Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Exposure during pregnancy, Headache, Myalgia
Clinical narrative: AMNIOTIC FLUID WAS LOW; COVID-19; FEVER; HEADACHE; MUSCLE PAIN; CHILLS; SORE ARM; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 20 year old female of unspecified ethnicity. 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: smoker (10 or fewer cigarettes a day before this pregnancy), and recreational drug use (monthly prior to this pregnancy), and concurrent conditions included: bulimia, depression, maternal alcohol use (once per month during the first three months pregnancy), electronic cigarette user (Several times a day during this pregnancy), multigravida (1 past pregnancy or 1 live baby), and anorexia, and other pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient was gravida 2 and para 1. Patient was not having any information regarding potential risk factors was provided maternal hypertension/preeclampsia, maternal diabetes, maternal dehydration, maternal hypoxia, placental issues. The patient was previously treated with escitalopram oxalate (Drug start period was 130 days and drug last period was 38 days, duration of drug administered was 93 days).  At the gestational age of 16 weeks and two days, the patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered 1 in total on 08-OCT-2021 for covid-19 immunisation. Drug start and last period was 144 days. The batch number was not reported. Age at time of vaccination 20 years old. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included loratadine (Drug start period was 8 days) , and paracetamol (Drug start period was 130 days).  On 08-OCT-2021, the patient experienced maternal exposure during pregnancy, chills, sore arm, headache, and muscle pain. On 09-OCT-2021, the patient experienced fever. On 16-JAN-2022, the patient was diagnosed with covid-19 based on a test. Laboratory data included: SARS-CoV-2 test (NR: not provided) diagnosed with COVID-19. On 01-MAR-2022, the patient experienced amniotic fluid was low. Patients first day of the last menstrual period (LMP) was calculated to be 16-JUN-2021. The estimated delivery date (EDD) was reported to be 23-MAR-2022. Type of pregnancy was reported as singleton. At a gestational age of 39 weeks and 6 days the patient delivered vaginally a live, full term female neonate. Patient spent 3 days in the hospital for delivery. the neonate birth weight was 7 pound and 8 ounce, body length was 21 inches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from maternal exposure during pregnancy on 22-MAR-2022, covid-19 on 16-FEB-2022, chills, and fever on 09-OCT-2021, and sore arm, headache, and muscle pain on 10-OCT-2021, and the outcome of amniotic fluid was low was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and amniotic fluid was low, maternal exposure during pregnancy, and covid-19 as not related, and between covid-19 vaccine ad26.cov2.s, and chills, sore arm, fever, headache, and muscle pain as related. Company causality between covid-19 vaccine ad26.cov2.s, and amniotic fluid was low, maternal exposure during pregnancy, and covid-19 as not related, and between covid-19 vaccine ad26.cov2.s, and chills, sore arm, fever, headache, and muscle pain as related.  This report was serious (Other Medically Important Condition).  Additional information was received from consumer on 20-MAY-2022. The following information was updated and incorporated into the case narrative: event amniotic fluid was low and covid-19 was added, lab data added. pregnancy outcome and child details were added, reporter and company causality was updated.; Sender's Comments: V1- This version updates-event amniotic fluid was low and covid-19 , lab data, pregnancy outcome and child details, reporter and company causality.  20211148563- covid-19 vaccine ad26.cov2.s Amniotic fluid was low. Follow-up received regarding Clinical Details. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.(Considering latency approximately 6 months)  20211148563- 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.