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VAERS ID: 1995608

AGE: 54| SEX: M|STATE: Unk

Description

Sickness; Clostridium difficile infection; FACILITATED COLLECT This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4129526-00. A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Oct2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Lot number: 1154004) at citrate free for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: 01Sep2021, when the patient was 53 years old, for COVID-19 Vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Sep2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 10Oct2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. No known allergies. The following information was reported: CLOSTRIDIUM DIFFICILE INFECTION (medically significant) with onset 2021, outcome "recovering", described as "Clostridium difficile infection"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "Sickness". The action taken for adalimumab was unknown. Clinical course: Solicited report from the USA by a consumer of a 54-year-old male with events of non-serious C-Diff and Sick with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced C-Diff. In Nov2021, the patient experienced Sick. The reporter's assessment of the causal relationship of the events 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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

Symptoms

Clostridium difficile infection, Illness

Vaccines

VAX DATE: 09 October 2021 | ONSET DATE: 31 October 2021 | DAYS TO ONSET: 22
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • 2
  • OT

RECVDATE:
30 December 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
Y
LAB_DATA:
V_ADMINBY:
UNK
OTHER_MEDS:
HUMIRA
CUR_ILL:
HISTORY:
PRIOR_VAX:
SPLTTYPE:
USPFIZER INC202101843934
FORM_VERS:
2
TODAYS_DATE:
29 December 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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