Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Gene mutation identification test negative, Muscle spasms, Premature delivery, Prenatal screening test
Clinical narrative: Delivery at 35.7 weeks of gestational age; Anaemia; Leg cramps; Gas; Bacterial vaginosis; Vaccine exposure during pregnancy; This is an observational study case from, initially received on 02-Jan-2020  concerning a 23-year-old female, pregnant subject, of body weight: 113 lbs, height: 63 inches and body mass index (BMI): 20, who was enrolled in in, a prospective observational safety study.  The subject's medical history was not reported.   The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject had no previous pregnancies. The subject had no history of offspring with major congenital malformations (MCMs) and no relevant maternal or paternal history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) was on 25-Jul-2019. Type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 15-Apr-2020, corrected estimated date of delivery (CEDD) was not reported.  On 10-Sep-2019, at approximately eight weeks of gestation (calculated per LMP), the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, batch number: P100110950, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunization.  On 17-Sep-2019, the subject underwent cystic fibrosis mutation analysis, and no MCM was noted.   On 09-Oct-2019, the subject underwent the first trimester screen, and no MCM was noted.   On 23-Oct-2019, the subject underwent the second trimester screen, and no MCM was noted.   On 11-Nov-2019, the subject developed bacterial vaginosis, gas and leg cramps. Also, she started treatment with Metrogel (metronidazole) at dose of 0.75%, every day, vaginally for bacterial vaginosis, Caltrate 600-D (calcium carbonate, colecalciferol) at dose of 600 mg, every day, orally for leg cramps and simethicone at dose of 80 mg, three times daily, via oral route of administration for gas.  On 16-Nov-2019, the subject finished treatment with Metrogel (metronidazole). After using full course of medication, the subject had no complaints on bacterial vaginosis.   On 21-Nov-2019, the subject finished treatment with simethicone.   On 27-Dec-2019, the subject underwent one-hour glucola test, and no MCM was noted.  On 23-Jan-2020, four months and 13 days after vaccination, the subject developed anemia and was treated with Ferrosul (ascorbic acid, cyanocobalamin, ferrous sulfate, folic acid) at a dose of 325 mg via oral route of administration.  On 19-Feb-2020, the subject recovered from gas and the outcome of leg cramp was resolved. However, the subject was still using Caltrate 600-D (calcium carbonate, colecalciferol).   On 16-Mar-2020, at gestational age of 35.7 weeks (as reported), the subject vaginally delivered live birth, male neonate of birth weight 2659 grams. The neonate's head circumference was 32 cm and body length was 47 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 at one minute and 10 at five minutes. APGAR score for 10 minutes was not reported. No pregnancy complications were reported and no MCM was identified at birth.  At the time of this report, the outcome of anemia was not resolved.  At the time of this report, the outcome of the event premature delivery' was not reported.  The reporter did not provide causality assessment to Afluria QIV.  The event of premature delivery' was assessed as serious, due to the criterion of medical significance.  The case is linked to 202003462, the corresponding child case.  Follow up information received from other health professional on 26-Feb-2020 and additional information received on the same day (being processed together): Lab data updated (One-hour glucola test added). Ferrosul added as treatment medication. Start and stop dates for events bacterial vaginosis, leg cramp and gas were updated, and the outcomes were changed from not reported' to resolved'. Anemia added as new event. The narrative was amended accordingly.  Follow up information received from other health professional on 23-Apr-2020: Start date added for the event of anaemia and the outcome was changed from not reported to not resolved. Events re-arranged. The narrative was amended accordingly.  Follow up received from other health professional on 18-May-2020: Outcome of pregnancy added. Event of premature delivery added and case became serious. Outcome of vaccine exposure during pregnancy changed from not reported to recovered and stop date added. Events re-arranged. Narrative was amended accordingly.   Company comment: The subject experienced bacterial vaginosis, muscle spasms and flatulence approximately 2 months after, while developed anaemia 4 months and 13 days after vaccination with the suspect product, Afluria QIV. Pregnant state may provide alternative aetiology for the events. No medical history was provided. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Due to unsuggestive chronology, causality between suspect product and the events bacterial vaginosis, flatulence, muscle spasms and anaemia is assessed as not related. Causality for premature delivery cannot be entirely excluded making it unlikely related to the product. (unlikely related defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The subject experienced bacterial vaginosis, muscle spasms and flatulence approximately 2 months after, while developed anaemia 4 months and 13 days after vaccination with the suspect product, Afluria QIV. Pregnant state may provide alternative aetiology for the events. No medical history was provided. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Due to unsuggestive chronology, causality between suspect product and the events bacterial vaginosis, flatulence, muscle spasms and anaemia is assessed as not related. Causality for premature delivery cannot be entirely excluded making it unlikely related to the product. (unlikely related defaults to "related" in the safety database for reporting purposes).