Age: 30.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Arrested labour, Arterial injury, Caesarean section, Cystoscopy, Exposure during pregnancy
Clinical narrative: Arrest of descent; Vaccine exposure during pregnancy; Uterine artery laceration (left side); This is an observational study case, initially received from other health professional on 31-Oct-2019, concerning a 30-year-old, female pregnant subject of body weight: 170.4 lbs, height: 60 inches and body mass index (BMI): 33.3 a prospective observational study on pregnancy outcomes in women immunized with Flucelvax, seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's medical history included: obesity, anxiety depression, human papilloma virus (HPV) infection, nausea, vomiting and gastroesophageal reflux disease (GERD). The subject was varicella non-immune.  The subject's concomitant medications included Bonjesta(doxylamine succinate, pyridoxine hydrochloride) and Zofran (ondansetron), both for nausea, Prenatal vitamins (minerals not otherwise specified (nos); vitamins nos) for obstetrical (OB) care, TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine and Pepcid (famotidine) for GERD.  The subject's obstetrical history included two previous pregnancies with one full-term live births and one spontaneous abortion. The subject had no maternal or paternal history with major congenital malformations (MCMs). The subject had no history of offspring with MCMs. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 03-Apr-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 08-Jan-2019. The type of pregnancy was singleton.  On 28-Jun-2019, the subject underwent first trimester screen and nuchal translucency and no MCM was noted.   On 26-Jul-2019, the subject underwent second trimester screen alpha-fetoprotein (AFP) and no MCM was noted.  On 23-Aug-2019, the subject underwent ultrasound scan and no MCM was noted.   On an unspecified date in 2019, the subject underwent Papanicolaou (Pap) test and the result was HPV positive.  On 18-Oct-2019, at gestational age of 28 weeks, the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261233, dose: 0.5 ml, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On the same date, the subject was administered non-company co-suspect Tdap [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid, dose: 0.5 ml, route of administration: intramuscular, batch number, expiration date and anatomical location: not reported] as vaccine.  On an unspecified date in 2019, foetal malpresentation was noted (referred to corresponding child case 202001714). On unspecified date in 2019 the subject underwent cystoscopy and the uterine artery laceration on left side was noted as pregnancy complication.  On 25-Dec-2019, at gestational age of 38 weeks, the subject delivered live female neonate by widelock caesarean method. Pregnancy complication noted during delivery were arrest of descent. The birth weight of the neonate was 3118 g, no data reported for head circumference and length. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute and at five minutes were 9 and at ten minutes were not reported. No MCM was identified at birth.  At the time of this report, the outcome of the events arrest of descent and uterine artery laceration on left side was not reported.  The events of arrest of descent and uterine artery laceration on left side were assessed as serious due to the criterion of medical significance, per company.  The causality assessment was not provided.  This case is linked with case 202001714 the corresponding child case.  Follow up received from other health professional on 07-Nov-2019: Type of pregnancy provided - singleton. The narrative was amended accordingly.  Follow up received from other health professional on 11-Feb-2020: Cystoscopy added as procedure. Arrest of descent and uterine artery laceration (left side) added as events. Pregnancy outcome provided. The narrative was amended accordingly.  Company comment: The subject experienced arterial injury and arrested labour after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 28 weeks. Chronology is plausible. Medical history of obesity (body mass index 33.3), human papilloma virus (HPV) infection and pregnant state may provide alternative aetiology for the events. Causality was also confounded with co-suspect vaccine TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) and multiple concomitant medications. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions. Considering all the above mentioned, causality between suspect product and the events arterial injury and arrested labour are assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The subject experienced arterial injury and arrested labour after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 28 weeks. Chronology is plausible. Medical history of obesity (body mass index 33.3), human papilloma virus (HPV) infection and pregnant state may provide alternative aetiology for the events. Causality was also confounded with co-suspect vaccine TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) and multiple concomitant medications. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions. Considering all the above mentioned, causality between suspect product and the events arterial injury and arrested labour are assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).