Sex: M
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: Nine doses of Jyneos were given that had temperature excursion between negative 0.99 and negative 8.04 degrees Celsius; Nine doses of Jyneos were given that had temperature excursion between negative 0.99 and negative 8.04 degrees Celsius; Case reference number US-BN-2023-001080 is a spontaneous case report initially received from other health professional via Communication (reference number: USBAV23-0816) on 26-Jun-2023 and concerns nine male adult patients.    The patients' medical history and concomitant medication details were not provided.  On an unspecified date, Jynneos vials (batch number: FDP00014; expiration date: 30-Sep-2024) were being stored in the refrigerator between two and eight degrees Celsius and went out of range from 11 a.m. to 4:30 p.m., for a total of 5.5 hours. The highest out of range temperature reached was -0.99 degrees Celsius and the lowest temperature was -8.04 degrees Celsius (explicitly coded as 'product storage error temperature too low').  On an unspecified date, an unknown time after the temperature excursion, the patients were vaccinated with a dose of affected Jynneos vaccine at unknown dose, route and site of administration, for unknown indication (explicitly coded as 'product administration error').  The reporter wanted to know if the patients need to be re-vaccinated and if the remaining 14 vials need to be wasted.  At the time of the initial report, it was unknown if any patient experience any adverse event due to Jynneos.  Additional information received from other health professional via Communication (reference number: USBAV23-0819) on 26-Jun-2023 included gender and date of birth for second of the nine patients.  Additional information received from other health professional via Communication (reference number: USBAV23-0818) on 26-Jun-2023 included gender and date of birth for third of the nine patients.  Additional information received from other health professional via Communication (reference number: USBAV23-0820) on 26-Jun-2023 included gender and date of birth for fourth of the nine patients.  Additional information received from other health professional via Communication (reference number: USBAV23-0821) on 26-Jun-2023 included gender and date of birth for fifth of the nine patients.  Additional information received from other health professional via Communication (reference number: USBAV23-0822) on 26-Jun-2023 included gender and date of birth for sixth of the nine patients.  Additional information received from other health professional via Communication (reference number: USBAV23-0823) on 26-Jun-2023 included gender and date of birth for seventh of the nine patients. Additional information received from other health professional via Communication (reference number: USBAV23-0824) on 26-Jun-2023 included gender and date of birth for eighth of the nine patients.  Additional information received from other health professional via Communication (reference number: USBAV23-0825) on 26-Jun-2023 included gender and date of birth for ninth of the nine patients.  Additional information received on 27-Jun-2023 included local case ID.; Reporter's Comments: On an unspecified date, Jynneos vials were being stored in the refrigerator between two and eight degrees Celsius and went out of range from 11 a.m. to 4:30 p.m., for a total of 5.5 hours, which is considered as product storage error. Nine male adult patients were vaccinated with the first dose of affected Jynneos vaccine for an unknown indication, which is considered as product administration error. No associated adverse events were reported. Product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: On an unspecified date, Jynneos vials were being stored in the refrigerator between two and eight degrees Celsius and went out of range from 11 a.m. to 4:30 p.m., for a total of 5.5 hours, which is considered as product storage error. Nine male adult patients were vaccinated with the first dose of affected Jynneos vaccine for an unknown indication, which is considered as product administration error. No associated adverse events were reported. Product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.