Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure during pregnancy, Product storage error
Clinical narrative: ADACEL vaccine received 30.6 weeks pregnant with no reportde adverse event; unsure how long the excursion was and unsure what the maximum or minimum temperature was during the excursion with no reportde adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional (Reference number- 00680364) and transmitted to Sanofi on 13-JUL-2021.  This case involves a 36-year-old pregnant female patient was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (exposure during pregnancy) and the reporter was unsure how long the excursion was and unsure what the maximum or minimum temperature was during the excursion (product storage error).  The patient's medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  Data regarding this pregnancy were received prospectively.   The date of last menstrual period was reported as 09-Dec-2020.   The estimated due date was 15-Sep-2021.  The actual date of delivery was not reported.  On 12-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6927AA; expiry date: 28-JAN-2023) via intramuscular route in right deltoid for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (latency same day).  It was reported as "Pregnancy: yes, 30.6 weeks pregnant"  It was also the case of potential medication error due to incorrect product storage.  It was reported as "Manager called to check stability of a product after a potential temperature excursion. The caller is unsure how long the excursion was and unsure what the maximum or minimum temperature was during the excursion. On Monday (12/JUL2021) the door to the fridge was found to be ajar. The door was not completely open but was not closed all the way. The door was discovered when the first patient arrived for their glucose test. When the staff member went to lab, she noticed the door was ajar. Upon opening the fridge, the ice had melted at the top and water was coming out of the fridge and onto the floor. The glucose bottle was cold when removed from the fridge. One of the ADACEL boxes was damaged but the indicator that was still working turned to a light pink. The box was wet from the ice melting. The thermometer was out and not working. They put a new battery in and closed the door. Shortly after, the thermometer started to register at approximately 27-29 (unsure if Celcius or Fahrenheit). The caller was unsure of the actual temperature. The opened door to the fridge was not reported until 2 pm, and two doses of ADACEL from this fridge were administered to two different patients. The thermometer did not show unusual readings from the last time the fridge was logged. The caller was not sure if someone knocked the thermometer over. The last log would have been Friday afternoon but the caller was not sure what the temperature was. They usually log the temperature between 4-4:30pm at the end of the day."  No laboratory data was provided.  At the time of report, the outcome of the events was unknown.   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.