chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Escherichia infection, Escherichia test positive, Magnetic resonance imaging abdominal, Magnetic resonance imaging abnormal
Clinical narrative: Cycstitis Date of Admission: 7/16/2024, Date of Discharge: 7/20/2024 Subject enrolled in the Janssen study received first dose of study medicatoin (Janssen ad26.CoV2.vaccine) on 8/29/2023 in Segment 1 low responder arm. Subject recently admitted 6/24-6/28 due to transplant pyelonephritis due to MDR. E. Coli, ID was consulted and it was recommended he be treated with 14 days of Ertapenem, which he completed on 7/8/24. A discussion was had about possible prophylactic antibiotics due to recurrent infections but it was not recommended at that time. He presented to Clinic ED on 7/16/24 with complaints of cloudy urine, dysuria, frequency, and urgency. Fever at home of 100.9F. In the ED, vitals were stabe. WBC 11.2. Lactate 0.73. Cr 3.39 (baseline 2.8-3.2). UA grossly abnormal. CXR negative. Renal US unremarkable. He received IV ertapenem and was admitted for further evaluation and treatment. Upon admission, ertapenem was continued. No changes were made to his immunosuppression regimen. Infectious disease was consulted; CT a/p and MR abd were completed to rule out abscess and/or infected stone. Transplant Nephrology was consulted for immunosuppression management. CT a/p showed fat stranding around RLQ renal allograft, slightly increased from prior on 6/14; mild perivesical fat stranding. 7/17 MR Pelvis -- Changes of acute pyelonephritis of the renal allograft; no evidence of renal or perinephric abscess. Multifocal small papillary lesions in the bladder with diffusion restriction, consistent with the patient's known bladder cancer Blood culture returned showing 1/2 positive for ESBL EColi. Infectious disease recommended Continue ertapenem x 4 weeks, renal equivalent of 1g q24h. ? Abx completion date expected 8/13. ? Recommend outpatient urology assessment of urodynamic studies Patient discharged 7/20/2024. Discharge diagnosis is Cystitis Study Prinicipal investigator has assessed the causality as not study related.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging pelvic, Micturition urgency, Multiple-drug resistance, Pollakiuria, Pyelonephritis
Clinical narrative: Cycstitis Date of Admission: 7/16/2024, Date of Discharge: 7/20/2024 Subject enrolled in the Janssen study received first dose of study medicatoin (Janssen ad26.CoV2.vaccine) on 8/29/2023 in Segment 1 low responder arm. Subject recently admitted 6/24-6/28 due to transplant pyelonephritis due to MDR. E. Coli, ID was consulted and it was recommended he be treated with 14 days of Ertapenem, which he completed on 7/8/24. A discussion was had about possible prophylactic antibiotics due to recurrent infections but it was not recommended at that time. He presented to Clinic ED on 7/16/24 with complaints of cloudy urine, dysuria, frequency, and urgency. Fever at home of 100.9F. In the ED, vitals were stabe. WBC 11.2. Lactate 0.73. Cr 3.39 (baseline 2.8-3.2). UA grossly abnormal. CXR negative. Renal US unremarkable. He received IV ertapenem and was admitted for further evaluation and treatment. Upon admission, ertapenem was continued. No changes were made to his immunosuppression regimen. Infectious disease was consulted; CT a/p and MR abd were completed to rule out abscess and/or infected stone. Transplant Nephrology was consulted for immunosuppression management. CT a/p showed fat stranding around RLQ renal allograft, slightly increased from prior on 6/14; mild perivesical fat stranding. 7/17 MR Pelvis -- Changes of acute pyelonephritis of the renal allograft; no evidence of renal or perinephric abscess. Multifocal small papillary lesions in the bladder with diffusion restriction, consistent with the patient's known bladder cancer Blood culture returned showing 1/2 positive for ESBL EColi. Infectious disease recommended Continue ertapenem x 4 weeks, renal equivalent of 1g q24h. ? Abx completion date expected 8/13. ? Recommend outpatient urology assessment of urodynamic studies Patient discharged 7/20/2024. Discharge diagnosis is Cystitis Study Prinicipal investigator has assessed the causality as not study related.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Renal disorder, Ultrasound kidney normal, Urine abnormality, Urine analysis abnormal
