Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, Respiratory rate, SARS-CoV-2 test
Clinical narrative: COVID-19 infections post vaccination; Lack of drug effect; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (COVID-19 infections post vaccination) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: Development of COVID-19 infection in transplant recipients after SARS-CoV-2 vaccination. Transplantation. 2021;105(9):e104-6     The patient's past medical history included Kidney transplant (24 months). Concurrent medical conditions included Immunosuppression. Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infections post vaccination) (seriousness criterion hospitalization). an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with REMDESIVIR for COVID-19, at an unspecified dose and frequency; DEXAMETHASONE for COVID-19, at an unspecified dose and frequency and CONVALESCENT PLASMA COVID-19 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 infections post vaccination) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: less than 94% on ambient air (Inconclusive) less than 94% on ambient air. On an unknown date, Respiratory rate: more than or equal to 24 breaths per minute) (Inconclusive) more than or equal to 24 breaths per minute. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (COVID-19 infections post vaccination) and DRUG INEFFECTIVE (Lack of drug effect) to be possibly related.    This case related to patient 9 as per article and patient initial symptoms included were fever, diarrhea, and vomiting. Vaccine to sx onset was 15 days.  The patient may also needed mechanical ventilation and supplemental oxygen.  Treatment also included Monoclonal antibody which was done outside of hospital.  Company Comment: This is a literature report of a severe COVID-19 more than 15 days after the second dose of the product in a renal transplant immunosuppressed patient of 71 years old. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event Drug ineffective a causal relationship cannot be excluded.   This case was linked to MOD-2021-303163, MOD-2021-303228, MOD-2021-303227, MOD-2021-303226 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received by safety on 02-Sep-2021 included an Email with FTA received from team and does not contain any new information.; Sender's Comments: This is a literature report of a severe COVID-19 more than 15 days after the second dose of the product in a renal transplant immunosuppressed patient of 71 years old. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event Drug ineffective a causal relationship cannot be excluded.