Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 6 | Unknown | — |
The patient received all five doses of RabAvert in one day and after three days received the sixth dose; The patient received all five doses of RabAvert in one day and after three days received the sixth dose; The patient received all five doses of RabAvert in one day and after three days received the sixth dose; Case reference number US-BN-2026-000492 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-2026-000035) on 24-Mar-2026 and concerns a 46-year-old male patient. The subject's medical history and concomitant medication were not provided. On 21-Mar-2026, reported as Saturday, the patient was bitten by an animal. On the same day, the patient inadvertently received all five doses of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, and site of administration, for indication reported as post-exposure prophylaxis/ bitten by an animal (explicitly coded as inappropriate schedule of vaccine administered' and overdose'). On 24-Mar-2026, three days after the five doses, the patient received sixth dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, and site of administration (explicitly coded as extra dose administered'). The patient received six doses total in four days. At the time of initial report, it was unknown if the patient experienced any adverse events due to RabAvert. No further information was provided.; Reporter's Comments: A 46-year-old male patient received all five doses of RabAvert on the same day, for indication reported as post-exposure prophylaxis/ bitten by an animal, which is considered as inappropriate schedule of vaccine administered and overdose. Three days after the five doses, the patient received the sixth dose of RabAvert, which is considered as extra dose administered. It was unknown if the patient experienced any adverse events due to RabAvert. Inappropriate schedule of product administration, overdose and extra dose administered are considered as listed per company convention. The subject's medical history and concomitant medication were not provided. Inappropriate schedule of product administration, overdose and extra dose administered are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 46-year-old male patient received all five doses of RabAvert on the same day, for indication reported as post-exposure prophylaxis/ bitten by an animal, which is considered as inappropriate schedule of vaccine administered and overdose. Three days after the five doses, the patient received the sixth dose of RabAvert, which is considered as extra dose administered. It was unknown if the patient experienced any adverse events due to RabAvert. Inappropriate schedule of product administration, overdose and extra dose administered are considered as listed per company convention. The subject's medical history and concomitant medication were not provided. Inappropriate schedule of product administration, overdose and extra dose administered are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None