chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient administered with only the liquid component with no reported adverse event; Initial information was received on 09-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2024SA052518.  This case involves a 5 months 11 days old female patient to whom only the liquid component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5V (Rotateq) and pneumococcal vaccine for Prophylactic vaccination.  On 23-Jan-2024, the patient received a 0.5 ml, once (dose 1) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ876AA, expiry date:19-Mar-2024, strength: standard) via intramuscular route in the right thigh for Immunization and patient administered with only the liquid component with no reported adverse event (single component of a two-component product administered) (Latency: same day).  Reportedly, Clinic coordinator said that they had an incident where PENTACEL liquid component (DTaP-IPV) was not reconstituted with the powder (lyophilized vaccine component which is the HIB).    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: PENTACEL liquid component (DTaP-IPV) was not reconstituted with the powder (lyophilized vaccine component, HIB). Patients was administered with only the liquid component with no reported adverse event; Initial information received on 09-Feb-2024 regarding an unsolicited valid non-serious case received from Other healthcare professional.  This case is linked to case 2024SA052568.  This case involves a 5 months old male patient who experienced Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [PENTACEL (VERO)] liquid component (DTAP-IPV) was not reconstituted with the powder (lyophilized vaccine component, Hib), patients was administered with only the liquid component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus vaccine Live REASSORT Oral 5V (ROTATEQ) for Prophylactic vaccination; and Pneumococcal vaccine for Prophylactic vaccination.  On 22-Jan-2024, the patient received 0.5 ml dose (frequency: once; strength: standard) of suspect Diphtheria/Tetanus/5 HYBRID AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of lot UJ876AA and expiry: 19-Mar-2024 via intramuscular route in the right thigh for immunization.  On 22-Jan-2024, the patient was administered with only the liquid component Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine liquid component, (DTAP-IPV) was not reconstituted with the powder (lyophilized vaccine component, Hib) with no reported adverse event (single component of a two-component product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: vaccine coordinator reporting that a different diluent, a Merck product was accidently reconstituted with ACTHIB with no reported adverse event; Initial information was received on 09-Feb-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient to whom vaccine coordinator reporting that a different diluent, a merck product was accidently reconstituted with HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 09-Feb-2024, the patient received a 0.5 ml, once dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot UJ965AA, expiry date: 08-Nov-2024, strength: standard) via intramuscular route in the left thigh for Immunization and vaccine coordinator reporting that a different diluent, a merck product was accidently reconstituted with acthib with no reported adverse event (product preparation error) (unknown latency).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Achy shot site; This spontaneous case was received on 05-Feb-2024 from other healthcare professional via Med Communications (reference number: SEQW24-00501) with additional information received on 13-Feb-2024 (being processed together), and concerned a 2-year-old female patient.  The patient's medical history included Covid-19. The patient's concurrent condition included allergy to cats and the patient  was not taking any concomitant medication.   On 27-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular; anatomical location: right thigh; dose and indication: not reported). The reported batch number was 370667, and the expiry date was 30-Jun-2024.  On the same date, the patient was vaccinated with a non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; dose: 0.5 ml (instead of recommended 0.25 ml), route of administration: intramuscular; anatomical location: left thigh; indication: not reported). The reported batch number was A05558B.  On an unspecified date in 2023, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, the patient experienced achy shot site.   On an unspecified date in 2023, the patient recovered from the event.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked with case 202400716 (the same reporter).  Company comment: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship, although causality was confounded by the administration of the co-suspect vaccine.; Sender's Comments: Company comment: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship, although causality was confounded by the administration of the co-suspect vaccine.
