Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
| TTOX | TETANUS TOXOID (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Unknown | — |
After got bitten in Sunday, the patient was given a Tetanus shot instead of rabies vaccine, but after some time the patient received the first dose of RabAvert on 14-Jan-2025; Case reference number US-BN-2025-000123 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV25-0112) on 14-Jan-2025 and concerns a 26-year-old, female patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported as on Sunday night, the patient got bitten. On an unspecified date, for unknown amount of time from the bite, the patient got Tetanus shot (batch number: unknown), at unknown dose, route or site of administration for post exposure prophylaxis On 14-Jan-2025, for unknown of time from the bite, the patient received the first dose of RabAvert vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration for post-exposure prophylaxis ( explicitly coded as 'inappropriate schedule vaccine administrated') and received co-suspect vaccine HRIG (immunoglobulin human anti-rabies; batch number: unknown), at unknown dose, route or site of administration for unknown indication. At the time of initial report, it was unknown if the patient experienced any adverse events due RabAvert. No further information was provided.; Reporter's Comments: A 26-year-old female patient received the first dose of RabAvert vaccine, unknown time from the bite, along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for post-exposure prophylaxis which is considered as inappropriate schedule vaccine administrated. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 26-year-old female patient received the first dose of RabAvert vaccine, unknown time from the bite, along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for post-exposure prophylaxis which is considered as inappropriate schedule vaccine administrated. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE
HRIG