chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Cardiac disorder, Death, Dyspnoea, Epistaxis
Clinical narrative: She started having shortness of breath, bloody noses and a lot of mucus around her heart and lungs. She did not have any issues like this prior to the vaccinations. They told us she had lung disease which was quite a surprise and not expected. She had bone issues, but not lung issues ever. Or heart issues, her heart was strong and it took a long time for her heart to stop beating!
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: She started having shortness of breath, bloody noses and a lot of mucus around her heart and lungs. She did not have any issues like this prior to the vaccinations. They told us she had lung disease which was quite a surprise and not expected. She had bone issues, but not lung issues ever. Or heart issues, her heart was strong and it took a long time for her heart to stop beating!
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Bursitis, COVID-19, Cognitive disorder, Contusion
Clinical narrative: Pt with history of 3 Covid vaccine first and second dose Moderna on 02/03/2021 and 03/08/2021, third dose Pfizer on 01/07/2022. After second dose of Moderna Covid vaccine Pt had frequent UTIs admitted in the hospital for urosepsis with E Coli and epididymitis on 06/21/2021, 2 months later after Pfizer booster vaccine Pt had an episode of Bursitis of right shoulder, and 3 months after vaccination he had an episode of syncope fall with laceration on the left eyebrow and bruise on the left forehead and he was admitted at hospital for 2 days for observation for UTI/pyelonephritis r/o for sepsis and had acute on CKD, was on cefepime and vanco and d/c on cefdinir for 10 days course. the following month on 05/04 had bursitis of left hip with steroid shot, on May/23 had respiratory symptoms and resulted positive for Covid infection, had ESI on 7/2022 with some resolution of sciatica and leg pain then worsening of weakness with bilateral legs giving out 7/22/22 needing assistive device for ambulation and he was admitted at hospital on 7/25/2022 with worsening of his radicular pain and myelopathy, and he was admitted for NS eval: had L2-L4 laminectomy complicated by epidural hematoma requiring evac on POD#1, discharged after 8 days to rehab to continue with aggressive physical therapy, 1 week later He was readmitted to hospital due hypotension and found extensive bilateral DVT, and severe dysphagia requiring EGD showing esophagitis with pathology resulted mild chronic gastritic with reactive appearing changes, mild reflux changes and erosion with chronic inflammation, stayed for 8 days and he is currently in a rehab facility but cognitive status still impaired.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Dysphagia, Epididymitis, Escherichia infection, Fall
Clinical narrative: Pt with history of 3 Covid vaccine first and second dose Moderna on 02/03/2021 and 03/08/2021, third dose Pfizer on 01/07/2022. After second dose of Moderna Covid vaccine Pt had frequent UTIs admitted in the hospital for urosepsis with E Coli and epididymitis on 06/21/2021, 2 months later after Pfizer booster vaccine Pt had an episode of Bursitis of right shoulder, and 3 months after vaccination he had an episode of syncope fall with laceration on the left eyebrow and bruise on the left forehead and he was admitted at hospital for 2 days for observation for UTI/pyelonephritis r/o for sepsis and had acute on CKD, was on cefepime and vanco and d/c on cefdinir for 10 days course. the following month on 05/04 had bursitis of left hip with steroid shot, on May/23 had respiratory symptoms and resulted positive for Covid infection, had ESI on 7/2022 with some resolution of sciatica and leg pain then worsening of weakness with bilateral legs giving out 7/22/22 needing assistive device for ambulation and he was admitted at hospital on 7/25/2022 with worsening of his radicular pain and myelopathy, and he was admitted for NS eval: had L2-L4 laminectomy complicated by epidural hematoma requiring evac on POD#1, discharged after 8 days to rehab to continue with aggressive physical therapy, 1 week later He was readmitted to hospital due hypotension and found extensive bilateral DVT, and severe dysphagia requiring EGD showing esophagitis with pathology resulted mild chronic gastritic with reactive appearing changes, mild reflux changes and erosion with chronic inflammation, stayed for 8 days and he is currently in a rehab facility but cognitive status still impaired.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Gastrointestinal erosion, Gastrointestinal inflammation, Gastrooesophageal reflux disease, Haematoma evacuation