Sex: M
Vaccine: FLUA4
Symptoms: Malaise, Pancreatic carcinoma
Clinical narrative: Pancreatic cancer; This spontaneous case was received on 05-Feb-2024 from other non-healthcare professional via agency (reference number: SEQW24-00502) and concerned an elderly (reported as nine decades), male patient.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location: not reported) as influenza vaccine for 65 years of age and older, as reported. The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient was sick with pancreatic cancer.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The event of pancreatic cancer was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance Department.  Company comment: An elderly patient experienced pancreatic carcinoma unspecified amount of time after receiving the suspect product Fluad Quadrivalent. The patient's medical history, concomitant medication as well as relevant laboratory and diagnostic results were not provided. Due to biological implausibility, causality is assessed as not related.; Sender's Comments: An elderly patient experienced pancreatic carcinoma unspecified amount of time after receiving the suspect product Fluad Quadrivalent. The patient's medical history, concomitant medication as well as relevant laboratory and diagnostic results were not provided. Due to biological implausibility, causality is assessed as not related.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Photophobia, Tinnitus
Clinical narrative: Light sensitivity, tinnitus (extremely loud ringing noise in ear)
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: Streptococcus 23-valent vaccine response: not protective;   Information has been received from the authors in a published literature article entitled as stated above concerning to a 9 year old male patient with dermatitis atopic. On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, route and lot # not reported).         On an unknown date, the patient's response to streptococcus 23-valent vaccine was found to be: not protective (vaccination failure). At the time of the report, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same article (2402USA005170).; Sender's Comments:  US-0098507513-2402USA005170:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Rhabdomyolysis
Clinical narrative: Patient underwent diffuse weakness and was hospitalized for rhabdomyolysis; This spontaneous case was reported by a physician and describes the occurrence of RHABDOMYOLYSIS (Patient underwent diffuse weakness and was hospitalized for rhabdomyolysis) in an 82-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 08-Feb-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced RHABDOMYOLYSIS (Patient underwent diffuse weakness and was hospitalized for rhabdomyolysis) (seriousness criteria hospitalization and medically significant). At the time of the report, RHABDOMYOLYSIS (Patient underwent diffuse weakness and was hospitalized for rhabdomyolysis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatine phosphokinase: CK max 20090 units/L.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient underwent diffuse weakness and was hospitalized for rhabdomyolysis, CK max 20090 units/L. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning a 82- year-old, male patient with no reported medical history, who experienced the serious (due to medically significant and hospitalization) unexpected AESI of Rhabdomyolysis. The event occurred on the same day after a dose of SPIKEVAX 2023-2024 (dose number was not provided). Patient underwent diffuse weakness and was hospitalized for rhabdomyolysis, CK max 20090 units/L. Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the event was reported as recovering. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was given a dose of MENQUADFI after it suffered a temperature excursion with no reported adverse event; Initial information received on 12-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was given a dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after it suffered a temperature excursion with no reported adverse event.  It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (with an unknown strength, expiry date, lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was given a dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after it suffered a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  It was reported, This is a Case received from Merck. HCP called to state that a patient was given a dose of MENQUADFI after it suffered a temperature excursion. No further information provided.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: YF
