Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder, Infection, Influenza like illness, Nephrolithiasis, Obstruction
Clinical narrative: Kidney stones; Obstruction; Infection; Flu like symptoms; Sepsis; Immune system disorder; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 21K-163-3977168-00.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 29Dec2020 as 40 ml (1 in 14 d) ((40mg/0.4ml(solution for injection in pre-filled) (Batch/Lot number: unknown) and on 29Dec2020 as 40 ml (1 in 3 wk) (40mg/0.4ml(solution for injection in pre-filled) (Batch/Lot number: unknown), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (caused and prolonged hospitalization) with onset 2021, outcome "recovered", described as "Flu like symptoms"; IMMUNE SYSTEM DISORDER (caused and prolonged hospitalization) with onset 2021, outcome "unknown"; INFECTION (caused and prolonged hospitalization) with onset 2021, outcome "recovered"; NEPHROLITHIASIS (caused and prolonged hospitalization, medically significant) with onset 2021, outcome "recovered", described as "Kidney stones"; OBSTRUCTION (caused and prolonged hospitalization) with onset 2021, outcome "unknown"; SEPSIS (caused and prolonged hospitalization, medically significant) with onset 2021, outcome "recovered". The patient was hospitalized and prolonged hospitalization for nephrolithiasis, obstruction, infection, influenza like illness, sepsis, immune system disorder (start date: 08Jul2021, discharge date: 12Jul2021, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: Ultrasound kidney: unknown results. The action taken for adalimumab was dosage permanently withdrawn in Jun2021. The reporter's assessment of the causal relationship of "kidney stones", "obstruction", "infection", "flu like symptoms", "sepsis" and "immune system disorder" 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 reporters assessment of the causal relationship of the event with the suspect product 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.   Clinical course: the patient experienced kidney stones and blockage, which led to an infection and subsequent sepsis, flu like symptoms with vaccinations and weak immune system. in 2021, the patient experienced kidney stones and blockage, which led to an infection and subsequent sepsis. on unknown dates, kidney stones and blockage, which led to an infection and subsequent sepsis, flu like symptoms with vaccinations and kidney stones and blockage, which led to an infection and subsequent sepsis resolved.   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 information in the case report and a plausible temporal relationship, a possible causal association between the reported events 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.