Sex: U
Vaccine: TDAP
Symptoms: Death, Foetal exposure during pregnancy, Intensive care, Pertussis
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of pertussis in a infant. The mother received DTPa (Reduced antigen) (dTpa vaccine.) for prophylaxis. The patient's mother's last menstrual period and the estimated date of delivery was unknown. The pregnancy resulted in a live neonate with no apparent congenital anomaly. On an unknown date, at [weeks gestation], the infant was born via unknown delivery. The infant was diagnosed with pertussis. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included maternal exposure during pregnancy. The outcome of pertussis was fatal. The outcome(s) of the additional event(s) included maternal exposure during pregnancy (unknown). The reported cause of death was pertussis. The investigator considered that there was a reasonable possibility that the pertussis may have been caused by dTpa vaccine. Additional information was provided. This retrospective pregnancy case was reported in a literature and described the occurrence of pertussis infection in an infant aged less than 4 months of unspecified gender whose mother was vaccinated with unspecified tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine (manufacturer unknown) during pregnancy (trimester unknown) for prophylaxis. The patient was part of study that interviewed the prenatal care providers to ascertain possible reasons for low Tdap vaccine coverage among pregnant women whose infants developed pertussis in 2016. The patient's mother's last menstrual period and the estimated date of delivery was unknown. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient's mother was vaccinated with unspecified Tdap vaccine (administration route and site unspecified; dosage unknown, batch number not provided) during pregnancy (trimester unknown). The patient's mother had received vaccine outside the recommended 27-36 week time frame. [In this study, 5 mothers received Tdap vaccine outside the recommended 27-36 week time frame (1 at 26, 1 at 38, and 1 at 39 weeks' gestation and 2 at 37 weeks). The maternal age of vaccination was not provided. The patient was exposed to vaccine in utero. On an unknown gestation week, the patient was born via unknown delivery method. On an unspecified date in 2016, an unknown period after exposure to vaccination, the patient developed pertussis infection. Subsequently, the patient was admitted to intensive care unit (ICU). On an unspecified date, the patient died. It was unknown if an autopsy was performed. In this study, it was reported that in 2016, a low-incidence pertussis year, 114 pertussis cases, which included two pertussis-related deaths, occurred among infants aged less than 4 months. This case has been considered serious due to death/hospitalisation. The treatment was unknown. The author did not comment on relationship between the event of pertussis infection and unspecified Tdap vaccine. The author concluded "In this state, pharmacists are permitted to provide immunizations, and all routinely recommended adult vaccines are covered by insurance when given in a provider's office or in a pharmacy. Recent state regulations require pharmacists to notify providers of immunizations administered and to enter all doses into the State's Immunization Registry, making it possible for providers to know whether vaccine referrals to pharmacies are successful. However, stocking vaccines on-site in prenatal clinics is the best way to ensure that all pregnant women are vaccinated and reduce the incidence of pertussis among infants too young to be vaccinated." This is 1 of 3 valid cases reported in this literature article. Reported Cause(s) of Death: Pertussis infection.