Sex: U
Vaccine: DTP, FLU3, FLU3
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Foetal non-stress test normal, Naevus flammeus, Vascular malformation
Clinical narrative: This report from a study was reported via Pregnancy Registry (initial receipt 19-Aug-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included unspecified prenatal vitamins, salmeterol/fluticasone, estradiol, progesterone, calcium carbonate, and diphtheria and tetanus toxoids and pertussis vaccine. The patient's mother had a medical history of asthma (diagnosed in 1982), pulmonary embolism (diagnosed in 2004), endometriosis and other uterine disorder, heartburn, and secondary infertility requiring salpingectomy (in 2009) in left tube due to hydrosalpinx. (Refer to the mother case: 2015053328).  On 02-Oct-2013, the patient received Afluria (influenza virus vaccine polyvalent, batch number R54507) from the mother, in-utero. The patient's mother underwent multiple ultrasound scans, multiple non-stress/stress tests, and alpha-fetoprotein test which were all normal during the course of her pregnancy. The first trimester serum screen was done on 10-Sep-2013. On 18-Mar-2014, the patient was born at the gestational age of 39.6 (patient's weight 3920.0 grams, Apgars at 1 min: 9, Apgar at 5 min: 9). The patient was diagnosed with vascular malformation (port wine stain) 3.6 x 2.7 cm on mid-chin extending to the right cheek (extension onto the cheek in 2.5 cm) with no involvement of V1, unilateral involvement. This was present since birth with no changes (color, size, shape) and no bleeding. At 4 weeks (on 15-Apr-2014), the patient was well. No further evaluation was required but laser treatment was available. The outcome was not reported. Follow-up (02-Sep-2015): The patient's mother had a history of two previous pregnancies- One was spontaneous abortion and the other was live born infant. Neither of the two were diagnosed with any major malformation. The gestational age of spontaneous abortion and cause were unknown. Follow-up information received from heath authority (23-Nov-2015): VAERS ID: 592058. On 02-Oct-2013, the patient received DTP vaccine (diphtheria and tetanus toxoids and pertussis vaccine, batch number not reported) via the mother in-utero. Reporter's Comments: Reporter's comments: The health authority reported preferred term 'Apgar score normal'. The health authority assessed the events as non-serious. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCSI and the Afluria PI, vascular malformation, port wine stain are unlisted. Foetal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Unrelated.   Port wine stain is dermal capillary malformation, usually unilateral or segmental distribution identified at birth. Incidence rate is 0.1 to 2 percent of newborns without sex predilection. It is generally sporadic, but familial cases have been reported. The etiology and pathogenesis is unknown. Of note, mother was exposed to salmeterol/fluticasone, hormones [estradiol, progesterone] and diphtheria and tetanus toxoids and pertussis vaccine during pregnancy. Influenza vaccination is used commonly in pregnancy with no previous link observed with vascular malformation. Causal attribution with Influenza vaccine is considered unrelated due to unlikely pathomechanism of vaccination in causation of vascular abnormality. Updated Company comments:07-Dec-2015. Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCSI and the Afluria PI, vascular malformation, port wine stains are unlisted. Normal APGAR score is also unlisted. Foetal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Unrelated.   Port wine stain is dermal capillary malformation, usually unilateral or segmental distribution identified at birth. Incidence rate is 0.1 to 2 percent of newborns without sex predilection. It is generally sporadic, but familial cases have been reported. The etiology and pathogenesis is unknown. Of note, mother was exposed to salmeterol/fluticasone, hormones [estradiol, progesterone] and diphtheria and tetanus toxoids and pertussis vaccine during pregnancy. Influenza vaccination is used commonly in pregnancy with no previous link observed with vascular malformation. Causal attribution with Influenza vaccine is considered unrelated due to unlikely pathomechanism of vaccination in causation of vascular abnormality.