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently received 1mL dose of YF-VAX instead of 0.5mL with no reported adverse event; Initial information received on 13-Feb-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age male patient who inadvertently received 1ml dose of Yellow Fever Vaccine - [YF-VAX] instead of 0.5ml with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Feb-2024, the patient received 1ml dose of suspect Yellow Fever Vaccine - Solution for injection (with an unknown strength, expiry date, lot number) via unknown route in unknown administration site for immunisation.  On 13-Feb-2024, the patient inadvertently received 1ml dose of Yellow Fever Vaccine - [YF-VAX] instead of 0.5ml with no reported adverse event (extra dose administered) (latency: same day).  It was reported, Call received from nurse reporting a patient inadvertently received 1mL dose of YF-VAX instead of 0.5mL. Caller refused to provide address or email address. Patient in office. MIS informed caller that we did not have data specific adverse reactions from an increased dosage but to refer to the Adverse reactions in the prescribing information in which caller reports she has already seen. Caller reports thus far the patient has not experienced any reaction. Caller also refused to provide any patient or vaccine data. Caller did agree to contact us back with information. No additional information available at time of call; caller declined to respond to questions and has accepted follow-up.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: left upper arm with approx 12 cm x 6 cm area of erythema, surrounding site of injection warm to the touch, not fluctuant
Sex: M
Vaccine: RSV
Symptoms: Blood test, Chest X-ray abnormal, Pulmonary thrombosis
Clinical narrative: After receiving the RSV vaccine I developed blood clots in my lungs about 5 days after vaccination. I was hospitalized and put on blood anti coagulants. Not sure of the specific test result numbers.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Allergy test negative, Chronic spontaneous urticaria
Clinical narrative: Chronic spontaneous urticaria 10 days after receiving COVID 19 booster on August 16, 2023. It is still happening as of February 15, 2024. I am on 3 different antihistamines to manage it. I've seen several doctors and two allergists. No cause could be found through allergy testing.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Rheumatoid arthritis, Systemic lupus erythematosus
Clinical narrative: Approx 4 months later just wasnt feeling well and difficultly dressing and daily activutues. Dr put on him on prednisone to help him until he could see a Rhuemetologist. Saw Rheumatoid dr in december 2022, diagnosed with SLE lupus and Rheumatoid Arthritis in Jan 2023
Age: 0.92
Sex: M
Vaccine: FLUX
Symptoms: Agonal respiration, Alanine aminotransferase normal, Aspartate aminotransferase normal, Aspiration, Blood albumin normal
Clinical narrative: Patient was an 11 month old boy with multiple medical problems including airway malformation and followed by pulmonology and cardiology.  He has been in care; this information was mostly obtained by his guardian.  He received his first palivizumab dose in November 2023 and had a difficult time the next three to four days with unusual fussiness, irritability and increased O2 need. He did return to baseline after a few days. When he received his 2nd palivizumab dose (Dec 2023) he had a similar reaction.  His third dose was received on Jan 22, 2024 as noted above.  His reaction was similar, accompanied by unsual tachycardia for several days into the 150-160 range on his monitor, even when sleeping. He also had a slight increased O2 need.  On the 3rd day after the palivizumab dose, he was at home, starting to resolve his fussiness, and seemed to be almost to baseline. Guardian then described that shortly after changing his diaper that morning, his pulse ox dropped precipitously, he lost consciousness very rapidly, and suddently was in cardiac arrest.  CPR was immediately performed and paramedics were called, who found him in an agonal breathing pattern and no pulse.  He was transferred to the local hospital where he was noted to have pulseless electrical activity.  Resuscitation efforts were unsuccessful and the patient was pronounced dead.   Based on my discussion with the guardian and the ED physician who ran the code that morning, I filled out his death certificate with the description of an aspiration event leading to respiratory failure and death. However this is an unproven assumption (no autopsy was performed).  I am filling out this VAERS report because  I am suspicious of a possible cardiac arrest secondary to an effect of the palivizumab.  I cannot find any reports of such events in the literature, but his unusual tachycardia for several days after the dose, his prior history of unusual adverse reactions to palivizumab, and the sudden nature of his witnessed cardiac arrest without any evidence of aspiration or pulmonary compromise only three days later make me suspicious of a possible drug induced fatal arrhythmia, possible due to a medication-caused cardiomyopathy or something similar.  Unfortunately, this is an unprovable assumption based on the unavailability of autopsy and would likely indeed be a rare complication.   I do note that during the second palivizumab dose, he recieved concurrent influenza vaccine as well (though not with the 3rd dose).   Also note that patient was a ward of the state at the time of his decease and had been recieving high quality care with a single family during almost the entirety of his life.
