Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
headache; giant cell arteritis; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 02857811 (Merck). A male patient in his 80's received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (death), outcome "fatal"; GIANT CELL ARTERITIS (death), outcome "fatal". The patient date of death was unknown. Reported cause of death: "headache", "giant cell arteritis". It was not reported if an autopsy was performed. Clinical course: The consumer was transferred from CRT with questions about Capvaxive (which neither she nor her husband were administered) and mentioned during the call that her husband had experienced a headache and giant cell arteritis after being administered one of Pfizer's vaccines. Consumer was not sure at this time if it was the Pfizer flu vaccine or the Covid vaccine that caused the side effects because her husband had received both. The dates of administration and when the side effects occurred were unknown. He has since passed away. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Reported Cause(s) of Death: headache; giant cell arteritis