Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Palatal swelling, Pyrexia, Rhinorrhoea, Tongue discomfort
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Aug2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous since 2021 (ongoing) (Lot number: 1158969) at citrate free, second regimen subcutaneous since Jan2018 (Lot number: 1137002) at citrate free and third regimen subcutaneous from 2017 (Lot number: 1130421) to 27Sep2017 at citrate free for psoriatic arthropathy. Relevant medical history included: "Ex Smoker/Cigarette", start date: 1989 (unspecified if ongoing), notes: Ex Smoker/Cigarette (Started 1989) Drank Socially; "FEMALE BREAST CANCER", start date: 27Sep2017, stop date: 2020; "right mastectomy", start date: 04Nov2017 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Route: Intramuscular), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Fatigue", "Hand pain", "Osteoarthritis", "Osteoporosis", "Balance disorder", "Fall", "Psoriasis flare-up"; Bnt162b2 (Dose:2, Route: Intramuscular), administration date: 24Mar2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Fatigue", "Hand pain", "Osteoporosis", "Balance disorder", "Osteoarthritis", "Fall", "Psoriasis flare-up". The following information was reported: FATIGUE (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "fatigue"; LYMPHADENOPATHY (hospitalization, medically significant) with onset Aug2021, outcome "unknown", described as "swollen lymph nodes on left side"; ILLNESS (hospitalization, medically significant), NASOPHARYNGITIS (hospitalization, medically significant) all with onset Dec2021, outcome "recovered" and all described as "sick with a cold"; OROPHARYNGEAL PAIN (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "sore throat"; PALATAL SWELLING (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "roof of mouth"; TONGUE DISCOMFORT (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "tongue raw"; RHINORRHOEA (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "runny nose"; PYREXIA (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "fever". The reporters assessment of the causal relationship of the events of Breast Cancer Female, Fatigue, Balance disorder, Osteoarthritis, Swollen Lymph Nodes, Fall, Drug Allergy, Psoriasis Flare-Up, Cold, Hand Pain with the suspect product Humira were No Reasonable Possibility at the time of this report and for events Osteoporosis, Psoriatic Arthritis Aggravated were Reasonable Possibility. The Causality as per manufacturer of Breast Cancer Female, Osteoporosis, Fatigue, Balance disorder, Osteoarthritis, Swollen Lymph Nodes, Fall, Drug Allergy, Psoriasis Flare-Up, Psoriatic Arthritis Aggravated, Hand Pain were No Reasonable Possibility and Not assessable for event Cold. The reporters assessment of the causal relationship of the events Breast Cancer Female, Osteoporosis, Fatigue, Balance Disorder, Osteoarthritis, Fall, Drug Allergy, Psoriasis Flare-Up, Psoriatic Arthritis Aggravated, Cold, Hand Pain were Not reported and Not related for event Swollen Lymph Nodes with the suspect product Pfizer BioNTech Covid-19. Since no determination has been received, the case is managed based on the company causality assessment. The action taken for adalimumab was dosage not changed. 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 reported information, the causal association between the event and the 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.