Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Exposure during pregnancy, Fatigue, Gestational diabetes
Clinical narrative: GESTATIONAL DIABETES; FATIGUE; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 38 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines International Pregnancy Exposure Registryt number: C08459). The patient's weight was 99.773 kilograms and height was 165 centimeters. The patient's past medical history included: spontaneous abortion (three previous pregnancies of which two resulted in live newborn and one ended in miscarriage/spontaneous abortion, less than 20 weeks gestation), and concurrent conditions included: multigravida (three previous pregnancies), high risk pregnancy. The patient had no history of exposure to tobacco, drugs for recreational use or alcoholic beverage. The patient was pregnant at the time of vaccination. It was reported that this was singleton pregnancy The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported,1 total administered on 11-MAR-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included minerals prenatal vitamin. On 11-MAR-2021, the patient experienced maternal exposure during pregnancy. The date of the patient's last menstrual period was 28-JAN-2021 and expected delivery date was 04-NOV-2021. On 12-MAR-2021, the patient experienced fatigue. On 05-MAY-2021, the patient experienced gestational diabetes and corrective treatment included humulin N. The pregnancy was continuing. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 36.32. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 13-MAR-2021, had not recovered from gestational diabetes, 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 gestational diabetes, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and fatigue was related.  This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received on 04-AUG-2021, the following information was updated and incorporated into case narrative: Patient's race added, patient's medical history added, expected delivery date (04-NOV-2021) added, The event gestational diabetes added and captured as serious with seriousness criteria as Other Medically Important Condition, the event seriousness for the event maternal exposure during pregnancy updated (non serious to serious) with seriousness criteria as Other Medically Important Condition, lab test details (body mass index) added, product added (humulin N) as treatment drug for gestational diabetes.; Sender's Comments: V2:Follow up information in this version Patient's race, medical history ,expected delivery date ,The event gestational diabetes was added  and the event seriousness for the event maternal exposure during pregnancy updated,lab test details (body mass index), product added (humulin N)   20210801461-Covid-19 vaccine ad26.cov2.s-Gestational Diabetes . Follow-up received regarding Clinical Details. 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   20210801461-Covid-19 vaccine ad26.cov2.s-3.Maternal exposure during pregnancy . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS