Sex: U
Vaccine: RAB
Symptoms: Medication error, No adverse event, Product dose omission issue, Product storage error, Refusal of vaccination
Clinical narrative: The patient refused RabAvert dose after a dog bit and the dose was left out at the temperature that was lower than 70 Fahrenheit degrees for about 15 hours; The patient refused RabAvert dose after a dog bit and the dose was left out at the temperature that was lower than 70 Fahrenheit degrees for about 15 hours; Case reference number US-BN-2022-001492 is a spontaneous case report initially received on 07-Jul-2022 from pharmacist (reference number: USBAV22-0505) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication were not provided.   On an unspecified date, un-reconstituted RabAvert vaccine (Rabies Virus (Inactivated, Strain Flury LEP); batch number: unknown) was sent to emergency room (ER) for a patient who was bitten by a dog for the first dose of RabAvert, but the patient refused the dose (explicitly coded as 'missed dose') and the dose was left out inset of being put back into the refrigerator. As reported, the vaccine was left on room temperature, at the temperature that was lower than 70 Fahrenheit degrees for about 15 hours (explicitly coded as 'product storage error').   At the time of this report, it was unknown if the patient received the vaccine at all.  Additional information received on 08-Jul-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: A patient of unknown demographics was about to vaccinated with RabAvert for post exposure prophylaxis, and on an unspecified date, un-reconstituted RabAvert vaccine was sent to emergency room (ER) for a patient who was bitten by a dog for the first dose of RabAvert, but the patient refused the dose, which is considered as product dose omission issue, and the dose was left out inset of being put back into the refrigerator. As reported, the vaccine was left on room temperature, at the temperature that was lower than 70 Fahrenheit degrees for about 15 hours, which is considered as product storage error. No associated adverse events have been reported with the reported medication error. Product storage error and product dose omission issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product dose omission issue have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was about to vaccinated with RabAvert for post exposure prophylaxis, and on an unspecified date, un-reconstituted RabAvert vaccine was sent to emergency room (ER) for a patient who was bitten by a dog for the first dose of RabAvert, but the patient refused the dose, which is considered as product dose omission issue, and the dose was left out inset of being put back into the refrigerator. As reported, the vaccine was left on room temperature, at the temperature that was lower than 70 Fahrenheit degrees for about 15 hours, which is considered as product storage error. No associated adverse events have been reported with the reported medication error. Product storage error and product dose omission issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product dose omission issue have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.