Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19/had sneezing and blocked nose; Lack of efficacy; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive for COVID-19/had sneezing and blocked nose) and DRUG INEFFECTIVE (Lack of efficacy) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 023M20A and 042L20A) for COVID-19 vaccination.     The patient had no drug allergy. The patient had previously received a COVID-19 vaccine.  The patient's past medical history included Prostatectomy in January 2007.   On 21-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient experienced COVID-19 (Patient tested positive for COVID-19/had sneezing and blocked nose). 03-May-2022, the patient experienced DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 11-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient tested positive for COVID-19/had sneezing and blocked nose) had not resolved and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 12-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had started to notice symptoms on 03-May-2022, and the patient was tested positive on 05-May-2022. The patient was called by the primary care provider and was prescribed Paxlovid.  The patient started the 5 day regimen of Paxlovid on the afternoon of 06-May-2022 and finished on the afternoon of 11-May-2022.  A couple of days before 16-May-2022, the patient started sneezing and having blocked nose.  The device date was reported as 18-May-2022.  Company Comment: This is a spontaneous case concerning  a  80-year-old, male patient with no relevant medical history, who experienced the unexpected AESI non-serious event of Covid-19 and  unexpected non-serious event of Drug Ineffective. The events occurred 188 days after the third dose of mRNA-1273 COVID 19 Vaccine.  Patient tested positive for SARS-CoV-2 test on May 5, 2022. Patient was treated with nirmatrelvir, ritonavir tablets of unknown dosage and frequency. The patient started the 5 day regimen of nirmatrelvir, ritonavir tablets on the afternoon of 06-May-2022 and finished on the afternoon of 11-May-2022. A couple of days before 16-May-2022, the patient started sneezing and having blocked nose. The event Covid-19 was reported as not resolved, event Drug Ineffective outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  80-year-old, male patient with no relevant medical history, who experienced the unexpected AESI non-serious event of Covid-19 and  unexpected non-serious event of Drug Ineffective. The events occurred 188 days after the third dose of mRNA-1273 COVID 19 Vaccine.  Patient tested positive for SARS-CoV-2 test on May 5, 2022. Patient was treated with nirmatrelvir, ritonavir tablets of unknown dosage and frequency. The patient started the 5 day regimen of nirmatrelvir, ritonavir tablets on the afternoon of 06-May-2022 and finished on the afternoon of 11-May-2022. A couple of days before 16-May-2022, the patient started sneezing and having blocked nose. The event Covid-19 was reported as not resolved, event Drug Ineffective outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.