Report #2887920

Overview

Sex

Male

Age

44 yrs

State

IA

Recovered

Unknown

Vaccinated

Nov 28, 2021

Onset

—

Days to onset

—

Hospital days

—

Symptoms (21)

Symptom narrative

weakness/paralysis; sensory and autonomic dysfunction; weakness/paralysis; neurological illness; major balance and mobility impairment; major balance and mobility impairment; hypothesis is that an abnormal immune-mediated inflammatory or demyelinating process may have followed the vaccination; This is a spontaneous report received from a Consumer or other non HCP. A 44-year-old male patient received BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Lot number: FJ8762, Expiration Date: Jun2022) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Manufacturer: Pfizer, Date: 03Apr2021, Lot Number: ER8734, ), administration date: 03Apr2021, when the patient was 43-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Manufacturer: Pfizer, Date: 24Apr2021, Lot Number: EW0170, ), administration date: 24Apr2021, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: PARALYSIS (disability, medically significant), ASTHENIA (disability), outcome "unknown" and all described as "weakness/paralysis"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (disability), outcome "unknown", described as "sensory and autonomic dysfunction"; NEUROLOGICAL SYMPTOM (disability), outcome "unknown", described as "neurological illness"; BALANCE DISORDER (disability), MOBILITY DECREASED (disability), outcome "unknown" and all described as "major balance and mobility impairment"; DEMYELINATION (disability), outcome "unknown", described as "hypothesis is that an abnormal immune-mediated inflammatory or demyelinating process may have followed the vaccination". Therapeutic measures were taken as a result of paralysis, autonomic nervous system imbalance, asthenia, neurological symptom, balance disorder, mobility decreased, demyelination. Clinical course: The reporter requested that Pfizer open a formal product-quality and safety investigation concerning Pfizer-BioNTech COVID-19 vaccine lot FJ8762, which was administered to the patient as a third dose on 28Nov2021. The vaccination was documented on the patient's original vaccination card and in official VAERS report. VAERS subsequently requested medical records to further assess the reported event. Following this dose, the patient developed a serious and persistent neurological illness, including significant balance and mobility impairment, weakness/paralysis, sensory and autonomic dysfunction, and ongoing disability requiring extensive evaluation and treatment. The reporter's working hypothesis was that an abnormal immune-mediated inflammatory or demyelinating process may have occurred following the vaccination. The reporter acknowledged that a temporal association and a VAERS report do not independently establish causation and stated that the request was for a rigorous, documented investigation rather than a predetermined conclusion. Please open a case, provide its reference number, and respond to the following requests: 1.Confirm the product presentation, formulation, manufacturing site or sites, fill/finish site, manufacturing and release dates, expiration, distribution pathway, and release status for lot FJ8762. 2.Provide the lot-specific Certificate of Analysis or Certificate of Release and releasable results or summaries for identity, potency, purity, integrity, sterility, endotoxin, particulate matter, appearance, pH, lipid nanoparticle or mRNA specifications, and other release or stability tests applicable to this lot. 3.Identify any deviation, out-of-specification or out-of-trend result, investigation, reprocessing, corrective or preventive action, stability concern, temperature excursion, shipping concern, complaint trend, recall consideration, or regulatory communication associated with lot FJ8762. 4.State whether Pfizer received adverse-event reports or product-quality complaints referencing FJ8762 and whether Pfizer performed lot-level signal detection or aggregate review. I do not request other patients' identities or protected information; de-identified counts or conclusions are sufficient. 5.Explain whether any retained sample from lot FJ8762 still exists and whether it was retested after distribution or after safety or quality complaints. If no sample remains, state the applicable retention policy and disposition date. 6.Provide the complete ingredient and excipient list and the applicable specifications for the presentation associated with FJ8762, while recognizing that legally protected manufacturing details may be redacted. 7.Identify the Pfizer department and qualified medical or quality professional responsible for the review, and explain the process for securely submitting a concise medical summary and supporting records.Preservation request. Please preserve all existing records, data, retained samples, complaint files, pharmacovigilance analyses, manufacturing and release documentation, distribution records, correspondence, and electronically stored information relating to lot FJ8762 and this inquiry while it remains pending.If Pfizer cannot disclose a requested item, please identify it by category, state whether it exists, explain the legal or confidentiality basis for withholding it, and provide any reasonably segregable non-confidential portion or summary. Please acknowledge receipt, assign a case number, and provide a written response within 30 calendar days.