Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Premature delivery, Ultrasound antenatal screen abnormal, Upper respiratory tract infection
Clinical narrative: Upper respiratory infection; Vaccine exposure during pregnancy; This is an observational study case, reported by other health professional and initially received on 03-Mar-2020, concerning a 23-year-old pregnant, female subject of body weight 185 lbs, height 67 inches and body mass index (BMI) 29, enrolled in a prospective observational safety study.   The subject's current medical condition included increased BMI, Rh D negative, ear pain/otalgia and two vessel cord single umbilical artery. The ear pain/otalgia was treated with oral cefprozil, 500 mg administered twice daily, from 19-Aug-2019 to 26-Aug-2019.  The subject's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) and Fusion plus (ascorbic acid, biotin, cyanocobalamin, ferrous fumarate, folic acid, lactobacillus casei, nicotinic acid, pantothenic acid, polysaccharide-iron complex, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride) both as vitamin, TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine, and Rhogam (anti-D immunoglobulin) as RhD negative.  The subject's obstetrical history noted that the subject had one previous full-term, live birth pregnancies with no birth defects. 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 21-Apr-2019. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 26-Jan-2020. The type of pregnancy was singleton.   On 15-Jul-2019, the subject underwent first trimester screen and nuchal translucency. There was no MCM noted.  On 10-Aug-2019, the subject underwent anatomy ultrasound and two vessel cords/single umbilical artery (SUA) were noted.   On 14-Aug-2019, the subject underwent maternal serum alpha fetoprotein screening (MSAFP/serum markes) and second trimester screen. There was no MCM noted.  On 08-Oct-2019, at approximately 24 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261207, 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 as vaccination and on 06-Nov-2019, the subject underwent ultrasound and two vessel cords/single umbilical artery (SUA) were noted.  On 18-Nov-2019, 1 month 10 days after vaccination, the subject developed upper respiratory infection and started treatment with oral Augmentin (amoxicillin; clavulanate potassium), 875-125 mg administered twice a day via oral route and with oral Virtussin AC (codeine phosphate, guaifenesin) administered every day at bedtime as needed via oral route.  On 25-Nov-2019, 1 month 17 days after vaccination, the subject stopped treatment with Augmentin.  At gestational age of 38.9 weeks (as reported), the subject vaginally delivered a live birth, male neonate. The neonate's birth weight was 3884 g, length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. It was reported that there were no MCM identified at birth.  At the time of this report, the outcome of the event upper respiratory infection was not reported.  The event of upper respiratory infection' was considered serious due to the criterion of medical significance per company.  The reporter did not provide causality assessment.  Company comment: A 23-year-old pregnant female subject developed upper respiratory tract infection after vaccination with the suspect product Flucelvax QIVc at approximately 24 weeks of gestation for an influenza immunisation. Reportedly, 1 month and 10 days after vaccination, the subject developed upper respiratory infection. Chronology seems plausible. The subject's current medical condition included increased BMI, Rh D negative, ear pain/otalgia and two vessel cord single umbilical artery. The ear pain/otalgia was treated with oral cefprozil, 500 mg administered twice daily, from 19-Aug-2019 to 26-Aug-2019. The subject's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) and Fusion plus (ascorbic acid, biotin, cyanocobalamin, ferrous fumarate, folic acid, lactobacillus casei, nicotinic acid, pantothenic acid, polysaccharide-iron complex, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride) both as vitamin, TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine, and Rhogam (anti-D immunoglobulin) as RhD negative. With information presented, causality is assessed as unlikely related. For drug exposure during pregnancy causality is assessed as not related per company conventions.(''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A 23-year-old pregnant female subject developed upper respiratory tract infection after vaccination with the suspect product Flucelvax QIVc at approximately 24 weeks of gestation for an influenza immunisation. Reportedly, 1 month and 10 days after vaccination, the subject developed upper respiratory infection. Chronology seems plausible. The subject's current medical condition included increased BMI, Rh D negative, ear pain/otalgia and two vessel cord single umbilical artery. The ear pain/otalgia was treated with oral cefprozil, 500 mg administered twice daily, from 19-Aug-2019 to 26-Aug-2019. The subject's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) and Fusion plus (ascorbic acid, biotin, cyanocobalamin, ferrous fumarate, folic acid, lactobacillus casei, nicotinic acid, pantothenic acid, polysaccharide-iron complex, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride) both as vitamin, TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine, and Rhogam (anti-D immunoglobulin) as RhD negative. With information presented, causality is assessed as unlikely related. For drug exposure during pregnancy causality is assessed as not related per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)