Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Ocular hyperaemia, Pain, Physical examination, Post-traumatic stress disorder
Clinical narrative: Cancer in left kidney/Moderna vaccine attacked his kidney; High Blood Pressure 200/150 mmHg; PTSD; Constant pain; Was a little off after; Whole body was hot; Eyes were red; Skin changing color; Felt tired; Headache; Cough; Pain; This spontaneous case was reported by a consumer and describes the occurrence of RENAL CANCER (Cancer in left kidney/Moderna vaccine attacked his kidney) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Malaria (back in the 70's), High cholesterol, Partial nephrectomy in June 2021 and Dietary control in June 2021.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced COUGH (Cough), PAIN (Pain) and HEADACHE (Headache). On 14-Mar-2021, the patient experienced FEELING HOT (Whole body was hot), OCULAR HYPERAEMIA (Eyes were red), SKIN DISCOLOURATION (Skin changing color), FEELING ABNORMAL (Was a little off after) and FATIGUE (Felt tired). In June 2021, the patient experienced RENAL CANCER (Cancer in left kidney/Moderna vaccine attacked his kidney) (seriousness criteria hospitalization and medically significant) and PAIN (Constant pain). In July 2021, the patient experienced POST-TRAUMATIC STRESS DISORDER (PTSD). On an unknown date, the patient experienced HYPERTENSION (High Blood Pressure 200/150 mmHg). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 500 mg; AMLODIPINE at a dose of 5 mg; DEXTRAN SULFATE SODIUM (DSS) at a dose of 100 mg; FLUOXETINE HYDROCHLORIDE (PROZAC) at an unspecified dose and frequency; HYDRALAZINE at a dose of 10 mg; MAGNESIUM OXIDE (MAG OXIDE) at a dose of 400 mg; OMEPRAZOLE at an unspecified dose and frequency; MACROGOL 3350 (MIRALAX) at an unspecified dose and frequency; TRAMADOL at a dose of 50 mg; TRAZODONE at a dose of 50 mg, at night; TADALAFIL (CIALIS) for Prostate infection, at a dose of 20 mg and Surgery for Renal cancer. On 12-Mar-2021, COUGH (Cough), PAIN (Pain) and HEADACHE (Headache) had resolved. On 23-Nov-2021, HYPERTENSION (High Blood Pressure 200/150 mmHg) had resolved. At the time of the report, RENAL CANCER (Cancer in left kidney/Moderna vaccine attacked his kidney), FEELING HOT (Whole body was hot), OCULAR HYPERAEMIA (Eyes were red), SKIN DISCOLOURATION (Skin changing color), POST-TRAUMATIC STRESS DISORDER (PTSD), FEELING ABNORMAL (Was a little off after), PAIN (Constant pain) and FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, Physical examination: normal (normal) normal. In June 2021, Blood test: result not reported (Inconclusive) Result not reported. In June 2021, Chest X-ray: result not reported (Inconclusive) Result not reported. In June 2021, Computerised tomogram: result not reported (Inconclusive) Result not reported. In June 2021, Magnetic resonance imaging: result not reported (Inconclusive) Result not reported. In June 2021, Ultrasound scan: result not reported (Inconclusive) Result not reported. In June 2021, X-ray: result not reported (Inconclusive) Result not reported. On an unknown date, Blood pressure measurement: 200/150 (High) 200/150, high (High) high and normal (normal) Fine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In Jun 2021 patient went for his annual physical, as usual they did blood tests and X-Ray. This time, they also did Cat-Scan and chest X-Ray, ultrasound and MRI. After the Moderna vaccine, he was diagnosed with cancer in left kidney. He had surgery and they removed 3/4 of his left kidneys. He states that the cancer doctor told him that the Moderna vaccine attacked his kidney. He was in constant pain and he cannot sleep from the pain. At the medical facility they found high blood pressure 200/150 and prescribed BP medication prior to surgery. After surgery his blood pressure was still high. He continued the blood pressure medication. He stopped the Blood pressure medication about 3 weeks ago and his blood pressure was fine now. He was on solid food diet. He was told that he had to give his kidneys time to heal. Cancer doctor told him that he cannot have the booster dose of Moderna COVID-19 vaccine. He states that he had done full physical exam and scans with blood works once a year for the past 20 years. He always had normal physical exam and tests. His last normal exam / tests were in Mar 2020.  COmpany comment: This regulatory case concerns a 65-year-old male patient, with no relevant medical history provided, who experienced the serious (medically significant, hospitalization) unexpected event of RENAL CANCER. The event occurred on un unknown date, approximately 3 months after receiving the second dose of mRNA-1273. The rechallenge is not applicable since no further dosing is expected. Patient states that his doctor said mRNA-1273 had affected his kidney. He had surgery and 75% of his left kidney was removed. No further information was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-412634 (Patient Link).; Sender's Comments: This regulatory case concerns a 65-year-old male patient, with no relevant medical history provided, who experienced the serious (medically significant, hospitalization) unexpected event of RENAL CANCER. The event occurred on un unknown date, approximately 3 months after receiving the second dose of mRNA-1273. The rechallenge is not applicable since no further dosing is expected. Patient states that his doctor said mRNA-1273 had affected his kidney. He had surgery and 75% of his left kidney was removed. No further information was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.