Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: patient was very sick due to both Moderna vaccines; COVID-19 positive; Patient received primary series of mRNA-1273 given at an interval of 29 days thus; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (patient was very sick due to both Moderna vaccines), COVID-19 (COVID-19 positive) and DRUG INEFFECTIVE (Patient received primary series of mRNA-1273 given at an interval of 29 days thus) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingrix. Past adverse reactions to the above products included Sickness with Shingrix.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (patient was very sick due to both Moderna vaccines), COVID-19 (COVID-19 positive) and DRUG INEFFECTIVE (Patient received primary series of mRNA-1273 given at an interval of 29 days thus). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 28-Apr-2022 for COVID-19, at a dose of Three tablets, by mouth, twice daily, for five days; RITONAVIR at a dose of 100 milligram and NIRMATRELVIR at a dose of 150 milligram. At the time of the report, ILLNESS (patient was very sick due to both Moderna vaccines), COVID-19 (COVID-19 positive) and DRUG INEFFECTIVE (Patient received primary series of mRNA-1273 given at an interval of 29 days thus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  On 29-Apr-2022, patient had serious events diarrhea with unknown outcome, stomach cramping with recovering as outcome due to paxlovid. On 28-Apr-2022, patient had non serious events metal taste in mouth with unknown outcome due to paxlovid. On 29-Apr-2022, patient had non serious events little bit dizzy, nausea with unknown outcome due to paxlovid. In Apr-2022, patient had also fever with resolved outcome due to paxlovid.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected serious AESI COVID-19 that occurred 74 days after receiving the 2nd dose of mRNA-1273 vaccine. SARS-Cov-2 test positive. Patient was treated with Paxlovid for five days. The outcome of event was unknown. Patient received primary series of mRNA-1273 given at an interval of 29 days thus, satisfy the dosing regimen criteria for lack of efficacy. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected serious AESI COVID-19 that occurred 74 days after receiving the 2nd dose of mRNA-1273 vaccine. SARS-Cov-2 test positive. Patient was treated with Paxlovid for five days. The outcome of event was unknown. Patient received primary series of mRNA-1273 given at an interval of 29 days thus, satisfy the dosing regimen criteria for lack of efficacy. The benefit-risk relationship of mRNA-1273 is not affected by this report.