Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | OT |
patient got an extra dose of menquadfi with no reported adverse event; Initial information received on 18-Mar-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 31 years old female patient who got an extra dose of meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] 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 hepatitis B vaccine for prophylactic vaccination (Immunisation). On 07-Sep-2024, the patient received an unknown dose of (dose 1) of suspect meningococcal A-C-Y-W135 (T conj) vaccine, Solution for injection then on 19-Jan-2025 she received (dose 2) of same vaccine both with (unknown strength, batch number and expiry date) via unknown route in unknown administration site and on 16-Mar-2025, patient received an extra dose of 0.5 ml (dose 3) of same vaccine, Solution for injection (lot number: U8194AA and expiry date 30-Sep-2027) (strength: standard, frequency: once) via intramuscular route in the left arm for prophylactic vaccination (Immunisation) with no reported adverse event (extra dose administered) (Latency: same day). Reportedly, They want to get some guidance in terms of if there is any side effects or any issues regarding an 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.
HEPATITIS B VACCINE