Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, PNC20, TDAP
Symptoms: Polymerase chain reaction, Pulmonary function test, Pyrexia, Red blood cell count, Renal impairment
Clinical narrative: Liver stopped working, is damaged, about to have liver cirrhosis; Kidneys are not working, damaged, lost right kidney, high bun and creatinine; Tumor in liver; Heart attack; Dizzy; Belly is swollen huge, looks l ke I am 9 months pregnant; Need oxygen for my lungs, can barely breathe; Testicles are swollen; My bones, it hurts a lot; I can hardly walk; cannot put my clothes;I have stayed in bed; Nipples swollen and getting bigger; Legs can hardly walk due to the recent swelling; I lose my vision, blurred vision, wearing glasses; I have fallen and hit myself; Very severe pain in my testicles; Disquisition in the bladder, can hardly urinate; Small benign liver cyst; Stool softness; Every day I feel worse, everything in the body is getting worse; Fevers everyday 2 or 3 times a day; My body swells; Sore throat; Feeling really bad; Feeling like I am dying slowly; I cannot drink or eat anything; 178 pounds before I was 120; tired; weakness in his body; no appetite, he is not eating; Headache; Hernia; pain in swollen belly; Feeling sick; Suspected lipoma in abdominal oblique muscle; mild osteoarthrosis, lower lumbar facet osteoarthrosis; Swelling in hernias, umbilical, inguinal. Will operate me on Thursday/ Pain in hernias he had treated before; constipation, 2 months, 14 days without evacuating; diarrhea, 3 months; This case was reported by a consumer via licensee and described the occurrence of liver failure in a 58-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 8js9e, expiry date 18th March 2024) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID-19 VACCINE BIONTECH/PFIZER) (batch number FM7553, expiry date 1st July 2022) for prophylaxis, PNEUMOCOCCAL 20 VALENT CONJUGATE VACCINE (PREVNAR 20) (batch number FJ2604, expiry date 30th June 2023) for prophylaxis, morphine unknown for product used for unknown indication and oxycodone hydrochloride + paracetamol (Percocet) unknown for product used for unknown indication.   The patient's past medical history included pericarditis, multisystem inflammatory syndrome (MIS-C or MIS-A) and myocarditis. Previously administered products included COVID-19 VACCINE BIONTECH/PFIZER with an associated reaction of pyrexia (received 1st dose on 23rd March 2021 through intramuscular route at right deltoid, batch number- EP7534, expiry date 31st July 2021), COVID-19 VACCINE BIONTECH/PFIZER with an associated reaction of pyrexia (received 2nd dose on 13th April 2021 and through intramuscular route at right deltoid, batch-EW0151, expiry- 31st Jul 2021), COVID-19 VACCINE BIONTECH/PFIZER with an associated reaction of pyrexia (received 3rd dose on 20th August 2021 through intramuscular route and with batch number FC3183), FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE) (FLUZONE QUAD 2021-2022 syringe, received on 21st September 2021), FLUCELVAX QUAD (FLUCELVAX QUAD 2020-2021 SYR, received on 9th December 2020, through intramuscular route at left deltoid, batch-276580, expiry- 30th June 2021), FLUARIX QUAD (FLUARIX QUAD 2016-2017 syringe, received on 13th January 2017), SHINGRIX (received on 3rd March 2020, through intramuscular route at left deltoid, batch-MT7C9, expiry- 30th August 2020) and SHINGRIX (received on 20th December 2019 through intramuscular route at right deltoid, batch-HY4GT, expiry- 17th June 2020). Concurrent medical conditions included hiv infection, allergy to vaccine (to component and previous doses of Covid-19 vaccine), swollen abdomen, impending doom, unable to eat, general body pain, nipple swelling, stenosis, osteopenia, gynecomastia, fatty liver, leg pain and hernia.   On 4th May 2022, the patient received Boostrix (intramuscular). On 10th May 2022, the patient received the 4th dose of COVID-19 VACCINE BIONTECH/PFIZER (intramuscular). On 4th May 2022, the patient received PREVNAR 20 (intramuscular). On an unknown date, the patient started morphine at an unknown dose and frequency and Percocet at an unknown dose and frequency. On 3rd June 2022, 30 days after receiving Boostrix, the patient experienced hernia pain, osteoarthrosis and lipoma. On an unknown date, the patient experienced liver failure (serious criteria GSK medically significant), kidney dysfunction (serious criteria GSK medically significant), hepatic neoplasm (serious criteria GSK medically significant), heart attack (serious criteria GSK medically significant), dizziness, swollen abdomen, shortness of breath, testicular swelling, bone pain, walking difficulty, mobility decreased, nipple swelling, swelling of legs, blurred vision, fall, testicular pain, urination difficulty, constipation, diarrhea, abdominal pain, feeling unwell, hepatic cyst, soft stools, condition aggravated, fever, swelling, sore throat, feeling bad, impending doom, unable to eat, weight gain, tiredness, weakness generalized, decreased appetite, headache and hernia. The patient was treated with ibuprofen, morphine (Morphine Patch), fentanyl (Fentanyl Patch), ibuprofen (Advil), panadol (nos) (Panadol), acetylsalicylic