Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Injection site pain, Product administered at inappropriate site, Product administration error, Wound
Clinical narrative: The patient had to be re-started on the rabies vaccination series on 08-Apr-2021 due to concern the immunoglobulin product would reduce patient's immune response; Patient did experience mild tenderness at the injection site for ~12 hours; HRIG, hyperRab 300U/ml, the patient was given 2,100 units or 7ml. This was given IM in right deltoid. Rabavert was given at this time also in the right deltoid; HRIG, hyperRab 300U/ml, the patient was given 2,100 units or 7ml. This was given IM in right deltoid. Rabavert was given at this time also in the right deltoid; Case reference number US-BN-2021-001596 is a spontaneous case report initially received via Agency (reference number USBAV21-0150) on 08-Apr-2021, and concerns a 76 years old male patient.  The patient's medical history included diabetes and kidney disease.   The patient's concomitant medication included HRIG, hyperRab 300U/ml.  On 07-Apr-2021 the patient received the first dose of RabAvert (Inactivated Rabies virus Vaccine, Batch no. ARBA801A) at dose of 1.0 mL, administrated intramuscularly in the right deltoid region, and for post-exposure prophylaxis.  *On the same day, after receiving the first dose of RabAvert and HRIG, hyperRab 300U/ml, the patient developed mild tenderness at the injection site that lasted approximately twelve hours.*  The reporter stated that the patient had a wound to his right hand. HRIG, hyperRab 300U/ml was given (2,100 units or 7ml) intramuscularly in right deltoid. Rabavert was given at this time also in the right deltoid. They were given as separate injections, but given in the same area (Product administration error, vaccine administered at inappropriate site).  *On 08-Apr-2021, the patient recovered from the event of mild tenderness at the injection site*.  *On the same day, as stated by the reporter, that patient had to be re-started on the rabies vaccination series due to concern the immunoglobin product would reduce patient's ability to mount an immune response (Inappropriate schedule of product administration).*  The reporter assessed the event of tenderness at the injection site as non-serious and not related to the RabAvert, but related to administration technique of the nurse.*  All follow up information are blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information was received from a pharmacist via Agency on 27-Apr-2021: New information included patient's initials and date of birth, additional event with information about onset date, stop date, outcome for the event and reporter's assessment of seriousness and causality.; Reporter's Comments: Product administration error, product administered at inappropriate site and inappropriate schedule of product administration are listed by convention. Injection site tenderness is listed per datasheet of Rabavert. Reportedly, the patient received RabAvert and HRIG in the same area, which is considered both product administration error and product administered at inappropriate site. The patient had to be restarted on the rabies vaccination series due to concern that the immunoglobin product would reduce patient's ability to mount an immune response, which is considered an inappropriate schedule of product administration. The patient developed injection site tenderness on the same day when RabAvert was administered. Product administration error, product administered at inappropriate site and inappropriate schedule of product administration are not related to RabAvert, but to a human action. Injection site tenderness is possibly related to RabAvert, concomitant administration of HRIG could be contributory to the event. Although the reporter assessed injection site tenderness as not related to RabAvert but to administration technique of the nurse, the contributory role of the injection itself cannot be excluded. The case is non-serious.; Sender's Comments: Product administration error, product administered at inappropriate site and inappropriate schedule of product administration are listed by convention. Injection site tenderness is listed per  datasheet of Rabavert. Reportedly, the patient received RabAvert and HRIG in the same area, which is considered both product administration error and product administered at inappropriate site. The patient had to be restarted on the rabies vaccination series due to concern the immunoglobin product would reduce patient's ability to mount an immune response, which is considered an inappropriate schedule of product administration. The patient developed injection site tenderness on the same day when RabAvert was administered. Product administration error, product administered at inappropriate site and inappropriate schedule of product administration are not related to RabAvert, but to a human action. Injection site tenderness is possibly related to RabAvert, concomitant administration of HRIG could be contributory to the event. Although the reporter assessed injection site tenderness as not related to RabAvert but to administration technique of the nurse, the contributory role of the injection itself cannot be excluded. The case is non-serious.