Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Caesarean section, Complication of pregnancy, Condition aggravated, Exposure during pregnancy, Gastrooesophageal reflux disease
Clinical narrative: Gastrooesophageal reflux disease (GERD); Vaccine exposure during pregnancy; Placenta previa antepartum in third trimester; Placenta previa antepartum in third trimester; This is an observational study case from, initially received from other health professional on 24-Jan-2020, concerning a 35-year-old, female pregnant subject of body weight: 143 lbs, height: 64.8 inches and body mass index (BMI): 23.9 enrolled in, a prospective observational safety study.  The subject's medical history included advanced maternal age, mixed anxiety and depressive disorder, morning sickness/nausea and low lying placenta.   The subject's concomitant medications included ondansetron for nausea, Prozac (fluoxetine hydrochloride) for anxiety and depression, Diclegis (doxylamine succinate, pyridoxine hydrochloride) for morning sickness, unspecified vitamin for obstetrics supplementation, TDAP vaccine (diphtheria vaccine toxioid, pertussis vaccine acellular, tetanus vaccine toxioid) for vaccination and fluoxetine for an unknown indication.  The subject had no previous pregnancies. The subject had no paternal history with major congenital malformation (MCM), but in maternal family history malignant neoplasm of uterus in subject's mother and malignant breast tumour in subject's grandmother were noted. The subject did not consume tobacco, alcohol and illicit-drugs during pregnancy.  The subject's last menstrual period (LMP) date was 19-Feb-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) was 26-Nov-2019 and corrected estimated delivery date (CEDD) was 06-Dec-2019.   On 15-May-2019, the subject underwent MaterniT21 and no MCM was noted.  On 19-Jun-2019, the subject underwent Maternal serum alpha fetoprotein (MSAFP/seum markers) and second trimester screen. No MCM was noted.  On 15-Jul-2019, the subject underwent anatomy ultrasound and no MCM was noted.   On 18-Sep-2019, at gestational age of 30 weeks, the subject was administered Flucelvax QIVc(Flu Vaccine Cell Subunit QIV NVD) (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 ml, route of administration, anatomical location and expiry date: not reported) (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On the same day, gastrooesophageal reflux disease (GERD) was noted in subject and she started treatment with one tablet of ranitidine every day via oral route of administration.  On an unspecified date in 2019, after vaccination, subject's pregnancy was complicated in third trimester with placenta previa antepartum.   On 02-Dec-2019, at gestation age of 39.4 weeks, the subject delivered a normal, male neonate by caesarean method. The birth weight of the neonate was 4026 g. No data for head circumference and length was provided.  Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8, at five minutes was 9. No data was provided for APGAR score at ten minutes. No MCM was identified at birth.   At the time of this report, the outcome of gastrooesophageal reflux disease was not resolved, while the outcome of placenta previa antepartum aggravated was not reported.   The reporter did not provide the causality assessment to Flucelvax.  This case is linked to 202001858, the corresponding child case.  Follow up received on 17-Feb-2020: The pregnancy outcome provided. The event of placenta previa aggravated added and event assessment for this event added. The case updated from non serious to serious. The outcome and stop date for vaccine exposure during pregnancy updated.  Narrative amended accordingly.  Company comment: The subject experienced placenta praevia/condition aggravated and gastrooesophageal reflux disease after vaccination with the suspect product, Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy at gestational age of 30 weeks. Chronology is very unsuggestive for gastrooesophageal reflux disease because of very short onset latency (same day). For the event placenta praevia chronology is incompatible because the site of placenta is determined during the phase of implantation which occurred before vaccine was administered. Pregnant state and medical history of anxiety, depressive disorder and morning sickness may provide alternative aetiology for the event. Causality was also confounded by therapy with multiple concomitant medications and TDAP vaccine (diphtheria vaccine toxioid, pertussis vaccine acellular, tetanus vaccine toxioid). Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events placenta praevia/condition aggravated and gastrooesophageal reflux disease is assessed as not related.; Sender's Comments: The subject experienced placenta praevia/condition aggravated and gastrooesophageal reflux disease after vaccination with the suspect product, Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy at gestational age of 30 weeks. Chronology is very unsuggestive for gastrooesophageal reflux disease because of very short onset latency (same day). For the event placenta praevia chronology is incompatible because the site of placenta is determined during the phase of implantation which occurred before vaccine was administered. Pregnant state and medical history of anxiety, depressive disorder and morning sickness may provide alternative aetiology for the event. Causality was also confounded by therapy with multiple concomitant medications and TDAP vaccine (diphtheria vaccine toxioid, pertussis vaccine acellular, tetanus vaccine toxioid). Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events placenta praevia/condition aggravated and gastrooesophageal reflux disease is assessed as not related.