acid (Aspirin), omeprazole, gabapentin and paracetamol (Acetaminophen). The action taken with morphine was unknown. The action taken with Percocet was unknown. On an unknown date, the outcome of the liver failure, kidney dysfunction, hepatic neoplasm, dizziness, swollen abdomen, shortness of breath, testicular swelling, hernia pain, bone pain, walking difficulty, mobility decreased, nipple swelling, swelling of legs, blurred vision, fall, testicular pain, urination difficulty, abdominal pain, osteoarthrosis, feeling unwell, lipoma, hepatic cyst, soft stools, condition aggravated, fever, swelling, sore throat, feeling bad, impending doom, unable to eat, weight gain, tiredness, weakness generalized, decreased appetite, headache and hernia were not recovered/not resolved and the outcome of the heart attack was unknown and the outcome of the constipation and diarrhea were recovered/resolved.   It was unknown if the reporter considered the liver failure, kidney dysfunction, hepatic neoplasm, heart attack, dizziness, swollen abdomen, shortness of breath, testicular swelling, hernia pain, bone pain, walking difficulty, mobility decreased, nipple swelling, swelling of legs, blurred vision, fall, testicular pain, urination difficulty, constipation, diarrhea, abdominal pain, osteoarthrosis, feeling unwell, lipoma, hepatic cyst, soft stools, condition aggravated, fever, swelling, sore throat, feeling bad, impending doom, unable to eat, weight gain, tiredness, weakness generalized, decreased appetite, headache and hernia to be related to Boostrix.     Additional Information: GSK receipt date: 22-Jun-2022 Reporter's comments: The patient self-reported this case. The reporter reported the side effects from Covid-19 vaccine. Lost his liver, kidney was not working, had a huge belly, and a tumor, contributing all of this to the Covid-19 vaccine. Since the first shot until the fourth shot had been writing down all the side effects and things he had been feeling since then. Got the first Covid vaccine on 23rd March 2021. After, had pain and redness in area of vaccine and had a 39.7-degree Celsius fever for 12 days. Pain for 12 consecutive days, strong headache pain for 3 months. Pain in lower part of back for 4 to 5 months and still had the pain. Pain in his legs for 5 to 6 months that was still there. Those were all the side effects he had for the first vaccine. Got the second vaccine on 13th April 2021. After, he had fever and pain in all his body. The pain was persistent. Fever of 39.2 degrees Celsius. Swelling of hands and pain in this lower back. Not able to take Tylenol because it would hurt liver. Could only take Advil. Brother had to help care for him now. Kidney was not working: Did an MRI of his kidneys and found that they were working at 40- 50 percent. Occurred after the vaccines. Before the vaccines he was very healthy. Now stomach was swollen, no appetite, he was not eating. His stomach was swelling because of his fatty liver and had to stop his medication. Now he had 9 medications. He used to take 30 medications. Got the third vaccine on 20th August 2021. Symptoms were the same. Had fevers are 3-4 times a day every day. Tummy was more swollen like he's pregnant. He had dizziness and had to lay down on bed. Feet were swollen, he could not walk at times, had to use cane to walk now. Nipples were swollen like a woman's breasts. Took pictures to show that this was not what he looked like before. Knows that it was from the vaccine because it was not like this before. Found some extra fat on his stomach. Half an inch of extra fat around his stomach. It's not because he was retaining fluid. It was because of the vaccine. All the fever and pain and legs and stomach swelling with the third vaccine. Sometimes he falls down from the leg pain. Testicle pain now. Hernia was starting to hurt again which was something he had a long time ago but was now back. Had diarrhea for 3 months, and constipation for 2 months, and now the constipation was back. He could not feel his legs. There was numbness on his legs, so he was not able to walk. Tumor discovered after the fourth vaccine on 10th May 2022. After the vaccine he started with pain that was like itching in the two hernias he had. Hernias did not hurt him every day but when he had the pain he had to lay down. Laying down gives him relief. He was tired, weak, his heart feels like it was beating fast, could not did anything. Not taking any heart medication because of his liver. Only one kidney was working properly. Could not breathe well. Would need to be on oxygen soon because of his lungs. Feels like he had small balls in his stomach and must lay down in bed. Could not be alone because he might fall down, and if he hits his head, he might need a surgery. He might not survive a surgery. Also gets dizzy, blurred vision, needs to stay in bed. Tired and could not did any activity. When he had his appointments with doctor, he did not always go because he feels really weak and not strong enough to go because of all the weakness in his body. All vaccines were given at unknown place. He did not think that he would be having all the symptoms that he was having now. He was