Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Myalgia, Nasopharyngitis, Night sweats, Tremor
Clinical narrative: Ear infection/His doctor said that his left ear was inflamed, red, and oozing and his right ear was cloudy with his eardrum inverted and pulled in instead of out; Head cold; doctor said left ear was oozing, red, and inflamed; It's affected my immune system in some way; Felt like he had 5 pounds of fluid built up in his head and it felt really heavy.; 6 weeks ago one morning I woke up and couldn't hear anything; He was sweating at night; His body shook all night long; His whole body was hurting like he had a severe case of the flu/muscles hurt; Joints hurt; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (6 weeks ago one morning I woke up and couldn't hear anything) in a 60-year-old male 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 never had COVID positive test or diagnosis.  The patient's past medical history included Ear infection (When patient was 16 years old). Concurrent medical conditions included Shellfish allergy, Peanut allergy and Blood pressure abnormal.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced NIGHT SWEATS (He was sweating at night), TREMOR (His body shook all night long), MYALGIA (His whole body was hurting like he had a severe case of the flu/muscles hurt) and ARTHRALGIA (Joints hurt). In 2022, the patient experienced DEAFNESS (6 weeks ago one morning I woke up and couldn't hear anything) (seriousness criterion medically significant). On 03-Nov-2022, the patient experienced HEAD DISCOMFORT (Felt like he had 5 pounds of fluid built up in his head and it felt really heavy.). On an unknown date, the patient experienced EAR INFECTION (Ear infection/His doctor said that his left ear was inflamed, red, and oozing and his right ear was cloudy with his eardrum inverted and pulled in instead of out), NASOPHARYNGITIS (Head cold), ERYTHEMA (doctor said left ear was oozing, red, and inflamed) and IMMUNE SYSTEM DISORDER (It's affected my immune system in some way). In September 2021, NIGHT SWEATS (He was sweating at night), TREMOR (His body shook all night long), MYALGIA (His whole body was hurting like he had a severe case of the flu/muscles hurt) and ARTHRALGIA (Joints hurt) had resolved. At the time of the report, DEAFNESS (6 weeks ago one morning I woke up and couldn't hear anything), EAR INFECTION (Ear infection/His doctor said that his left ear was inflamed, red, and oozing and his right ear was cloudy with his eardrum inverted and pulled in instead of out), NASOPHARYNGITIS (Head cold) and ERYTHEMA (doctor said left ear was oozing, red, and inflamed) had not resolved and IMMUNE SYSTEM DISORDER (It's affected my immune system in some way) and HEAD DISCOMFORT (Felt like he had 5 pounds of fluid built up in his head and it felt really heavy.) outcome was unknown.            Concomitant medication included blood pressure medication. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient states that he could have had a possible COVID infection in the past but he was not sure because he never got tested at that time. The patient did not experienced any reactions to the 1st dose, not even a headache. Approximately 8 hours after receiving 2nd shot the patient started experiencing side effects as body shook all night long, whole body was hurting like patient had a severe case of the flu, sweating at night, joints and muscles hurt and stated it was just overall rough for 10 hours. Patient felt better the next morning after drinking coffee and taking a hot bath. However, approximately 6 weeks ago, patient woke up one morning and just could not hear out of his ears, went to see ENT who told patient that the patient had severe infection in ears. Doctor said that left ear was inflamed, red, oozing and right ear was cloudy with eardrum inverted and pulled in instead of out. The patient had two perforations in left ear since the ear issues started. Even at the time of report patient's ears were so sore that patient can barely touch them. Both ears had been getting fluids in them. Draining the fluids out of patient's ears every day. Hearing was decreased dramatically. A week after found out had an ear infection, fluid built up in left ear and blew out eardrum. The patient had similar issue when patient was 16 years old. Patient had a major ear infection due to which eardrum blew out. The patient was almost going for a surgery for that issue, but the infection healed itself and patient did not need it. The patient stated that it was definitely to be the Moderna COVID-19 vaccine causing it. The patient was put on two rounds of antibiotics and 1 round of steroids. Also tried taking over the counter medications as well as natural supplements but nothing seems to be working in healing ears.   This case was linked to MODERNATX, INC.-MOD-2022-669102, MODERNATX, INC.-MOD-2022-669115 (E2B Linked Report).  Company comment: This is a spontaneous case concerning a 60-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of deafness and unexpected non-serious events of decreased appetite, malaise, arthralgia, chills, nausea, myalgia, fatigue and headache and expected non-serious events of  Myalgia, Arthralgia. The exact date of administration of first and second dose of mRNA-1273 and onset of the events was not specified, however reported stated some days interval after the event occurred. The patient did not experienced any reactions to the 1st dose, not even a headache. Approximately 8 hours after receiving 2nd shot the patient started experiencing side effects as body shook all night long, whole body was hurting like patient had a severe case of the flu, sweating at night, joints and muscles hurt and stated it was just overall rough for 10 hours. Patient felt better the next morning after drinking coffee and taking a hot bath. However, approximately 6 weeks ago, patient woke up one morning and just could not hear out of his ears, went to see ENT who told patient that the patient had severe infection in ears. Doctor said that left ear was inflamed, red, oozing and right ear was cloudy with eardrum inverted and pulled in instead of out. The patient had two perforations in left ear since the ear issues started  No further details on lab test results and treatment received were reported. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2022: Follow up received. Updated reporter and patient details, added medical history, suspect information, events and updated narrative.; Sender's Comments: This is a spontaneous case concerning  a  60-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of deafness and unexpected non-serious events of decreased appetite, malaise, arthralgia, chills, nausea, myalgia, fatigue and headache and expected non-serious events of  Myalgia, Arthralgia. The exact date of administration of first and second dose of mRNA-1273 and onset of the events was not specified, however reported stated some days interval after the event occurred. The patient did not experienced any reactions to the 1st dose, not even a headache. Approximately 8 hours after receiving 2nd shot the patient started experiencing side effects as body shook all night long, whole body was hurting like patient had a severe case of the flu, sweating at night, joints and muscles hurt and stated it was just overall rough for 10 hours. Patient felt better the next morning after drinking coffee and taking a hot bath. However, approximately 6 weeks ago, patient woke up one morning and just could not hear out of his ears, went to see ENT who told patient that the patient had severe infection in ears. Doctor said that left ear was inflamed, red, oozing and right ear was cloudy with eardrum inverted and pulled in instead of out. The patient had two perforations in left ear since the ear issues started  No further details on lab test results and treatment received were reported. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report. MODERNATX, INC.-MOD-2022-669102:same reporter MODERNATX, INC.-MOD-2022-669115:same reporter