Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red, slightly raised, warm welt at the injection site; Ears feel pressure, clogged, fullness; I decided not to take second shot; One sided headache; Red, slightly raised, warm welt at the injection site; Red, slightly raised, warm welt at the injection site; tinnitus; ear ringing for 3 weeks/ bilateral tinnitus began; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021. The most recent information was received on 02-Jun-2021 and was forwarded to Moderna on 02-Jun-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (tinnitus; ear ringing for 3 weeks/ bilateral tinnitus began), INJECTION SITE WARMTH (Red, slightly raised, warm welt at the injection site), EAR DISCOMFORT (Ears feel pressure, clogged, fullness), PRODUCT DOSE OMISSION ISSUE (I decided not to take second shot) and HEADACHE (One sided headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NORETHISTERONE (CAMILA) from 28-Nov-2019 to an unknown date for Contraception.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced TINNITUS (tinnitus; ear ringing for 3 weeks/ bilateral tinnitus began). On an unknown date, the patient experienced INJECTION SITE WARMTH (Red, slightly raised, warm welt at the injection site), EAR DISCOMFORT (Ears feel pressure, clogged, fullness), PRODUCT DOSE OMISSION ISSUE (I decided not to take second shot), HEADACHE (One sided headache), VACCINATION SITE ERYTHEMA (Red, slightly raised, warm welt at the injection site) and VACCINATION SITE SWELLING (Red, slightly raised, warm welt at the injection site). The patient was treated with MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Tinnitus, at a dose of 1 dosage form and MEDROL [METHYLPREDNISOLONE] (oral) for Tinnitus, at a dose of 1 dosage form. At the time of the report, TINNITUS (tinnitus; ear ringing for 3 weeks/ bilateral tinnitus began) was resolving, INJECTION SITE WARMTH (Red, slightly raised, warm welt at the injection site) outcome was unknown, EAR DISCOMFORT (Ears feel pressure, clogged, fullness) had not resolved and HEADACHE (One sided headache) and VACCINATION SITE ERYTHEMA (Red, slightly raised, warm welt at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment drug also included various vitamin supplements    Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 02-Jun-2021: Updated the Patient demographics, Event outcome, Suspect product details, Concomitant medication details, reporter details ,treatment medication details and vaccine facility details.