Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ulcer
Clinical narrative: off label use; Interchange of vaccine products; Ulcer; Swelling of hands; Red hands; COVID; COVID; COLD; FLU LIKE SYMPTOMS; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4181663-00.  A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single and intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 23Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 19Oct2021. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2021, outcome "unknown", COVID-19 (medically significant) with onset Aug2021, outcome "recovering" and all described as "COVID"; NASOPHARYNGITIS (non-serious) with onset Aug2021, outcome "unknown", described as "COLD"; INFLUENZA LIKE ILLNESS (non-serious) with onset Aug2021, outcome "unknown", described as "FLU LIKE SYMPTOMS"; ULCER (non-serious), outcome "not recovered", described as "Ulcer"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "Swelling of hands"; ERYTHEMA (non-serious), outcome "not recovered", described as "Red hands"; OFF LABEL USE (non-serious), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Interchange of vaccine products". The patient underwent the following laboratory tests and procedures: pregnancy test: positive; sars-cov-2 test: positive. The action taken for adalimumab and covid-19 vaccine mrna (mrna 1273) was unknown. Clinical information: On an unknown date, the pregnancy was confirmed. The fetus was exposed to Maternal use of  Humira in utero during the First trimester. Maternal use of Humira was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira(Adalimumab) The reporter's causality for the event(s) of Maternal exposure during pregnancy, Hands swollen with red sores  unknown onset, COVID, Hands swollen with red sores unknown onset and Hands swollen with red sores unknown onset with Humira(Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of Cold Flu like symptoms and not sure if Humira was working was not provided.  The reporter's assessment of the causal relationship of the events  with the suspect product 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 lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Drug Ineffective, COVID 19, Nasopharyngitis, influenza like illness,Ulcer,Peripheral Swelling,Erythema,Off label Use,Interchange of vaccine products 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