Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: DELIVERY AT GESTATIONAL AGE 36 WEEKS AND TWO DAYS; MARGINAL CORD INSERTION; MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM; HEADACHE; This solicited pregnancy report received from a consumer concerned a 39 year old female of unspecified ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight was 85.26 kilograms, and height was not reported. The patient Body Mass Index (BMI) was 22.21.  The patient's concurrent conditions included: anxiety, and attention deficit disorder. Patient had history of multigravida. Patient had no history of exposure to drugs for recreational use, tobacco use, or alcoholic beverage consumption. The patient's obstetrical history included two previous pregnancies, of which one resulted in live newborn.  The first day of the last menstrual period (LMP) was calculated to be 05-DEC-2020. The estimated delivery date (EDD) was reported to be 11-SEP-2021. It was reported that this was singleton pregnancy. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 at gestational age 17 weeks 3 days for covid-19 immunisation. Concomitant medications included doxylamine succinate, fluoxetine hydrochloride, and minerals nos/vitamins nos.  On 06-APR-2021, within 48 hours after receiving the (Ad26.COV2-S) vaccine, patient experienced headache, sore arm and maternal exposure during pregnancy. On 29-Apr-2021, patient experienced marginal cord insertion. It was stated that provider requested ultrasounds every 4 weeks to monitor baby's growth. No issues were noted. On 16-Aug-2021, at gestational age 36 weeks and two days, patient vaginally delivered a live, pre-term, male neonate. Patient spent two days in the hospital for the delivery. On 18-AUG-2021 patient was discharged from hospital. The neonate's birth weight was 6.43 (6 pounds and 7 ounces), body length was 18 inches. The neonate spent more than 10 days in Neonate Intensive Care Unit (NICU) due to problems with breathing. Laboratory data included: Ultrasound scan (NR: not provided) Marginal cord insertion.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache, had not recovered from marginal cord insertion, and the outcome of maternal exposure during pregnancy and delivery at gestational age 36 weeks and two days was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and marginal cord insertion as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and delivery at gestational age 36 weeks and two days, maternal exposure during pregnancy, sore arm, and headache. Company causality between covid-19 vaccine ad26.cov2.s, and sore arm, and headache was related, and between covid-19 vaccine ad26.cov2.s, and marginal cord insertion, delivery at gestational age 36 weeks and two days, maternal exposure during pregnancy was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20211011488.  This case was reassessed as serious based on additional information received from a consumer on 06-OCT-2021. The following information was updated and incorporated into the case narrative: event added (delivery at gestational age 36 weeks and two days, event marginal cord insertion), event maternal exposure during pregnancy upgraded to serious and outcome of event headache, sore arm updated to recovered, patient medical history, pregnancy related information added, causality, labelling updated accordingly.; Sender's Comments: V1: 20210728727-covid-19 vaccine ad26.cov2.s- marginal cord insertion, delivery at gestational age 36 weeks and two days. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY  20210728727-covid-19 vaccine ad26.cov2.s-maternal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS