Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Mobility decreased, Pain, SARS-CoV-2 test negative, Somnolence
Clinical narrative: Sudden slurring of speech slight mouth droopiness; Sudden slurring of speech slight mouth droopiness; Sudden loss of consciousness; difficulty in bringing her hand to mouth to eat-opposite arm from injection site / Difficulty walking, getting out of bed; Increasing confusion, soreness, pain, throughout as well as injection site; Increasing confusion, soreness, pain, throughout as well as injection site; Increasing confusion, soreness, pain, throughout as well as injection site; Difficulty walking, getting out of bed.; Severe lethargy, tiredness, sleepiness; Severe lethargy, tiredness, sleepiness; Severe lethargy, tiredness, sleepiness; This is a spontaneous report from a contactable other HCP. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EK9231) intramuscular in left arm on 19Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included beginning signs of dementia, stage II breast cancer not immune compromised, no chemo no radiation only hormone therapy, and hormone therapy. There was no known allergies. The patient was not pregnant. There were other unspecified medications in two weeks. After 3-4 hours after injection on 19Jan2021 19:30 she had difficulty in bringing her hand to mouth to eat-opposite arm from injection site. Increasing confusion, soreness, pain, throughout as well as injection site. Difficulty walking, getting out of bed. Severe lethargy, tiredness, sleepiness. Day 3 after vaccine on 22Jan2021, all other symptoms still present and worsening, then sudden slurring of speech slight mouth droopiness, then sudden loss of consciousness. Could not be woke up for about 15 minutes then opened eyes but not aware of surroundings. Taken to hospital for work up. On day 4 after vaccine still confused not at normal baseline. Needs assistance in walking, eating, etc. Events resulted in: Emergency room/department or urgent care, Hospitalization for 7 days, Disability or permanent damage. The patient received treatment such as ER and ongoing hospital stay with Pt and OT for events. She received COVID test via nasal swab on 22Jan2021 with result of negative. Events outcome of difficulty in bringing her hand to mouth to eat-opposite arm from injection site, increasing confusion, soreness, pain, throughout as well as injection site, difficulty walking/getting out of bed, severe lethargy, tiredness, sleepiness was not recovered, while for others was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.