Received Jan 16, 2026
| 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 | — | RA |
Sinus headache; congestion; runny nose; sneezing; Developed symptoms of a cold; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Jan2026 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; influenza vaccine (FLU), on 04Jan2026 as dose number unknown, single, in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: STATIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 06Jan2026 at 21:00, outcome "recovering", described as "Developed symptoms of a cold"; SINUS HEADACHE (non-serious) with onset 06Jan2026 at 21:00, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 06Jan2026 at 21:00, outcome "recovering", described as "congestion"; RHINORRHOEA (non-serious) with onset 06Jan2026 at 21:00, outcome "recovering", described as "runny nose"; SNEEZING (non-serious) with onset 06Jan2026 at 21:00, outcome "recovering". Therapeutic measures were taken as a result of sinus headache, nasal congestion, rhinorrhoea, sneezing, nasopharyngitis. Additional information: Developed symptoms of a cold. Stated she thought this was related to the flu vaccine as this was a known side effect. Sinus headache, congestion, runny nose, sneezing. Treatment received for the adverse event was Benadryl and Motrin. Facility where vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which they were reporting. The patient taking other medications within 2 weeks of the event starting was statin. No known allergies. No Hospitalization Prolonged. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
STATIN