Age: 50.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, FLUX
Symptoms: Urticaria
Clinical narrative: online research and read about Arthus reaction; vaccination area where received was itchy/itching got worse; a small lump/the lump became wider and harder; Area of arm was sore/tenderness at the site; a large welt-looked like a bad bug bite; had trouble sleeping due to the itchiness and tenderness at the site; This is a spontaneous report received from a Nurse.  A 50-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Oct2024 at 11:30 as dose 1, single (Lot number: LM2216) at the age of 50 years, in right deltoid for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 19Oct2024 as dose number unknown,single (Lot number: JT322), in left arm for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]; RITALIN [METHYLPHENIDATE]; NORVASC; PROZAC; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization, reaction(s): "had some itchiness and soreness the evening before but no more than I've exp with prev COVID shots"; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization, reaction(s): "had some itchiness and soreness the evening before but no more than I've exp with prev COVID shots".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Oct2024, outcome "recovering", described as "Area of arm was sore/tenderness at the site"; URTICARIA (non-serious) with onset 20Oct2024, outcome "recovering", described as "a large welt-looked like a bad bug bite"; VACCINATION SITE MASS (non-serious) with onset 20Oct2024, outcome "recovering", described as "a small lump/the lump became wider and harder"; INSOMNIA (non-serious) with onset 20Oct2024, outcome "recovering", described as "had trouble sleeping due to the itchiness and tenderness at the site"; TYPE III IMMUNE COMPLEX MEDIATED REACTION (medically significant) with onset 20Oct2024, outcome "recovering", described as "online research and read about Arthus reaction"; VACCINATION SITE PRURITUS (non-serious) with onset 20Oct2024, outcome "recovering", described as "vaccination area where received was itchy/itching got worse". Therapeutic measures were taken as a result of type iii immune complex mediated reaction, vaccination site pruritus, vaccination site mass, vaccination site pain, urticaria, insomnia. Clinical course: The patient had no other vaccine in four weeks. The patient had no known allergies. The morning after vaccination area where the patient received the vaccine was itchy and she felt a small lump (had some itchiness and soreness the evening before but no more than she had exp with previous COVID shots). As day went on the itching got worse and the lump became wider and harder. The area of arm was sore and when she checked in mirror saw a large welt-looked like a bad bug bite. By Sunday evening (at the time of reporting), the patient had trouble sleeping due to the itchiness and tenderness at the site. The patient did some online research and read about Arthus reaction so made a virtual appointment at (withheld) on Monday morning. The PA prescribed 3 days of Prednisone and Zyrtec.; Sender's Comments: Based on the information provided , known safety profile, temporal association and the administration  of the suspect drug a possible contributory role of the suspect drug in triggering the onset of  the event Arthus reaction  cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.