Sex: F
Vaccine: RAB
Symptoms: Anxiety, Ear discomfort, Erythema, Eye pruritus, Eye swelling
Clinical narrative: Syncope; allergic reaction; low blood pressure; Anxiety; Ear canal felt as though they were closing (difficulty hearing and pressure in both ears); Ear canal felt as though they were closing (difficulty hearing and pressure in both ears); Ear canal felt as though they were closing (difficulty hearing and pressure in both ears); Red and hot face and red and itchy hands; Eye pruritus; Eyes partially swollen; Pounding headache; Hives began appearing on abdomen, face, and arms; Itchy hands; Case reference number US-BN-2021-002404, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 08-Nov-2021, is a spontaneous case received from a consumer via health authority VAERS (1659211-1) and concerns a 22-year-old male patient.  The patient's medical history and concomitant medication details were not provided.    On unspecified dates, the patient was vaccinated with the first two doses of RabAvert (inactivated rabies virus vaccine; batch number was not provided), at an unknown dose or route of administration, for unknown indication.   On 30-Aug-2021, around 16:30h, the patient was vaccinated with the third dose of RabAvert (inactivated rabies virus, vaccine; batch number: ARBA851A), at an unknown dose, administered intramuscularly in the left arm, for unknown indication. The patient experienced pounding headache, red and hot face, and red and itchy hands, 10 to 15 minutes post-vaccination.  On the same date, reported as approximately five minutes after onset of symptoms, the patient arrived home and the symptoms worsened. Hives began to appear on abdomen, face and arms. The hand irritation also began to worsen. The patient's eyes were partially swollen, the ear canal felt as though the ears were closing, the patient had difficulty hearing and pressure in both ears.  On the same date, reported as approximately at 17:20, the patient arrived at the emergency room. At that time, the hives were more severe and there was no improvement of other symptoms. The patient underwent venipuncture and had unspecified intravenous fluids, during which the patient experienced syncope multiple times. The patient also experienced several moments of low blood pressure and anxiety. The patient's treatment included fluids, diphenhydramine, famotidine and steroids, all administered intravenously.  On the same date, reported as within 30 minutes of treatment, the patient mostly recovered from all symptoms.  The patient was prescribed three days of prednisone, five days of famotidine and five days of diphenhydramine.  The events syncope, hypersensitivity and hypotension were assessed as serious due to the seriousness criteria of medical significance. The reporter assessed all the events as non serious and did not provide causality assessment of the events.  No further information was provided.; Reporter's Comments: The 22-year-old female patient was vaccinated with the third dose of RabAvert for unknown indication, and 10 to 15 minutes post-vaccination, the patient experienced non-serious events of headache, erythema and itchy hands. Reportedly, as the patient arrived home, the symptoms worsened, and the patient experienced non-serious events of urticaria, eye swelling, eye pruritus, ear discomfort, ear swelling and hypoacusis. As reported, approximately 20 minutes after that, the patient arrived at the emergency room, the hives were more severe, and the patient underwent venepuncture and had unspecified intravenous fluids, during which the patient experienced the serious events of syncope, hypersensitivity and hypotension (seriousness criteria: medically significant), and non-serious event of anxiety. The events of headache, erythema, pruritus, urticaria, eye swelling, eye pruritus, ear swelling, syncope, hypersensitivity and hypotension are listed for RabAvert according to the local SmPC and Datasheet, whilst the events of anxiety, ear discomfort and hypoacusis are not listed for RabAvert according to the local SmPC and Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of all the events was recovered/resolved. Considering suggestive temporal relationship and absence of confounding factors, the events of headache, erythema, pruritus, urticaria, eye swelling, eye pruritus, ear swelling, syncope, hypersensitivity, hypotension, anxiety, ear discomfort and hypoacusis have been considered as related to RabAvert.; Sender's Comments: The 22-year-old female patient was vaccinated with the third dose of RabAvert for unknown indication, and 10 to 15 minutes post-vaccination, the patient experienced non-serious events of headache, erythema and itchy hands. Reportedly, as the patient arrived home, the symptoms worsened, and the patient experienced non-serious events of urticaria, eye swelling, eye pruritus, ear discomfort, ear swelling and hypoacusis. As reported, approximately 20 minutes after that, the patient arrived at the emergency room, the hives were more severe, and the patient underwent venepuncture and had unspecified intravenous fluids, during which the patient experienced the serious events of syncope, hypersensitivity and hypotension (seriousness criteria: medically significant), and non-serious event of anxiety. The events of headache, erythema, pruritus, urticaria, eye swelling, eye pruritus, ear swelling, syncope, hypersensitivity and hypotension are listed for RabAvert according to the Datasheet, whilst the events of anxiety, ear discomfort and hypoacusis are not listed for RabAvert according to the Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of all the events was recovered/resolved. Considering suggestive temporal relationship and absence of confounding factors, the events of headache, erythema, pruritus, urticaria, eye swelling, eye pruritus, ear swelling, syncope, hypersensitivity, hypotension, anxiety, ear discomfort and hypoacusis have been considered as related to RabAvert.