Sex: F
Vaccine: FLU3, FLU3
Symptoms: Apgar score abnormal, Cerebrovascular accident, Congenital anomaly, Foetal exposure during pregnancy, Gross motor delay
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, neurological conditions (migraines from 1991 until 2000 which had resolved), headaches, nausea, constipation, heartburn, low iron, and infertility and was pregnant via IVF (In Vitro Fertilisation). The mother's concomitant medications included prenatal vitamins, estradiol, progesterone injection in oil, progesterone vaginal insert, ondansetron for nausea, paracetamol for headaches, docusate for constipation, iron for low iron, diphenhydramine for sleep and ranitidine for heartburn. The patient's mother drank tea and drank wine between 08-Feb-2013 and 27-Feb-2013 and then again between 06-Jun-2013 until 09-Nov-2013. The mother had an ultrasound on the 06-Aug-2013 saw mild ventriculomegaly. On the 14-Aug-013, the patient's mother had an ultrasound which saw stable mild ventriculomegaly and was also seen on the 22-Aug-2013 during an MRI (Magnetic Resonance Imaging). On the 02-Oct-2013, the patient received the Afluria vaccine (influenza virus vaccine polyvalent, batch number 'R55601') via the mother (intra-uterine) 1 shot 1 day. On the 09-Nov-2013, the patient was born at 39.1 weeks with a birth weight of 3990.0 grams, and Apgars of 0 at one and five minutes. On an unspecified date, the baby was diagnosed with neonatal left MCA (middle cerebral artery) stroke per the pediatric neurology medical record. The baby was seen for follow-up on the 10-Dec-2013. As of the 14-Jan-2014, the baby was off seizure medications. Testing had showed that she was 25% behind in gross motor skills. She was recommended physical therapy when child is older. Neurology will continue to follow up. Outcome was unknown. Follow up information was received from the health authority on 23-Nov-2015: The site and route of administration for Afluria were unknown. The reporter reported events 'Apgar score abnormal' and 'congenital anomaly'. VAERS case ID: 592068. Reporter's Comments: Reporter comments: The reporter stated that the events were a congenital anomaly. Reporter comments: The healthy authority assessed the case 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, Neonatal stroke is unlisted. Foetal exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Unassessable. The time to onset of left MCA stroke is not known.  There was history of infertility and ventriculomegaly in mother of unknown etiology. Concomitant treatments included estradiol, progesterone, ondansetron, diphenhydramine and ranitidine. Stroke in neonates may be due to thrombotic, embolic events however the etiology is not known. Haematological factors in cerebral infarction are possibly due to increased incidence of heterozygosity for factor V Leiden. Further information such as time of stroke in relation to vaccination in child, past obstetric history, clinical presentation and mode of diagnosis, are required for causal assessment. Additionally test for factor V Leiden may also assist causality assessment. However there is insufficient information to attribute causality to vaccination. Company comments/assessment: 07-Dec-2015. Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CSL Inactivated Influenza Virus Vaccine CCSI and the Afluria PI, Neonatal stroke is unlisted. APGAR score abnormal' and congenital anomaly are also unlisted.  Foetal exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Unassessable. The time to onset of left MCA stroke is not known.  There was history of infertility and ventriculomegaly in mother of unknown etiology. Concomitant treatments included estradiol, progesterone, ondansetron, diphenhydramine and ranitidine. Stroke in neonates may be due to thrombotic, embolic events however the etiology is not known. Haematological factors in cerebral infarction are possibly due to increased incidence of heterozygosity for factor V Leiden. Further information such as time of stroke in relation to vaccination in child, past obstetric history, clinical presentation and mode of diagnosis, are required for causal assessment. Additionally test for factor V Leiden may also assist causality assessment. However there is insufficient information to attribute causality to vaccination.