Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | FD000502 | — |
Patient has experienced changes in menstrual cycle after receiving the Rabavert it hasn't been regular and the bleeding was brown and spotty; Patient has experienced changes in menstrual cycle after receiving the Rabavert it hasn't been regular and the bleeding was brown and spotty; The patient experienced itching all over the body intermittently after receiving the first dose of Rabavert; The patient recalls that the Rabavert dose appeared clear and colorless; Case reference number US-BN-2024-002191 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV24-1595) on 08-Jul-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication were not provided. On unspecified date, the patient was vaccinated with the first dose of Rabavert (batch number: FD000502, expiry date: Aug-2027), at an unknown dose, route and site of administration for post exposure and with the first dose of co-suspect HRIG (immunoglobulin human anti-rabies) at an unknown dose, route and site of administration for unknown indication. As reported, the patient recalls that the Rabavert dose appeared clear and colorless (explicitly coded as 'product discoloration'). On unspecified dates, the patient was vaccinated with the second and third dose of Rabavert (batch number: FD000502, expiry date: Aug-2027), at an unknown dose, route and site of administration for post exposure. On an unspecified date, the patient had itching all over the body intermittently after receiving the first dose of Rabavert and had changes in menstrual cycle after receiving the Rabavert, it hasn't been regular, and the bleeding was brown and spotty. At the time of the initial report, it was unknown if the patient recovered from the events itching all over, menstrual irregularity and spotting menstrual. The reporter did not provide seriousness and causality assessment for the events 'itching all over', 'menstrual irregularity' and 'spotting menstrual'. Additional information received from a consumer via Med Communication (reference number: USBAV24-1653) on 15-Jul-2024: included added reference number (USBAV24-1653), patient gender, Rabavert dosage information, suspect (HRIG), additional events (itching all over, menstrual irregularity and spotting menstrual). Additional information received via Bavarian Nordic on 17-Jul-2024: included confirmation on patient's name.; Reporter's Comments: A female patient of unknown age was vaccinated with the first dose of Rabavert for post exposure and with the first dose of co-suspect HRIG. As reported, the patient recalls that the Rabavert dose appeared clear and colourless, which is considered as product discoloration. The patient had itching all over the body intermittently after receiving the first dose of Rabavert and had changes in menstrual cycle after receiving the Rabavert, it hasn't been regular, and the bleeding was brown and spotty. Menstruation irregular, intermenstrual bleeding and pruritus are unlisted and unexpected for RabAvert, whilst product colour issue is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. The outcome was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. Product colour issue is not related to the suspect vaccine. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first dose of Rabavert for post exposure and with the first dose of co-suspect HRIG. As reported, the patient recalls that the Rabavert dose appeared clear and colourless, which is considered as product discoloration. The patient had itching all over the body intermittently after receiving the first dose of Rabavert and had changes in menstrual cycle after receiving the Rabavert, it hasn't been regular, and the bleeding was brown and spotty. Menstruation irregular, intermenstrual bleeding and pruritus are unlisted and unexpected for RabAvert, whilst product colour issue is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. The outcome was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. Product colour issue is not related to the suspect vaccine. This case is considered as non-serious.
Comments: None.
HRIG