Clinical narrative: Pt with history of 3 Covid vaccine first and second dose Moderna on 02/03/2021 and 03/08/2021, third dose Pfizer on 01/07/2022. After second dose of Moderna Covid vaccine Pt had frequent UTIs admitted in the hospital for urosepsis with E Coli and epididymitis on 06/21/2021, 2 months later after Pfizer booster vaccine Pt had an episode of Bursitis of right shoulder, and 3 months after vaccination he had an episode of syncope fall with laceration on the left eyebrow and bruise on the left forehead and he was admitted at hospital for 2 days for observation for UTI/pyelonephritis r/o for sepsis and had acute on CKD, was on cefepime and vanco and d/c on cefdinir for 10 days course. the following month on 05/04 had bursitis of left hip with steroid shot, on May/23 had respiratory symptoms and resulted positive for Covid infection, had ESI on 7/2022 with some resolution of sciatica and leg pain then worsening of weakness with bilateral legs giving out 7/22/22 needing assistive device for ambulation and he was admitted at hospital on 7/25/2022 with worsening of his radicular pain and myelopathy, and he was admitted for NS eval: had L2-L4 laminectomy complicated by epidural hematoma requiring evac on POD#1, discharged after 8 days to rehab to continue with aggressive physical therapy, 1 week later He was readmitted to hospital due hypotension and found extensive bilateral DVT, and severe dysphagia requiring EGD showing esophagitis with pathology resulted mild chronic gastritic with reactive appearing changes, mild reflux changes and erosion with chronic inflammation, stayed for 8 days and he is currently in a rehab facility but cognitive status still impaired.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypotension, Muscular weakness, Myelopathy, Oesophagitis, Oesophagogastroduodenoscopy abnormal
Clinical narrative: Pt with history of 3 Covid vaccine first and second dose Moderna on 02/03/2021 and 03/08/2021, third dose Pfizer on 01/07/2022. After second dose of Moderna Covid vaccine Pt had frequent UTIs admitted in the hospital for urosepsis with E Coli and epididymitis on 06/21/2021, 2 months later after Pfizer booster vaccine Pt had an episode of Bursitis of right shoulder, and 3 months after vaccination he had an episode of syncope fall with laceration on the left eyebrow and bruise on the left forehead and he was admitted at hospital for 2 days for observation for UTI/pyelonephritis r/o for sepsis and had acute on CKD, was on cefepime and vanco and d/c on cefdinir for 10 days course. the following month on 05/04 had bursitis of left hip with steroid shot, on May/23 had respiratory symptoms and resulted positive for Covid infection, had ESI on 7/2022 with some resolution of sciatica and leg pain then worsening of weakness with bilateral legs giving out 7/22/22 needing assistive device for ambulation and he was admitted at hospital on 7/25/2022 with worsening of his radicular pain and myelopathy, and he was admitted for NS eval: had L2-L4 laminectomy complicated by epidural hematoma requiring evac on POD#1, discharged after 8 days to rehab to continue with aggressive physical therapy, 1 week later He was readmitted to hospital due hypotension and found extensive bilateral DVT, and severe dysphagia requiring EGD showing esophagitis with pathology resulted mild chronic gastritic with reactive appearing changes, mild reflux changes and erosion with chronic inflammation, stayed for 8 days and he is currently in a rehab facility but cognitive status still impaired.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pathology test, Pyelonephritis, Radicular pain, Respiratory symptom
Clinical narrative: Pt with history of 3 Covid vaccine first and second dose Moderna on 02/03/2021 and 03/08/2021, third dose Pfizer on 01/07/2022. After second dose of Moderna Covid vaccine Pt had frequent UTIs admitted in the hospital for urosepsis with E Coli and epididymitis on 06/21/2021, 2 months later after Pfizer booster vaccine Pt had an episode of Bursitis of right shoulder, and 3 months after vaccination he had an episode of syncope fall with laceration on the left eyebrow and bruise on the left forehead and he was admitted at hospital for 2 days for observation for UTI/pyelonephritis r/o for sepsis and had acute on CKD, was on cefepime and vanco and d/c on cefdinir for 10 days course. the following month on 05/04 had bursitis of left hip with steroid shot, on May/23 had respiratory symptoms and resulted positive for Covid infection, had ESI on 7/2022 with some resolution of sciatica and leg pain then worsening of weakness with bilateral legs giving out 7/22/22 needing assistive device for ambulation and he was admitted at hospital on 7/25/2022 with worsening of his radicular pain and myelopathy, and he was admitted for NS eval: had L2-L4 laminectomy complicated by epidural hematoma requiring evac on POD#1, discharged after 8 days to rehab to continue with aggressive physical therapy, 1 week later He was readmitted to hospital due hypotension and found extensive bilateral DVT, and severe dysphagia requiring EGD showing esophagitis with pathology resulted mild chronic gastritic with reactive appearing changes, mild reflux changes and erosion with chronic inflammation, stayed for 8 days and he is currently in a rehab facility but cognitive status still impaired.