Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid on Friday. Started Paxlovid on Sunday.  tested negative Saturday to Monday (at home antigen). Tuesday symptoms returned and tested positive (at home antigen); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid on Friday. Started Paxlovid on Sunday.  tested negative Saturday to Monday (at home antigen). Tuesday symptoms returned and tested positive (at home antigen)) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose number: 1 Batch/Lot number was unknown) on 24-Mar-2021 and Pfizer / BioNTech (Dose number: 2 Batch/Lot number was unknown) on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy (No drug was specified).    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for covid on Friday. Started Paxlovid on Sunday.  tested negative Saturday to Monday (at home antigen). Tuesday symptoms returned and tested positive (at home antigen)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-May-2022 to 27-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for covid on Friday. Started Paxlovid on Sunday.  tested negative Saturday to Monday (at home antigen). Tuesday symptoms returned and tested positive (at home antigen)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive for COVID on friday. On 28-May-2022, SARS-CoV-2 test: negative (Negative) tested negative Saturday to Monday (at home antigen). On 29-May-2022, SARS-CoV-2 test: negative (Negative) tested negative Saturday to Monday (at home antigen). On 30-May-2022, SARS-CoV-2 test: negative (Negative) tested negative Saturday to Monday (at home antigen). On 31-May-2022, SARS-CoV-2 test: positive (Positive) Around lunch time on Tuesday symptoms returned and tested positive.         Patient not had any other medications/Products within 2 weeks of started covid-19 treatment. Patient experienced COVID rebound after taking full course of paxlovid.  Patient tested positive for COVID on a friday. And started paxlovid on  sunday. Patient got tested negative on Saturday Monday (at home  antigen). Around lunch time on Tuesday 31 May 2022 symptoms  returned and patient tested positive (at home antigen)  Device  Date  31 May2022.  Company comment: This spontaneous case concerns a 41-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occured 6 months 10 days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 22-may-2022 to 27-may-202. She was tested positive again 4 days after the treatment with Paxlovid. Patient had received 2 doses of Comirnaty COVID-19 vaccine approximately 6 months 27 days prior to mRNA-1273 vaccination (Interchange of vaccine products). After paxlovid patient got tested negative at home antigen, symptoms returned again patient tested positive. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occured 6 months 10 days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 22-may-2022 to 27-may-202. She was tested positive again 4 days after the treatment with Paxlovid. Patient had received 2 doses of Comirnaty COVID-19 vaccine approximately 6 months 27 days prior to mRNA-1273 vaccination (Interchange of vaccine products). After paxlovid patient got tested negative at home antigen, symptoms returned again patient tested positive. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.