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; ACUTE BRONCHITIS; Heart attack; Discharging blood; Persistent hands swellness with pain on the fingers articulations; they put me on Morphine and I feel like a little dizzy; my body swells I do not know if it swelled my fingers,my feet, Leg swelling; He fell; Sore throat; to operate my chest; have a big, like a big ball inside in both one; fatty liver; I have fevers everyday 2 or 3 times a day; Testicle surgery; got a lot of pain in my belly; Chronic diarrhea; nipples swelling; belly is swollen huge,got a lot of pain in my belly,My belly looks l ke I am nine months pregnant;; I am doing worse; 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; redness on the vaccine area right arm; can't urinate almost, just drops of urine; Hernia; my bones, it hurts a lot; Congestion; I am doing worse; liver is real bad; all those things like my liver, it is not working how it is supposed to be; Tumor; Kidneys are not working; Strong pain in my testicles and swelling; Then constipation for 2 months; I cannot put my clothes; I cannot walk; I have stayed in bed; Strong pain in my testicles and swelling; bladder dyskinesis; have a lot of pain in my body that hurts a lot and I been for six months with all this; headache; Leg swelling; I was feeling really bad,I am feeling l ke I am dying slowly; I cannot put my clothes; I cannot walk; I have stayed in bed; cannot wash dishes, stay doing something because it,hurts in my back, Very strong pain in the lower part of the back for 5 months and ongoing; I cannot drink or eat anything; Panadol doesn't make anything for me,take two of them and it doesn't make any difference for the pain,I was drinking two Percocet every four hours and they don't do me anything; Severe arthritis; Irregular heartbeats; Initial information regarding this unsolicited valid Serious case downloaded from database, was received on 23-Jun-2023 from a Non-health care professional via Health Authorities under reference US-HALEON-USCH2022AMR028047. The following narrative is based on the information retrieved from all other accessible data.  This case involves 57 years old male patient (168 cm and 79.83 kg) who experienced sepsis, acute bronchitis, heart attack, discharging blood, persistent hands swellness with pain on the fingers articulations, they put me on morphine and i feel like a little dizzy, irregular heartbeats, my body swells i do not know if it swelled my fingers,my feet, leg swelling, he fell, sore throat, to operate my chest; have a big, like a big ball inside in both one, severe arthritis, fatty liver, i have fevers everyday 2 or 3 times a day, testicle surgery, got a lot of pain in my belly, chronic diarrhea, nipples swelling, belly is swollen huge,got a lot of pain in my belly,my belly looks l ke i am nine months pregnant;, i am doing worse; 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, redness on the vaccine area right arm, can't urinate almost, just drops of urine, hernia, my bones, it hurts a lot, congestion, i am doing worse; liver is real bad; all those things like my liver, it is not working how it is supposed to be, tumor, kidneys are not working, strong pain in my testicles and swelling, then constipation for 2 months, i cannot put my clothes; i cannot walk; i have stayed in bed, strong pain in my testicles and swelling, bladder dyskinesis, have a lot of pain in my body that hurts a lot and i been for six months with all this, headache, leg swelling, i was feeling really bad,i am feeling l ke i am dying slowly, i cannot put my clothes; i cannot walk; i have stayed in bed, cannot wash dishes, stay doing something because it,hurts in my back, very strong pain in the lower part of the back for 5 months and ongoing, i cannot drink or eat anything and panadol doesn? make anything for me,take two of them and it doesn? make any difference for the pain,i was drinking two percocet every four hours and they don? do me anything while receiving vaccines PFIZER BIONTECH COVID-19 VACCINE, Fluarix, PREVNAR, Flucelvax QUAD and influenza vaccine and while treated with salbutamol sulfate, lansoprazole, levofloxacin, mirtazapine, Clopidogrel