Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
The patient had side effects that included dizziness, so the patient didn't get second dose of Rabavert on day seven; The patient had side effects that included dizziness, so the patient didn't get second dose of Rabavert on day seven; The patient had side effects that included dizziness, so the patient didn't get second dose of Rabavert on day seven; Case reference number US-BN-2024-002821 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-3137) on 26-Nov-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 19-Nov-2024, the patient received the first dose of RabAvert vaccine along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration, for indication pre-exposure prophylaxis. On unspecified date, reported as seven days later from the first dose, the patient had some dizziness and some other symptoms that were not so good, as reported the past two to three days. As reported, the patient had side effects that included dizziness, so the patient didn't get the second dose of RabAvert on day seven (explicitly coded as 'Inappropriate schedule of product administration'). At the time of the initial report, the outcome for the events 'adverse reaction' and 'dizziness' was unknown. The reporter assessed the events of 'adverse reaction' and 'dizziness' as non-serious and possibly related to the product of RabAvert. No further information was provided.; Reporter's Comments: A male patient of unspecified age experienced non-serious events of dizziness and some other symptoms that were not so good reported as seven days after the patient received the first dose of RabAvert vaccine for indication pre-exposure prophylaxis. The patient had side effects, so the patient didn't get the second dose of RabAvert on day seven, which is considered as inappropriate schedule of product administration. Dizziness is listed and expected for RabAvert per CCDS v4 and USPI, whilst adverse reaction and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome for the events 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. 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 experienced non-serious events of dizziness and some other symptoms that were not so good reported as seven days after the patient received the first dose of RabAvert vaccine for indication pre-exposure prophylaxis. The patient had side effects, so the patient didn't get the second dose of RabAvert on day seven, which is considered as inappropriate schedule of product administration. Dizziness is listed and expected for RabAvert per CCDS v4 and USPI, whilst adverse reaction and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome for the events 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. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-3137:
Comments: NONE