Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 3 | UT8496JA | IM / RL |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 3 | UT8496JA | OT / LL |
patient received extra dose of vaccine on 26-Jun-2025 with no reported adverse event; Initial information received on 27-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 9 months old male patient who was received extra dose of influenza usp trival a-b subvirion no preservative vaccine [fluzone] on 26-Jun-2025 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Jun-2025, the patient received an extra dose of 0.5 ml (dose 3) of suspect influenza usp trival a-b subvirion no preservative vaccine, Suspension for injection (lot UT8496JA, frequency: once, strength: standard and expiry date 30-Jun-2025) via intramuscular route in the left thigh for immunisation with no reported adverse event (extra dose administered) (Latency: same day). Reportedly, Nurse mentioned that patient had received his second dose on 25-Jun-2025 in a different facility, but on 26-Jun-2025, he was given another shot (extra dose). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.