Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, Foetal death, Laboratory test normal, Premature delivery
Clinical narrative: Premature rupture of membranes; Intra-uterine death; Laboratory test normal; Premature labour; 27-year-old pregnant female patient received a injection of ADACEL; Upon internal review on 19-Apr-2021, the case 2010-01165 was incorrectly created for fetus from current case will be deleted and all information merged in current case  SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT  Initial report received 08 July 2009 from a health care professional.   A 27-year-old pregnant female patient with a history of a latex allergy, had received a 0.5mL injection of Adacel (lot number, route and site not reported) on 07 July 2009. Her date of last menstrual period was not reported; however, her expected date of confinement was estimated to be 30 January 2010. She had two previous full term pregnancies with normal outcomes. She had not been taking any concomitant medications at the time of vaccination.  At the time of the report, the patient had not experienced any adverse events since receiving Adacel.   Follow-up information was received 19 February 2010 from a health care professional.   Based upon new information received, this case now meets seriousness criteria and has been upgraded from non serious to serious.  According to the reporter, the patient was reported to have been in good health. She had no illness at the time of vaccination and she had not received any other vaccines within four weeks of receiving Adacel (lot number, route, and site not reported).  The patient had a history of two prior pregnancies, both which resulted in full term live births with no congenital anomalies.  Her last menstrual period occurred 26 April 2009 and her estimated date of delivery had been 31 January 2010 (previously reported as 30 January 2010).   Prenatal testing had been normal.  On 22 August 2009, 46 days post vaccination, the patient delivered a male fetus vaginally at 22 weeks gestation weighing 296 grams (0.296 kilograms) with no congenital anomalies. Apgar scores were 0 / 0 at one and five minutes respectively; outcome was demise. The patient had not experienced any complications during labor and/or delivery. Per the reporter, it was not known if the patient had experienced any adverse events; however, the reporter further stated that the patient had not experienc ed any problems until delivery at 22 weeks gestation.  According to the reporter, the patient recovered.   Follow-up information received from a health care professional on 18 March 2010.   The patient had received the Adacel (lot number UF460BA, Sanofi Pasteur SA lot number C3066) intramuscular in the left deltoid.    Follow-up information was received on 19 April and 20 April 2010 from a health care professional.  According to the reporter, prenatal testing had not been performed (previously reported with results of normal findings). Fetal demise had been known prior to birth and an autopsy had not been performed. The onset of preterm labor was 22 August 2009. Per the reporter, the etiology for both preterm labor and early fetal death was reported as premature rupture of membranes. According to the reporter, the patient recovered on 22 August 2009.    Documents held by sender: None  Additional information was received on 19-Apr-2021 regarding an unsolicited valid serious case from other healthcare professional via the health authority (Vaers ID: 381304).  Events intra-uterine death, and laboratory test normal were added. Event coding of premature delivery updated to premature labour and considered non-serious.  The patient had not been taking any concomitant medications at the time of vaccination. From information received 19 February 2010, the patient had no concurrent illness at the time of vaccination, no maternal drug exposures, and she had not received any other vaccines within four weeks of receiving ADACEL.   On 07-Jul-2009, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C3066 and expiry date: 08-Aug-2010) via intramuscular route in the left deltoid for prophylactic vaccination. While patient was 10 week pregnant.  On an unknown date, the patient developed a non-serious laboratory test normal, following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient visited to emergency department.  On an unknown date the patient experienced serious intra-uterine death (foetal death) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant and the patient visited to emergency department.  On 22-AUG-2009, the patient developed a non-serious premature labour, one month 15 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient visited to emergency department.  It was case of vaccine exposure during pregnancy (exposure during pregnancy) (latency same day). While patient was 10 week pregnant  It was unknown if patient received any corrective treatment.  The patient was recovered from the events.; Sender's Comments: This case concerns a 27 years old female patient who experienced premature delivery, premature rupture of membranes, foetal death, premature labour, and exposure during pregnancy, after vaccination with ADACEL. The time to onset is not compatible for premature labour and premature delivery whereas unknown for rest of the events. The patient was in good condition during vaccination. The patient's medical history, concomitant medication, medical condition at time of vaccination and other lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.