Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Malaise, Myalgia, Pain in extremity, Pre-eclampsia
Clinical narrative: LABOR NOT PROGRESSING; PREECLAMPSIA; MATERNAL EXPOSURE DURING PREGNANCY; FEELING UNWELL; SORE ARM; MUSCLE PAIN; This solicited pregnancy report received from a consumer concerned a 36 year old female of unknown ethnicity. The patient's weight was 79.36 kilograms, and height was not reported. The patient's past medical history included: covid-19, smoker (tobacco user) 11 to 20 cigarettes per day, and miscarriage, three past pregnancies ended in miscarriage and concurrent conditions included: multigravida, hypothyroidism, and non alcohol user and obesity. Other pre-existing medical conditions included: Patient had no history of recreational drug use. 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: unknown, expiry date: unknown) dose was not reported, 1 total, administered on 19-MAY-2021 for prevention of covid-19.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Concomitant medications included acetylsalicylic acid for drug used for unknown indication, ascorbic acid/biotin/folic acid/iodine/nicotinic acid/omega-3 fatty acids/pantothenic acid/pyridoxine hydrochloride/riboflavin/thiamine/vitamin b12 nos/vitamin e nos for drug used for unknown indication, levothyroxine for drug used for unknown indication, and progesterone for drug used for unknown indication.  On 19-NOV-2020, Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. On 19-MAY-2021, the patient experienced maternal exposure during pregnancy, feeling unwell, sore arm and muscle pain. The date of the patient's last menstrual period was 22-DEC-2020 and expected delivery date was 28-SEP-2021. The patient was gravida 4, para 1, abortions (miscarriage) 3.  On 17-SEP-2021, the patient experienced preeclampsia. On SEP-2021, the patient experienced labor not progressing and the patient got hospitalized (date unspecified). On SEP-2021, the pregnancy resulted in a c-section delivery. Primary reason for the C-section was reported as labor not progressing. Patient spent six days in the hospital for the delivery. The patient gave birth via caesarean section to a 7 pound, 19 inch, male baby. Gestation period was 39 weeks and 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling unwell on 20-MAY-2021, and sore arm, and muscle pain on 21-MAY-2021, and the outcome of maternal exposure during pregnancy, preeclampsia and labor not progressing was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and preeclampsia, and labor not progressing as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, feeling unwell, sore arm, and muscle pain. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and feeling unwell, sore arm, and muscle pain was related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).  Additional information was received from reporter on 21-OCT-2021. The following information was updated and incorporated into the case narrative: Pregnancy details added, race was updated, outcome of the events feeling unwell, muscle pain and sore arm updated to recovered and resolved, two serious events pre-eclampsia and labor not progressing added, patient history added, case upgraded to serious, Narrative updated accordingly.; Sender's Comments: V1: 20210761811-covid-19 vaccine ad26.cov2.s-preeclampsia and 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 20210761811-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