Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 5 | Unknown | IM / RL |
Patient received the first and the second dose of RabAvert in the thigh region; Case reference number US-BN-2024-002693 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2830) on 28-Oct-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was near water source and there was fluttering in hair, but the patient was not sure if saw bat or not. On 05-Aug-2024, unknown amount of time after exposure with animal, the patient was vaccinated with the first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscular use in right thigh for post exposure (explicitly coded as 'vaccine administered at inappropriate site') and with immunoglobulins (brand name: unknown; batch number: unknown) at an unknown dose and route in the deltoid for unknown indication.. On 08-Aug-2024, unknown amount of time after exposure with animal, the patient was vaccinated with the second dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscular use in left thigh (explicitly coded as 'vaccine administered at inappropriate site'). On 12-Aug-2024, unknown amount of time after exposure with animal, the patient was vaccinated with the third dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscular use in left deltoid. On 19-Aug-2024, unknown amount of time after exposure with animal, the patient was vaccinated with the fourth dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscular use in right deltoid. On an unspecified date, as reported the patient was in Africa and there was something hopping in room, it was bat, the security come and pick it up out of room, bat was not flying so the patient was very nervous. On 25-Oct-2024, unknown amount of time after second exposure with animal, the patient was vaccinated with the fifth dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscular use in left deltoid . On unspecified dates, the patient was vaccinated with the second dose and third dose of immunoglobulins (brand name: unknown; batch number: unknown) at an unknown dose and route, in the thigh and left deltoid respectively. At the time of the initial report, the patient did not experience any adverse events due to RabAvert, reported as no irritations or side effects whatsoever. No further information was provided.; Reporter's Comments: A female patient of unknown age was vaccinated with the first and the second dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution, intramuscular use in right thigh for post exposure, which is considered as vaccine administered at inappropriate site. The patient did not experience any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first and the second dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution, intramuscular use in right thigh for post exposure, which is considered as vaccine administered at inappropriate site. The patient did not experience any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.
Immunoglobulins