Age: 0.92
Sex: M
Vaccine: FLUX
Symptoms: Blood alkaline phosphatase increased, Blood bilirubin decreased, Cardiac arrest, Death, Globulins decreased
Clinical narrative: Patient was an 11 month old boy with multiple medical problems including airway malformation and followed by pulmonology and cardiology.  He has been in care; this information was mostly obtained by his guardian.  He received his first palivizumab dose in November 2023 and had a difficult time the next three to four days with unusual fussiness, irritability and increased O2 need. He did return to baseline after a few days. When he received his 2nd palivizumab dose (Dec 2023) he had a similar reaction.  His third dose was received on Jan 22, 2024 as noted above.  His reaction was similar, accompanied by unsual tachycardia for several days into the 150-160 range on his monitor, even when sleeping. He also had a slight increased O2 need.  On the 3rd day after the palivizumab dose, he was at home, starting to resolve his fussiness, and seemed to be almost to baseline. Guardian then described that shortly after changing his diaper that morning, his pulse ox dropped precipitously, he lost consciousness very rapidly, and suddently was in cardiac arrest.  CPR was immediately performed and paramedics were called, who found him in an agonal breathing pattern and no pulse.  He was transferred to the local hospital where he was noted to have pulseless electrical activity.  Resuscitation efforts were unsuccessful and the patient was pronounced dead.   Based on my discussion with the guardian and the ED physician who ran the code that morning, I filled out his death certificate with the description of an aspiration event leading to respiratory failure and death. However this is an unproven assumption (no autopsy was performed).  I am filling out this VAERS report because  I am suspicious of a possible cardiac arrest secondary to an effect of the palivizumab.  I cannot find any reports of such events in the literature, but his unusual tachycardia for several days after the dose, his prior history of unusual adverse reactions to palivizumab, and the sudden nature of his witnessed cardiac arrest without any evidence of aspiration or pulmonary compromise only three days later make me suspicious of a possible drug induced fatal arrhythmia, possible due to a medication-caused cardiomyopathy or something similar.  Unfortunately, this is an unprovable assumption based on the unavailability of autopsy and would likely indeed be a rare complication.   I do note that during the second palivizumab dose, he recieved concurrent influenza vaccine as well (though not with the 3rd dose).   Also note that patient was a ward of the state at the time of his decease and had been recieving high quality care with a single family during almost the entirety of his life.
Age: 0.92
Sex: M
Vaccine: FLUX
Symptoms: Infant irritability, Loss of consciousness, Oxygen saturation decreased, Protein total normal, Pulse absent
Clinical narrative: Patient was an 11 month old boy with multiple medical problems including airway malformation and followed by pulmonology and cardiology.  He has been in care; this information was mostly obtained by his guardian.  He received his first palivizumab dose in November 2023 and had a difficult time the next three to four days with unusual fussiness, irritability and increased O2 need. He did return to baseline after a few days. When he received his 2nd palivizumab dose (Dec 2023) he had a similar reaction.  His third dose was received on Jan 22, 2024 as noted above.  His reaction was similar, accompanied by unsual tachycardia for several days into the 150-160 range on his monitor, even when sleeping. He also had a slight increased O2 need.  On the 3rd day after the palivizumab dose, he was at home, starting to resolve his fussiness, and seemed to be almost to baseline. Guardian then described that shortly after changing his diaper that morning, his pulse ox dropped precipitously, he lost consciousness very rapidly, and suddently was in cardiac arrest.  CPR was immediately performed and paramedics were called, who found him in an agonal breathing pattern and no pulse.  He was transferred to the local hospital where he was noted to have pulseless electrical activity.  Resuscitation efforts were unsuccessful and the patient was pronounced dead.   Based on my discussion with the guardian and the ED physician who ran the code that morning, I filled out his death certificate with the description of an aspiration event leading to respiratory failure and death. However this is an unproven assumption (no autopsy was performed).  I am filling out this VAERS report because  I am suspicious of a possible cardiac arrest secondary to an effect of the palivizumab.  I cannot find any reports of such events in the literature, but his unusual tachycardia for several days after the dose, his prior history of unusual adverse reactions to palivizumab, and the sudden nature of his witnessed cardiac arrest without any evidence of aspiration or pulmonary compromise only three days later make me suspicious of a possible drug induced fatal arrhythmia, possible due to a medication-caused cardiomyopathy or something similar.  Unfortunately, this is an unprovable assumption based on the unavailability of autopsy and would likely indeed be a rare complication.   I do note that during the second palivizumab dose, he recieved concurrent influenza vaccine as well (though not with the 3rd dose).   Also note that patient was a ward of the state at the time of his decease and had been recieving high quality care with a single family during almost the entirety of his life.
