Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
slept 18 hours straight after symptom onset; skin sensitivity; fever spiked to 103; severe muscle aches; All-night vomiting; chills; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 16Oct2025 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 16Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCORTISONE, start date: May2025; TAMSULOSIN, start date: Aug2005. Past drug history included: Opdualag, start date: Nov2023, stop date: May2024, for Cancer. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: VOMITING (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025), described as "All-night vomiting"; CHILLS (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025); PYREXIA (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025), described as "fever spiked to 103"; MYALGIA (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025), described as "severe muscle aches"; SKIN SENSITISATION (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025), described as "skin sensitivity"; HYPERSOMNIA (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025), described as "slept 18 hours straight after symptom onset". Therapeutic measures were not taken as a result of hypersomnia, skin sensitisation, pyrexia, myalgia, vomiting, chills. Additional information: The patient had no known allergies. Other vaccine in four weeks was reported as no. 12 hours after injection fever spiked to 103, severe muscle aches, all-night vomiting, chills- 36 hours later severe muscle aches, skin sensitivity, slept 18 hours straight after symptom onset. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
HYDROCORTISONE; TAMSULOSIN