Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Foetal disorder, Streptococcus test positive
Clinical narrative: Group B streptococcus (GBS) positive; Constipation; Anemia; Possible pruritic urticarial papules and plaques of pregnancy (PUPPS); Vaccine exposure during pregnancy; This is an observational study case from, initially received from other health professional on 06-Feb-2020, concerning a 29-year-old pregnant, female subject (Race:; Ethnicity:), (subject ID:) of body weight 136 lbs, height 61 inches and body mass index (BMI) 25.7,  enrolled in,a prospective observational safety study.   The subject's past medical history included subchorionic haemorrhage and loop electrosurgical excision procedure, while the subject's current medical history included anxiety, depression, interstitial cystitis, history of pre-eclampsia, migraines, gastroesophageal reflux disease (GERD) and increased BMI. The subject was Rh negative.  The subject's concomitant medications included Wellbutrin XL (bupropion hydrochloride) for depression, Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Klonopin (clonazepam) for anxiety and depression and omeprazole for GERD.  The subject's obstetrical history noted two previous pregnancies which included one full term live birth and one spontaneous abortion. The subject did not have offspring with major congenital malformation (MCM), nor relevant maternal or paternal history with MCM. The subject did not consume alcohol, tobacco and illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 17-May-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) was 21-Feb-2020, while corrected estimated delivery date (CEDD) was not reported.   On 16-Jul-2019, the subject underwent ultrasound and no MCM was noted.  On 13-Aug-2019, the subject underwent nuchal translucency and first sequential testing and no MCM was noted.  On 03-Sep-2019, the subject underwent second sequential testing and no MCM was noted.  On 07-Oct-2019, the subject underwent 20-week anatomy ultrasound and possible arachnoid cyst in foetus was noted.  On 20-Nov-2019, at gestational age of 26 weeks (calculated per LMP), the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation.  On 05-Dec-2019, at gestational age of 29 weeks, arachnoid cyst in foetus was resolved. On the same day, the subject developed possible pruritic urticarial papules and plaques of pregnancy (PUPPS).  On an unknown date, the subject underwent group B streptococcus (GBS) test and result was positive.  On 22-Jan-2020, the outcome of the event PUPPS was resolved.  On 30-Jan-2020, two months and 10 days after vaccination, the subject developed constipation and anaemia. On the same day, the subject started treatment with ferrous sulfate tablet, at a dose of 325 mg, one tablet every day via oral route of administration for anemia and Colace capsule (docusate sodium) at a dose of 100 mg, twice daily and with one packet of Miralax (macrogol 3350), at a dose of 17 g, every day; the both were administered via oral route of administration for constipation.  At gestational age of 39.4 weeks (as reported), the subject delivered live birth male neonate via vaginal method of delivery. The neonate's birth weight was 3317 grams, head circumference and body length were not reported and APGAR (appearance, pulse, grimace, activity and respiration) score was 7 at one minute, 9 at five minutes and was not reported for ten minutes. There were no major MCMs identified at birth.  On 31-Mar-2020, the outcome of constipation and anaemia was resolved.  At the time of this follow up, the outcome for Bacterial infection due to streptococcus, group B' was not reported.  The event of Bacterial infection due to streptococcus, group B' was assessed as serious, due to seriousness criteria of medical significance.  This reporter did not provide causality assessment to Afluria QIV.  Follow up information from other health professional with additional documents (being processed together) were both received on 07-May-2020: Pregnancy outcome was provided. Medical history was updated with start and stop dates for subchorionic haemorrhage. Omeprazole was changed from treatment to concomitant medication and action taken was added. Group B streptoccocus (GBS) positive was added as lab and new event and accordingly, the case was upgraded from non-serious to serious. GERD was removed as an event and was moved to current condition as it was confirmed that start date was prior vaccination. Start date was added for PUPPS, stop dates were added for the events of PUPPS, constipation, anaemia and vaccine exposure during pregnancy' and outcome was changed from not resolved to resolved for anemia and constipation and from not reported to resolved for PUPPS and vaccine exposure during pregnancy'. The narrative was amended accordingly.    Company comment: A 29-year-old pregnant female subject developed beta haemolytic streptococcal infection, polymorphic eruption of pregnancy, constipation and anaemia  after vaccination with the suspect product Flu Vaccine Egg Split QIV CSL for an unknown indication. Reportedly, at gestational age of 26 weeks, the subject was administered Afluria QIV. 2 months and 10 days after vaccination the subject started developing events. Chronology seems plausible. On unspecified date in 2019, reported as 12 weeks of gestation, the subject had a sub chorionic haemorrhage. The subject's medical history included anxiety, depression, interstitial cystitis, history of pre-eclampsia, migraines, loop electrosurgical excision procedure and increased body mass index. The patient was Rh negative. The subject's concomitant medications included Wellbutrin XL (bupropion hydrochloride) for depression, Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and Klonopin (clonazepam) for anxiety and depression. With information presented, causality is assessed as not related since bupropion and clonazepam may produce constipation and anemia. Beta haemolytic streptococcal infection is considered unrelated. Also the subject had a sub chorionic haemorrhage which could explain anaemia. Polymorphic eruption of pregnancy is assessed as possibly related. Exposure during pregnancy is assessed as not related per labeling conventions.; Sender's Comments: A 29-year-old pregnant female subject developed beta haemolytic streptococcal infection, polymorphic eruption of pregnancy, constipation and anaemia  after vaccination with the suspect product Flu Vaccine Egg Split QIV CSL for an unknown indication. Reportedly, at gestational age of 26 weeks, the subject was administered Afluria QIV. 2 months and 10 days after vaccination the subject started developing events. Chronology seems plausible. On unspecified date in 2019, reported as 12 weeks of gestation, the subject had a sub chorionic haemorrhage. The subject's medical history included anxiety, depression, interstitial cystitis, history of pre-eclampsia, migraines, loop electrosurgical excision procedure and increased body mass index. The patient was Rh negative. The subject's concomitant medications included Wellbutrin XL (bupropion hydrochloride) for depression, Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and Klonopin (clonazepam) for anxiety and depression. With information presented, causality is assessed as not related since bupropion and clonazepam may produce constipation and anemia. Beta haemolytic streptococcal infection is considered unrelated. Also the subject had a sub chorionic haemorrhage which could explain anaemia. Polymorphic eruption of pregnancy is assessed as possibly related. Exposure during pregnancy is assessed as not related per labeling conventions.