Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-1 test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: After resolution of symptomatic covid, and negative pcr and antigen tests, covid recurred.; Vaccination failure; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (After resolution of symptomatic covid, and negative pcr and antigen tests, covid recurred.) and VACCINATION FAILURE (Vaccination failure) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Overweight and Drug allergy (Naproxen). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 04-Jan-2021 to 02-May-2022 and ASPIRIN [ACETYLSALICYLIC ACID] from 14-Jun-2021 to 02-May-2022 for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 02-May-2022, the patient experienced COVID-19 (After resolution of symptomatic covid, and negative pcr and antigen tests, covid recurred.) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (After resolution of symptomatic covid, and negative pcr and antigen tests, covid recurred.) had resolved and VACCINATION FAILURE (Vaccination failure) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2022, SARS-CoV-1 test: positive (Positive) Positive. On 06-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 08-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 11-May-2022, SARS-CoV-1 test: negative (Negative) Negative. On 12-May-2022, SARS-CoV-1 test: negative (Negative) Negative. On 13-May-2022, SARS-CoV-1 test: positive (Positive) Positive. On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 15-May-2022, SARS-CoV-1 test: positive (Positive) Positive. On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 16-May-2022, SARS-CoV-1 test: positive (Positive) Positive. On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 17-May-2022, SARS-CoV-1 test: negative (Negative) Negative. On 18-May-2022, SARS-CoV-1 test: negative (Negative) Negative. On 19-May-2022, SARS-CoV-1 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient  took  other medications/products within 2 weeks of starting COVID-19 treatment.   Patient previously received a COVID-19 Vaccine.  Reporter reported after resolution of symptomatic covid and negative pcr and antigen tests, covid recurred 5 Days after last paxlovid dose. This was confirmed by positive by PCR and antigen test.  Infection started on 29/30 April- 2022. On 01-May-2022  there was onset of symptom and on 05-May-2022 symptoms resolved. On 10-May-2022 symptoms returned.  For treatment patient was scheduled to get monoclonal on 14-May-2022.  It was reported that patient received Bebtelovimab on 14-May-2022.   On 16-May-2022 symptoms resolved.  Company comment- This spontaneous case concerns a 50-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 1 year and 67 days after receiving the second dose of mRNA-1273 Vaccine.  Additionally, Vaccination Failure was also reported.  The interval between the first and second doses of mRNA was noted to be 28 days. The patient tested for Covid-19 1 year and 67 days after his second dose of mRNA-1273 and was symptomatic. He took Paxlovid and the symptoms resolved along with a negative PCR and antigen test. However, 5 days after taking paxlovid, the symptoms recurred along with a positive PCR and antigen test. He then took Bebtelovimab and symptoms resolved 2 days after. Outcome of the events was resolved at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Follow-up received lab test and infection date updated.; Sender's Comments: This spontaneous case concerns a 50-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 1 year and 67 days after receiving the second dose of mRNA-1273 Vaccine.  Additionally, Vaccination Failure was also reported.  The interval between the first and second doses of mRNA was noted to be 28 days. The patient tested for Covid-19 1 year and 67 days after his second dose of mRNA-1273 and was symptomatic. He took Paxlovid and the symptoms resolved along with a negative PCR and antigen test. However, 5 days after taking paxlovid, the symptoms recurred along with a positive PCR and antigen test. He then took Bebtelovimab and symptoms resolved 2 days after. Outcome of the events was resolved at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.