Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Immunisation, Renal function test, Renal impairment
Clinical narrative: 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-163-4174506-00.  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Jan2021 (Batch/Lot number: unknown) at the age of 71 years as dose 1, single, intramuscular, administration date 11Feb2021 (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 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at single (dose number unknown, single) for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL IMPAIRMENT (medically significant) with onset 2021, outcome "recovering", described as "LOST KIDNEY FUNCTION/DOWN TO 25 PERCENT"; DEHYDRATION (hospitalization) with onset 2021, outcome "recovering", described as "Dehydration"; DIARRHOEA (hospitalization) with onset 2021, outcome "recovering", described as "Diarrhea"; IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster". The patient was hospitalized for dehydration, diarrhoea (start date: 01Nov2021, discharge date: 05Nov2021, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: renal function test: down to 25 percent. The action taken for adalimumab was dosage not changed.  Clinical course: In 2021, the patient experienced Lost Kidney function/Down to 25 percent function, Dehydration and Diarrhea. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 08Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 11Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, On 2021, lot number unknown, expiration date unknown. Patient was in the hospital from 01Nov2021 to 05Nov2021 for dehydration and diarrhea. He lost kidney function and was down to 25 percent function. He stated that all this happened after he got his third covid vaccination. Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of Lost Kidney function/Down to 25 percent function, Dehydration and Diarrhea with HUMIRA(ADALIMUMAB) was no reasonable possibility. AbbVie's opinion is that the events of Lost Kidney function/Down to 25 percent function, Dehydration and Diarrhea are not assessable.  Relevant Laboratory & Other Diagnostic Tests, Unknown date KIDNEY FUNCTION: Down to 25 percent. Suspect drugs: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) Daily dose: citrate free, Route of administration: Subcutaneous, Indication for use: Moderate to severe Hidradenitis Suppurativa Therapy dates: Unknown- Ongoing INFLUENZA VACCINE (INFLUENZA VACCINE)(INFLUENZA VACCINE),UNKNOWN, Route of administration: Intramuscualr, Indication for use: COVID-19 Vaccination, Therapy dates: 08Jan2021 Product-Reaction level HUMIRA HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB), Daily dose: Citrate free, Route of administration: Subcutaneous, Therapy dates: Unknown-Ongoing  Causality: Function kidney decreased, Action(s) taken with drug:  Dose Not Changed, Causality as per reporter (Drug/Vaccine):  No reasonable possibility, Causality as per Mfr.(Drug/Vaccine): Not assessable, Dechallenge: N/A  Dehydration Action(s) taken with drug:  Dose Not Changed, Causality as per reporter (Drug/Vaccine):  No reasonable possibility, Causality as per Mfr.(Drug/Vaccine): Not assessable, Dechallenge: N/A  Diarrhea Action(s) taken with drug:  Dose Not Changed Causality as per reporter (Drug/Vaccine):  No reasonable possibility, Causality as per Mfr.(Drug/Vaccine): Not assessable, Dechallenge: N/A  Causality: Function kidney decreased, Action(s) taken with drug:  Unknown, Causality as per reporter (Drug/Vaccine):  Possible, Dechallenge: N/A  Dehydration Action(s) taken with drug:  Unknown, Causality as per reporter (Drug/Vaccine):  Possible Dechallenge: N/A  Diarrhea Action(s) taken with drug:  Unknown, Causality as per reporter (Drug/Vaccine):  Possible Dechallenge: N/A  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 available in narrative the reported  events of   Dehydration , diarrhea, booster and renal function impaired  were assessed as related to suspected vaccine BNT162B2 The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.