Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Caesarean section, Exposure during pregnancy, Pre-eclampsia, Premature delivery
Clinical narrative: Post-partum pre-eclampsia; Delivery at 34.7 week of gestation; Vaccine exposure during pregnancy; This is an observational study case, initially received on 07-Dec-2020 from other health professional and concerned a 40-year-old, pregnant, female subject of body weight: 173.5 lbs, height: 65 inches and body mass index (BMI): 28.9, enrolled in, a prospective observational study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's concurrent conditions included advanced maternal age, chronic neck pain, anxiety and body mass index high (BMI 28.9). The subject's concomitant medications included folic acid for pregnancy, Zoloft (sertraline hydrochloride) for anxiety, Prenatal vitamins (unspecified vitamins and mineral) for pregnancy, Flexeril (cyclobenzaprine hydrochloride) and gabapentin for chronic neck pain. The subject had a history of previous pre-eclampsia.    The subject's obstetrical history included three previous pregnancies, with two full term live births and one abortion. The subject did not have a history of offspring with major congenital malformations (MCMs). Also, the subject had no relevant maternal or paternal history with MCMs. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 09-Mar-2020, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 14-Dec-2020.  The type of pregnancy was singleton.   On 18-May-2020, the ultrasound revealed no MCMs.    On 20-May-2020, the first trimester screen revealed no MCM  On 16-Jul-2020, the maternal serum alpha-fetoprotein screening (MSAFP) / serum markers revealed no MCMs.   On 20-Jul-2020, the ultrasound revealed no MCMs.    On 10-Sep-2020, at approximately 26 weeks of gestation (calculated per LMP) the subject was vaccinated with Afluria Quadrivalent (Flu Vaccine Egg Split QIV) [influenza vaccine, dose, route of administration, anatomical location: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation. The batch number reported was P100230203.  At gestational age of 34.7 weeks (as reported), the subject delivered live birth, male neonate via caesarean method of delivery. The neonate's birth weight was 2807 g, the body length was 47.6 cm and head circumference 34.5cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 7 at one minute and 8 at five minutes. APGAR score was not reported for ten minutes. No MCM was identified at birth.   On 19-Nov-2020, two months and nine days after receiving Afluria Quadrivalent, the subject experienced post-partum pre-eclampsia.    At the time of initial reporting on 07-Dec-2020, the subject had not recovered from the event of 'pre-eclampsia'.   The outcome of the event 'premature delivery' was not reported.   The reporter did not provide a causality assessment.   The events of 'pre-eclampsia' and 'premature delivery' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case is linked with the case 202007585 (the corresponding baby case).  Company comment:The pregnant subject experienced pre-eclampsia and premature delivery approximately two months after vaccination with the suspect product, Afluria Quadrivalent. The patient was administered vaccine at approximately 26 weeks of gestation. Chronology is unsuggestive. The subject's story of previous pre-eclampsia highly confounds causality.  Underlying conditions of advanced maternal age, body mass index high and therapy with concomitant drug sertraline also confound causality for the events .Considering all above mentioned, causal relationship for the events of pre-eclampsia and premature delivery is assessed as not related due to due to biological implausibility, unsuggestive chronology and presented confounders. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The pregnant subject experienced pre-eclampsia and premature delivery approximately two months after vaccination with the suspect product, Afluria Quadrivalent. The patient was administered vaccine at approximately 26 weeks of gestation. Chronology is unsuggestive. The subject's history of previous pre-eclampsia highly confounds causality.  Underlying conditions of advanced maternal age, body mass index high and therapy with concomitant drug sertraline also confound causality for the events .Considering all above mentioned, causal relationship for the events of pre-eclampsia and premature delivery is assessed as not related due to due to biological implausibility, unsuggestive chronology and presented confounders. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.