Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: The nurse had a hard time drawing vaccine up and noticed maybe slightly frozen, warmed up a little bit on hand; The nurse had a hard time drawing vaccine up and noticed maybe slightly frozen, warmed up a little bit on hand; Case reference number US-BN-2024-001860 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0871) on 29-Apr-2024 and concerns a 3-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  *On 15-Apr-2024, the patient was vaccinated with the first dose of RabAvert (batch number: ARBB101A, expiry date: 31-Jan-2026) at a dose of 1.0 milliliter, via intramuscular use at unknown site of administration* for post exposure rabies.   *On 18-Apr-2024, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: ARBB101B, expiry date: 31-Jan-2026) at a dose of 1.0 milliliter, via intramuscular use in left lateral thigh*.   *On 22-Apr-2024, seven days after the first dose, the patient was vaccinated with the third dose of RabAvert (batch number: FDB00448, expiry date: 01-Apr-2027) at a dose of 1.0 milliliter, via intramuscular use in right lateral thigh*.   *On 29-Apr-2024, 14 days after the first dose*, the patient was vaccinated with the fourth dose of RabAvert (batch number: FDP00419, expiry date: 01-Apr-2027) *at a dose of 1.0 milliliter, via intramuscular use in left lateral thigh*.  *On 13-May-2024, 28 days after the first dose, the patient was vaccinated with the fifth dose of RabAvert (batch number: FDP00419, expiry date: 01-Apr-2027) at a dose of 1.0 milliliter, via intramuscular use in left anterior thigh*. As reported, patient was given the Rabies series and one of the doses looked that it was partially frozen and the nurse had drawing it up and noticed maybe slightly frozen, nurse warmed up a little bit on hand so the nurse could get the rest of it drawn up (explicitly coded as 'product storage error' and 'product administration error').  At the time of the *follow up* report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received from Bavarian Nordic on 07-May-2024: included batch number (FDP00419) and expiry date (01-Apr-2027) for fourth dose.  Additional information received from Bavarian Nordic on 07-May-2024: included product quality complaint number (QE-009933).  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a pharmacist on 15-May-2024: New information included patient initials and RabAvert dosage information for all doses.; Reporter's Comments: A 3-year-old female patient was vaccinated with the fifth dose of RabAvert for post exposure rabies. As reported, patient was given the Rabies series and one of the doses looked that it was partially frozen and the nurse had drawing it up and noticed maybe slightly frozen, nurse warmed up a little bit on hand so the nurse could get the rest of it drawn up, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to RabAvert. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error 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 3-year-old female patient was vaccinated with the fifth dose of RabAvert for post exposure rabies. As reported, patient was given the Rabies series and one of the doses looked that it was partially frozen and the nurse had drawing it up and noticed maybe slightly frozen, nurse warmed up a little bit on hand so the nurse could get the rest of it drawn up, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to RabAvert. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.