BISULFATE, ranitidine hydrochloride, clonazepam, aciclovir, atorvastatin calcium, ibuprofen, famotidine, pantoprazole sodium, gabapentin, acetylsalicylic acid [ASPIRINE], fluoxetine hydrochloride, mirtazapine, ziprasidone hydrochloride, spironolactone, glyceryl trinitrate, fenofibrate, guaifenesin, valproate SEMISODIUM [Depakote emergency room], alprazolam, paracetamol [PANADOL], morphine sulfate, cobicistat, elvitegravir, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE [Genvoya], cobicistat, elvitegravir, emtricitabine, Tenofovir DISOPROXIL FUMARATE [Stribild], colecalciferol [cholecalciferol], dexlansoprazole [Dexilant], VARICELLA ZOSTER VACCINE RGE (CHO) [Shingrix], oxycodone hydrochloride, paracetamol [Percocet [oxycodone hydrochloride;paracetamol]], DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [Boostrix], Fluticasone propionate, olodaterol hydrochloride, tiotropium bromide MONOHYDRATE [Stiolto RESPIMAT], nabumetone, estazolam, cobicistat, darunavir ETHANOLATE, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE [Symtuza] and abacavir sulfate, dolutegravir sodium, lamivudine [Triumeq].  The patient's past medical history included Herpes simplex, Endoscopy on 29-Jul-2015, COVID-19 with 5 months, Family stress, Antisocial personality disorder, Acute pneumonia, Depressive disorder, Hernia on 10-Sep-2022 and Opioid abuse. The patient's past medical treatment included diphenhydramine, hydroxyzine and tramadol. The patient's past vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Cancer, HIV positive in Jun-1979 with last 35 years, Blurred vision, Fever on 08-Jul-2021, Transient ischemic attack, Spinal stenosis, Dyspnea, Allergic reaction, Pelvic pain in Sep-2022, Painful urination in Sep-2022 with Urine with discomfort, Coronary artery disease, Pulmonary tuberculosis, Intermittent fever in Sep-2022, Headache on 08-Jul-2021, Disorder circulatory system with chronic heart or circulatory system disease., Renal disorder, Neurovascular conflict, Obstructive airways disorder and Multiple sclerosis. Notes: Denied vomiting , diarrhea, no another symptoms. Patient has not experienced corona.  On 20-Dec-2019, the patient started taking Shingrix (VARICELLA ZOSTER VACCINE RGE (CHO)) formulation unknown dosage unknown intramuscular (lot - HY4GT) for Shingles. On 03-Mar-2020 Shingrix (VARICELLA ZOSTER VACCINE RGE (CHO)) dosage was changed to dosage unknown. On 04-May-2022, the patient started taking Boostrix (DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID) formulation unknown 0.5 mL intramuscular (lot - 3is9e) for Cough. On an unknown date, the patient started taking salbutamol sulfate at a dsoe of 90 ug As needed (with an unknown batch number) for Product used for unknown indication, lansoprazole at a dose of 30 mg daily orally (with an unknown batch number) for Drug use for unknown indication, levofloxacin at a dose of 500 mg daily orally (with an unknown batch number) for Drug use for unknown indication, mirtazapine at a dose of 15 mg oral (with an unknown batch number), Clopidogrel BISULFATE at a dose of 75 mg daily orally (with an unknown batch number) for Drug use for unknown indication, ranitidine hydrochloride at a dose of 300 mg daily orally (with an unknown batch number) for Drug use for unknown indication, clonazepam at a dose of 1 mg daily orally (with an unknown batch number) for Drug use for unknown indication, aciclovir at a dose of 400 mg every 12 hours oral (with an unknown batch number) for Product used for unknown indication, atorvastatin calcium at a dose of 40 mg daily orally (with an unknown batch number) for Drug use for unknown indication, ibuprofen Unknown dosage unknown (with an unknown batch number) for Pain, famotidine at a dose of 80 mg daily orally (with an unknown batch number) for Drug use for unknown indication, pantoprazole sodium at a dose of 40 mg oral (with an unknown batch number) for Drug use for unknown indication, gabapentin at a dose of 800 mg oral (with an unknown batch number) for Drug use for unknown indication, ASPIRINE (acetylsalicylic acid) Unknown dosage unknown (with an unknown batch number) for