Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, SARS-CoV-2 test
Clinical narrative: Chills; Joint pain; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient himself) based on the information received by Pfizer (Mfr. Control Number: 21K-163-3874424-00). A 56-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly on 27Mar2021 as dose 1, single (at the age of 56-years-old) for COVID-19 immunization and received ongoing adalimumab [HUMIRA, dose as 40 milligrams, solution for injection in pre-filled pen, Lot number- UNKNOWN, Citrate free (4-2) Pfizer (1 in 2 week)], via subcutaneous route of administration from an unspecified date in 2018 for psoriatic arthritis. Patient medical history included mold allergy, mold allergy manifested by runny nose, wheezing, cough and no tobacco use, COVID-19 from 19Dec2020 to Jan2021, blood pressure, cholesterol, joint pain from 19Dec2020 to Jan2021, alcohol use, ten bottles of beer a week from 1980, pollen allergy (seasonal allergy) manifested by runny nose (rhinorrhoea), wheezing, cough. The concomitant medications included irbesartan (AVAPRO) taken for blood pressure, LIPITOR (atorvastatin calcium) taken for cholesterol, clopidogrel bisulfate (PLAVIX) taken as blood thinner, methotrexate taken for an unspecified indication. On 27Mar2021, the patient experienced chills and joint pain. On 28Mar2021, the events chills and joint pain resolved. The patient underwent lab tests and procedures which included body temperature with result as 102, Sars-Cov-2 test with result as positive on 22Dec2020, Sars-Cov-2 test with result as negative in 2021. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly on 17Apr2021 as dose 2, single for COVID-19 immunization. On 17Apr2021, the patient experienced fever and recurred joint pain. On 18Apr2021, the fever and recurred joint pain resolved. The patient was treated with prednisone, tylenol and motrin. The reporter causality for the events of chills, fever, joint pain onset 19Dec2020, recurred joint pain, COVID-19 and joint pain onset 27Mar2021 with HUMIRA 40mg/0.4ml (adalimumab) was reported as no reasonable possibility. This is a solicited report from the USA by a consumer of a 57-year-old male with events of non-serious chills, fever, joint pain, recurred joint pain and COVID-19 with Humira 40mg/0.4ml (adalimumab). On 19Dec2020, the patient experienced joint pain and COVID-19. On an unspecified date in Jan2021, the joint pain and COVID-19 resolved. On 27Mar2021, the patient experienced chills and joint pain. On 28Mar2021, the chills and joint pain resolved. On 17Apr2021, the patient experienced fever and recurred joint pain. On 18Apr2021, the fever and recurred joint pain resolved. COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 27Mar2021, patient received first dose of COVID-19 vaccine manufactured by Pfizer. On 17Apr2021, patient received second dose COVID-19 vaccine manufactured by Pfizer. The patient was treated with prednisone, tylenol and motrin. Causality for HUMIRA 40 mg/0.4 ml (adalimumab): The reporter causality for the events of chills, fever, joint pain onset 19Dec2020, recurred joint pain, COVID-19 and joint pain onset 27Mar2021 with HUMIRA 40MG/0.4ML (adalimumab) was no reasonable possibility. On 28Apr2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. The events chills, recurred joint pain and COVID 19 were added. The event of aches was removed. The outcome of the events was resolved on 28Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.