Clinical narrative: Cycstitis Date of Admission: 7/16/2024, Date of Discharge: 7/20/2024 Subject enrolled in the Janssen study received first dose of study medicatoin (Janssen ad26.CoV2.vaccine) on 8/29/2023 in Segment 1 low responder arm. Subject recently admitted 6/24-6/28 due to transplant pyelonephritis due to MDR. E. Coli, ID was consulted and it was recommended he be treated with 14 days of Ertapenem, which he completed on 7/8/24. A discussion was had about possible prophylactic antibiotics due to recurrent infections but it was not recommended at that time. He presented to Clinic ED on 7/16/24 with complaints of cloudy urine, dysuria, frequency, and urgency. Fever at home of 100.9F. In the ED, vitals were stabe. WBC 11.2. Lactate 0.73. Cr 3.39 (baseline 2.8-3.2). UA grossly abnormal. CXR negative. Renal US unremarkable. He received IV ertapenem and was admitted for further evaluation and treatment. Upon admission, ertapenem was continued. No changes were made to his immunosuppression regimen. Infectious disease was consulted; CT a/p and MR abd were completed to rule out abscess and/or infected stone. Transplant Nephrology was consulted for immunosuppression management. CT a/p showed fat stranding around RLQ renal allograft, slightly increased from prior on 6/14; mild perivesical fat stranding. 7/17 MR Pelvis -- Changes of acute pyelonephritis of the renal allograft; no evidence of renal or perinephric abscess. Multifocal small papillary lesions in the bladder with diffusion restriction, consistent with the patient's known bladder cancer Blood culture returned showing 1/2 positive for ESBL EColi. Infectious disease recommended Continue ertapenem x 4 weeks, renal equivalent of 1g q24h. ? Abx completion date expected 8/13. ? Recommend outpatient urology assessment of urodynamic studies Patient discharged 7/20/2024. Discharge diagnosis is Cystitis Study Prinicipal investigator has assessed the causality as not study related.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Cycstitis Date of Admission: 7/16/2024, Date of Discharge: 7/20/2024 Subject enrolled in the Janssen study received first dose of study medicatoin (Janssen ad26.CoV2.vaccine) on 8/29/2023 in Segment 1 low responder arm. Subject recently admitted 6/24-6/28 due to transplant pyelonephritis due to MDR. E. Coli, ID was consulted and it was recommended he be treated with 14 days of Ertapenem, which he completed on 7/8/24. A discussion was had about possible prophylactic antibiotics due to recurrent infections but it was not recommended at that time. He presented to Clinic ED on 7/16/24 with complaints of cloudy urine, dysuria, frequency, and urgency. Fever at home of 100.9F. In the ED, vitals were stabe. WBC 11.2. Lactate 0.73. Cr 3.39 (baseline 2.8-3.2). UA grossly abnormal. CXR negative. Renal US unremarkable. He received IV ertapenem and was admitted for further evaluation and treatment. Upon admission, ertapenem was continued. No changes were made to his immunosuppression regimen. Infectious disease was consulted; CT a/p and MR abd were completed to rule out abscess and/or infected stone. Transplant Nephrology was consulted for immunosuppression management. CT a/p showed fat stranding around RLQ renal allograft, slightly increased from prior on 6/14; mild perivesical fat stranding. 7/17 MR Pelvis -- Changes of acute pyelonephritis of the renal allograft; no evidence of renal or perinephric abscess. Multifocal small papillary lesions in the bladder with diffusion restriction, consistent with the patient's known bladder cancer Blood culture returned showing 1/2 positive for ESBL EColi. Infectious disease recommended Continue ertapenem x 4 weeks, renal equivalent of 1g q24h. ? Abx completion date expected 8/13. ? Recommend outpatient urology assessment of urodynamic studies Patient discharged 7/20/2024. Discharge diagnosis is Cystitis Study Prinicipal investigator has assessed the causality as not study related.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Bladder cancer, Blood bicarbonate decreased, Blood creatinine increased, Blood pressure decreased
Clinical narrative: Sepsis Date of Admission: 12/22/2023, Date of Discharge: 12/31/2024 Subject enrolled in the Janssen study received first dose of study medication (Janssen ad26.CoV2. vaccine) on 8/29/2023 in Segment 1 low responder arm. Patient was recently diagnosed with bladder cancer has been followed by Urology and status post PCG x1 on 12/20/23 presented to ER on 12/22/2023 with complaints of fever, T-max 103.1, associated with rigors, nausea without vomiting or diarrhea or abdominal pain. Patient also denied cough, shortness of breath, chest pain, dysuria. was febrile to 39.1. Lab work was remarkable for leukocytosis to 11, creatinine of 4.3 (baseline roughly 2.0). Chest x-ray was unremarkable. 12/23/2023 patient demonstrative of large leukocyte esterase and pyuria. tachycardia 120s with soft blood pressure at 110/70. Patient had borderline leukocytosis at 11 with left shift and was found to have acute kidney injury with a creatinine of 4.3 and mild metabolic acidosis with bicarbonate at 17. Urinalysis showed multiple leukocyte esterase and severe leukocyturia. Patient received CT scan of the abdomen pelvis that showed stranding surrounding the transplant kidney with findings suggesting transplant pyelonephritis. Patient was started on cefepime and was admitted for further evaluation. 