Received Dec 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8873MA | OT |
tired; received the FLUZONE vaccine and they already had one this season; Initial information received on 09-Dec-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 months old male patient who had tired after receiving influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] and they already had one this season. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine inact (Vaqta) for Immunisation. On 08-Sep-2025, the patient received 0.5 ml of dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- unknown, expiry date- 30-JUN-2026 and lot UT8873MA) via unknown route in unknown administration site for Immunization. On 09-Dec-2025 the patient received 0.5 ml of dose 2 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2026 and lot UT8873MA) once via intramuscular route in the left thigh for Immunization in the same season (extra dose administered) (latency- same day). On 09-DEC-2025 the patient was tired (fatigue) (latency- same day). It was reported that, the nurse only knew about this when they went back to review the patient's chart. Patient's mother wanted to follow-up on it and that there's nothing of severe concern or nothing they need to do on their end. Patient's mother mentioned to the nurse that patient's tired today but patient had additional vaccine as well. Nurse needed to get clarification about this, if there's anything of concern long term or short term. However, nurse mentioned that it was only the mother who brought up the fact that patient had received the FLUZONE NP before. When they looked it up in their health department record, the nurse says she's guessing the prior physician didn't report it so it wasn't in that system. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (fatigue). At time of reporting, the outcome was Unknown for the event (fatigue). 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.
Vaqta