Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Influenza like illness, Injection site lymphadenopathy, Malaise
Clinical narrative: short of breath; Missed dose 2; heart rate dropped below 40; dizziness; "hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive); Pea Sized Nodes/nodes were tender; Sore Muscles; fatigue; fever; sore bones; patient felt like he was "hit by a bus"; This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (heart rate dropped below 40) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BONE PAIN (sore bones), MALAISE (patient felt like he was "hit by a bus"), MYALGIA (Sore Muscles), FATIGUE (fatigue) and PYREXIA (fever). On 16-Feb-2021, the patient experienced INJECTION SITE LYMPHADENOPATHY (Pea Sized Nodes/nodes were tender). On 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS ("hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive)). On 25-Feb-2021, the patient experienced DIZZINESS (dizziness). On 26-Feb-2021, the patient experienced BRADYCARDIA (heart rate dropped below 40) (seriousness criterion medically significant). On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose 2). On an unknown date, the patient experienced DYSPNOEA (short of breath). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and Surgery (Pacemaker) for Bradycardia. On 19-Feb-2021, INJECTION SITE LYMPHADENOPATHY (Pea Sized Nodes/nodes were tender) had resolved. On 21-Feb-2021, INFLUENZA LIKE ILLNESS ("hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive)) had resolved. At the time of the report, BRADYCARDIA (heart rate dropped below 40) was resolving and DIZZINESS (dizziness), DYSPNOEA (short of breath), BONE PAIN (sore bones), MALAISE (patient felt like he was "hit by a bus"), PRODUCT DOSE OMISSION ISSUE (Missed dose 2), MYALGIA (Sore Muscles), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Heart rate: 40 bpm (Low) 40 BPM.         It was reported that, in total the patient recorded 3 negative COVID tests. There was no history of cardiovascular disease in patient's family.  The patient was advised by his doctor to not receive the second dose of the vaccine.   Treatment medication include Advil.  Company Comment : This case concerns a 63-year-old male patient who was advised by physician not to receive the second dose (product dose omission) due to adverse events. The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Injection site lymphadenopathy, myalgia, fatigue and fever are consistent with the product known safety profile.  Product dose omission is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Additional information received and case was upgraded to serious, Height, age, race and Ethnicity updated in patient tab, Suspect product Batch number and route of administration updated  in products tab, Updated events and event outcome in events tab.; Sender's Comments: This case concerns a 63-year-old male patient who was advised by physician not to receive the second dose (product dose omission) due to adverse events. The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Injection site lymphadenopathy, myalgia, fatigue and fever are consistent with the product known safety profile.  Product dose omission is not applicable.