12/27/2023. Found to have E. Coli bacteremia and transplant pyelonephritis. Infectious Disease team following - patient on ertapenem and daptomycin. Urology engaged, recommended foley placement, no surgical intervention. Acute kidney injury with creatinine of 5.84, sodium bicarbonate increased to 1,300 mg TID. 12/31/2023. Patient condition improved unfortunately also developed AKI AKIN III transplant kidney. Transplant Nephrology was consulted and followed during hospitalization. Fortunately, did not require dialysis and had improvement of renal function with treatment of underlying infection. AKI is likely due to hypoperfusion, ATN inactive infection of transplant kidney. Transplant Nephrology assisted with acid-base management in addition to immunosuppression during his hospitlization Regarding pyelonephritis of transplant kidney infectious disease was consulted and recommended 2 weeks of IV antimicrobial therapy in the form of renally adjusted ertapenem and daptomycin to continue post hospitalization. Patient discharged 12/31/2024. Discharge diagnosis is Sepsis. Study Principal investigator has assessed the causality as not study related.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chills, Computerised tomogram abdomen abnormal, Escherichia bacteraemia, Leukocytosis
Clinical narrative: Sepsis Date of Admission: 12/22/2023, Date of Discharge: 12/31/2024 Subject enrolled in the Janssen study received first dose of study medication (Janssen ad26.CoV2. vaccine) on 8/29/2023 in Segment 1 low responder arm. Patient was recently diagnosed with bladder cancer has been followed by Urology and status post PCG x1 on 12/20/23 presented to ER on 12/22/2023 with complaints of fever, T-max 103.1, associated with rigors, nausea without vomiting or diarrhea or abdominal pain. Patient also denied cough, shortness of breath, chest pain, dysuria. was febrile to 39.1. Lab work was remarkable for leukocytosis to 11, creatinine of 4.3 (baseline roughly 2.0). Chest x-ray was unremarkable. 12/23/2023 patient demonstrative of large leukocyte esterase and pyuria. tachycardia 120s with soft blood pressure at 110/70. Patient had borderline leukocytosis at 11 with left shift and was found to have acute kidney injury with a creatinine of 4.3 and mild metabolic acidosis with bicarbonate at 17. Urinalysis showed multiple leukocyte esterase and severe leukocyturia. Patient received CT scan of the abdomen pelvis that showed stranding surrounding the transplant kidney with findings suggesting transplant pyelonephritis. Patient was started on cefepime and was admitted for further evaluation. 12/27/2023. Found to have E. Coli bacteremia and transplant pyelonephritis. Infectious Disease team following - patient on ertapenem and daptomycin. Urology engaged, recommended foley placement, no surgical intervention. Acute kidney injury with creatinine of 5.84, sodium bicarbonate increased to 1,300 mg TID. 12/31/2023. Patient condition improved unfortunately also developed AKI AKIN III transplant kidney. Transplant Nephrology was consulted and followed during hospitalization. Fortunately, did not require dialysis and had improvement of renal function with treatment of underlying infection. AKI is likely due to hypoperfusion, ATN inactive infection of transplant kidney. Transplant Nephrology assisted with acid-base management in addition to immunosuppression during his hospitlization Regarding pyelonephritis of transplant kidney infectious disease was consulted and recommended 2 weeks of IV antimicrobial therapy in the form of renally adjusted ertapenem and daptomycin to continue post hospitalization. Patient discharged 12/31/2024. Discharge diagnosis is Sepsis. Study Principal investigator has assessed the causality as not study related.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Leukocyturia, Metabolic acidosis, Nausea, Pyelonephritis, Pyrexia
Clinical narrative: Sepsis Date of Admission: 12/22/2023, Date of Discharge: 12/31/2024 Subject enrolled in the Janssen study received first dose of study medication (Janssen ad26.CoV2. vaccine) on 8/29/2023 in Segment 1 low responder arm. Patient was recently diagnosed with bladder cancer has been followed by Urology and status post PCG x1 on 12/20/23 presented to ER on 12/22/2023 with complaints of fever, T-max 103.1, associated with rigors, nausea without vomiting or diarrhea or abdominal pain. Patient also denied cough, shortness of breath, chest pain, dysuria. was febrile to 39.1. Lab work was remarkable for leukocytosis to 11, creatinine of 4.3 (baseline roughly 2.0). Chest x-ray was unremarkable. 12/23/2023 patient demonstrative of large leukocyte esterase and pyuria. tachycardia 120s with soft blood pressure at 110/70. Patient had borderline leukocytosis at 11 with left shift and was found to have acute kidney injury with a creatinine of 4.3 and mild metabolic acidosis with bicarbonate at 17. Urinalysis showed multiple leukocyte esterase and severe leukocyturia. Patient received CT scan of the abdomen pelvis that showed stranding surrounding the transplant kidney with findings suggesting transplant pyelonephritis. Patient was started on cefepime and was admitted for further evaluation. 