Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Tinnitus
Clinical narrative: Bilateral tinnitus; Successfully completed the course of Paxlovid on 5/13/22. Symptomatically improved. Afebrile. Rapid antigen test negative. Repeated rapid antigen test negative on 5/14/22 and again 5/16/22 prior to re; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Successfully completed the course of Paxlovid on 5/13/22. Symptomatically improved. Afebrile. Rapid antigen test negative. Repeated rapid antigen test negative on 5/14/22 and again 5/16/22 prior to re) and TINNITUS (Bilateral tinnitus) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 025L20A and 007M20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Tinnitus. Concomitant products included IBUPROFEN from 09-May-2022 to 13-May-2022 for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 17-May-2022, the patient experienced COVID-19 (Successfully completed the course of Paxlovid on 5/13/22. Symptomatically improved. Afebrile. Rapid antigen test negative. Repeated rapid antigen test negative on 5/14/22 and again 5/16/22 prior to re). On an unknown date, the patient experienced TINNITUS (Bilateral tinnitus). At the time of the report, COVID-19 (Successfully completed the course of Paxlovid on 5/13/22. Symptomatically improved. Afebrile. Rapid antigen test negative. Repeated rapid antigen test negative on 5/14/22 and again 5/16/22 prior to re) had not resolved and TINNITUS (Bilateral tinnitus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: negative (Negative) negative. On 16-May-2022, SARS-CoV-2 test: negative (Negative) negative. On 17-May-2022, Body temperature: 100.4 (High) fever as high as 100.4°F. On 17-May-2022, SARS-CoV-2 test: negative (Negative) negative and positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient Successfully completed the course of Paxlovid on 5/13/22. Symptomatically improved. Afebrile. Rapid antigen test negative. Repeated rapid antigen test negative on 5/14/22 and again 5/16/22 prior to re returning to work. On Tuesday, 5/17/22, awoke with headache, worsening nasal congestion, cough, scratchy throat, malaise. Retested at my office and rapid antigen test now positive. Confirmed by PCR same day. Symptoms have worsened throughout the day including fever as high as 100.4°F. Bilateral tinnitus. No loss of taste or smell. Device Date: 17May2022  Company comment: This spontaneous case concerns a 66-year-old male patient with no relevant medical history, who experienced the unexpected non-serious AESI of COVID-19 which occurred unspecified days after receiving the third dose of mRNA-1273 vaccine It was reported that the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose on 09-May-2022 and experienced COVID-19 (Successfully completed the course of Paxlovid on 5/13/22. Symptomatically improved. Afebrile. Rapid antigen test negative. Repeated rapid antigen test negative on 5/14/22 and again 5/16/22 ). 17-May-2022, SARS-CoV-2 test was negative and positive later as on 17-May-2022.COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66-year-old male patient with no relevant medical history, who experienced the unexpected non-serious AESI of COVID-19 which occurred unspecified days after receiving the third dose of mRNA-1273 vaccine It was reported that the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose on 09-May-2022 and experienced COVID-19 (Successfully completed the course of Paxlovid on 5/13/22. Symptomatically improved. Afebrile. Rapid antigen test negative. Repeated rapid antigen test negative on 5/14/22 and again 5/16/22 ). 17-May-2022, SARS-CoV-2 test was negative and positive later as on 17-May-2022.COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.