Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Genital herpes, Hypersensitivity, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: This is a serious clinical study case received from other health professional on 21-May-2019, concerning a 41-year-old adult pregnant female patient of body weight: 134 lbs, height: 64 inches and body mass index (BMI): 23, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with AFLURIA QIV, a seasonal quadrivalent vaccine, during pregnancy. The subject's pregnancy history included one preterm live birth. 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 current condition included anxiety. The subject's concomitant medications included Prenatal vitamins (minerals NOS, vitamins NOS) and choline for pregnancy. The subject's last menstrual period (LMP) date was 12-Dec-2018 and type of pregnancy was singleton. On an unspecified date, prior to vaccination, the pregnancy status of the subject was collected, and pregnancy complication noted was advanced maternal age gravida. On 11-Feb-2019, at gestational age of 8 weeks (first trimester), the pregnant subject was administered with Flu Vaccine Egg Split QIV CSL (influenza vaccine, batch number: YF41608, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On 11-Feb-2019, the subject underwent ultrasound scan and no congenital malformations were noted. On 21-Feb-2019, the subject underwent ultrasound scan and non-invasive prenatal test and no congenital malformations were noted. On an unspecified date, after vaccination, the subject developed genital herpes and allergies. The subject's treatment medications included valacyclovir (dose: 500 mg, frequency: bid, prn for 3 days, route: oral, from 20-Mar-2019 and was ongoing), Tetrahydrozoline (tetryzoline) (frequency: prn, route: intraocular, from 17-Apr-2019 and was ongoing), Nasacort (triamcinolone acetonide) (frequency: qd, route: nasal, ongoing) and Zyrtec (cetirizine hydrochloride) (dose: 10 mg, frequency: qd, route: oral and was ongoing). On 17-Apr-2019, the subject underwent ultrasound scan and no congenital malformations were noted. The outcome of the events was not recovered (reported as ongoing). The reporter assessed the case as non-serious. The subject's estimated delivery date (EDD) and corrective estimated delivery date (CEDD) were reported as 18-Sep-2019.; Reporter's Comments: A 41-year-old, female subject developed hypersensitivity, on an unspecified day after administration of study vaccine at 8 weeks of gestation (coded to exposure during pregnancy). The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported event (hypersensitivity), vaccination details, concurrent medical conditions and investigations to provide alternate aetiologies, the causal role of study vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information. Considering the inactivated nature of the suspect vaccine and infectious aetiology of the reported event of genital herpes the causal role of suspect vaccine was assessed as not related. 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 exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).