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Sciatica, Sepsis, Skin laceration, Spinal epidural haematoma
Clinical narrative: Pt with history of 3 Covid vaccine first and second dose Moderna on 02/03/2021 and 03/08/2021, third dose Pfizer on 01/07/2022. After second dose of Moderna Covid vaccine Pt had frequent UTIs admitted in the hospital for urosepsis with E Coli and epididymitis on 06/21/2021, 2 months later after Pfizer booster vaccine Pt had an episode of Bursitis of right shoulder, and 3 months after vaccination he had an episode of syncope fall with laceration on the left eyebrow and bruise on the left forehead and he was admitted at hospital for 2 days for observation for UTI/pyelonephritis r/o for sepsis and had acute on CKD, was on cefepime and vanco and d/c on cefdinir for 10 days course. the following month on 05/04 had bursitis of left hip with steroid shot, on May/23 had respiratory symptoms and resulted positive for Covid infection, had ESI on 7/2022 with some resolution of sciatica and leg pain then worsening of weakness with bilateral legs giving out 7/22/22 needing assistive device for ambulation and he was admitted at hospital on 7/25/2022 with worsening of his radicular pain and myelopathy, and he was admitted for NS eval: had L2-L4 laminectomy complicated by epidural hematoma requiring evac on POD#1, discharged after 8 days to rehab to continue with aggressive physical therapy, 1 week later He was readmitted to hospital due hypotension and found extensive bilateral DVT, and severe dysphagia requiring EGD showing esophagitis with pathology resulted mild chronic gastritic with reactive appearing changes, mild reflux changes and erosion with chronic inflammation, stayed for 8 days and he is currently in a rehab facility but cognitive status still impaired.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Spinal laminectomy, Syncope, Ultrasound Doppler abnormal, Ultrasound scan abnormal, Urinary tract infection
Clinical narrative: Pt with history of 3 Covid vaccine first and second dose Moderna on 02/03/2021 and 03/08/2021, third dose Pfizer on 01/07/2022. After second dose of Moderna Covid vaccine Pt had frequent UTIs admitted in the hospital for urosepsis with E Coli and epididymitis on 06/21/2021, 2 months later after Pfizer booster vaccine Pt had an episode of Bursitis of right shoulder, and 3 months after vaccination he had an episode of syncope fall with laceration on the left eyebrow and bruise on the left forehead and he was admitted at hospital for 2 days for observation for UTI/pyelonephritis r/o for sepsis and had acute on CKD, was on cefepime and vanco and d/c on cefdinir for 10 days course. the following month on 05/04 had bursitis of left hip with steroid shot, on May/23 had respiratory symptoms and resulted positive for Covid infection, had ESI on 7/2022 with some resolution of sciatica and leg pain then worsening of weakness with bilateral legs giving out 7/22/22 needing assistive device for ambulation and he was admitted at hospital on 7/25/2022 with worsening of his radicular pain and myelopathy, and he was admitted for NS eval: had L2-L4 laminectomy complicated by epidural hematoma requiring evac on POD#1, discharged after 8 days to rehab to continue with aggressive physical therapy, 1 week later He was readmitted to hospital due hypotension and found extensive bilateral DVT, and severe dysphagia requiring EGD showing esophagitis with pathology resulted mild chronic gastritic with reactive appearing changes, mild reflux changes and erosion with chronic inflammation, stayed for 8 days and he is currently in a rehab facility but cognitive status still impaired.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urosepsis
