Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
chest tightening; SOB; Itchy throat; Lightheadedness; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 08Oct2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 08Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: THROAT IRRITATION (non-serious) with onset 10Oct2025 at 23:30, outcome "recovering", described as "Itchy throat"; DIZZINESS (non-serious) with onset 10Oct2025 at 23:30, outcome "recovering", described as "Lightheadedness"; DYSPNOEA (non-serious) with onset 10Oct2025 at 23:30, outcome "recovering", described as "SOB"; CHEST DISCOMFORT (non-serious) with onset 10Oct2025 at 23:30, outcome "recovering", described as "chest tightening". Therapeutic measures were taken as a result of chest discomfort, dyspnoea, throat irritation, dizziness. Additional information: The patient was taking any other medications within 2 weeks of the event starting. Patient has not taken Breo in over a week, may be due to that, however has experienced chest tightening since getting Comirnaty/Flu vaccines. Tonight, SOB, itchy throat, and lightheadedness landed him at urgent care. The treatment received with Steroids, inhaler for the adverse events. Upon follow up his wife mentioned that he hasn't taken his Breo in 10 days, most likely the issue. However, he had just received both Covid and flu vaccines. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Asthma; Hypersensitivity; Shellfish allergy
ATORVASTATIN