Sex: M
Vaccine: COVID19, FLU3, FLUC4, FLUX, PNC, TDAP, VARZOS, COVID19, FLUC3, COVID19, FLUX, PNC, TDAP
Symptoms: Generalised oedema, Gynaecomastia, Haemorrhage, Headache, Heart rate
Clinical narrative: Sepsis; Heart attack; Discharging blood; Can't urinate almost, just drops of urine; Kidneys are not working; Strong pain in my testicles; Testicles swelling; Gynaecomastia / Have a big, like a big ball inside in both one; Acute bronchitis; Persistent hands swellness/Swelled my fingers,my feet, leg swelling; Irregular heartbeats; My body swells/Persistent hands swellness/Swelled my fingers,my feet, leg swelling/Nipples swelling; Fell; Arthritis; Fatty liver; Belly is swollen huge/my belly looks l ke i am nine months pregnant; Liver is real bad; all those things like my liver, it is not working how it is supposed to be; Everything in the body is getting worse,my body is real worse/have a lot of pain in my body that hurts a lot; Stay doing something because it,hurts in my back, very strong pain in the lower part of the back; Cannot drink or eat anything; My bones, it hurts a lot; Congestion; Tumor; Got a lot of pain in my belly; Pain on the fingers articulations; Little dizzy; Sore throat; Chronic diarrhea; Redness on the vaccine area right arm; Cannot walk; Bladder dyskinesis; I am doing worse/i was feeling really bad,i am feeling l ke i am dying slowly; AGAP; Test Result: 8.2 (Normal range: 10 to 20); Blood CO2; Test Result: 32.8 {DF} (normal range 20 to 31); C reactive protein; Test Result: 1.1 {DF} (normal high: 1); Abdominal tenderness; RDW; Test Result: 49.8 {DF} (Normal range: 35.3 to 46.9); Saturation was 94%; Hernia/Umbliccal hernia; Painful urination; Have fevers everyday 2 or 3 times a day / Intermittent fever; Pelvic pain; Constipation; This spontaneous case was retrieved on 15-Aug-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2664871-1), reported by other healthcare professional, and concerned a 57-year-old, male patient.   The patient's concurrent conditions included cancer, HIV positive (in Jun-1979 with last 35 years), blurred vision, transient ischemic attack, spinal stenosis, dyspnea, allergic reaction, coronary artery disease, pulmonary tuberculosis, disorder circulatory system with chronic heart or circulatory system disease, renal disorder, neurovascular conflict, obstructive airways disorder, multiple sclerosis, pain, fever, and headache.   The patient's past conditions included herpes simplex, COVID-19 (with five months), family stress, antisocial personality disorder, acute pneumonia, depressive disorder, and opioid abuse. The patient's past procedure included endoscopy on 29-Jul-2015. The patient's concomitant medications included salbutamol sulfate, lansoprazole, levofloxacin, mirtazapine, clopidogrel bisulfate, ranitidine hydrochloride, clonazepam, aciclovir, atorvastatin calcium, famotidine, pantoprazole sodium, gabapentin, fluoxetine hydrochloride, ziprasidone hydrochloride, spironolactone, glyceryl trinitrate, fenofibrate, guaifenesin, Depakote er (valproate semisodium), alprazolam, morphine sulfate, Genvoya (cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate), Stribild (cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarate), cholecalciferol, Dexilant (dexlansoprazole), Percocet (oxycodone hydrochloride, paracetamol), fluticasone propionate, Stiolto respimat (olodaterol hydrochloride, tiotropium bromide monohydrate), nabumetone, estazolam, Symtuza (cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide fumarate), and Triumeq (abacavir sulfate, dolutegravir sodium, lamivudine), all used for an unreported indication, ibuprofen, Aspirine (acetylsalicylic acid), and Panadol (paracetamol), all used for pain.  The patient's historical drugs included diphenhydramine, hydroxyzine, and tramadol. The patient's historical vaccines included one dose of Fluarix (influenza vaccine inact split 3v), received on 13-Jan-2017, for an unknown indication, and two doses of Shingrix (varicella zoster vaccine rge (cho)), first dose received on 20-Dec-2019, for shingles, and second dose received on 03-Mar-2020, two doses of Pfizer BioNTech COVID-19 vaccine (tozinameran), first received on 23-Mar-2021 (batch number: EP7534) and second dose received on 13-Apr-2021 (batch number: EW0151), both used for an unreported indication and Flucelvax Quadrivalent, received on 09-Dec-2020 (batch number: 276580), for immunization.  On 20-Aug-2021, the patient was vaccinated with third dose of non-company co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; route of administration: intramuscular; dose: reported as '3'; anatomical location, and indication: not reported). The batch number reported was FC3183.  