Pain, fluoxetine hydrochloride at a dose of 20 mg daily orally (with an unknown batch number) for Drug use for unknown indication, mirtazapine at a dose of 60 mg daily orally (with an unknown batch number) for Drug use for unknown indication, ziprasidone hydrochloride at a dose of 80 mg daily orally (with an unknown batch number) for Drug use for unknown indication, spironolactone at a dose of 25 mg daily orally (with an unknown batch number) for Drug use for unknown indication, glyceryl trinitrate Unknown dosage unknown sublingual (with an unknown batch number) for Product used for unknown indication, fenofibrate at a dose of 145 mg oral (with an unknown batch number) for Drug use for unknown indication, guaifenesin at a dose of 10 mL Q6H oral (with an unknown batch number) for Drug use for unknown indication, Depakote emergency room (valproate SEMISODIUM) at a dose of 500 mg oral (with an unknown batch number) for Drug use for unknown indication, alprazolam at a dose of 6 mg daily orally (with an unknown batch number) for Drug use for unknown indication, PANADOL (paracetamol) Unknown dosage unknown (with an unknown batch number) for Pain, morphine sulfate Unknown dosage unknown (with an unknown batch number) for Drug use for unknown indication, Genvoya (cobicistat, elvitegravir, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE) Tablet 1 dosage form daily orally (with an unknown batch number) for Drug use for unknown indication, Stribild (cobicistat, elvitegravir, emtricitabine, Tenofovir DISOPROXIL FUMARATE) Tablet 1 dosage form daily orally (with an unknown batch number) for Drug use for unknown indication, cholecalciferol (colecalciferol) formulation unknown 1000 U oral (with an unknown batch number) for Drug use for unknown indication, Dexilant (dexlansoprazole) at a dose of 60 mg oral (with an unknown batch number) for Drug use for unknown indication, Percocet [oxycodone hydrochloride;paracetamol] (oxycodone hydrochloride, paracetamol) formulation unknown dosage unknown (with an unknown batch number) for Drug use for unknown indication, Fluticasone propionate at a dose of 32 g daily (with an unknown batch number) for Drug use for unknown indication, Stiolto RESPIMAT (olodaterol hydrochloride, tiotropium bromide MONOHYDRATE) formulation unknown 4 g daily (with an unknown batch number) for Drug use for unknown indication, nabumetone formulation unknown 500 mg oral (with an unknown batch number) for Drug use for unknown indication, estazolam formulation unknown 2 mg oral (with an unknown batch number) for Drug use for unknown indication, Symtuza (cobicistat, darunavir ETHANOLATE, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE) formulation unknown dosage unknown (with an unknown batch number) for Drug use for unknown indication and Triumeq (abacavir sulfate, dolutegravir sodium, lamivudine) formulation unknown dosage unknown (with an unknown batch number) for Drug use for unknown indication. On 09-Dec-2020, the patient received a dose of suspect Flucelvax QUAD not produced by Sanofi Pasteur lot 276580 via intramuscular route in unknown administration site for immunization. On 04-May-2022, the patient received a dose of suspect PREVNAR not produced by Sanofi Pasteur lot FJ2604 via intramuscular route in unknown administration site for prophylactic vaccination. On 13-Jan-2017, the patient received a dose of suspect Fluarix not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for unknown indication. On 10-May-2022, the patient received a dose 4 dose of suspect PFIZER BIONTECH COVID-19 VACCINE not produced by Sanofi Pasteur lot FM7553 via intramuscular route in unknown administration site. On 13-Apr-2021 he also received a dose 2 dose of the same vaccine lot EW0151 via intramuscular route in unknown administration site. On 20-Aug-2021 he also received a dose 3 dose of the same vaccine lot FC3183 via intramuscular route in unknown administration site for unknown indication. On 23-Mar-2021 he also received a dose 1 dose of the same vaccine lot EP7534 via intramuscular route in unknown administration site for unknown indication. On 21-Sep-2021, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for flu vaccination.  