Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure during pregnancy, Fatigue, Headache, Malaise
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; PRE-ECLAMPSIA; COVID 19; SORE ARM; FEELING UNWELL; MUSCLE PAIN; FATIGUE; HEADACHE; This solicited pregnancy report received from a consumer concerned a 26 year old female. The patient was enrolled in a non-company sponsored study.  The patient's weight was 50.794 kilograms, and height was 168 centimeters. The patient's past medical history included miscarriage. Concurrent conditions included multigravida. The patient was on prenatal vitamins. No history of tobacco, alcohol or recreational drug use. The patient was gravida 5, para 3, abortions 2. The patient received treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 for covid-19 immunisation. Concomitant medications included amoxicillin, calcium carbonate, famotidine, loratadine, and macrogol 3350.  In MAR-2021, the patient experienced sore arm, feeling unwell, muscle pain and fatigue. On 11-MAR-2021, the patient experienced maternal exposure during pregnancy. The date of the patient's last menstrual period was 17-DEC-2020 and expected delivery date was 23-SEP-2021. On 21-SEP-2021, the patient experienced pre-eclampsia starting with blurry vision, headache, high blood pressure and protein in urine. On 22-SEP-2021, at gestational age 39 weeks and six days the pregnancy resulted in a live birth. The patient gave birth via natural birth to a 8 pound, 22 inch, male baby. The patient's blood pressure went down after delivery and then went home. The patient spent two days in the hospital for the delivery. On 26-SEP-2021, the patient experienced same symptoms of pre-eclampsia and went to the emergency room (ER). The patient admitted for pre-eclampsia and stayed in the hospital for 24 hours on intravenous magnesium sulfate. Treatment also included labetalol, administered two times per day until 6-week postpartum appointment. On 02-NOV-2021, the patient received Moderna vaccine (MRNA 1273) for the prevention of covid-19. On an unspecified date in 2021, the patient's laboratory data included: SARS-CoV-2 test showed positive (NR: not provided) which indicates covid 19 infection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pre-eclampsia on 03-NOV-2021, and maternal exposure during pregnancy, sore arm, feeling unwell, muscle pain, fatigue, and headache, and the outcome of covid 19 was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and pre-eclampsia, covid 19, sore arm, feeling unwell, muscle pain, fatigue, and headache was related, and between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint.  Additional information was received from consumer/other non health professional on 12-NOV-2021. The following information was updated and incorporated into the case narrative: Patient details (Date of birth, Race, pregnancy information (outcome, expected delivery date, child information (weight, length, gestation age) pre-existing medical history, Event (pre-eclampsia), Suspect Product (Batch number), Concomitant product (amoxicillin, pepcid). Therapy end updated for loratadine, tum, miralax) added.; Sender's Comments: V2: 20210725719-covid-19 vaccine ad26.cov2.s-Pre-eclampsia. 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). 20210725719-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