Sex: U
Vaccine: FLU3, FLU3
Symptoms: Aplasia cutis congenita, Foetal exposure during pregnancy
Clinical narrative: This report from a study was reported via Pregnancy Registry (initial receipt 25-Jul-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero included lavender oil, prenatal vitamins, doxylamine, wine, docosahexanoic acid, folic acid, zinc, magnesium, ubidecarenone, copper, selenium, zingiber officinale rhizome, green or black tea, unspecified antibiotics, oxycocet, ondansetron, progesterone, magnesium hydroxide, paracetamol, docusate sodium, calcium carbonate, hydrocortisone, oenothera biennis oil and miconazole nitrate. The 34-year-old mother had medical history of BRCA1 gene mutation, chronic fatigue syndrome (in 2007), was suspected to have Raynaud's and also had history of uterine cysts (in 2007) (refer to the mother case 2015052718). On 17-Oct-2014, the patient received Afluria vaccine (influenza virus vaccine polyvalent, batch number not reported) at 1 shot 1x QD, in-utero via the mother. On 04-Nov-2014, the patient's mother underwent ultrasound scan which was normal. On 02-Dec-2014, the patient's mother underwent first trimester serum screen, the result of which was normal. On 12-Dec-2014, the patient's mother underwent an ultrasound scan and on 01-Jan-2015, she underwent alpha fetoprotein test, both of which were normal. On the 02-Feb-2015, the patient's mother underwent an ultrasound scan which was normal. On 21-Mar-2015, she underwent glucose tolerance test which was normal. On the 17-Apr-2015, the patient also received TDAP vaccine (diphtheria and tetanus toxoids and pertussis vaccine, batch number not reported) at 1 shot per day, in-utero via the mother. On the 28-Apr-2015 and 01-May-2015, the patient's mother underwent a non-stress/stress test. On the 01-May-2015, she also underwent an ultrasound which was normal. On the 19-May-2015, the patient's mother underwent a non-stress/stress test and on the 29-May-2015, the patient's mother underwent an untrasound which was normal. On 25-Jun-2015, the patient was born (gestational age of delivery 40.3), and was diagonsed with aplasia cutis congenita at delivery. The patient's birth weight was 3093 grams and Apgars at 1 min was 8 and Apgars at 5 mins was 9. The outcome was was not reported. VAERS #: 588455. Follow up (23-Sep-2015): The Health Authority assessed the events as non-serious. Reporter's Comments: VAERS #: 588455. Reporter comments: The reporter assessed the event as serious (congenital anomaly). Sender's Comments: Company comments:  Seriousness: Serious. Congenital anomaly. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS and Afluria PI, hydronephrosis and other associated events are unlisted; foetal drug exposure in pregnancy is listed as vaccine is not contraindicated in pregnant women. Causality: Unlikely. Aplasia cutis congenita is a congenital group of disorders characterized by a localized or widespread absence of a portion of the skin, most commonly on the scalp. The exact causative factor for the condition has not been fully elucidated but is considered to be a result of more than one disease process, with the 10th to 15th week of gestation as the most critical. Events like trauma, intake of teratogens, genetic factors are all thought to be contributory. To date, no evidence linking influenza vaccines with aplasia cutis congenita is available. Given the multifactorial nature of the disease etiology, and the other conditions and drug exposure experienced by the mother during and before gestation, the vaccine is unlikely related to the event. Company comment (01-Oct-2015): No change in assessment.