Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Heart rate increased, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: inappropriate schedule of vaccine administered; heart has been hurting; heart starting to beat faster; arm hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (heart has been hurting), HEART RATE INCREASED (heart starting to beat faster), VACCINATION SITE PAIN (arm hurt really bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 053E21A) for COVID-19 vaccination.     The patient's past medical history included Seizure. Concurrent medical conditions included Hypertension and High cholesterol.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). In October 2021, the patient experienced ANGINA PECTORIS (heart has been hurting), HEART RATE INCREASED (heart starting to beat faster) and VACCINATION SITE PAIN (arm hurt really bad). On 04-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, ANGINA PECTORIS (heart has been hurting) and HEART RATE INCREASED (heart starting to beat faster) had not resolved and VACCINATION SITE PAIN (arm hurt really bad) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  A few days after receiving the second dose of the vaccine she noticed her heart starting to beat faster and her "heart has been hurting." This has continued to today. She has not taken any medications or treatments and has not talked to her HCP. She has not had a previous diagnosis of covid-19 and does not have a history of previous myocarditis or pericarditis.  Company Comment: This case concerns Inappropriate schedule of product administration in a 55 year-old female patient with relevant medical history of hypertension and high cholesterol, who experienced the unexpected non-serious event of heart has been hurting. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. Manual override was done to remove the seriousness criteria of Medically significant from the event of Angina pectoris based on medical judgement and review of source document that noted the description of the event, including that the patient did not visit a physican or require treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-359694 (Patient Link).; Sender's Comments: This case concerns Inappropriate schedule of product administration in a 55 year-old female patient with relevant medical history of hypertension and high cholesterol, who experienced the unexpected non-serious event of heart has been hurting. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. Manual override was done to remove the seriousness criteria of Medically significant from the event of Angina pectoris based on medical judgement and review of source document that noted the description of the event, including that the patient did not visit a physican or require treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.