Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Cold symptoms; COVID-19; Covid-19 on 00-Dec-2021; Vaccination site pruritus; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Covid-19 on 00-Dec-2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, received third 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) Citrate Free, first dose. In 2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling). In December 2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Covid-19 on 00-Dec-2021). In April 2022, the patient experienced NASOPHARYNGITIS (Cold symptoms). In 2021, VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. At the time of the report, NASOPHARYNGITIS (Cold symptoms), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Covid-19 on 00-Dec-2021) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided.  Company Comment: This is a Spontaneous case concerning a 60-year-old female patient, with concurrent condition of Psoriatic arthritis treated with Adalimumab (HUMIRA), who experienced the non-serious unexpected AESI of COVID-19. Also, the special situation of Drug ineffective was added to this case. The event occurred approximately 4 months after the administration of the 3rd dose of the mRNA-1273 vaccine (in an appropriate schedule of administration). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as non-serious.; Sender's Comments: This is a Spontaneous case concerning a 60-year-old female patient, with concurrent condition of Psoriatic arthritis treated with Adalimumab (HUMIRA), who experienced the non-serious unexpected AESI of COVID-19. Also, the special situation of Drug ineffective was added to this case. The event occurred approximately 4 months after the administration of the 3rd dose of the mRNA-1273 vaccine (in an appropriate schedule of administration). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as non-serious.