Report #2859970

Overview

Sex

Female

Age

Age unknown

State

—

Recovered

Not recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (14)

Symptom narrative

had multiple symptoms that fall under the category of anaphylaxis/she was prescribed an EpiPen; chest pain; tachycardic; I was becoming very shaky; mild swelling; flushing; redresses; intense nausea; dizziness/lightheadedness; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart condition" (ongoing), notes: pre-existing heart condition; "reacted to a certain type of sunscreen" (unspecified if ongoing), notes: learned that she need to avoid oxybenzones, because that's what was giving her a rash; "rash" (unspecified if ongoing), notes: learned that she need to avoid oxybenzones, because that's what was giving her a rash; "had reactions like to the CT contrast, radio contrast, CT contrast dye" (unspecified if ongoing), notes: need to be pre-medicated and monitored. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization; Moderna vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), administration date: 2023, for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "had multiple symptoms that fall under the category of anaphylaxis/she was prescribed an EpiPen"; CHEST PAIN (non-serious), outcome "not recovered"; TACHYCARDIA (non-serious), outcome "unknown", described as "tachycardic"; TREMOR (non-serious), outcome "unknown", described as "I was becoming very shaky"; SWELLING (non-serious), outcome "unknown", described as "mild swelling"; FLUSHING (non-serious), outcome "unknown"; ERYTHEMA (non-serious), outcome "unknown", described as "redresses"; NAUSEA (non-serious), outcome "unknown", described as "intense nausea"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness/lightheadedness". The patient underwent the following laboratory tests and procedures: Blood test: (16Sep2025) Unknown results, notes: blood work on Tuesday for immunology and some other allergy panel; Computerised tomogram: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) tachycardic, notes: that was demonstrable during EKGs, and the vitals and she (doctor) that's not anaphylaxis. Therapeutic measures were taken as a result of anaphylactic reaction. Clinical course: Patient wanted Pfizer to clarify what they consider an anaphylactic reaction. She asked if, moving forward, in the event of a severe reaction, she should receive another vaccination or whether she should be looking at different brands for COVID vaccinations. She also asked at what point, and with what symptoms, she should go to the hospital. She reported there was a discrepancy between what was in the paperwork she had received from Pfizer regarding anaphylactic reactions versus what she was told by the ER doctor, based on the symptoms she experienced. She had multiple symptoms that fall under the category of anaphylaxis, and her understanding how it was described in Pfizer paperwork and her understanding and how it was descried in # clinic and what may other doctors have described as anaphylaxis. To say multiple symptoms within that just because she didn't have all of them it was labeled as either anaphylaxis or mild anaphylaxis but the ER doctor thought because she did not stop breathing, or vomiting specifically, she (doctor) thought that therefore it does not could as anaphylaxis, she was curious what that's differs from her other doctors when she has even less intense reactions to certain medication they say it's best to avoid those medications or you need to be pre-medicated. such as her mild anaphylaxis reaction that she had to CT contrast, radio contrast, it was mild and she didn't need to be intubated or anything, they still say next time you need to be pre-medicated and then monitored longer so that's just what she does when she needs to get that. CT contrast dye. Asked to provide a clarification, what do you think the symptoms that she had count as anaphylaxis or not, refer to treating HCP regarding her individual situation. So basically, since she experienced multiple symptoms that are in the paperwork, it says possible side effects, seek immediate medical attention if you experience XYZ, and she had symptoms XYZ. The pharmacist upon witnessing redresses and flushing and seeing that she was becoming very shaky, said he was worried she could go into shock, that this could get worse and in his opinion, they needed to call ambulance. and the ambulance upon hearing things said we need to take her to the hospital, and then when she went to the hospital and said she has a symptom of abc XYZ it was not anaphylaxis because she doesn't have abc and she was having those but she (doctor) she doesn't think she was paying attention, but mainly she (doctor) said because she did not stop breathing her throat did not close all the way it was clear now mild swelling or closing initially the fact that it did not get worse, and closed even further or because she was not vomiting despite having intense nausea, and lightheadedness and all those other things and she was tachycardic and that was demonstrable during EKGs, and the vitals and she (doctor) that's not anaphylaxis. The paperwork said comeback if you experience symptoms of anaphylaxis including and it list the symptoms that she was having that's a bit confusing. She was prescribed an EpiPen. What happens if she starts having those symptoms again. Should she use EpiPen or not and she (doctor) basically said since she already had abc XYZ wait till it gets worse than that until she was struggling to breathe, even more. That goes against instructions of people with EpiPen supposed to do it specifically says if you get that throat closing sensation you don't wait till closes and you stop breathing to inject yourself, It was confusing. So there was no one at Pfizer who can advise her whether was safe for her to get another dose of the vaccine. Asked, was there any way to find out what any of the ingredients are. She doesn't have any known allergies any foods besides berry and kiwi, eggs are fine, most she doesn't have any known inform what she was allergic to, was there any info on this product that should be provided to someone that had allergic reaction to say, you may talk to your doctor whether you should avoid those chemicals or ingredients. She might need to do allergy testing so she might need to say this was what Pfizer said. That she might need to get the allergy blood work tested for those specific things. Reiterated contraindications information from PI explained that we can provide the list of the ingredients in the vaccine, but it would be HCP working with her closely to determine what she may be allergic to. She already did a blood work on Tuesday for immunology and some other allergy panel. For example when she reacted to a certain type of sunscreen, she learned that she needs to avoid oxybenzones, because that's what was giving her a rash. and she wants to get a covid vaccine at least annually because her risk is too high with long covid, and her preexisting conditions to not. She does not know if other covid vaccines would be safer for her (refer to HCP). She never had a vaccine this severe to the vaccine before she had reactions like to the CT contrast and they made it clear you need to be pre-medicated and monitored, Asking if at this point she should not be getting the covid vaccine at the pharmacy and instead in the hospital setting such a s hospital. What counts as a severe allergic reaction, when her cat had reaction to the vaccine pharmaceutical company was able to provide more specific information, so it sounds like for humans there was more restrictions, refer to treating HCP regarding her individual situation and prescribing information for the vaccine. Asked are there any doctors at Pfizer that are able to provide medical advice to people who experiencing adverse reactions (Refer to treating HCP, Pfizer unable to provide treatment recommendations. She already has a preexisting heart condition, and she knows it says in rare cases inflammation of the heart such as myocarditis or pericarditis can develop like a week or more after, it does not say in that piece of the papers what the symptoms may be because she already has like a lot of chest pain, dizziness all those type of issues have been ongoing, through the pandemic years. Asked can you email her anything like that if she was experiencing those symptoms she needs to talk to her doctor. To rule out myocarditis or something. As per her this was her seventh covid vaccine and at least 6 of them if not all 7 have been form Pfizer. There was a chance she may have had Moderna vaccine in 2023 but was not sure. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.

Current illness

Heart disorder (pre-existing heart condition)

Medical history

Medical History/Concurrent Conditions: Contrast media reaction (need to be pre-medicated and monitored); Rash (learned that she need to avoid oxybenzones, because that's what was giving her a rash); Sunscreen sensitivity (learned that she need to avoid oxybenzones, because that's what was giving her a rash)

Lab data

Test Date: 20250916; Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Comments: blood work on Tuesday for immunology and some other allergy panel; Test Name: CT contrast; Result Unstructured Data: Test Result:Unknown results; Test Name: EKGs; Result Unstructured Data: Test Result:tachycardic; Comments: that was demonstrable during EKGs, and the vitals and she (doctor) that's not anaphylaxis