Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 8080473 | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8409CA | OT |
covid; urticaria; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp(non-healthcare professional). This case involves a patient with unknown age and gender who had covid and urticaria after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] and treated with Elasomeran [Spikevax]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2024, the patient received 1DF (dosage form) of suspect Influenza Quadrival A-B Multidose Vaccine Preserved, Suspension for injection (lot UT8409CA) via unknown route in unknown administration site for product used for unknown indication and Spikevax (Elasomeran) (0.5 mL, frequency once, lot 8080473, formulation unknown) intramuscular for COVID-19 (expiry date not reported for both). On an unknown date in 2024, the patient developed covid (covid-19), urticaria (latency approximately few months) following intake of Elasomeran and administration of Influenza Quadrival A-B Multidose Vaccine Preserved. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for the event (covid-19) and was Recovered / Resolved on an unknown date for the event (urticaria).