Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: 23 year old pregnant female patient administered dose of ADACEL vaccine with no reported adverse event; potential temperature excursion the door to the fridge was found to be ajar with no reported adverse event; Initial information received on 13-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 23 years old pregnant female patient who was vaccinated with a potential temperature excursion dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Data regarding this pregnancy were received prospectively.   The date of last menstrual period was reported as 13-Dec-2020.  The estimated due date is 09-Sep-2021 (32 weeks pregnant).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 12-Jul-2021, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6927AA and expiry date: 28-Jan-2023) (Frequency: once) via an intramuscular route in the right deltoid (Exposure during pregnancy and Product storage error) for prophylactic vaccination.  It was a case of actual medication error due to Incorrect product storage (latency same day).  It was also the case of vaccine exposure during pregnancy (latency same day).   It was reported that "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 Celsius or Fahrenheit). The caller was unsure of the actual temperature. The opened door to the fridge was not reported until 2pm. 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. If baby was delivered: delivery date and if baby experienced an adverse event: not applicable, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug administration) requirement. Reporter relationship: HCP (health care professional) Product used: Used".  At the time of reporting, no adverse event was reported.   Pregnancy outcome was unknown at the time of report.  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.