On 21-Sep-2021, the patient was vaccinated with influenza vaccine (brand not specified; route of administration, dose, and anatomical location: not reported) for flu vaccination. The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient experienced sepsis, acute bronchitis, heart attack, discharging blood, sore throat, severe arthritis, irregular heartbeats, fatty liver, chronic diarrhea, hernia, redness on the vaccine area right arm, congestion, tumor, bladder dyskinesis, persistent hands swellness with pain on the fingers articulations. His kidneys were not working. The patient's body swelled, the patient did not know if it swelled fingers, feet, leg swelling. The patient fell. The patient experienced nipples swelling, had a big, like a big ball inside in both one, and had to operate his chest. He experienced strong pain in his testicles and swelling, and had to have a testicle surgery. The patient's belly was swollen huge, he got a lot of pain in belly, belly looked like the patient was nine months pregnant. The patient was doing worse, liver was real bad, all those things like liver, it was not working how it was supposed to be, everything in the body was getting worse, the patient's body was real worse. The patient could not put clothes, could not walk, he stayed in bed, had a lot of pain in body that hurt a lot and the patient had been for six months with all this. The patient was feeling real bad, the patient was feeling like he was dying slowly. He could not wash dishes, stayed doing something because it, hurt in back, very strong pain in the lower part of the back for five months and ongoing. The patient could not drink or eat anything. The patient was constipated for two months. The patient's bones hurt a lot. They put the patient on morphine and the patient felt like a little dizzy. Panadol didn't make anything for the patient, he took two of them and it didn't make any difference for the pain, the patient was drinking two Percocet every four hours and they didn't do the patient anything.  The patient denied vomiting, diarrhea, no another symptoms. The patient had not experienced corona. The patient was hospitalized.  On an unspecified date, the patient recovered from the event of constipation. As reported, constipation for two months.  On 30-Nov-2021, the patient underwent a Covid 19 test, and the result was negative.  On 14-Feb-2022, the patient underwent a Covid 19 test, and the result was negative.  On 04-May-2022, the patient was vaccinated with non-company, co-suspects Prevnar (pneumococcal vaccine conj 7v (crm197); route of administration: intramuscular; batch number: FJ2604; dose, and anatomical location and: not reported) for prophylactic vaccination, and Boostrix (diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid; dose: 0.5 ml; route of administration: intramuscul; batch number: 3is9e; anatomical location: not reported) for cough.  On 10-May-2022, the patient was vaccinated with non-company co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; route of administration: intramuscular; dose: reported as '4'; anatomical location, and indication: not reported). The batch number reported was FM7553.  On 30-Jun-2022, the patient underwent a Covid 19 test, and the result was negative.  On 28-Jul-2022, the patient measured his blood pressure, however the results were not provided, pulse was 70 {DF}, saturation was 93 %, physical examination showed palpable umbilical hernia, respiration rate was 16, and Covid 19 test was negative.  On 10-Aug-2022, the patient underwent a Covid 19 test, and the result was negative.  On 16-Aug-2022, the patient underwent a Covid 19 test, and the result was negative.  On an unspecified date in Sep-2022, the patient experienced intermittent fever, pelvic pain, and painful urination with, with urine with discomfort. The patient couldn't urinate almost, just drops of urine.   On 07-Sep-2022, the patient underwent a Covid 19 test, and the result was negative.  On 14-Sep-2022, the patient's lab results revealed: anion gap (AGAP) was 8.2 {DF} (normal range: 10 to 20), osmolarity (OSMO) was 274, blood pressure results were not provided, body temperature was 36.8 {DF}, blood CO2 was 32.8 {DF} (normal Range: 20 to 31), C reactive protein was 1.1 {DF} (normal high: 1) eosinophil was 0.63x10(3)/uL, pulse was 78 {DF}, lymphocyte was 4.50 (normal range: 0.77 to 2.96), monocyte was 1.29 {DF}, saturation was 94 %, physical examination showed abdominal tenderness, red cell distribution width (RDW) was 49.8 {DF} (normal range: 35.3 to 46.9), respiration rate was 17, Covid 19 test was negative, and white blood count (WBC) was 14.31 {DF}.  At the time of initial reporting, the patient had not recovered from the events of nipple swelling and intermittent fever.  