Sex: F
Vaccine: RAB, TTOX
Symptoms: Anxiety, Bone pain, Brief resolved unexplained event, Cold sweat, Dysphagia
Clinical narrative: time sensitive and potentially life threatening disease; The patient was concerned about how the RabAvert vaccine was given/feeling distressed; Increased salivation; Feeling out of sorts; Headache; Clamminess; Feeling hot; Feeling unwell; Throat closing; Brain felt tingly; difficulty swallowing; Deep bone pain at the site of administration/HRIG administered at the same site as RabAvert; Rabavert administered at gluteal region/HRIG not administered near the wound; Case reference number US-BN-2022-001276 is a spontaneous case report initially received on 13-Jun-2022 from a consumer via agency (reference number: USBAV22-0312; USBAV22-0313; USBAV22-0323) and concerns a 43-year-old female patient.  The patient's medical history was not provided.  Concomitant medication details included amoxicillin-pot clavulanate 875-125 mg.  On 05-Jun-2022, the patient was bitten by a wild racoon on her left index finger and on the same day the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: unknown), intramuscularly, at the right gluteus medius (explicitly coded as 'vaccine administered at inappropriate site') for post-exposure immunization against rabies after a racoon bite and with co-suspect tetanus vaccine, at an unknown dose, administered via an unknown route of administration at the right arm area for an unknown indication. The patient also received a dose of Hyperrab (Immunoglobulin Human Anti-Rabies) in the left gluteus and another dose at 09:03h in the left arm, not near the wound site, for post exposure immunization (explicitly coded as ''vaccine administered at inappropriate site').  The patient was worrying if the vaccination was performed right, since the vaccine was administered in the gluteus area and her weight was not recorded. The patient was complaining why no one was answering her questions in the hospital as she had a time sensitive and potentially life threatening disease (unspecified).  On 08-Jun-2022, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) intramuscularly, in the left arm.  On an unspecified date, also reported as on the 05-Jun-2022, but also as after the second vaccination, the patient experienced throat closing, deep bone pain at the injection site, difficulty swallowing, increased salivation, headache, clamminess, was feeling out of sorts, her brain felt tingly, was feeling hot, and the patient was feeling unwell in general.  On an unspecified date, the patient stated that most of the events subsided and improved a bit.   On 12-Jun-2022, seven days after the first dose, the patient was vaccinated with the third dose of RabAvert (batch number: unknown) intramuscularly, at an unknown site. .   The outcome for the events of difficulty swallowing, increased salivation, headache, clamminess, brain felt tingly, feeling hot, feeling unwell was considered as recovering/resolving. The outcome for the events of feeling out of sorts' and throat closing' was provided as not recovered/not resolved. The outcome for the events of time sensitive and potentially life threatening disease', anxiety and injection site pain' was not provided.  The reporter assessed the event of time sensitive and potentially life threatening disease' as serious due to a life threatening criteria. All other events were assessed as serious due to medical criterion of medical significance. Causality assessment was not provided. The patient was not sure which medication caused the events as the patient received multiple medications at the same time.  Additional information received from a consumer via Communications on 13-Jun-2022, included local BN case ID.  Additional information received from a consumer via Communications on 14-Jun-2022, included: new events of throat closing, deep bone pain at the injection site, difficulty swallowing, increased salivation, feeling out of sorts, a headache, her brain felt tingly, clamminess, feeling hot, and she was feeling unwell in general.  Additional information received from a consumer via Communications on 15-Jun-2022 included patients age, gender and details regarding the third dose.  