Sex: M
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Aches; Swelling in legs; Rash; Fever; Chills; Did not give the fourth dose; Case reference number US-BN-2021-002321 is a spontaneous case report initially received from a physician via GSK (reference number NUS2021US146437_NC) on 07-Oct-2021, and concerns a male patient born in 1967.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as on 20-Aug, the patient was vaccinated with the first dose of Rabipur (inactivated rabies virus , vaccine; batch number was not provided), at an unknown dose or route of administration, for immunization since the patient lived with a bat.  On an unspecified date, reported as after the first dose, the patient experienced fever and aches.  On an unspecified date, reported as on 23-Aug, the patient was vaccinated with the second dose of Rabipur (inactivated rabies virus , vaccine; batch number was not provided), at an unknown dose or route of administration, for immunization since the patient lived with a bat.  On an unspecified date, reported as after the second dose, the patient experienced mild fever and aches.  On an unspecified date, reported as on 27-Aug, the patient was vaccinated with the third dose of Rabipur (inactivated rabies virus , vaccine; batch number was not provided), at an unknown dose or route of administration, for immunization since the patient lived with a bat.  On an unspecified date, reported as after the third dose, the patient experienced high fever, chills, aches, rash and swelling in the legs.   The patient was treated with steroids for the swelling in the legs.  It was reported that the patient did not receive the fourth dose (explicitly coded as Incomplete course of vaccination').  At the time of this report, the outcome of the events was unknown.  The reporter did not provide seriousness and causality assessment.  Additional information received from GSK on 07-Oct-2021 included country of occurrence.  No further information was provided.; Reporter's Comments: Pyrexia, chills and rash are listed for Rabipur according to the Datasheet and PI, whilst pain and peripheral swelling are unlisted for Rabipur according to the Datasheet and PI. Incomplete course of vaccination is listed per convention. As reported, the patient was vaccinated with the first dose of Rabipur for immunization since the patient lived with a bat. On an unspecified date, reported as after the first dose, the patient experienced fever and aches. On an unspecified date, reported as after the second dose, the patient experienced mild fever and aches. On an unspecified date, reported as after the third dose, the patient experienced high fever, chills, aches, rash and swelling in the legs. It was reported that the patient did not receive the fourth dose, which is considered incomplete course of vaccination. Due to plausible temporal relationship and since contributory role of Rabipur cannot be excluded, the causality for the events of pyrexia, chills, rash, pain and peripheral swelling is assessed as possibly related. Incomplete course of vaccination is not related to the suspect vaccine, but to a human action. This case is non-serious.; Sender's Comments: Pyrexia, chills and rash are listed for Rabipur according to the Datasheet and PI, whilst pain and peripheral swelling are unlisted for Rabipur according to the Datasheet and PI. Incomplete course of vaccination is listed per convention. As reported, the patient was vaccinated with the first dose of Rabipur for immunization since the patient lived with a bat. On an unspecified date, reported as after the first dose, the patient experienced fever and aches. On an unspecified date, reported as after the second dose, the patient experienced mild fever and aches. On an unspecified date, reported as after the third dose, the patient experienced high fever, chills, aches, rash and swelling in the legs. It was reported that the patient did not receive the fourth dose, which is considered incomplete course of vaccination. Due to plausible temporal relationship and since contributory role of Rabipur cannot be excluded, the causality for the events of pyrexia, chills, rash, pain and peripheral swelling is assessed as possibly related. Incomplete course of vaccination is not related to the suspect vaccine, but to a human action. This case is non-serious.