Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | RA |
Couldn't sleep; Excessive pain in left arm; Feeling really cold and warm throughout the night; Feeling really cold and warm throughout the night; This is a spontaneous report received from a Consumer or other non HCP. A 32-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Oct2025 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; hepatitis a vaccine (HEPATITIS A), on 01Oct2025 as dose 2, single, in right arm for hepatitis a immunisation; influenza vaccine (INFLUENZA VACCINE), on 01Oct2025 as dose number unknown, single, in left arm for influenza immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ABILIFY, start date: 01Oct2025; BUSPIRONE, start date: 01Oct2025; EFFEXOR, start date: 01Oct2025. Past drug history included: Imitrex, reaction: "Drug allergy". Vaccination history included: Hepatitis a (dose 1, single), for Hepatitis A immunisation. The following information was reported: INSOMNIA (non-serious) with onset 02Oct2025, outcome "recovering", described as "Couldn't sleep"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2025, outcome "recovering", described as "Excessive pain in left arm"; FEELING COLD (non-serious), FEELING HOT (non-serious) all with onset 02Oct2025, outcome "recovering" and all described as "Feeling really cold and warm throughout the night". Therapeutic measures were not taken as a result of insomnia, pain in extremity, feeling cold, feeling hot. Additional information: The suspected vaccines were administered at a pharmacy or drug store. The patient didn't receive any other vaccines with 4 weeks prior to the suspected vaccines. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
ABILIFY; BUSPIRONE; EFFEXOR