in the hospital and some patients had almost the same symptoms like him. Saying that some of them would survive and some were complicated, and they survived, and some passed away in the ICU. Was admitted in 3 different hospitals and filed a claim in every hospital because in the first hospital, he stayed there for 3 hours with lots of pain and could not find any doctors. The nurses were young and did not know what they were doing. Did not check him, just gave him a pill for the chest pain and gave him Panadol. Gave him pills he could find in a pharmacy. Informed insurance and made 4- 5 phone calls to report that. Asked for a supervisor and they never answered phones or contacted him. Told the practitioners there that he would need something else. He did not want the young doctor because the young doctor didn't know what to do with the pain. The hospital wrote a paper saying he was responsible for his own health, and if something happened it was his responsibility. Still had the pain and everything was still hurting him. The nurses and doctors did not check his temperature or anything. Caller wanted an electrocardiogram, but they did not do anything. At second hospital, he stayed in a wheelchair then went to a bed and stayed there for 2 hours. He was given another Panadol, but that was it. Filed another claim and its under investigation. After that, he went to another hospital and this doctor was sitting there typing everything and did not look him in the eyes the whole time. Doctor was just typing everything while caller was explaining all the pain. Explained that he could not eat and felt like everything was moving inside him. Doctor gave him four injections and four morphine patches and that was all. The patches were small, and caller put patch on side of hurt. Helped for 72 hours. Had 5 different medications in the patches. The patches were last resorts for someone who as feeling pain. Only used two patches but might be he would need the other ones later. Never checked his stomach, liver, or legs though. Just prescribed the injections and patches. Helped for a while, but then the pain came back again. Now he had the pain in his legs. Needs to take the pills for the pain, but they are hurting his liver., Needs 2-3 different pills. Didn't receive the correct attention at these hospitals. Did not like how he was treated. Saved all the documents for his records. With the patches, he must wait 72 hours between the patches. He never even had the flu before all this. Never had any of this before. Gave him Panadol and ibuprofen, but he could not have that because of his liver. Clarified that caller was never admitted to the hospital. He was seen in the emergency department and was sent home emergency department. At the first hospital, it was Aspirin that he had to bite that was given to him for the chest pain. Concomitant Medications: Been an HIV patient for 39 years, but he did not had symptoms. Takes medication from the health department for the HIV. The medications did not had any side effects on him. Since the covid-19 vaccine, he started with all the symptoms. His PCP couldn't help him because she checked his nipples, legs, hands, and fingers. She stopped his medications. 20-25 different pills he was on, but she stopped them. Doctor checked everything, but there must have been a mistake because she said it was because of fluid retention. She prescribed omeprazole for his stomach and fluid retention. That was what he was taking now. He takes Sympuza for HIV and had been taking that for 25 years. Virus count was at 0. Takes Gabapentin for his legs and the swelling and neuropathy. Takes 800 mg. Takes omeprazole and the Advil for the pain. Still needs to take 15 more medications, but doctor needs to see how they would affect his liver first. These were the medications he was taking now. CD-fentanyl patch 72HR 12 mcg per hour. It was required to evaluate if patient could tolerate opioids. (taking for a week or month, with at least 60 mg of morphine daily or its equivalent). Consumer stated, He threw Ibuprofen and Panadol in the garbage can. Not he, his doctor, all his medicines that had to drink. The patient only drinking the Sanctum. That was the only one. He was not drinking anything. He had to stay with his pain, and he could not drink or eat anything, he did not purchase anything because they were going to operate him on Thursday. This was something that was happening with the vaccine, the 4 vaccine, starting at the first one, he wrote everything he was feeling in his body until the fourth one but he sent papers and he had a reference here about his document and right now, he was doing worse. his liver was really bad. he could not drink any kind of Aspirin or Ibuprofen or something for the pain. All his bones, it hurts a lot every day. He had fevers everyday 2 or 3 times a day. Sometimes he could not put his clothes. A lot of times he could not walk. had stayed in bed. With vaccine he had no medicine for the pain, and he had a big headache every day, every single day, sometimes two or three times. It was horrible the pain that he had in his head and all his body swells do not know if it swelled his