Sex: M
Vaccine: RAB
Symptoms: Injection site pruritus, Product administered at inappropriate site
Clinical narrative: The injection site or sites developed scratching; The first dose of RabAvert vaccine was administered in glute region; Case reference number US-BN-2023-000838 is a spontaneous case report initially received from a consumer (reference number: USBAV23-0633) on 10-May-2023 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 dog.  On an unspecified date, an unknown amount of time after the bite, the patient was vaccinated in hospital with the first dose of RabAvert, also reported as Bavarian Rabid chicken viper + vaccine, (batch number: unknown) at unknown dose and route of administration, in the glute region, for an unknown indication (explicitly coded as 'vaccine administered at inappropriate site').  On an unspecified date, reported as three days later, the patient was vaccinated in another hospital with the second dose of RabAvert (batch number: unknown), at unknown dose and route of administration, in the shoulder region. As reported, a nurse told the patient that shoulder region was the correct place to be injected.  On an unspecified date, an unknown amount of time after the first dose of RabAvert vaccine, the patient developed scratching at the injection site or sites, as reported.  At the time of the initial report, the outcome of the event 'the injection site or sites developed scratching' was unknown.  The reporter assessed the event 'the injection site or sites developed scratching' as non-serious and as related to RabAvert vaccine.  Additional information received from Bavarian Nordic on 11-May-2023 included local case ID.; Reporter's Comments: A male patient of unknown age developed scratching at the injection site (or sites), unknown time after he was vaccinated with the first dose of RabAvert  (second dose was administered three days after the first dose), at unknown dose and route of administration, in the glute region, for an unknown indication, which is considered as vaccine administered at inappropriate site. Injection site injury is unlisted according to summary and unexpected according to insert while product administered at inappropriate site is considered listed per company convention. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Causality for injection site injury is conservatively assessed as related since contributory role of 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 male patient of unknown age developed scratching at the injection site (or sites), unknown time after he was vaccinated with the first dose of RabAvert  (second dose was administered three days after the first dose), at unknown dose and route of administration, in the glute region, for an unknown indication, which is considered as vaccine administered at inappropriate site. Injection site injury is unlisted according to summary and unexpected according to insert while product administered at inappropriate site is considered listed per company convention. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Causality for injection site injury is conservatively assessed as related since contributory role of 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.