Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Therapeutic product effect decreased
Clinical narrative: spondylitis ankylosing aggravated/flare of ankylosing spondylitis; flushed face/face felt flushed; extremities hot feeling of/arm felt hot; patient received bnt162b2; dose 3; patient received bnt162b2; dose 3; Humira was not working anymore.; generalized aching/achiness all over; flu like symptoms/felt as if had the flu but without a fever; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer from Company (MFR Control No.: 21K-163-4051118-00) from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 20Aug2021 (batch/lot number and expiry date unknown) at 74 years of age as dose 3, single for covid-19 immunization, and adalimumab (HUMIRA, solution for injection in pre-filled pen, 40 mg/0.4 ml (adalimumab)) via subcutaneous from an unspecified date in 2020 (batch/lot number and expiry date unknown) and ongoing, at 40 mg (1 in 2 weeks/citrate free) for ankylosing spondylitis. The patient medical history included no tobacco, no alcohol. The patient was unknown if enrolled in a COVID-19 vaccine trial. The patient previously took dose 1 of bnt162b2 on 29Jan2021 (batch/lot number EL0142), and dose 2 of bnt162b2 on 19Feb2021 (batch/lot number EL9269); both intramuscular at 74 years of age for COVID-19 immunization. Concomitant medication was not reported. In Aug2021, the patient experienced generalized aching, flu like symptoms. On 21Aug2021, the patient experienced extremities hot feeling of. On 22Aug2021, the patient experienced flushed face. On 22Sep2021, the patient informed the patient informed that she experienced non-serious arm felt hot, face felt flushed, achiness all over, felt as if had the flu but without a fever, flare of ankylosing spondylitis after taking third covid shot and Humira was not working anymore with Humira 40 mg/0.4 ml (adalimumab). In Aug2021, the patient experienced achiness all over, felt as if had the flu but without a fever and Humira was not working anymore. On 21Aug2021, the patient experienced arm felt hot. On 22Aug2021, the patient experienced face felt flushed. In Aug2021, the arm felt hot, achiness all over and felt as if had the flu but without a fever resolved. In Sep2021, the patient experienced flare of ankylosing spondylitis after taking third covid shot. The patient informed that she was treated with Excedrin. The action taken in response to the events for adalimumab was dose not changed. The clinical outcome of the events flushed face, 3rd dose-20aug2021 was reported as unknown. The clinical outcome of the events generalized aching/achiness all over, flu like symptoms/felt as if had the flu but without a fever, extremities hot feeling of/arm felt hot was recovered in Aug2021, while unknown for the rest of the events. The reporter's causality for Humira 40m g/0.4 ml (adalimumab) for extremities hot feeling of (feeling hot), flushed face (flushing), generalized aching (pain), flu like symptoms (influenza like illness) was not reported; while spondylitis ankylosing aggravated (ankylosing spondylitis) was reasonable possibility. The reporter also informed that the causality for drug effect decreased (therapeutic product effect decreased) was not assessable. The reporter's causality for PFIZER BIONTECH COVID-19 VACCINE extremities hot feeling of (feeling hot), flushed face (flushing), generalized aching (pain), flu like symptoms (influenza like illness), spondylitis ankylosing aggravated (ankylosing spondylitis) was not related. The patient also informed that the causality of drug effect decreased (therapeutic product effect decreased) was not reported.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.  Amendment: This follow up is being submitted to amend previously reported information: Updated reporter causality for events (Off label use, and Extra dose administered).  Follow-up (22Sep2021): New information received from a a solicited report based on the information received by Pfizer from Company (manufacturer control number: 21K-163-4051118-00) via a contactable consumer (patient) included: patient demographics, medical history, suspect drug data (therapy details, dose not changed), course of events (arm felt hot, face felt flushed, achiness all over, felt as if had the flu but without a fever, seriousness), reaction data (flare of ankylosing spondylitis), treatment details, causality.; Sender's Comments: Based on current information available, the event flare of ankylosing spondylitis mostly represented intercurrent condition in this patient with advanced age and with previous history, unrelated to Bnt162b2. Previous medical evaluation of non-serious events were retained.