Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Malaise, Vomiting
Clinical narrative: GESTATIONAL DIABETES; DIARRHEA; VOMITING; MATERNAL EXPOSURE DURING PREGNANCY; COULD NOT SLEEP; CHILLS; FEELING UNWELL; HEADACHE; FATIGUE; This solicited pregnancy report received from a consumer concerned a 35 year old female of unknown ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight was 67.12 kilograms, and height was not reported. The patient's past medical history included: miscarriage, and recreational drug use, and concurrent conditions included: anxiety, non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no history of exposure to tobacco. The patient was gravida 3, para 1, abortion 1. Patient was pregnant at the time of vaccination. Patient's last menstrual period was on 26-DEC-2020. The estimated delivery date (EDD) was reported to be 02-OCT-2021. It was reported that this was singleton pregnancy. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-MAR-2021 (gestational age 13 weeks and 4 days) for prevention of covid-19 (covid-19 immunisation). Concomitant medications included Prenatal vitamins, and Zoloft (sertraline hydrochloride). On the same day, after receiving the vaccine, the patient experienced chills, fatigue, headache, vomiting, was feeling unwell and couldn't sleep from chills. Vomiting resolved during the same day, as the patient reportedly threw up only once, in the evening after getting the vaccine. On 01-APR-2021, the patient experienced diarrhea. On the same day, the patient recovered from chills, difficulty sleeping and diarrhea. On 02-APR-2021, the patient recovered from fatigue, feeling unwell and headache. On 30-JUL-2021, at gestational age of 30 weeks and 6 days, the patient developed gestational diabetes. On 12-SEP-2021, at gestational age of 37 weeks and 1 day, the patient delivered vaginally live male neonate. The patient spent one day in the hospital for the delivery. The neonate's birth weight was 2.57 kilograms, body length 18 inches. On an unspecified date in 2021, the patient recovered from gestational diabetes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gestational diabetes on 2021, could not sleep, chills, and diarrhea on 01-APR-2021, feeling unwell, headache, and fatigue on 02-APR-2021, and vomiting on 31-MAR-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and gestational diabetes, could not sleep, chills, feeling unwell, headache, fatigue, diarrhea, and vomiting was related, and between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related.  This report was serious (Other Medically Important Condition).  Additional information was received from consumer on 29-SEP-2021. The following information was updated and incorporated into the case narrative: Pregnancy details added (outcome, gravida, para, EOP date, expected delivery date, number of abortions and child information), Event added (gestational diabetes), updated onset of event (diarrhea), added cessation and updated outcome for events (could not sleep, chills, diarrhea, feeling unwell, headache, vomiting and fatigue).; Sender's Comments: V1- 20210760467- covid-19 vaccine ad26.cov2.s Gestational diabetes. Follow-up received regarding Clinical Details. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210760467- covid-19 vaccine ad26.cov2.s  Maternal exposure during pregnancy. Follow-up received regarding Clinical Details. 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