Sex: F
Vaccine: RAB
Symptoms: Injection site urticaria, Pyrexia, SARS-CoV-2 test
Clinical narrative: at injection site appeared redness and raised region like a hive; at injection site appeared redness and raised region like a hive; low grade fever; chills; headache; Tiredness; Case reference number US-BN-2021-000262 is a spontaneous case report initially received from a consumer on 19-Mar-2021, and concerns a female patient.  The patient's medical history was not provided.  Concomitant medication included Tylenol (Paracetamol).   On 11-Mar-2021, the patient started therapy with RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for post exposure from bat, but no confirmation of bite.  On 14-Mar-2021, patient received  second dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for post exposure from bat, but no confirmation of bite.  On 18-Mar-2021, patient received third dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal bite. The same day, at dinner time, the patient experienced low grade fever, chills, headache and tiredness.   On the same 18-Mar-2018, an unknown amount of time after receiving the 3rd dose, reported as "at dinner time", the patient experienced a low grade fever, chills and felt tired. The patient took Tylenol on 18-Mar-2021, and the patient's symptoms went away few hours latter.  On 19-Mar-2018, an unknown amount of time after receiving the 3rd dose, reported as next day, in the morning, at injection site appeared redness and raised region like a hive.   On 19-Mar-2021 patient was recommended to get tested for COVID-19, after that she was tested the same day.(COVID-19 test result was not provided).   On unknown date (between 18th and 19-Mar-2021.) the patient recovered from fever, chills and tiredness. At the time of this report it is no known whether patient recovered from administration site reaction.  The reporter assessed the events as non-serious and possibly related to RabAvert vaccine.  Further information was not provided.; Reporter's Comments: Pyrexia, chills, headache, fatigue, injection site erythema and injection site urticaria are listed for RabAvert according to the Agency and Prescriber Information. Reportedly, the patient experienced low grade fever, chills, headache and tiredness on the same day when she received third dose of RabAvert. Next morning, at injection site appeared redness and raised region like a hive. The patient was to get tested for COVID-19 on the day of the reporting. Temporal relationship is considered plausible for all events. Due to that and vaccine safety profile the causality for injection site erythema and injection site urticaria is assessed as probably related to RabAvert. For events of pyrexia, chills, headache and fatigue contributory role of confounding factors cannot be excluded and causality is assessed as possibly related to RabAvert.; Sender's Comments: Pyrexia, chills, headache, fatigue, injection site erythema and injection site urticaria are listed for RabAvert according to the Agency and Prescriber Information. Reportedly, the patient experienced low grade fever, chills, headache and tiredness on the same day when she received third dose of RabAvert. Next morning, at injection site appeared redness and raised region like a hive. The patient was to get tested for COVID-19 on the day of the reporting. Temporal relationship is considered plausible for all events. Due to that and vaccine safety profile the causality for injection site erythema and injection site urticaria is assessed as probably related to RabAvert. For events of pyrexia, chills, headache and fatigue contributory role of confounding factors cannot be excluded and causality is assessed as possibly related to RabAvert.