Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Pyrexia, Syncope
Clinical narrative: FAINTING WHICH WAS DESCRIBED AS DIZZINESS; VACCINE EXPOSURE DURING PREGNANCY; FEVER WAS WORSE; INTERMITTENT HEADACHE; FATIGUE WAS WORSE; This spontaneous pregnancy report received from a consumer concerned a 35-year-old female. The patient's weight was 124 (unit not reported) and height was 144.78 centimeters. The patient had no known allergies. The patient had no illness at the time of vaccination. The patient had no history of allergy to vaccine, drug, or food. The patient had no past history of similar event. The patient had no pre-existing acute illness 30 days prior to vaccination. The patient had no history of hospitalization in last 30 days. The patient's grandmother had history of Hypercholesterolemia and Diabetes Mellitus. The patient's father died from Hepatitis C approximately 10 years ago. The patient's mother had no history of chronic disease. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination in left deltoid. Concomitant medications included Prenatal Multivitamin, calcium, magnesium, vitamin D3 and vitamin K2. The date of the subject's last menstrual period was 06-JAN-2021 and expected delivery date was on an unspecified date in 2021. On 2021, Laboratory data included: Pregnancy test (NR: not provided) POSITIVE. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.4. The patient mentioned that the day, she took the vaccine she had not symptoms. The patient was feeling very good. The patient's gestation period was 9 weeks and 3 Days. On 17-MAR-2021 the patient experienced vaccine exposure during pregnancy. The patient mentioned that she fainted the next day after receiving the vaccine. The patient discussed this symptom with OBGYN on a phone visit in 18-March-2021.The husband stated that she had not had any fainting spells prior to receiving the vaccine. The patient mentioned her symptoms improved two days after receiving the vaccine. However, she reports she still feels an intermittent headache (pain rate: 6/10) described as "stitching pain" (Left Side temporal irradiating to occipital area. The patient stated that she was already fatigued due to the pregnancy and now her fatigue was worse. She had no history of headaches, and he reported a fever of 99.4, although he said his thermometer, may not be accurate. The patient's home thermometer was broken therefore she was unable to measure her fever. The patient's husband said that her side effects started on yesterday, and were worse today (as reported). The patient was resting at the time of this call. The patient mentioned that she had lab work done on 19-Mar-2021. The pregnancy result was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fainting which was described as dizziness, fever was worse, and fatigue was worse, and had not recovered from vaccine exposure during pregnancy, and intermittent headache. This report was serious (Other Medically Important Condition).   Additional information was received from consumer on 26-MAR-2021 following information was updated and incorporated into case narrative: Patient demographic details (height, weight), patient history, parent history (patient's grandmother had history of Hypercholesterolemia and Diabetes Mellitus, Patient's father had hepatitis C), concomitant medications (Prenatal Multivitamin, Calcium, Magnesium, Vitamin D3, Vitamin K2), pregnancy details (gestation, LMP date, gravida), event (intermittent headache), outcome of the events (recovering from fainting which was described as dizziness, fever was worse, and fatigue was worse; and not recovered from intermittent headache), reporter details (contact), other identification numbers and event description was updated.; Sender's Comments: V1: Follow up information received updates patient demographic details (height, weight), patient history, parent history (patient's grandmother had history of Hypercholesterolemia and Diabetes Mellitus, Patient's father had hepatitis C), concomitant medications (Prenatal Multivitamin, Calcium, Magnesium, Vitamin D3, Vitamin K2), pregnancy details (gestation, LMP date, gravida), event (RRT amended  to intermittent headache), outcome of the events (recovering from fainting which was described as dizziness, fever was worse, and fatigue was worse; and not recovered from intermittent headache), reporter details (contact), other identification numbers and event description. This updated information does not alter prior causality assessment of reported event. 20210335441-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Fainting. This event is considered unassessable. The event 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.