Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Exposure during pregnancy, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Subchorionic hematoma; Vaginal bleeding; Maternal exposure during pregnancy; Sore throat; Sore arm; Fatigue; Headache; This solicited pregnancy report received from a consumer concerned a 38-year-old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 53.061 kilograms, and height was 168 centimeters.  The patient past medical history included COVID-19 infection prior to pregnancy and was diagnosed on 19-Dec-2020. The patient's history also included three previous pregnancies, of which two resulted in a live newborn and one ended with miscarriage. The patient had no history of exposure to drugs for recreational use, non-tobacco user, and abstains from alcohol. The first day of the last menstrual period (LMP) was calculated to be 10-Feb-2021. The estimated delivery date (EDD) was reported to be 17-Nov-2021. The type of pregnancy was singleton. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805070, expiry: Unknown) dose was not reported, 1 total administered on 19-MAR-2021 for COVID-19 immunisation. Concomitant medications included multivitamin or prenatal vitamin 4 to 6 times a week. The patient's body Mass Index (BMI) was 18.7. On 19-MAR-2021, after receiving the vaccine, patient experienced fatigue, headache, sore arm, sore throat and maternal exposure during pregnancy, On 25-Mar-2021, she experienced vaginal bleeding with large subchorionic haematoma (up to 3.1cm) and was evaluated day later without any findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 19-MAR-2021, sore arm on 21-MAR-2021, and fatigue, and headache on 20-MAR-2021, and the outcome of subchorionic hematoma, vaginal bleeding and maternal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and subchorionic hematoma, vaginal bleeding, sore throat, sore arm, fatigue, and headache as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and subchorionic hematoma, vaginal bleeding, and maternal exposure during pregnancy was not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211106386-covid-19 vaccine ad26.cov2.s-Subchorionic hematoma, Vaginal bleeding. 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   20211106386-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