Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Weight
Clinical narrative: The patient tested positive for Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (The patient tested positive for Covid) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product SIROLIMUS (RAPAMUNE) for Liver transplant.    The patient's past medical history included Liver transplant in October 2005. Previously administered products included for Liver transplant: Prograf (Prograf off due to damage to kidneys) in 2005. Past adverse reactions to the above products included Kidney disorder with Prograf. Concurrent medical conditions included Congestive heart failure (biggest problem), Kidney disorder (Damaged kidneys) since 2005 and Diabetic (Recently found patient was diabetic in Jun-2021 and stated diabetes was not a real big problem.) since June 2021.   In 2005, the patient started SIROLIMUS (RAPAMUNE) (unknown route) 3 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced COVID-19 (The patient tested positive for Covid) (seriousness criterion hospitalization). The patient was hospitalized on 13-Jan-2022 due to COVID-19. At the time of the report, COVID-19 (The patient tested positive for Covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Weight: 192 kilogram and 87.09 kilogram.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.   No concomitant product use was reported.  Reporter stated that they are (at the time of report) giving patient Rapamune medication in the hospital. They are giving it to him every morning, 3 mg. The patient started taking it a long time ago when he had his liver transplant. In Oct-2005, when they went back to the Clinic for his 4 months checkup, he had been on Prograf when he first had the transplant. He went back to the Clinic for the 4 months checkup in 2005 and they had said that the Prograf had damaged his kidneys, so they put him on Rapamune. He had been on the Rapamune since then. Reporter stated that the dosage was a little more at first but, he had been on the 3 mg for years.   The patient tested positive for Covid, reporter thinks, the night patient got to the hospital, 13-Jan-2022. The patient had been vaccinated with the Covid vaccine prior to testing positive for Covid. The patient was having trouble breathing and when he got to hospital. Reporter stated that when he got to the hospital, they tested him for Covid when he was in the emergency room. They told him he had Covid and that he had to stay. Reporter stated they are expecting him to come home pretty soon. Also states they told him 5 to 10 days. At the time of reporting about patient being hospitalized and being on the mediation Rapamune.  No treatment information was provided.  Company Comment: This spontaneous case concerns a male patient aged 84  years with  relevant medical history of Liver transplant, Congestive heart failure and Renal disorder reported, who experienced the unexpected serious (hospitalization) AESI of COVID-19 (with positive SARS-CoV-2 test) that occurred unspecified days after a dose of mRNA-1273 vaccination. Patient was hospitalized due to breathing difficulty. No further details available. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounder to the event Covid -19. Relevant medical history could have led to hospitalization of the patient. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 84  years with  relevant medical history of Liver transplant, Congestive heart failure and Renal disorder reported, who experienced the unexpected serious (hospitalization) AESI of COVID-19 (with positive SARS-CoV-2 test) that occurred unspecified days after a dose of mRNA-1273 vaccination. Patient was hospitalized due to breathing difficulty. No further details available. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounder to the event Covid -19. Relevant medical history could have led to hospitalization of the patient. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.