Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Foetal disorder, Haemorrhage, Labour induction, Postpartum disorder, Rhesus antibodies positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician referring to a 23 year old female patient. The patient's medical history and concurrent condition were not reported. The patient was 32 weeks and 4 days pregnant with LMP of 11-AUG-2014 and Estimated Date of Delivery (EDD) approximately on 18-MAY-2015. On 27-MAR-2015, the pregnant patient was vaccinated in error with a dose of VARIVAX (Merck) (dose, frequency and route were not reported). The physician did not have access to the lot number and expiration date, since it was not administered in her practice. There was no concomitant medication provided. No adverse effects had been observed or reported. The outcome of exposure during pregnancy was unknown. Follow up information has been received on 20-MAY-2015 by the physician and other unspecified reporter via pregnancy questionnaire referring to a (single pregnancy) female patient with chronic hypertension and hypothyroidism. The patient's medical history included varicella reported as chicken pox when the patient was 4 or 5 years old. It was unknown and uncertain if the patient was tested for varicella antibodies before vaccination. On 19-SEP-2014, an ABO test and Rhesus antibodies were performed: reported O positive, on 02-OCT-2014 an Ultrasound: Estimated Gestational age (EGA) by EDC: 7w3d, Estimated Gestational Age (EGA) by US: 7w4d, Scan (Estimated Date of Confinement) EDC: 17-MAY-2015, on 25-NOV-2014 a Maternal serum Alpha foetoprotein (MSAFP): Negative, on 30-DEC-2014, an Ultrasound: EGA by EDC: 20w1d, EGA by US 19w5d, Scan EDC: 21-MAY-2015, Placenta: post, Presenting: breech, Amn fluid: 11.9 cm, Estimated fetal weight (EFW): 12oz, Comments 40%, on 03-MAR-2015 a glucose was reported as 28K Neg 3 degree 6 II, on 13-MAR-2015 an Ultrasound: EGA by EDC: 30w4d, EGA by US 32w0d, Scan EDC: 08-MAY-2015, Placenta: post, Presenting: ceph, Amn fluid: 14.2 cm, Estimated fetal weight (EFW): 4#3oz, Comments 84% and on 25-MAR-2015 an Ultrasound: EGA by EDC: 32w2d, EGA by US -, Scan EDC: -, Placenta: post, Presenting: ceph, Amn fluid: 11.3 cm, Estimated fetal weight (EFW): -, Comments BPP 6/8. On 26-MAR-2015 (previously reported as 27-MAR-2015), the patient was vaccinated at private doctor's office with a dose of VARIVAX (Merck) intramuscular in the arm, lot # K001390, expiry date 29-JAN-2016 (dose was not reported). Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (unspecified) daily (QD), levothyroxine sodium (manufacturer unknown) orally, 50 microgram, daily (QD) and on 27-MAR-2015 a dose of Tdap (manufacturer unknown) lot number C4888AA, expiry date 11-SEP-2016 in the right deltoid intramuscularly. The initial exposure to VARIVAX (Merck) was 32-33 weeks approximately (potential adverse effects of fetus). So the physician was aware for any signs of varicella and also stated that if the patient was to deliver in the next week, the infant would need to be monitored closely for signs of varicella and likely need varicella zoster immune globulin, human (VZIG) but if the patient delivered at term, should not be an issue. On 06-APR-2015, other ultrasound was performed: (EGA by EDC: 34w0d, EGA by US 35w6d, Scan EDC: 05-MAY-2015, Placenta: posterior, Presenting: cephalic, Amn fluid: 13.2 cm, Estimated fetal weight (EFW): 6#7oz, Comments BPP 8/8 95%) and on 13-APR-2015 reported: EGA by EDC: 35w0d, EGA by US -, Scan EDC: -, Placenta: posterior, Presenting: cephalic, Amn fluid: 14.7 cm, Estimated fetal weight (EFW): -, Comments BPP 8/8 and a Streptococcus test (B-strep) Negative. On 04-MAY-2015, the patient was admitted to the hospital, due to complications during and after delivery, a labour induction due to chronic hypertension and a blood transfusion was required for an unspecified haemorrhage reported as acute blood loss. At 38 weeks gestation, the patient delivered a female infant weighing 3854.75 gms via vaginal delivery. The pregnancy outcome was live birth - full-term. The infant's APGAR scores were 8 at one minute and 9 at five minutes. There were no neonatal problems or any congenital anomalies in the infant. The outcome of the haemorrhage was unknown. The outcome of labour induction was recovered. On 07-MAY-2015, the patient was discharge from the hospital. Relatedness between the therapy with VARIVAX (Merck) and the events: haemorrhage and labour induction was not reported. Additional information is not expected, since all follow up information has been received.