Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Psoriasis, Therapeutic product effect incomplete, Vaccination site pain
Clinical narrative: Drug effect incomplete; Psoriasis; Ache; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), PSORIASIS (Psoriasis), PAIN (Ache), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), PSORIASIS (Psoriasis), PAIN (Ache), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness). At the time of the report, THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), PSORIASIS (Psoriasis) and PAIN (Ache) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication use information was not provided by reporter. On unknown dates, the patient experienced psoriasis on area of scalp and base of neckline that has been resistant to humira, aches and pain from old age, arm soreness following vaccine and general tiredness following vaccine. On unknown dates, arm soreness following vaccine and general tiredness following vaccine resolved. Primary reporter did not have the lot number information, because the packaging was discarded.The reporter's causality of humira vaccine for the event(s) of psoriasis on area of scalp and base of neckline that has been resistant to humira unknown onset with humira(adalimumab) was a reasonable possibility, the event(s) of aches and pain from old age with humira(adalimumab) was no reasonable possibility and the event(s) of arm soreness following vaccine and general tiredness following vaccine was not provided.Treatment Medication use information was not provided by reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an elderly female patient with concurrent condition of psoriatic arthritis and reported non serious event of Therapeutic product effect incomplete (reported as Drug effect incomplete) along with the non serious event of psoriasis, unknown days after receiving a dose of mRNA-1273 vaccine. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 and the second dose details was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an elderly female patient with concurrent condition of psoriatic arthritis and reported non serious event of Therapeutic product effect incomplete (reported as Drug effect incomplete) along with the non serious event of psoriasis, unknown days after receiving a dose of mRNA-1273 vaccine. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 and the second dose details was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.