Report #2896603

Overview

Sex

Female

Age

75 yrs

State

FL

Recovered

Not recovered

Vaccinated

Apr 28, 2026

Onset

—

Days to onset

—

Hospital days

—

Symptoms (5)

Symptom narrative

Skin from the upper part of the arm around the injection site turned red; Severe pain in the muscle; Developed pustules that have now that have since broken; Skin is now itching; blistering of the skin around the injection site after the vaccinations; This is a spontaneous report received from a Pharmacist. A 75-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 28Apr2026 as dose 1, 0.3 ml single (Lot number: NA0738, Expiration Date: 19Jun2026) at the age of 75 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation; Bnt162b2 (dose 2), for COVID-19 immunisation; Bnt162b2 (dose 3), for COVID-19 immunisation; Bnt162b2 (dose 4), for COVID-19 immunisation; Bnt162b2 (dose 5), for COVID-19 immunisation; Bnt162b2 (dose 6), for COVID-19 immunisation; Bnt162b2 (dose 7), for COVID-19 immunisation; Bnt162b2 (dose 8), for COVID-19 immunisation; Bnt162b2 (dose 9), for COVID-19 immunisation; Bnt162b2 (dose 10), for COVID-19 immunisation; Bnt162b2 (dose 11), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PUSTULE (non-serious) with onset 2026, outcome "unknown", described as "Developed pustules that have now that have since broken"; MYALGIA (non-serious) with onset 2026, outcome "not recovered", described as "Severe pain in the muscle"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2026, outcome "unknown", described as "Skin from the upper part of the arm around the injection site turned red"; PRURITUS (non-serious) with onset 2026, outcome "unknown", described as "Skin is now itching"; VACCINATION SITE VESICLES (non-serious) with onset 2026, outcome "unknown", described as "blistering of the skin around the injection site after the vaccinations". Therapeutic measures were taken as a result of vaccination site erythema, myalgia, vaccination site pustule, pruritus, vaccination site vesicles. Additional information: After a couple days of receiving the vaccine, both patients developed severe pain in the muscle and then the skin from the upper part of the arm around the injection site turned red. It was reported that both were husband and wife and that it was unusual that both experienced the same events. The reporter stated that after the redness, the wife developed "small little like pustules" which have since broken, while the husband did not develop any blistering. The reporter stated that the wife experienced onset of symptoms a couple of days after vaccination, approximately around 30Apr2026 or 01May2026, although the exact date was not recalled. It was reported that the patient initially had mild muscle pain which then became more severe two or three days after the vaccination. Around the same time, redness on the skin at the injection site started. The reporter further stated that the wife then "started to develop the Blistering or Pustules, she called them, that then broke." The patient also experienced itching of the skin. The muscle pain had not completely resolved at the time of reporting. The reporter stated that all symptoms were local to the arm where the vaccination was administered, and both patients experienced redness and severe muscle pain; however, only the wife developed pustules that subsequently broke. It was reported that both patients experienced symptoms at the same time. Treatment included over-the-counter pain reliever (unspecified) and hydrocortisone cream (1%) applied to the skin. No visit to emergency room or physician's office and no hospitalization were reported; the patients presented to the pharmacy. The reporter stated that there were no known medical conditions, concomitant medications, recent laboratory investigations, height, or weight reported. No known allergies to previous vaccinations, medications, food, or other products were reported. The patient had not received any other vaccine on the same day or within 4 weeks prior to the suspect vaccination. The reporter stated that the patients had previously received multiple doses of Pfizer COVID-19 vaccine, reporting that they have only ever received Pfizer vaccines and have received all doses they were eligible for, with approximately 11-12 previous doses without any prior reactions. This was reported as the first time such reaction occurred. The reporter considered the causal relationship as very high and stated, "I think the likelihood is very high. Yes, for both of the patients." NDC number of Comirnaty is 00069252810.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202600088357 same reporter and drug, similar event, different patient;