Sex: F
Vaccine: RAB
Symptoms: Stress, Viral titre
Clinical narrative: Extremely stressed out; Tingling in that hand and she has even felt like it spread up her shoulder; Spine pain; Slight numbness in that arm; Case reference number US-BN-2022-001258 is a spontaneous case report initially received on 09-Jun-2022 from a consumer via Agency (reference number: USBAV22-0298) and concerns a 31-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 14-May-2022, the patient has been exposed to a bat and had a possible bat bite on her arm. About 12 hours later the patient was in emergency room starting her Rabavert vaccine series. The patient was vaccinated with the first dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: not reported)  and rabies immune globulin (RIG; immunoglobulin human anti-rabies; batch number: not reported), both at an unknown dose or anatomical location, administered intramuscularly for post exposure immunisation.    On the same day, shortly after receiving RIG as reported, the patient developed slight numbness in that arm and as time passed she began to have tingling in that same hand and she has even felt like it spread up her shoulder and even complained of spine pain.  On 17-May-2022, three days after the first dose, the patient was vaccinated with the second dose of Rabavert (batch number: not reported), at an unknown dose or anatomical location, administered intramuscularly.  On 21-May-2022, seven days after the first dose, the patient was vaccinated with the third dose of Rabavert (batch number: not reported), at an unknown dose or anatomical location, administered intramuscularly.  On 28-May-2022, 14 days after the firs dose, the patient was vaccinated with the fourth dose of Rabavert (batch number: not reported), at an unknown dose or anatomical location, administered intramuscularly.  On an unspecified date in 2022, the patient went three times to the ER and the last time magnetic resonance imaging (MRI) of the patient's spine was done and that ruled out transverse myelitis. Then titer test was done and that came back good as the patient was fully protected. The patient was extremely stressed out over it, as reported. The patient's husband spoke with doctors about Gillian Barre, but usually that affects the legs first and the patient's legs were fine.  The outcome of all events was unknown.  The reporter assessed all events as serious due to medically significance and possibly related to Rabavert.  Additional information received on 10-Jun-2022 from included ID.; Reporter's Comments: A 31-year-old female patient has been exposed to a bat and had a possible bat bite on her arm. Reportedly, about 12 hours later the patient was in the emergency room starting her RabAvert vaccine series. The patient was vaccinated with the first dose of Rabavert and rabies immune globulin, for post exposure immunisation. On the same day, shortly after receiving RIG as reported, the patient developed serious events of paraesthesia, hypoesthesia and spinal pain (seriousness criterion: medical significance). Reportedly, the patient was vaccinated with 3 more doses of RabAvert in the next 14 days. On an unspecified date, the patient went three times to the ER and the last time magnetic resonance imaging (MRI) of the patient's spine was done and that ruled out transverse myelitis. Then titer test was done and that came back good as the patient was fully protected. Reportedly, the patient experienced a serious event of stress an unknown amount of time after receiving the suspect vaccine. Paraesthesia is listed, whilst hypoesthesia, spinal pain and stress 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 events was unknown, as reported. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events of paraesthesia, hypoesthesia, spinal pain and stress have been considered as related to RabAvert.; Sender's Comments: A 31-year-old female patient has been exposed to a bat and had a possible bat bite on her arm. Reportedly, about 12 hours later the patient was in the emergency room starting her RabAvert vaccine series. The patient was vaccinated with the first dose of Rabavert and rabies immune globulin, for post exposure immunisation. On the same day, shortly after receiving RIG as reported, the patient developed serious events of paraesthesia, hypoesthesia and spinal pain (seriousness criterion: medical significance). Reportedly, the patient was vaccinated with 3 more doses of RabAvert in the next 14 days. On an unspecified date, the patient went three times to the ER and the last time magnetic resonance imaging (MRI) of the patient's spine was done and that ruled out transverse myelitis. Then titer test was done and that came back good as the patient was fully protected. Reportedly, the patient experienced a serious event of stress an unknown amount of time after receiving the suspect vaccine. Paraesthesia is listed, whilst hypoesthesia, spinal pain and stress 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 events was unknown, as reported. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events of paraesthesia, hypoesthesia, spinal pain and stress have been considered as related to RabAvert.