Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 4 | FDP00756 | IM / LL |
The patient received second dose of RabAvert 13 days after the first dose, third dose 17 days after the first dose and fourth dose 24 days after first dose; Case reference number US-BN-2026-000267 is a spontaneous case report initially received from a pharmacist via Bavarian Nordic (reference number: CASE-002126) on 12-Feb-2026 and concerns a 4-years-old male patient. The patient's medical history concomitant medications details were not provided. On 30-Jan-2026, as reported, the patient was bitten to the face by a pit bulldog. On the same day, 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: FDP00756, Exp. date: 30-Nov-2028), one milliliter (ml), intramuscularly in left thigh for dog bite. The patient was transferred to for surgical care of the bite and received first dose at the hospital. On the same day, the patient also received HRIG (brand name: unknown), at an unknown dose, at an unknown route of administration, at unknown site of administration for postexposure prophylaxis. On 12-Feb-2026, 13 days after the first dose, the patient received the second dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP 00756, Expiry date: 31-Jan-2029), at 1ml dose, intramuscularly, in left thigh (explicitly coded as 'inappropriate schedule of vaccine administered'. On 16-Feb-2026, 17 days after the first dose, the patient received the third dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution *(batch number: FDP 00776, Expiry date: 31-Jan-2029), at 1ml dose, intramuscularly, in right thigh* (explicitly coded as 'inappropriate schedule of vaccine administered'). On 23-Feb-2026, 24 days after the first dose, the patient received the fourth dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP 00776, Expiry date: 31-Jan-2029), at 1ml dose, intramuscularly, in left thigh (explicitly coded as 'inappropriate schedule of vaccine administered'). *As reported, the patient received four doses for postexposure prophylaxis as patient is immunosuppressed. * At the time of the follow-up report, it was confirmed that the patient did not experience any adverse event due to RabAvert vaccine. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up received from a pharmacist via Bavarian Nordic on 24-Mar-2026: New information included patient initials, product dosing details and confirmation that the patient did not experience any adverse event after receiving Rabipur vaccine. Follow-up information received from a pharmacist via Bavarian Nordic on 31-Mar-2026: New information included details regarding RabAvert dosing details and additional dose (third dose). Follow-up information received from a pharmacist via Bavarian Nordic on 01-Apr-2026: New information included RabAvert dosing information for the third dose and confirmation that patient is immunosuppressed and received four doses for postexposure prophylaxis.; Reporter's Comments: A 4-year-old male patient received the second dose of RabAvert vaccine for postexposure prophylaxis on the day 17 after the first dose, and the fourth dose on the day 24, which is considered as inappropriate schedule of vaccine administered. As reported, the patient received only four doses of Rabipur as post-exposure treatment, which is considered as incomplete course of vaccination. It was confirmed that the patient did not experience any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration and incomplete course of vaccination are considered as listed per company convention. The patient's concomitant medications were not provided. Inappropriate schedule of product administration and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 4-year-old male patient received the second dose of RabAvert vaccine for postexposure prophylaxis on the day 17 after the first dose, and the fourth dose on the day 24, which is considered as inappropriate schedule of vaccine administered. As reported, the patient received only four doses of Rabipur as post-exposure treatment, which is considered as incomplete course of vaccination. It was confirmed that the patient did not experience any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration and incomplete course of vaccination are considered as listed per company convention. The patient's concomitant medications were not provided. Inappropriate schedule of product administration and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None
HRIG