Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Maternal exposure during pregnancy, Myalgia, Nausea
Clinical narrative: LABOR NOT PROGRESSING; COVID-19; GESTATIONAL DIABETES; MATERNAL EXPOSURE DURING PREGNANCY; HEART PALPITATION; FEELING UNWELL; CHILLS; JOINT PAIN; SORE ARM; FEVER; NAUSEA; FATIGUE; HEADACHE; MUSCLE PAIN; This solicited pregnancy report received from a consumer concerned a 28 year old female of unspecified ethnic origin. The patient was enrolled in a non-company sponsored study. The patient's weight was 65.76 kilograms, and height was 165 centimeters. The patient's past medical history included: multigravida (2 pregnancies / 2 live babies), pre-eclampsia, smoker (11 to 20 cigarettes per day before this pregnancy), and recreational drug use (Daily, before this pregnancy), however reported no alcohol use. The patient's obstetrical history included two previous pregnancies, both resulting in a live baby. The patient was para 2 and gravida 3. The first day of the last menstrual period (LMP) was calculated to be 10-MAR-2021. The estimated delivery date (EDD) was reported to be 15-DEC-2021. Type of pregnancy was reported as singleton. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 27-JUL-2021, at gestational age 19 weeks and six days, for covid-19 immunisation. Age at time of vaccination 28 years old. Concomitant medications included ascorbic acid/biotin/minerals NOS/nicotinic acid/retinol/tocopherol/vitamin B NOS/vitamin D NOS. On 27-JUL-2021, the patient experienced heart palpitation, maternal exposure during pregnancy, feeling unwell, chills, joint pain, sore arm, fever, nausea, fatigue, headache, and muscle pain. On 03-NOV-2021, the patient was diagnosed with gestational diabetes. At gestational age 39 weeks and one day, the patient delivered a live, full-term, male neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be labor not progressing. The patient spent four days in the hospital for the delivery. The neonate's birth weight was 7 pounds and 4 ounces, body length 20 inches. On 07-JAN-2022, the patient was diagnosed with covid-19, based on a test. Laboratory data included: SARS-CoV-2 test (NR: not provided) COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from labor not progressing, and maternal exposure during pregnancy on 09-DEC-2021, covid-19 on 14-JAN-2022, heart palpitation, fever, and nausea on 28-JUL-2021, feeling unwell, chills, joint pain, fatigue, headache, and muscle pain on 29-JUL-2021, and sore arm on 31-JUL-2021, and the outcome of gestational diabetes was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and gestational diabetes, labor not progressing, heart palpitation, feeling unwell, chills, joint pain, sore arm, fever, nausea, fatigue, headache, and muscle pain as related, and between covid-19 vaccine ad26.cov2.s, and covid-19 as not 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 covid-19 and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and gestational diabetes, labor not progressing, heart palpitation, feeling unwell, chills, joint pain, sore arm, fever, nausea, fatigue, headache, and muscle pain was related. This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received from patient on 21-APR-2022, the following information was updated and incorporated into case narrative: Added patient race, height and weight, Updated delivery details (pregnancy outcome, End of pregnancy (EOP) date, Expected delivery date and child details), Outcome of event maternal exposure during pregnancy updated to recovered (with cessation date 09-DEC-2021), Gestational diabetes, Labor not progressing, and COVID-19 added as adverse events, event (maternal exposure during pregnancy) and case was upgraded to serious, lab data (SARS-CoV-2 test) added, narrative updated accordingly.; Sender's Comments: V1: This follow-up version updates : patient race, height and weight, Updated delivery details (pregnancy outcome, End of pregnancy (EOP) date, Expected delivery date and child details), Outcome of event maternal exposure during pregnancy updated to recovered (with cessation date 09-DEC-2021), Gestational diabetes, Labor not progressing, and COVID-19 added as adverse events, event (maternal exposure during pregnancy) and case upgraded to serious, lab data (SARS-CoV-2 test) . 20211138951-covid-19 vaccine ad26.cov2.s-Gestational diabetes, Labor not progressing. Follow-up received regarding Clinical Details. 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). Therefore, this event(s) is considered related. 20211138951-covid-19 vaccine ad26.cov2.s.-Maternal exposure during pregnancy. Follow-up received regarding Clinical Details. 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.