Report #2900007

Overview

Sex

Female

Age

78 yrs

State

IA

Recovered

Not recovered

Vaccinated

Apr 2, 2021

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

She did not have lot of energy; she is still experiencing just debilitation after having the issue that she is had with the vaccine; 002191-PFIZER FIRST CONNECT This is a solicited report received from a Consumer or other non HCP, Program ID:. An 83-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: ER8737) at the age of 78 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, batch/lot number EL1284, intramuscular in the left deltoid), administration date: 04Jan2021, when the patient was 78-year-old, for COVID-19 immunisation. The following information was reported: FATIGUE (disability), outcome "not recovered", described as "She did not have lot of energy"; ASTHENIA (disability), outcome "not recovered", described as "she is still experiencing just debilitation after having the issue that she is had with the vaccine". Additional information: Patient was reported that she has already done two reports previously for side that she is had with the Pfizer-BioNTech or Comirnaty vaccine for COVID and she wanted to follow up on them and let us know that she is still experiencing just debilitation after having the issue that she is had with the vaccine. She did give me two reports numbers, if you would like to have them." When probed for the adverse event: Transferring agent stated, "She mentioned she was feeling debilitated." When again for adverse event: Transferring agent stated, "She was feeling debilitated, like she did not have lot of energy and then she also mentioned that, after that she was having issues when needing to use a walker and a motorized wheelchair, just because she could not have enough strength to move by herself, and she felt very debilitated." The reporter's assessment of the causal relationship of "she did not have lot of energy" and "she is still experiencing just debilitation after having the issue that she is had with the vaccine" 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.; Sender's Comments: Based on drug safety and plausible temporal association, there is reasonable possibility of causal association between the reported event FATIGUE , ASTHENIA and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer drug 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.