Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Received Janssen vaccine; I tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive) and INTERCHANGE OF VACCINE PRODUCTS (Received Janssen vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J+J (Dose Number: 1 Batch/Lot No: 202A21A Location of injection: Arm Left) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with J+J. Concurrent medical conditions included Allergy.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced COVID-19 (I tested positive). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Janssen vaccine). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 01-May-2022 for COVID-19 vaccination, at an unspecified dose and frequency. At the time of the report, COVID-19 (I tested positive) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Received Janssen vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) positive, positive (Positive) taking two home tests and negative (Negative) Negative.         Patient took Paxlovid the day after I tested positive, and took 4 doses over 2 days. I felt better immediately and discontinued because my mouth tasted l ke dirty metal and I was worried about what it was doing to my liver. I then tested negative over the following five days and felt fine, believing I was in the clear. Suddenly on day 6 after stopping Paxlovid, I felt ill with congestion and feeling very tired, and then tested positive within seconds of taking two home tests. This time I chose to ride it out based on what I am seeing online about rebound covid.  Company Comment:  This is a spontaneous case concerning a 51-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred 5 months and 11 days after a dose of mRNA-1273 vaccine. Interchange of vaccine products described as patient had received a dose of Janssen COVID-19 vaccine approximately 7 months prior to mRNA-1273, was also reported as an additional event. The patient took Paxlovid the day after she tested positive, and took 4 doses over 2 days. Patient felt better immediately and discontinued because of metal taste in the mouth. Patient tested negative for COVID-19 over the following days and felt fine, however few days after, patient felt ill with congestion and felt very tired. Patient underwent self-administered COVID-19 test and tested positive. Outcome of the event COVID-19 was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 51-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred 5 months and 11 days after a dose of mRNA-1273 vaccine. Interchange of vaccine products described as patient had received a dose of Janssen COVID-19 vaccine approximately 7 months prior to mRNA-1273, was also reported as an additional event. The patient took Paxlovid the day after she tested positive, and took 4 doses over 2 days. Patient felt better immediately and discontinued because of metal taste in the mouth. Patient tested negative for COVID-19 over the following days and felt fine, however few days after, patient felt ill with congestion and felt very tired. Patient underwent self-administered COVID-19 test and tested positive. Outcome of the event COVID-19 was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.