Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Beta haemolytic streptococcal infection, Caesarean section, Exposure during pregnancy, Premature delivery, Prenatal screening test
Clinical narrative: This is a serious observational study case initially received on 26-Nov-2018, concerning a 30-year-old, adult, female pregnant subject of body weight: 164 lbs, height: 63.5 inches and body mass index (BMI): 28.6, 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 no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject's obstetrical history included three previous pregnancies which included 1 elective abortion, 1 full term pregnancy and 1 preterm live birth. No birth defects were reported. The father did not receive any medications prior to conception. The subject's last menstrual period (LMP) date was 22-Aug-2018. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. On 29-Sep-2018, at gestational age of 5 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252232, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication. On 01-Oct-2018, the subject started to take CITRANATAL 90 DHA (as reported) for healthy pregnancy. On 16-Nov -2018, the patient underwent first trimester screening, and no major congenital malformation was noted. The pregnancy status of the subject was collected, and no pregnancy complications were noted. On an unspecified date, after vaccination, the subject experienced rash on left arm and group B streptococcus infection. The patient was treated with hydrocortisone cream (dose: 2.5 percent, BID, route of administration: topical, started on: 30-Oct-2018 and stopped on: 10-Nov-2018) at gestational age of 9.9 weeks for left arm rash and amoxicillin (dose: 500 mg, PRN, route of administration: oral, started on: 10-Nov-2018 and stopped on: 17-Nov-2018) at gestational age of 11.4 weeks for group B streptococcus infection. On 04-Dec-2018, the subject underwent 2nd trimester screen and no major congenital malformation was noted. On 5 month and 6 days after vaccination, the subject delivered a pre-term female neonate at 27.9 weeks of gestation. The delivery method was caesarean. At the time of delivery, no pregnancy complications were noted. The neonate's birth weight was 1200 grams, head circumference was 29 cm and body length was 37.5 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 5 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth. The subject's estimated date of delivery (EDD) was reported as 29-May-2019. Non-significant follow up received from the reporter on 13-Dec-2018: Added lab investigation (2nd trimester screening test) in patient tab and narrative. Non-significant follow up received from the reporter on 01-Feb-2019: The reporter confirmed the treatment duration for the event left arm rash (start date: 30-Oct-2018, stop date: 10-Nov-2018) and group B streptococcus infection (start date: 10-Nov-2018, stop date: 17-Nov-2018). No new information was received; hence no changes were made in the narrative. Follow up received from other health professional on 13-May-2019: On 5 months and 6 days after vaccination, the subject delivered a pre-term female neonate at 27.9 weeks of gestation. The delivery method was caesarean. At the time of delivery, no pregnancy complications were noted. The neonate's birth weight was 1200 grams, head circumference was 29 cm and body length was 37.5 cm. The APGAR scores were 5 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth. Added new event: premature delivery in the event tab. The narrative was amended accordingly. Reporter's Comments: A 30-year-old pregnant female subject experienced rash and group B streptococcus infection, unspecified period of time after administration of Flu Vaccine Cell Subunit QIV NVD at 5 weeks of gestation (considered as vaccine exposure during pregnancy). The subject experienced premature delivery (27.9 weeks of gestation), 5 months 6 days post vaccination. Despite the lack of onset latency, the company assessed the event group B streptococcus infection as not related to the suspect vaccine due to the infectious aetiology (Bacterial) of the event. The causality of event rash is unassessable due to lack of onset latency. The event vaccine exposure during pregnancy assessed as not related considering the intended use of vaccine. Considering implausible temporal relationship, lack of evidence along with lab data regarding the causal association of vaccine to reported event premature delivery and maternal obstetrical history (three previous pregnancies which included 1 elective abortion, 1 full term pregnancy and 1 preterm live birth), which provide a more plausible explanation of the event, rather than study vaccine, the causality assessed as not related.