Additional information received on 17-Jun-2022 from a consumer via Communications included statement that the patient will be having a titer antibody test, to make sure the vaccination was performed properly.; Reporter's Comments: A 43-year-old female patient was bitten by a wild racoon on her left index finger and on the same day the patient was vaccinated with the first dose of RabAvert at the right gluteus medius for post-exposure immunization against rabies, with co-suspect tetanus vaccine and with a dose of Hyperrab (Immunoglobulin Human Anti-Rabies) in the left gluteus, and another dose at in the left arm, not near the wound site, for post-exposure immunization, which is considered as product administered at inappropriate site. The patient experienced a serious event of time sensitive and potentially life-threatening disease (seriousness criterion: life-threatening). On the day 3, the patient was vaccinated with the second dose of RabAvert. Reportedly, after the second vaccination, the patient experienced serious events of throat closing, deep bone pain at the injection site, difficulty swallowing, increased salivation, headache, clamminess, was feeling out of sorts, her brain felt tingly, was feeling hot, and the patient was feeling unwell in general (seriousness criterion: medical significance). Headache, malaise, paraesthesia and injection site pain are listed, whilst throat tightness and dysphagia are considered as listed per Datasheet v6. Feeling abnormal and product administered at inappropriate site are considered as listed per company convention. Brief resolved unexplained event, anxiety, salivary hypersecretion, cold sweat and feeling hot are not listed for RabAvert per Datasheet v6. The patient's medical history was not provided ad concomitant medication details included amoxicillin-pot clavulanate. The outcome for the events of difficulty swallowing, increased salivation, headache, clamminess, brain felt tingly, feeling hot, feeling unwell was considered as resolving. The outcome for the events of feeling out of sorts and throat closing was provided as not resolved, whilst the outcome for the events of time sensitive and potentially life-threatening disease, anxiety and injection site pain was not provided. The patient's co-suspect vaccination confounded the causality for the events. However, since the contributory role of the suspect vaccine cannot be excluded with certainty, at this point, the events of headache, malaise, paraesthesia, injection site pain, throat tightness, dysphagia, feeling abnormal, brief resolved unexplained event, anxiety, salivary hypersecretion, cold sweat and feeling hot have been conservatively considered as related to RabAvert. Product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human factor.; Sender's Comments: A 43-year-old female patient was bitten by a wild racoon on her left index finger and on the same day the patient was vaccinated with the first dose of RabAvert at the right gluteus medius for post-exposure immunization against rabies, with co-suspect tetanus vaccine and with a dose of Hyperrab (Immunoglobulin Human Anti-Rabies) in the left gluteus, and another dose at in the left arm, not near the wound site, for post exposure immunization, which is considered as product administered at inappropriate site. The patient experienced a serious event of time sensitive and potentially life-threatening disease (seriousness criterion: life-threatening). On the day 3, the patient was vaccinated with the second dose of RabAvert. Reportedly, after the second vaccination, the patient experienced serious events of throat closing, deep bone pain at the injection site, difficulty swallowing, increased salivation, headache, clamminess, was feeling out of sorts, her brain felt tingly, was feeling hot, and the patient was feeling unwell in general (seriousness criterion: medical significance). Headache, malaise, paraesthesia and injection site pain are listed, whilst throat tightness and dysphagia are considered as listed per USPI and Global Datasheet v6. Feeling abnormal and product administered at inappropriate site are considered as listed per company convention. Brief resolved unexplained event, anxiety, salivary hypersecretion, cold sweat and feeling hot are not listed for RabAvert per Datasheet v6. The patient's medical history was not provided ad concomitant medication details included amoxicillin-pot clavulanate. The outcome for the events of difficulty swallowing, increased salivation, headache, clamminess, brain felt tingly, feeling hot, feeling unwell was considered as resolving. The outcome for the events of feeling out of sorts and throat closing was provided as not resolved, whilst the outcome for the events of time sensitive and potentially life-threatening disease, anxiety and injection site pain was not provided. The patient's co-suspect vaccination confounded the causality for the events. However, since the contributory role of the suspect vaccine cannot be excluded with certainty, at this point, the events of headache, malaise, paraesthesia, injection site pain, throat tightness, dysphagia, feeling abnormal, brief resolved unexplained event, anxiety, salivary hypersecretion, cold sweat and feeling hot have been conservatively considered as related to RabAvert. Product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human factor.