Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Amniocentesis normal, Caesarean section, Exposure during pregnancy, Live birth, Multiple pregnancy
Clinical narrative: Delivery at 35.7 weeks of gestation period; Vaccine exposure during pregnancy; This observational study case, initially received on 30-Nov-2020 from other health professional and concerned a 32-year-old pregnant, female subject of body weight 129 lbs, height 58 inches and body mass index (BMI) 27.  The subject's concurrent conditions included BMI high. The subject's concomitant medications Vitafol one (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, magnesium oxide, nicotinamide, omega-3 fatty acids, polysaccharide-iron complex, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) used for healthy pregnancy.  The subject's obstetrical history included two previous pregnancies with two full term live births. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history of MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was reported as 20-Jun-2020. The subject's estimated delivery date (EDD) was reported as 27-Mar-2021 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was multiple (exact number of foetuses was not reported).   On 16-Sep-2020, the first trimester screen and panorama test revealed no MCM.  On 19-Oct-2020, the second trimester screen revealed increased risk of Down syndrome. No MCM were noted.  On 23-Oct-2020, follow up amniocentesis regarding increased risk of Down syndrome revealed normal result. No MCM were noted.  On 02-Sep-2020, at approximately 10 weeks of gestation (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunization. The batch number reported was P100239705.  At 35.7 weeks of gestation (as reported), the subject delivered two premature live male neonates by caesarean method. The characteristics of the first neonate included: birth weight 2710 g, head circumference: 33 cm, length: 47 cm. APGAR (appearance, pulse, grimace, activity and respiration) scores at one minute was 9, at five minutes was 9 and at ten minutes were not reported. The characteristics of the second neonate included: birth weight 3056 g, head circumference: 35 cm, length: 48.3 cm. APGAR scores at one minute was 7, at five minutes was 9 and at ten minutes were not reported. No MCM was identified at birth.  The outcome of the event of 'premature delivery' was not reported.  The reporter did not provide a causality assessment.  The event of 'premature delivery' was considered to be medically significant by a Physician within Seqirus's.  This case is linked to cases 202101843 and 202102001 (the corresponding baby cases).  Additional information received on 09-Mar-2021 from other health professional: Pregnancy outcome was provided. 'Premature delivery' was added as new event. Stop date added and the outcome of the event 'Vaccine exposure during pregnancy' was changed from 'not reported' to 'resolved'. The narrative was amended accordingly.  Company comment: A 32-year-old subject was administered Afluria QIV at approximately 10 weeks of gestation. Five months and 23 days after receiving Afluria QIV, the subject experienced premature delivery. The subject's concurrent conditions included BMI high. The subject's obstetrical history included two previous pregnancies with two full term live births. Causal role of the suspect vaccine is assessed as not related, due to implausible chronology and mentioned confounders. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A 32-year-old subject was administered Afluria QIV at approximately 10 weeks of gestation. Five months and 23 days after receiving Afluria QIV, the subject experienced premature delivery. The subject's concurrent conditions included BMI high. The subject's obstetrical history included two previous pregnancies with two full term live births. Causal role of the suspect vaccine is assessed as not related, due to implausible chronology and mentioned confounders. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.