fingers, his feet (Event captured as per verbatim). Everything in the body was getting worse. Right now, his belly was a little bit better' but now he had it worse than before and it was getting worse and he got a lot of pain in his belly. he had been before like; 20 or 25 years and it was supposed to be that thing the hernia. He had three hernias that was going to make him operated this Thursday and his body was really worse. he means a lot of pain that he could not control himself and he would like to speak with somebody who speak or if you want to take my reference number because he sent a lot of documents to you, to the legal section. Consumer stated, when asked to provide clarification if patient had the side effects after taking the Pfizer COVID-19 vaccine: Consumer stated, well he do not understand but had four, the first one (Vaccine) was horrible because he was for 10 days with fever. he never went to the hospital because at this hospital over here have a lot of COVID-19 people in bed and he was supposed to be there even that next on it because he was afraid if he gets the COVID. he never had COVID and during this all these months of this he never had because he takes himself the safety about that because he was an HIV patient, but his HIV does not make anything with his same that he had. If you see his little chest looks like a woman. his belly looks like he was nine months pregnant. He had sore throat. his bones, they hurt a lot and he get so dizzy. he cannot wash dishes, stay doing something because it hurts in his back, low in his back and was looking that he was getting worse and worse every day. They told him that they are going to send him, he was waiting for a document that he had to fill up and send it to them. Also they told him that all my things from disaster to send it to them but his doctor, his first doctor, she said that she sent papers because she was with cancer (Further clarifications unknown) in and now he do not know how she was writing or doing because she said that he had the symptoms that he had before and it is written in the medical record and those things like my back and all those things like his liver, it is not working how it was supposed to be. He had two heart attacks. He was supposed to be drinking pills where he drinks those pills and he can only drink Panadol. Panadol did not make anything for him because he was using before for those pains like a drug, it was like that white thing you drink, he forgot the name (Further not clarified) and that does not make any difference because he took two of them and it doesn't make any difference for the pain, anything, just the Pantanal' (Further clarifications unknown hence captured unspecified Medication conservatively) something like that. He had five or six drugs on in (Further clarifications unknown). This one was a patch (Further not appropriately clarified hence suspect captured as Unspecified Patch conservatively), he put it on his back body, but it doesn't make any difference. The pain feels, he was getting worse and he had family, he had a lot of family. When probed to clarify if patient experienced all these side effects after Pfizer COVID-19 Vaccine: Consumer stated, No, he had it before he had his injections. They put him four and I sent all those papers within the place that, that put me the four vaccines and then for the one, he was feeling really bad. he wrote everything he was feeling until the last one but now he feels the same. He did not see anything that it would be better for me. He feels like waking with you know, the hospitals, he went to the hospitals and they did not want to give him nothing They just put him in the bed and wait for four hours and they did not put him anything for the pain. He just brings me 2 Panadols and said to him, you drink it. He did not drink that and went home because he signed the paper and made to the person to had to be those things the way they treat him. They treat him like a dog, like an animal. They did not put him, nothing. They were in the place supposed to be in the place, they were inside the emergency room. They were laughing, talking, talking by phone and there was doing nothing and then he called them, he told them what happened in three hours and he was having the pain and he can't resist and they bring me those Panadols and then he just go away from the three hospital. he went to 3 hospitals and they did not do nothing for him. They did not even see his test. They did not even see his belly. They did not look at his face, they did not even look at his face and then the only hospital that put him 4 vaccines for the pain was in. That was the only place and the doctor, he doesn't look on his face. He doesn't do anything for him and right now. He was drinking Percocet (5mg, every 4 hours) and he was drinking two Percocet every four hours and they did not do me anything, so he threw it away. When asked about Lot number of Percocet consumer stated, No, because he threw them. He did not had medicines. he was not drinking anything. He had to stay with pain. Reporter gave permission to follow up with healthcare professional. The reporter consent to follow up.