Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Metastases to lung, Oxygen saturation
Clinical narrative: woke up the following night and couldn't breathe and just had hard time breathing like I couldn't catch my breathe, I was gasping for air.; He stated that his cancer has metastasized to his lungs; This spontaneous case was reported by a patient and describes the occurrence of METASTASES TO LUNG (He stated that his cancer has metastasized to his lungs) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nephrectomy (one of his kidneys removed before getting any of the vaccines). Concurrent medical conditions included Renal cell carcinoma and Immunocompromised.   On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced METASTASES TO LUNG (He stated that his cancer has metastasized to his lungs) (seriousness criterion medically significant). On 19-Jan-2022, the patient experienced DYSPNOEA (woke up the following night and couldn't breathe and just had hard time breathing like I couldn't catch my breathe, I was gasping for air.). The patient was treated with PEMBROLIZUMAB (KEYTRUDA) ongoing from 20-Jan-2022 for Lung metastases, at an unspecified dose and frequency. At the time of the report, METASTASES TO LUNG (He stated that his cancer has metastasized to his lungs) and DYSPNOEA (woke up the following night and couldn't breathe and just had hard time breathing like I couldn't catch my breathe, I was gasping for air.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 93/94% (Low) 93/94%.         No concomitant medication reported.  The patient reported that the events were still experiencing but not as bad. He was advised by his doctor to take vaccine. Further he mentioned that Keytruda could also cause respiratory issues, but he was experiencing these before he got that treatment. Inhaler was reported under treatment.  Company Comment:  This spontaneous case concerns a 63-year-old male patient with concurrent Renal cell carcinoma in Immunocompromised state, and concomitant use of Keytruda, who experienced the unexpected serious (medically significant) event of Metastases to lung, that occurred on an unknown date after receiving the booster dose of mRNA-1273 vaccine (latency between vaccine and event could not be established). Patient woke up the following night of vaccination with difficulty of breathing that felt like he could not get enough oxygen. Emergency Room visit showed his O2 Saturation between 93-94%.  Patient was told his cancer has metastasized to his lungs and was started on PEMBROLIZUMAB (KEYTRUDA) 2 days post vaccination. Outcome of the event was reported as not resolved. Patient previously received 2 doses of mRNA-1273 on unknown dates. The concurrent medical conditions of Renal cell carcinoma and Immunocompromised state, and concomitant use of Keytruda remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-541254 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63-year-old male patient with concurrent Renal cell carcinoma in Immunocompromised state, and concomitant use of Keytruda, who experienced the unexpected serious (medically significant) event of Metastases to lung, that occurred on an unknown date after receiving the booster dose of mRNA-1273 vaccine (latency between vaccine and event could not be established). Patient woke up the following night of vaccination with difficulty of breathing that felt like he could not get enough oxygen. Emergency Room visit showed his O2 Saturation between 93-94%.  Patient was told his cancer has metastasized to his lungs and was started on PEMBROLIZUMAB (KEYTRUDA) 2 days post vaccination. Outcome of the event was reported as not resolved. Patient previously received 2 doses of mRNA-1273 on unknown dates. The concurrent medical conditions of Renal cell carcinoma and Immunocompromised state, and concomitant use of Keytruda remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.