Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUCELVAX) | SEQIRUS, INC. | UNK | No batch number | — |
Hives on his wrists 10 days after taking Flucelvax; Allergic reaction 10 days after taking Flucelvax; Sore; This spontaneous case from United States, initially received on 07-Mar-2025, was reported by a non health professional and concerns an child male patient. Medical History: No. Patient's mom mentioned that he never had a adverse reaction or allergic reaction to a vaccine before. Concomitant medications reported as no. Administration of company suspect drug: On 25-Feb-2025, the patient received Flucelvax (TIV) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine, Dose regimen: 0.5 ml, Route of administration: Unknown, Lot number: No batch number available and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Mar-2025, the patient experienced hives on his wrists 10 days after taking Flucelvax (outcome: not recovered / not resolved), allergic reaction 10 days after taking Flucelvax (outcome: not recovered / not resolved), sore (outcome: not recovered / not resolved). Consumer inquired that her son had an allergic reaction 10 days after taking Flucelvax, he started to sore, presented some hives on his wrists. But he never had an allergic reaction specially related to the skin. She wants to know if we ever had any report such as hers, any adverse reaction report related to skin. Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event: Patient's mom reported that she took him to a doctor and his on medication for the allergy reaction. Reporter assessment: The reporter considered events hives on his wrists 10 days after taking Flucelvax, allergic reaction 10 days after taking Flucelvax and sore and causality was not reported.; Reporter's Comments: The causality of events were related to the administration of the product Flucelvax (TIV)
Comments: None