Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cataract, Neoplasm malignant, SARS-CoV-2 test
Clinical narrative: cataract; Covid-19; diagnosed about 2 weeks ago/ the cancer on the forehead and has to get it removed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (diagnosed about 2 weeks ago/ the cancer on the forehead and has to get it removed) and CATARACT (cataract) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (he only had one kidney left due to cancer).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEOPLASM MALIGNANT (diagnosed about 2 weeks ago/ the cancer on the forehead and has to get it removed) (seriousness criterion medically significant). On an unknown date, the patient experienced CATARACT (cataract) (seriousness criterion medically significant) and COVID-19 (Covid-19). At the time of the report, NEOPLASM MALIGNANT (diagnosed about 2 weeks ago/ the cancer on the forehead and has to get it removed), CATARACT (cataract) and COVID-19 (Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant medication was provided.  Patient's height was reported as 5 feet 9 inches or 5 feet 10 inches.  Patient received second booster Moderna vaccine on 12May2023. Patient further stated at the time of report, patient was covid positive but had not yet started the Paxlovid treatment. Patient was prescribed a 100mg of Paxlovid with 3 doses in the morning and 3 in the evening and to take six a day for 5 days. The reporter was enquiring if the patient could take the Paxlovid as he had only one kidney left and if the Paxlovid could affect his kidney. It was further reported that patient had cancer on the forehead and had to get it removed and due to covid he would not get it removed for a while; then would have cataract surgery when patient tests negative.   This case was linked to US-MODERNATX, INC.-MOD-2023-725636 (E2B Linked Report).  Company Comment: This is a spontaneous case concerning an 85-year-old male patient with medical history of cancer (has one kidney left due to cancer), who experienced the serious (medically significant) unexpected events of neoplasm malignant and cataract. The event neoplasm malignant occurred approximately 1 year after a dose of mRNA-1273 vaccine, given as a booster dose of COVID vaccine schedule, was administered while the event cataract occurred on an unknown date hence latency cannot be assessed. Patient also received as primary COVID series two doses of mRNA-1273 vaccine (in an appropriate schedule of vaccination).  It was reported that at the time of report, patient was COVID positive but had not yet started the Paxlovid treatment because he was enquiring if he could take it as he had only one kidney left and if the Paxlovid could affect his kidney. It was further reported that patient had cancer on the forehead and had to get it removed and due to COVID he would not get it removed for a while; then would have cataract surgery when patient tests negative. Medical history of cancer remains as a confounder for the event neoplasm malignant. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2023: Follow-up received, updated patient information and added additional event. On 24-May-2023: Updated quality complaint number.; Sender's Comments: This is a spontaneous case concerning an 85-year-old male patient with medical history of cancer (has one kidney left due to cancer), who experienced the serious (medically significant) unexpected events of neoplasm malignant and cataract. The event neoplasm malignant occurred approximately 1 year after a dose of mRNA-1273 vaccine, given as a booster dose of COVID vaccine schedule, was administered while the event cataract occurred on an unknown date hence latency cannot be assessed. Patient also received as primary COVID series two doses of mRNA-1273 vaccine (in an appropriate schedule of vaccination).  It was reported that at the time of report, patient was COVID positive but had not yet started the Paxlovid treatment because he was enquiring if he could take it as he had only one kidney left and if the Paxlovid could affect his kidney. It was further reported that patient had cancer on the forehead and had to get it removed and due to COVID he would not get it removed for a while; then would have cataract surgery when patient tests negative. Medical history of cancer remains as a confounder for the event neoplasm malignant. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-725636:Wife case