Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Near death experience, Oxygen saturation, Pain
Clinical narrative: high fever; slept for 20 hours a day; terrible headache; aches and pain; could not eat; could not get out of bed; sick; she thought she was going to die; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2022 14:00 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Arthritis" (unspecified if ongoing), notes: Verbatim: arthritis; "glucose problems" (unspecified if ongoing), notes: Verbatim: glucose problems; "Hypertension" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shot (The only vaccine she got sick from was 10 years ago and it was from the flu shot), for immunization, reaction(s): "sick". The following information was reported: NEAR DEATH EXPERIENCE (medically significant) with onset 2022, outcome "unknown", described as "she thought she was going to die"; PAIN (non-serious) with onset 02Feb2022, outcome "not recovered", described as "aches and pain"; FEEDING DISORDER (non-serious) with onset 2022, outcome "unknown", described as "could not eat"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "could not get out of bed"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "sick"; SOMNOLENCE (non-serious) with onset 02Feb2022, outcome "unknown", described as "slept for 20 hours a day"; HEADACHE (non-serious) with onset 02Feb2022, outcome "recovered" (Feb2022), described as "terrible headache"; PYREXIA (non-serious) with onset 04Feb2022, outcome "not recovered", described as "high fever". The events "aches and pain", "terrible headache" and "high fever" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Feb2022) unknown; body temperature: (Feb2022) 101 degree, notes: High; heart rate: (Feb2022) unknown; oxygen saturation: (Feb2022) unknown. Therapeutic measures were taken as a result of pain, headache, pyrexia.  Clinical course: Caller calling about the Pfizer Covid Vaccine that she received 2 and a half weeks ago. States she feels that this was nothing but publicity and total bogus. She had never been so sick. The only vaccine she got sick from was 10 years ago and it was from the flu shot. Caller stated 2 days after the first Covid shot she slept 20 hours a day. She could not get out of bed. Stated she could not eat and was forced to drink water and was running a high temperature. Caller proceeded to state do not take the Pfizer vaccine it was dangerous. It was a horrible vaccine. Caller stated she does not want anyone showing up at her house. She was a nurse of over 25 years, she had many master degrees and worked in public health. She stated she knows it was the state department from # that came with the fridge, the thermometer, the vaccines, and the questionnaires. She is familiar with all of this from working with the health department. This was the first and last time, it had put her out of commission for 3 weeks. Caller proceeds to state all these doctors, especially the cute doctors on TV saying that they were vaccinated and their families were vaccinated and they were so proud was proof that it was false advertising. They should take him off the air. There were more sick people and dying people from this vaccine, than there were healthy people. Caller states she would rather take saline injected into her body over this poison because that's what it was. It was a terrible vaccine and no one should take it. We were heading towards endemic proportions and it was not so terrible that you were not vaccinated. She had to show her stupid card to go anywhere, she couldn't even go to her cousin's home because he wanted her to show her card that she had the vaccine. She was not a communist. Headache was started 2 days after getting the vaccine. It stopped about about a week ago after taking almost an entire case of Tylenol and Ibuprofen. High Fever started sometime Friday night. High Fever outcome she had to take almost an entire case of Tylenol and Ibuprofen. Aches and pains that were not relieved by any type of over the counter medication. Caller stated she would have to sit on the edge of the bed because she ached so bad because she was in so much pain she was in tears; she had to take prescription pain killers. This vaccination should be taken off the air and not be dispensed. The vaccine had affected her life, her marriage, and her quality of living because she had been so sick; she was tired from being so sick. Caller states on the television they were showing an add that if you had any serious reaction to call this number but she didn't call them she called Pfizer DSU instead. She had serious problems. She doesn't want to be a long term survivor of this horrible vaccine. It did not required hospitalization, she was told by her doctor bed rest and water. Monitoring pulse ox and blood pressure. Confirmed with caller, she does not have NDC, Lot or expiry of the other products she mentioned she took for treatment of this event. Caller stated she thought she was going to die. She tried to watch a bit of TV and every 5 minutes she would see these two doctors from the # Health Department on TV folding their hands saying they were vaccinated, their families were vaccinated. She was so critically ill. When she woke up in the morning she couldn't get out of the bed the day after receiving the vaccine. Caller states she does not want this information to be publicized and she had it. She was a statistic and publication for every bad reaction. She does not recommend this vaccine to anyone. Whoever got the vaccine was just a number. Moderna and Johnson & Johnson were trying to push this on poor little children. Product complaint included: Pfizer Covid Vaccine that she received 2 and a half weeks ago. States she feels that this was nothing but publicity and total bogus. She had never been so sick. High Fever started sometime Friday night. She had to take almost an entire case of Tylenol and Ibuprofen. Caller states she sits on the edge of the bed because she ached so bad because she was in so much pain, she had to take prescription pain killers because no over the counter medication would relieve the pain. Confirmed with caller, she does not have NDC, Lot or expiry of the other products she mentioned she took for treatment of these events. Product strength and count size dispensed was unknown. Additional lot numbers was unknown. Packaging sealed and intact was not provided. History of all previous immunization was unknown. No additional vaccines administered on same date. When she woke up in the morning she couldn't get out of the bed the day after receiving the vaccine. She never had any vaccines just as a child. Caller states she had arthritis, which was a contributing fact of pain, and she had hypertension. Family Medical History included all the callers family was dead. Did not require to visit to Emergency Room. No prior Vaccinations (within 4 weeks).  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available in narrative ,the casual association between the reported event Near death experience and suspected vaccine BNT162B2 cannot be completely 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.