Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Abortion spontaneous, Exposure during pregnancy, Incorrect dose administered, Pain in extremity
Clinical narrative: MISCARRIAGE; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; SORE ARM; FEVER; MATERNAL EXPOSURE DURING PREGNANCY; WEIRD FEVER DREAMS; This solicited pregnancy report received from a consumer concerned a 36 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 58.05 kilograms, and height was not reported. The patient's Body Mass Index (BMI) was 23.22. The patient's concurrent conditions included: no tobacco use, and no alcohol use and The patient had no history of exposure to drugs for recreational use. The patient was gravida 2, para 1. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021, and dose was not reported, 1 total administered on 29-JUL-2021 (Inappropriate dose of Vaccine administered) for prevention of covid-19. Concomitant medications included minerals nos/vitamins nos and sertraline hydrochloride for drug used for unknown indication.  On 06-APR-2021 within 48 hours, the patient experienced weird fever dreams, sore arm and fever. The date of the patient's last menstrual period was 07-JUL-2021 and expected delivery date is 13-APR-2022 and It was singleton pregnancy. On 29-Jul-2021, the patient had maternal exposure during pregnancy, at gestational age 3 weeks and 1 day, the patient received the second dose of the JANSSEN or JOHNSON &JOHNSON (Ad26.COV2-S) vaccine for the prevention of COVID-19. The patient was the part of a clinical trial. On 09-Sep-2021, the confirmation ultrasound showed no detectable heartbeat and fetus was measured 6 weeks instead of expected 9 weeks. On 16-Sep-2021, at gestational age 10 weeks and 1 days, the miscarriage was confirmed and patient underwent dilation and curettage procedure on 17-Sep-2021. On an unspecified date, the pregnancy resulted in a spontaneous abortion. No additional details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird fever dreams, sore arm, and fever on 07-APR-2021, and the outcome of maternal exposure during pregnancy, miscarriage and inappropriate dose of vaccine administered was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and miscarriage, weird fever dreams, sore arm, and fever was related, and between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, and inappropriate dose of vaccine administered was not related.  This report was serious (Other Medically Important Condition).  Additional information was received from patient on 29-SEP-2021. The following information was updated and incorporated in to the case narrative: patient history including pre-existing condition added, event added (miscarriage, Inappropriate dose of Vaccine administered), in product tab batch/lot number, drug used to treat ae added (prenatal vitamins), lab added(ultrasound fetal).; Sender's Comments: V0: 20210941092-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  20210941092-covid-19 vaccine ad26.cov2.s-Miscarriage. 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).