Received Jan 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
prescribed with nuvaxovid even if patient is only 11 years old with no reported adverse event; Initial information received on 28-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who was prescribed NVX-COV2373 (Original) Adjuvanted Vaccine [Nuvaxovid] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was prescribed an unknown dose of suspect NVX-COV2373 (Original) Adjuvanted Vaccine, Injection (unknown strength and expiry date) lot number not reported for immunisation, with no reported adverse event (product prescribing issue) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. It was reported that, "Reporter had a patient coming in, requesting the Novavax shot, but they are 11 years old with a prescription from the doctor's office, saying to get one" 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.