Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Echocardiogram, Fatigue, Irritability, Malaise
Clinical narrative: had a tooth that began to hurt; abcessed tooth; feeling of being unwell; bad rash on my back; rash at the site of the injection; periodic muscle pain, still expiriencing muscle pain, muscle ache; rash is tender to touch; cannot get enough sleep; Rash is itchy; tired all day long, still experiencing fatigue, tiredness; irritable; arm hurt; Slight fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (rash is tender to touch), POOR QUALITY SLEEP (cannot get enough sleep), RASH PRURITIC (Rash is itchy), PAIN IN EXTREMITY (arm hurt) and IRRITABILITY (irritable) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided  by reporter.  Previously administered products included for Product used for unknown indication: Flu Vaccine (2 years ago and rash broke out on buttocks and legs after Flu Vaccine administration). Past adverse reactions to the above products included Rash with Flu Vaccine. Concurrent medical conditions included Urticaria and Hay fever. Concomitant products included ANASTROZOLE and TADALAFIL (CIALIS) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). 16-Apr-2021, the patient experienced PYREXIA (Slight fever) and CHILLS (Chills). On 17-Apr-2021, the patient experienced IRRITABILITY (irritable). On an unknown date, the patient experienced TENDERNESS (rash is tender to touch), POOR QUALITY SLEEP (cannot get enough sleep), RASH PRURITIC (Rash is itchy), TOOTHACHE (had a tooth that began to hurt), TOOTH DISORDER (abcessed tooth), MALAISE (feeling of being unwell), RASH (bad rash on my back), VACCINATION SITE RASH (rash at the site of the injection), MYALGIA (periodic muscle pain, still expiriencing muscle pain, muscle ache) and FATIGUE (tired all day long, still experiencing fatigue, tiredness). The patient was treated with PENICILLIN NOS for Tooth ache, at an unspecified dose and frequency. At the time of the report, TENDERNESS (rash is tender to touch), POOR QUALITY SLEEP (cannot get enough sleep), RASH PRURITIC (Rash is itchy), PAIN IN EXTREMITY (arm hurt), IRRITABILITY (irritable), TOOTHACHE (had a tooth that began to hurt), TOOTH DISORDER (abcessed tooth), MALAISE (feeling of being unwell), RASH (bad rash on my back), VACCINATION SITE RASH (rash at the site of the injection), MYALGIA (periodic muscle pain, still expiriencing muscle pain, muscle ache), PYREXIA (Slight fever), CHILLS (Chills) and FATIGUE (tired all day long, still experiencing fatigue, tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: pvcs and pacs (Inconclusive) PVCs and PACs at the exercise induced higher heart rates. On an unknown date, Serum ferritin: low (Low) Low ferritin level. On an unknown date, Vitamin B12: low (Low) Vitamin B12 was low. On an unknown date, White blood cell count: low (Low) WBC count was dropped by 44%.         On an unknown date, patient was treated with Steroids for the events, at an unspecified dose and frequency. On an unknown date, colonoscopy was ordered.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-Up received Updated events - Pain in extremity, irritable, Feeling unwell, Tooth ache, Tooth disorder NOS. Updated vaccine dosage information, concomitant medications, diagnostic data and patient demographics; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded