Age: 30.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Caesarean section, Complication of pregnancy, Exposure during pregnancy, Laboratory test, Premature separation of placenta
Clinical narrative: complication of pregnancy; premature separation of placenta; Exposure during pregnancy; Caesarean section; Initial information was received on 19-Apr-2021 regarding an unsolicited valid serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210428001482).  This case involves a 30-year-old female patient (height: 162 cm and weight: 67.13 kg) who was exposed to vaccines TDAP and INFLUENZA VACCINE in context of complication of pregnancy, premature separation of placenta, caesarean section and exposure during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Caesarean section occurred at 38 weeks of pregnancy and the patient was exposed to INFLUENZA VACCINE at 28 weeks of pregnancy and to TDAP at 28 weeks of pregnancy, during third pregnancy trimester for INFLUENZA VACCINE and during third pregnancy trimester for TDAP.  The date of last menstrual period was reported as 26-Mar-2019.  The estimated due date was not reported.  The patient's past medical history included Live birth, Spontaneous abortion and Multigravida.  The patient's family history included Tetralogy of Fallot.  The patient's past medical treatment, vaccination was not provided . At the time of the event, the patient had ongoing Body mass index high.  Concomitant medications included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS; VITAMINS NOS]); and INFLUENZA VACCINE INACT SAG 4V (FLUCELVAX QUADRIVALENT).  On 04-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number: 261727 expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   On 04-Oct-2019, the patient received a 0.5 ml dose of suspect TDAP not produced by Sanofi Pasteur [lot number and expiry date not reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious complication of pregnancy and premature separation of placenta (unknown latency) following the administration of INFLUENZA VACCINE and TDAP. These events were assessed as medically significant.  On 26-DEC-2019 the patient developed a serious caesarean section 2 months 22 days following the administration of INFLUENZA VACCINE and TDAP. This event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovered from the reported events.  Additionally, at time of reporting, the outcome of the pregnancy and fetal outcome is unknown.; Sender's Comments: This case involves a 30-year-old female patient (height: 162 cm and weight: 67.13 kg) who was exposed to vaccines TDAP (not produced by Sanofi Pasteur) and INFLUENZA VACCINE (produced by unknown manufacturer) in context of complication of pregnancy, premature separation of placenta and caesarean section. The time to onset was compatible. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be assessed.