Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia postoperative, Exposure during pregnancy, Fatigue, Headache
Clinical narrative: ANEMIA RELATED TO GASTRIC BYPASS SURGERY; MATERNAL EXPOSURE DURING PREGNANCY; FATIGUE; HEADACHE; This solicited pregnancy report received from a consumer concerned a 38 year old female of unspecified race and ethnic origin. The patient was enrolled in a non-company sponsored study. The patient's weight was 77.098 kilograms, and height was 173 centimeters. The patient's past medical history included: recreational drug use, elective abortion, and gastric bypass surgery, and concurrent conditions included: hypothyroidism, polycystic ovarian syndrome, multigravida, non-smoker, and non- alcohol user, and other pre-existing medical conditions included: Patient was Pregnant at the time of Vaccination, this was singleton pregnancy, Body Mass Index (BMI) was 25.64.The patient was gravida 4, para 1, abortions 2. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 for covid-19 immunisation. Concomitant medications included ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos for drug used for unknown indication, estradiol for drug used for unknown indication, levothyroxine for drug used for unknown indication, and progesterone for drug used for unknown indication.  On 12-MAR-2021, the patient had maternal exposure during pregnancy. On the same day, the patient experienced fatigue and headache. The date of the patient's last menstrual period was 04-FEB-2021 and expected delivery date was unknown. On 14-MAR-2021, the fatigue and headache were improved. On 16-MAY-2021, the patient experienced anemia related to gastric bypass surgery. The patient received low energy and iron infusion was used as treatment for anemia related to gastric bypass surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 14-MAR-2021, was recovering from anemia related to gastric bypass surgery, 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 anemia related to gastric bypass surgery, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and fatigue, and headache was related.  This report was serious (Other Medically Important Condition)  This case was reassessed as serious based on additional information received from Consumer on 02-NOV-2021, the following information was updated and incorporated into case narrative: Consumer added as Primary Reporter, Patients weight (77.098 kilograms), Gestation period (5 week), Para (1), Gravida (4), abortions details, Event Anemia related to gastric bypass surgery, fatigue, headache and maternal exposure during pregnancy reassessed as serious, Cessation date and Outcome for Events (Fatigue and Headache), past condition (gastric bypass surgery), Concurrent conditions (non-smoker, non-alcohol user), Dosage text and concomitant drugs end date.; Sender's Comments: V1:20210728844-covid-19 vaccine ad26.cov2.s-Anemia related to gastric bypass surgery. 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