12/27/2023. Found to have E. Coli bacteremia and transplant pyelonephritis. Infectious Disease team following - patient on ertapenem and daptomycin. Urology engaged, recommended foley placement, no surgical intervention. Acute kidney injury with creatinine of 5.84, sodium bicarbonate increased to 1,300 mg TID. 12/31/2023. Patient condition improved unfortunately also developed AKI AKIN III transplant kidney. Transplant Nephrology was consulted and followed during hospitalization. Fortunately, did not require dialysis and had improvement of renal function with treatment of underlying infection. AKI is likely due to hypoperfusion, ATN inactive infection of transplant kidney. Transplant Nephrology assisted with acid-base management in addition to immunosuppression during his hospitlization Regarding pyelonephritis of transplant kidney infectious disease was consulted and recommended 2 weeks of IV antimicrobial therapy in the form of renally adjusted ertapenem and daptomycin to continue post hospitalization. Patient discharged 12/31/2024. Discharge diagnosis is Sepsis. Study Principal investigator has assessed the causality as not study related.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyuria, Renal ischaemia, Renal tubular necrosis, Sepsis, Tachycardia
Clinical narrative: Sepsis Date of Admission: 12/22/2023, Date of Discharge: 12/31/2024 Subject enrolled in the Janssen study received first dose of study medication (Janssen ad26.CoV2. vaccine) on 8/29/2023 in Segment 1 low responder arm. Patient was recently diagnosed with bladder cancer has been followed by Urology and status post PCG x1 on 12/20/23 presented to ER on 12/22/2023 with complaints of fever, T-max 103.1, associated with rigors, nausea without vomiting or diarrhea or abdominal pain. Patient also denied cough, shortness of breath, chest pain, dysuria. was febrile to 39.1. Lab work was remarkable for leukocytosis to 11, creatinine of 4.3 (baseline roughly 2.0). Chest x-ray was unremarkable. 12/23/2023 patient demonstrative of large leukocyte esterase and pyuria. tachycardia 120s with soft blood pressure at 110/70. Patient had borderline leukocytosis at 11 with left shift and was found to have acute kidney injury with a creatinine of 4.3 and mild metabolic acidosis with bicarbonate at 17. Urinalysis showed multiple leukocyte esterase and severe leukocyturia. Patient received CT scan of the abdomen pelvis that showed stranding surrounding the transplant kidney with findings suggesting transplant pyelonephritis. Patient was started on cefepime and was admitted for further evaluation. 12/27/2023. Found to have E. Coli bacteremia and transplant pyelonephritis. Infectious Disease team following - patient on ertapenem and daptomycin. Urology engaged, recommended foley placement, no surgical intervention. Acute kidney injury with creatinine of 5.84, sodium bicarbonate increased to 1,300 mg TID. 12/31/2023. Patient condition improved unfortunately also developed AKI AKIN III transplant kidney. Transplant Nephrology was consulted and followed during hospitalization. Fortunately, did not require dialysis and had improvement of renal function with treatment of underlying infection. AKI is likely due to hypoperfusion, ATN inactive infection of transplant kidney. Transplant Nephrology assisted with acid-base management in addition to immunosuppression during his hospitlization Regarding pyelonephritis of transplant kidney infectious disease was consulted and recommended 2 weeks of IV antimicrobial therapy in the form of renally adjusted ertapenem and daptomycin to continue post hospitalization. Patient discharged 12/31/2024. Discharge diagnosis is Sepsis. Study Principal investigator has assessed the causality as not study related.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased, White blood cells urine positive
Clinical narrative: Sepsis Date of Admission: 12/22/2023, Date of Discharge: 12/31/2024 Subject enrolled in the Janssen study received first dose of study medication (Janssen ad26.CoV2. vaccine) on 8/29/2023 in Segment 1 low responder arm. Patient was recently diagnosed with bladder cancer has been followed by Urology and status post PCG x1 on 12/20/23 presented to ER on 12/22/2023 with complaints of fever, T-max 103.1, associated with rigors, nausea without vomiting or diarrhea or abdominal pain. Patient also denied cough, shortness of breath, chest pain, dysuria. was febrile to 39.1. Lab work was remarkable for leukocytosis to 11, creatinine of 4.3 (baseline roughly 2.0). Chest x-ray was unremarkable. 12/23/2023 patient demonstrative of large leukocyte esterase and pyuria. tachycardia 120s with soft blood pressure at 110/70. Patient had borderline leukocytosis at 11 with left shift and was found to have acute kidney injury with a creatinine of 4.3 and mild metabolic acidosis with bicarbonate at 17. Urinalysis showed multiple leukocyte esterase and severe leukocyturia. Patient received CT scan of the abdomen pelvis that showed stranding surrounding the transplant kidney with findings suggesting transplant pyelonephritis. Patient was started on cefepime and was admitted for further evaluation. 