Clinical narrative: Pt with history of 3 Covid vaccine first and second dose Moderna on 02/03/2021 and 03/08/2021, third dose Pfizer on 01/07/2022. After second dose of Moderna Covid vaccine Pt had frequent UTIs admitted in the hospital for urosepsis with E Coli and epididymitis on 06/21/2021, 2 months later after Pfizer booster vaccine Pt had an episode of Bursitis of right shoulder, and 3 months after vaccination he had an episode of syncope fall with laceration on the left eyebrow and bruise on the left forehead and he was admitted at hospital for 2 days for observation for UTI/pyelonephritis r/o for sepsis and had acute on CKD, was on cefepime and vanco and d/c on cefdinir for 10 days course. the following month on 05/04 had bursitis of left hip with steroid shot, on May/23 had respiratory symptoms and resulted positive for Covid infection, had ESI on 7/2022 with some resolution of sciatica and leg pain then worsening of weakness with bilateral legs giving out 7/22/22 needing assistive device for ambulation and he was admitted at hospital on 7/25/2022 with worsening of his radicular pain and myelopathy, and he was admitted for NS eval: had L2-L4 laminectomy complicated by epidural hematoma requiring evac on POD#1, discharged after 8 days to rehab to continue with aggressive physical therapy, 1 week later He was readmitted to hospital due hypotension and found extensive bilateral DVT, and severe dysphagia requiring EGD showing esophagitis with pathology resulted mild chronic gastritic with reactive appearing changes, mild reflux changes and erosion with chronic inflammation, stayed for 8 days and he is currently in a rehab facility but cognitive status still impaired.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Decreased appetite, Infant irritability, Pyrexia, Rash
Clinical narrative: fever of 103 within 24 hours, fine rash that started on head and spread over torso over 24 hours. More fussy. Decrease in appetite
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Decreased appetite, Irritability, Rash
Clinical narrative: fever of 103 within 24 hours, fine rash that started on head and spread over torso over 24 hours. More fussy. Decrease in appetite
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus- both ears  high pitched hissing sound
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Death, Dementia, Urinary tract infection
Clinical narrative: Patient had 4 Pfizer Covid vaccine with health decline after each one. Had dementia, urinary track infection, stroke and then death. Patient had Pfizer Covid vaccine on 12/29/2020 and 1/19/2021 followed with declining cognitive status with MOCA score 16/20, followed with worsening of depressed mood on antidepressants with no improvement. Then she had UTI on 04/01/2021. She had Pfizer Covid vaccine on 9/28/21 and influenza Vaccine on 10/10/21, followed by worsening of cognitive decline. Patient can not perform serial 7s (counting backwards from 100), can only calculate to number 93. Brain MRI showed progressive atrophy and micro-vascular changes on 11/16/2021. Then on 12/23/21 nurse reports that pt took a turn for the worse and can not remember any names. Admitted to hospital from 4//11/22 to 4/13/22 for UTI, AKI, diarrhea. Emergency room visit on 4/19/22 for UTI. Then had 4th Pfizer Covid vacc on 4/21/22. Patient passed away on 4/30/22 from stroke.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis
Clinical narrative: Pt had covid RNA gene therapy in April 2021 and 12/21; first J&J then Moderna.. After first vaccine had a colitis flare treated with steroids and mesalamine.
Age: 0.08
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: administer monovalet moderna covid 19 booster vaccine  on 09/02/22 to- patient  and on 09/06/2022  monovalent moderna covid 19 vaccine administered to two other patients  Toatal 3 people got Monovalet moderna covid 19 vaccine after 08/31/2022
Age: 0.75
Sex: M
Vaccine: COVID19, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This 9 month old patient was given covid 12+, waited for 45 minutes no adverse reaction noted/observed. Parent notified, manufacturer notified, physician notified
Age: 63.0
Sex: M
Vaccine: YF
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: 4/19/23 8:25 AM Incoming call from patient, he states he is have sx of fever (103T), chills, head ache, increased HR (107bpm), body aches, fatigue, diarrhea ( last bm was yesterday and looste). Denies n/v, SOB, or chest pain. Patient is calling his PCP for appointment. Advised per RN, for patient to see PCP today and to let us know what his doctor says and we will follow up  Prn. Patient was administered YF vax  4/7/2023 and called initially with sx on 4/14/2023, with todays follow up of sx as mentioned above.  4/19/23 9:12 AM Outgoing caall to patient, to follow up on appointment status with PCP. Patient state he has appointment with PCP at 2pm today 4/19/2023. Advised patitient I will follow up with him at 3;30pm today.  