chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Mar2024 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "thyroid cancer" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: contrast dye" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Mar2024, outcome "not recovered", described as "COVID 19". Therapeutic measures were taken as a result of covid-19. Additional information: Paxlovid was used from 12Mar2024 to 16Mar2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "generalized anxiety disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used as treatment from 08Mar2024 to 13Mar2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5, BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 15Mar2024, outcome "unknown" and all described as "COVID 19". The event "covid 19" required physician office visit. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical courses: Started to feel symptoms on 15Mar2024. Contacted Dr on that day and received a prescription for paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine brand other: Spikevax/vaccine brand: Pfizer BioNTech; COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation; elasomeran (SPIKEVAX), on 20Oct2023 as dose number unknown, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing); "contrast dye" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Oct2015, stop date: 13Mar2024; TAMSULOSIN, start date: Feb2023, stop date: 14Mar2024. Past drug history included: Bextra, reaction(s): "Allergies: Bextra". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other: Spikevax/vaccine brand: Pfizer BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Mar2024 to 18Mar2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4, single (Lot number: GV3277) at the age of 50 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9267), on 08Mar2021 as dose 2, single (Lot number: EN6199) and on 13Dec2021 as dose 3, single (Lot number: FJ8762) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from15Mar2024 to 20Mar2024.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, start date: 2021, notes: some side effects from Cipro 3 years before. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: patient quickly felt much better for about 5 days, then felt bad and half sick for about 10 days. Got Covid from daughter who became ill 2-3 days before him, She had the same sequence, better for 5 days, then half sick for about 10 days. The patient has no known allergies.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 24-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (start date: 06Mar2024, stop date: 11Mar2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Crohn's disease, Vaccination site irritation
Clinical narrative: GI discomfort that exacerbated Crohn's Disease; Experiencing irritation at the injection site immediately after administration; Chills; This is a spontaneous report received from a Consumer or other non HCP.  A female patient in her 40's received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "recovered", described as "GI discomfort that exacerbated Crohn's Disease"; VACCINATION SITE IRRITATION (non-serious), outcome "recovered", described as "Experiencing irritation at the injection site immediately after administration"; CHILLS (non-serious), outcome "recovered". Clinical course: Patient in her mid 40s, experienced irritation at the injection site immediately after administration, then a few hours later experiencing, chills and GI (gastrointestinal) discomfort that exacerbated Crohn's Disease. According to her report, it took two to three days for symptoms to disappear. That was all the information that they had to report regarding interaction.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400070851 same reporter/drug; different patient/AE;
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: chronic diarrhea; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Jan2024 as dose 1, single (Lot number: HG2649) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series, unknown manufacturer), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 16Jan2024, outcome "not recovered", described as "chronic diarrhea". The event "chronic diarrhea" required physician office visit.  Additional information: Patient had booster on 16Jan2024 and have had diarrhea since that day. Doctors have not been able to find what was causing chronic diarrhea. Patient believe it has something to do with the vaccine patient received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: having covid and rx with Paxlovid; having covid and rx with Paxlovid; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "having covid and rx with Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: Patient inquired that How long after having covid and rx with Paxlovid should a patient wait to get 2nd Cominarty vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: severe hearing loss in her right ear and hearing loss; tinnitus in her left ear; Initial information received on 19-Mar-2024 regarding an unsolicited valid Legal serious case received from a lawyer.  This case involves a patient of an unknown age and gender who experienced severe hearing loss in her right ear and hearing loss and tinnitus in her left ear after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer (strength, expiry date, formulation and lot number not reported) via intramuscular route in unknown administration site as Prophylactic vaccination (immunization). There will be no information available on the batch number for this case.  On an unknown date the patient developed severe hearing loss in her right ear and hearing loss (deafness unilateral) and tinnitus in her left ear (tinnitus) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  This event (deafness unilateral) was assessed as medically significant and was leading to disability for both events.; Sender's Comments: Sanofi company comment dated on 22-Mar-2024: This case involves a patient of an unknown age and gender who experienced severe hearing loss in her right ear and hearing loss and tinnitus in her left ear after receiving Influenza vaccine. Further information regarding tolerance family history, concurrent condition and concomitant medication for the reported event is needed to fully assess this case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of expired ACTHIB with no reported adverse event; Initial information received on 15-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 months old male patient who had inappropriate use due to administration of expired 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 Hepatitis A Vaccine (Hepatitis A Vaccine); Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR); Pneumococcal Vaccine CONJ 20V (CRM197) (Prevnar 20); and Influenza Vaccine (Influenza Vaccine) all for Immunisation.  On 06-Mar-2024, the patient had inappropriate use due to administration of expired 0.5 ml (dose 4) of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ833AA, expiry date: 1 Mar-2024, strength not reported) via intramuscular route in the left thigh for Prophylactic Vaccination with no reported adverse event (expired 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: 2.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered subcutaneously in the right thigh an expired dose of IPOL, with no reported adverse event; Initial information received on 18-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to 2024SA087940 (Cluster).   This case involves a 2 years old female patient who was administered subcutaneously in the right thigh an expired dose of IPV (Vero) [IPOL] 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) for Prophylactic Vaccination.  On 15-Mar-2024, the patient was administered Suspension for injection (dose 3) 0.5 ml of an expired dose of IPV (Vero) (Ipol) (lot V1A021M, expiry date: 17-Feb-2024, strength not reported) via subcutaneous route in the right thigh for Immunization with no reported adverse event (expired 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: 1.17
