Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: fast respirations/to every 1 of her respirations, he would take 3 breaths; Chills; was so cold that his fingertips were blue; Fever (103.2 degrees); lost the ability to walk and needed a wheelchair; needed help getting him in and out of bed; conscious but was not responding to commands and was staring at space; conscious but was not responding to commands and was staring at space; This is a spontaneous report from a contactable other healthcare professional (patient's wife). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533), intramuscular administered in the right arm, on 06Apr2021 12:00, as single dose, for COVID-19 immunisation, at a clinic. Medical history included dementia (frontotemporal dementia, behavior variant) from Jun2010 and ongoing, could not speak, hypothyroidism, prostate and urinary problems, and COVID-19 in Dec2020. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 2020 and ongoing; and morniflumate (FLOMAX tablet 4 mg) taken for prostate and urinary problems from an unspecified date (reported as 5 or more years) and ongoing. The patient did not have prior vaccinations (within 4 weeks). On 06Apr2021 at 17:00, 5 hours after the vaccination, the patient experienced fever (103.2 degrees), lost the ability to walk and needed a wheelchair, needed help getting him in and out of bed, conscious but was not responding to commands and was staring at space, chills, and was so cold that his fingertips were blue. On 07Apr2021, the patient experienced fast respirations/to every 1 of her respirations, he would take 3 breaths. The reporter further explained that the patient experienced chills, fever, lost the lability to walk and needed a wheelchair, and needed help getting help in and out of bed. She stated he was unresponsive but clarified that he was conscious but was not responding to commands and was staring at space. The chills lasted for less than an hour. She put a heating blanket on him. She added that he was so cold that his fingertips were blue. The chills ended and he ran into a fever which lasted for 10 hours. She mentioned that if his fever would have been greater than 105 degrees, she would have sent him to the emergency room. The highest it reached was 103.2 degrees. She gave him Tylenol and cold compresses which brought his temperature down to 101. He was comfortable. Initially, on an unspecified date, his breathing, color and blood pressure were all good. While he had a fever, she observed that to every 1 of her respirations, he would take 3 breaths. From a cardiovascular view he is healthy. The local paramedics come and check on him periodically and the reporter monitors his glucose and blood pressure (unknown results). She stated that all of these were complicated by him having dementia. The reporter stated that he was getting better. She was not panicked and was not complaining. She wanted the officials to know that she thinks people who have had Covid should be tested to see the level of antibodies present or a titer test before having the vaccine and that maybe they not need the vaccine. The events did not require visits to emergency room and physician's office. The reporter assessed the events "Fever (103.2 degrees)", "lost the ability to walk and needed a wheelchair", "needed help getting him in and out of bed", "conscious but was not responding to commands and was staring at space", "fast respirations/to every 1 of her respirations, he would take 3 breaths" as serious (medically significant). The patient recovered from chills on 06Apr2021 (after less than an hour), "Fever (103.2 degrees)" on 07Apr2021 03:00, "fast respirations/to every 1 of her respirations, he would take 3 breaths" on 07Apr2021, "conscious but was not responding to commands and was staring at space" on 12Apr2021; recovered with sequel from "lost the ability to walk and needed a wheelchair", "needed help getting him in and out of bed" on 09Apr2021; and was recovering from "was so cold that his fingertips were blue".; Sender's Comments: Based from know drug safety profile and sequence of events,  the reported events in relation to suspected drug BNT162B2 cannot be totally excluded.  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