Received Dec 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
Paramedic checked patient's blood pressure and it was 80/40; Patient passed out; cracked her chin; fell; hit her head; She broke her tooth; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A 77-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 26Sep2024 at 14:49 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE DECREASED (hospitalization) with onset 28Sep2024 at 04:30, outcome "unknown", described as "Paramedic checked patient's blood pressure and it was 80/40"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 28Sep2024 at 04:30, outcome "unknown", described as "Patient passed out"; TOOTH FRACTURE (non-serious) with onset 28Sep2024 at 04:30, outcome "unknown", described as "She broke her tooth"; JAW FRACTURE (medically significant) with onset 28Sep2024 at 04:30, outcome "unknown", described as "cracked her chin"; FALL (non-serious) with onset 28Sep2024 at 04:30, outcome "unknown", described as "fell"; HEAD INJURY (non-serious) with onset 28Sep2024 at 04:30, outcome "unknown", described as "hit her head". The patient was hospitalized for blood pressure decreased, loss of consciousness (start date: Sep2024, discharge date: Sep2024, hospitalization duration: 2 day(s)). The events "paramedic checked patient's blood pressure and it was 80/40", "patient passed out", "cracked her chin", "fell", "hit her head" and "she broke her tooth" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (28Sep2024) 80/40. Clinical course: Patient passed out, fell and hit her head on the floor at 4:30am on 28Sep2024. She broke her tooth and cracked her chin and was brought to the emergency room. Later on the evening of 28Sep2024, patient passed out again and EMS was contacted and arrived at patient's location. Paramedic checked patient's blood pressure and it was 80/40, so patient was brought to the hospital and stayed at the hospital for 2 days. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with COMIRNATY (2024-2025 FORMULA) can not be fully excluded. 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.
Test Date: 20240928; Test Name: blood pressure; Result Unstructured Data: Test Result:80/40