Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Bacterial vaginosis, Caesarean section, Exposure during pregnancy, Muscle spasms
Clinical narrative: Vaccine exposure during pregnancy; Leg cramps; Bacterial vaginosis; This is a non-serious prospective spontaneous pregnancy case, initially received from other health professional on 26-Nov-2018, concerning a 40-year-old, pregnant female, patient, of body mass index: 25.2, weight: 142 lbs and height: 63 inches.  The patient had no history of offspring with major congenital malformation. Also, the patient had no maternal/paternal history with major congenital malformations. The patient's obstetrical history included no previous pregnancies. The father did not receive any medications prior to conception. The patient did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy.  The pregnancy status of the subject was collected, and no pregnancy complications were noted. The patient's current conditions included allergy to chocolate, cat fur, dust and leaves.  The subject's last menstrual period date was 11-May-2018. The gestational age of the patient was 19 weeks.  On 04-Aug -2018, the patient underwent first trimester screening, and no major congenital malformation was found. On 31Aug-2018, the patient underwent second trimester screening and Down Syndrome risk was identified. The subject's concomitant medications included: Vitafol one (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, magnesium oxide, nicotinamide, omega-3 fatty acids, polysaccharide-iron complex, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) for healthy pregnancy (200 mg, daily, oral; since 31-Aug-2018) and ibuprofen (200 mg, qid, oral, start date: 15-Sep-2018 and stop date: 26-Sep-2018) for abdominal pain.   On 26-Sep-2018, the pregnant patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, batch number: 252232, dose, route of administration, expiry date and anatomical location: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On an unspecified date, after vaccination, the patient experienced bacterial vaginosis and leg cramps. The patient was treated with Metrogel Vaginal (metronidazole) (dose: 5 mg, apply once at night, route of administration: topical, from 18-Oct-2018 to 22-Oct-2018) for bacterial vaginosis and Caltrate (calcium carbonate, dose: 600 mg, route of administration: oral, from 18-Oct-2018 and was ongoing) for leg cramps.  At 4 months and 13 days after vaccination, the mother delivered a full-term male neonate at 39 weeks gestation. The delivery method was reported as caesarean. There were no pregnancy complications noted during the pregnancy. The neonate's birth weight was 3174.5 grams (reported as 7 lbs), head circumference: 48.26cm (reported as 19 inches) and body length: 48.3cm. The APGAR scores were 9 (one minute) and 9 (five minutes). APGAR score was unknown for 10 minutes. It was unknown if there was any major congenital malformation.  The outcome of the events was not reported.  The subject's estimated date of delivery was reported as 15-Feb-2019.  Follow up received from the reporter on 11-Feb-2019. It was reported that, 4 months and 13 days after vaccination, the mother delivered a full-term male neonate at 39 weeks gestation. The delivery method was reported as caesarean. There were no pregnancy complications noted during the pregnancy. The neonate's birth weight was 3174.5 grams (reported as 7 lbs), head circumference: 48.26cm, body length: 48.3cm. The APGAR scores were 9 (one minute) and 9 (five minutes). APGAR score was unknown for 10 minutes. It was unknown if there was any major congenital malformation. Narrative was amended accordingly.  Non-significant follow up received from the reporter on 20-Mar-2019: Reporter was unable to identify the patient through the screen ID which was provided. No new information received. Hence, no changes were made in the narrative.  Case re-opened for completion of full data entry: 20-Mar-2019.; Reporter's Comments: A 40-year-old pregnant female patient experienced bacterial vaginosis and leg cramps after administration of Flucelvax QIVc (vaccine exposure during pregnancy). The company assessed the causality of the event- bacterial vaginosis as not related to the suspect vaccine due to the infectious nature of the event. The causality of the event- leg cramps was unassessable due to lack of event onset latency. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of vaccine exposure during pregnancy was assessed as not related considering the intended use of the vaccine.