Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Drug ineffective, Immunisation reaction, Suspected COVID-19, Therapeutic response shortened
Clinical narrative: Wearing off effect; COVID-19; COVID-19; Covid vaccine related issues; Joint pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4240995-00  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 12Jan2022 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous, administration date Oct2021 (Batch/Lot number: unknown) as unk (citrate free) for ankylosing spondylitis. Relevant medical history included: "Pneumonia", start date: 2019 (unspecified if ongoing), notes: In 2019, the patient experienced pneumonia and bronchitis; "Bronchitis", start date: 2019 (unspecified if ongoing), notes: In 2019, the patient experienced pneumonia and bronchitis. The patient's concomitant medications were not reported. It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 14Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 14Jan2022, outcome "not recovered" and all described as "COVID-19"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Joint pain"; VACCINATION COMPLICATION (non-serious) with onset Jan2022, outcome "unknown", described as "Covid vaccine related issues"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "unknown", described as "Wearing off effect".  Causality for Humira (Adalimumab): The reporter's causality for the events of Covid vaccine related issues, Covid, joint pain three to four days before injection with Humira. Onset in Oct2021, joint pain three to four days before injection with Humira was not provided.  Causality for Suspect Drug Pfizer Biontech Covid-19 vaccine: The reporter's causality for the events Vaccination adverse reaction, COVID-19 and Joint pain was possible. Wearing off effect was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events suspected Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of suspected covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.  Based on available information and the drug temporal relationship, the causality between the events - arthralgia, vaccination complication, and the suspect drug "BNT162B2" cannot be completely excluded.  Based on available information, the causality between the event "Therapeutic response shortened" and the suspect drug "BNT162B2" is assessed as UNRELATED as it can be explained by the other suspect "HUMIRA"