12/27/2023. Found to have E. Coli bacteremia and transplant pyelonephritis. Infectious Disease team following - patient on ertapenem and daptomycin. Urology engaged, recommended foley placement, no surgical intervention. Acute kidney injury with creatinine of 5.84, sodium bicarbonate increased to 1,300 mg TID. 12/31/2023. Patient condition improved unfortunately also developed AKI AKIN III transplant kidney. Transplant Nephrology was consulted and followed during hospitalization. Fortunately, did not require dialysis and had improvement of renal function with treatment of underlying infection. AKI is likely due to hypoperfusion, ATN inactive infection of transplant kidney. Transplant Nephrology assisted with acid-base management in addition to immunosuppression during his hospitlization Regarding pyelonephritis of transplant kidney infectious disease was consulted and recommended 2 weeks of IV antimicrobial therapy in the form of renally adjusted ertapenem and daptomycin to continue post hospitalization. Patient discharged 12/31/2024. Discharge diagnosis is Sepsis. Study Principal investigator has assessed the causality as not study related.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Loss of consciousness, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: She was still breathing but had passed out; Slid down into the chair and became unresponsive to touch; Urinated on her self; This spontaneous case, initially received on 08-Oct-2024, was reported by a health authority, Vaccine Adverse Event Reporting System (VAERS) (Reference number: 2792403-1), and concerns an adolescent female patient.  The patient had previously received Flucelvax on 30-Sep-2022, at the age of 12.  Administration of company suspect drug(s): On 21-Sep-2024, the patient received Flucelvax (TIV) for Indication Not reported, Dose: 0.5 ml, Dose Number: 1 Dose Route of administration: Intramuscular, Site of administration: Left Arm, Lot number: 946611.  Non-company suspect drugs: Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), Indication: COVID-19 immunisation, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatomical site: Left Arm.  Adverse reactions/events and outcomes: On 21-Sep-2024, the patient experienced She was still breathing but had passed out (Medically Significant, outcome: Recovered / Resolved, stop date: 21-Sep-2024), Slid down into the chair and became unresponsive to touch (Medically Significant, outcome: Recovered / Resolved, stop date: 21-Sep-2024), Urinated on her self (outcome: Recovered / Resolved).  The patient received both shots in her left arm. As patient was ready to leave the room, she slid down into the chair and become unresponsive to touch. She was still breathing but had passed out. At this time, her father who was also in the room began to hold her legs up to keep her horizontal and to help her blood return to her head. She came to and also urinated on herself. After 2 minutes she was sitting up by herself and was given a cup Of water to drink, She then was allowed to sit and recuperate with her mother for 10 minutes. Patient was asked if she needed anything but she seemed to be in good spirits,  Flucelvax (TIV) action taken: Not Applicable  Reporters assessment: The reporter considered the events as non-serious and did not provide the causality assessment.  Follow-up (25-Oct-2024) received from Other: Indication was updated to COVID-19 immunisation and dosing details added for for non-company suspect drug Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)). Event stop date added for She was still breathing but had passed out and Slid down into the chair and became unresponsive to touch, Secondary reporter added. Narrative updated.; Reporter's Comments: Causality: Events are considered related to the administration of the vaccine, due to close temporal relationship (the same day of vaccination).
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Muscle spasms, Syncope
Clinical narrative: Fainted; Spasming; This spontaneous case, initially received on 05-Nov-2024, was reported by a health authority Vaccine Adverse Event Reporting System (VAERS) (Reference number:2795326-1) and concerns an adolescent female patient.  Administration of company suspect drugs: On 28-Sep-2024, the patient received Flucelvax (TIV) for influenza immunization, dose 1, Route of administration: Intramuscular in left arm, Lot number: 946611.  Non-company suspect drugs: On 28-Sep-2024, the patient received Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373), influenza Immunization, dose 1, route of administration Intramuscular in left arm. Lot number 6024MF014A.  Adverse reactions/events and outcomes: On 28-Sep-2024, the patient experienced Fainted (Medically Significant, outcome: Unknown), Spasming (outcome: Unknown).  After about 10 minutes from getting vaccine, she was walking out in the store and fainted and was spasming.   Flucelvax (TIV) action taken: Not Applicable  Reporter s assessment The reporter considered events as non-serious, and causality was not provided.  Follow up (22-Nov-2024) received from health professional: Product details updated (indication). Narrative updated accordingly.; Reporter's Comments: Causality: Related for the events considering close temporal relationship (10 minutes after vaccination).
