Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19 /  tested positive for covid, symptoms returning; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Treatment of COVID-19 /  tested positive for covid, symptoms returning) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J (Batch/Lot No: 1805018 Location of injection: Arm Left) on 20-May-2021. Past adverse reactions to the above products included No adverse event with J&J. Concurrent medical conditions included Drug allergy.   On 31-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient experienced COVID-19 (Treatment of COVID-19 /  tested positive for covid, symptoms returning). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Treatment of COVID-19 /  tested positive for covid, symptoms returning) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: positive, tested positive for covid on 10may (Positive) Positive,tested positive for covid on 10May. On 20-May-2022, SARS-CoV-2 test: positive positive.         Pfizer has permission to contact patient about this report  Pfizer also has permission to contact patient's healthcare provider about this report Patient post COVID vaccination medication was not tracked  Reported Event: patient tested positive for covid on 10th May, and doctor prescribed Paxlovid. patient took the full course of pills and felt better each day. patient took several home antigen tests, and each one showed a positive result,but with a fading positive line. However on May 20th, Patient felt symptoms returning and took another test and found the positive line thick and clear, indicating patients viral load has increased since getting off Paxlovid. Device Date :20May2022  Company comment: This is a spontaneous case concerning a 40-year-old, male patient with no reported medical history and with vaccine history of receiving unknown dose number of unspecified J and J vaccine and unknown dose number of mRNA-1273, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 4 days after the unknown dose number of mRNA-1273 vaccine administration. Allegedly the event was described as, approximately 4 days after the unknown dose number of mRNA-1273 vaccine patient was tested positive with Covid-19. The same day patient was prescribed with Nirmatrelvir (Paxlovid). Patient took the full course and felt better each day. Patient took several home antigen tests and each one showed a positive result, but with a fading positive line. However approximately 5 days after the full course of Nirmatrelvir (Paxlovid), patient felt that his symptoms were returning. Patient took another test which revealed positive line thick and clear. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 40-year-old, male patient with no reported medical history and with vaccine history of receiving unknown dose number of unspecified J and J vaccine and unknown dose number of mRNA-1273, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 4 days after the unknown dose number of mRNA-1273 vaccine administration. Allegedly the event was described as, approximately 4 days after the unknown dose number of mRNA-1273 vaccine patient was tested positive with Covid-19. The same day patient was prescribed with Nirmatrelvir (Paxlovid). Patient took the full course and felt better each day. Patient took several home antigen tests and each one showed a positive result, but with a fading positive line. However approximately 5 days after the full course of Nirmatrelvir (Paxlovid), patient felt that his symptoms were returning. Patient took another test which revealed positive line thick and clear. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.