Received Mar 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
completely blacked out and almost fell in the shower; really sick; fever; pains/aches; chills; very weak; This is a solicited report received from a Pharmacist and a Consumer or other non HCP, Program ID. A 75-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid vaccine (dose 1; unknown manufacturer), for COVID-19 immunization, reaction(s): "chills", "felt really sick", "aches/pains", "fever"; Covid vaccine (dose 2; unknown manufacturer), for COVID-19 immunization, reaction(s): "chills", "felt really sick", "aches/pains", "fever"; Covid vaccine (dose 3; unknown manufacturer), for COVID-19 immunization, reaction(s): "chills", "felt really sick", "aches/pains", "fever"; Covid vaccine (dose 4; unknown manufacturer), for COVID-19 immunization, reaction(s): "chills", "felt really sick", "aches/pains", "fever"; Covid vaccine (dose 5; unknown manufacturer), for COVID-19 immunization, reaction(s): "chills", "felt really sick", "aches/pains", "fever"; Covid vaccine (dose 6; unknown manufacturer), for COVID-19 immunization, reaction(s): "chills", "felt really sick", "aches/pains", "fever". The following information was reported: CHILLS (non-serious) with onset 30Sep2025, outcome "unknown"; LOSS OF CONSCIOUSNESS (medically significant) with onset 30Sep2025, outcome "recovering", described as "completely blacked out and almost fell in the shower"; PYREXIA (non-serious) with onset 30Sep2025, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 30Sep2025, outcome "unknown", described as "pains/aches"; MALAISE (non-serious) with onset 30Sep2025, outcome "unknown", described as "really sick"; ASTHENIA (non-serious) with onset 30Sep2025, outcome "unknown", described as "very weak". The events "completely blacked out and almost fell in the shower" required emergency room visit. Additional information: Patient reported that she will not get another COVID vaccine. With every vaccine she was given, she felt really sick for a few days with fever, aches, pains, and chills. The last COVID vaccine she received, she had these same side effects, but this time she had completely blacked out and almost fell in the shower. EMT's were called, by the time they arrived, she was better, but very weak. She contacted her MD who checked up on her every couple of days. The reporter's assessment of the causal relationship of "completely blacked out and almost fell in the shower", "really sick", "fever", "pains/aches", "chills" and "very weak" with the suspect product(s) BNT162b2 omicron (lp.8.1) 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 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: Based on the known drug safety profile and temporal relationship, a causal association between suspect product and reported event CHILLS , LOSS OF CONSCIOUSNESS , PYREXIA , PAIN , MALAISE , ASTHENIA Cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.