Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Polyhydramnios, Prolonged labour
Clinical narrative: LABOR NOT PROGRESSING; POLYHYDRAMNIOS; HIGH BLOOD SUGAR; FATIGUE; MUSCLE ACHES; HEADACHE; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a patient concerned a 40 year old white female of unspecified ethnic origin. The patient was enrolled in a non-company sponsored study. The patient's weight was 80.73 kilograms, and height was 173 centimeters. The patient's past medical history included: multigravida, and concurrent conditions included: non tobacco user, and non alcohol user, and other pre-existing medical conditions included: patient had no history of exposure to drugs for recreational use. Patient Body Mass Index(BMI) was 26.85. Her obstetrical history included four previous pregnancies, of which one resulted in live newborn and two ended with miscarriage. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: unknown) dose was not reported, frequency time 1 total was administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included (Zyrtec) cetirizine hydrochloride for allergy, (Prenatal vitamins) ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide for drug used for unknown indication, and (Aspirin 81) acetylsalicylic acid.  On 06-MAR-2021, the patient experienced maternal exposure during pregnancy. Laboratory data included: Blood sugar was Increased. On 07-MAR-2021, the patient experienced high blood sugar, fatigue, muscle aches and headache. On 19-APR-2021, the patient experienced excessive amniotic fluid (polyhydramnios). The first day of the last menstrual period (LMP) was calculated to be 11-SEP-2020. The estimated delivery date (EDD) was reported to be 18-JUN-2021. It was reported that this was singleton pregnancy. On 15-JUN-2021, at gestational age of 39 weeks and 4 days patient delivered female neonate by caesarean method of delivery. Patient spent two days in the hospital for the delivery. The neonate's birth weight was 3.38 kilogram, body length: 21 inches. It was reported that reason for caesarean method of delivery was that labor was not progressing.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from polyhydramnios, and labor not progressing on 15-JUN-2021, and high blood sugar, fatigue, muscle aches, and headache on 07-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 fatigue, muscle aches, high blood sugar and headache was related, and between covid-19 vaccine ad26.cov2.s, and labor not progressing, polyhydramnios, and maternal exposure during pregnancy was not related.  This report was serious (Other Medically Important Condition).  Additional information was received from patient on 27-JUL-2021. The following information was updated and incorporated into the case narrative: Patient race, pre-existing, concurrent condition and pregnancy details was added. additional event of (polyhydramnios and labor not progressing) was added and outcome and dates of event (headache, fatigue, muscle pain, high blood glucose) was updated. concomitant medication dates and dosage text was updated. latency period was added in causality.; Sender's Comments: V0: 20210725572-COVID-19 VACCINE AD26.COV2.S- polyhydramnios , labor not progressing. 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: MEDICAL HISTORY.  20210725572-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