Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | RA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Experienced brief (visual) aura immediately following vaccination, for 5 min or less; Moderate arm pain in the arm where the Comirnaty and flu shot were administered; This is a spontaneous report received from a Consumer or other non HCP. An adult female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19Sep2025 at 17:00 as dose number unknown, single (upper right arm) (Batch/Lot number: unknown), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 19Sep2025 as dose number unknown, single (flu shot) for immunisation. The patient's relevant medical history included: "Yes but the only relevant one is migraines that sometimes have aura" (ongoing), notes: I did not have a migraine, headache, or nausea post vaccination, only the aura. The patient's concomitant medications were not reported. Vaccination history included: shingrix (DOSE NUMBER UNKNOWN, SINGLE), administration date: 05Sep2025, for Immunization; Tdap (DOSE NUMBER UNKNOWN, SINGLE), for Immunization; Typhoid (DOSE NUMBER UNKNOWN, SINGLE), for Immunization; Comirnaty (DOSE NUMBER UNKNOWN, SINGLE), administration date: Jan2021, for COVID-19 immunization; Influenza (DOSE NUMBER UNKNOWN, SINGLE), for Immunization; Shingrix (DOSE NUMBER UNKNOWN, SINGLE), for Immunization. The following information was reported: AURA (non-serious) with onset 19Sep2025, outcome "recovering", described as "Experienced brief (visual) aura immediately following vaccination, for 5 min or less"; VACCINATION SITE PAIN (non-serious) with onset 19Sep2025, outcome "not recovered", described as "Moderate arm pain in the arm where the Comirnaty and flu shot were administered". Therapeutic measures were not taken as a result of aura. Additional information: The patient was taking other medications within 2 weeks of the event starting. The patient experienced brief (visual) aura immediately following vaccination, for 5 minutes or less. This has never happened before with Comirnaty (have had every recommended dose since Jan2021), or other vaccinations like influenza, shingrix, TdaP, typhoid, etc. Additionally, the patient had moderate arm pain in the arm where the Comirnaty and flu shot were administered, that has not yet resolved though patient expected it to resolve within 72 hours or so of the vaccination. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Migraine with aura (I did not have a migraine, headache, or nausea post vaccination, only the aura)