Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Otitis media, Rhinitis allergic, Ultrasound antenatal screen normal, Wheezing
Clinical narrative: This is a serious study case initially received on 11-Apr-2019, concerning a 38-year-old adult, female, pregnant subject of body weight 194 lbs, height 64 inches and body mass index (BMI) 33.3, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject had 3 previous pregnancies among which 1 was full term live birth, 1 preterm live birth and 1 spontaneous abortion. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was 23-May-2018. The type of pregnancy was singleton. The pregnancy status of the subject was collected, and no pregnancy complications was noted. The subject's historical conditions included, headache, urinary tract infection, cough (from 03-Oct-2018 to 10-Oct-2018), sinusitis (from 10-Aug-2018 to 20-Aug-2018) and vaginitis (from 25-Sep-2018 to 09-Oct-2018). The historical drug included Flagyl and Metrogel for vaginitis, Codeine Guaifenesin syrup for cough, Augmentin for sinusitis, terconazole for candidiasis and Macrobid for urinary tract infection. The subject's current conditions included breast tenderness and nausea. The concomitant medications included promethazine for nausea and prenatal vitamins for pregnancy. On 20-Jul-2018, ultrasound was performed, and no major congenital malformation was noted. On 26-Jul-2018, spinal muscular atrophy and cystic fibrosis mutation analysis were performed, and no major congenital malformation were noted. On 14-Sep-2018, ultrasound and Maternal Serum Alpha-Fetoprotein Screening (MSAFP)/serum marker were performed, and no major congenital malformation was noted. On 12-Oct-2018, 20 weeks gestation period, the subject received Flu Vaccine Cell Subunit QIV NVD (batch number: 252664, dose, route of administration, expiry date and anatomical location: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On 04-Dec-2018, 1 month 22 days after vaccination, the subject experienced otitis media and was treated with Claritin (clarithromycin, 10 mg, qd, oral from 04-Dec-2018 to 03-Jan-2019). On the same day, the subject also experienced allergic rhinitis and was treated with Flonase (mometasone furoate, dose: 50 ug, qd, nasal, from 04-Dec-2018 to 24-Dec-2018). On 24-Dec-2018, the subject had recovered from the event allergic rhinitis. On an unspecified date the subject experienced heartburn and was treated with Zantac (ranitidine hydrochloride, 150 mg, from 18-Dec-2018 to 16-Feb-2019). On 08-Jan-2019, the subject experienced bronchitis and wheezing and was treated with Zithromax (azithromycin, 250 mg, prn, from 08-Jan-2019 to 09-Jan-2019). On 09-Jan-2019, the subject had recovered from the events bronchitis and wheezing. On 30-Jan-2019, the subject recovered from the event otitis media. On 05-Feb-2019, the subject developed anaemia and was treated with ferrous sulfate (1 tablet, bid, oral, from 05-Feb-2019). 39.1-week gestational age, the subject gave birth to a female infant. The delivery method was caesarean. Infant's body weight was 3515 grams, body length was 49.5 cm, head circumference was 34.9 cm and the appearance, pulse, grimace, activity, and respiration (Apgar) score: 8 at minute 1 and 9 at minute 5. The subject's estimated date of delivery (EDD) was reported as 27-Apr-2019. The subject had not recovered from the event anaemia. The outcome of the event heartburn was not reported.; Reporter's Comments: A 38-year-old pregnant subject experienced allergic rhinitis and otitis media, 1 month 22 days after receipt of Flu vaccine cell subunit QIV (considered as vaccine exposure during pregnancy). The subject also experienced heart burn, unspecified date post vaccination and bronchitis, 2 months 27 days post vaccination. Considering the implausible temporal relationship between the events and vaccination, the company assessed all the events except heart burn as not related to study vaccine. Due to lack of information regarding the onset latency of the event heart burn, causality assessed as unassessable. The subject also experienced anaemia, 3 months 24 days post vaccination. Considering the pregnancy state (known risk factor) of the subject which provide more plausible explanation rather than the study vaccine, the event anaemia assessed as not related. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company had assessed the case as serious (medically significant).