Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival disorder, Pain, Pyrexia
Clinical narrative: surgery which was a result of fighting gum disease/gum disorder; Fever; Pain; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a non-contactable consumer (patient) based on the information received by Pfizer from AbbVie (mfr. control no.: 21k-163-3898981-00).  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 60 years old), intramuscular on Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2019 (Batch/Lot number was not reported) and ongoing, at 40 mg, weekly (daily dose: 1 in 1 wk) and 40 mg, (1 in 2 weeks) for rheumatoid arthritis/moderate to severe rheumatoid arthritis. Medical history included habitual alcohol use stopped in 1991, habitual tobacco user stopped in 1991, hypertension, allergies, rheumatoid arthritis, gum disease, oral surgery on Mar2021 and seasonal allergies manifested by nasal drip, sneezing, clogged at the back at throat, and painful sinuses. Concomitant medications included methotrexate sodium taken for rheumatoid arthritis, losartan taken for hypertension, cetirizine hydrochloride (ZYRTEK) taken for allergies, folic acid taken for rheumatoid arthritis, fluticasone propionate (FLONASE ALLERGY RELIEF) taken for allergies, calcium carbonate, chondroitin sulfate, glucosamine hydrochloride (GLUCOSAMINE CHONDROITIN CALCIUM) taken for rheumatoid arthritis, mometasone furoate taken for allergies and an unknown drug to help her sleep. The patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (at the age of 60 years old), intramuscular on Mar2021 for covid-19 immunisation. The patient reported events of oral surgery as a result of fighting gum disease for a lifetime and non-serious sick with fever from the second Covid vaccine and pain with Humira 40mg/0.8ml and 40mg/0.4ml. On an unknown date, the patient experienced pain. On Apr2021, the patient experienced sick with fever from the second Covid vaccine. On May2021, the patient experienced oral surgery as a result of fighting gum disease for a lifetime. The patient had gum disorder on May2021, fever on Apr2021 for 2 days and pain on an unspecified date for 2 days. In Mar2021, the patient underwent oral surgery which was a result of fighting gum disease for a lifetime and not side effects from Humira. In Apr2021, she was a little sick with the second covid vaccine and she had a fever for two days. She stated that, she cannot eat hard foods and still on soft diet foods. The patient stated that she was given an unknown drug to put her to sleep during the surgery. She was taking an unknown drug to help her sleep. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient was treated with Naproxen.  The action taken in response to the events for adalimumab was dose not changed. The outcome of the event gum disorder was recovering, fever was recovered on Apr2021 while pain was unknown. Causal relationship of event gum disorder with BNT162B2 was assessed as not related per reporter while not reported for fever.  The reporter's assessment of the causal relationship of the event pain with the BNT162B2 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.  The reporter's causality for the event(s) of oral surgery was a result of fighting gum disease for a life time with humira 40mg/0.8ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of sick with fever from the second covid vaccine and pain was not provided. AbbVies opinion is that there is no reasonable possibility that the events of oral surgery was a result of fighting gum disease for a life time and sick with fever from the second covid vaccine are related to humira. 40mg/0.8ml(adalimumab). AbbVies opinion is that the event of pain is not assessable. The reporter's causality for the event(s) of oral surgery was a result of fighting gum disease for a life time and sick with fever from the second covid vaccine with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of pain was not provided. AbbVies opinion is that there is no reasonable possibility that the events of oral surgery was a result of fighting gum disease for a life time and sick with fever from the second covid vaccine are related to Humira 40mg/0.4ml(adalimumab). AbbVies opinion is that the event of pain is not assessable.  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 available information the causality between the events pyrexia and pain and the suspect vaccine BNT162B2 cannot be ruled out completely 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