chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Mobility decreased, Pain in extremity, Peripheral coldness, Pruritus
Clinical narrative: Patient described that her arm swelled up starting at the injection site and travelled down her whole arm causing significant pain. She stated that she also felt soreness all over her whole body. Her arm became cold to the touch and her fingers could barely move. She went to the urgent care clinic and received a steroid shot which helped resolve the reaction.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: patient developed a bump on the left side of the injection site. looks like a spider or an insect bite and is tender, warm, and itchy per patient report. the reaction is not at the reaction site but to the right so unable to verify if patient got bitten by some type of insect or is from the actual vaccine administration
Age: 70.0
Sex: F
Vaccine: COVID19, FLU4, PNC20, RSV, VARZOS
Symptoms: Dizziness, Injection site erythema
Clinical narrative: On Friday 9/6/24 patient received 5 vaccinations. Fluzone, Spikevax and Prevnar 20 in the left arm. And Arexvy and Shingrix in the right arm. She came in Sunday 9/8/24 with slight redness in both upper arms. I explained to her that these were normal side effects from vaccines and recommended she take tylenol if she was having pain (she states she's unable to use ibuprofen), and ice packs for swelling/redness. She also stated she was feeling a little light headed and dizzy and was concerned it was from the vaccines. But she then immediately followed up by stating that she has been struggling with lightheadedness and dizziness lately because she has lost a lot of weight and her blood pressure medications are making her blood pressure too low. Her drug profile also shows history of meclizine prescriptions. She took her blood pressure in the store and it read back as low. I recommended she follow up with her prescriber for her blood pressure. If her prescriber is unable to see her, I recommended she go to an urgent care to be evaluated by a physician. She stated that she would definitely be doing so.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Aphasia, Confusional state, Death, Panic attack
Clinical narrative: I talked to my neurologist about what happened to my mom. He said Alzheimer'swould not have killed her with in 11 months. Had to be something else. She was getting confused. Didn't know how to get out her home. So I brought her to live with me. Took her to hospital numerous times for confusion. 1 of the times she had uti. They treated it. All the other times there was no uti. They'd keep her anyway give blanket antibiotics because they didn't know what was going on. The week she died she talked to my brother as best she could. 4 days later she lost all ability to speak. Was confused and panicking. Even used the bathroom on my floor. She was making grunting sound and in a total panic. Id hold her hand, try to get her calm, she'd sit with me a few minutes then back to walking back and forth. Total panic. One of the scariest things, helpless things I'd ever been through. What happened to my mom? She died on the 4th day of this. She had to be sedated. Whatever she was going through was to much for her.  I'm scared because I'm also going through states of confusion. I was diagnosed with a form of amnesia. But if it wasn't the Alzheimer's what was it? I want to know! What took my mom? I know she's gone, but I want know why and what took her!
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: I talked to my neurologist about what happened to my mom. He said Alzheimer'swould not have killed her with in 11 months. Had to be something else. She was getting confused. Didn't know how to get out her home. So I brought her to live with me. Took her to hospital numerous times for confusion. 1 of the times she had uti. They treated it. All the other times there was no uti. They'd keep her anyway give blanket antibiotics because they didn't know what was going on. The week she died she talked to my brother as best she could. 4 days later she lost all ability to speak. Was confused and panicking. Even used the bathroom on my floor. She was making grunting sound and in a total panic. Id hold her hand, try to get her calm, she'd sit with me a few minutes then back to walking back and forth. Total panic. One of the scariest things, helpless things I'd ever been through. What happened to my mom? She died on the 4th day of this. She had to be sedated. Whatever she was going through was to much for her.  I'm scared because I'm also going through states of confusion. I was diagnosed with a form of amnesia. But if it wasn't the Alzheimer's what was it? I want to know! What took my mom? I know she's gone, but I want know why and what took her!
Age: 32.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Burning sensation, Dizziness, Feeling hot, Immediate post-injection reaction
Clinical narrative: Pt received Fluzone and Prevnar immunizations.  She was fine after the 1st immunization (fluzone).  Almost immediately after Prevnar, she said her arm felt like it was on fire.  Then she said she "could taste it".  Then she said she was getting hot.  At her request, I asked her husband to get a water for her.  I got some wet paper towels to put on her neck and forehead and an ice pack to use to cool her down.  She said she felt like she was going to pass out. Then she said she felt like she was going to throw up.  I handed her the small trash can that was in the cubicle and she started throwing up, approximately 5 minutes after the Prevnar shot.  She continued vomiting for about 15-20 minutes.  Then she said she was feeling better.  She no longer felt weak, hot or like she was going to throw up.  I asked if she wanted me to call anyone, an ambulance and she declined.  She went to the bathroom to "freshen up" after.  She came back after a few minutes and said she was feeling better. I spoke with her about 3 hours later by phone and she said she got a shower when she got home to "clean up" and she feels much better with no more feeling faint, feeling hot or vomiting.  I asked her to please let us know if she has any more problems.