Sex: M
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Bad shingles-like rashes; This non-serious case was reported by a consumer and described the occurrence of vesicular rash in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-SEP-2024, the patient received Shingrix. On 02-OCT-2024, 2 days after receiving Shingrix, the patient experienced vesicular rash (Verbatim: Bad shingles-like rashes). The outcome of the vesicular rash was not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     It was unknown if the company considered the vesicular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-OCT-2024 The patient self-reported this case. The patient reported that no one warned him of the shingles rashes before the vaccine. Further he said that, there was little to no information, even at the CDC (centers for disease control and prevention). The patient experienced bad shingles-like rashes and symptoms were not treated. The patient did not receive other products.
Sex: M
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Bad shingles-like rashes; This non-serious case was reported by a consumer and described the occurrence of vesicular rash in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-SEP-2024, the patient received Shingrix. On 02-OCT-2024, 2 days after receiving Shingrix, the patient experienced vesicular rash (Verbatim: Bad shingles-like rashes). The outcome of the vesicular rash was not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     It was unknown if the company considered the vesicular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-OCT-2024 The patient self-reported this case. The patient reported that no one warned him of the shingles rashes before the vaccine. Further he said that, there was little to no information, even at the CDC (centers for disease control and prevention). The patient experienced bad shingles-like rashes and symptoms were not treated. The patient did not receive other products.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Rash, Urticaria, Vaccine positive rechallenge
Clinical narrative: Patient site of injection had swelling for several days, then after 7 days had hives all over. Patient's allergist was having him take 4 Allegra a day to help with reaction.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Patient site of injection had swelling for several days, then after 7 days had hives all over. Patient's allergist was having him take 4 Allegra a day to help with reaction.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chills, Decreased appetite, Feeling cold, Hallucination
Clinical narrative: he was hospitalized for covid; he was hospitalized for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 5 (booster), single (Lot number: GL0446), in right arm (probably injection in the right arm) and on 19Jul2023 as dose 6 (booster), single (Lot number: GK0928) at the age of 71 years, in left arm (probably injection in the left arm), all parenteral for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9267), in left deltoid (injection in the left or right shoulder), on 08Mar2021 as dose 2, single (Lot number: EN6199), in left deltoid (injection in the left arm/shoulder), on 04Oct2021 as dose 3 (booster), single (Lot number: 301308A), in right arm (injection in the right arm probably) and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm (probably in the left arm), all parenteral for covid-19 immunisation. The patient's relevant medical history included: "Open heart surgery" (unspecified if ongoing), notes: Open heart surgery 30 years ago and said that he was 43 years old; somewhere between 1991-1993. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Dec2023, outcome "unknown" and all described as "he was hospitalized for covid". The patient was hospitalized for drug ineffective, covid-19 (start date: Dec2023, discharge date: 13Dec2023). His pulmonary doctor told him not to have the vaccine anymore. His doctors said that he should not take it if he gets that sick. They told him it was up to him though. He never got covid (prior). He was cautious about going into crowds.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Illness, Insomnia, Magnetic resonance imaging head, Pneumonia
Clinical narrative: he was hospitalized for covid; he was hospitalized for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 5 (booster), single (Lot number: GL0446), in right arm (probably injection in the right arm) and on 19Jul2023 as dose 6 (booster), single (Lot number: GK0928) at the age of 71 years, in left arm (probably injection in the left arm), all parenteral for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9267), in left deltoid (injection in the left or right shoulder), on 08Mar2021 as dose 2, single (Lot number: EN6199), in left deltoid (injection in the left arm/shoulder), on 04Oct2021 as dose 3 (booster), single (Lot number: 301308A), in right arm (injection in the right arm probably) and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm (probably in the left arm), all parenteral for covid-19 immunisation. The patient's relevant medical history included: "Open heart surgery" (unspecified if ongoing), notes: Open heart surgery 30 years ago and said that he was 43 years old; somewhere between 1991-1993. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Dec2023, outcome "unknown" and all described as "he was hospitalized for covid". The patient was hospitalized for drug ineffective, covid-19 (start date: Dec2023, discharge date: 13Dec2023). His pulmonary doctor told him not to have the vaccine anymore. His doctors said that he should not take it if he gets that sick. They told him it was up to him though. He never got covid (prior). He was cautious about going into crowds.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis, Sinus disorder
