Sex: M
Vaccine: RAB
Symptoms: Depressed level of consciousness, Malaise
Clinical narrative: Patient even passed out, but remained conscious and felt sick after the first dose of Rabavert; Patient even passed out, but remained conscious and felt sick after the first dose of Rabavert; Patient received first dose of RabAvert in the wrist region, all around that area it was like 20 pokes; Case reference number US-BN-2024-002511 is a spontaneous case initially received from a consumer via agency (reference number: USBAV24-2397) on 17-Sep-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was bitten by a stray cat.  On 01-Mar-2024, unknown amount of time after the animal exposure, the patient was vaccinated with the first dose of Rabavert (batch number: ARBB101A), at a dose of 2.5 units, via unknown route in wrist for cat bite (explicitly coded as 'vaccine administered at inappropriate site').  On an unspecified date, unknown amount of time after receiving RabAvert, the patient passed out but remained conscious and felt sick. As reported, the same happened when the patient received blood work.  On 04-Mar-2024, unknown amount of time after the animal exposure, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at a dose of 2.5 units, via unknown route in left shoulder.  On 08-Mar-2024, unknown amount of time after the animal exposure, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at a dose of 2.5 units, via unknown route in right shoulder.  On 15-Mar-2024, unknown amount of time after the animal exposure, the patient was vaccinated with the fourth dose of RabAvert (batch number: unknown), at a dose of 2.5 units, via unknown route in left shoulder.  At the time of the initial report, the outcome for the events of passed out and felt sick was unknown.  The reporter assessed the events of passed out and felt sick as non-serious, however the event of passed out was additionally considered as serious due to criteria of medical significance. The reporter assessed the events of passes out and felt sick as possibly related to RabAvert.  No further information was provided.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of RabAvert in wrist for cat bite, which is considered as vaccine administered at inappropriate site. On an unspecified date, unknown amount of time after receiving RabAvert, the patient passed out but remained conscious (medical significance) and felt sick. Malaise is listed and expected for RabAvert per CCDS v4, whilst loss of consciousness is unlisted and unexpected. Product administered at inappropriate site 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. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of RabAvert in wrist for cat bite, which is considered as vaccine administered at inappropriate site. On an unspecified date, unknown amount of time after receiving RabAvert, the patient passed out but remained conscious (medical significance) and felt sick. Malaise is listed and expected for RabAvert per CCDS v4, whilst loss of consciousness is unlisted and unexpected. Product administered at inappropriate site 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. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.