Age: 79.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I received the positive results and now I am coughing again and am a bit congested, so took a rapid test and am positive but I was negative four days ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I received the positive results and now I am coughing again and am a bit congested, so took a rapid test and am positive but I was negative four days ago) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 033C21A, 012M20A and 012L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergy NOS (unknown historical drug). Concomitant products included APIXABAN (ELIQUIS), ROSUVASTATIN CALCIUM (CRESTOR) and TAMSULOSIN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-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 16-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 14-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (I received the positive results and now I am coughing again and am a bit congested, so took a rapid test and am positive but I was negative four days ago). At the time of the report, COVID-19 (I received the positive results and now I am coughing again and am a bit congested, so took a rapid test and am positive but I was negative four days ago) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications was provided by the reporter.  Patient date of birth was reported as AUG-1942.  Patient had symptoms such coughing again and a bit congested and so took a rapid test and patient was positive.  the patient took other medications/products within 2 weeks of starting COVID-19 treatment and patient previously receive a COVID-19 Vaccine  Company comment: This spontaneous case concerns a 79 year old male patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, about 1 month and 28 days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Additionally, an event of Vaccination failure was noted. The patient received the previous three doses with mRNA-1273 vaccine and the primary series was in accordance with the recommended schedule. Patient was taking Paxlovid for COVID-19 infection after which he tested negative. However, soon he developed cough and congestion and tested positive for COVID-19. The outcome of the event was not known. Elderly age of the patient and ongoing COVID-19 pandemic could be risk factors for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79 year old male patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, about 1 month and 28 days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Additionally, an event of Vaccination failure was noted. The patient received the previous three doses with mRNA-1273 vaccine and the primary series was in accordance with the recommended schedule. Patient was taking Paxlovid for COVID-19 infection after which he tested negative. However, soon he developed cough and congestion and tested positive for COVID-19. The outcome of the event was not known. Elderly age of the patient and ongoing COVID-19 pandemic could be risk factors for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.