Sex: M
Vaccine: FLU3, FLU3
Symptoms: Apgar score normal, Factor VIII deficiency, Foetal exposure during pregnancy, Hooded prepuce
Clinical narrative: This report from a study was reported via Pregnancy Registry (initial receipt 19-Aug-2015), concerns a neonatal patient. The patient's mother had a medical history of anemia and was an hemophilia A carrier. The mother's concomitant medications included prenatal vitamins and iron for borderline anemia. The mother had caffeine (1/2 diet coke) from 31-Mar-2013 until 24-Dec-2013, wine (1/4 glass of wine, 0.25 serving 1 day) on the 07-Dec-2013, and had a respiratory infection (cold) between 22-Jul-2013 until 31-Jul-2013. On the 10-Jun-2013, the mother had a 1st trimester serum screen which showed that the PAPPA (pregnancy-associated plasma protein A) marker was low and on the 07-Aug-2013 had an ultrasound which saw a choroid plexus cyst. All other ultrasounds and tests were normal (see 2015053323). On the 15-Oct-2013, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number R53207) via the mother (intrauterine) 1 shot 1 day. On the 01-Nov-2013, the patient received Boostrix (tetanus, pertussis and diphtheria vaccine, batch number not reported) via the mother (intra-uterine) 1 shot 1 day. On the 24-Dec-2013, the patient was born at 38.3 weeks, with a birth weight of 3350g and Apgars of 8 at both 1 minute and 5 minutes. On an unspecified date, the patient was diagnosed with hemophilia A which was confirmed by haematology and paediatric records. The baby was also diagnosed with a hooded foreskin (ICD9752.860) by urology. Outcome was not reported. Additional information was received from the health authority on 23-Nov-2015: VAERS case ID: 592069. The site and route of administration for Afluria were unknown. The reporter reported the event 'apgar score normal'. Reporter's Comments: Reporter comments: The reporter did not consider either of these major malformations but reported the events as congenital anomalies. Reporter comments: The health authority assessed the events as non-serious and reported the term 'Apgar score normal'. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information all events are unlisted. Causality: Unrelated. Hemophilia is a genetic mutaion and is not causally linked to flu vaccination. Hooded prepuce is attributed to incomplete preputial development which occurs 8 to 16 weeks gestation. Exposure in utero occured during the mother's third trimester. Company comments/assessment:updated 04-Dec-2015. Company comments: Seriousness criterion/criteria: Congenital anomalies. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information Haemophilia, hooded prepuce are unlisted. Normal APGAR score is also unlisted event. Foetal exposure during pregnancy is listed as vaccination is not contraindicated in pregnancy. Causality: Unrelated. Haemophilia is a genetic mutation and is not causally linked to flu vaccination. Of note, mother was a carrier of haemophilia A gene. Hooded prepuce is attributed to incomplete preputial development which occurs 8 to 16 weeks gestation. As exposure in utero occurred during the third trimester, causality is considered unrelated as organogenesis is completed at this stage. Importantly baby had normal APGAR at birth. Normal APGAR and foetal exposure during pregnancy are unassessable in relation to Afluria administration. Other events considered causally unrelated to vaccination.