Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: On an unknown date patient was treated with Nirmatrelvir and Ritonavir for covid-19; Interchange of vaccine products; Tested positive for covid on day 11; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (On an unknown date patient was treated with Nirmatrelvir and Ritonavir for covid-19), COVID-19 (Tested positive for covid on day 11), DRUG INEFFECTIVE (Lack of drug effect) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Dose 1, Batch lot no. EL9267, Administration site- Left arm and time of vaccination 12:00 PM) on 15-Feb-2021, Pfizer / BioNTech (Dose 2, Batch lot no. EN6198, Administration site- Left arm and time of vaccination 12:00 PM) on 08-Mar-2021, Pfizer / BioNTech (Dose 3, Batch lot no. FF8839 and Administration site- Left arm and time of vaccination 12:00 PM) on 10-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy. Concomitant products included ROSUVASTATIN from an unknown date to 05-May-2022 and AMLODIPINE BESYLATE for an unknown indication.    On 30-Mar-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On 14-May-2022 at 10:00 PM, the patient experienced COVID-19 (Tested positive for covid on day 11). On an unknown date, the patient experienced COVID-19 (On an unknown date patient was treated with Nirmatrelvir and Ritonavir for covid-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 10-May-2022, COVID-19 (On an unknown date patient was treated with Nirmatrelvir and Ritonavir for covid-19) had resolved. At the time of the report, COVID-19 (Tested positive for covid on day 11) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: negative Tested negative on day 6.. On 14-May-2022, SARS-CoV-2 test: positive Tested positive for COVID on day 11.. On an unknown date, SARS-CoV-2 test: positive Positive.         It was reported as patient tested positive again one day after completed treatment with paxlovid.  Company Comment: This spontaneous case concerns a 60-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine and unexpected non-serious AESI of COVID-19 which occurred 1 month and 14 days after the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Drug ineffective was also reported.  Patient was treated with Nirmatrelvir and Ritonavir for covid-19 from 05-May-2022 to 09-May-2022, Patient tested negative for COVID-19 on day 6. As the symptoms reoccurred on day 10 and she was tested positive again one day after completing the treatment with paxlovid.  Patient was noted to have received three doses with Pfizer / BioNTech approximately 14, 13 and 7 months prior to current vaccination (Interchange of vaccine products). COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine and unexpected non-serious AESI of COVID-19 which occurred 1 month and 14 days after the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Drug ineffective was also reported.  Patient was treated with Nirmatrelvir and Ritonavir for covid-19 from 05-May-2022 to 09-May-2022, Patient tested negative for COVID-19 on day 6. As the symptoms reoccurred on day 10 and she was tested positive again one day after completing the treatment with paxlovid.  Patient was noted to have received three doses with Pfizer / BioNTech approximately 14, 13 and 7 months prior to current vaccination (Interchange of vaccine products). COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.