Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Pain in extremity, Polyarthritis
Clinical narrative: GENERALIZED CHEST PAIN; ARTHRITIS MULTIPLE JOINT; CHILLS; FEELING UNWELL; JOINT PAIN; FEVER 99.9 FAHRENHEIT; MUSCLE PAIN; FATIGUE; SORE ARM; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 28 year old female. The patient was enrolled in a non-company sponsored study:  The patient's weight was 88.89 kilograms, and height was not reported. The patient's past medical history included: tobacco user, e-cigarette smoker, and recreational drug use, and concurrent conditions included: anxiety, attention deficit hyperactivity disorder, bipolar disorder, body mass index increased (34.713), multigravida, and no history of alcohol use, and other pre-existing medical conditions included: The patient's obstetrical history included one previous pregnancy resulting in an elective termination. The patient was gravida 2, para 1. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid (Aspirin 81) and ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos (Prenatal vitamins) for product use for unknown indication.  On 07-APR-2021, the patient was pregnant when she had vaccine (captured as maternal exposure during pregnancy) and experienced sore arm, and fatigue (gestation period 169 days). On 08-APR-2021, the patient experienced chills, feeling unwell, joint pain and had fever 99.9 fahrenheit, and muscle pain. On the same day, laboratory data included: Body temperature (NR: not provided) 99.9 F (fahrenheit). The date of the patient's last menstrual period was 20-OCT-2020 and expected delivery date was 27-JUL-2021. The pregnancy resulted in a live birth. The patient gave birth via natural birth (vaginally, full term neonate) to a 3.68 kilogram, 20 inches, male baby. The type of pregnancy was reported as singleton. The patient had blood clots in her uterus after the delivery, which were removed by midwife. On 13-SEP-2021, the patient experienced generalized chest pain, the pain was described as intense and reported to reoccur occasionally. The pain was limiting movement, breathing and speech and was bad enough, was in the emergency room (ER) for the chest pain and was hospitalized due to chest pain on an unspecified date for an unspecified number of days. On 20-DEC-2021, the patient experienced arthritis multiple joint and reported to affect hands and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 99.9 fahrenheit on 08-APR-2021 and chills, sore arm, feeling unwell, joint pain, fatigue, and muscle pain on 09-APR-2021, while, not recovered from arthritis multiple joint, generalized chest pain 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 generalized chest pain and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and arthritis multiple joint, chills, sore arm, feeling unwell, joint pain, fatigue, fever 99.9 fahrenheit, and muscle pain was related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).  This case was reassessed as serious based on additional information received from consumer on 30-DEC-2021. The following information was updated and incorporated into the case narrative: Patient details (race), new events (Arthritis multiple joint and Generalized chest pain), delivery details (expected delivery date, EOP date, outcome updated to live birth, pregnancy type updated to retrospective, child information added (weight, height, gestation age, delivery method, birth outcome, gender), medical history (multigravida, no-history of alcohol use, added disease comments for BMI, recreational drug use, e-cigarette smoker, tobacco user) were added. Premedical history, event onset date, cessation date and outcome updated and narrative amended accordingly. Event (maternal exposure during pregnancy) upgraded to serious. Upon review the following information was amended: In previous version age at the time of vaccination was incorrectly captured as 58 year and it was corrected as 28 years.; Sender's Comments: V1: 20210763257-covid-19 vaccine ad26.cov2.s-Arthritis multiple joint. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210763257-COVID-19 VACCINE AD26.COV2.S -Chest pain. 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 20210763257-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