Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperemesis gravidarum, Injection site erythema, Maternal exposure during pregnancy
Clinical narrative: HYPEREMESIS GRAVIDARUM; MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; SORE ARM; FATIGUE; FEVER; MUSCLE PAIN; REDNESS AT INJECTION SITE; This solicited pregnancy report received from a consumer concerned a 27 year old female of unspecified ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight was 86.168 kilograms, and height was 168 centimeters.  The patient's concurrent conditions included Anxiety, Ehlers-danlos syndrome, postural orthostatic tachycardia syndrome, multi gravida, and body mass index increased. The patient obstetrical history included one previous pregnancy, resulting in a live birth. The patient had no history of tobacco, alcohol or recreational drug use. The patient had on past pregnancy (one live baby). The last menstruation period (LMP) was reported as 06-MAR-2021. Expected delivery date was reported as 11-DEC-2021. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) frequency one total, dose was not reported, administered on 13-MAR-2021 for covid-19 immunisation. Age at time of vaccination 27 years old. Drug start period was reported as 42 days. The batch number was not reported and has been requested. Concomitant medication included prenatal vitamins every day (QD). On 13-MAR-2021, the patient experienced maternal exposure during pregnancy, chills (Duration: 2880 minutes), sore arm (Duration: 2880 minutes), fatigue (Duration: 2880 minutes), fever (Duration: 2880 minutes), muscle pain (Duration: 2880 minutes), and redness at injection site (Duration: 2880 minutes) (dose number in series 1). On 21-APR-2021, Laboratory data included: Antenatal sonogram (NR: not provided) Normal, and Prenatal screening test (NR: not provided) Normal, On 24-APR-2021, the patient experienced hyperemesis gravidarum (Duration: 228 days). (event occurred dose number ins series 1). Laboratory data (dates unspecified) included: Weight loss (NR: not provided) 20 pound. Treatment medications (dates unspecified) included: promethazine, and ondansetron. The type of pregnancy was reported as singleton. The physician prescribed Zofran and Phenergan, which the participant stopped when she was in the third trimester. Reportedly, she lost 20 pounds as a result of hyper emesis gravidarum. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hyperemesis gravidarum on 08-DEC-2021, and chills, sore arm, fatigue, fever, muscle pain, and redness at injection site on 14-MAR-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and hyperemesis gravidarum, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, sore arm, fatigue, fever, muscle pain, and redness at injection site was related.   At gestational age 33 weeks and three days, the patient additionally received non-company booster vaccine included: Elasomeran (Spikevax) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 26-OCT-2021 for COVID-19 immunisation. It was unknown whether patient had any adverse events following vaccination with Elsomeran (Spikevax) (dose number in series 2). The action taken with Elasomeran (Spikevax)  was not applicable. This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received from reporter on 11-APR-2022. The following information was updated and incorporated into the case narrative: Patient tab (race added) disease added (Body mass index increased added), Expected delivery date added, lab data added, Moderna (Spikevax) vaccine added in narrative, product tab (treatment drug added) event (hyperemesis gravidarum ) narrative was updated accordingly. Upon review, the following information was amended: Reporter causality for exposure term updated to not reported, Pregnancy ticked to yes, narrative updated.; Sender's Comments: V1: This version updates Patient tab, disease added , Expected delivery date added, lab data added, Moderna (Spikevax) vaccine added in narrative, product tab, event (hyperemesis gravidarum ) narrative was updated accordingly. Upon review, the following information was amended: Reporter causality for exposure term updated to not reported, Pregnancy ticked to yes.  20211110812-covid-19 vaccine ad26.cov2.s-Chills, sore arm, fatigue, fever, muscle pain, redness at injection site. This event(s) is labeled per RSI and is therefore considered potentially related.  20211110812-covid-19 vaccine ad26.cov2.s-Hyperemesis gravidarum. 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: UNDERLYING DISEASE(Pregnancy). Therefore, this event(s) is considered not related.  20211110812-covid-19 vaccine ad26.cov2.s-Maternal exposure during pregnancy. 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. Therefore, this event(s) is considered not related.