Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus
Clinical narrative: chest cold; left arm still is a little sore; racing heartbeat; dizzy; problems breathing/shortness of breath/not able to have a deep breath; lump at injection site; Injection site itchy; a red circle, like a lump, on the injection site.; nausea; chills; 102 degree fever knocked out the chest infection; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (chest cold) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concurrent medical conditions included Drug allergy (had a reaction to Botox). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (chest cold) (seriousness criterion medically significant), PAIN IN EXTREMITY (left arm still is a little sore), PALPITATIONS (racing heartbeat), DIZZINESS (dizzy), DYSPNOEA (problems breathing/shortness of breath/not able to have a deep breath), VACCINATION SITE MASS (lump at injection site), LUNG DISORDER (lung related issues), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (a red circle, like a lump, on the injection site.), NAUSEA (nausea), CHILLS (chills) and PYREXIA (102 degree fever knocked out the chest infection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LOWER RESPIRATORY TRACT INFECTION (chest cold), PALPITATIONS (racing heartbeat), DIZZINESS (dizzy), NAUSEA (nausea) and CHILLS (chills) had resolved, PAIN IN EXTREMITY (left arm still is a little sore), DYSPNOEA (problems breathing/shortness of breath/not able to have a deep breath), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (a red circle, like a lump, on the injection site.) had not resolved and VACCINATION SITE MASS (lump at injection site), LUNG DISORDER (lung related issues) and PYREXIA (102 degree fever knocked out the chest infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 degree.         The patient took diphenhydramine, which she which was the cause of the lung related issues which they thought was from the vaccine. She got a chest cold and 102 degree fever which knocked out the chest infection. She had normal reactions to the second dose of the vaccine. Action taken with mRNA-1273 in response to the events was not Applicable. Treatment information included that the patient used Inhaler for the breathing problems.  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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: New event chest cold was added and case was upgraded to serious; 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.