Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8823BA | OT |
chest tightness; injection site felt really warm x 24 hours; mild shortness of breath; hard lump on the injection site the size of a baseball, redness, burning sensation and itchiness; hard lump on the injection site the size of a baseball, redness, burningsensation and itchiness; hard lump on the injection site the size of a baseball, redness, burningsensation and itchiness; hard lump on the injection site the size of a baseball, redness, burningsensation and itchiness; Initial information received on 14-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 52 years old female patient (73.48 kg) who experienced chest tightness, injection site felt really warm x 24 hours, mild shortness of breath and hard lump on the injection site the size of a baseball, redness, burning sensation and itchiness after receiving vaccine INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Mitral valve prolapse. On 12-Nov-2025, the patient received dose 0.5 ml of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE, Solution for injection (lot U8823BA) (strength and expiry: unknown) via intramuscular route in unknown administration site for it's a fu shot so it's only one dose not an ongoing treatment (Influenza immunisation). On 12-NOV-2025 the patient developed chest tightness (chest discomfort), injection site felt really warm x 24 hours (vaccination site warmth), mild shortness of breath (dyspnoea) and hard lump on the injection site the size of a baseball, redness, burning sensation and itchiness (vaccination site swelling, vaccination site erythema, vaccination site pruritus and vaccination site pain) (latency same day). dyspnea: intensity mild Action taken was not applicable Corrective:- ADVIL [IBUPROFEN] for injection site felt really warm x 24 hours and hard lump on the injection site the size of a baseball, redness, burning sensation and itchiness and cold pack application ALLEGRA [FEXOFENADINE HYDROCHLORIDE] and BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] for chest discomfort and mild shortness of breath. At time of reporting, the outcome was Recovered / Resolved on 12-Nov-2025 for all events.
Mitral valve prolapse