Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Localised infection, Pyrexia
Clinical narrative: Fever; Flu like symptoms; could not sleep/insomnia probably gotten worse; could not get comfortable; inflamed; Abscess; infection in rear end area; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4002485-00). A contactable consumer (patient) reported a 63-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), second dose, intramuscularly on 23Mar2021 (Lot Number: EP6955; Expiration Date: 30Jun2021) at the age of 63 years old, as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneously from 2017 and ongoing, at 40 mg [(40 mg,1 in 2 wk) for moderate to severe adult crohn's disease. Medical history included insomnia from 1997, Crohn's disease from 1997, non smoker, abstains from alcohol, six surgeries in the same area, unknown medication for nausea allergy manifested by skin crawling and uncomfortable. The patient's concomitant medications were not reported. The patient previously took prednisone, She was on and off with the high dose of Prednisone for 15 to 18 years and it did not work anymore before she was put on Humira. The patent previous took BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), first dose, intramuscularly on 02Mar2021 (Lot Number: EP6198; Expiration Date: 30Jun2021) at the age of 63 years old, for covid-19 immunisation and experienced sore arm. In Mar2021, the patient experienced inflamed, abscess and infection in rear end area. These events inflamed, abscess and infection in rear end area were reported as serious with hospitalization and other medically important condition. On 28Mar2021, the patient experienced fever, flu like symptoms, could not sleep and could not get comfortable. On 29Mar2021, the fever, flu like symptoms, could not sleep and could not get comfortable resolved. In Apr2021, the inflamed, abscess and infection in rear end area resolved. The patient's insomnia probably gotten worse. On 28Mar2021, after the second dose of Covid 19 vaccine, the infection was really bad. On 29Mar2021, morning she went to the emergency room. She had a surgery to drain the abscess and two stents placed in the rear end of the rectum. It took two to three weeks for it to be healed and the stent locked already through a fistula. She was anesthetized for the surgery and had unknown tests. She mentioned that the combination of the second dose of Covid 19 vaccine and Humira shot caused her to get fever and flu like symptoms for a day and a half. Two days later, she ended up having the infection. The alternative etiology for the event of Infection in rear end area and inflamed was reported as abscess and infection. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was dose not changed.  The patient was treated with Ambien. The outcome of the events inflamed, abscess and infection in rear end area was recovered in Apr2021, of the other events was recovered on 29Sep2021.  The reporter's causality for the events of inflamed, abscess, infection in rear end area, fever, flu like symptoms, could not sleep and could not get comfortable with Humira 40MG/0.4ML (Adalimumab) was a reasonable possibility. The reporter's causality for the events of insomnia was not provided. Opinion is that there is no reasonable possibility that the events of inflamed, abscess, infection in rear end area, insomnia, fever, flu like symptoms, could not sleep, could not get comfortable and sore arm are related to Humira 40MG/0.4ML (Adalimumab). The reporter's causality for the events of inflamed, abscess, infection in rear end area, fever, flu like symptoms, could not sleep and could not get comfortable with BNT162b2 was probable. The reporter's causality for the events of insomnia was not provided.  The reporter's assessment of the causal relationship of the event insomnia with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the events inflammation, abscess, localized inflammation, pyrexia, influenza like illness, insomnia, discomfort and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.