Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction
Clinical narrative: Headache; Fatigue; Tested positive for Covid; Sore throat; nasal drainage; an earache twinge that feels like when your ear pops on an airplane; Lump on right arm; Right Covid Arm; Redness on right arm; Soreness on right arm; Rash on right arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Jul-2021. The most recent information was received on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump on right arm), VACCINATION SITE REACTION (Right Covid Arm), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (nasal drainage) and EAR PAIN (an earache twinge that feels like when your ear pops on an airplane) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic sinusitis.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump on right arm), VACCINATION SITE REACTION (Right Covid Arm), VACCINATION SITE ERYTHEMA (Redness on right arm) and VACCINATION SITE PAIN (Soreness on right arm). 08-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash on right arm). On 03-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (nasal drainage) and EAR PAIN (an earache twinge that feels like when your ear pops on an airplane). On 09-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 05-Aug-2021, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (nasal drainage), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE MASS (Lump on right arm), VACCINATION SITE REACTION (Right Covid Arm), COVID-19 (Tested positive for Covid), VACCINATION SITE RASH (Rash on right arm), VACCINATION SITE ERYTHEMA (Redness on right arm) and VACCINATION SITE PAIN (Soreness on right arm) outcome was unknown and EAR PAIN (an earache twinge that feels like when your ear pops on an airplane) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported.   Patient reported that on 30-Jul-2021, the original Covid arm came back, however as of 09-Aug-2021, all that was left of the Covid arm was a dot where she was injected, but the lump and redness were gone.  She stated it had a bruised feeling.  The treatment information was not reported.   This case was linked to MOD-2021-272207 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up (updated additional events, current conditions, lab data and case outcome)