Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Premature delivery, Prenatal screening test, Rash erythematous, Ultrasound antenatal screen abnormal
Clinical narrative: Delivery at gestational age of 36.3 weeks; Erythematosus dots on inner left arm, abdomen; Vaccine exposure during pregnancy; Flu; This is an observational study case, initially received from other health professional on 02-Jan-2020, concerning a 20-year-old, female, pregnant subject of body weight: 135.5 lbs, height: 66 inches and body mass index (BMI): 21.9, enrolled in, a prospective observational study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's current medical conditions included seasonal asthma and ovarian cyst.    The subject's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.   The subject's obstetrical history included no previous pregnancies. Also, the subject had no maternal or paternal history with major congenital malformations (MCM). The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 24-Aug-2019. Estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 30-May-2020. The type of pregnancy was singleton.   On 17-Oct-2019, the subject underwent ultrasound scan and no MCM was noted.  On 24-Oct-2019, at gestational age of 8 weeks (calculated per LMP), the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100126099, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.  On an unspecified date in 2019, an unknown amount of time after vaccination, the subject developed flu.   On 23-Nov-2019, the subject underwent non-invasive prenatal testing, and no MCM was noted.   On 25-Nov-2019, the subject started treatment with Tamiflu (oseltamivir phosphate), at a dose of 75 mg, every day for 10 days, administered orally.  On 05-Dec-2019, treatment with Tamiflu was finished.  On 19-Dec-2019, the subject underwent cystic fibrosis mutation analysis and no MCM was noted.   On 06-Jan-2020 and 05-Feb-2020, the subject underwent ultrasound scans and identified MCM was foetal gastroschisis.   On 10-Feb-2020, three months and 17 days after vaccination, the subject developed erythematosus dots on inner left arm and abdomen and started treatment with 2.5 percent hydrocortisone, two times a day, administered topically.   At gestational age of 36.3 weeks (as reported), the subject vaginally delivered a male neonate. The neonate's birth weight was 2500 g, head circumference was 31.5 cm and body length was 46 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 1, at five minutes was 7 and at 10 minutes was 9.  No pregnancy complications were noted. MCM foetal gastroschisis was identified at birth. It was unknown if there were other factors contributing to MCM.   At the time of follow up, outcome of 'rash erythematosus' was not resolved, while the outcome of events flu and 'premature delivery' was not reported.   Per company, the events of flu and premature delivery' were assessed as serious due to the criterion of medical significance.  The reporter did not provide a causality assessment to Afluria QIV.  This case is linked to 202001857, the corresponding child case.   Follow-up information received from other health professional on 18-Feb-2020: New event of 'erythematosus dots on inner left arm and abdomen' added, laboratory tests updated, linked case added. The narrative was amended accordingly.  Follow-up information received from other health professional on 29-Jul-2020: Pregnancy outcome was provided and MCM of fetal gastroschisis was confirmed. New event of premature delivery' was added. Stop date added and outcome of vaccine exposure during pregnancy' was changed from not reported' to resolved'. Narrative amended accordingly.  Company comment: The subject experienced premature delivery, influenza and rash erythematous after vaccination with the suspect product, Afluria QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 8 weeks. Medical history of seasonal asthma and pregnant state may have contributed to development of the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering implausible chronology, causality between suspect product and the events rash erythematous (three months after vaccination) and premature delivery (six months after vaccination) is assessed as not related. Regarding the event of influenza, causality is unassessable due to lack of information regarding onset latency.; Sender's Comments: The subject experienced premature delivery, influenza and rash erythematous after vaccination with the suspect product, Afluria QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 8 weeks. Medical history of seasonal asthma and pregnant state may have contributed to development of the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering implausible chronology, causality between suspect product and the events rash erythematous (three months after vaccination) and premature delivery (six months after vaccination) is assessed as not related. Regarding the event of influenza, causality is unassessable due to lack of information regarding onset latency.