bigger, however she wasn't eating more." Caller stated in Jan2022, she got covid and received the Pfizer Covid-19 booster vaccine in Sep2022. Caller stated that she consulted with another doctor in which they were unsure what her side effects were from. Caller stated that she is a physician working and she got sick in the ER. Caller stated that she read the labeling information and noted that if a person had bleeding or a bleeding disorder, it was advised for them not to take the vaccine. Caller asked if that would be considered a contraindication. Caller stated she tried to apply for temporary medical exemption, as she wasn't sure if her reactions were related to the vaccine and needed to do a workup. Caller stated that she is a physician herself who is going against another physician for a medical exemption and she believes she should be able to provide a medical exemption for personal reasons, her own concerns and uncertainties. Caller stated their facility is forcing providers to get vaccinated and some are getting 3-4 boosters back to back. Caller stated, "I wish you had a protocol, you put out the product and the medical exemption needs to be coming from you. You should be able to file medical exemptions for things other than the listed contraindications of anaphylaxis." Caller asked if Pfizer had any resource that she could get guidance on for medical exemptions. Caller stated that her medical exemption is being denied under oath based on an opinion. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500060744 Same patient, Different vaccine dose number and event;US-PFIZER INC-202500061347 Same patient, Different vaccine dose number and event;
Test Name: weight; Result Unstructured Data: Test Result:gained