Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6; Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6; Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6; Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6; Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6; Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6; Patient's left arm became sore and very tender later in evening after receiving 1st dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Patient's left arm became sore and very tender later in evening after receiving 1st dose), FATIGUE (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6), HEADACHE (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6), MYALGIA (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6) and ARTHRALGIA (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and VITAMINS NOS for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE PAIN (Patient's left arm became sore and very tender later in evening after receiving 1st dose). On 02-Mar-2021, the patient experienced FATIGUE (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6), HEADACHE (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6), MYALGIA (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6), ARTHRALGIA (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6), CHILLS (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6) and PYREXIA (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6). At the time of the report, INJECTION SITE PAIN (Patient's left arm became sore and very tender later in evening after receiving 1st dose), FATIGUE (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6), HEADACHE (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6), MYALGIA (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6), ARTHRALGIA (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6), CHILLS (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6) and PYREXIA (Next morning, Patient developed fatigue, headache, muscle and joint pain and chills, fever 100.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, COVID-19: positive (Positive) Positive for 5 weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-030811 (Patient Link).