Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Burning sensation, Dyspnoea, Feeling abnormal, Head discomfort
Clinical narrative: her body is burning up/Felt very hot like she was on fire; Didn't know if she could breathe; Her insides, outsides, brain, she felt like she had flames coming out of her head; Her insides, outsides, brain, she felt like she had flames coming out of her head; stated that she almost died/Scared her to death almost; It was like she was paralyzed and on fire; allergic reaction 1 hour after taking the Pfizer Covid 19 vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: B36J2524) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "knee pain" (unspecified if ongoing); "Discomfort" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); TYLENOL taken for discomfort, arthralgia. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EL9264.), administration date: 01Feb2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot Number: EN6200.), administration date: 22Feb2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot Number: TF2587., documented as provided and verified with caller.), administration date: 06Oct2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot Number: FX9894 or FS9894.), administration date: 27Apr2022, when the patient was 84-year-old, for COVID-19 immunization. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset Sep2022, outcome "unknown", described as "allergic reaction 1 hour after taking the Pfizer Covid 19 vaccine"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "stated that she almost died/Scared her to death almost"; PARALYSIS (medically significant), outcome "unknown", described as "It was like she was paralyzed and on fire"; BURNING SENSATION (non-serious), outcome "unknown", described as "her body is burning up/Felt very hot like she was on fire"; DYSPNOEA (non-serious), outcome "unknown", described as "Didn't know if she could breathe"; FEELING ABNORMAL (non-serious), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "Her insides, outsides, brain, she felt like she had flames coming out of her head".  Clinical course: No PQC Present. Prior Vaccinations (within 4 weeks): other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), and Relevant Tests were None. Patient had a reaction to the Pfizer Covid-19 Vaccine. The caller reported that when she got the vaccine, 1 hour later she had an experience like she almost died and she experienced like her body is burning up and so she wanted to know if she can take the booster shot. Caller asking if she could take the Pfizer Covid 19 booster shot because as she had an allergic reaction 1 hour after taking the Pfizer Covid 19 vaccine. She explains that she almost died and experienced like she was burning up. Additional Information for Other medicines Amlodipine: Caller statesd that she gets three months of this medication and has had three refills, she guesses she has been on this medication for a couple of years. Other Conditions and Investigations: No. Caller came onto the line and verifies information received from the transferring agent. Caller stated that her insides, outsides, brain, she felt like she had flames coming out of her head. States that it scared her to death almost. Caller laughed and stated that she thought her brain was still in there though. Caller said that she got the vaccine. She understood that this booster was stronger than the other boosters, the first strong booster for Pfizer, better than the others. Stated that she got the vaccine and had no feelings until about an hour afterwards. Stated she walked home from her vaccine, she walked slow anyway with a walker, so it took her about an hour to get across the skywalk and back to her floor. She got to her building, it took her about 15 minutes to walk that part to get to her room. She was sitting in her chair and was okay at first. Then she felt very hot like she was on fire. She didn't know if she could breathe, she could breathe though because she called a neighbor for help. Caller stated that she thought if she would have stayed, she would've ended up in the hospital. She had to wait a few minutes before she could move, it was like she was paralyzed and on fire, it was horrible. Caller mentiond that she liked Pfizer, she knows Pfizer is the best.Caller states that now she is just wondering if there is another booster, should she get another shot of a booster. Reporter Details included Caller states that she was a Practical Nurse for 40 years and worked in Obstetrics. States that she eventually retired due to her knees, but she loved her job. HCP Information: Caller stated that she had had her same doctor for about 12 years, she hasn't called him or his nurse about this particular event yet though but is going to. Mailing address, phone number, fax number, email address for HCP is unknown. Caller cannot recall the date of these events. Stated that she knew it was the same date as the vaccine, about an hour later. Caller states that she is sure it was a couple of weeks ago and in the month of Oct, but her card says it was 21Sep2022. Caller did not believe that to be an accurate date. Caller states that her symptoms lasted for about a half of an hour. States it was a pretty severe half an hour for her. Caller says that she was scared to death and didn't really look at her watch but should have. Caller states that she just knows it was about an hour after she was administered the vaccine. Seriousness: When prompted for specific seriousness criteria related to her events the caller replies with no. States that she would've ended up in the hospital if she had fallen on the floor or something, but she did not. Caller states that she called her neighbor for help, to check on the caller; caller states that her neighbor took a couple of hours to get to the caller. Caller states that the symptoms just kept getting milder and milder, and then were done. Additional Vaccines Administered on Same Date of the Pfizer Suspect were None; caller states that they offered her a flu vaccine, but she declined and decided to wait to get the flu vaccine until she saw how she did with the latest dose of the Covid Vaccine. Caller stated that she had to get flu vaccines for 40 years while working at the hospital, and she never did get the flu all those years. No further information provided related to flu vaccines.; Sender's Comments: Based on the available information in the case, the causal association between the events 'near death experience', 'paralysis' and the suspect drug BNT162B2 cannot be 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.