Age: 0.92
Sex: M
Vaccine: FLUX
Symptoms: Pulseless electrical activity, Respiratory failure, Resuscitation, Similar reaction on previous exposure to drug, Tachycardia
Clinical narrative: Patient was an 11 month old boy with multiple medical problems including airway malformation and followed by pulmonology and cardiology.  He has been in care; this information was mostly obtained by his guardian.  He received his first palivizumab dose in November 2023 and had a difficult time the next three to four days with unusual fussiness, irritability and increased O2 need. He did return to baseline after a few days. When he received his 2nd palivizumab dose (Dec 2023) he had a similar reaction.  His third dose was received on Jan 22, 2024 as noted above.  His reaction was similar, accompanied by unsual tachycardia for several days into the 150-160 range on his monitor, even when sleeping. He also had a slight increased O2 need.  On the 3rd day after the palivizumab dose, he was at home, starting to resolve his fussiness, and seemed to be almost to baseline. Guardian then described that shortly after changing his diaper that morning, his pulse ox dropped precipitously, he lost consciousness very rapidly, and suddently was in cardiac arrest.  CPR was immediately performed and paramedics were called, who found him in an agonal breathing pattern and no pulse.  He was transferred to the local hospital where he was noted to have pulseless electrical activity.  Resuscitation efforts were unsuccessful and the patient was pronounced dead.   Based on my discussion with the guardian and the ED physician who ran the code that morning, I filled out his death certificate with the description of an aspiration event leading to respiratory failure and death. However this is an unproven assumption (no autopsy was performed).  I am filling out this VAERS report because  I am suspicious of a possible cardiac arrest secondary to an effect of the palivizumab.  I cannot find any reports of such events in the literature, but his unusual tachycardia for several days after the dose, his prior history of unusual adverse reactions to palivizumab, and the sudden nature of his witnessed cardiac arrest without any evidence of aspiration or pulmonary compromise only three days later make me suspicious of a possible drug induced fatal arrhythmia, possible due to a medication-caused cardiomyopathy or something similar.  Unfortunately, this is an unprovable assumption based on the unavailability of autopsy and would likely indeed be a rare complication.   I do note that during the second palivizumab dose, he recieved concurrent influenza vaccine as well (though not with the 3rd dose).   Also note that patient was a ward of the state at the time of his decease and had been recieving high quality care with a single family during almost the entirety of his life.
Age: 8.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received inappropriate vaccines. Hep A was given 2 months ago; too old for DTaP and not needed.  Patient seen with sibling.  Two vaccine records for sister were given to provider which lead to mistake.  Patient without adverse reaction.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Alcoholic seizure, Anticoagulation drug level above therapeutic, COVID-19, Catheter placement
Clinical narrative: Admit date: 2/5/2024  Discharge date: 2/11/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: DO Summary HPI:"Patient is a 73 YO male w/ PMHx recent bilateral inguinal herniorraphy 1/25/24 complicated by hemorrhage/hematoma bilateral inguinal regions, atrial fibrillation on coumadin, AV stenosis and WHO type 2 pHTN s/p bioprosthetic aortic valve replacement(12/6/2018), prediabetes, LVH, HTN who presented 2/5/2024 with a chief complaint of dyspnea. "  Please see admission H&P for further details.  Summary of Hospitalization: Patient is a 73-year-old male with a past medical history of bilateral inguinal herniorraphy 1/25/24, atrial fibrillation on Coumadin, aortic stenosis status post AV replacement, pulmonary hypertension, HFpEF, HTN, alcohol abuse who presents with dyspnea.  Found to have supratherapeutic INR and bilateral inguinal hematoma.  General surgery consulted, recommend holding warfarin but no acute surgical Intervention.  Discussed embolization as salvage option with Interventional radiology, but this would cause testicular infarction.  Incidentally found to be positive for COVID.  Had episode of agitation and suspected alcohol withdrawal seizure and was transferred to the intensive care unit 2/6.  Neurology did not recommend any long-term AED therapy.  Stable for transfer to general medical floor 2/10.  On 02/11 patient wanted to return home.  