Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Fungal skin infection, Immunisation, Knee operation
Clinical narrative: Booster; Knee surgery; Fungal rash; Tired; This is a solicited report received from contactable reporter(s) (Consumer) from a Non-Interventional Study based on information received by Pfizer from a company, manufacturer control number: 21K-163-4113015-00. The reporter is the patient. Other Case identifier(s): 21K-163-4113015-00 (company).  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single, intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization (age at vaccination 64 years old); adalimumab (HUMIRA), subcutaneous (Lot number: 1146181) citrate free for ankylosing spondylitis. Relevant medical history included: "Tiredness", start date: 01Feb2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; KNEE OPERATION (medically significant) with onset 2021, outcome "recovered" (2021), described as "Knee surgery"; FUNGAL SKIN INFECTION (medically significant) with onset 2021, outcome "recovering", described as "Fungal rash"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Tired". The action taken for adalimumab was unknown.  Causality for Humira (adalimumab): The reporter's causality for the events of knee surgery and tired with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of fungal rash was not provided. Company's opinion is that there is no reasonable possibility that the events of knee surgery and tired are related to Humira (adalimumab). Company's opinion is that the event of fungal infection that caused a large burn like rash is not assessable.  Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for the event of tired with BNT162B2 was possible. The reporter's causality for the event(s) of knee surgery and fungal rash 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 available information, known drug profile and considering drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the reported event of Fatigue cannot be completely excluded. However, the reported Knee operation and Fungal rash are more likely intercurrent conditions and unrelated to vaccination with BNT162B2. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug 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.