Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Body temperature, Chills, Guttate psoriasis, Headache
Clinical narrative: left ventral proximal forearm lesion/incidental skin cancer/Invasive Squamous Cell Carcinoma; itchy red spots on lower left ankle/Psoriasis continued to spread to arms and trunk and became inflammed/severe psoriasis from head to toe/Guttate Psoriasis; Headache; Chills; Fever of 101.6; This spontaneous case was reported by a consumer and describes the occurrence of SQUAMOUS CELL CARCINOMA OF SKIN (left ventral proximal forearm lesion/incidental skin cancer/Invasive Squamous Cell Carcinoma) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021 at 1:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 7:40 PM, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever of 101.6). On 09-Sep-2021, the patient experienced GUTTATE PSORIASIS (itchy red spots on lower left ankle/Psoriasis continued to spread to arms and trunk and became inflammed/severe psoriasis from head to toe/Guttate Psoriasis). On 11-Nov-2021, the patient experienced SQUAMOUS CELL CARCINOMA OF SKIN (left ventral proximal forearm lesion/incidental skin cancer/Invasive Squamous Cell Carcinoma) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) 25-Mar-2021 at a dose of UNK, bid; HYDROCORTISONE (topical) from 06-Apr-2021 to 2021 at an unspecified dose and frequency; HYDROCORTISONE (topical) from 23-Jun-2021 to 2021 at a dose of UNK UNK, bid; PREDNISONE (oral) from 23-Jul-2021 to 03-Aug-2021 at a dose of 10 mg, deceasing dose pack for 12 days; CICLOSPORIN (CYCLOSPORIN) (oral) from 18-Aug-2021 to 17-Sep-2021 at a dose of 25 mg twice a day; FLUOCINONIDE (topical) on 26-Sep-2021 at an unspecified dose and frequency and CLOTRIMAZOLE (TRIDERM [CLOTRIMAZOLE]) on 09-Sep-2021 for Psoriasis, at a dose of UNK UNK, bid. On 27-Mar-2021, HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever of 101.6) had resolved. At the time of the report, SQUAMOUS CELL CARCINOMA OF SKIN (left ventral proximal forearm lesion/incidental skin cancer/Invasive Squamous Cell Carcinoma) and GUTTATE PSORIASIS (itchy red spots on lower left ankle/Psoriasis continued to spread to arms and trunk and became inflammed/severe psoriasis from head to toe/Guttate Psoriasis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 101.6 (High) Fever of 101.6. On 09-Sep-2021, Biopsy skin: guttate psoriasis (abnormal) A punch biopsy of lesion right anterior proximal thigh came back with diagnosis: Guttate Psoriasis. On 28-Oct-2021, Biopsy skin: invasive squamous cell carcinoma (abnormal) On 11/11/2021 diagnosis: Lesion on left ventral proximal forearm: Invasive Squamous cell carcinoma. On 09-Dec-2021, Biopsy skin: invasive squamous cell carcinoma (abnormal) On12/20/2021:Sutures were removed from left forearm.  Pathology showed: Invasive Squamous Cell Carcinoma, Well Differentiated on the left ventral proximal forearm. Margins clear..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that 6 hours after receiving Moderna dose, started with headache and chills, then fever of 101.6. Took Tylenol two  times on the 25-Mar-2021, which didn't help the headache. 48 hours after having the vaccination the symptoms subsided. On April 06th at 7:30 pm, patient noticed five itchy red spots on lower left ankle that were treated with OTC Hydrocortisone 1 percent cream. The itchy rash continued to spread to right leg and back of both legs. On 06/04/20211 noticed lesion on left forearm, raised, hard and painful. (Looked like a wart that popped up overnight). On 06/23/2021 patient was seen by CNP, diagnosed as psoriasis on both legs and prescribed Hydrocortisone 2.5 percent  cream apply 2 times daily to all lesions. On 07/23/2021 Psoriasis continued to spread to arms and trunk. Doctor ordered Prednisone 10 mg decreasing Dose Pack for 12 days. Patient had no relief from the itching, burning and inflammation of the lesions. On 08/13/2021 seen by physician. Psoriasis continued to spread and became inflammed. Physician ordered Cyclosporin 25mg 2 times daily for 1 month. On 08/18/2021 patient started taking Cyclosporin 25 mg 2 times daily for one month. On 09/09/2021 psoriasis continued to spread to scalp, even with the cyclopsporin medication. Patient was seen by dermatologist, who ordered Triderm 0.1 percent  to affected area 2 times daily. A punch biopsy of lesion right anterior proximal thigh came back with diagnosis: Guttate Psoriasis. On 09/23/2021 suture removed from punch biopsy. Lesion on left forearm brought to dermatologists attention, as it was different than any of the psoriasis lesions. On 09/26/2021 Scalp psoriasis lesions became unbearable. Dermatologist ordered Fluocinonide 0.05 percent Topical Solution for scalp plaques. Patient stated that after nine long months of living with severe psoriasis from head to toe and the incidental skin cancer, patient was convinced that vaccine was the culprit that exacerbated condition.  Company comment:  This case concerns a 72-year-old female patient with no reported medical history who experienced serious unexpected event of invasive squamous cell carcinoma. The lesion on the left forearm which was later diagnosed as invasive squamous cell carcinoma was noticed approximately 13 days after the dose of the mRNA-1273, whereas the diagnosis was made approximately 7 months later  The rechallenge was not applicable due unspecified number of doses administered so no rechallenge was done and thus, recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 72-year-old female patient with no reported medical history who experienced serious unexpected event of invasive squamous cell carcinoma. The lesion on the left forearm which was later diagnosed as invasive squamous cell carcinoma was noticed approximately 13 days after the dose of the mRNA-1273, whereas the diagnosis was made approximately 7 months later  The rechallenge was not applicable due unspecified number of doses administered so no rechallenge was done and thus, recurrence was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.