Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema
Clinical narrative: Sinus infection; Anxious after positive COVID test; Lack of drug effect; Angry after positive COVID test; Positive test for COVID-19; Muscle pain; Nausea; Moderna Arm after 2nd shot; Arm was hurting; Red from elbow to shoulder after 2nd shot; Fatigue/Tired after positive COVID test after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive test for COVID-19), VACCINATION COMPLICATION (Moderna Arm after 2nd shot), PAIN IN EXTREMITY (Arm was hurting), SINUSITIS (Sinus infection) and ANXIETY (Anxious after positive COVID test) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026O21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION COMPLICATION (Moderna Arm after 2nd shot), PAIN IN EXTREMITY (Arm was hurting), VACCINATION SITE ERYTHEMA (Red from elbow to shoulder after 2nd shot), FATIGUE (Fatigue/Tired after positive COVID test after 2nd shot) and NAUSEA (Nausea). On 29-Jul-2021, the patient experienced COVID-19 (Positive test for COVID-19), SINUSITIS (Sinus infection), DRUG INEFFECTIVE (Lack of drug effect), ANGER (Angry after positive COVID test) and MYALGIA (Muscle pain). 29-Jul-2021, the patient experienced ANXIETY (Anxious after positive COVID test). In July 2021, VACCINATION COMPLICATION (Moderna Arm after 2nd shot), PAIN IN EXTREMITY (Arm was hurting), VACCINATION SITE ERYTHEMA (Red from elbow to shoulder after 2nd shot), FATIGUE (Fatigue/Tired after positive COVID test after 2nd shot) and NAUSEA (Nausea) had resolved. At the time of the report, COVID-19 (Positive test for COVID-19), SINUSITIS (Sinus infection), ANXIETY (Anxious after positive COVID test), DRUG INEFFECTIVE (Lack of drug effect), ANGER (Angry after positive COVID test) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: positive (Positive) was positive for COVID-19. On an unknown date, SARS-CoV-2 test: negative (Negative) was negative on the spot.         Concomitant medication included cholesterol medication. Treatment included Antibody infusion on 31-JUL-2021.  At the urgent care, they did 2 tests for COVID-19 they told patient was negative on the spot, but the next day someone called from the department of health and told that patient was positive for COVID-19.   This case was linked to MOD-2021-067211; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events, 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.