Age: 32.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Nausea, Product after taste, Vomiting
Clinical narrative: Pt received Fluzone and Prevnar immunizations.  She was fine after the 1st immunization (fluzone).  Almost immediately after Prevnar, she said her arm felt like it was on fire.  Then she said she "could taste it".  Then she said she was getting hot.  At her request, I asked her husband to get a water for her.  I got some wet paper towels to put on her neck and forehead and an ice pack to use to cool her down.  She said she felt like she was going to pass out. Then she said she felt like she was going to throw up.  I handed her the small trash can that was in the cubicle and she started throwing up, approximately 5 minutes after the Prevnar shot.  She continued vomiting for about 15-20 minutes.  Then she said she was feeling better.  She no longer felt weak, hot or like she was going to throw up.  I asked if she wanted me to call anyone, an ambulance and she declined.  She went to the bathroom to "freshen up" after.  She came back after a few minutes and said she was feeling better. I spoke with her about 3 hours later by phone and she said she got a shower when she got home to "clean up" and she feels much better with no more feeling faint, feeling hot or vomiting.  I asked her to please let us know if she has any more problems.
Age: 63.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Mobility decreased
Clinical narrative: Fever,  headache, chills, sweats, aches/pains, dizziness, nausea, in bed for 2 days after vaccines.
Age: 63.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever,  headache, chills, sweats, aches/pains, dizziness, nausea, in bed for 2 days after vaccines.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Aches, chills, fever, fatigue, malaise began about five hours after the injection and continue more than 24 hours later.  Currently 101 degrees.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt recieved dose outside of completed series, pt stated no adverse effects
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Alanine aminotransferase increased, Angiogram normal, Aortic valve incompetence, Aspartate aminotransferase increased
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin increased, Bronchial wall thickening, C-reactive protein increased, CSF culture negative, CSF glucose normal
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Chest X-ray abnormal, Cytotoxic lesions of corpus callosum
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Cytotoxic oedema, Diarrhoea, Dyspnoea, Echocardiogram abnormal, Generalised oedema
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypervolaemia, Illness, Imaging procedure, Immunoglobulin therapy
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Lung consolidation, Lung opacity, Lymphocyte count decreased, Lymphopenia
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging head normal, Meningitis aseptic, Mitral valve incompetence, Multisystem inflammatory syndrome in children
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide increased, Neurological examination abnormal, Noninfective conjunctivitis, Platelet count decreased, Pleural effusion
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive, Scan with contrast abnormal
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Shock, Skin lesion, Thrombocytopenia, Tricuspid valve incompetence, VIth nerve paralysis
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Venogram normal, Vomiting
Clinical narrative: Patient developed symptoms of MISC on 8/12/24; fevers began on 8/12/24 with a Tmax of 43 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, thrombocytopenia, headache, abdominal pain, vomiting, diarrhea, aseptic meningitis, rash, mucocutaneous lesions/conjunctivitis, shortness of breath, pleural effusions, and hypotension/shock. Abnormal labs included elevated CRP, decreased lymphocytes, decreased platelets, elevated AST, elevated ALT, elevated NT-pro BNP. ECHO showed only mild TR, trivial MR, trivial aortic regurgitation, left & right pleural effusions. Chest x-ray initially showed peribronchial thickening, then pleural effusions, then only peribronchial thickening. Patient was admitted to the hospital on 8/19/24 and treated with IVIG and infliximab; he was discharged on 8/31/24. He was admitted to the PICU 8/19/24-8/21/24 and was treated with norepinephrine to maintain adequate blood pressure. He developed focal neurologic findings (bilateral CN VI palsy) with normal neuroimaging and elevated CSF WBC with negative culture; focal neurological findings were attributed to cytotoxic edema and aseptic meningitis. Recovery prior to discharge was also complicated by anasarca/fluid overload treated with furosemide.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: patient felt nauseous, and dizzy after 15 min after receiving the 2 immunizations.  after putting his head below his heart, and ice on his forehead, and sitting for another 15 minutes, patient felt better and left the pharmacy area.  He received the vaccines around 12:56pm, and left by 13:34pm.  Patient did not look pale or sweaty, also was talking normally.  He stated that he only ate a donut and coffee this morning.
