Sex: U
Vaccine: TD, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines were stored at 18 F for approximately 30 days, with no reported adverse event; Initial information received on 11-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 9 patients of unknown demographics who were administered vaccines stored at 18 F for approximately 30 days, with no reported adverse event ,while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection (lot - C5823BA, 02-Jun-2023) (unknown dose via unknown route in unknown administration site) as prophylactic vaccination. On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (lot U73068A,11-MAR-2024) (unknown dose via unknown route in unknown administration site) as prophylactic vaccination. On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Suspension for injection (lot U7189AA ,30-SEP-2023) (unknown dose via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "vaccines were stored at 18 f for approximately 30 days, with no reported adverse event "(product storage error) (unknown latency).  It was reported"Caller reported a temperature excursion. The caller stated that the vaccines had been stored improperly. The vaccines were stored at 18 F for approximately 30 days. The box of ADACEL was not opened and was not administered to anyone post excursion. The caller stated that they may have administered the TENIVAC and TUBERSOL post excursion to 9 patients potentially. However, the caller did not have exact information regarding the patients. The caller stated that they will call back once they have confirmed how many and which patients received these vaccines that were no longer suitable for use."  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL), DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) and TUBERCULIN TEST (TUBERSOL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (vaccines were stored at 18 F for approximately 30 days, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event vaccines were stored at 18 f for approximately 30 days, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.