Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test
Clinical narrative: had rebound/breakthrough infections/tested positive/disease comes back, not re-infected its the same infection but it goes away for a week; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (had rebound/breakthrough infections/tested positive/disease comes back, not re-infected its the same infection but it goes away for a week) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 017A21A, 032L20A and 026L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer and Heart disease, unspecified. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), CARVEDILOL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and LOSARTAN for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BREAKTHROUGH COVID-19 (had rebound/breakthrough infections/tested positive/disease comes back, not re-infected its the same infection but it goes away for a week). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, BREAKTHROUGH COVID-19 (had rebound/breakthrough infections/tested positive/disease comes back, not re-infected its the same infection but it goes away for a week) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         They had 4 doses of Moderna each and were at a super spreader event. Patient had chills, was sicker than the caller. Patient took it twice Paxlovid (pfizer antiviral for covid) because of his heart condition. Patient had rebound where the disease comes back, not re-infected its the same infection but it went away for a week and comes back. Patient had to isolate.  Company Comment: This spontaneous case concerns a 69-year-old, male patient with relevant medical history of Cancer (unspecified) and Heart disease (unspecified), and past drug history of administration of three doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious event of breakthrough COVID-19. The event occurred approximately 1 month after receiving the fourth dose (first booster dose) of the mRNA-1273 vaccine. It was reported that the patient experienced chills and tested positive for SARS-CoV-2. It was also reported that the patient took Paxlovid (nirmatrelvir, ritonavir) 'twice' due to his heart condition (unspecified). The dose, frequency and duration were not provided. Of note, it was reported that the patient had 'rebound infection' (where the disease comes back, not re-infected it's the same infection but it goes away for a week and comes back) and he had to isolate. Moreover, it was also reported that the patient 'had breakthrough infections with the Moderna vaccine after all of their doses' (four doses). The medical history of Cancer (unspecified) and Heart disease (unspecified), which are known risk factors for COVID-19, remains a confounder. The patient's advanced age (high risk for infections) also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old, male patient with relevant medical history of Cancer (unspecified) and Heart disease (unspecified), and past drug history of administration of three doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious event of breakthrough COVID-19. The event occurred approximately 1 month after receiving the fourth dose (first booster dose) of the mRNA-1273 vaccine. It was reported that the patient experienced chills and tested positive for SARS-CoV-2. It was also reported that the patient took Paxlovid (nirmatrelvir, ritonavir) 'twice' due to his heart condition (unspecified). The dose, frequency and duration were not provided. Of note, it was reported that the patient had 'rebound infection' (where the disease comes back, not re-infected it's the same infection but it goes away for a week and comes back) and he had to isolate. Moreover, it was also reported that the patient 'had breakthrough infections with the Moderna vaccine after all of their doses' (four doses). The medical history of Cancer (unspecified) and Heart disease (unspecified), which are known risk factors for COVID-19, remains a confounder. The patient's advanced age (high risk for infections) also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.