Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Exposure during pregnancy, Headache, Malaise, Pre-eclampsia
Clinical narrative: PRE-ECLAMPSIA; FEELING UNWELL; HEADACHE; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 37 year old female. The patient was enrolled in a non-company sponsored study: The patient's weight was 176.87 kilograms, and height was not reported. The patient's concurrent conditions included: anxiety, depression, non-tobacco user, non-alcohol user, and obesity, and other pre-existing medical conditions included: The patient had no relevant obstetrical history and no history of recreational drug use. The type of pregnancy was singleton. The patient was gravida 1, para 1. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018 and expiry: Unknown) dose was not reported, dose number in series was 1, 01 total administered on 24-MAR-2021 (at gestational age of 15 weeks and one day) for covid-19 immunisation. Concomitant medications included Prenatal vitamins (ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide) for unknown indication.  On 24-MAR-2021, the patient experienced maternal exposure during pregnancy. On 25-MAR-2021, the patient experienced feeling unwell, and headache. On 18-AUG-2021, the patient was diagnosed with pre-eclampsia. (dose number in series was 1) Laboratory data (dates unspecified) included: Body mass index 69.072 (unit unspecified). The date of the patient's last menstrual period was 08-DEC-2020 and expected delivery date was 14-SEP-2021. On 31-AUG-2021, at gestational age 38 weeks, the patient delivered a live, early-term, 3.486-kilogram, 19 inch, male neonate by cesarean method of delivery (C-section). Primary reason for C-section was reported as pre-eclampsia. Birth outcome was normal. The patient spent two days in hospital for the delivery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pre-eclampsia on 31-AUG-2021, feeling unwell on 26-MAR-2021, and headache on 31-MAR-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and pre-eclampsia as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, feeling unwell, and headache. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy and pre-eclampsia was not related, and between covid-19 vaccine ad26.cov2.s, and feeling unwell, and headache was related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20211260896.  This case was reassessed as serious based on additional information received from consumer on 18-DEC-2021, the following information was updated and incorporated into case narrative: Event (pre-eclampsia) added with its details, patient demographic updated (initials, date of birth), Event onset and end date of headache and feeling unwell updated, Outcome of event feeling unwell and headache updated to recovered/resolved, Batch number added, indication updated, delivery details added, dose number in series added.; Sender's Comments: V1: 20210753294-COVID-19 VACCINE AD26.COV2.S -Pre-eclampsia. 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 20210753294-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