Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Caesarean section, Complication of pregnancy, Depression, Exposure during pregnancy
Clinical narrative: Depression; Anxiety; Delivery at 33.7 weeks of gestation; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-May-2020, concerning a 28-year-old pregnant, female subject, of body weight 226 lbs, height 67 inches and body mass index (BMI) 35.4, enrolled in a prospective observational safety study.   The subject's current condition included proteinuria, asthma, hypothyroid, obesity/body mass index (BMI) 35.4 and Rhesus (Rh) negative.   The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, levothyroxine for hypothyroid, Albuterol (salbutamol sulfate) and QVAR (beclometasone dipropionate), both for asthma.  The subject had two previous pregnancies, one full time live birth and spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 25-May-2019. The subject's estimated date of delivery (EDD) was 01-Mar-2020, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 22-Aug-2019, the subject underwent sequential 1 and nuchal translucency, and no MCMs were noted.  On 23-Sep-2019, the subject underwent sequential 2 and no MCMs were noted.  On 15-Oct-2019, at approximately 20 weeks of gestation (calculated per LMP), the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived; batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.  On an unspecified date, after vaccination, the subject developed depression and anxiety reported as pregnancy complication. Also, intrauterine growth restriction (IUGR) in foetus was noted as pregnancy complication.  At gestational age of 33.7 weeks (as reported), the subject delivered a preterm live birth, male neonate by caesarean method. The neonate's birth weight was 1800 grams. The neonate's head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 at one minute and 7 at five minutes. APGAR score for 10 minutes was not reported. No MCMs were identified at the time of birth.   At the time of this report, the outcome of event premature delivery', anxiety and depression was not reported.  The event of premature delivery' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.   This case is linked to 202003308 (the corresponding baby case).  Company comment: A 28-year-old pregnant, female subject developed premature delivery, depression and anxiety after vaccination with the suspect product Afluria QIV for influenza immunisation. Reportedly, on an unspecified date after vaccination, the subject developed depression and anxiety reported as pregnancy complication. Chronology needs more clarification. The subject had two previous pregnancies, one full time live birth and spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM).  The subject's current condition included proteinuria, asthma, hypothyroid, obesity/body mass index (BMI) 35.4 and Rhesus (Rh) negative. The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, levothyroxine for hypothyroid, Albuterol (salbutamol sulfate) and QVAR (beclometasone dipropionate), both for asthma. Reported hypothyroid state, although regulated with medication, can lead to depression and anxiety especially if reported medication does not regulates efficiently this state. Pregnancy may also be an additional confounder for both events. Reported medical history along with anxiety may also contribute in developing preterm birth. With information presented, causality is assessed as not related for all events. Exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: A 28-year-old pregnant, female subject developed premature delivery, depression and anxiety after vaccination with the suspect product Afluria QIV for influenza immunisation. Reportedly, on an unspecified date after vaccination, the subject developed depression and anxiety reported as pregnancy complication. Chronology needs more clarification. The subject had two previous pregnancies, one full time live birth and spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM).  The subject's current condition included proteinuria, asthma, hypothyroid, obesity/body mass index (BMI) 35.4 and Rhesus (Rh) negative. The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, levothyroxine for hypothyroid, Albuterol (salbutamol sulfate) and QVAR (beclometasone dipropionate), both for asthma. Reported hypothyroid state, although regulated with medication, can lead to depression and anxiety especially if reported medication does not regulates efficiently this state. Pregnancy may also be an additional confounder for both events. Reported medical history along with anxiety may also contribute in developing preterm birth. With information presented, causality is assessed as not related for all events. Exposure during pregnancy is assessed as unrelated per company conventions.