Sex: F
Vaccine: RAB, TTOX
Symptoms: Blister, Injection site erythema, Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: Pain in extremity; Peripheral swelling; Pruritus; Tetanus injection site was redden and swollen; Tetanus injection site was redden and swollen; Blister; Fever; Case reference number US-BN-2021-002252, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 06-Sep-2021, is a spontaneous case received from consumer via health authority (VAERS ID: 1418152-1) and concerns a 20-year-old female patient.  The patient's medical history included penicillin and coconut allergy.  The patient's concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert (Inactivated Rabies Virus Vaccine; batch number was not provided), at an unknown dose, route or site of administration, for an unknown indication. It was reported that the patient did very well with the first rabies vaccine.  On 17-Jun-2021, the patient was vaccinated with the second dose of RabAvert (Inactivated Rabies Virus Vaccine; batch number: ARBA801B), at an unknown dose, administered intramuscularly in the right arm, for an unknown indication.  On 18-Jun-2021, the patient developed a slight fever.  On 19-Jun-2021, the patient developed a blister on hand.  On an unspecified date, the patient developed bilateral swelling in fingers which progressed to her palms. The patient also complained on itching and pain at the sites of the swelling.  On an unspecified date, the patient also developed swelling in feet.  On an unspecified date, the patient received co-suspect Tetanus vaccine (brand name unknown; batch number not provided) at an unknown dose, unknown route of administration, for an unknown indication.  On an unspecified date, the patient developed injection site redness and injection site swelling, also reported as Tetanus injection site.  At the time of this report, outcome for blister, pain in extremity, peripheral swelling, pruritis, pyrexia, injection site erythema and injection site swelling was not provided.  It was reported that the patient visited emergency room for an unknown reason.  The reporter assessed the events as non-serious. Causality assessment was not provided.  No further information was provided.; Reporter's Comments: Pruritus, pyrexia, injection site erythema and injection site swelling are listed for Rabipur according to the Prescriber Information, while blister, pain in extremity and peripheral swelling are unlisted for Rabipur according to the Prescriber Information. The patient developed pyrexia one day after the second dose of RabAvert was administrated. Two days after the second dose, the event of blister occurred. On an unspecified date, the patient developed peripheral swelling, pruritus and pain in extremity. On an unspecified date, the patient received co-suspect Tetanus vaccine. On an unspecified date, the patient developed injection site erythema and injection site swelling. The patient's medical history included penicillin and coconut allergy, while the patient's concomitant medication details were not provided. The patient's medical history and the fact that he received co-suspect Tetanus vaccine may have contributed to development of the events. Having in mind that contributory role of the suspect product cannot be excluded, the causality for all events is assessed as possibly related to Rabipur at the moment. This case is considered as non-serious.; Sender's Comments: Pruritus, pyrexia, injection site erythema and injection site swelling are listed for Rabipur according to the Prescriber Information, while blister, pain in extremity and peripheral swelling are unlisted for Rabipur according to the Prescriber Information. The patient developed pyrexia one day after the second dose of RabAvert was administrated. Two days after the second dose, the event of blister occurred. On an unspecified date, the patient developed peripheral swelling, pruritus and pain in extremity. On an unspecified date, the patient received co-suspect Tetanus vaccine. On an unspecified date, the patient developed injection site erythema and injection site swelling. The patient's medical history included penicillin and coconut allergy, while the patient's concomitant medication details were not provided. The patient's medical history and the fact that he received co-suspect Tetanus vaccine may have contributed to development of the events. Having in mind that contributory role of the suspect product cannot be excluded, the causality for all events is assessed as possibly related to Rabipur at the moment. This case is considered as non-serious.