Clinical narrative: he was hospitalized for covid; he was hospitalized for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 5 (booster), single (Lot number: GL0446), in right arm (probably injection in the right arm) and on 19Jul2023 as dose 6 (booster), single (Lot number: GK0928) at the age of 71 years, in left arm (probably injection in the left arm), all parenteral for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9267), in left deltoid (injection in the left or right shoulder), on 08Mar2021 as dose 2, single (Lot number: EN6199), in left deltoid (injection in the left arm/shoulder), on 04Oct2021 as dose 3 (booster), single (Lot number: 301308A), in right arm (injection in the right arm probably) and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm (probably in the left arm), all parenteral for covid-19 immunisation. The patient's relevant medical history included: "Open heart surgery" (unspecified if ongoing), notes: Open heart surgery 30 years ago and said that he was 43 years old; somewhere between 1991-1993. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Dec2023, outcome "unknown" and all described as "he was hospitalized for covid". The patient was hospitalized for drug ineffective, covid-19 (start date: Dec2023, discharge date: 13Dec2023). His pulmonary doctor told him not to have the vaccine anymore. His doctors said that he should not take it if he gets that sick. They told him it was up to him though. He never got covid (prior). He was cautious about going into crowds.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he was hospitalized for covid; he was hospitalized for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 5 (booster), single (Lot number: GL0446), in right arm (probably injection in the right arm) and on 19Jul2023 as dose 6 (booster), single (Lot number: GK0928) at the age of 71 years, in left arm (probably injection in the left arm), all parenteral for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9267), in left deltoid (injection in the left or right shoulder), on 08Mar2021 as dose 2, single (Lot number: EN6199), in left deltoid (injection in the left arm/shoulder), on 04Oct2021 as dose 3 (booster), single (Lot number: 301308A), in right arm (injection in the right arm probably) and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm (probably in the left arm), all parenteral for covid-19 immunisation. The patient's relevant medical history included: "Open heart surgery" (unspecified if ongoing), notes: Open heart surgery 30 years ago and said that he was 43 years old; somewhere between 1991-1993. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Dec2023, outcome "unknown" and all described as "he was hospitalized for covid". The patient was hospitalized for drug ineffective, covid-19 (start date: Dec2023, discharge date: 13Dec2023). His pulmonary doctor told him not to have the vaccine anymore. His doctors said that he should not take it if he gets that sick. They told him it was up to him though. He never got covid (prior). He was cautious about going into crowds.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported. No additional AE details reported.; Caller reported AE on behalf of a patient who was administered expired MMR-II on 10/22/2024; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-OCT-2024, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 ml/ dose, lot #W029541, valid lot for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live with expiration date: 15-SEP-2024, albumin status (rHA) with not temperature excursion, administered for prophylaxis (strength, and route of administration were not provided). No symptoms reported. No additional adverse event (AE) details reported.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: no adverse event; HCP calling to report a child was given PROQUAD and VARIVAX together. This child is 4 years old and had not been vaccinated against as an infant as recommended in the Prescribing Information. Requested information on potential side effects, see reque; HCP calling to report a child was given PROQUAD and VARIVAX together. This child is 4 years old and had not been vaccinated against as an infant as recommended in the Prescribing Information. Requested information on potential side effects, see reque; This spontaneous report was received from a medical assistant regarding a 4-year-old patient of unspecified gender.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 28-OCT-2024, the patient (reported as the child) was vaccinated with the first doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y011018, expiration date: 18-JUN-2026 (strength, dose, anatomical location, and route of administration were not provided) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot#Y012077, date: 05-JAN-2026 (strength, lot #, and route of administration were not provided), both administered together for prophylaxis and diluted with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose, lot #, expiry date, and route of administration were not provided) by a health professional, and had not been vaccinated against as an infant as recommended in the prescribing Information (Inappropriate schedule of product administration) (Overdose). The reporter requested information about potential side effects, but no adverse side effects, further adverse events (AEs), nor product quality complaints (PQC) were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; HCP called to report T/E for ROTATEQ. HCP stated it was administered to 1 patient. T/E occurred on 9/6/2024.  Administered on 9/19/2024. Permission to contact HCP was granted. No other information was known or provided. No additional AE or PQC report; This spontaneous report was received from a certified medical assistant (C.M.A) regarding a patient of unspecified age and gender.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.   On 06-SEP-2024, a temperature excursion (TE) occurred at 13.0 C, during 6 hours, for doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, and on 19-SEP-2024, the patient was vaccinated with one of this doses, lot #2003176, expiration date: 04-OCT-2025, administered orally for prophylaxis (strength was not provided) (Improper storage of product in use). The reporter stated that it had not been a data logger, and that a previous excursion had not happened. No additional adverse events (AE) or product quality complaints were reported (PQC). No other information was known or provided.