Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Antibody test, Arthritis, SARS-CoV-2 antibody test negative, Skin exfoliation
Clinical narrative: no antibodies against Covid-19 despite vaccination; Skin peeling/ Peeling of skin; Arthritis aggravated/ Arthritis worse; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Skin peeling/ Peeling of skin), ARTHRITIS (Arthritis aggravated/ Arthritis worse) and SARS-COV-2 ANTIBODY TEST NEGATIVE (no antibodies against Covid-19 despite vaccination) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Psoriatic arthritis.   On 02-Aug-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. In March 2022, the patient experienced SKIN EXFOLIATION (Skin peeling/ Peeling of skin) and ARTHRITIS (Arthritis aggravated/ Arthritis worse). On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (no antibodies against Covid-19 despite vaccination). At the time of the report, SKIN EXFOLIATION (Skin peeling/ Peeling of skin), ARTHRITIS (Arthritis aggravated/ Arthritis worse) and SARS-COV-2 ANTIBODY TEST NEGATIVE (no antibodies against Covid-19 despite vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative.          No concomitant medication was provided.  No treatment medication was provided.  The reporter's causality for co-suspect (HUMIRAand JANSSEN COVID-19 VACCINE) for the events Skin peeling and Arthritis aggravated was not reported.  Company comment: This spontaneous case concerns a 65-year-old female patient with relevant medical history of Psoriatic arthritis on Humira (Adalimumab) and interchange of vaccine products, who experienced the unexpected non-serious AESI of Arthritis (reported as arthritis aggravated), on an unspecified date/interval after receiving a dose of mRNA-1273 vaccine. Additionally, unexpected non-serious events of COVID-19 antibody test negative and Skin exfoliation were also reported. Details of clinical course, investigation reports and treatment were not provided. The patient had received a dose of Janssen (JNJ 78436735) Covid-19 vaccine and two doses of mRNA-1273 vaccine (total 3 doses), but dates were unspecified. Co-suspect drugs Humira and Janssen (JNJ 78436735) Covid-19 vaccine could be confounders for the event COVID-19 antibody test negative. Medical history of Psoriatic arthritis remains a confounder for the events Arthritis and skin exfoliation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with relevant medical history of Psoriatic arthritis on Humira (Adalimumab) and interchange of vaccine products, who experienced the unexpected non-serious AESI of Arthritis (reported as arthritis aggravated), on an unspecified date/interval after receiving a dose of mRNA-1273 vaccine. Additionally, unexpected non-serious events of COVID-19 antibody test negative and Skin exfoliation were also reported. Details of clinical course, investigation reports and treatment were not provided. The patient had received a dose of Janssen (JNJ 78436735) Covid-19 vaccine and two doses of mRNA-1273 vaccine (total 3 doses), but dates were unspecified. Co-suspect drugs Humira and Janssen (JNJ 78436735) Covid-19 vaccine could be confounders for the event COVID-19 antibody test negative. Medical history of Psoriatic arthritis remains a confounder for the events Arthritis and skin exfoliation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.