Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive, Tinnitus
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (a week after getting the booster, I tested positive for COVID/mild COVID/a week after that I got a really bad headache for one day), TINNITUS (tinnitus started on that day and hasn't gone away/it's there 24/7/worse at night when I try to lie down/it's very pronounced for the first 1.5 hours in the morning/still dealing with it/signals in her brain are pulling this sound) and FRUSTRATION TOLERANCE DECREASED (it was extremely depressing when I found out that ENT couldn't help me) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 044B21A and 045A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (a week after getting the booster, I tested positive for COVID/mild COVID/a week after that I got a really bad headache for one day). On 17-Jan-2022, the patient experienced TINNITUS (tinnitus started on that day and hasn't gone away/it's there 24/7/worse at night when I try to lie down/it's very pronounced for the first 1.5 hours in the morning/still dealing with it/signals in her brain are pulling this sound) and FRUSTRATION TOLERANCE DECREASED (it was extremely depressing when I found out that ENT couldn't help me). At the time of the report, COVID-19 (a week after getting the booster, I tested positive for COVID/mild COVID/a week after that I got a really bad headache for one day), TINNITUS (tinnitus started on that day and hasn't gone away/it's there 24/7/worse at night when I try to lie down/it's very pronounced for the first 1.5 hours in the morning/still dealing with it/signals in her brain are pulling this sound) and FRUSTRATION TOLERANCE DECREASED (it was extremely depressing when I found out that ENT couldn't help me) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2022, SARS-CoV-2 test: (Positive) Positive.- No concomitant medications was reported. The patient had gone to the ENT but has not had any luck diagnosing or treating her symptoms. Her ENT had dismissed this stating that the signals in her brain are pulling this sound up based on a childhood memory. Patient said that the pitch of the tinnitus was like crickets chirping at night time. Event headache was the reported symptom of COVID-19. No treatment medications was reported. Company Comment: This is a spontaneous case concerning a 51-year-old, female patient with no reported medical history, who experienced the unexpected non-serious events of (AESI) Covid-19, Tinnitus and Frustration. The event Covid-19, occurred 7 days after the third dose of mRNA-1273 Vaccine. While the events Tinnitus and Frustration occurred 14days after the third dose of mRNA-1273 Vaccine. Patient tested positive for SARS COV-2. No further details on clinical course and treatment received were reported. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 51-year-old, female patient with no reported medical history, who experienced the unexpected non-serious events of (AESI) Covid-19, Tinnitus and Frustration. The event Covid-19, occurred 7 days after the third dose of mRNA-1273 Vaccine. While the events Tinnitus and Frustration occurred 14days after the third dose of mRNA-1273 Vaccine. Patient tested positive for SARS COV-2. No further details on clinical course and treatment received were reported. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.