Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Body temperature, COVID-19, Chills, Malaise
Clinical narrative: FEELING UNWELL; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19; Chills; FEVER 102.4 FAHRENHEIT; Maternal exposure during pregnancy; This solicited pregnancy report received from a consumer concerned a 31 year old white female. The patient was enrolled in a non-company sponsored study. The patient's weight was 104.31 kilograms, and height was 163 centimeters. The patient's past medical history included: 2 previous stillborn babies, and 2 previous miscarriage, and concurrent conditions included: vaginal bleeding, and smokers cough, and other pre-existing medical conditions included: no history of exposure to tobacco, drugs for recreational use or alcoholic beverage. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, one total administered on 26-MAY-2021 for covid-19 immunisation. Concomitant medications included minerals nos (not specified)/vitamins nos (not specified). On 26-MAY-2021, the patient experienced maternal exposure during pregnancy. On 27-MAY-2021, the patient experienced chills and fever 102.4 fahrenheit. Laboratory data included: Body temperature (NR: not provided) 102.4 F. On 09-AUG-2021, the patient experienced suspected clinical vaccination failure and covid-19. On an unspecified date, the patient experienced feeling unwell. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 39.16, and Body temperature (NR: not provided) 104 F. The first day of the last menstrual period (LMP) was calculated to be 22-DEC-2020. The estimated delivery date (EDD) was reported to be 28-SEP-2021. It was reported that this was singleton pregnancy. On 26-MAY-2021, at gestational age 22 weeks and 1 day. Drug start and end period was 75 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 on 15-AUG-2021, and chills, and fever 102.4 fahrenheit on 28-MAY-2021, had not recovered from maternal exposure during pregnancy, and the outcome of feeling unwell and suspected clinical vaccination failure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and suspected clinical vaccination failure, feeling unwell, covid-19, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, and fever 102.4 fahrenheit was related.  This report was serious (Other Medically Important Condition, and Disability Or Permanent Damage).  This case was reassessed as serious based on additional information received on 16-AUG-2021. The following information was updated and incorporated into the case narrative: patient (height, concurrent condition, race, expected delivery date), event (covid-19, feeling unwell was added, chills and fever onset, cessation dates and outcome was updated), drug start period, drug end period, Lab (body temperature) added,; Sender's Comments: V1: 20210800799-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure, 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