Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder, Infection, Influenza like illness, Nephrolithiasis, Obstruction
Clinical narrative: Obstruction; Flu like symptoms; Immune system disorder; Kidney stones; Infection; Sepsis; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3977168-00. A 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 number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 29Dec2020 as 40 mg/ 0.4ml (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "surgery" (unspecified if ongoing), notes had the surgery to remove stones and stents placement. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: INFECTION (hospitalization) with onset 2021, outcome "unknown"; NEPHROLITHIASIS (hospitalization) with onset 2021, outcome "unknown", described as "Kidney stones"; SEPSIS (hospitalization) with onset 2021, outcome "unknown"; OBSTRUCTION (hospitalization), outcome "unknown"; INFLUENZA LIKE ILLNESS (hospitalization), outcome "unknown", described as "Flu like symptoms"; IMMUNE SYSTEM DISORDER (hospitalization), outcome "unknown". The patient was hospitalized for nephrolithiasis, obstruction, influenza like illness, infection, 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 result, notes: For Kidney stones. The action taken for adalimumab was unknown. The patient experienced kidney stones and blockage, which led to an infection and subsequent sepsis, flu like symptoms with vaccinations and weak immune system with HUMIRA 40mg/o .4ml on unknown dates, (adalimumab). 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.Kidney stones, Infection, Flu like symptoms and Sepsis (Sepsis): Recovered/ resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) and MODERNA COVID-19 VACCINE (ELASOMERAN) were also considered suspect. The patient developed Had kidney stones, and a blockage, which led to an infection and was hospitalized for four days from 08Jul 2021 to 12Jul2021. had the surgery to remove stones and stents placement. Was hospitalized as she developed sepsis from a kidney stone had been cleared, physician had adjusted the dosage frequency with Humira to every three weeks received periodic ultrasounds to check on stone development. She had a weak immune system and this was determined to influence the infection. had flu like symptoms with each vaccination. The last vaccination had affected for 12 hours. Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of kidney stones and blockage, which led to an infection and Subsequent sepsis unknown onset, in 2021 and weak immune System was not provided. The reporter's causality for the event(s) of flu like symptoms with vaccinations with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. AbbVie's opinion is that there is a reasonable possibility that the events of kidney stones and blockage, which led to an infection and subsequent sepsis unknown onset, flu like symptoms with vaccinations, kidney stones and blockage, which led to an infection and subsequent sepsis onset in 2021 and weak immune system are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).Change History: On 13Jul2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "KIDNEY INFECTION" was added. On 28 Oct 2021, received updates to concomitant drug information and narrative description. On 23Feb2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, concomitant drug information and narrative description. The event of "DEVELOPED SEPSIS FROM A KIDNEY STONE" was added. The event of "KIDNEY STONES" was removed. On 23 Jun 2022, received updates to event information, reporter opinion of causality, company opinion of causality, suspect drug information, concomitant drug information, laboratory/diagnostic procedures and narrative description. The events of "FLU LIKE SYMPTOMS WITH VACCINATIONS" and "WEAK IMMUNE SYSTEM" were added. Causality: Flu like symptoms Causality as per reporter for Humira: Not Related. Immune system disorder, Sepsis, Infection, Obstruction and Kidney stones Causality as per reporter for Humira: Not Reported and Causality as per Mfr for Humira: Reasonable possibility. Kidney stones Causality as per Mfr for Humira: No reasonable possibility. Flu like symptoms Causality as per reporter for BNT162b2: Possible. Flu like symptoms Causality as per reporter for MODERNA COVID-19 VACCINE: Possible. For all other events its not reported.  The reporter's assessment of the causal relationship of "kidney stones", "obstruction", "flu like symptoms", "infection", "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.   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 known safety profile and Limited information in the case report, a casual association between reported events and the suspect drug 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