Sex: M
Vaccine: RAB, UNK
Symptoms: Myalgia, Product administered at inappropriate site
Clinical narrative: RabAvert was given on the left gluteal area and was very painful; RabAvert was given on the left gluteal area and was very painful; Case reference number US-BN-2022-001789 is a spontaneous case report initially received on 05-Aug-2022 from consumer via Communication (reference number: USBAV22-0827) and concerns a 39-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 29-Jul-2022, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury LEP) (PCEC); batch number: unknown) at an unknown dose or route of administration, in the unknown deltoid region, for post-exposure immunisation (post-exposure rabies treatment) due to possible bat exposure and with co-suspect HRIG (immunoglobulin human anti-rabies) at an unknown dose, route or site of administration, for unknown indication.  On 01-Aug-2022, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at an unknown dose, administered intramuscularly in the left gluteal regional (explicitly coded as 'vaccine administered at inappropriate site').  On the same day, the patient experienced very painful left gluteal area. As reported, duration of this event was a few days.  On an unspecified date, the patient recovered from the event.  The reporter assessed this event as non-serious and possibly related to RabAvert.  The case is linked to the case BN-2022-001790 concerning the same reporter.  Additional information received on 08-Aug-2022 included local case ID.; Reporter's Comments: A 39-year-old male patient was vaccinated with the second dose of RabAvert, at an unknown dose, administered intramuscularly in the left gluteal regional which is considered as vaccine administered at inappropriate site and on the same day he experienced very painful gluteal area. The first dose was administered  three days before the second dose for post exposure immunization due to possible bat exposure and with co-suspect HRIG (immunoglobulin human anti-rabies). Injection site pain is listed for RabAvert while product administered at inappropriate site is considered listed per company convention. The outcome was resolved. The patient's medical history and concomitant medication details were not provided. Causal relationship is assessed as related for injection site pain due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Product administered at inappropriate site is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 39-year-old male patient was vaccinated with the second dose of RabAvert, at an unknown dose, administered intramuscularly in the left gluteal regional which is considered as vaccine administered at inappropriate site and on the same day he experienced very painful gluteal area. The first dose was administered  three days before the second dose for post exposure immunization due to possible bat exposure and with co-suspect HRIG (immunoglobulin human anti-rabies). Injection site pain is listed for RabAvert while product administered at inappropriate site is considered listed per company convention. The outcome was resolved. The patient's medical history and concomitant medication details were not provided. Causal relationship is assessed as related for injection site pain due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Product administered at inappropriate site is assessed as not related to suspect product but to human factor. The case is non-serious.