Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00722 | IM |
The patient received second dose of RabAvert 38 days after the first dose, not seven days apart; Case reference number US-BN-2026-000418 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-002571) on 09-Mar-2026 and concerns a 39-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 13-Jan-2026, the patient received the first dose of RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00722 and expiration date: 31-Dec-2027) at dose of 1 millilitre, intramuscularly on deltoid for pre-exposure prophylaxis. On 20-Feb-2026, 38 days after the first dose, the patient received second dose of RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00756 and expiration date: 30-Nov-2028) at dose of 1 millilitre, intramuscularly on deltoid (explicitly coded as 'inappropriate schedule of vaccine administration'). At the time of initial report, it was unknown if the patient experienced any adverse event due to the RabAvert vaccination. No further information was provided.; Reporter's Comments: A 39-year-old male patient received the second dose of RabAvert for pre-exposure prophylaxis 38 days after the first dose, which is considered as inappropriate schedule of vaccine administration. It was unknown if the patient experienced any adverse event due to the RabAvert vaccination. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 39-year-old male patient received the second dose of RabAvert for pre-exposure prophylaxis 38 days after the first dose, which is considered as inappropriate schedule of vaccine administration. It was unknown if the patient experienced any adverse event due to the RabAvert vaccination. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.