Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Exposure during pregnancy, Pain in extremity
Clinical narrative: LABOR NOT PROGRESSING; MATERNAL EXPOSURE DURING PREGNANCY; JOINT PAIN; SORE ARM; CHILLS; FEVER 103 FAHRENHEIT; This solicited pregnancy report received from a consumer concerned a 32 year old female of unknown ethnic origin. The patient was enrolled in a non-company sponsored study, COVID 19 Vaccines. The patient's weight was 49.89 kilograms, and height was not reported. The patient's past medical history included: elective abortion, tobacco user, e-cigarette smoker, recreational drug use, and non alcoholic, and concurrent conditions included: bipolar disorder, and multigravida, and other pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported,1 total, (Dose number in series :1) administered on 09-APR-2021 for covid-19 immunisation. Concomitant medications included carbamazepine, lamotrigine, minerals nos/vitamins nos, pantoprazole sodium sesquihydrate, and quetiapine fumarate. The patient was gravida 3, para 1, abortions 2. The date of the patient's last menstrual period was 15-MAR-2021. On 09-APR-2021, at gestational age three weeks and four days, the patient had experienced joint pain, chills, sore arm and fever 103 fahrenheit. Aat gestational age 40 weeks, the study participant delivered a live, full-term, male neonate by cesarean method of delivery (C-section). Primary reason for C-section was reported as labor not progressing. The patient was hospitalized on 20-DEC-2021 and spent three days in hospital for the delivery. Neonate's birth weight was 7 pounds and 15 ounces, body length 20 inches (Dose number in series:1). 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 20-DEC-2021, joint pain, chills, and fever 103 fahrenheit on 10-APR-2021, and sore arm on 11-APR-2021. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and labor not progressing, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and joint pain, sore arm, chills, and fever 103 fahrenheit was related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20220113564.  Additional information was received from consumer on 29-DEC-2021. The following information was updated and incorporated into the case narrative: Patient medical history (non alcoholic and multigravida) added, Pregnancy details and outcome was updated (C-section), concomitant drug (pantoprazole sodium sesquihydrate), outcome of events maternal exposure during pregnancy, joint pain, sore arm, chills, and fever 103 Fahrenheit was updated from unknown to recovered/resolved and cessation dates updated accordingly, event (labor not progressing) added. Case upgraded to serious (Hospitalization Caused / Prolonged) for the events maternal exposure during pregnancy, labor not progressing and narrative updated accordingly. Upon review lab test body temperature coded.; Sender's Comments: V1:Follow up information in this version updated: Patient medical history ,Pregnancy details and outcome was updated (C-section), concomitant drugs, outcome of events maternal exposure during pregnancy, joint pain, sore arm, chills, and fever 103 Fahrenheit was updated from unknown to recovered/resolved, event (labor not progressing) added. Case upgraded to serious (Hospitalization Caused / Prolonged) for the events maternal exposure during pregnancy, labor not progressing. 20210800839-covid-19 vaccine ad26.cov2.s- 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  20210800839-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