Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Myalgia, Pruritus, Pyrexia, Swelling
Clinical narrative: feeling shaky and runned out, just weak like having the flu; 101.4°F fever; headache; Dry cough; Short of Breath; severe itching like a bee sting; pain, and aches terrible terrible aches,the aches lasted 24 hours; the arm is still swollen and red half way down to the arm from the injection site; red half way down to the arm from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling shaky and runned out, just weak like having the flu), COUGH (Dry cough), SWELLING (the arm is still swollen and red half way down to the arm from the injection site), DYSPNOEA (Short of Breath) and PRURITUS (severe itching like a bee sting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Influenza B virus infection from 18-Jan-2021 to 25-Jan-2021. Concurrent medical conditions included Blood pressure raised (High blood pressure.). Concomitant products included ASA, ESTRADIOL (ESTRACE), GLICLAZIDE (DIAZIDE [GLICLAZIDE]), DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]) and POTASSIUM CHLORIDE for an unknown indication.   On 29-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced SWELLING (the arm is still swollen and red half way down to the arm from the injection site), MYALGIA (pain, and aches terrible terrible aches,the aches lasted 24 hours) and INJECTION SITE ERYTHEMA (red half way down to the arm from the injection site). On 01-Feb-2021, the patient experienced COUGH (Dry cough) and DYSPNOEA (Short of Breath). In February 2021, the patient experienced PRURITUS (severe itching like a bee sting). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feeling shaky and runned out, just weak like having the flu), PYREXIA (101.4°F fever) and HEADACHE (headache). On 31-Jan-2021, MYALGIA (pain, and aches terrible terrible aches,the aches lasted 24 hours) had resolved. On 02-Feb-2021, COUGH (Dry cough) and DYSPNOEA (Short of Breath) had resolved. In February 2021, SWELLING (the arm is still swollen and red half way down to the arm from the injection site) and INJECTION SITE ERYTHEMA (red half way down to the arm from the injection site) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (feeling shaky and runned out, just weak like having the flu), PRURITUS (severe itching like a bee sting), PYREXIA (101.4°F fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.4 (High) Fahrenheit.         The patient was treated with Tylenol (acetaminophen) every 46 hours. Action taken with mRNA-1273 in response to events was not applicable.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-102250.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received and reporter details, patient demographics, Med history,concomitant medication, event and outcome updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.