Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | — | — |
headache; lightheadedness; light sensitivity; lower back pain; This is a spontaneous report received from a Pharmacist from medical information team. A 75-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Oct2025 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 75 years, in arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 05Oct2025 as unk unk, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Oct2025, outcome "unknown"; PHOTOPHOBIA (non-serious) with onset Oct2025, outcome "unknown", described as "light sensitivity"; DIZZINESS (non-serious) with onset Oct2025, outcome "unknown", described as "lightheadedness"; BACK PAIN (non-serious) with onset Oct2025, outcome "unknown", described as "lower back pain". Therapeutic measures were not taken as a result of headache, dizziness, photophobia, back pain. Additional information: patient who got the Comirnaty complains of headache, lightheadedness, light sensitivity and lower back pain. The patient was fine the first day and all symptoms started the next day. The patient declined any treatment. The patient sounds very uncomfortable and assumes patient is not doing well, patient had to go lay down. Caller stated something else but did not remember. Seriousness: It is not medically significant but significant enough since the patient called. Caller states the patient is a registered nurse. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.