Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient received an Adacel which had been frozen and thawed which was dropped to 1.4 C and 1.5 C and same vaccines have gotten down to -4 C a month before this current excursion occurred /No AE; Based on information received on 07-Aug-2019, the report previously considered as non-valid became valid: [patient received the vaccine identified].  Initial information received on 17-Jul-2019 regarding an unsolicited non-valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA224076, 2019SA224136, 2019SA224137, 2019SA224138, 2019SA224139, 2019SA224140, 2019SA224141, 2019SA224142, 2019SA224144, 2019SA224145 and 2019SA224143 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 C range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C.Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated  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 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.  Documents held by sender: none.  Follow up information received on 18-Jul-2019 regarding an unsolicited non-valid non-serious case received from a consumer (Office Staff).  No new information updated.  Documents held by sender: none.  Follow up information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from non health care professional (office staff).  Validity of case was updated, vaccine route, batch number and expiry date was updated.  Documents held by sender: none.