Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: t a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes. with no adverse event; poor quality product administered; currently pregnant with 3rd child taking Adacel with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA373167, 2022SA372581 and 2022SA372123.  This case involves a 33 years old female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of currently pregnant with 3rd child taking adacel with no reported adverse event, poor quality product administered and t a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes. with no adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported currently pregnant with 3rd child taking Adacel with no reported adverse event, poor quality product administered and t a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes. with no adverse event occurred at unknown gestation period.   The date of last menstrual period was not reported. The estimated due date is 11-Oct-2022. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE once (lot U7461AA; expiry date: 12-Jul-2024) via intramuscular route in the right arm for immunization.  On 30-AUG-2022 the patient developed a non-serious currently pregnant with 3rd child taking adacel with no reported adverse event (exposure during pregnancy), poor quality product administered and to a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes. with no adverse event (product storage error) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.   Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event currently pregnant with 3rd child taking adacel with no reported adverse event, was Unknown for the event poor quality product administered and was Unknown for the event t a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes. with no adverse event.  Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as Birth Type unknown and fetal outcome was reported as Outcome 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 guidelines. 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.; Sender's Comments:  01266747: 01266903: 01266768: 01266921: 01266924: 01266780: 01266792: 01266974: 01266976: 01266978: 01266980: 01266982: 01266983: 01266985: US-SA-2022SA372080: