Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Remove the wax in her ears; mild hearing loss at 8 khz; ringing in her ears, high pitched & constant, it's in both ears/ongoing; Canceled second dose appointment; Had a pretty hard lump; It had a pretty hard lump, which was warm to touch; hard lump; It had a pretty hard lump, which was tender; It had a pretty hard lump, which was itchy; some swelling in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing), CERUMEN REMOVAL (Remove the wax in her ears) and PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), VACCINATION SITE INDURATION (hard lump), VACCINATION SITE PAIN (It had a pretty hard lump, which was tender), VACCINATION SITE PRURITUS (It had a pretty hard lump, which was itchy) and VACCINATION SITE SWELLING (some swelling in injection site arm). On 24-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment). On 26-Apr-2021, the patient experienced TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing). On an unknown date, the patient experienced CERUMEN REMOVAL (Remove the wax in her ears) and HYPOACUSIS (mild hearing loss at 8 khz). At the time of the report, VACCINATION SITE MASS (Had a pretty hard lump), VACCINATION SITE WARMTH (It had a pretty hard lump, which was warm to touch), TINNITUS (ringing in her ears, high pitched & constant, it's in both ears/ongoing), CERUMEN REMOVAL (Remove the wax in her ears), PRODUCT DOSE OMISSION ISSUE (Canceled second dose appointment), HYPOACUSIS (mild hearing loss at 8 khz), VACCINATION SITE INDURATION (hard lump), VACCINATION SITE PAIN (It had a pretty hard lump, which was tender), VACCINATION SITE PRURITUS (It had a pretty hard lump, which was itchy) and VACCINATION SITE SWELLING (some swelling in injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Acoustic stimulation tests: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: VAER form appended