Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Blood pressure fluctuation, Cardiac complication associated with device, Chest pain, Oxygen saturation
Clinical narrative: Sharp pain in heart/feels like scar tissue around heart; hurting in his chest, boom in chest; He felt severe pain from the pacemaker jolt on his heart/pacemakers is giving him violent reactions; Almost passed out; blood pressure has been erratic; severe swelling at injection site/swelling right arm; a lot of pain at the injection site/swelling and pain in his right arm; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Sharp pain in heart/feels like scar tissue around heart) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation and Pacemaker insertion (cardiac) (He has a pacemaker for 10 years, implanted on 2007. He had the battery replaced in his pacemaker on 01/Dec/2018). Concurrent medical conditions included Post-traumatic stress disorder and Plantar fasciitis. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PRESYNCOPE (Almost passed out), BLOOD PRESSURE FLUCTUATION (blood pressure has been erratic), VACCINATION SITE SWELLING (severe swelling at injection site/swelling right arm) and VACCINATION SITE PAIN (a lot of pain at the injection site/swelling and pain in his right arm). On 27-Apr-2021, the patient experienced ANGINA PECTORIS (Sharp pain in heart/feels like scar tissue around heart) (seriousness criteria hospitalization and medically significant) and CARDIAC COMPLICATION ASSOCIATED WITH DEVICE (He felt severe pain from the pacemaker jolt on his heart/pacemakers is giving him violent reactions). On an unknown date, the patient experienced CHEST PAIN (hurting in his chest, boom in chest). At the time of the report, ANGINA PECTORIS (Sharp pain in heart/feels like scar tissue around heart), CARDIAC COMPLICATION ASSOCIATED WITH DEVICE (He felt severe pain from the pacemaker jolt on his heart/pacemakers is giving him violent reactions), CHEST PAIN (hurting in his chest, boom in chest), BLOOD PRESSURE FLUCTUATION (blood pressure has been erratic), VACCINATION SITE SWELLING (severe swelling at injection site/swelling right arm) and VACCINATION SITE PAIN (a lot of pain at the injection site/swelling and pain in his right arm) outcome was unknown and PRESYNCOPE (Almost passed out) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Oxygen saturation: 63 percent (Low) low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.  Concomitant medication used by patient includes Aspirin 325 mg.  No treatment medication information provided.   This case was linked (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Angina pectoris was added as event. Start date of other events are updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.