Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Delivery, Exposure during pregnancy, Foetal heart rate abnormal, Folliculitis, Haemorrhoids
Clinical narrative: Questionable abruption; Hemorrhoids; Folliculitis; Vaccine exposure during pregnancy; This is an observational study case initially received on 06-Dec-2019, concerning a 31-year-old female pregnant subject of body weight 102 lbs, height 67 inches and body mass index (BMI) 16, enrolled in, a prospective observational safety study.  The subject's current medical conditions included decreased BMI, depressive disorder, anxiety, muscle spasms and herpes simplex on hand.   The subject's concomitant medication included prenatal vitamins (unspecified vitamins and minerals) as obstetrical (OB) supplement, valacyclovir for herpes simplex, cyclobenzaprine for muscle spasms, unspecified probiotics as probiotic and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject's obstetrical history noted that the subject had three previous pregnancies with one full term live birth, one preterm live birth and one ectopic pregnancy. Also, the subject had history of caesarean section. The subject had no history of offspring with major congenital malformation (MCM). The subject's aunt had a history of malignant breast tumor and grandmother had history of colon polyp. The subject had no paternal history with MCM. The subject used one-fourth pack of cigarettes per day during pregnancy (as reported). The subject did not use alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 15-Apr-2019. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were both reported as 20-Jan-2020. The type of pregnancy was singleton.  On 11-Jul-2019, the subject underwent first trimester screen, nuchal translucency and ultrasound. No MCMs were noted.  On 07-Aug-2019, the subject underwent maternal serum alpha fetoprotein (MSAFP) screening and second trimester screen. No MCMs were noted.  On 26-Aug-2019, the subject underwent anatomy ultrasound and no MCMs were noted.  On 23-Sep-2019, at approximately 23 weeks of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 mL, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation.   On the same day, the patient developed folliculitis and received treatment medication Bactrim (sulfamethoxazole and trimethoprim) at the dose of one tablet, twice daily, orally.  On an unspecified date, after vaccination, the subject developed haemorrhoids.  On an unspecified date, the subject experienced questionable abruption, reported as pregnancy complication. Also, the foetus experienced heart rate rhythm abnormalities.  On 30-Sep-2019, the subject stopped treatment with Bactrim.  On 24-Oct-2019, the subject started treatment with Anusol HC (hydrocortisone acetate) at the dose of 25 %, three times a day, topically.  On 13-Jan-2020, at approximately 39 weeks of gestation, the subject gave live birth to a female neonate vaginally. The characteristics of the neonate included birth weight: 2863 grams, head circumference and length were not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were not reported. No major congenital malformations (MCMs) were identified at the time of birth.   At the time of this report, the subject did not recover from the event of haemorrhoids, while the outcome for the events of folliculitis and abruptio placentae was not reported.  Per company, the event of abruptio placentae' was considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIVc.  This case is linked to case number 202001614 (corresponding baby case).  Follow up was received by other health professional on 31-Jan-2020: The subject's obstetrical history was updated. Pregnancy outcome and pregnancy complications were provided. The stop date and outcome were updated for the event of vaccine exposure during pregnancy'. New serious event 'abruptio placentae' and linked case were added. Additionally, the case was upgraded from non-serious' to serious'. Narrative was amended accordingly.  Company Comment: The subject experienced premature separation of placenta, folliculitis and haemorrhoids after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at 23 weeks of gestation. Chronology is plausible for haemorrhoids and incompatible for folliculitis because the event appeared on the day of vaccination. For the event premature separation of placenta chronology is very unclear.  Pregnant state may provide alternative aetiology for the events. Medical history of depressive disorder, anxiety, muscle spasms and herpes simplex may have contributed to development of the events. Causality is also confounded with multiple concomitant medications. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event haemorrhoids is assessed as unlikely related (defaults to related for reporting purposes). Event folliculitis is assessed as not related. Limited and unclear reported information concerning the event premature separation of placenta precludes thorough causality assessment, therefore causality for the event is unassessable.; Sender's Comments: The subject experienced premature separation of placenta, folliculitis and haemorrhoids after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at 23 weeks of gestation. Chronology is plausible for haemorrhoids and incompatible for folliculitis because the event appeared on the day of vaccination. For the event premature separation of placenta chronology is very unclear.  Pregnant state may provide alternative aetiology for the events. Medical history of depressive disorder, anxiety, muscle spasms and herpes simplex may have contributed to development of the events. Causality is also confounded with multiple concomitant medications. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the event haemorrhoids is assessed as unlikely related (defaults to related for reporting purposes). Event folliculitis is assessed as not related. Limited and unclear reported information concerning the event premature separation of placenta precludes thorough causality assessment, therefore causality for the event is unassessable.