Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I felt covid symptoms on May 3 and tested positive with a home antigen test on May 4th/. I took another home antigen test and it is positive again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I felt covid symptoms on May 3 and tested positive with a home antigen test on May 4th/. I took another home antigen test and it is positive again) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056a22a) for COVID-19 vaccination.  Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.  The patient was taking unspecified medications/products within 2 weeks of starting COVID-19 treatment.  Previously administered products included for Product used for unknown indication: COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine. Concurrent medical conditions included Drug allergy (Name of Drug as Reported- no). Concomitant products included VENLAFAXINE for an unknown indication.  On 23-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (I felt covid symptoms on May 3 and tested positive with a home antigen test on May 4th/. I took another home antigen test and it is positive again). At the time of the report, COVID-19 (I felt covid symptoms on May 3 and tested positive with a home antigen test on May 4th/. I took another home antigen test and it is positive again) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive with a home antigen test. On 10-May-2022, SARS-CoV-2 test: negative (Negative) tested negative 7 days after. On 18-May-2022, SARS-CoV-2 test: positive (Positive) Home antigen test positive again.  On 17-May-2022 and 18-May-2022, the patient was feeling some symptoms again, stuffy nose, sore throat, sneezing, tired, a migraine headache and assumed it was allergies.  Company comment: This is a Spontaneous case concerning a 50-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious ADR of COVID-19, 25 days after the fourth dose of mRNA-1273 vaccine. No information about previous doses was disclosed. Patient reports that approximately 10 days after vaccination with mRNA-1273 vaccine, she felt COVID-19 symptoms and tested positive with a home antigen test, starting treatment with paxlovid. After 7 days, she completed treatment and tested negative for COVID-19. 25 days after the fourth dose of mRNA-1273 vaccine, she started feeling some symptoms again, such as stuffy nose, sore throat, sneezing, tiredness, migraine. She took another home antigen test and the result was positive again. At the time of the report, the event had not resolved. Paxlovid remains as a co-suspect product. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 50-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious ADR of COVID-19, 25 days after the fourth dose of mRNA-1273 vaccine. No information about previous doses was disclosed. Patient reports that approximately 10 days after vaccination with mRNA-1273 vaccine, she felt COVID-19 symptoms and tested positive with a home antigen test, starting treatment with paxlovid. After 7 days, she completed treatment and tested negative for COVID-19. 25 days after the fourth dose of mRNA-1273 vaccine, she started feeling some symptoms again, such as stuffy nose, sore throat, sneezing, tiredness, migraine. She took another home antigen test and the result was positive again. At the time of the report, the event had not resolved. Paxlovid remains as a co-suspect product. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.