Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound Covid after taking Paxlovid May 3-7 2022. First tested positive morning of May 3. Tested negative on May 8; Patient received 1st and 2nd dose of Pfizer and 3rd dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound Covid after taking Paxlovid May 3-7 2022. First tested positive morning of May 3. Tested negative on May 8) and INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st and 2nd dose of Pfizer and 3rd dose of Moderna) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient had received Covid-19 vaccine previously.  Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EP6955 Location of injection: Arm Right) on 22-Mar-2021 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EW0164 Location of injection: Arm Right) on 29-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Allergy.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st and 2nd dose of Pfizer and 3rd dose of Moderna). On 03-May-2022, the patient experienced COVID-19 (Rebound Covid after taking Paxlovid May 3-7 2022. First tested positive morning of May 3. Tested negative on May 8). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 07-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound Covid after taking Paxlovid May 3-7 2022. First tested positive morning of May 3. Tested negative on May 8) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st and 2nd dose of Pfizer and 3rd dose of Moderna) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 08-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information provided.  There was a rebound Covid after taking Paxlovid. The patient first tested positive on morning of 03 May 2022 and then tested negative on 08 May 2022. The symptoms started again on 16 May 2022 (worse this time) and tested positive again on 18 May 2022. The patient still feeling symptomatic  Device date reported as 21-May-2022.  Company comment: This spontaneous case concerns a 65 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, about 5 months and 11 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Additionally, Interchange of vaccine products was noted. The patient received the previous two doses with Pfizer vaccine, the last dose being given about 5 months and 24 days prior to mRNA-1273 vaccine, with no reported adverse events. The patient tested positive for COVID-19 and started taking Paxlovid for 5 days after which she tested negative for COVID-19. However, she developed rebound COVID-19 and tested positive for COVID-19, 9 days later. The event was not resolved. Elderly age of the patient and the ongoing COVID-19 pandemic could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, about 5 months and 11 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Additionally, Interchange of vaccine products was noted. The patient received the previous two doses with Pfizer vaccine, the last dose being given about 5 months and 24 days prior to mRNA-1273 vaccine, with no reported adverse events.The patient tested positive for COVID-19 and started taking Paxlovid for 5 days after which she tested negative for COVID-19. However, she developed rebound COVID-19 and tested positive for COVID-19, 9 days later. The event was not resolved. Elderly age of the patient and the ongoing COVID-19 pandemic could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.