Age: 75.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Bedridden, Disability, Dysstasia, Guillain-Barre syndrome, Loss of personal independence in daily activities
Clinical narrative: Apparent Guillain Barre Syndrome about 2 days after receiving vaccine.  Patient began to have extreme difficulty sitting and standing and began losing the use of her arms and hands.  Within two days she became completely bed-bound which where she is now one year later.  She was treated with high dose Prednisone by Dr., MD from the Clinic which did not help.  As stated above she is now totally disabled and needs help with ALL of her personal needs.
Age: 75.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Musculoskeletal disorder
Clinical narrative: Apparent Guillain Barre Syndrome about 2 days after receiving vaccine.  Patient began to have extreme difficulty sitting and standing and began losing the use of her arms and hands.  Within two days she became completely bed-bound which where she is now one year later.  She was treated with high dose Prednisone by Dr., MD from the Clinic which did not help.  As stated above she is now totally disabled and needs help with ALL of her personal needs.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: A rash appeared on both knees. Mild patchy redness on the left knee, smaller than the kneecap. One painful red bump to the side of the left knee. On the right knee, the rash was larger than kneecap and spread below the knee. The patchy red rash extended from the bottom of the knee area to the upper middle area of the knee. Three painful red bumps ranged from below the kneecap to below the knee area. The rash was not itchy, but the bumps were painful to the touch. The rash steadily got worse over a period of half an hour, and stagnated. Everything was clear by the next morning with the exception of a couple bumps.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acne, Dermatitis allergic
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Patient went to their PCP on 9/3/24 and got fluocinonide and desonide 0.05% cream for rash on face on body.  , Other Vaccines:  VaccineTypeBrand: FLUCELVAX TRIVAL; Manufacturer: SEQUIRUS; LotNumber: 946585; Route: INTRAMUSCULAR; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lethargy, Pyrexia, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Patient went to their PCP on 9/3/24 and got fluocinonide and desonide 0.05% cream for rash on face on body.  , Other Vaccines:  VaccineTypeBrand: FLUCELVAX TRIVAL; Manufacturer: SEQUIRUS; LotNumber: 946585; Route: INTRAMUSCULAR; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN
Age: 81.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Asthenia, Brain fog, Confusional state, Cough, Dysphonia
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Severe, Additional Details: unable to get out of bed for 3 days
Age: 81.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Lethargy
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Severe, Additional Details: unable to get out of bed for 3 days
Age: 81.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Confusional state, Fatigue, Lethargy, Mobility decreased, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Severe, Additional Details: unable to get out of bed for 3 days
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: herpes zoster; inappropriate schedulle of vaccine administered; Literature report:   This literature marketed report has been received from the authors of the published article, titled as stated above regarding a 19-month-old healthy female patient. Her mother denied any significant dermatologic history, including chickenpox, known allergies of the child, recent travel, recent illness, or sick contacts.  On unspecified dates, the patient received first two immunizations of varicella with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (strength, dose, route, anatomical location, lot#, and expiration date were not provided) as prophylaxis. At that visit, her mother stated that the child was up to date regarding her vaccinations, including the first two immunizations of the varicella vaccine received at the age of 12 months (Inappropriate schedule of vaccine administered).  On an unspecified date, the patient experienced herpes zoster. She presented with a 2-day history of pruritic eruptions overlying her right upper back. A 14-point review of systems, including fevers, chills, irritability, feeding problems, or respiratory distress, was negative. A full skin examination revealed no abnormalities, except grouped lesions on an erythematous base in a dermatomal distribution overlying the patient's right upper back and extending to her right proximal posterior arm. Consultation with the pediatric infectious disease service recommended intravenous acyclovir infusion whereas the pediatric dermatology consultant recommended oral acyclovir. Risks and benefits of both therapies were discussed, and the patient was transferred to the emergency department of a neighboring hospital for further evaluation and treatment for presentation\consistent with herpes zoster. Oral acyclovir, 20 mg/kg/dose four times daily for 7-10 days was initiated. Additionally, human immunodeficiency virus (HIV) testing , lymphocyte CD4-CD8 count, and differential complete blood count (CBC) were normal. Subsequently, follow-up with pediatric immunology was scheduled 7 days after the initial presentation for an additional immunodeficiency diagnostic examination which was also negative. The authors did not provide the outcome of the event.  The authors considered that the event of herpes zoster was due to varicella virus vaccine live (Oka/Merck) (manufacturer unknown). Additionally, authors reports that Herpes zoster must be considered in the examination of pediatric patients without prior varicella infection, as the live attenuated disposition of the varicella vaccine may cause a subclinical primary varicella infection or mutations of the live vaccine itself.  A copy of the published article is attached as further documentation of the patient's experience. Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms reported.; extra dose of PROQUAD on 8/14/2024.; This spontaneous report was received from a certified medical assistant referring to a 5 year old patient. The patient's historical vaccines included varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). The patient's pertinent concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 08-AUG-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter/dose, lot # X011437, expiration date: 18-JUL-2024 (strength, dose number, route and anatomical location) for prophylaxis.  On 14-AUG-2024, the patient was vaccinated with an extra dose (extra dose administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter/dose, lot # X025823, expiration date: 29-APR-2025 (strength, dose number, route and anatomical location) for prophylaxis.  The primary reporter stated that their office used a system,  to document patient's health records, which stated that the patient was due for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD).   After patient was administered the extra dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), Caller checked the patient's health records against their EMR system and confirmed that patient received an extra dose of the vaccine in error.   No symptoms reported (no adverse event).
