Age: 35.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Congenital anomaly, Foetal death, Foetal exposure during pregnancy, Right atrial dilatation
Clinical narrative: This report from a study was reported via Pregnancy Registry (initial receipt 29-Jul-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included venlafaxine, prenatal vitamins, vitamin D, Krill Oil, diphenhydramine, cinnamon capsules, ondansetron, docusate, TUMS, paracetamol, iron, fibre laxative/supplement and trazodone. The 35-year-old mother had a medical history of high blood pressure (diagnosed in 2010), anemia (diagnosed in 1999), depression (diagnosed in 2001), psoriasis (diagnosed in 2000), Multiple Sclerosis (diagnosed in 2011), indigestion, headache, insomnia and low iron. The mother also consumed coffee (from 03-Mar-2014, oral, 8 oz 3/week), caffeine (soda, from 03-Mar-2014, oral), beer (on 07-Apr-2014, 3 servings a day, oral), and inhaled cigarette smoking (from 03-Mar-2014 to 07-Apr-2014, 2 cigarettes per day, stopped at approximately 5 weeks). The mother had an emergency room visit on 30-Mar-2014 for the cut finger in which she needed stitches and took ibuprofen/diphenhydramine on 30-Mar-2014. (refer to the mother case: US-BEH-2015052801). On 01-Oct-2014, the patient received Afluria vaccine injection (influenza virus vaccine polyvalent, batch number T56905) at 1 shot a day, in utero via the mother who received it to prevent infection caused by influenza virus. On the same day, the patient also received Adacel vaccine injection (diphtheria, pertussis and tetanus, batch number not provided) at 1 shot a day, in utero via the mother. On 29-Oct-2014, the patient's mother underwent a glucose tolerance test which was normal. On 08-Nov-2014, the patient's mother developed a respiratory infection. On 09-Dec-2014, the patient was born /stillbirth (gestational age at delivery 37.1, birth weight was 2611 grams), and was diagnosed with right atrial enlargement at birth. Medical record confirmation was pending. The outcome was not reported. VAERS case ID: 589720. Follow up (23-Sep-2015): The Health Authority reported the term 'congenital anomaly', and also reported the term 'stillbirth' (NB: In context, stillbirth belongs to the mother - see US-BEH-2015052801). The Health Authority reported the case as non-serious. Reporter's Comments: VAERS case ID: 589720. Reporter comments: The reporter assessed the event as serious (congenital anomaly). Sender's Comments: Company comments: Seriousness: Serious. Fatal. Listedness: Unlisted. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, right atrial enlargement is unlisted. Causality: Unlikely. Congenital cardiac malformations have multiple etiologies, and may be detected as a singular defect or in association with other congenital syndromes. To date, available literature does not indicate that maternal influenza vaccination is associated with an increased risk of fetal death, spontaneous abortion, or congenital malformations. Furthermore, the heart is one of the earliest differentiating and functioning organs in an embryo with the development occurring in the first up to the 2nd trimester. The patient's mother received the vaccine during her third trimester lessening embryological impacts. Company comments 05-Oct-2015: No change in overall assessment.