The outcome of pelvic pain was not reported, and the outcome of all other events was unknown.  The reporter did not provide a causality assessment.   All events were considered as serious due to the seriousness criterion of hospitalization. Additionally, the events of sepsis, heart attack, hemorrhage, 'unable to urinate' and 'kidney dysfunction', testicular pain, testicular swelling and gynaecomastia were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked to the case 202303679 (the same patient).  Company comment: A 57-year-old, male patient was vaccinated with the suspect product Flucelvax Quadrivalent. Ten months after vaccination the patient experienced anion gap decreased, carbon dioxide increased, oxygen saturation decreased, abdominal tenderness, abdominal pain, red cell distribution width increased, red cell distribution width increased and C-reactive protein increased, pelvic pain, urinary retention and dysuria. An unspecified time after vaccination the patient experienced sepsis, acute bronchitis, heart attack, discharging blood, sore throat, arthritis, irregular heartbeats, hepatic steatosis, diarrhoea, hernia, vaccination site erythema, congestion, bladder disorder, tumour, peripheral swelling, dizziness, renal impairment, generalised oedema, fall, testicular pain, testicular swelling, gait inability, feeling abnormal, general body pain, back pain, bone pain, constipation and feeding disorder. Causality is confounded by patient's concurrent conditions cancer, HIV positive (in Jun-1979 with last 35 years at time of reporting), spinal stenosis, neurovascular conflict, multiple sclerosis and pain. Causality for the events anion gap decreased, carbon dioxide increased, oxygen saturation decreased, red cell distribution width increased, pelvic pain, urinary retention, dysuria, sepsis, heart attack, discharging blood, irregular heartbeats, hepatic steatosis, hernia, bladder disorder, tumour, renal impairment, generalised oedema, gynaecomastia, fall, constipation, testicular pain and testicular swelling is assessed as not related due to biological implausibility. Causality for the events pyrexia, abdominal tenderness, red cell distribution width increased C-reactive protein increased is assessed as not related based on chronological implausibility. Causality for the events acute bronchitis, sore throat, arthritis, diarrhoea, dizziness, vaccination site erythema, congestion, feeling abnormal, general body pain, gait inability, abdominal pain, back pain, bone pain and feeding disorder is unassessable due to unclear temporal relationship.; Sender's Comments: A 57-year-old, male patient was vaccinated with the suspect product Flucelvax Quadrivalent. Ten months after vaccination the patient experienced anion gap decreased, carbon dioxide increased, oxygen saturation decreased, abdominal tenderness, abdominal pain, red cell distribution width increased, red cell distribution width increased and C-reactive protein increased, pelvic pain, urinary retention and dysuria. An unspecified time after vaccination the patient experienced sepsis, acute bronchitis, heart attack, discharging blood, sore throat, arthritis, irregular heartbeats, hepatic steatosis, diarrhoea, hernia, vaccination site erythema, congestion, bladder disorder, tumour, peripheral swelling, dizziness, renal impairment, generalised oedema, fall, testicular pain, testicular swelling, gait inability, feeling abnormal, general body pain, back pain, bone pain, constipation and feeding disorder. Causality is confounded by patient's concurrent conditions cancer, HIV positive (in Jun-1979 with last 35 years at time of reporting), spinal stenosis, neurovascular conflict, multiple sclerosis and pain. Causality for the events anion gap decreased, carbon dioxide increased, oxygen saturation decreased, red cell distribution width increased, pelvic pain, urinary retention, dysuria, sepsis, heart attack, discharging blood, irregular heartbeats, hepatic steatosis, hernia, bladder disorder, tumour, renal impairment, generalised oedema, gynaecomastia, fall, constipation, testicular pain and testicular swelling is assessed as not related due to biological implausibility. Causality for the events pyrexia, abdominal tenderness, red cell distribution width increased C-reactive protein increased is assessed as not related based on chronological implausibility. Causality for the events acute bronchitis, sore throat, arthritis, diarrhoea, dizziness, vaccination site erythema, congestion, feeling abnormal, general body pain, gait inability, abdominal pain, back pain, bone pain and feeding disorder is unassessable due to unclear temporal relationship.