Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Night sweats, Pain in extremity, SARS-CoV-2 test
Clinical narrative: night sweats after COVID-19; COVID-19; a bit of dizziness; very sore arm; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), NIGHT SWEATS (night sweats after COVID-19), DIZZINESS (a bit of dizziness) and PAIN IN EXTREMITY (very sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies (medications, food and other products). There was no other vaccines given within one month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma (Started 20 years ago. There was no improvement or worsening.) and Diabetes (Started 20 years ago. There was some improvement in the condition.). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, METFORMIN and EMPAGLIFLOZIN (JARDIANCE) for Diabetes.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced DIZZINESS (a bit of dizziness) and PAIN IN EXTREMITY (very sore arm). On 30-Jun-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced NIGHT SWEATS (night sweats after COVID-19). In November 2021, DIZZINESS (a bit of dizziness) and PAIN IN EXTREMITY (very sore arm) had resolved. At the time of the report, COVID-19 (COVID-19) was resolving and NIGHT SWEATS (night sweats after COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jun-2022, SARS-CoV-2 test: (Positive) Positive.         The patient did not experience similar events in the past and did not seek medical care (office visit, Urgent care, ER, hospitalization). The patient was still experiencing symptoms because of COVID-19. The patient experienced bit of dizziness and very sore arm for 1 or 2 days.  No treatment was provided for the symptoms. Company comment: This Spontaneous case concerns a 62-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 occurred approximately 8 months after receiving a dose of third dose of mRNA-1273 vaccine and SARS-CoV-2 test was positive approximately 8 months after to the current vaccination. No information was provided regarding the symptoms, clinical course, other labs, and diagnostic procedures done and treatment details. Ongoing Covid 19 pandemic and interchange of vaccine products remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event Seriousness assessment assessed as per medical judgement.   This case was linked to MOD-2022-599993 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 62-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 occurred approximately 8 months after receiving a dose of third dose of mRNA-1273 vaccine and SARS-CoV-2 test was positive approximately 8 months after to the current vaccination. No information was provided regarding the symptoms, clinical course, other labs, and diagnostic procedures done and treatment details. Ongoing Covid 19 pandemic and interchange of vaccine products remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event Seriousness assessment assessed as per medical judgement.