On the patient had serious events of sepsis, acute bronchitis, heart attack, discharging blood and non-serious events of persistent hands swellness with pain on the fingers articulations, they put me on morphine and i feel like a little dizzy, irregular heartbeats, my body swells i do not know if it swelled my fingers,my feet, leg swelling, he fell, sore throat, to operate my chest; have a big, like a big ball inside in both one, severe arthritis, fatty liver, i have fevers everyday 2 or 3 times a day, testicle surgery, got a lot of pain in my belly, chronic diarrhea, nipples swelling, belly is swollen huge,got a lot of pain in my belly,my belly looks l ke i am nine months pregnant;, i am doing worse; 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, redness on the vaccine area right arm, can't urinate almost, just drops of urine, hernia, my bones, it hurts a lot, congestion, i am doing worse; liver is real bad; all those things like my liver, it is not working how it is supposed to be, tumor, kidneys are not working, strong pain in my testicles and swelling, then constipation for 2 months, i cannot put my clothes; i cannot walk; i have stayed in bed, strong pain in my testicles and swelling, bladder dyskinesis, have a lot of pain in my body that hurts a lot and i been for six months with all this, headache, leg swelling, i was feeling really bad,i am feeling l ke i am dying slowly, i cannot put my clothes; i cannot walk; i have stayed in bed, cannot wash dishes, stay doing something because it,hurts in my back, very strong pain in the lower part of the back for 5 months and ongoing, i cannot drink or eat anything and panadol doesn? make anything for me,take two of them and it doesn? make any difference for the pain,i was drinking two percocet every four hours and they don? do me anything. Action taken with salbutamol sulfate, VARICELLA ZOSTER VACCINE RGE (CHO) (Shingrix), lansoprazole, levofloxacin, mirtazapine, cobicistat, elvitegravir, emtricitabine, Tenofovir DISOPROXIL FUMARATE (Stribild), ranitidine hydrochloride (ranitidine hydrochloride), clonazepam (clonazepam), cobicistat, elvitegravir, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE (Genvoya), ibuprofen (ibuprofen), famotidine (famotidine), dexlansoprazole (Dexilant), colecalciferol (cholecalciferol), Clopidogrel BISULFATE (Clopidogrel BISULFATE), pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR), atorvastatin calcium (atorvastatin calcium), oxycodone hydrochloride, paracetamol (Percocet [oxycodone hydrochloride;paracetamol]), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (Boostrix), valproate SEMISODIUM (Depakote emergency room), aciclovir (aciclovir), Fluticasone propionate (Fluticasone propionate), paracetamol (PANADOL), olodaterol hydrochloride, tiotropium bromide MONOHYDRATE (Stiolto RESPIMAT), acetylsalicylic acid (ASPIRINE), morphine sulfate (morphine sulfate), nabumetone (nabumetone), guaifenesin (guaifenesin), gabapentin (gabapentin), fenofibrate (fenofibrate), TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), spironolactone (spironolactone), alprazolam (alprazolam), estazolam (estazolam), glyceryl trinitrate (glyceryl trinitrate), cobicistat, darunavir ETHANOLATE, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE (Symtuza), pantoprazole sodium (pantoprazole sodium), fluoxetine hydrochloride (fluoxetine hydrochloride), abacavir sulfate, dolutegravir sodium, lamivudine (Triumeq), MIRTAZAPINERANITIDINE hydrochloride, clonazepam, cobicistat, elvitegravir, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE (Genvoya), ibuprofen, famotidine, dexlansoprazole (Dexilant), colecalciferol (cholecalciferol), Clopidogrel BISULFATE, pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR), atorvastatin calcium, oxycodone hydrochloride, paracetamol (Percocet [oxycodone hydrochloride;paracetamol]), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (Boostrix), valproate SEMISODIUM (Depakote emergency room), aciclovir, Fluticasone propionate, paracetamol (PANADOL), olodaterol hydrochloride, tiotropium bromide MONOHYDRATE (Stiolto RESPIMAT), acetylsalicylic acid (ASPIRINE), morphine sulfate, nabumetone, guaifenesin, gabapentin, fenofibrate, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), spironolactone, alprazolam, estazolam, glyceryl trinitrate, cobicistat, darunavir ETHANOLATE, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE (Symtuza), pantoprazole sodium, fluoxetine HYDROCHLORIDEMIRTAZAPINE, cobicistat, elvitegravir, emtricitabine, Tenofovir DISOPROXIL FUMARATE (Stribild), ranitidine hydrochloride (ranitidine hydrochloride), clonazepam (clonazepam), cobicistat, elvitegravir, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE (Genvoya), ibuprofen (ibuprofen), famotidine (famotidine), dexlansoprazole (Dexilant), colecalciferol (cholecalciferol), Clopidogrel BISULFATE (Clopidogrel BISULFATE), pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR), atorvastatin calcium (atorvastatin calcium), oxycodone hydrochloride, paracetamol (Percocet [oxycodone hydrochloride;paracetamol]), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (Boostrix), valproate SEMISODIUM (Depakote emergency room), aciclovir (aciclovir), Fluticasone propionate (Fluticasone propionate), paracetamol (PANADOL), olodaterol hydrochloride, tiotropium bromide MONOHYDRATE (Stiolto RESPIMAT), acetylsalicylic acid (ASPIRINE), morphine sulfate (morphine sulfate), nabumetone (nabumetone), guaifenesin (guaifenesin), gabapentin (gabapentin), fenofibrate (fenofibrate), TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), spironolactone (spironolactone), alprazolam (alprazolam), estazolam (estazolam), glyceryl trinitrate (glyceryl trinitrate), cobicistat, darunavir ETHANOLATE, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE (Symtuza), pantoprazole sodium (pantoprazole sodium), fluoxetine hydrochloride (fluoxetine hydrochloride), abacavir sulfate, dolutegravir sodium, lamivudine (Triumeq), mirtazapine and ziprasidone hydrochloride was unknown.  Action taken with influenza vaccine INACT SAG 4V (Flucelvax QUAD), influenza vaccine INACT SPLIT 3V (Fluarix) and influenza vaccine was not applicable and unknown for all other suspects.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all other events  and was Not Recovered for the event i have fevers everyday 2 or 3 times a day, nipples swelling.  Seriousness criteria : Hospitalization for sepsis and acute bronchitis and Medically significant for sepsis, Heart attack and hemorrhage.; Sender's Comments: Sanofi Company Comment dated 30-Jun-2023 :  This case involves an 57 years old male patient who had sepsis, acute bronchitis, heart attack and hemorrhage while receiving vaccines PFIZER BIONTECH COVID-19 VACCINE, Fluarix, PREVNAR, Flucelvax QUAD and influenza vaccine and while treated with salbutamol sulfate, lansoprazole, levofloxacin, mirtazapine, Clopidogrel BISULFATE, ranitidine hydrochloride, clonazepam, aciclovir, atorvastatin calcium, ibuprofen, famotidine, pantoprazole sodium, gabapentin, acetylsalicylic acid [ASPIRINE], fluoxetine hydrochloride, mirtazapine, ziprasidone hydrochloride, spironolactone, glyceryl trinitrate, fenofibrate, guaifenesin, valproate SEMISODIUM [Depakote emergency room], alprazolam, paracetamol [PANADOL], morphine sulfate, cobicistat, elvitegravir, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE [Genvoya], cobicistat, elvitegravir, emtricitabine, Tenofovir DISOPROXIL FUMARATE [Stribild], colecalciferol [cholecalciferol], dexlansoprazole [Dexilant], VARICELLA ZOSTER VACCINE RGE (CHO) [Shingrix], oxycodone hydrochloride, paracetamol [Percocet [oxycodone hydrochloride;paracetamol]], DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [Boostrix], Fluticasone propionate, olodaterol hydrochloride, tiotropium bromide MONOHYDRATE [Stiolto RESPIMAT], nabumetone, estazolam, cobicistat, darunavir ETHANOLATE, emtricitabine, Tenofovir ALAFENAMIDE FUMARATE [Symtuza] and abacavir sulfate, dolutegravir sodium, lamivudine [Triumeq]. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of patient's past and concomitant medication and any family history, lab data and indication of drug precludes comprehensive case assessment. Further, the patient medical history would be cofounding factor for this events.