4/19/23 3:00 PM no answer , left voicemail  4/19/23 3:43 PM outgoing vall at 3pm to follow up, no answer, left voicemail for patient to call back. Called again 3:40 PM.04/19/23- no answer, left voicemail for pt to call back for follow up post PCP visit. Left call back number.  4/19/23 4:04 PM At 3:49pm 04/19/23, incoming call from patient, he states he saw his PCP, states labs were ordered , UA done patient states he was assessed and Dr believes he was having reaction to YF vax and "not worried about it" ( the sx), states he was given RX for steroids, states he will start today. Patient states he is taking both tylenol and Aleve for fever. Advised  patient to call back prn and that I will be following up with him everyday until labs resulted.  04/20/23 3:52 PM Outgoing call to patient, he states he feeling better, no fever, currently taking steroid rx from PCP . States he has h/a when coughing and continued fatigue. Patient states he is flying out of town ( unk destination). Advised him that either I or RN will be available for follow up. Understanding verbalized. No further questions or concerns at this time. Call terminated.  4/27/23 7:46 AM Outgoing call , spoke with patient, he states he saw his PCP yesterday as he is continuing to have a 10-102 fever, body aces and chills; denies any upper respiratory involvement. He states his pcp advised him antipyretic use prn. He is waiting results of more lab work.  No records received yet from pcp.  5/2/23 3:54 PM Incoming email from paitent "I wanted to let you know that I am still very sick and will be canceling my trip. It is possible I will need something from you for my insurance claim - I will let you know. This is a doozy. Please do warn your over 60+ patients about my experience. Have you reported everything you needed to the CDC? If someone there is available to talk to me, that would be great."  Outgoing call, no answer, left vm for pt to call back.
Age: 63.0
Sex: M
Vaccine: YF
Symptoms: Heart rate increased, Immunisation reaction, Laboratory test, Loss of personal independence in daily activities, Malaise
Clinical narrative: 4/19/23 8:25 AM Incoming call from patient, he states he is have sx of fever (103T), chills, head ache, increased HR (107bpm), body aches, fatigue, diarrhea ( last bm was yesterday and looste). Denies n/v, SOB, or chest pain. Patient is calling his PCP for appointment. Advised per RN, for patient to see PCP today and to let us know what his doctor says and we will follow up  Prn. Patient was administered YF vax  4/7/2023 and called initially with sx on 4/14/2023, with todays follow up of sx as mentioned above.  4/19/23 9:12 AM Outgoing caall to patient, to follow up on appointment status with PCP. Patient state he has appointment with PCP at 2pm today 4/19/2023. Advised patitient I will follow up with him at 3;30pm today.  4/19/23 3:00 PM no answer , left voicemail  4/19/23 3:43 PM outgoing vall at 3pm to follow up, no answer, left voicemail for patient to call back. Called again 3:40 PM.04/19/23- no answer, left voicemail for pt to call back for follow up post PCP visit. Left call back number.  4/19/23 4:04 PM At 3:49pm 04/19/23, incoming call from patient, he states he saw his PCP, states labs were ordered , UA done patient states he was assessed and Dr believes he was having reaction to YF vax and "not worried about it" ( the sx), states he was given RX for steroids, states he will start today. Patient states he is taking both tylenol and Aleve for fever. Advised  patient to call back prn and that I will be following up with him everyday until labs resulted.  04/20/23 3:52 PM Outgoing call to patient, he states he feeling better, no fever, currently taking steroid rx from PCP . States he has h/a when coughing and continued fatigue. Patient states he is flying out of town ( unk destination). Advised him that either I or RN will be available for follow up. Understanding verbalized. No further questions or concerns at this time. Call terminated.  4/27/23 7:46 AM Outgoing call , spoke with patient, he states he saw his PCP yesterday as he is continuing to have a 10-102 fever, body aces and chills; denies any upper respiratory involvement. He states his pcp advised him antipyretic use prn. He is waiting results of more lab work.  No records received yet from pcp.  5/2/23 3:54 PM Incoming email from paitent "I wanted to let you know that I am still very sick and will be canceling my trip. It is possible I will need something from you for my insurance claim - I will let you know. This is a doozy. Please do warn your over 60+ patients about my experience. Have you reported everything you needed to the CDC? If someone there is available to talk to me, that would be great."  Outgoing call, no answer, left vm for pt to call back.
