Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT / LL |
mistakenly given the vaccine, which was not indicated for her age; light bruising at the injection site; Initial information received on 09-Apr-2025 regarding an unsolicited valid non-serious case received from a Patient's Father. This case involves a 6 months old female patient who was mistakenly given MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], which was not indicated for her age and had light bruising at the injection site The patient's past medical history, medical treatment(s) and family history were not provided. No other vaccines On 07-Apr-2025, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) vaccine Solution for injection, which was not indicated for her age, (Frequency: Once, strength: standard; expiry date and lot number not reported) via intramuscular route in the left thigh for Immunization (Immunization) (product administered to patient of inappropriate age) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested On an unknown date in Apr-2025 the patient developed light bruising at the injection site (vaccination site bruising) (latency: approximately few hours to few days) Reportedly, Patient's Father was further advised to monitor and speak with their HCP (healthcare professional) Action taken was not applicable Corrective treatment: none for vaccination site bruising At time of reporting, the outcome was Unknown for the event vaccination site bruising. 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.