Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Eye swelling, Neoplasm malignant, Ocular hyperaemia, Rash
Clinical narrative: diagnosed with cancer; just around her eyes; eyes are still red, some days darker than others.; hair loss; full swelling of the face and neck; full swelling of the face and neck; rash she cannot get rid of/extremely dry/panful/itches; This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (diagnosed with cancer) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient never had COVID-19 positive test or diagnosis.  The patient's past medical history included Cancer (27 years). Concurrent medical conditions included Seasonal allergy (spring time allergies) and Heart disorder.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, 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 experienced NEOPLASM MALIGNANT (diagnosed with cancer) (seriousness criterion medically significant), EYE SWELLING (just around her eyes), OCULAR HYPERAEMIA (eyes are still red, some days darker than others.), ALOPECIA (hair loss), SWELLING (full swelling of the face and neck), SWELLING FACE (full swelling of the face and neck) and RASH (rash she cannot get rid of/extremely dry/panful/itches). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency. At the time of the report, NEOPLASM MALIGNANT (diagnosed with cancer) and ALOPECIA (hair loss) outcome was unknown, EYE SWELLING (just around her eyes), OCULAR HYPERAEMIA (eyes are still red, some days darker than others.) and RASH (rash she cannot get rid of/extremely dry/panful/itches) had not resolved and SWELLING (full swelling of the face and neck) and SWELLING FACE (full swelling of the face and neck) had resolved.            Concomitant medications included heart and blood thinner medicine.  Company comment: This is a spontaneous case concerning a 76-year-old, female patient with relevant medical history of unspecified cancer 27 years ago and concurrent medical condition of springtime allergies and vaccine history of receiving first and second dose of mRNA-1273 vaccine, who experienced the unexpected serious (medically significant) event of neoplasm malignant and the unexpected non-serious events of eye swelling, ocular hyperemia, alopecia, swelling (full swelling of the face and neck) and swelling face and the expected non-serious event of rash. The events occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. The event was described as, patient experienced rash that cannot rid of, full swelling of the face and neck but now it is just around the patient's eyes. The rash was described as extremely dry, itchy and painful. It was reported that the patient's eyes are still red and, in some days, darker than others. Also, experienced hair loss. Patient was diagnosed with cancer after receiving the vaccination. Patient was given Prednisone for the rash. No other information surrounding the events was reported. The medical history of unspecified cancer 27 years ago remain confounder for the event neoplasm malignant. The concurrent medical condition of springtime allergies remain confounder for the events eye swelling, ocular hyperemia, swelling (full swelling of the face and neck), swelling face and rash. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 76-year-old, female patient with relevant medical history of unspecified cancer 27 years ago and concurrent medical condition of springtime allergies and vaccine history of receiving first and second dose of mRNA-1273 vaccine, who experienced the unexpected serious (medically significant) event of neoplasm malignant and the unexpected non-serious events of eye swelling, ocular hyperemia, alopecia, swelling (full swelling of the face and neck) and swelling face and the expected non-serious event of rash. The events occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. The event was described as, patient experienced rash that cannot rid of, full swelling of the face and neck but now it is just around the patient's eyes. The rash was described as extremely dry, itchy and painful. It was reported that the patient's eyes are still red and, in some days, darker than others. Also, experienced hair loss. Patient was diagnosed with cancer after receiving the vaccination. Patient was given Prednisone for the rash. No other information surrounding the events was reported. The medical history of unspecified cancer 27 years ago remain confounder for the event neoplasm malignant. The concurrent medical condition of springtime allergies remain confounder for the events eye swelling, ocular hyperemia, swelling (full swelling of the face and neck), swelling face and rash. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.