Age: 63.0
Sex: M
Vaccine: YF
Symptoms: Pain, Pyrexia, Urine analysis
Clinical narrative: 4/19/23 8:25 AM Incoming call from patient, he states he is have sx of fever (103T), chills, head ache, increased HR (107bpm), body aches, fatigue, diarrhea ( last bm was yesterday and looste). Denies n/v, SOB, or chest pain. Patient is calling his PCP for appointment. Advised per RN, for patient to see PCP today and to let us know what his doctor says and we will follow up  Prn. Patient was administered YF vax  4/7/2023 and called initially with sx on 4/14/2023, with todays follow up of sx as mentioned above.  4/19/23 9:12 AM Outgoing caall to patient, to follow up on appointment status with PCP. Patient state he has appointment with PCP at 2pm today 4/19/2023. Advised patitient I will follow up with him at 3;30pm today.  4/19/23 3:00 PM no answer , left voicemail  4/19/23 3:43 PM outgoing vall at 3pm to follow up, no answer, left voicemail for patient to call back. Called again 3:40 PM.04/19/23- no answer, left voicemail for pt to call back for follow up post PCP visit. Left call back number.  4/19/23 4:04 PM At 3:49pm 04/19/23, incoming call from patient, he states he saw his PCP, states labs were ordered , UA done patient states he was assessed and Dr believes he was having reaction to YF vax and "not worried about it" ( the sx), states he was given RX for steroids, states he will start today. Patient states he is taking both tylenol and Aleve for fever. Advised  patient to call back prn and that I will be following up with him everyday until labs resulted.  04/20/23 3:52 PM Outgoing call to patient, he states he feeling better, no fever, currently taking steroid rx from PCP . States he has h/a when coughing and continued fatigue. Patient states he is flying out of town ( unk destination). Advised him that either I or RN will be available for follow up. Understanding verbalized. No further questions or concerns at this time. Call terminated.  4/27/23 7:46 AM Outgoing call , spoke with patient, he states he saw his PCP yesterday as he is continuing to have a 10-102 fever, body aces and chills; denies any upper respiratory involvement. He states his pcp advised him antipyretic use prn. He is waiting results of more lab work.  No records received yet from pcp.  5/2/23 3:54 PM Incoming email from paitent "I wanted to let you know that I am still very sick and will be canceling my trip. It is possible I will need something from you for my insurance claim - I will let you know. This is a doozy. Please do warn your over 60+ patients about my experience. Have you reported everything you needed to the CDC? If someone there is available to talk to me, that would be great."  Outgoing call, no answer, left vm for pt to call back.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swelling in left arm, getting bigger; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2022, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 1 day after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swelling in left arm, getting bigger). The outcome of the swelling arm was not resolved.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.     It was unknown if the company considered the swelling arm to be related to Shingrix.   Additional Information: GSK receipt date: 01-May-2023 This case was self reported by the patient. The patient received first dose of Shingrix in March 2022. The patient stated that a day after receiving the vaccine had swelling in left arm, which was the same arm were received vaccine.  The swelling had not resolved in over a year and it was getting bigger.  The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria began on wrists and forearms/ Urticaria continued to develop over entire body except for face and bottom feet.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04May2023 at 10:00 as dose 6 (booster), single (Lot number: GL0447) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Oysters" (ongoing); "Known allergies: Bee stings" (ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone"; Doxycycline, reaction(s): "Known allergies: Oxycodone". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for COVID-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN, (1st Covid bivalent)), for COVID-19 immunization. The following information was reported: URTICARIA (medically significant) with onset 04May2023 at 22:00, outcome "recovering", described as "Urticaria began on wrists and forearms/ Urticaria continued to develop over entire body except for face and bottom feet.". The events "urticaria began on wrists and forearms/ urticaria continued to develop over entire body except for face and bottom feet" required emergency room visit. Therapeutic measures were taken as a result of urticaria.  Clinical course: It was reported that 2nd Covid Bivalent Booster was received at 10 a.m. By 10 p.m, urticaria began on wrists and forearms. Began taking diphenhydramine per package directions at 12 p.m. the following day. Urticaria continued to develop over the entire body except for face and bottom feet. Was driven to local Urgent Care unit. Patient was taken to emergency room. The treatment for the adverse event was methylprednisolone (SOLU-Medrol (PF) shot. There was no covid prior vaccination and covid was not tested post vaccination.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Breast pain, Pain in extremity, Paraesthesia
