Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Pain in extremity, Psoriasis, SARS-CoV-2 test
Clinical narrative: Psoriasis flare-up/PSORIASIS FLARE ON BOTH FEET; Foot pain; Interchange of vaccine products; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/PSORIASIS FLARE ON BOTH FEET), PAIN IN EXTREMITY (Foot pain), COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Psoriasis.    No Medical History information was reported.   On 19-Jan-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 25-Jan-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/PSORIASIS FLARE ON BOTH FEET), PAIN IN EXTREMITY (Foot pain) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, PSORIASIS (Psoriasis flare-up/PSORIASIS FLARE ON BOTH FEET), PAIN IN EXTREMITY (Foot pain) and COVID-19 (COVID-19) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) positive.         There was no reported medical history. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. Company comment This is a spontaneous case concerning a 55-year-old female patient with no medical history reported, treated with Adalimumab for moderate to severe chronic plaque psoriasis, previously received Pfizer COVID-19 Vaccine, who experienced the non-serious, unexpected AESI event of COVID-19. The vaccination dates of the 2 doses of mRNA-1273 is not provided, thus latency between vaccination and event could not be assessed. Interchange of vaccine products was considered an additional event. The patient also experienced psoriasis flare-up on both feet and foot pain. It was reported that Adalimumab, Pfizer COVID-19 vaccine and mRNA-1273 are suspect drugs. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Live significant follow up- New events added On 30-Jun-2022: Live significant follow up added- dose information updated for the co suspect drug.; Sender's Comments: This is a spontaneous case concerning a 55-year-old female patient with no medical history reported, treated with Adalimumab for moderate to severe chronic plaque psoriasis, previously received Pfizer COVID-19 Vaccine, who experienced the non-serious, unexpected AESI event of COVID-19. The vaccination dates of the 2 doses of mRNA-1273 is not provided, thus latency between vaccination and event could not be assessed. Interchange of vaccine products was considered an additional event. The patient also experienced psoriasis flare-up on both feet and foot pain. It was reported that Adalimumab, Pfizer COVID-19 vaccine and mRNA-1273 are suspect drugs. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.