Received Dec 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 3 | U8883CA | OT / LL |
patient accidentally received a third dose of FLUZONE NP with no reported adverse event; Initial information received on 18-Dec-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 12 months old male patient who accidentally received a third dose of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] NP with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. On 17-Dec-2025, the patient accidentally received a 0.5 mL dose 3 of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE with no reported adverse event (extra dose administered) (latency: same day) (Suspension for injection) (lot U8883CA and expiry date: 30-Jun-2026) (frequency: once) (strength: standard) via intramuscular route in the left vastus lateralis for Immunization. Action taken: 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.
MMR; PREVNAR; VARICELLA VACCINE