Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Fatigue, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tiredness; Pain in hip; Injection site pain; Coronavirus test positive; Coronavirus test positive; This is a report received from a non-contactable consumer (patient) or other non hcp. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date as unknown single for COVID-19 immunization and Adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for Moderate to severe Rheumatoid Arthritis. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced tiredness, pain in hip and injection site pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of the events was recovered on an unspecified date in 2021.  The reporter's causality for the event of Tired was no reasonable possibility, Hip pain was not provided with respect to HUMIRA (ADALIMUMAB) and for the event(s)of Injection site pain with HUMIRA (ADALIMUMAB) was a reasonable possibility.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow up (21Jun2021): This is a report received from a non-contactable 59-year-old female consumer (patient) based on information received by Pfizer. (manufacturer control number: 21K-163-3956129-00) that:  Describe Reactions: Coronavirus test positive (Coronavirus test positive)- Recovered/resolved Solicited report by a consumer of a 59 year old female with an event of non-serious CORONA VIRUS TESTED POSITIVE with HUMIRA (ADALIMUMAB). There was no reported medical history.  On 03Jun2021, the patient experienced CORONA VIRUS TESTED POSITIVE. In Jun2021, the CORONA VIRUS TESTED POSITIVE resolved. COVID-19 VACCINE was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  On an unspecified date, the patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 21Apr2021 (at the age of 59 years old), patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer.  SUSPECT DRUG(S) INFORMATION: SUSPECT DRUG(S) (include generic name): HUMIRA(ADALIMUMAB) Route: Subcutaneous Indication: Moderate to severe Rheumatoid Arthritis  Therapy dates: Unk  COVID-19 VACCINE(COVID-19 VACCINE)(COVID-19 VACCINE),UNKNOWN Daily Dose : Pfizer Route: Intra-muscular Indication: COVID-19 VACCINATION Therapy dates: Unk  Concomitant drugs: Concomitant drugs not reported Other relevant history: Not reported Report source: report Report type: Initial Did event abate after stopping drug? NA  Reaction information: Seq. no: 1 Reaction: Coronavirus test positive (Coronavirus test positive) Start date: 03Jun2021 Stop date: Jun2021  Describe Reaction: Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of CORONA VIRUS TESTED POSITIVE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Relevant Laboratory & Other Diagnostic Tests 03Jun2021 COVID-19 VIRUS TEST: Positive  Seq.No: 1 Drug: Humira (Solution for injection in pre-filled pen) (ADALIMUMAB) Causality  1) Coronavirus test positive (Coronavirus test positive) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) :  No reasonable possibility Dechallange : N/A  Seq. No: 2 Drug: COVID-19 VACCINE(COVID-19 VACCINE)(COVID-19 VACCINE),UNKNOWN Daily Dose : 1)Pfizer  First dose (1 in 1 Once) 2)Pfizer  second dose (1 in 1 Once) Route of Admin:  1) Intra-muscular 2)Intra-muscular Therapy Dates/Duration : 2) 21Apr2021 - 21-Apr2021  Causality 1) Coronavirus test positive (Coronavirus test positive) Action(s) taken with drug : Not Applicable Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallange : N/A  Lab Result : Test name: COVID-19 VIRUS TEST Test date: 03Jun2021; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causative relation between the events and the administration of the BNT162B2 vaccine cannot be excluded.