Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Paraesthesia, Product administered at inappropriate site, Product dose omission issue, Tremor
Clinical narrative: Caller does not report receiving the fifth rabies vaccine; RabaVert was administered in patient's buttocks; tremors in left foot; tingling and numbness in left foot; tingling and numbness in left foot; Case reference number US-BN-2021-000031 is a spontaneous case report initially received from a consumer via GSK (reference number US2021014356) on 21-Jan-2021 and concerns a 42-year-old female patient.  The patient's medical history and concomitant medications details were not provided.  On 20-Apr-2019, the patient was bitten by an unknown dog.  On 21-Apr-2019, the patient received first dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) given in her buttocks (drug administered at inappropriate site) at unknown dose for post-exposure prophylaxis. On the same date, approximately 4 hours after receiving the first dose of RabaVert, the patient developed signs of muscule tremor and tingling of the bottom of her left foot and the numbness and tingling began going up her left leg and finally spread to her upper chest on both sides.  On 24-Apr-2019, the patient received second dose of RabaVert (Batch no. was not provided) at unknown dose in left arm.  On 28-Apr-2019, the patient received third dose of RabaVert (Batch no. was not provided) at unknown dose in right arm.  On 05-May-2019, the patient received fourth dose of RabaVert (Batch no. was not provided) at unknown dose in left arm.  On 07-May-2019, the patient went to a neurologist for her continued symptoms and the neurologist prescribed gabapentin to the patient, but the patient had never took the drug.  The consumer did not report that she received fifth dose of RabaVert (possible missed dose).  At the time of this report the outcome for the all events was reported as resolved with sequelae after 3 weeks to a month from receiving the first dose of RabaVert.   The reporter did not provide the seriousness and causality assessment.   Reporter refused to be contacted. No further follow up is possible.  No further information was provided.; Reporter's Comments: Tremor and hypoaesthesia are unlisted for RabaVert as per prescriber information and as per Agency, while paraesthesia is listed. Product administered at inappropriate site and product dose omission issue are listed by convention. Reportedly, the patient received first dose of RabaVert in buttocks, which is considered as product administered at inappropriate site. On the same date, approximately 4 hours after receiving the first dose of RabaVert, the patient developed tremor, hypoaesthesia and paraesthesia. In addition, there is no information if the patient received fifth dose of RabaVert, which is considered as product dose omission issue. There is no information regarding the patient's medical history and concomitant medications. However, due to plausible temporal relationship and as the contributory role of RabaVert cannot be excluded, the causality is assessed as possibly related for tremor, hypoaesthesia and paraesthesia. The causality for product administered at inappropriate site and product dose omission issue is not related to RabaVert but to decision of prescribing physician.; Sender's Comments: Tremor and hypoaesthesia are unlisted for RabaVert as per prescriber information and as per Agency, while paraesthesia is listed. Product administered at inappropriate site and product dose omission issue are listed by convention. Reportedly, the patient received first dose of RabaVert in buttocks, which is considered as product administered at inappropriate site. On the same date, approximately 4 hours after receiving the first dose of RabaVert, the patient developed tremor, hypoaesthesia and paraesthesia. In addition, there is no information if the patient received fifth dose of RabaVert, which is considered as product dose omission issue. There is no information regarding the patient's medical history and concomitant medications. However, due to plausible temporal relationship and as the contributory role of RabaVert cannot be excluded, the causality is assessed as possibly related for tremor, hypoaesthesia and paraesthesia. The causality for product administered at inappropriate site and product dose omission issue is not related to RabaVert but to decision of prescribing physician.