Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Non-small cell lung cancer, Pyrexia
Clinical narrative: approximately 2 and a half years ago with non-small cell carcinoma, the diagnose happened after getting at least 1 dose of COVID-19 Vaccine; fever and got sick approximately for 1 day.; fever and got sick approximately for 1 day.; This spontaneous case was reported by a consumer and describes the occurrence of NON-SMALL CELL LUNG CANCER (approximately 2 and a half years ago with non-small cell carcinoma, the diagnose happened after getting at least 1 dose of COVID-19 Vaccine) in a 74-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Vancomycin 125 mg (Vancomycin 125 mg), Temazepam 30 mg (Temazepam 30 mg), Levothyroxine (Levothyroxine 88 mg (44 mg during the day and 44 mg during the night),) and Rosuvastatin 10 mg a day (Rosuvastatin 10 mg a day). Past adverse reactions to the above products included No adverse event with Levothyroxine, Rosuvastatin 10 mg a day, Temazepam 30 mg and Vancomycin 125 mg. Concurrent medical conditions included AFib. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for COVID-19 prophylaxis.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NON-SMALL CELL LUNG CANCER (approximately 2 and a half years ago with non-small cell carcinoma, the diagnose happened after getting at least 1 dose of COVID-19 Vaccine) (seriousness criterion medically significant), ILLNESS (fever and got sick approximately for 1 day.) and PYREXIA (fever and got sick approximately for 1 day. ). At the time of the report, NON-SMALL CELL LUNG CANCER (approximately 2 and a half years ago with non-small cell carcinoma, the diagnose happened after getting at least 1 dose of COVID-19 Vaccine) had not resolved and ILLNESS (fever and got sick approximately for 1 day.) and PYREXIA (fever and got sick approximately for 1 day. ) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Patient stated she already received 3 COVID-19 shots and 2 boosters, but she did not remember dates or brands (unknown if any of them were Moderna).  Reported mentioned after first 3 shots she experienced fever and got sick approximately for 1 day. Patient stated she did not remember very well but was diagnosed approximately 2 and a half years ago with non-small cell carcinoma, the diagnose happened after getting at least 1 dose of COVID-19 Vaccine (again unknown brand). Patient was under Keytruda every 3 weeks since a year ago approximately, and also under a blood thinner due to cancer.  Reporter told that she just got flu shot. Patient was diagnosed with non-small cell carcinoma now stage VI.  Patient was under Keytruda every 3 weeks, she started about a year ago. She was on a blood thinner  vitamins. Patient had a pacemaker and also had AFib.  Company comment: This is a spontaneous case concerning a 74-year-old female patient with no reported relevant medical history, who experienced the serious (due to medically significant) unexpected, event of Non-small cell lung cancer, which occurred on an unknown date and with unknown latency after a dose of SPIKEVAX NOS (SPIKEVAX NOS) vaccine. Patient stated she received 3 COVID-19 shots and 2 boosters, but she did not remember dates or brands (unknown if any of them were Moderna). She mentioned that after first 3 shots she experienced fever and got sick approximately for 1 day. Patient stated she did not remember very well but was diagnosed approximately 2 and a half years ago with non-small cell carcinoma, which happened after getting at least 1 dose of COVID-19 Vaccine (again unknown brand). Patient was under Keytruda every 3 weeks since a year ago approximately, and under a blood thinner due to cancer. The event Non-small cell lung cancer was considered unrelated to the vaccine due to lack of biological plausibility. The benefit-risk relationship SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.  No treatment information was provided; Sender's Comments: Company Comment: This is a spontaneous case concerning a 74-year-old female patient with no reported relevant medical history, who experienced the serious (due to medically significant) unexpected, event of Non-small cell lung cancer, which occurred on an unknown date and with unknown latency after a dose of SPIKEVAX NOS (SPIKEVAX NOS) vaccine. Patient stated she received 3 COVID-19 shots and 2 boosters, but she did not remember dates or brands (unknown if any of them were Moderna). She mentioned that after first 3 shots she experienced fever and got sick approximately for 1 day. Patient stated she did not remember very well but was diagnosed approximately 2 and a half years ago with non-small cell carcinoma, which happened after getting at least 1 dose of COVID-19 Vaccine (again unknown brand). Patient was under Keytruda every 3 weeks since a year ago approximately, and under a blood thinner due to cancer. The event Non-small cell lung cancer was considered unrelated to the vaccine due to lack of biological plausibility. The benefit-risk relationship SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.