I discussed that I wanted to wean him completely off oxygen (requiring 2 L still), discussed timing of anticoagulation restarting (Dr. off this weekend), and potentially reduce some of the swelling around his scrotum for consideration of catheter removal but he wanted to return home.  He was alert oriented x3 at the time of our conversation. He ultimately left against medical advice. Urgent General surgery and Urology for all set up for patient.  Home oxygen was arranged.  His hypoxia may be secondary to COVID but also may be related to fluid overload from boluses during his hospital stay.  He was given 1 dose of IV Lasix prior to discharge but none prescribed on discharge as I was not positive is related to fluid overload.  Home health care set up for patient. Discharged to Home Health Care Services.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Haematoma, Haemorrhage, Hypoxia, Inguinal hernia repair
Clinical narrative: Admit date: 2/5/2024  Discharge date: 2/11/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: DO Summary HPI:"Patient is a 73 YO male w/ PMHx recent bilateral inguinal herniorraphy 1/25/24 complicated by hemorrhage/hematoma bilateral inguinal regions, atrial fibrillation on coumadin, AV stenosis and WHO type 2 pHTN s/p bioprosthetic aortic valve replacement(12/6/2018), prediabetes, LVH, HTN who presented 2/5/2024 with a chief complaint of dyspnea. "  Please see admission H&P for further details.  Summary of Hospitalization: Patient is a 73-year-old male with a past medical history of bilateral inguinal herniorraphy 1/25/24, atrial fibrillation on Coumadin, aortic stenosis status post AV replacement, pulmonary hypertension, HFpEF, HTN, alcohol abuse who presents with dyspnea.  Found to have supratherapeutic INR and bilateral inguinal hematoma.  General surgery consulted, recommend holding warfarin but no acute surgical Intervention.  Discussed embolization as salvage option with Interventional radiology, but this would cause testicular infarction.  Incidentally found to be positive for COVID.  Had episode of agitation and suspected alcohol withdrawal seizure and was transferred to the intensive care unit 2/6.  Neurology did not recommend any long-term AED therapy.  Stable for transfer to general medical floor 2/10.  On 02/11 patient wanted to return home.  I discussed that I wanted to wean him completely off oxygen (requiring 2 L still), discussed timing of anticoagulation restarting (Dr. off this weekend), and potentially reduce some of the swelling around his scrotum for consideration of catheter removal but he wanted to return home.  He was alert oriented x3 at the time of our conversation. He ultimately left against medical advice. Urgent General surgery and Urology for all set up for patient.  Home oxygen was arranged.  His hypoxia may be secondary to COVID but also may be related to fluid overload from boluses during his hospital stay.  He was given 1 dose of IV Lasix prior to discharge but none prescribed on discharge as I was not positive is related to fluid overload.  Home health care set up for patient. Discharged to Home Health Care Services.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Procedural complication, SARS-CoV-2 test positive, Scrotal swelling
Clinical narrative: Admit date: 2/5/2024  Discharge date: 2/11/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: DO Summary HPI:"Patient is a 73 YO male w/ PMHx recent bilateral inguinal herniorraphy 1/25/24 complicated by hemorrhage/hematoma bilateral inguinal regions, atrial fibrillation on coumadin, AV stenosis and WHO type 2 pHTN s/p bioprosthetic aortic valve replacement(12/6/2018), prediabetes, LVH, HTN who presented 2/5/2024 with a chief complaint of dyspnea. "  Please see admission H&P for further details.  Summary of Hospitalization: Patient is a 73-year-old male with a past medical history of bilateral inguinal herniorraphy 1/25/24, atrial fibrillation on Coumadin, aortic stenosis status post AV replacement, pulmonary hypertension, HFpEF, HTN, alcohol abuse who presents with dyspnea.  Found to have supratherapeutic INR and bilateral inguinal hematoma.  General surgery consulted, recommend holding warfarin but no acute surgical Intervention.  Discussed embolization as salvage option with Interventional radiology, but this would cause testicular infarction.  Incidentally found to be positive for COVID.  Had episode of agitation and suspected alcohol withdrawal seizure and was transferred to the intensive care unit 2/6.  Neurology did not recommend any long-term AED therapy.  Stable for transfer to general medical floor 2/10.  On 02/11 patient wanted to return home.  I discussed that I wanted to wean him completely off oxygen (requiring 2 L still), discussed timing of anticoagulation restarting (Dr. off this weekend), and potentially reduce some of the swelling around his scrotum for consideration of catheter removal but he wanted to return home.  