Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Myalgia, Pain in extremity, Premature labour, Pyrexia
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; PRETERM LABOR SYMPTOMS; HIGH BLOOD PRESSURE OF PREGNANCY; FATIGUE; FEVER; JOINT PAIN; MUSCLE PAIN; CHILLS; REDNESS AT THE INJECTION SITE; SORE ARM; This solicited pregnancy report received from a consumer concerned a 35 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was not reported, and height was 170 centimeters. The patient's past medical history included: miscarriage (Three past pregnancies), elective abortion (Three past pregnancies), e-cigarette smoker (Monthly / before this pregnancy), and recreational drug use (Less than monthly / before this pregnancy), and concurrent conditions included: multigravida (Eight past pregnancies/ Two live babies), anxiety, bipolar disorder, depression, migraine, tobacco user (10 or fewer cigarettes per day during this pregnancy), and alcohol use (Once per week during the first three months of pregnancy), and other pre-existing medical conditions included: Para 2 and gravida 8. The patient's obstetrical history included eight previous pregnancies: two resulting in a live baby, three in miscarriage and three in elective termination. The first day of the last menstrual period (LMP) was unknown. The estimated delivery date (EDD) was calculated to be 09-MAR-2022. Type of pregnancy was reported as singleton. The patient received treatment with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: unknown) 0.5 ml, 1 total administered on 20-MAY-2021 for covid-19 immunisation. Drug start period and last period was 229 days. Concomitant medications included paracetamol (Tylenol Extra Strength), prenatal vitamins and iron supplements. On an unspecified date, the patient experienced maternal exposure during pregnancy. On 20-MAY-2021, the patient experienced sore arm, redness at the injection site. On 21-MAY-2021, the patient experienced chills, and muscle pain. On 22-MAY-2021, the patient experienced joint pain, fatigue, and fever (dose number in series 1). On 20-OCT-2021, Laboratory data included: Antenatal sonogram (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and muscle pain on 10-JUN-2021, joint pain, and sore arm on 27-MAY-2021, and redness at the injection site on 16-JUN-2021 and the outcome of fatigue, maternal exposure during pregnancy not reported. The patient received booster non-company suspect vaccine MRNA 1273 (Moderna vaccine) (Dose number in series 2) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 15-DEC-2021 for a prophylactic vaccination. On 04-JAN-2022, the patient diagnosed with high blood pressure of pregnancy (dose number in series 2). On an unspecified date, patient was hospitalized for unspecified number of days. Blood pressure was being monitored weekly. On 09-FEB-2022, the patient experienced preterm labor symptoms (dose number in series 2). Steroids were introduced as treatment. The action taken with MRNA 1273 was not applicable. The patient not recovered from high blood pressure of pregnancy, and the outcome of preterm labor symptoms was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and chills, joint pain, sore arm, fatigue, fever, muscle pain, and redness at the injection site as related, and between covid-19 vaccine ad26.cov2.s, and high blood pressure of pregnancy, and preterm labor symptoms as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy; and between MRNA 1273, and maternal exposure during pregnancy, chills, joint pain, sore arm, fatigue, fever, muscle pain, redness at the injection site, high blood pressure of pregnancy, and preterm labor symptoms. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, high blood pressure of pregnancy and preterm labor symptoms was not related. Company causality between covid-19 vaccine ad26.cov2.s, and chills, joint pain, sore arm, fatigue, fever, muscle pain, and redness at the injection site was related. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).  Additional information was received from reporter (consumer) on 11-FEB-2022. The following information was updated and incorporated into the case narrative: Added booster dose of Moderna, events high blood pressure of pregnancy and preterm labor symptoms. Ongoing condition updated as yes for the anxiety, bipolar disorder, depression, migraine, tobacco user, and alcohol use. Case upgraded to serious (hospitalization and prolonged, and disability or permanent damage), Concomitant medications added, lab data of antenatal sonogram was added and narrative updated accordingly.; Sender's Comments: V1: This version updates :Non company co-suspect of Moderna vaccine, added events high blood pressure of pregnancy and preterm labor symptoms. Ongoing condition updated as yes for the anxiety, bipolar disorder, depression, migraine, tobacco user, and alcohol use. Case upgraded to serious (hospitalization and prolonged, and disability or permanent damage), Concomitant medications added, lab data of antenatal sonogram added. 20211240188-COVID-19 VACCINE AD26.COV2.S-Maternal exposure during pregnancy.. 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. 20211240188-COVID-19 VACCINE AD26.COV2.S- High blood pressure of pregnancy, Preterm labor symptoms. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. 20211240188-COVID-19 VACCINE AD26.COV2.S-Chills, Joint pain, Sore arm, Fatigue, Fever, Muscle pain, Redness at the injection site,. This event(s) is labeled per RA and is therefore considered potentially related.