Received Mar 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
at age 75 she started menstruation after the immunization; reoccuring loss of taste; reoccuring loss of smell; ASSESSMENT PROGRAM This is a solicited report received from a Pharmacist and a Consumer or other non HCP, Program ID. A 72-year-old female patient received BNT162b2 (BNT162B2 NOS), on 19Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious) with onset 19Oct2022, outcome "unknown", described as "reoccuring loss of smell"; AGEUSIA (non-serious) with onset 19Oct2022, outcome "unknown", described as "reoccuring loss of taste"; POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "at age 75 she started menstruation after the immunization". The events "at age 75 she started menstruation after the immunization", "reoccuring loss of taste" and "reoccuring loss of smell" required physician office visit. The reporter's assessment of the causal relationship of the events with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Considering the strong temporal relationship, causal role of the suspect drug cannot be ruled out, therefore the events have been assessed as possibly related to BNT16. b2 Case will be reassessed should additional information become available. 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.