Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 4 | Unknown | — |
Pain; Case reference number US-BN-2025-001296 is a spontaneous case initially received from nurse via agency (reference number: USBAV25-1785) on 22-Jul-2025 and concerns a female patient of unspecified age, reported as around 60-years-old. The patient's medical history and concomitant medication details were not provided. The patient was not immunocompromised. On an unspecified date, the patient had exposure to the animal. On an unspecified date, unknown time after exposure to the animal, the patient received the first dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration for unknown indication. On an unspecified date, unknown time after exposure to the animal, the patient received the second dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration. On an unspecified date, unknown time after exposure to the animal, the patient received the third dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration. 02-Jun-2025, unknown time after exposure to the animal, the patient received the fourth dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration. On an unspecified date, unknown time after the vaccination with Rabavert, the patient experienced pain, as reported the patient saw the provider for epidural injections for pain. At the time of initial report, it was unknown if the patient recovered from the event of pain. The reporter assessed seriousness for event of pain as non-serious and did not provide a causality assessment. Additional information received from nurse via agency (reference number: USBAV25-1800) on 23-Jul-2025: Information included reference number and details of next dose schedule inquiry.; Reporter's Comments: A female patient of unspecified age, reported as around 60-years-old experienced a non-serious event of pain on an unspecified date, unknown time after the vaccination with RabAvert for unknown indication. Pain is unlisted and unexpected for RabAvert per CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. The patient was not immunocompromised. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age, reported as around 60-years-old experienced a non-serious event of pain on an unspecified date, unknown time after the vaccination with RabAvert for unknown indication. Pain is unlisted and unexpected for RabAvert per CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. The patient was not immunocompromised. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to RabAvert. This case is considered as non-serious.
Comments: None.