Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / RA |
my allergic reactions; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck; This is a spontaneous report received from a Nurse from medical information team. A 72-year-old female patient received BNT162b2 (BNT162B2), in Dec2019 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "elevated cholesterol level" (unspecified if ongoing); "elevated calcium levels" (unspecified if ongoing); "food allergies" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Shingrix vaccine (DOSE 1, SINGLE), administration date: 2019, for Immunization, reaction(s): "blisters and a circle around her left lower leg above the ankle"; Shingrix vaccine (DOSE 2, SINGLE), administration date: 2019, for Immunization, reaction(s): "blister in a circle below the shot in her right arm"; Tetanus toxoid, for Immunization, reaction(s): "Allergic". The following information was reported: ANGINA PECTORIS (medically significant), EAR PAIN (non-serious), NECK PAIN (non-serious) all with onset Dec2019, latency 20 min after the suspect product(s) administration, outcome "unknown" and all described as "I had stabbing like knife stabbing in my heart and I had stabbing in both of my ears radiating down my neck"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "my allergic reactions". The patient underwent the following laboratory tests and procedures: Blood test: (Jul2025) Unknown results; Computerised tomogram heart: (unspecified date) showed that she had calcium deposits,; (unspecified date) showed two of the veins in the heart; Lab work: (2025) Unknown results; physicals: (unspecified date) Unknown results. Therapeutic measures were not taken as a result of angina pectoris, ear pain, neck pain, hypersensitivity. Clinical course: The patient reported an adverse event that she experienced from the Pfizer Covid-19 vaccine last Dec2019. It was during the first release of the vaccine and only people in the hospital can have them. The reporter had a reaction to her first shot. She remembered it happened in the hospital where she works, around 5 o'clock in the afternoon. She had to use the stairs in the hospital, and then within 20 minutes after receiving the shot, while she was on the stairs, she sat down and experienced a stabbing pain in her heart, like a knife stabbing her heart. It felt like a knife was stabbing both her ears, going down her neck, similar to a reaction she gets from food allergies. It was like a jellyfish stung her. The patient provided a brief history about the vaccines she had in the past and the reactions she experienced. One of them was the Shingrix vaccine. She had 2 Shingrix shots. The first time, she had blisters and a circle around her left lower leg above the ankle, and then on her second shot, she had another blister in a circle below the shot in her right arm. She also had a reaction with the tetanus toxoid, so she was not allowed to have any of those; she was allergic to tetanus toxoid. She was just telling about the reactions she had with other vaccines; she clarified that it was not related to the Covid vaccine. The patient said she was terrified to have the shot. She even asked her coworkers why she should have the vaccine. She was told to get it so she wouldn't end up in the ICU or on a respirator, so she said that okay, she'll get it. The one that she had with the Covid vaccine, she first reported to VAERS since her side effects were not on the list on the paperwork. She was referred to call Pfizer. She only had a reaction on the first shot, and in the second shot (booster) that she received around January, they were given Tylenol and she did not experience any side effects. They had a calcium CT scan on her heart and it showed that she had calcium deposits, and her husband and daughter have had the vaccines and they have that too, so they're on statins now and that was like 5 years after the vaccine. She had bloodwork last month, and she has her physicals twice a year with her doctor. The reason for the transfer was she was asked if she wants to know what she should do next if she gets the Covid vaccine, so she said sure, so that's why she was transferred to (withheld), so she can find out what to do. Before, she asked what she could have done when she had the reaction to the shot. She was told to call the rapid response team, but she didn't call anybody. She got away and took care of her babies. The patients HCP had not mention for her to have any more vaccines, she did tell her that she had that but she wanted to make sure that her HCP can check her. When probed if consumer took any Pfizer vaccine on the same date or 4 weeks prior, patient stated, her hospital was offering them and she did not want one. She was terrified to get that vaccine because she did not know, She was allergic to the Tetanus Toxoid and may have had an allergic response which she had this after her other vaccine, but was wondering if she could have, the Shingrix she had before, it was in 2019 and so, she had blisters in a circle around my ankle with that vaccine the first shot, the second shot, had blisters in a circle around my right arm which is where she had the vaccine given both times. When clarified if consumer took Pfizer COVID-19 vaccine and Shingrix, consumer stated, "No, I do not have any, I do not take vaccines together. I give them, I am a pediatric RN in (withheld). Pfizer is the one that she had. I have all the paperwork, it is Pfizer and anyway, that was the one that she had. They did not have the (withheld) one quite yet, her daughter had that one, but she had the Pfizer. That was the only one available when she had it. she have not had the Shingles vaccine a year and a half before approximately, she had the COVID vaccines. Yes, they were giving the vaccines to healthcare workers first she was one of those people. Yes, she had the two. She reacted to the first one with that was not on the list on the paperwork that they gave them with the Pfizer vaccine at the hospital and so, she reported it, but she found out and she called VAERS with her allergic reactions. Other medical conditions and other medication: Consumer stated, "At the time no, she was taking statins now, but was not taking them before. Rosuvastatin, elevated cholesterol level, it has gone way down, but she did have a CT scan of her heart a year and a little about a year and a half ago and it showed two of the veins in the heart, widowmaker, and the other one that she had elevated calcium levels and her daughter has it too and so, and her husband (Further details was not available). Patient not had any lab tests in two weeks but had some about a month ago. Patient did not hd any treatments for the events. Consumer stated, "The blisters were from the Shingles vaccine. The COVID vaccine, she had started with in 20 minutes, she had stabbing like knife stabbing in her heart and she had stabbing in both of her ears radiating down her neck and she received no treatment. I called VAERS because they were not on the list, those reactions were not on the VAERS list for the COVID. So, I called them, but I did not know I needed to call you." Anatomical location or site of administration: Consumer stated, "The right arm, they wanted to give it to her left arm, but she only take vaccine shots in her right arm always." Route of administration: Consumer stated, she cannot remember, she was very paranoid of needles. she did not look and see what either she do not ever watch. It was straight in, she did not do it at an angle, it was straight in. If any adverse event resulted in hospitalization: Consumer stated, "No, she had asked them because she was allergic to the Tetanus Toxoid. So, she asked them since she had that vaccine allergy, what should I do because I was working, I was taking care of premature infants, I had my shot and so, I said what do I do if I react to the shot and he says you call for if you have one." The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Considering close temporal association, the event of Angina pectoris is assessed as related to BNT162b2. 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.
Medical History/Concurrent Conditions: Blood calcium abnormal; Blood cholesterol abnormal; Food allergy
ROSUVASTATIN
Test Date: 202507; Test Name: bloodwork; Result Unstructured Data: Test Result:Unknown results; Test Name: calcium CT scan on her heart; Result Unstructured Data: Test Result:showed that she had calcium deposits,; Test Name: CT scan of my heart; Result Unstructured Data: Test Result:showed two of the veins in the heart; Test Date: 2025; Test Name: Lab work; Result Unstructured Data: Test Result:Unknown results; Test Name: physicals; Result Unstructured Data: Test Result:Unknown results