He was alert oriented x3 at the time of our conversation. He ultimately left against medical advice. Urgent General surgery and Urology for all set up for patient.  Home oxygen was arranged.  His hypoxia may be secondary to COVID but also may be related to fluid overload from boluses during his hospital stay.  He was given 1 dose of IV Lasix prior to discharge but none prescribed on discharge as I was not positive is related to fluid overload.  Home health care set up for patient. Discharged to Home Health Care Services.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Moderna Spikevax that was received in a temperature monitored refrigerator on 10/16/2023, and administered on 1/26/2024, the vaccine was beyond use by 72 days. It should have been removed fridge and disposed of after its beyond use date of 11/16/2023.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Acute kidney injury, Bile duct stone, Biliary dilatation, COVID-19
Clinical narrative: Admit date: 2/7/2024  Discharge date: 2/12/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: NP  Summary HPI: "Patient is a 79 YO female with a past medical history of HTN, HLD, T2DM, glaucoma and cryptogenic CVA with chronic left sided deficits that presents to the ED via EMS with complaints of chest pain for the past 2 days. "  Please see admission H&P for further details.  Summary of Hospitalization: Patient is a 79- YO F with a PMHx of dementia who lives at AFC, CVA with left hemiplegia, DM2, HTN who presents with cough and chest pain.  Suspect secondary to COVID infection.  Symptom onset approximately 2/6 and will require isolation until 2/16.  Patient will not need isolation on 02/17.  Cardiology consulted for chest pain and as echo showed no wall motion abnormalities and chest pain resolved; no further workup planned.  Due to RUQ pain, extrahepatic dilation, elevated LFTs MRCP obtain and showed cholelithiasis and choledocholithiasis.  Due to COVID isolation status, ERCP planned for outpatient followed by outpatient cholecystectomy.  Appreciate GI and General surgery recommendations.  Cholelithiasis and choledocholithiasis CBD dilation, Elevated transaminases -GI consulted, ERCP planned for outpatient -Zosyn due to question of infection with fever, which is most likely due to respiratory status.  Antibiotics not continued and discharge after discussion with Gastroenterology  -general surgery consulted, plan for cholecystectomy as outpatient  AKI with high anion gap metabolic acidosis-resolved Almost certainly secondary to poor oral intake while NPO for MRCP Patient does have poor oral intake at baseline and nutritional supplements discussed with patient's son  COVID pneumonia Testing negative, but with exposure and symptoms will elect to remain in isolation. No evidence of superimposed bacterial pneumonia Isolation 2/6-16.  Patient is out of isolation 2/17. -treatment not indicated without hypoxia, supportive care Discharged to Home.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest pain, Cholelithiasis, Cough, Echocardiogram normal
Clinical narrative: Admit date: 2/7/2024  Discharge date: 2/12/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: NP  Summary HPI: "Patient is a 79 YO female with a past medical history of HTN, HLD, T2DM, glaucoma and cryptogenic CVA with chronic left sided deficits that presents to the ED via EMS with complaints of chest pain for the past 2 days. "  Please see admission H&P for further details.  Summary of Hospitalization: Patient is a 79- YO F with a PMHx of dementia who lives at AFC, CVA with left hemiplegia, DM2, HTN who presents with cough and chest pain.  Suspect secondary to COVID infection.  Symptom onset approximately 2/6 and will require isolation until 2/16.  Patient will not need isolation on 02/17.  Cardiology consulted for chest pain and as echo showed no wall motion abnormalities and chest pain resolved; no further workup planned.  Due to RUQ pain, extrahepatic dilation, elevated LFTs MRCP obtain and showed cholelithiasis and choledocholithiasis.  Due to COVID isolation status, ERCP planned for outpatient followed by outpatient cholecystectomy.  Appreciate GI and General surgery recommendations.  Cholelithiasis and choledocholithiasis CBD dilation, Elevated transaminases -GI consulted, ERCP planned for outpatient -Zosyn due to question of infection with fever, which is most likely due to respiratory status.  Antibiotics not continued and discharge after discussion with Gastroenterology  -general surgery consulted, plan for cholecystectomy as outpatient  AKI with high anion gap metabolic acidosis-resolved Almost certainly secondary to poor oral intake while NPO for MRCP Patient does have poor oral intake at baseline and nutritional supplements discussed with patient's son  COVID pneumonia Testing negative, but with exposure and symptoms will elect to remain in isolation. No evidence of superimposed bacterial pneumonia Isolation 2/6-16.  Patient is out of isolation 2/17. -treatment not indicated without hypoxia, supportive care Discharged to Home.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Hypophagia, Liver function test increased, Magnetic resonance cholangiopancreatography, Magnetic resonance imaging hepatobiliary abnormal
