Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | IM |
The patient had very elevated and rapid heart rate, was tachycardic and also was nauseous and dizzy; Six hours after the patient received the first dose of RabAvert, patient experienced severe tingling and numbness in feet, legs, arms, hands and face upper lip tingling; The patient had very elevated and rapid heart rate, was tachycardic and also was nauseous and dizzy; Six hours after the patient received the first dose of RabAvert, patient experienced severe tingling and numbness in feet, legs, arms, hands, face, cheeks and upper lip; The patient had very elevated and rapid heart rate, was tachycardic and also was nauseous and dizzy; The patient had very elevated and rapid heart rate, was tachycardic and also was nauseous and dizzy; Six hours after the patient received the first dose of RabAvert, patient experienced severe tingling and numbness in feet, legs, arms, hands, face, cheeks and upper lip; The patient felt generally ill; Case reference number US-BN-2025-000023 is a spontaneous case initially received from a physician via Med Communication (reference number: USBAV25-0042) on 07-Jan-2025 and concerns a female patient with unspecified age. The patient's medical history and concomitant medication details were not provided. On 03-Jan-2025, at emergency room, the patient received first dose of RabAvert vaccine (batch number: unknown) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, intramuscularly, at unknown site of administration for post exposure treatment. On unspecified date, reported as on Friday, within 6 hours of receiving the first dose of RabAvert vaccine, the patient experienced severe tingling and numbness in feet, legs, arms, hands and face. The patient had a very, very elevated heart rate for about 24 hours and patient was nauseous and dizzy. Patient was tachycardic and felt generally ill and by the next day most of it had resolved after about 24 hours except for still some tingly feelings, cheek and lips of face. At the time of initial report, the patient was not recovered from the events of 'tingling lips' and 'tingling', but was recovered from the events of 'numbness', 'tachycardia', 'heart rate increased', 'illness', 'nauseous' and 'dizzy'. The reporter did not provide seriousness assessment for the events 'tingling lips' and 'tingling', 'numbness', 'tachycardia', 'heart rate increased', 'illness', 'nauseous' and 'dizzy'. Causality assessment for events 'tingling lips' and 'tingling', 'numbness', 'tachycardia', 'heart rate increased', 'illness', 'nauseous' and 'dizzy' was reported as related to RabAvert. No further information was provided.; Reporter's Comments: A female patient with unspecified age experienced non-serious events of paraesthesia, nausea, dizziness, tachycardia, paraesthesia oral, heart rate increased, hypoaesthesia and illness within 6 hours after the patient received first dose of RabAvert vaccine for post exposure treatment. Paraesthesia, nausea and dizziness are considered as listed and expected for RabAvert per CCDS v4 and USPI, whilst tachycardia, paraesthesia oral, heart rate increased and hypoaesthesia are unlisted and unexpected. Illness is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the events of tingling lips and tingling, but recovered from the events of numbness, tachycardia, heart rate increased, illness, nauseous and dizzy. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: A female patient with unspecified age experienced non-serious events of paraesthesia, nausea, dizziness, tachycardia, paraesthesia oral, heart rate increased, hypoaesthesia and illness within 6 hours after the patient received first dose of RabAvert vaccine for post exposure treatment. Paraesthesia, nausea and dizziness are considered as listed and expected for RabAvert per CCDS v4 and USPI, whilst tachycardia, paraesthesia oral, heart rate increased and hypoaesthesia are unlisted and unexpected. Illness is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the events of tingling lips and tingling, but recovered from the events of numbness, tachycardia, heart rate increased, illness, nauseous and dizzy. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. This case is considered as non-serious.
Comments: None