Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response shortened
Clinical narrative: Cold; Wearing off effect; Pain in hand; Injection site stinging; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), PAIN IN EXTREMITY (Pain in hand), INJECTION SITE PAIN (Injection site stinging) and COVID-19 (COVID-19) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis aggravated.    No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 01-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), PAIN IN EXTREMITY (Pain in hand) and INJECTION SITE PAIN (Injection site stinging). At the time of the report, NASOPHARYNGITIS (Cold), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), PAIN IN EXTREMITY (Pain in hand), INJECTION SITE PAIN (Injection site stinging) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication use information was not provided by reporter.  On unknown dates, the patient experienced cold, original formulation of humira was stinging and before humira dose two weeks was up, started felt pain in hands. On 01Jan2021, patient experienced COVID-19.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality of humira vaccine for the event(s) of cold, covid-19, original formulation of humira was stinging, before humira dose two weeks was up, started felt pain in hands unknown onset and before humira dose two weeks was up, started felt pain in hands unknown onset 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.   Reporter did not allow further contact  Company comment: This spontaneous case concerns an 80-year-old, male patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19 and other unexpected and expected, non-serious events. The event COVID-19 occurred unknown number of days after receiving Humira. Of note, the administration dates of Humira were not provided, hence, the onset latency could not be assessed. However, the event COVID-19 occurred 13 days before receiving the first dose of the mRNA-1273 vaccine. On an unspecified date in 2021, the patient tested positive for SARS-CoV-2. No symptoms were reported and treatment information was not provided. The outcome of the event was unknown at the time of the report. The start dates of the other events were not provided, hence, the onset latency could not be assessed. On unknown dates, the patient experienced a cold. It was reported that the original formulation of Humira was stinging and before the Humira dose effect of 2 weeks ended, the patient started to feel pain in his hands. The history of co-suspect administration of Humira remains a confounder for the events. The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 80-year-old, male patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19 and other unexpected and expected, non-serious events. The event COVID-19 occurred unknown number of days after receiving Humira. Of note, the administration dates of Humira were not provided, hence, the onset latency could not be assessed. However, the event COVID-19 occurred 13 days before receiving the first dose of the mRNA-1273 vaccine. On an unspecified date in 2021, the patient tested positive for SARS-CoV-2. No symptoms were reported and treatment information was not provided. The outcome of the event was unknown at the time of the report. The start dates of the other events were not provided, hence, the onset latency could not be assessed. On unknown dates, the patient experienced a cold. It was reported that the original formulation of Humira was stinging and before the Humira dose effect of 2 weeks ended, the patient started to feel pain in his hands. The history of co-suspect administration of Humira remains a confounder for the events. The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.