Clinical narrative: I got the shot on Friday on my left arm/shoulder. By Sat my lymph nodes in my arm pit and on the side of my breast (left side) began to swell. It got more swollen on Sunday and Monday. By Monday night a vein in my left arm began tingling and the muscle between my thumb and index finger  (left hand) began bothering me. Also spots on the under side of my left arm (above the elbow) became sensitive.  The side of my breast and the upper part of my arm became more swollen as my lymph nodes swelled up. Currently (05/10/2023) I am less swollen and not as sensitive.  Side note-I am not sure which version of the Tdap shot I received.  So please call the doctor to ask.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Breast swelling, Injection site warmth, Lymphadenopathy, Muscle discomfort, Paraesthesia
Clinical narrative: I got the shot on Friday on my left arm/shoulder. By Sat my lymph nodes in my arm pit and on the side of my breast (left side) began to swell. It got more swollen on Sunday and Monday. By Monday night a vein in my left arm began tingling and the muscle between my thumb and index finger  (left hand) began bothering me. Also spots on the under side of my left arm (above the elbow) became sensitive.  The side of my breast and the upper part of my arm became more swollen as my lymph nodes swelled up. Currently (05/10/2023) I am less swollen and not as sensitive.  Side note-I am not sure which version of the Tdap shot I received.  So please call the doctor to ask.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Sensitive skin
Clinical narrative: I got the shot on Friday on my left arm/shoulder. By Sat my lymph nodes in my arm pit and on the side of my breast (left side) began to swell. It got more swollen on Sunday and Monday. By Monday night a vein in my left arm began tingling and the muscle between my thumb and index finger  (left hand) began bothering me. Also spots on the under side of my left arm (above the elbow) became sensitive.  The side of my breast and the upper part of my arm became more swollen as my lymph nodes swelled up. Currently (05/10/2023) I am less swollen and not as sensitive.  Side note-I am not sure which version of the Tdap shot I received.  So please call the doctor to ask.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; PROQUAD was administered  during a temperature excursion.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-APR-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter, lot #W038815, expiration date: 04-JUN-2024, administered as prophylaxis (strength, and route of administration were not provided), during a temperature excursion at a temperature of 5.5 Celsius degrees that lasted for 60 hours (product storage error). No additional adverse events or previous temperature excursion were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Office manager informed T/E and also administered vaccine ROTATEQ. T/E CASE 02379617. No additional AE/PQC.  ROTATEQ: lOT NUMBER : I879870  exp DATE: 10/15/2023 TIME: 8 Hours 25 Minutes 0 Seconds TEMPERATURE: BELOW 36°F (24.0F) for 2 hours 58 minute; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 18-APR-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (dose not reported) lot number reported as I879870 and expiration date 15-OCT-2023, but upon internal validation was confirmed as 1879870, expiration date 16-OCT-2023 oral for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion was of 24 degrees Fahrenheit (°F) for 2 hours and 58 minutes, -40°F for 1 hour and 47 minutes, 16°F for 1 hour and 40 minutes and 17.6°F for 30 minutes. No other excursions were detected.; Sender's Comments:  US-009507513-2305USA000768:02380645
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Vaccine that expired in 2023 was administered on 01-MAY-2023; Provider calling to report a temperature excursion. Product administered to 1 patient. No additional AEs. No PQCs.    ?    Names of vaccines involved (including lot/exp) VARIVAX W031816 10/05/2024        ?    Temperature: 45.03F        ? ; This spontaneous report was received from a provider referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 01-MAY-2023, the patient was vaccinated with an improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose not reported) oral, lot number W031816, expiration date reported as 05-OCT-2024, but upon internal validation was confirmed as 16-NOV-2022 (expired product administered) for prophylaxis. No adverse event was reported.  The excursion of the vaccine was of 45.03 degrees Fahrenheit for 1 hour and 20 minutes. No other excursions were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received the first two doses of GARDASIL-9, and was late for the 3rd dose.; Caller was advised of indication up to 45 years of age; No additional AE/PQC; This spontaneous report was received from a nurse concerning a 50-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.   On unknown dates, the patient was vaccinated with the first and second doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, for prophylaxis (dose, route of administration, injection anatomical location, lot # and expiration date were not reported) (Product administered to patient of inappropriate age).  The patient was supposed to receive the 3rd dose in July 2022, but at the time of the report she had not received it yet (Inappropriate schedule of product administration). No additional adverse events or product quality complaints were reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional ae; VARIVAX was administered following temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 01-MAY-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #W031815, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse events reported.  