Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | Unknown | IM |
Patient had exposure last Saturday, received the first dose of RabAvert on Monday and second dose on day seven; Case reference number US-BN-2024-002695 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2842) on 28-Oct-2024 and concerns a male patient of unspecified age. The patient had no relevant medical history. The patient's concomitant medication details were not provided. On unspecified dates in 2020, reported as four years ago, the patient was vaccinated with the whole series of RabAvert (batch number: unknown) at an unknown dose, administered intramuscularly in unknown site of administration, for post exposure. On unspecified date, reported as on last Saturday, patient had exposure. On 21-Oct-2024, reported as a week ago on Monday, at emergency room, 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, intramuscularly, at unknown site of administration, for post-exposure (explicitly coded as 'inappropriate schedule of vaccine administered'). On 28-Oct-2024, seven days after the previous dose and unspecified amount of time after exposure, reported in urgent care, 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, intramuscularly at unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert. No further information was provided.; Reporter's Comments: A male patient of unspecified age was vaccinated with the first dose of RabAvert for post-exposure, along with device constituents prefilled syringe, needle for injection and needle for reconstitution, reported as a week ago on Monday, after the patient had exposure reported as on the last Saturday, which is considered as inappropriate schedule of vaccine administered. Seven days after the previous dose and unspecified amount of time after the exposure, the patient was vaccinated with the second dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient had no relevant 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 male patient of unspecified age was vaccinated with the first dose of RabAvert for post-exposure, along with device constituents prefilled syringe, needle for injection and needle for reconstitution, reported as a week ago on Monday, after the patient had exposure reported as on the last Saturday, which is considered as inappropriate schedule of vaccine administered. Seven days after the previous dose and unspecified amount of time after the exposure, the patient was vaccinated with the second dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient had no relevant 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.