Received Mar 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
breathing difficulty; Very high temperature; This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 66-year-old female patient received BNT162b2 (COMIRNATY), on 06Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (hospitalization) with onset 06Mar2021, outcome "not recovered", described as "Very high temperature"; DYSPNOEA (hospitalization) with onset 06Mar2021, outcome "not recovered", described as "breathing difficulty". The events "breathing difficulty" and "very high temperature" required emergency room visit. The reporter's assessment of the causal relationship of "breathing difficulty" and "very high temperature" with the suspect product(s) 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. Clinical course: Patient reported having severe side effects and had to be hospitalized for few days. She reported having very high temperature and breathing difficulty. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on close temporal relationships and known drug safety profile, a possible contributory role of BNT162b2 cannot be excluded for the reported events pyrexia, dyspnea. 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.