Sex: F
Vaccine: FLUX, TDAPIPV
Symptoms: Premature delivery, Ultrasound scan normal
Clinical narrative: pre eclampsia; premature delivery; delivery complications; Hypertension; exposure during pregnancy; Initial information received on 19-Apr-2021 regarding an unsolicited valid serious case received from other health professional.  This case is linked to case 202000579 (the corresponding baby case).  This case involves a 29-year old female patient who experienced pre eclampsia (pre-eclampsia), premature delivery, complication of delivery, hypertension and exposure during pregnancy, after she received INFLUENZA VACCINE (QUADRIVALENT), TDAP IPV and while treated with LAMOTRIGINE.  Data regarding this pregnancy were received retrospectively (at gestation age of 36.7 weeks, the subject vaginally delivered a live birth, female neonate. The neonate's birth weight was 3402 g, length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). It was reported that there were no MCM identified at birth), i.e. after pregnancy outcome was known.  The date of last menstrual period was reported as 28-Mar-2019. The estimated due date was 02-Jan-2020. The actual date of delivery was not reported.  Medical history included Intrauterine contraception (intrauterine insemination), Assisted fertilisation (Abortion spontaneous with Primigravida; Spontaneous abortion Prior Vaccinations).  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing obesity (obesity with BMI 31.6), anxiety, depression, nausea and cardiac disorder.  Concomitant medications included LETROZOLE (FEMARA), DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) and PROMETHAZINE for Nausea and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS; VITAMINS NOS]).  On 09-Oct-2019, the patient received 0.5 ml dose of suspect TDAP IPV not produced by Sanofi Pasteur (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received 0.5 ml dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer (lot number: 261215 and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient started taking LAMOTRIGINE, unknown dosage unknown route unknown (with an unknown batch number) for anxiety and depression.  On an unknown date, the patient developed a serious pre eclampsia (pre-eclampsia), premature delivery and complication of delivery (unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT) and following the administration of TDAP IPV and following the last dose intake of LAMOTRIGINE.  On an unknown date, the patient was also found to have hypertension and exposure during pregnancy (unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT) and following the administration of TDAP IPV and following the last dose intake of LAMOTRIGINE.  Seriousness criteria was assessed as medically significant as per reporter for the events pre-eclampsia, premature delivery and complication of delivery.  Relevant laboratory test results included: ultrasound scan (Anatomy scan, Maternal serum alpha fetoprotein screening and Maternity 21)- On 11-Jun-2019: [Unstructured Data: No major congenital malformation noted]; on 22-Jul-2019: [Unstructured Data: No major congenital malformation noted] then [Unstructured Data: No major congenital malformation noted]; on 13-Aug-2019: [No major congenital malformation noted].  Action taken with respect to suspect drug LAMOTRIGINE was unknown.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the events.  Information about batch number requested.; Sender's Comments: This case concerns a 29-year old female patient who presented with pre-eclampsia, premature delivery, complication of delivery after vaccination, hypertension and exposure during pregnancy with INFLUENZA VACCINE (QUADRIVALENT), TDAP IPV and LAMOTRIGINE. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.