Received Apr 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8442BA | OT / LA |
adminsitered post excursion with no adverse event; temperature excursion of fluzone Max/low temperature reached: 8.5 °C to 8.8 °C Duration: 30minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases- US-SA- 2025SA114290. This case involves a 42 years old male patient who was administered INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] post excursion with no adverse event and temperature excursion of fluzone max/low temperature reached: 8.5 °c to 8.8 °c duration: 30minutes 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation. On 04-APR-2025 temperature excursion of fluzone max/low temperature reached: 8.5 °c to 8.8 °c duration: 30minutes with no reported adverse event (product storage error) (unknown latency). On 14-Apr-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE Suspension for injection (strength standard) dose 0.5 ml, 1x (once) lot U8442BA expiry date-20-Jun-2025 via intramuscular route in the left deltoid for influenza administered post excursion with no adverse event (poor quality product administered) (latency same day). Cause of excursion-Human error (Reason: Monthly cycle count, inventory checking) and patient did not report any adverse events 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.; Sender's Comments: US-SA-2025SA113376:cluster case US-SA-2025SA114290:Master case
ADACEL