Sex: U
Vaccine: COVID19
Symptoms: Cardiac function test, Cardiac stress test, Chest pain, Laboratory test, Pain in extremity
Clinical narrative: pain in her legs; she had big, large chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her legs) and CHEST PAIN (she had big, large chest pain) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her legs) (seriousness criterion hospitalization) and CHEST PAIN (she had big, large chest pain) (seriousness criterion hospitalization). At the time of the report, PAIN IN EXTREMITY (pain in her legs) and CHEST PAIN (she had big, large chest pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac function test: 86 % heart was functioning at 86%. On an unknown date, Cardiac stress test: they did a stress test which came back normal. On an unknown date, Laboratory test: They also did lab work and images. Everything is normal.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. 1 to 2 weeks after receiving the vaccine patient had deep pain in both legs which lasted 2 to 3 minutes. The next day patient also had pain in legs but not as strong as last day. 1 week after this patient had big, large chest pain. For this reason, patient visits cardiologist, and they did a stress test. Doctor also checked for clogs in veins and arteries and patient had none. Patient never had any heart conditions before.  Treatment drug was not reported.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported , who experienced the unexpected serious (hospitalization) events of Pain in extremity (Pain in leg) and Chest pain that occurred after receiving mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Approximately 1 to 2 weeks after receiving the vaccine patient experienced deep pain in both legs which lasted 2 to 3 minutes. 1 week later patient had chest pain . Patient visited cardiologist, stress test was done which came back normal. It was reported that other lab tests including imagining studies were done which were normal. There were no clots in veins and arteries. Patients' heart is functioning at 86% as reported by physician. No further information regarding risk factors, medical history, concurrent condition, concomitant medication, additional vaccination details, additional lab reports and treatment received were provided.  The outcome of the events was recovered. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported , who experienced the unexpected serious (hospitalization) events of Pain in extremity (Pain in leg) and Chest pain that occurred after receiving mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Approximately 1 to 2 weeks after receiving the vaccine patient experienced deep pain in both legs which lasted 2 to 3 minutes. 1 week later patient had chest pain . Patient visited cardiologist, stress test was done which came back normal. It was reported that other lab tests including imagining studies were done which were normal. There were no clots in veins and arteries. Patients' heart is functioning at 86% as reported by physician. No further information regarding risk factors, medical history, concurrent condition, concomitant medication, additional vaccination details, additional lab reports and treatment received were provided.  The outcome of the events was recovered. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 is not affected by this report.