Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fluid retention, Magnetic resonance imaging, Myocarditis, Peripheral swelling
Clinical narrative: DYSPNOEA (SHORTNESS OF BREATH); PERIPHERAL SWELLING (LEG SWELLING); CATHETERISATION CARDIAC; COMPUTERISED TOMOGRAM; MAGNETIC RESONANCE IMAGING; FATIGUE; ASTHENIA; FLUID RETENTION; CARDIAC FAILURE; MYOCARDITIS; JAW SURGERY; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1350646) concerned a 37 year old female. The patient's weight was 101 pounds, and height was 63.6 inches. The patient was not pregnant at the time of vaccination, was not breastfeeding, no medical history and had no illness at the time of vaccination. The patient had no past history of similar event, no adverse event after any previous vaccinations and no history of allergy to drug, vaccine or food. The patient had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days and no family history of any disease or allergy. The patient had no other suspected vaccine co-administered, and no known risk factors. The patient takes flu shot every year. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate. On 25-MAR-2021, the patient underwent jaw surgery. On 01-APR-2021, the patient experienced cardiac failure, myocarditis, fluid retention, weakness (asthenia) and fatigue. On 07-MAY-2021, the patient experienced leg swelling (peripheral swelling) and shortness of breath (dyspnoea). The patient had visited the emergency room and was admitted to the hospital. The patient had also visited physician's office for the events. The patient's laboratory data included catheterisation cardiac (result not reported), computerised tomogram (result not reported), magnetic resonance imaging (result not reported), COVID-19 PCR test (negative), Cardiovascular function test (NR: not provided) Not reported, and scan with contrast (NR: not provided) Not reported. The patient also needed a work-up for a heart transplant. On 19-MAY-2021, the patient was discharged from the hospital. The patient was hospitalized for 12 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cardiac failure, dyspnoea (shortness of breath), fatigue, fluid retention, asthenia, catheterisation cardiac, computerised tomogram, magnetic resonance imaging, myocarditis, and peripheral swelling (leg swelling), and the outcome of jaw surgery was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, Life Threatening, and Disability Or Permanent Damage). This case is a duplicate of 20210546838.  Additional information received on 22-JUN-2021. It was determined that nullification and deletion was required for Manufacturer Report Number (20210546838) as it was duplicate of Manufacturer Case Number (20210625616). All relevant information regarding Manufacturer Report Number (20210546838) will be submitted under Manufacturer Case Number (20210625616).The following information was updated and incorporated into case narrative: reporter details, patient demographics added (ID, weight, height, race and ethnic origin), event added (jaw surgery), onset date of dsypnoea and peripheral swelling (updated from 01-APR-2021 to 07-MAY-2021), lab test added (nasal swab test, contrast study, workup for heart transplant), past vaccine added (influenza vaccine).; Sender's Comments: V2: Additional information received on 22-JUN-2021. All relevant information regarding Manufacturer Report Number (20210546838) will be submitted under Manufacturer Case Number (20210625616).The following information was updated and incorporated into case narrative: reporter details, patient demographics added, event added (jaw surgery), onset date of dsypnoea and peripheral swelling (updated from 01-APR-2021 to 07-MAY-2021), lab test added, past vaccine added (influenza vaccine). This does not change causality of previously reported events. 20210625616-covid-19 vaccine ad26.cov2.s-Jaw surgery. This event(s) is considered unassessable. 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). 20210625616-COVID-19 VACCINE AD26.COV2.S-Cardiac failure, Myocarditis, Dyspnoea, Fluid retention, Peripheral swelling, Asthenia, Fatigue, Catheterisation cardiac, Computerised tomogram, Magnetic resonance imaging. This event(s) is considered unassessable. 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).