Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, SARS-CoV-2 test, Scratch, Sinus congestion, Upper-airway cough syndrome
Clinical narrative: lot of phlegm in her system,she had a cough, a lot of cough; scratches on her right ear; fullness in her head; felt like blood in her upper system/She had a strange feeling,panic attack; ear infection,ear bulging; inflammation/inflammation in her leg and body.; blood pressure was going up; vascular issue; light headed/felt dizzy; woke up deaf on her left side; congested in the sinus area; very, very congested with post nasal dripping; voice changed in the front/voice got hoarse; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (woke up deaf on her left side) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure low.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced SINUS CONGESTION (congested in the sinus area), UPPER-AIRWAY COUGH SYNDROME (very, very congested with post nasal dripping) and DYSPHONIA (voice changed in the front/voice got hoarse). On an unknown date, the patient experienced DEAFNESS UNILATERAL (woke up deaf on her left side) (seriousness criterion medically significant), PRODUCTIVE COUGH (lot of phlegm in her system, she had a cough, a lot of cough), SCRATCH (scratches on her right ear), HEAD DISCOMFORT (fullness in her head), PANIC ATTACK (felt like blood in her upper system/She had a strange feeling, panic attack), EAR INFECTION (ear infection, ear bulging), INFLAMMATION (inflammation/inflammation in her leg and body.), HYPERTENSION (blood pressure was going up), ANGIOPATHY (vascular issue) and DIZZINESS (light headed/felt dizzy). The patient was treated with BENZYLPENICILLIN POTASSIUM (PENICILLIN [BENZYLPENICILLIN POTASSIUM]) at an unspecified dose and frequency and PREDNISONE at a dose of prednisone high dose. At the time of the report, DEAFNESS UNILATERAL (woke up deaf on her left side), DYSPHONIA (voice changed in the front/voice got hoarse), PRODUCTIVE COUGH (lot of phlegm in her system, she had a cough, a lot of cough), SCRATCH (scratches on her right ear), HEAD DISCOMFORT (fullness in her head), PANIC ATTACK (felt like blood in her upper system/She had a strange feeling, panic attack), EAR INFECTION (ear infection, ear bulging), INFLAMMATION (inflammation/inflammation in her leg and body.), HYPERTENSION (blood pressure was going up), ANGIOPATHY (vascular issue) and DIZZINESS (light headed/felt dizzy) outcome was unknown and SINUS CONGESTION (congested in the sinus area) and UPPER-AIRWAY COUGH SYNDROME (very, very congested with post nasal dripping) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Blood pressure measurement: blood pressure going up (High) blood pressure going up and had low bp (Low) had low BP.         No concomitant medication was reported.  It was reported that after her booster dose of the Moderna COVID-19 vaccine on 30-Nov-2021, she started to experience adverse reactions.  She came back, she had a cough, a lot of cough, and a lot of phlegm in her system. She reported being light headed. She woke up deaf on her left side, scratches on her right ear, she did not know what to do. She had a sense of fullness in her head, she panicked, she went to the ER, she had a panic attack, felt like blood in her upper system. She had a strange feeling. So, she went to the hospital, the hospital misdiagnosed her. They said she had an ear infection; her ear was bulging. They gave her penicillin, she got it, she started taking it, she felt dizzy. She called her PCP, and she said she felt it was inflammation. She never had her blood pressure going up, she always had low BP. 3 days later, they started her on steroids, she reported it must be a vascular issue.  Company comment: This spontaneous case concerns a 59-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event Deafness unilateral on an unspecified date after the third dose of mRNA-1273. The patient experienced congestion in the sinus area with postnasal dripping, change of voice and then next day, she woke up deaf on her left side. SARS-CoV-2 test was negative. At the time of reporting, the event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD22-010135 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a 59-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event Deafness unilateral on an unspecified date after the third dose of mRNA-1273. The patient experienced congestion in the sinus area with postnasal dripping, change of voice and then next day, she woke up deaf on her left side. SARS-CoV-2 test was negative. At the time of reporting, the event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. MOD22-010135:Cross linked