Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Allergic reaction to excipient, Vaccination site discomfort, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: allergic to polyethylene glycol/ PEG in it; arm started burning where given the shot, could feel pressure, continued to get red and swollen, and it got a huge hard lump in it, was 4 inches across, 2 inches tall, wide; arm started burning where given the shot, could feel pressure, continued to get red and swollen, and it got a huge hard lump in it, was 4 inches across, 2 inches tall, wide; arm started burning where given the shot, could feel pressure, continued to get red and swollen, and it got a huge hard lump in it, was 4 inches across, 2 inches tall, wide; arm started burning where given the shot, could feel pressure, continued to get red and swollen, and it got a huge hard lump in it, was 4 inches across, 2 inches tall, wide; arm started burning where given the shot, could feel pressure, continued to get red and swollen, and it got a huge hard lump in it, was 4 inches across, 2 inches tall, wide; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left deltoid for covid-19 immunisation; polyethylene glycol [macrogol] (POLYETHYLENE GLYCOL [MACROGOL]). The patient's relevant medical history included: "contact dermatitis on hands", start date: 1978 (unspecified if ongoing); "polyethylene glycol allergy" (ongoing); "phenylmercuric acetate allergy" (unspecified if ongoing); "Asthma" (ongoing); "Supraventricular tachycardia" (ongoing); "Cholesterol abnormal" (ongoing); "Osteoporosis" (ongoing). Concomitant medication(s) included: ARNUITY ELLIPTA taken for asthma, start date: 05Feb2024 (ongoing); DILTIAZEM oral taken for supraventricular tachycardia (ongoing); PRAVASTATIN oral taken for blood cholesterol abnormal (ongoing); ALENDRONATE oral taken for osteoporosis, start date: 13Nov2023 (ongoing). Past drug history included: Medrol, reaction(s): "drug allergy"; Dichlorophen, reaction(s): "drug allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 11Feb2021, when the patient was 71-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 05Mar2021, when the patient was 71-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 05Oct2021, when the patient was 72-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 05Jan2022, when the patient was 72-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE), administration date: 29Jun2022, when the patient was 72-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 6 (BOOSTER), SINGLE), administration date: 09Nov2022, when the patient was 73-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 7 (BOOSTER), SINGLE), administration date: 04Oct2023, when the patient was 74-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 1, SINGLE), administration date: 06Mar2024, when the patient was 74-year-old, for Covid-19 Immunization; Pneumococcal vaccine, for Immunization; Influenza vaccine, for Immunization; Varicella zoster vaccine, for Immunization; Tetanus vaccine, for Immunization. The following information was reported: ALLERGIC REACTION TO EXCIPIENT (non-serious) with onset 02Sep2024, outcome "unknown", described as "allergic to polyethylene glycol/ PEG in it"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE MASS (non-serious) all with onset 02Sep2024, outcome "unknown" and all described as "arm started burning where given the shot, could feel pressure, continued to get red and swollen, and it got a huge hard lump in it, was 4 inches across, 2 inches tall, wide". The action taken for polyethylene glycol [macrogol] was unknown.  Additional information: Pharmacy wanted to know if patient needed COVID and flu vaccines, patient said yes, but not together. Patient has never gotten those vaccines together before, because if she had a reaction, she wouldn't know which one it was from. She only got the COVID vaccine on 02Sep2024. She got home, arm started burning where given the shot, could feel pressure. Continued to get red and swollen, and it got a huge hard lump in it, was 4 inches across, 2 inches tall, wide. Went back to pharmacy to show pharmacist. Back in 1978 patient had contact dermatitis on hands, could not see anything, but felt like sandpaper, itched, and she had to be put on prednisone. Was sent to dermatologist to have testing done to find out what allergic to, at time said she was allergic to polyethylene glycol, Medrol, dichlorophen, and phenylmercuric acetate. Said her back lit up like tree from allergy test where put scratches. Said those were the four worst ones. After that episode and being on cortisone creams and steroids, it went away. She never had an outbreak before. This was all when she was in 20s when this first happened. Her first colonoscopy when she was 50 years old, she was given Golytely, but she looked at ingredients, and the number one ingredients was polyethylene glycol, so she called pharmacy and explained the other situation and the testing, and pharmacist said for herto not drink that. If she had such a bad reaction topically, who knew what would happen internally if she had drank a gallon of it. Instead had she take other stuff, like mag citrate, which she did. She has never had an adverse reaction to any COVID, flu, pneumonia, shingles, or tetanus. Her arm would get a little sore, but she never had it swell up like this and get red and hard. On 05Sep2024, she went back to pharmacy to show her arm, and she said she was allergic to polyethylene glycol, and the paperwork she was given after the shot says PEG in it, pharmacist said for her to not ever get another COVID shot ever. Patient received a total of 9 doses of Pfizer COVID vaccines, confirmed all doses were Pfizer. Has asthma inhaler, clarified Arnuity, was her newest one, discontinued the other inhaler she was on before that she was on for years, no specific product name provided. She was freaking out, being asthmatic she tried to stay on top of medications and be proactive, so to tell her that she cannot have another COVID shot ever. Since patient had an adverse reaction to it she wanted to know if Pfizer covid vaccine always had polyethylene glycol in them. She was allergic to polyethylene glycol and she was under the impression that Pfizer didn't have it, Moderna did, that's why she never had Moderna covid shots. This was her 9th covid shot and had first time ever had such a bad reaction to any injection to anything. Ahe mean she had pneumonia shots, tetanus shots and shingles shots and all that I had flu shots and she never had a reaction like this.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.