Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Headache, Hyperemesis gravidarum, Myalgia
Clinical narrative: HYPEREMESIS GRAVIDARUM; MATERNAL EXPOSURE DURING PREGNANCY; ALL BODY HURT; CHILLS; MUSCLE PAIN; HEADACHE; This solicited pregnancy report received from a consumer concerned a 29 year old, female of unspecified race. The patient was enrolled in a non-company sponsored study. The patient's weight was 55.329 kilograms, and height was 163 centimeters. The patient's past medical history included: miscarriage, and concurrent conditions included: anxiety, depression, multigravida, no alcohol use, and no tobacco use, and patient had no history of recreational drug use.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 20-MAR-2021 for prevention of covid-19 (Dose number in series 1). The batch number was not reported and has been requested. Drug start period was 26 days. Concomitant medications included sertraline and Prenatal vitamin for drug used for unknown indication.  On 20-MAR-2021, the patient experienced maternal exposure during pregnancy, all body hurt, chills, muscle pain and headache.  The date of the patient's last menstrual period was 28-JAN-2021 and expected delivery date was 04-NOV-2021.  On 15-APR-2021, the patient experienced hyperemesis gravidarum. On 01-NOV-2021, at gestational age 3 9 weeks and four days, the study participant delivered vaginally a live female, full term neonate.  Labor was induced due to hyperemesis gravidarum. The study participant spent one day in the hospital for the delivery. The patient gave birth to a 6 pound, 19 inch baby. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from maternal exposure during pregnancy on 01-NOV-2021, and all body hurt, chills, muscle pain, and headache on 21-MAR-2021, and the outcome of hyperemesis gravidarum was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, hyperemesis gravidarum, and all body hurt was not related, and between covid-19 vaccine ad26.cov2.s, and chills, muscle pain, and headache was related.  This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received from consumer on 26-NOV-2021, the following information was updated and incorporated into case narrative: Patient details (ethnicity, height), pre-existing medical history text, disease tab (No alcohol use and no tobacco use), pregnancy tab (Outcome, EOP date, expected delivery date, retrospective), Child info (sex, weight, length, gestational age), event coding updated for (all body hurt), outcome updated and cessation date added for events (all body hurt, chills, headache, Muscle pain, maternal exposure during pregnancy), dose number in series (event and product screen), product tab concomitant (duration and dosage text) were added and batch number statement updated.  Upon review following information was amended: Prenatal vitamin removed from product tab.; Sender's Comments: V1: 20210760879-COVID-19 VACCINE AD26.COV2.S-Hyperemesis gravidarum. 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). 20210760879-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