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; PROQUAD was administered after experiencing a temperature excursion; This spontaneous report was received from a nurse referring to a 4 year old female patient. The patient's pertinent medical history, concurrent conditions, and drug reactions or allergies were not reported. The patient's concomitant therapies included sterile diluent(MERCK STERILE DILUENT).  On 29-AUG-2024 , the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # Y002100, expiration date 09-JUL-2025 for prophylaxis after experiencing a temperature excursion.   The temperature excursión was: -8.5 C, the time frame was 4 Hours 41 Minutes 0 Seconds and there was no previous temperature excursión.  No side effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Significant redness; Pain; This non-serious case was reported by a other health professional via sales rep and described the occurrence of erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Significant redness) and pain (Verbatim: Pain). Shingrix was discontinued. The outcome of the erythema and pain were resolved.   The reporter considered the erythema and pain to be related to Shingrix.     The company considered the erythema and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-AUG-2024 The patient self-reported this case. The patient received 1st dose of Shingrix vaccine and experienced significant redness and pain which was not serious. The patient was employee who self-reported during educational in-service while she was last person in room besides two GlaxoSmithKline (GSK) vaccine representatives.  She stated she would not get her second dose of Shingrix as she had what seemed like either an allergic reaction or a cellulitis.  She was attended to by healthcare professional (HCP) who prescribed medicine to treat. The redness resolved in several days.  The patient reported only vaccine she received that day and GSK representative did not know if she was taking any other medication at the time.
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 16 months old patient received Boostrix vaccine; 16 months old patient received Boostrix vaccine; label was misread/patient was to have received DTaP; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TD2FD, expiry date 31-MAY-2026) for prophylaxis.   Previously administered products included Dtap vaccine (received 3 doses of Dtap of different manufacturer on an unknown date).   On 22-JUL-2024, the patient received the 4th dose of Boostrix (intramuscular) .5 ml. On 22-JUL-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 16 months old patient received Boostrix vaccine), underdose (Verbatim: 16 months old patient received Boostrix vaccine) and wrong vaccine administered (Verbatim: label was misread/patient was to have received DTaP). The outcome of the inappropriate age at vaccine administration, underdose and wrong vaccine administered were not reported.   Additional Information: GSK receipt date: 28-AUG-2024 A registered nurse called GlaxoSmithKline to report that a 16 months old patient received a dose of Boostrix as their 4th dose of the Tdap series instead of the Dtap series at an inappropriate age, which led to underdose, wrong vaccine administered and inappropriate age at vaccine administration. The reporter reported that the label was misread and patient was to have received Dtap. The error was noticed until after the administration. There was no adverse event had been reported by patient's parents. The reporter wanted to know how to proceed.  During the phone call they requested two bits of information that any damage was going to be caused to the patient and did any of those had to be repeated. During the call, the nurse also mentioned that the patient had received another manufacturer's Dtap vaccine for the 1st dose and then the second and third vaccine were from GlaxoSmithKline.  No more information was provided.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Generalized rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced generalized rash (Verbatim: Generalized rash). The outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     It was unknown if the company considered the generalized rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-AUG-2024 Customer reported developing a generalized rash the day after receiving the Shingrix vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash
Clinical narrative: painful rash appearing near the injection site; Rash on collarbone and chin; soreness and warmth at the injection site.; warmth at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 26-AUG-2024, the patient received the 2nd dose of Shingrix. On 26-AUG-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness and warmth at the injection site.) and injection site warmth (Verbatim: warmth at injection site). On 28-AUG-2024, the patient experienced injection site rash (Verbatim: painful rash appearing near the injection site) and rash (Verbatim: Rash on collarbone and chin). The outcome of the injection site pain, injection site rash and rash were unknown and the outcome of the injection site warmth was unchanged.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site rash and rash to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site warmth, injection site rash and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-AUG-2024 The patient reported that she received her 2nd dose of Shingrix on 8/26/2024.  That evening she began having soreness and warmth at the injection site. On 8/28/2024 she noticed a non-blistered, painful rash appearing near the injection site, along her collarbone on the same side, and on her chin.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Pain in extremity, Rash
