Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had 2 moderna doses and 2 boosters, got covid, had symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (had 2 moderna doses and 2 boosters, got covid, had symptoms) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 23-Dec-2020 at 4:15 PM, the patient received first 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, the patient experienced COVID-19 (had 2 moderna doses and 2 boosters, got covid, had symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (had 2 moderna doses and 2 boosters, got covid, had symptoms) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) took antigen at home and tested positive again, negative (Negative) Negative and positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. The patient reported that he had 2 Moderna doses and 2 boosters. The patient got covid, had symptoms, took paxlovid after a bad night of symptoms and within 3 days symptoms gone, tested negative. Then 4 days later started getting bad cold like symptoms again, retested tested positive in pcr test. Took antigen test at home and tested positive again. Also stated reading of others reporting the same thing, feel like paxlovid in the end made things much worse because it made patient feel like after is 10 days isolation period, he was non-infectious. The patient think it somehow lowered his immune response allowing the same virus to get through what would have been his body's reaction period, since paxlovid in early 5 days the virus took hold again, and symptoms came back almost worse than initial plus we went out and exposed people. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Company Comment: This spontaneous case concerns a 51 year old male patient with no relevant medical history reported , who experienced Non-serious, unexpected.  AESI of Covid 19 which occurred on an unknown date post vaccination with the dose 1 and dose 2 of mRNA-1273 vaccine. Date of vaccination for dose 1 was reported on 23-12-2020 while for dose 2 date of vaccination was not reported. This patient mentioned that he had two booster doses  of Covid 19 vaccine however it is not clear if these two booster doses were mRNA-1273 vaccine as well .  He took  NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency  after a bad night of symptoms and within 3 days symptoms  were gone, and tested negative. Then  four  days later started getting bad cold like symptoms again, retested tested positive in  PCR  test,  took antigen test at home and tested positive again. The other treatment details, results of other laboratories .diagnostic procedures were not reported. There was also no report if any medical consult was done. Outcome of the event is resolving. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51 year old male patient with no relevant medical history reported , who experienced Non-serious, unexpected.  AESI of Covid 19 which occurred on an unknown date post vaccination with the dose 1 and dose 2 of mRNA-1273 vaccine. Date of vaccination for dose 1 was reported on 23-12-2020 while for dose 2 date of vaccination was not reported. This patient mentioned that he had two booster doses  of Covid 19 vaccine however it is not clear if these two booster doses were mRNA-1273 vaccine as well .  He took  NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency  after a bad night of symptoms and within 3 days symptoms  were gone, and tested negative. Then  four  days later started getting bad cold like symptoms again, retested tested positive in  PCR  test,  took antigen test at home and tested positive again. The other treatment details, results of other laboratories .diagnostic procedures were not reported. There was also no report if any medical consult was done. Outcome of the event is resolving. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.