Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body mass index, Body temperature, Chills, Depression
Clinical narrative: DEPRESSION; ANXIETY; MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; SORE ARM; FEVER 100.2 FAHRENHEIT; FATIGUE; This solicited pregnancy report received from a health care professional concerned a 34 year old female. The patient was enrolled in a non-company sponsored study: C00309). The patient's weight was 72.56 kilograms, and height was 155 centimeters. The patient's pre-existing medical conditions included: The study participant had no history of exposure to tobacco, drugs for recreational use or alcoholic beverage, no relevant obstetrical history was reported. The study participant's Body Mass Index (BMI) was 29.99. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included docosahexaenoic acid.  On APR-2021, the patient experienced maternal exposure during pregnancy, chills, sore arm, fever 100.2 fahrenheit, fatigue. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 04-MAY-2021, the patient experienced depression and anxiety. It was further clarified study participant was seeing psychologist. The patient was pregnant at the time of vaccination and this was singleton pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, fever 100.2 fahrenheit, and fatigue on 12-APR-2021, had not recovered from depression, and anxiety, 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 maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and  depression, anxiety, chills, sore arm, fever 100.2 fahrenheit, and fatigue was related.  This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received on 30-JUL-2021, the following information was updated and incorporated into case narrative: Patient history and expected date of delivery was added, Cessation date and outcome for events (chills, fatigue, fever and sore arm) was updated to recovered, the events anxiety and depression was added.; Sender's Comments: V1- This follow up adds- Patient history and expected date of delivery, Cessation date and outcome, the events anxiety and depression was added. This case was reassessed as serious based on additional information received on 30-JUL-2021  20210726943- 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   20210726943- covid-19 vaccine ad26.cov2.s - anxiety and depression. 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).  20210726943- covid-19 vaccine ad26.cov2.s - chills, fatigue, fever 100.2 Fahrenheit and sore arm This event(s) is labeled and is therefore considered potentially related.