Received Dec 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 7+ | — | IM |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | — | OT |
difficulty breathing; cough; headaches; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A 71-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Nov2024 at 13:58 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years intramuscular for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 27Nov2024 at 13:58 as dose number unknown, single intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 03Dec2024 at 09:00, outcome "unknown"; DYSPNOEA (non-serious) with onset 03Dec2024 at 09:00, outcome "unknown", described as "difficulty breathing"; HEADACHE (non-serious) with onset 03Dec2024 at 09:00, outcome "unknown", described as "headaches". The events "difficulty breathing", "cough" and "headaches" required physician office visit. Therapeutic measures were taken as a result of dyspnoea, cough, headache. Additional information: After receiving the vaccine patient reports having difficulty breathing, a cough, and headaches. Leading the patient to go to the doctor. She was prescribed albuterol, prednisone, and doxycycline. She was then referred to a specialist. Patient did not have an prior history of lung disease and has since been put on Trelegy. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.