Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test, Streptococcal infection, Streptococcus test
Clinical narrative: tested positive for Strep; Sore arm; achy, had a headache and dry cough/tested positive for COVID-19/felt really bad; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (achy, had a headache and dry cough/tested positive for COVID-19/felt really bad), STREPTOCOCCAL INFECTION (tested positive for Strep) and PAIN IN EXTREMITY (Sore arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure abnormal and Allergy to antibiotic (Macrolide antibiotic). Concomitant products included LOSARTAN POTASSIUM for Blood pressure abnormal.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (achy, had a headache and dry cough/tested positive for COVID-19/felt really bad). On an unknown date, the patient experienced STREPTOCOCCAL INFECTION (tested positive for Strep) and PAIN IN EXTREMITY (Sore arm). At the time of the report, COVID-19 (achy, had a headache and dry cough/tested positive for COVID-19/felt really bad) was resolving and STREPTOCOCCAL INFECTION (tested positive for Strep) and PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Streptococcus test: (Positive) positive.         It was reported that the patient tested positive for COVID-19 and Streptococcus after receiving some of the Moderna COVID-19 vaccines. It was reported that patient received 5 doses of the Moderna COVID-19 Vaccine: the primary series (2) and 3 boosters. The patient felt really bad, achy, had a headache and dry cough and then tested positive for COVID-19 and Streptococcus. The patient was diagnosed with COVID-19 on the last days of Jun-2022.The major symptoms lasted a few days, then the patient just had a dry cough. Sore arm had not caused the patient to seek medical care and patient had not experienced a similar event in the past. COVID-19 and streptococcal infection caused patient to seek medical care, went to first care clinic. The patient had not experienced a similar event in the past. Antivirals and antibiotics were given as treatment. Event felt really bad subsumed under Covid-19  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No acute illness at the time of vaccination.   Company comment: This is a spontaneous case concerning a 58 years old male patient, with no relevant medical history, who experienced unexpected non serious AESI event of Covid-19, which occurred unspecified days after fourth dose (reported as second booster). Patient felt really bad, achy, had a headache and dry sough then tested positive for streptococcus and SARS-CoV-2 test Positive, patient went to first care clinic started on antibiotic macrolide. At the time of reporting event was resolving, Current ongoing pandemia is confounding for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-643485 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 58 years old male patient, with no relevant medical history, who experienced unexpected non serious AESI event of Covid-19, which occurred unspecified days after fourth dose (reported as second booster). Patient felt really bad, achy, had a headache and dry sough then tested positive for streptococcus and SARS-CoV-2 test Positive, patient went to first care clinic started on antibiotic macrolide. At the time of reporting event was resolving, Current ongoing pandemia is confounding for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.