Clinical narrative: Admit date: 2/7/2024  Discharge date: 2/12/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: NP  Summary HPI: "Patient is a 79 YO female with a past medical history of HTN, HLD, T2DM, glaucoma and cryptogenic CVA with chronic left sided deficits that presents to the ED via EMS with complaints of chest pain for the past 2 days. "  Please see admission H&P for further details.  Summary of Hospitalization: Patient is a 79- YO F with a PMHx of dementia who lives at AFC, CVA with left hemiplegia, DM2, HTN who presents with cough and chest pain.  Suspect secondary to COVID infection.  Symptom onset approximately 2/6 and will require isolation until 2/16.  Patient will not need isolation on 02/17.  Cardiology consulted for chest pain and as echo showed no wall motion abnormalities and chest pain resolved; no further workup planned.  Due to RUQ pain, extrahepatic dilation, elevated LFTs MRCP obtain and showed cholelithiasis and choledocholithiasis.  Due to COVID isolation status, ERCP planned for outpatient followed by outpatient cholecystectomy.  Appreciate GI and General surgery recommendations.  Cholelithiasis and choledocholithiasis CBD dilation, Elevated transaminases -GI consulted, ERCP planned for outpatient -Zosyn due to question of infection with fever, which is most likely due to respiratory status.  Antibiotics not continued and discharge after discussion with Gastroenterology  -general surgery consulted, plan for cholecystectomy as outpatient  AKI with high anion gap metabolic acidosis-resolved Almost certainly secondary to poor oral intake while NPO for MRCP Patient does have poor oral intake at baseline and nutritional supplements discussed with patient's son  COVID pneumonia Testing negative, but with exposure and symptoms will elect to remain in isolation. No evidence of superimposed bacterial pneumonia Isolation 2/6-16.  Patient is out of isolation 2/17. -treatment not indicated without hypoxia, supportive care Discharged to Home.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic acidosis, Nothing by mouth order, Pyrexia, Respiratory disorder, SARS-CoV-2 test negative
Clinical narrative: Admit date: 2/7/2024  Discharge date: 2/12/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: NP  Summary HPI: "Patient is a 79 YO female with a past medical history of HTN, HLD, T2DM, glaucoma and cryptogenic CVA with chronic left sided deficits that presents to the ED via EMS with complaints of chest pain for the past 2 days. "  Please see admission H&P for further details.  Summary of Hospitalization: Patient is a 79- YO F with a PMHx of dementia who lives at AFC, CVA with left hemiplegia, DM2, HTN who presents with cough and chest pain.  Suspect secondary to COVID infection.  Symptom onset approximately 2/6 and will require isolation until 2/16.  Patient will not need isolation on 02/17.  Cardiology consulted for chest pain and as echo showed no wall motion abnormalities and chest pain resolved; no further workup planned.  Due to RUQ pain, extrahepatic dilation, elevated LFTs MRCP obtain and showed cholelithiasis and choledocholithiasis.  Due to COVID isolation status, ERCP planned for outpatient followed by outpatient cholecystectomy.  Appreciate GI and General surgery recommendations.  Cholelithiasis and choledocholithiasis CBD dilation, Elevated transaminases -GI consulted, ERCP planned for outpatient -Zosyn due to question of infection with fever, which is most likely due to respiratory status.  Antibiotics not continued and discharge after discussion with Gastroenterology  -general surgery consulted, plan for cholecystectomy as outpatient  AKI with high anion gap metabolic acidosis-resolved Almost certainly secondary to poor oral intake while NPO for MRCP Patient does have poor oral intake at baseline and nutritional supplements discussed with patient's son  COVID pneumonia Testing negative, but with exposure and symptoms will elect to remain in isolation. No evidence of superimposed bacterial pneumonia Isolation 2/6-16.  Patient is out of isolation 2/17. -treatment not indicated without hypoxia, supportive care Discharged to Home.