Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Rash macular, Vaccination site discomfort
Clinical narrative: pain had progressed and radiates from the red spot to the shoulder, under the arm, towards the chest under the breast area and down to the elbow; doesn't feel very good; feeling unwell; red spot appeared in the middle of the upper arm about 3 inches from the injection site; arm was painful; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (right arm was sore), PAIN IN EXTREMITY (arm was painful), RASH MACULAR (red spot appeared in the middle of the upper arm about 3 inches from the injection site), PAIN IN EXTREMITY (pain had progressed and radiates from the red spot to the shoulder, under the arm, towards the chest under the breast area and down to the elbow) and MALAISE (doesn't feel very good) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect (Medical history not provided). Concomitant products included LISINOPRIL, METOPROLOL, LEVOTHYROXINE, CITALOPRAM, GABAPENTIN and ALLERGY MEDICATION.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (right arm was sore). On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was painful). On 06-Jan-2021, the patient experienced RASH MACULAR (red spot appeared in the middle of the upper arm about 3 inches from the injection site). On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain had progressed and radiates from the red spot to the shoulder, under the arm, towards the chest under the breast area and down to the elbow), MALAISE (doesn't feel very good) and MALAISE (feeling unwell). At the time of the report, VACCINATION SITE DISCOMFORT (right arm was sore), PAIN IN EXTREMITY (arm was painful), RASH MACULAR (red spot appeared in the middle of the upper arm about 3 inches from the injection site), PAIN IN EXTREMITY (pain had progressed and radiates from the red spot to the shoulder, under the arm, towards the chest under the breast area and down to the elbow), MALAISE (doesn't feel very good) and MALAISE (feeling unwell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment was reported as taking ibuprofen to help with the symptoms.  This case concerns a 49-year-old female with a nonserious unexpected vaccination site discomfort, rash macular, malaise, and expected pain in extremity. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on 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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 12 Apr 2021 included no new information; Sender's Comments: This case concerns a 49-year-old female with a nonserious unexpected vaccination site discomfort, rash macular, malaise, and expected pain in extremity. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on 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.