Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lyme disease, Paraesthesia, Therapeutic product effect incomplete
Clinical narrative: Lyme disease; Paraesthesia of limbs; Drug effect incomplete; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4375216-00 (Company).  A 37-year-old female patient received BNT162b2 (BNT162B2), on 10May2021 as dose 1, single (Batch/Lot number: unknown), on 01Jun2021 as dose 2, single (Batch/Lot number: unknown), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since Jan2022 (Lot number: 1159933), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious) with onset 2022, outcome "not recovered", described as "Drug effect incomplete"; LYME DISEASE (medically significant) with onset 2022, outcome "not recovered"; PARAESTHESIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "Paraesthesia of limbs". The patient underwent the following laboratory tests and procedures: Lab Test: (2022) Positive, notes: Positive for lyme disease. The action taken for adalimumab was unknown. In 2022, the patient experienced tingling in all four extremities/vaccine caused paresthesia in hands and feet for about seven days, tested positive for lyme disease and not had great results yet with humira. In 2022, the tingling in all four extremities/vaccine caused paresthesia in hands and feet for about seven days resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. 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 tingling in all four extremities/vaccine caused paresthesia in hands and feet for about seven days, tested positive for lyme disease and not had great results yet with Humira was not provided. For the events Paraesthesia of limbs (Paraesthesia),Causality as per reporter (Drug/Vaccine) was Possible. For Lyme disease (Lyme disease), Causality as per reporter (Drug/Vaccine) was not Reported. For Drug effect incomplete (Therapeutic product effect incomplete), Causality as per reporter (Drug/Vaccine) was not Reported.  The reporter's assessment of the causal relationship of "lyme disease" and "drug effect incomplete" with the suspect product(s) 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 considered "paraesthesia of limbs" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information in the case the report events  "lyme disease" and "drug effect incomplete" and "paraesthesia of limbs" assessed as Related to suspect drug BNT162b2.