The vaccine was stored in a temperature of 9 degree Fahrenheit (°F) for 2 hours and 6 minutes. There was no previous temperature excursion reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional ae; VARIVAX was administered following temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 03-MAY-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #W031815, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  The vaccine was stored in a temperature of 9 degree Fahrenheit (°F) for 2 hours and 6 minutes. There was no previous temperature excursion reported.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22-APR-2023) for prophylaxis.   On 01-MAY-2023, the patient received Boostrix. On 01-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 01-MAY-2023 The reporter was practice manager. The reporter reported that the patient received an expired dose of Boostrix at the time of reporting No symptoms were reported.  The vaccine administration facility was same as the primary reporter.  The healthcare professional (HCP) did not have any patient details.  The reporter consented to follow up via email. The patient received an expired dose of Boostrix, which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: didnt receive the second dose/ a second dose has not been administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAV (Havrix) for prophylaxis.  Previously administered products included Havrix (she received the 1st dose of Havrix on 17 June 2017 with lot number 5D952).  On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: didnt receive the second dose/ a second dose has not been administered). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK receipt date: 01-MAY-2023 Pharmacist was the reporter, as well as the patient. She reported that, she had received a dose of Havrix and did not receive the second dose. At the time of reporting, a second dose has not been administered. The reporter had consented to follow up. The reported corresponded to the 1st dose. Until the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired Hiberix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received Hib (Hiberix) (batch number cH392, expiry date 22-MAR-2023) for prophylaxis.   On 03-MAY-2023, the patient received Hiberix. On 03-MAY-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired Hiberix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 03-MAY-2023 The medical assistant reported that two patients (twins) were administered an expired dose of Hiberix. The reporter declined to follow up. The patient received an expired dose of Havirx, which led to expired vaccine used. This case was linked with case US2023064471, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023064471:Same reporter (female patient)
Age: 89.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient had received a 3rd dose; 1st dose Oct2020, 2nd dose Sep2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number 477X5, expiry date 27-MAY-2024) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose had been administered in October 2020).  On 01-MAY-2023, the patient received the 3rd dose of Shingrix. In SEP-2021, the patient received the 2nd dose of Shingrix. In SEP-2021, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Oct2020, 2nd dose Sep2021). On 01-MAY-2023, the patient experienced extra dose administered (Verbatim: Patient had received a 3rd dose). The outcome of the extra dose administered and drug dose administration interval too long were unknown.  Additional Information: GSK Receipt Date: 03-MAY-2023 A pharmacist called to inform that a patient had received a third dose of Shingrix. According to the reporter, the patient had already received two doses of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. At the time of reporting, the patient had received the third dose of Shingrix vaccine, which had led to extra dose administered. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: has not yet received their second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (received first dose of Shingrix in October 2021).  On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received their second dose). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 03-MAY-2023 Pharmacy technician reported that, the patient received first dose of Shingrix in October 2021 and had not yet received their second dose. No additional adverse event (AE) details available at this time per Healthcare Professional (HCP). The vaccine administration facility was the same as primary reporter. VAERS details provided for 1st dose. The reporter had consented to follow-up. Until the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (2 years ago received 1st dose.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2 years ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 The patient received 1st dose 2 years ago, not able to remember the date and did not think that ever got a second shot. The patient did not have any further information about his first Shingrix dose. No further information was provided for second dose. The reporter consented to follow up with the health care professionals. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 08-APR-2023) for prophylaxis.   Previously administered products included Kinrix (has had previous dose of Kinrix ).   On 04-MAY-2023, the patient received Pediarix. On 04-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Pediarix administered). The outcome of the expired vaccine used 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: 04-MAY-2023 The nurse reported that the patient received Pediarix vaccine, which was expired on April 08, 2023. The reported that the patient was being caught up on vaccines and has had received previous dose of Kinrix. The vaccine administration facility was same as primary reporter. Patient received a dose of Pediarix on May 04, 2023 which was expired on April 08, 2023, which led to expired vaccine used. The reporter consented to follow up.