Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Body temperature, COVID-19, Chills, Cholestasis of pregnancy
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; DEPRESSION; CHOLESTASIS OF PREGNANCY; MATERNAL EXPOSURE DURING PREGNANCY; FEELING UNWELL; SORE ARM; CHILLS; FATIGUE; FEVER 103.3 DEGREE F; HEADACHE; MUSCLE PAIN; NAUSEA; This solicited pregnancy report received from a consumer concerned a 31-year-old female. The patient was enrolled in a non-company sponsored study.  The patient's weight was 91.16 kilograms, and height was not reported. The patient's past medical history included tobacco user, e-cigarette smoker, and recreational drug use, and concurrent conditions included anxiety, and non alcohol user, and other pre-existing medical conditions included Multigravida, family history of liver damage and chronic hepatitis. The patient was gravida 3, para 3 (2 past pregnancies/2 live babies). The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: unknown) dose was not reported, 1 total administered on 20-MAY-2021 for prevention of covid 19. Concomitant medications included metoclopramide, ondansetron hydrochloride and prenatal vitamins. The date of the patient's last menstrual period was 14-JAN-2021 and expected delivery date was 21-OCT-2021. On 20-MAY-2021, the patient experienced maternal exposure during pregnancy, felt unwell, sore arm, chills, fatigue, fever 103.3 degree f, headache, muscle pain, and nausea. Laboratory data included: Body temperature (NR: not provided) 103.3 F. On 15-SEP-2021, the patient experienced cholestasis of pregnancy. On 07-OCT-2021, the patient experienced depression and at gestational age 38 weeks, the pregnancy resulted in a live birth. The patient gave birth via caesarean section to a 2.81 kilogram, 16 inch, male baby. Birth outcome was normal. On an unspecified date, the patient experienced Confirmed covid-19 infection and confirmed clinical vaccination failure. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 35.598, and SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test (NR: not provided) Positive. On 07-OCT-2021, the pregnancy resulted in a live birth. The patient gave birth via caesarean section to a 2.81 kilogram, 16 inch, male baby. Birth outcome was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt unwell, sore arm, chills, fatigue, fever 103.3 degree f, headache, muscle pain, and nausea on 02-JUN-2021, was recovering from depression, and the outcome of maternal exposure during pregnancy, cholestasis of pregnancy, Confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and cholestasis of pregnancy as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, confirmed clinical vaccination failure, Confirmed covid-19 infection, depression, felt unwell, sore arm, chills, fatigue, fever 103.3 degree f, headache, muscle pain, and nausea. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, confirmed clinical vaccination failure, and cholestasis of pregnancy, and Confirmed covid-19 infection was not related, and between covid-19 vaccine ad26.cov2.s, and depression, felt unwell, sore arm, chills, fatigue, fever 103.3 degree f, headache, muscle pain, and nausea was related. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority. This parent/child case is linked to 20220122145.  Additional information was received from a consumer on 03-JAN-2022. The following information was updated and incorporated into the case: Cholestasis of pregnancy, Depression, Confirmed clinical vaccination failure and Confirmed covid-19 infection added as adverse events. Case was reassessed and upgraded as serious. Delivery details added, narrative updated.; Sender's Comments: V2: 20210807762 - covid-19 vaccine ad26.cov2.s - cholestasis of 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: UNDERLYING CONDITION (pregnancy)  20210807762 - covid-19 vaccine ad26.cov2.s maternal exposure during pregnancy, confirmed clinical vaccination failure. 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