Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain, Visual impairment
Clinical narrative: recovering kidneys; Sore arm for two days; I had sparkles in my eyes; Burning Left Foot; ringing in both ears, started soft and grew louder, loud buzzing in my head; I developed a persistant dry cough; Dry cough turned into shortness of breath; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (I developed a persistant dry cough), DYSPNOEA (Dry cough turned into shortness of breath), BURNING SENSATION (Burning Left Foot) and TINNITUS (ringing in both ears, started soft and grew louder, loud buzzing in my head) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder. Concomitant products included OMEGA-3 FATTY ACIDS from 07-Jan-2019 to an unknown date for Fatty acid supplementation, MAGNESIUM from 02-Jan-2021 to an unknown date for Magnesium supplementation, CYANOCOBALAMIN (B-12) from 07-Jan-2019 to an unknown date for Vitamin B12 supplementation.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 03-May-2021, the patient experienced COUGH (I developed a persistant dry cough) (seriousness criterion hospitalization prolonged). 03-May-2021, the patient experienced DYSPNOEA (Dry cough turned into shortness of breath) (seriousness criterion hospitalization prolonged). On 11-May-2021, the patient experienced BURNING SENSATION (Burning Left Foot) (seriousness criterion hospitalization prolonged) and TINNITUS (ringing in both ears, started soft and grew louder, loud buzzing in my head) (seriousness criterion hospitalization prolonged). On 11-Jun-2021, the patient experienced VISUAL IMPAIRMENT (I had sparkles in my eyes). On an unknown date, the patient experienced RENAL DISORDER (recovering kidneys) and MYALGIA (Sore arm for two days). The patient was hospitalized from 11-Jun-2021 to 28-Jul-2021 due to BURNING SENSATION, COUGH, DYSPNOEA and TINNITUS. At the time of the report, COUGH (I developed a persistant dry cough), DYSPNOEA (Dry cough turned into shortness of breath), BURNING SENSATION (Burning Left Foot) and TINNITUS (ringing in both ears, started soft and grew louder, loud buzzing in my head) had not resolved, VISUAL IMPAIRMENT (I had sparkles in my eyes) outcome was unknown, RENAL DISORDER (recovering kidneys) was resolving and VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Sore arm for two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jun-2021, Computerised tomogram: normal (normal) normal. On 18-Jun-2021, Chest X-ray: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COUGH (I developed a persistant dry cough), DYSPNOEA (Dry cough turned into shortness of breath), BURNING SENSATION (Burning Left Foot) and TINNITUS (ringing in both ears, started soft and grew louder, loud buzzing in my head) to be possibly related. No further causality assessments were provided for VISUAL IMPAIRMENT (I had sparkles in my eyes), RENAL DISORDER (recovering kidneys), VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Sore arm for two days).    Treatment information was not provided by the reporter.  Upon follow up information received on 13 Aug 2021, event myalgia was added. Other relevant history added.  Company comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-259201 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received on 30-JUL-2021. Contains  No New Information. On 13-Aug-2021: Follow-up received on 13-AUG-2021 and included New event , Relevant history and reporters were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the events, a causal relationship cannot be excluded.