Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID, patient had mild to moderate COVID symptoms; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive for COVID, patient had mild to moderate COVID symptoms) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart failure, Hypertension and Sarcoidosis.   In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient experienced COVID-19 (Patient tested positive for COVID, patient had mild to moderate COVID symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) at an unspecified dose and frequency. On 14-May-2022, COVID-19 (Patient tested positive for COVID, patient had mild to moderate COVID symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: positive (Positive) tested positive for COVID.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  HCP stated that a patient received the Moderna COVID-19 vaccine for the primary series as well as first booster dose (AUG2021) was past due for his 2nd booster dose. The patient tested positive for COVID on 9MAY2022.  The patient had mild to moderate COVID symptoms that lasted for 5 days. Patient was treated with Paxlovid for the COVID. Patient had recovered from COVID at this time. Patient had a history of heart failure, hypertension, and sarcoidosis. Patient was on medications but they were unknown to the HCP. HCP did not have information on the Moderna COVID-19 vaccination lot numbers or dates of administration of the previous doses and stated that the patient received one of the doses of the vaccine at a Pharmacy, but it was unknown which dose.  Company Comment: This is a spontaneous case concerning a 57-year-old male patient with concurrent medical conditions of heart failure, hypertension, and sarcoidosis, who experienced the unexpected non-serious AESI COVID-19 which occurred approximately 9 months after receiving the first booster dose of mRNA-1273 Vaccine. The patient tested positive for COVID and had unspecified mild to moderate COVID symptoms that lasted for 5 days. He was treated with Nirmatrelvir, Ritonavir (Paxlovid), Tylenol, and Mucinex DM. There is no available information regarding the first 2 doses in the COVID-19 vaccine series. The patient's heart failure, hypertension, and sarcoidosis, all of which increase the risk for COVID-19 infection, remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2022: Follow-up received contains no new information.; Sender's Comments: This is a spontaneous case concerning a 57-year-old male patient with concurrent medical conditions of heart failure, hypertension, and sarcoidosis, who experienced the unexpected non-serious AESI COVID-19 which occurred approximately 9 months after receiving the first booster dose of mRNA-1273 Vaccine. The patient tested positive for COVID and had unspecified mild to moderate COVID symptoms that lasted for 5 days. He was treated with Nirmatrelvir, Ritonavir (Paxlovid), Tylenol, and Mucinex DM. There is no available information regarding the first 2 doses in the COVID-19 vaccine series. The patient's heart failure, hypertension, and sarcoidosis, all of which increase the risk for COVID-19 infection, remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.