Sex: M
Vaccine: COVID19
Symptoms: Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Oxygen saturation, Pathology test
Clinical narrative: Non-reducible hemorrhoid; PHASE 2 CLINICAL TRIAL TO OPTIMIZE IMMUNE COVERAGE OF SARS-COV-2 EXISTING AND EMERGING VARIANTS  This is a non-Pfizer sponsored interventional study report.  A 35-year-old male subject received BNT162b2 omi (BNT162B2 OMI), on 17May2022 as dose 4 (booster), 30 ug single (Batch/Lot number: unknown) intramuscular for COVID-19 immunisation. The subject's relevant medical history included: "Sickle cell anemia", start date: 30Jan1988 (unspecified if ongoing), notes: followed by a hematologist; "Malaria", start date: 2017 (unspecified if ongoing), notes: unknown type-while in country in 2017; "Sickle cell disease", start date: 2020 (unspecified if ongoing), notes: hospitalization; "Sickle cell disease", start date: Nov2021 (unspecified if ongoing), notes: hospitalization; "Hemorrhoids" (unspecified if ongoing), notes: Historical Condition; "Transfusion" (unspecified if ongoing); "Abnormal liver function tests" (unspecified if ongoing), notes: Liver function test abnormal, Historical Condition; "Gilbert's syndrome" (unspecified if ongoing); "Hyperbilirubinemia" (unspecified if ongoing); "Chronic frontal sinusitis" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing), notes: Immunodeficiency; "Pleural effusion" (unspecified if ongoing), notes: left; "prolapsing internal hemorrhoids" (unspecified if ongoing), notes: Grade 3, reversible. Concomitant medications included: FOLIC ACID oral taken for sickle cell anaemia, start date: 30Jan1988 (ongoing); HYDROXYUREA oral taken for sickle cell anaemia, start date: 23Jun2022 (ongoing). Past drug history included: Chloroquine, reaction: "allergy", notes: (reaction not specified). Vaccination history included: MODERNA COVID-19 VACCINE (DOSE 1; Moderna coronavirus disease 2019 (COVID-19) vaccine-prior to study enrollment), administration date: 08Jul2021, for COVID-19 immunisation; MODERNA COVID-19 VACCINE (DOSE 2-prior to study enrollment), administration date: 05Aug2021, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER); Pfizer-BioNTech COVID-19 vaccine-prior to study enrollment), administration date: 06Jan2022, for COVID-19 immunisation. The following information was reported: HAEMORRHOIDS (hospitalization) with onset 10May2023, outcome "recovered" (12May2023), described as "non-reducible hemorrhoid". The subject was hospitalized for haemorrhoids (start date: 10May2023, discharge date: 12May2023, hospitalization duration: 3 days). Clinical course: on 17May2022, the subject received the first dose of the study product BNT162b2 (Omicron), 30 mcg (0.3 mL) administered intramuscularly (IM). Per the reactogenicity records, the subject experienced local reaction of mild pain (Intensity Level 1) on Day 1 and Day 2. The subject experienced systemic reaction of mild myalgia (Intensity Level 1) on Day 2. The study product was last administered prior to the onset of the serious adverse event (SAE) on this day. From 10Jul2022 until 13Jul2022, the subject was hospitalized with pyelonephritis. The event, pyelonephritis, was considered recovered/resolved on 13Jul2022. On 16Jul2022, the subject was hospitalized for a sickle cell crisis. The event, sickle cell crisis, was considered recovered/resolved on 19Jul2022. On 05Aug2022, the subject was hospitalized for a sickle cell crisis. The event, sickle cell crisis, was considered recovered/resolved on 12Aug2022. On 10May2023, the subject presented to the emergency room with a 1-day history of prolapsed hemorrhoids and anal pain associated with bright red blood per rectum that did not resolve with at-home measures such as witch hazel and manual reduction. On examination, the subject had prolapsed internal hemorrhoids (Grade 4) with evidence of strangulation which remained irreducible, and he was admitted for hemorrhoidectomy scheduled for the following morning. The serious adverse event (SAE), non-reducible hemorrhoid, was considered to have begun on this day.  On 11May2023, laboratory results included a complete blood count (CBC) and differential which showed white blood cell (WBC) count of 10.1 x10^3/mcL (Normal Range [NR]: 3.6-9.6), red blood cell (RBC) count of 2.50 x10^6/mcL (NR: 4.35-5.67), hemoglobin of 9.0 g/dL (noted to be "normal" for the subject) (NR: 13.1-17.1), hematocrit of 25.1% (NR: 39.5-50.3), mean cell volume (MCV) of 100.4 fL (NR: 80.0-100.0), mean corpuscular hemoglobin (MCH) of 36.0 pg (NR: 27.7-33.1), mean corpuscular hemoglobin concentration (MCHC) of 35.9 g/dL (NR: 31.7-35.7), red cell distribution width (RDW) of 16.3% (NR: 10.0-15.0), and platelets of 480 x10^3/mcL (NR: 150-440). All other CBC results were within normal limits (WNL).  The subject underwent a complex hemorrhoidectomy procedure without complications. Per the surgical operation note, surgical findings included acute hemorrhoidal disease with incarcerated grade 4 internal hemorrhoids and thrombosed external hemorrhoids in the right posterior and left lateral positions. The hemorrhoid tissue was excised and sent to pathology which showed skin and squamocolumnar functional mucosa with epithelial erosion, reactive epithelial changes and underlying dilated vessels consistent with hemorrhoids. No suspicious lesions or masses were identified. The subject tolerated the procedure well and was in stable condition. Post operatively, the subject was unable to void (x2). A Foley catheter had to be replaced and the subject voided 1 liter of urine. On 12May2023, the subject's vital signs included a blood pressure (BP) of 117/76 mmHg, heart rate of 78 beats per minute, respiratory rate of 16 breaths per minute, temperature of 37.4 degrees Celsius (C), and oxygen saturation (SpO2) of 96%. The subject weighed 54.4 kg, was 160 cm tall and had a body mass index (BMI) of 21.26 kg/m2. Review of systems was positive for rectal pain and difficulty urinating but was otherwise negative. Physical examination showed that the subject had a normal appearance and was unremarkable. The subject was discharged and per the discharge summary, he was prescribed oxycodone for pain management (dose not provided) and instructed to continue home medications. He was discharged on a regular diet and was also instructed to take a stool softener to avoid straining and to follow up with colorectal surgery. The event, Non-Reducible Hemorrhoid, was considered resolved. On 05Jun2023, during the last study visit, the subject reported his recent hospitalization for non-reducible hemorrhoid to the site. Per the Principal Investigator (PI), the event was related to hemorrhoids. Assessment: The Investigator has assessed the event, Non-Reducible Hemorrhoid, as serious (Hospitalization) and not related to the study product. Per the PI, the severity of the event was marked as "moderate", however the subject was hospitalized for more than 24 hours.  Therapeutic measures were taken as a result of haemorrhoids.  The investigator considered there was not a reasonable possibility that the event "non-reducible hemorrhoid" was related to BNT162b2 omi.; Sender's Comments: Based on the lack of a plausible pathophysiological mechanism, there was not a reasonable possibility that the event "non-reducible hemorrhoid" was related to BNT162b2 omi.