Clinical narrative: in her left arm, she experienced pain; pain on touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 29-APR-2024, the patient received the 2nd dose of Shingrix (left arm). In APR-2024, several hours after receiving Shingrix, the patient experienced pain in arm (Verbatim: in her left arm, she experienced pain) and tenderness (Verbatim: pain on touch). The outcome of the pain in arm and tenderness were not resolved.   It was unknown if the reporter considered the pain in arm and tenderness to be related to Shingrix.     It was unknown if the company considered the pain in arm and tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 The patient reported that she received her 2nd dose of Shingrix and that evening she began having soreness and warmth at the injection site. On 28th August 2024 she noticed a non-blistered, painful rash appearing near the injection site, along her collarbone on the same side and on her chin.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: in her left arm, she experienced pain; pain on touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 29-APR-2024, the patient received the 2nd dose of Shingrix (left arm). In APR-2024, several hours after receiving Shingrix, the patient experienced pain in arm (Verbatim: in her left arm, she experienced pain) and tenderness (Verbatim: pain on touch). The outcome of the pain in arm and tenderness were not resolved.   It was unknown if the reporter considered the pain in arm and tenderness to be related to Shingrix.     It was unknown if the company considered the pain in arm and tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 The patient reported that she received her 2nd dose of Shingrix and that evening she began having soreness and warmth at the injection site. On 28th August 2024 she noticed a non-blistered, painful rash appearing near the injection site, along her collarbone on the same side and on her chin.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number L7L55, expiry date 30-SEP-2025) and (batch number AMVA728A, expiry date 30-SEP-2023) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Menveo (1st dose received on 28 October 2022) and Boostrix (1st dose received on 28 October 2022).   On 05-AUG-2024, the patient received the 2nd dose of Menveo. On 05-AUG-2024, the patient received the 2nd dose of Boostrix. On 05-AUG-2024, an unknown time after receiving Menveo and Boostrix, the patient experienced drug dose administration interval too short (Verbatim: Early second dose). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-AUG-2024 Health Care Professional called to report that a patient who received a Menveo vaccine too soon, it was an issue with her and she needed the vaccine but she actually got a vaccine prior to and, for some reason, her did pulled through and she was revaccinated too soon. So, they just wanted to call to know if we did not need to do anything else before alerting the patient's Mom. She was actually given a tdap Boostrix vaccine on the same dates just 2 years apart, which was also your product. During the call the HCP said that the patient was given a tdap Boostrix on the same dates just 2 years apart. The patient received 2nd dose of Menveo and Boostrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: MENB
Symptoms: Poor quality product administered, Wrong technique in product usage process
Clinical narrative: Prefilled syringe with air bubble administered; Prefilled syringe with air bubble administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong technique in drug usage process (Verbatim: Prefilled syringe with air bubble administered) and poor quality vaccine administered (Verbatim: Prefilled syringe with air bubble administered). The outcome of the wrong technique in drug usage process and poor quality vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-AUG-2024 Nurse explained they had been having trouble for months with different lot numbers (not provided) of Bexsero prefilled syringes. They were not being able to extract the large air bubble and already administered numerous doses to 16 year old patients in several dates. Patient demographics were not provided but caller gave consent to follow up with Safety Team if the information is needed in the future.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: report 9 patients were administered with expired Boostrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 27-OCT-2023) for prophylaxis.   On 22-AUG-2024, the patient received Boostrix. On 22-AUG-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: report 9 patients were administered with expired Boostrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2024 The nurse called and reported that the patient was administered with an expired dose of Boostrix vaccine, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The case is 1 of the 9 linked case, by same reporter.; Sender's Comments:  US-GSK-US2024107939:Same reporter,Different patient US-GSK-US2024107929:Same reporter/Different patient US-GSK-US2024107925:Same reporter/Different patient US-GSK-US2024107927:Same reporter/Different patient US-GSK-US2024107932:Same reporter/Different patient US-GSK-US2024107933:Same reporter/Different patient US-GSK-US2024107937:Same reporter/Different patient US-GSK-US2024107935:Same reporter/Different patient