Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | — | OT |
severe shakes/chills; severe shakes/chills; patient was too weak to get her to the ER on their own; altered mental status; dizziness; TARGETED IMMUNIZATION ENGAGEMENT (TIE) This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Oct2024 at 15:52 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years and 8 months intramuscular, in arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 05Oct2024 at 15:52 as dose 1, single intramuscular, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: MENTAL STATUS CHANGES (hospitalization) with onset 05Oct2024 at 19:00, outcome "unknown", described as "altered mental status"; DIZZINESS (hospitalization) with onset 05Oct2024 at 19:00, outcome "unknown"; ASTHENIA (hospitalization) with onset 05Oct2024 at 19:00, outcome "unknown", described as "patient was too weak to get her to the ER on their own"; CHILLS (hospitalization), TREMOR (hospitalization) all with onset 05Oct2024 at 19:00, outcome "unknown" and all described as "severe shakes/chills". The patient was hospitalized for chills, tremor, asthenia, mental status changes, dizziness (start date: Oct2024, discharge date: Oct2024, hospitalization duration: 1 day(s)). The events "severe shakes/chills", "patient was too weak to get her to the er on their own", "altered mental status" and "dizziness" required emergency room visit. Clinical course: Patient reported having severe shakes/chills a few hours after receiving the vaccines. Patient's family member came to help but patient was too weak to get her to the ER on their own. Patient also experienced altered mental status and dizziness. Patient was taken to the ER via ambulance and was admitted and stayed overnight. The reporter's assessment of the causal relationship of "severe shakes/chills", "patient was too weak to get her to the er on their own", "altered mental status" and "dizziness" with the suspect product(s) BNT162b2 omicron (kp.2) 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 (kp.2) will be requested and submitted if and when received.; Sender's Comments: There is a reasonable possibility that the reported events chills, asthenia, and dizziness were related to COMIRNATY (2024-2025 FORMULA) based on known drug safety profile. Based on the close temporal relationship, the association between the events tremor and mental status change 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.