Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: feeling hot; not feeling well; rrlocalized edness; local rash- arm; swelling- localized; experienced local reactions: arm was itchy; local reaction such tenderness after the 2nd shot; fever of 102.9 F degree; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (feeling hot), MALAISE (not feeling well), VACCINATION SITE PRURITUS (experienced local reactions: arm was itchy), VACCINATION SITE PAIN (local reaction such tenderness after the 2nd shot) and PYREXIA (fever of 102.9 F degree) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis, Osteoarthritis, Iodine allergy (allergic reaction-Immediate hives) since 01-Jan-1987, Poison ivy rash (spreads quickly; requires steroids) since 01-Jan-1986 and Dust allergy (allergic to dust mites; causes nasal polyps and sinus headaches) since 01-Jan-2016. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) from 01-Jan-2016 to an unknown date for Dust allergy, ZOLPIDEM from 01-Jan-2010 to an unknown date for Insomnia.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE PRURITUS (experienced local reactions: arm was itchy), VACCINATION SITE PAIN (local reaction such tenderness after the 2nd shot) and PYREXIA (fever of 102.9 F degree). On an unknown date, the patient experienced FEELING HOT (feeling hot), MALAISE (not feeling well), VACCINATION SITE ERYTHEMA (rrlocalized edness), VACCINATION SITE RASH (local rash- arm) and VACCINATION SITE SWELLING (swelling- localized). On 02-May-2021, PYREXIA (fever of 102.9 F degree) had resolved. On 07-May-2021, VACCINATION SITE PRURITUS (experienced local reactions: arm was itchy) and VACCINATION SITE PAIN (local reaction such tenderness after the 2nd shot) had resolved. At the time of the report, FEELING HOT (feeling hot), MALAISE (not feeling well), VACCINATION SITE ERYTHEMA (rrlocalized edness), VACCINATION SITE RASH (local rash- arm) and VACCINATION SITE SWELLING (swelling- localized) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Body temperature: 102.9 (Inconclusive) 102.9°F. On 02-May-2021, Body temperature: 99.8 (Inconclusive) 99.8°F. On 03-May-2021, Body temperature: 96.8 (Inconclusive) 96.8°F. On 04-May-2021, Body temperature: 96.7 (Inconclusive) 96.7°F. On 05-May-2021, Body temperature: 96.2 (Inconclusive) 96.2°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was also having centrum silver(multivitamin) from 01-jan-2019 and critical slow release (calcium supplement) from 01-jan-2010 as concomitant medication. It was reported that events resolved eight days later. Action taken with mRNA-1273 in response to the events was not applicable.      Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received: Patient demographics, lab data, medical history and concomitant medications updated. New events added and outcome of events also updated