Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tinnitus, Vaccination site reaction
Clinical narrative: it was like my ears were opening up on a plane and my sinuses were opening up/sinnus pressure; pain that felt weird that night; it did something weird to my sinuses; my nose wouldn't stop running; you sort of sleep a day or two; got Covid arm from the second shot; ear pressure and it feels plugged up, It's weird it effects your ears/ Ear fullness; Tinnitus, tinnitus got worse, the tinnitus is worse at night & I still have the tinnitus; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus, tinnitus got worse, the tinnitus is worse at night & I still have the tinnitus), EAR DISCOMFORT (ear pressure and it feels plugged up, It's weird it effects your ears/ Ear fullness), VACCINATION SITE REACTION (got Covid arm from the second shot), PARANASAL SINUS DISCOMFORT (it was like my ears were opening up on a plane and my sinuses were opening up/sinnus pressure) and PAIN (pain that felt weird that night) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: VACCINES (Pneumovax 23 vaccine), PNEUMOVAX 23 and SHINGRIX. Concurrent medical conditions included Drug allergy (Ibandronate sodium tablet, cipro.), Penicillin allergy, Hypertension since 01-Jan-2009, Hypothyroidism (Prior to C-19 vax TSH level had dropped. Very slight reduction in synthyroid medication.) since 01-Jan-1992, Anxiety (Mild generalized anxiety prior to C-19 vax much less anxiety overall. No treatment changes.) since 01-Jan-2006, Cholesterol (Mild elevated cholesterol levels.levels now in mid-range. No treatment changes) since 01-Jan-2018 and Osteoporosis since 01-Jan-2018. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety, ATORVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHYROID) for Hypothyroidism, RALOXIFENE HYDROCHLORIDE (EVISTA) for Osteoporosis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced TINNITUS (Tinnitus, tinnitus got worse, the tinnitus is worse at night & I still have the tinnitus). On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EAR DISCOMFORT (ear pressure and it feels plugged up, It's weird it effects your ears/ Ear fullness). On 07-Apr-2021, the patient experienced VACCINATION SITE REACTION (got Covid arm from the second shot). On an unknown date, the patient experienced PARANASAL SINUS DISCOMFORT (it was like my ears were opening up on a plane and my sinuses were opening up/sinnus pressure), PAIN (pain that felt weird that night), SINUS DISORDER (it did something weird to my sinuses), RHINORRHOEA (my nose wouldn't stop running) and SOMNOLENCE (you sort of sleep a day or two). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Ear discomfort, at a dose of 1 dosage form; VITAMIN C [ASCORBIC ACID] at a dose of 1 dosage form; ANTIOXIDANTS NOS at a dose of 1 dosage form; DICLOFENAC SODIUM (ANTI-INFLAMMATORY) at a dose of 1 dosage form and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) at an unspecified dose and frequency. On 12-Apr-2021, VACCINATION SITE REACTION (got Covid arm from the second shot) had resolved. On 06-Jun-2021, EAR DISCOMFORT (ear pressure and it feels plugged up, It's weird it effects your ears/ Ear fullness) had resolved. At the time of the report, TINNITUS (Tinnitus, tinnitus got worse, the tinnitus is worse at night & I still have the tinnitus) had not resolved, PARANASAL SINUS DISCOMFORT (it was like my ears were opening up on a plane and my sinuses were opening up/sinnus pressure), PAIN (pain that felt weird that night), RHINORRHOEA (my nose wouldn't stop running) and SOMNOLENCE (you sort of sleep a day or two) outcome was unknown and SINUS DISORDER (it did something weird to my sinuses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Patient used simple saline wash three times a day.  Patient also takes black pepper   This case was linked to MOD-2021-107101 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Updated the Patients Historical conditions, Allergies and Historical Vaccinations. Concomitant and treatment medications and Events also updated and Reporter information updated.