Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | Unknown | — |
The patient received three doses of post-exposure Rabavert but did not receive any additional doses; Cold-like symptoms; Fever; Case reference number US-BN-2024-002393 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2095) on 23-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient had unspecified rabies exposure. On 09-Aug-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, route or site of administration for post exposure treatment. On 12-Aug-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, route or site of administration. On 16-Aug-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at an unknown dose, route or site of administration. On an unspecified date, reported two days ago, the patient experienced fever and cold like symptoms. As reported patient did not receive any additional doses and reporter asked for recommendation in case of a delayed last dose (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient recovered from the events fever and cold symptoms. The reporter assessed the events of fever and cold symptoms as non-serious and possibly related to RabAvert. No further information was provided.; Reporter's Comments: A female patient of unknown age experienced non-serious events of fever and cold like symptoms on an unspecified date after the patient was vaccinated with the third dose of RabAvert for post exposure treatment. As reported the patient did not receive any additional doses, which is considered as inappropriate schedule of vaccine administered. Pyrexia is listed and expected for RabAvert per CCDS v4 and USPI, whilst nasopharyngitis is unlisted and unexpected. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. 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 female patient of unknown age experienced non-serious events of fever and cold like symptoms on an unspecified date after the patient was vaccinated with the third dose of RabAvert for post exposure treatment. As reported the patient did not receive any additional doses, which is considered as inappropriate schedule of vaccine administered. Pyrexia is listed and expected for RabAvert per CCDS v4 and USPI, whilst nasopharyngitis is unlisted and unexpected. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. 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.