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report a TE with GARDASIL 9.  GARDASIL 9 was administered after being improperly stored; This spontaneous report was received from a nurse regarding a 16-year-old male patient. The patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided.  On 30-OCT-2024, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, 0.5 milliliters, lot number x024727 which has been verified to be valid, expiration date reported and validated as 15-MAY-2026 (strength, route of administration and anatomical location not reported).  The vaccine was administered after being improperly stored, outside of the allowable parameters listed in the physician insert (PI) (improper storage  of product in use). No adverse events were reported.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose, and Has Not Received Second Dose; Initial report received on 17-Oct-2024.  A pharmacist in the reported that a 38-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose after four months.  The patient has no allergies. No relevant concomitant medications were reported.  On 19-Jun-2024, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot # 941428, expiration date 30-Apr-2025, and NDC # 43528-002-01)] intramuscularly in the left deltoid from a pharmacist. At the time of reporting, the patient has not received the second dose of HEPLISAV-B yet.  No additional information was reported.   The event was reported as unknown and as non-serious.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Arthus reactions; swelling, redness, and pain at her pneumococcal polysaccharide vaccine injection site within several hours; swelling, redness, and pain at her pneumococcal polysaccharide vaccine injection site within several hours; swelling, redness, and pain at her pneumococcal polysaccharide vaccine injection site within several hours; This serious case was reported in a literature article and described the occurrence of arthus reaction in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. Literature Reference:   On an unknown date, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced arthus reaction (Verbatim: Arthus reactions) (serious criteria GSK medically significant), vaccination site swelling (Verbatim: swelling, redness, and pain at her pneumococcal polysaccharide vaccine injection site within several hours), vaccination site erythema (Verbatim: swelling, redness, and pain at her pneumococcal polysaccharide vaccine injection site within several hours) and vaccination site pain (Verbatim: swelling, redness, and pain at her pneumococcal polysaccharide vaccine injection site within several hours). The outcome of the arthus reaction, vaccination site swelling, vaccination site erythema and vaccination site pain were not reported (duration 1 week).   The reporter considered the arthus reaction, vaccination site swelling, vaccination site erythema and vaccination site pain to be related to Tdap Vaccine.   The company considered the arthus reaction, vaccination site swelling, vaccination site erythema and vaccination site pain to be related to Tdap Vaccine.   GSK receipt date: 30-OCT-2024  This case consider as historical case as the patient developed a similar reactions (swelling, redness, and pain) to the Tdap vaccine two years prior.  This case series emphasizes the need for providers to recognize arthus reactions with vaccines beyond tetanus toxoid.  This article corresponding to this case is not available for regulatory submission due to copyright restriction.; Sender's Comments: Type III immune complex mediated reaction is an unlisted event which, due to the following criteria ( This case consider as historical case as the patient developed a similar reactions  to the Tdap vaccine two years prior) is considered related to GSK Tdap Vaccine. US-GSK-US2024GSK136310:Same article different patient
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient had been administered only the liquid adjuvant portion of the vaccine; patient had been administered only the liquid adjuvant portion of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-OCT-2024, the patient received Shingrix. On 10-OCT-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient had been administered only the liquid adjuvant portion of the vaccine) and inappropriate dose of vaccine administered (Verbatim: patient had been administered only the liquid adjuvant portion of the vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 11-OCT-2024 The clinic pharmacist reported that that patient had been administered only the liquid adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not know any patient details and also did not know the product lot number or date of administration, but thought it might had been yesterday on 10Oct2024.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site swelling
Clinical narrative: Incomplete course of vaccination; hours after vaccination the injection site was swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12-MAR-2024, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, the patient did not receive the 2nd dose of Shingrix. In MAR-2024, 24 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site swelling (Verbatim: hours after vaccination the injection site was swollen). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the injection site swelling was resolved (duration 48 hrs) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix and Shingrix.     It was unknown if the company considered the injection site swelling to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-OCT-2024 Reporter was the patient. Reporter stated she received the shingrix vaccine. Also stated that 24 hours after vaccination the injection site was swollen and swelling resolved in 48 hours after it began. Till the time of reporting patient did not receive the 2nd dose of vaccine which led to incomplete course of vaccination. Reporter also stated she did not get the second dose of series and still has to schedule the second dose. Till the time of reporting patient did not receive 2nd dose of shingrix which led to incomplete course of vaccination.