Sex: F
Vaccine: COVID19
Symptoms: Basal cell carcinoma, Intervertebral disc degeneration
Clinical narrative: Basal cell carcinoma in her lower lid; Degenerative disc/Intervertebral disc degeneration; This spontaneous case was reported by a patient and describes the occurrence of BASAL CELL CARCINOMA (Basal cell carcinoma in her lower lid) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Prurigo nodularis.    The patient's past medical history included Benign neoplasm of skin, Depressive disorder, Neoplasm malignant, Esophageal reflux, Esophagitis, Postmenopausal atrophic vaginitis and Hormone replacement therapy. Concurrent medical conditions included Drug allergy (Enalapril Maleate 10 mg, Tablet), Drug allergy (Naproxen 250 mg, Tablet), Chronic pain, Pollen allergy (Allergic rhinitis to pollen), Hypertension, Essential hypertension, Osteoarthrosis (Localised, primary, involving lower leg.), Malignant hypertension, Neoplasm of uncertain behaviour of skin, Malignant neoplasm of skin, other, Fruit allergy, Prurigo nodularis and Drug allergy (Fentanyl 100 mcg/Hr patch TD72). Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM 600 WITH VITAMIN D3), CLONIDINE, CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINA CONDROITI), OMEPRAZOLE, MONTELUKAST SODIUM (SINGULAIR), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), AMLODIPINE BESILATE, CLONIDINE HCL and GLUCOSAMINE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On an unknown date, the patient experienced BASAL CELL CARCINOMA (Basal cell carcinoma in her lower lid) (seriousness criterion medically significant) and INTERVERTEBRAL DISC DEGENERATION (Degenerative disc/Intervertebral disc degeneration). The patient was treated with Surgery (Mohs surgery to clear margins, Plastic surgery for reconstruction) for Basal cell carcinoma. At the time of the report, BASAL CELL CARCINOMA (Basal cell carcinoma in her lower lid) and INTERVERTEBRAL DISC DEGENERATION (Degenerative disc/Intervertebral disc degeneration) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient started therapy with Dupixent (having form of solution for injection and concentration strength of 300 mg/2 mL) at a dose of 300 mg every other week, via pre-filled pen (subcutaneous route of administration).  Patient reported that she had first dupixent dose injection and would be getting a steroid injection on next Tuesday by her pain physician for degenerative disc. Patient stated that dupixent had been a miracle drug for her and that it was taken night and day from when she started therapy.  The patient had undergone scheduled Mohs surgery on her eyelids to clear margins, and then plastic surgery for reconstruction.  Company Comment: This spontaneous case report concerns an elderly female patient with relevant medical history of Neoplasm of uncertain behaviour of skin and Malignant neoplasm of skin, who developed serious (medically significant) unexpected event of Basal cell carcinoma, as well as non serious unexpected event of Intervertebral disc degeneration. The events occurred on an unknown dates. In addition, the date of vaccination with the mRNA-1273 vaccine and dose of the vaccine in vaccination schedule were not given, as well. Therefore, temporal relationship between vaccination and event occurrence cannot be determined. Reportedly, the patient underwent surgery (Mohs surgery to clear margins and plastic surgery for reconstruction) for Basal cell carcinoma. At the time of this report, the outcome remained unknown for both events. The patient's elderly age remains a confounder for both events. In addition, the patient's underlying history of skin malignancy also remains a major confounder for the event of Basal cell carcinoma. Taking into consideration nature of the reported event of intervertebral disc degeneration (human intervertebral discs undergo age-related degenerative changes), the company causality for this event is assessed as not related to the mRNA-1273 vaccine, since the patient's elderly age provides better and more reasonable explanation for this event. Furthermore, having in mind already existing medical history of Malignant neoplasm of skin, the patient's elderly age, as well as that until this moment, there is no evidence to suggest that mRNA-1273 vaccine has malignant or neoplasm potential, the company causality for this event is also assessed as not related to the mRNA-1273 vaccine, but most likely related to already existing condition. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns an elderly female patient with relevant medical history of Neoplasm of uncertain behaviour of skin and Malignant neoplasm of skin, who developed serious (medically significant) unexpected event of Basal cell carcinoma, as well as non serious unexpected event of Intervertebral disc degeneration. The events occurred on an unknown dates. In addition, the date of vaccination with the mRNA-1273 vaccine and dose of the vaccine in vaccination schedule were not given, as well. Therefore, temporal relationship between vaccination and event occurrence cannot be determined. Reportedly, the patient underwent surgery (Mohs surgery to clear margins and plastic surgery for reconstruction) for Basal cell carcinoma. At the time of this report, the outcome remained unknown for both events. The patient's elderly age remains a confounder for both events. In addition, the patient's underlying history of skin malignancy also remains a major confounder for the event of Basal cell carcinoma. Taking into consideration nature of the reported event of intervertebral disc degeneration (human intervertebral discs undergo age-related degenerative changes), the company causality for this event is assessed as not related to the mRNA-1273 vaccine, since the patient's elderly age provides better and more reasonable explanation for this event. Furthermore, having in mind already existing medical history of Malignant neoplasm of skin, the patient's elderly age, as well as that until this moment, there is no evidence to suggest that mRNA-1273 vaccine has malignant or neoplasm potential, the company causality for this event is also assessed as not related to the mRNA-1273 vaccine, but most likely related to already existing condition. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.