Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Acne cystic, Ear disorder, Ear swelling, Eye swelling, Heart rate
Clinical narrative: My ears have mutated with painful cysts and my right ear swelled up like a balloon.; My ears have mutated with painful cysts and my right ear swelled up like a balloon.; I've had really bad sores on face/ head/ neck that I've never experienced before and there is infection involved.; I've had really bad sores on face/ head/ neck that I've never experienced before and there is infection involved.; It started with cystic acne breakout that was so out of control along the sides of my neck.; Sores seems to be around lymph nodes.; heartbeat being irregular; my eye was swollen completely shut; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 22May2021 as dose 2, single (Lot number: EW0186) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: PAXIL [PAROXETINE HYDROCHLORIDE]; CLONAZEPAM. Vaccination history included: comirnaty (Dose Number: 1, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 29Apr2021, when the patient was 32-year-old, for Covid-19 Immunization. The following information was reported: PAIN (hospitalization, disability, life threatening), INFECTION (hospitalization, disability, life threatening) all with onset 01Aug2021, outcome "not recovered" and all described as "I've had really bad sores on face/ head/ neck that I've never experienced before and there is infection involved."; ACNE CYSTIC (hospitalization, disability, life threatening) with onset 01Aug2021, outcome "not recovered", described as "It started with cystic acne breakout that was so out of control along the sides of my neck."; EAR DISORDER (hospitalization, disability, life threatening), EAR SWELLING (hospitalization, disability, life threatening) all with onset 01Aug2021, outcome "not recovered" and all described as "My ears have mutated with painful cysts and my right ear swelled up like a balloon."; LYMPHADENOPATHY (hospitalization, disability, life threatening) with onset 01Aug2021, outcome "not recovered", described as "Sores seems to be around lymph nodes."; HEART RATE IRREGULAR (hospitalization, disability, life threatening) with onset 01Aug2021, outcome "not recovered", described as "heartbeat being irregular"; EYE SWELLING (hospitalization, disability, life threatening) with onset 01Aug2021, outcome "not recovered", described as "my eye was swollen completely shut". The patient was hospitalized for ear disorder, ear swelling, pain, infection, acne cystic, lymphadenopathy, heart rate irregular, eye swelling (hospitalization duration: 4 day(s)). The events "my ears have mutated with painful cysts and my right ear swelled up like a balloon.", "i've had really bad sores on face/ head/ neck that i've never experienced before and there is infection involved.", "it started with cystic acne breakout that was so out of control along the sides of my neck.", "sores seems to be around lymph nodes.", "heartbeat being irregular" and "my eye was swollen completely shut" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (01Aug2021) irregular. Therapeutic measures were taken as a result of ear disorder, ear swelling, pain, infection, acne cystic, lymphadenopathy, heart rate irregular, eye swelling.  Addition information: other vaccine in four weeks was none. Other medications in two weeks included many antibiotics since onset. AE treatment included Iv antibiotics. Covid prior vaccination was none. Covid tested post vaccination was none. Known allergies was none. ENT states my ears looks like an autoimmune process is off. My ears have mutated with painful cysts and my right ear swelled up like a balloon. I've had really bad sores on face/ head/ neck that I've never experienced before and there is infection involved. It started with cystic acne breakout that was so out of control along the sides of my neck. Sores seems to be around lymph nodes. I have two on each lymph node on neck. It also started with my heartbeat being irregular. That comes and goes still. I also woke up one day and my eye was swollen completely shut. I've been admitted 4 times in span of 4 mos.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events 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.