Sex: U
Vaccine: FLU3, FLU3
Symptoms: Chordee, Congenital anomaly, Foetal exposure during pregnancy
Clinical narrative: This report from a study was reported via Pregnancy Registry (initial receipt 18-Aug-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included prenatal vitamins, cyanocobalamin, fish oil, calcium, cholecalciferol, clomiphene citrate, monoclonal antibodies, prednisone, esomeprazole magnesium, paracetamol, ibuprofen, loratadine, pseudoephedrine hydrochloride, docusate sodium, doxylamine succinate, lorazepam, folic acid and diphtheria, and tetanus toxoid and pertussis vaccine. The neonate patient's mother had a medical history of rheumatoid/RA (rheumatoid arthritis) (diagnosed in 2001), infertility (received fertility treatment), hip replacement (in 2006), IBS (irritable bowel syndrome, resolved), ulcers from NSAIDS, Thyroid dysfunction - Graves (diagnosed in 2013), fibroids (that were removed in 2014), GI upset, stomach flu, diarrhoea, vomiting, respiratory infection/cold, headache, carpal tunnel, ulcers, and a carrier for CF (cystic fibrosis). The mother's date of conception was 09-Mar-2014 with twin pregnancy. At first ultrasound at 5.7 weeks, 2 sacs were seen, the first sac had a pole and heartbeat and the second sac had no pole or heartbeat. Twin B was spontaneously aborted at 6 weeks of gestation. At follow-up ultrasound on 6.9 weeks there was still heartbeat in the first sac but the second sac hadn't developed any further. (Refer to case 2015053273). The ultrasound scans (performed on 11-May-2014, 07-Sep-2014, 21-Jul-2014, 05-Oct-2014 and 09-Nov-2014), alfa-fetoprotein test (performed on 01-Jul-2014) and non-invasive prenatal tests (performed on 04-May-2014). On 25-Sep-2014, the patient received Afluria vaccine (influenza virus vaccine polyvalent, batch number: T58606) via the mother in utero. On 01-Dec-2014, the patient was live born at 40.1 week gestation (weight: 2835 grams, Apgar score at 1 min: 9, Apgar score at 5 mins: 9. The patient was born full term and diagnosed with congenital chordee which was diagnosed and confirmed by paediatric urology medical records. The outcome was not reported. Additional information was received from the health authority on 23-Nov-2015: The route and site of administration for Afluria was unknown. On an unspecified date, the patient had congenital anomaly (outcome: unknown). VAERS case ID: 592066. Reporter's Comments: Reporter Comments: The health authority assessed the events as non-serious. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CSL Inactivated Influenza Virus Vaccine CCSI and the Afluria PI, Pneumonia and other events are unlisted. Heavy flu/Influenza is listed. Causality: Unrelated. Diagnosis of chordee was at birth. Chordee is observed in 4-10% of male births. Of note patient was 1 of a twin who was spontaneously aborted. Mother had history of Rheumatoid arthritis and on treatment with several medications including monoclonal antibody, prednisone, esomeprazole and diphtheria, tetanus toxoid pertussis vaccine. Causality is considered not related to vaccination due to absence of biological plausibility. Influenza vaccination is used in pregnancy with no prior association with chordee observed, therefore causality is considered unrelated. Company's evaluation and comment: 07-Dec-2015 (Note: error in listedness commentary in previous company comment). Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CSL Inactivated Influenza Virus Vaccine CCSI and the Afluria PI, Congenital chordee and congenital anomaly are unlisted. Foetal exposure in utero/Foetal exposure during pregnancy is listed as vaccine is not contraindicated during pregnancy. Causality: Unrelated. Diagnosis of chordee was at birth. Chordee is observed in 4-10% of male births. Of note patient was 1 of a twin who was spontaneously aborted. Mother had history of Rheumatoid arthritis and on treatment with several medications including monoclonal antibody, prednisone, esomeprazole and diphtheria, tetanus toxoid pertussis vaccine. Causality is considered not related to vaccination due to absence of biological plausibility. Influenza vaccination is used in pregnancy with no prior association with chordee observed, therefore causality is considered unrelated.