Received Jan 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | OT |
double vaccination of flublok was given to a patient, with no reported adverse event; Initial information received on 09-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 83 years old male patient to whom double vaccination of INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV] was given, with no reported adverse. The patient's past medical history included Renal transplant and taking transplant medications. The patient's past medical treatment(s), vaccination(s) and family history were not provided. List of concomitant vaccines: No other vaccines On 07-Oct-2025, the patient received a dose 1 of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE Solution for injection (unknown lot, strength, dose and expiry). On 06-Jan-2026 he also received a dose 2 with dosage 0.5 ml dose of vaccine (lot U8790BA, strength: standard, Expiry: 30-Apr-2026) both doses via unknown route in unknown administration site for Influenza, which was double vaccination with no reported adverse event (extra dose administered) (Latency: same day following the latest dose). It was reported, "the patient's next follow-up appointment with their provider is next month." 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.
Medical History/Concurrent Conditions: Kidney transplant (taking transplant medications)