Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Exposure during pregnancy, Fatigue, HELLP syndrome, Headache
Clinical narrative: HELLP SYNDROME; MATERNAL EXPOSURE DURING PREGNANCY; FATIGUE; HEADACHE; This solicited pregnancy report received from a consumer concerned a 35 year old female.The patient was enrolled in a non-company sponsored study. The patient's weight was 74.83 kilograms, and height was not reported. The patient's past medical history included: alcohol use once per month prior to knowing the pregnancy, and concurrent conditions included: hyperthyroidism, and other pre-existing medical conditions included: Patient had history of multigravida. The patient did not use drugs for recreational use. The patient did not use tobacco during pregnancy.  The patient was gravida 2, para 2. The patient obstetrical history included two previous pregnancies, which result in two live birth. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, 1 total administered on 31-MAR-2021 for prophylactic vaccination. (dose number in series 1) On 31-MAR-2021, at gestational age 15 weeks and 2 days, the patient experienced maternal exposure during pregnancy fatigue and headache.  The date of the patient's last menstrual period was 14-DEC-2020 and expected delivery date was 20-SEP-2021. Type of pregnancy was reported as singleton. On 19-JUL-2021, the patient experienced hellp syndrome.  Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 28.09.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 02-APR-2021, and the outcome of maternal exposure during pregnancy and hellp syndrome was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and hellp syndrome as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, fatigue, and headache.  Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and fatigue, hellp syndrome and headache was related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20211156274.  This case was reassessed as serious based on additional information received from consumer on 13-SEP-2021, the following information was updated and incorporated into case narrative: Patient para gravida and estimated delivery date was added. Pregnancy outcome was updated (from ongoing to live birth). Patient history text (The patient did not use drugs for recreational use. The patient did not use tobacco during pregnancy) was added. Event (headache and fatigue) cessation date added and outcome updated (from unknown to recovered). Event (hellp syndrome and upgrade seriousness of event maternal exposure during pregnancy) was added. Lab test(Body mass index) was added.; Sender's Comments: V1: 20210761753-COVID-19 VACCINE AD26.COV2.S-HELLP syndrome. 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).  20210761753-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  20210761753-COVID-19 VACCINE AD26.COV2.S-headache and fatigue. This event(s) is labeled per RA and is therefore considered potentially related.