Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Drug ineffective, Peripheral swelling, Psoriasis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up), PERIPHERAL SWELLING (Swelling of hands), BLOOD CHOLESTEROL INCREASED (High cholesterol) and DRUG INEFFECTIVE (DRUG INEFFECTIVE) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis. No Medical History information was reported. On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In February 2022, the patient experienced PSORIASIS (Psoriasis flare-up). In May 2022, the patient experienced PERIPHERAL SWELLING (Swelling of hands) and BLOOD CHOLESTEROL INCREASED (High cholesterol). On an unknown date, the patient experienced DRUG INEFFECTIVE (DRUG INEFFECTIVE). At the time of the report, PSORIASIS (Psoriasis flare-up), PERIPHERAL SWELLING (Swelling of hands), BLOOD CHOLESTEROL INCREASED (High cholesterol) and DRUG INEFFECTIVE (DRUG INEFFECTIVE) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Blood cholesterol: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported. The causality for the events of Psoriasis flare-up, Swelling of hands and High cholesterol with RISANKIZUMAB were not related and for event of Drug ineffective with HUMIRA was not reported.  No treatment drug details was reported. Company Comment: This is a spontaneous case concerning a 76-year-old, male patient with no reported medical history, who experienced the unexpected non-serious events of Psoriasis, Peripheral swelling, Blood cholesterol increased and Drug ineffective as an additional event. The event Psoriasis occurred on an unknown date in February 2022, after the unspecified dose of mRNA-1273 COVID 19 Vaccine which was administered on September 20, 2021. The event Peripheral swelling, Blood cholesterol increased occurred on unspecified date in May 2022. On an unknown date event Drug ineffective occurred. Patient noted to have elevated blood cholesterol. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 31-May-2022: Live-Significant follow up contains- Events added. Reporter's Comments: Sender's Comments: Company Comment: This is a spontaneous case concerning a 76-year-old, male patient with no reported medical history, who experienced the unexpected non-serious events of Psoriasis, Peripheral swelling, Blood cholesterol increased and Drug ineffective as an additional event. The event Psoriasis occurred on an unknown date in February 2022, after the unspecified dose of mRNA-1273 COVID 19 Vaccine which was administered on September 20, 2021. The event Peripheral swelling, Blood cholesterol increased occurred on unspecified date in May 2022. On an unknown date event Drug ineffective occurred. Patient noted to have elevated blood cholesterol. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.