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: quadracel is administered to a 14 month old patient with no reported adverse event; Initial information received on 22-Mar-2024 regarding an unsolicited valid non-serious case received via Nurse.  This case involves, diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was administered to a 14-month-old patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 HYBRID AC pertussis/IPV (MRC5) vaccine, Suspension for injection (strength: unknown) (lot: U7931AB, expiry date: 09-Nov-2025) via unknown route in unknown administration site for Immunization and quadracel was administered to a 14 month old patient with no reported adverse event (product administered to patient of inappropriate age) (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: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: quadracel was given to a 13-month-old baby with no reported adverse event; Initial information received on 22-Mar-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 13 months old male patient who was administered with Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Mar-2024, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine Solution for injection (lot number: C6002BA) (Expiry date: 18-May-2024) (Strength: standard) (Frequency: once) via intramuscular route in the right thigh for immunization.  On 11-MAR-2024, the patient was administered with Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine with no reported adverse event (product administered to patient of inappropriate age) (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: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Cyanosis, Decreased activity, Diet refusal, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Pte with blue lips, decreased activity and emesis. She had 4 episodes of NBNB emesis and has been refusing feeds
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Pte with blue lips, decreased activity and emesis. She had 4 episodes of NBNB emesis and has been refusing feeds
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Arteriogram coronary abnormal, Burning sensation, Dizziness, Dyspnoea
Clinical narrative: pericardial effusion and bilateral pleural effusion from Sprycel.  Not vaccine related.  Hospitalized 2/1-2/2/24 with dizziness, fatigue, shortness of breath, weight gain, edema, wheezing, lung burning, orthopnea).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Fatigue, Oedema, Orthopnoea, Pericardial effusion
Clinical narrative: pericardial effusion and bilateral pleural effusion from Sprycel.  Not vaccine related.  Hospitalized 2/1-2/2/24 with dizziness, fatigue, shortness of breath, weight gain, edema, wheezing, lung burning, orthopnea).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Weight increased, Wheezing
Clinical narrative: pericardial effusion and bilateral pleural effusion from Sprycel.  Not vaccine related.  Hospitalized 2/1-2/2/24 with dizziness, fatigue, shortness of breath, weight gain, edema, wheezing, lung burning, orthopnea).
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Shortly after receiving the last vaccine of seven, the patient experience syncope for approximately 30 seconds.  The time of the event was approximately 12:36 PM. Patient remained in chair and was supported by administrator of vaccine. Patient roused shortly there after approximately 30 seconds. An hour times for the patient was observed for 40 minutes afterward with no other findings observed.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Autoscopy, Back pain, Blood test normal, Chest pain, Dizziness
Clinical narrative: Received vaccine due threat of termination of employment. Felt rush of dizziness and panic after receiving injection within 2 minutes. Sick for about 24 hours after. Life resumed as usual. Approximately 2 months post-vaccination, I developed chest pain, shortness of breath, and head pressure. By 6 months, I had developed numbness and tingling in my hands and feet, purple fingernails, dysautonomia-like symptoms including blood pooling in my hands and feet, heart rate fluctuations greater than 30+ bpm upon standing, and losing the ability to sweat from my arms and legs. I became cold nearly always, and developed panic/adrenaline episodes not triggered by any external stimulus. Previous to vaccination, I was active in my local gym 15+ hours a week with weight training and cardiovascular training, and 3-6 months post vaccination, but exercise ability had become less than a tenth of what I was capable of before. Despite no evident physical injury as measured by MRI, physical therapists, X-Rays, or limited range of mobility, I developed extreme back, leg, neck, and calf tightness/pain, as though there is something poking me or clogging from the inside. The most troubling adverse event was a subjective sense of derealization as though I was not in my own body. This is not a psychological phenomenon, rather it is a transient loss of agency. A sensation of watching another person through my own eyes, especially given that I was no longer able to feel much of my body due to the loss of function. Specifically, I could no longer walk or even stand for long periods of time without becoming exhausted as though I would pass out. I went to the emergency room 3 times in 12 months, and I also pursued specialists in cardiology, rheumatology, neurology, orthopedic doctors, vascular surgeons, and so on. All tests performed suggested no pathology despite the
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dysstasia, Echocardiogram normal, Electrocardiogram normal, Electromyogram normal
Clinical narrative: Received vaccine due threat of termination of employment. Felt rush of dizziness and panic after receiving injection within 2 minutes. Sick for about 24 hours after. Life resumed as usual. Approximately 2 months post-vaccination, I developed chest pain, shortness of breath, and head pressure. By 6 months, I had developed numbness and tingling in my hands and feet, purple fingernails, dysautonomia-like symptoms including blood pooling in my hands and feet, heart rate fluctuations greater than 30+ bpm upon standing, and losing the ability to sweat from my arms and legs. I became cold nearly always, and developed panic/adrenaline episodes not triggered by any external stimulus. Previous to vaccination, I was active in my local gym 15+ hours a week with weight training and cardiovascular training, and 3-6 months post vaccination, but exercise ability had become less than a tenth of what I was capable of before. Despite no evident physical injury as measured by MRI, physical therapists, X-Rays, or limited range of mobility, I developed extreme back, leg, neck, and calf tightness/pain, as though there is something poking me or clogging from the inside. The most troubling adverse event was a subjective sense of derealization as though I was not in my own body. This is not a psychological phenomenon, rather it is a transient loss of agency. A sensation of watching another person through my own eyes, especially given that I was no longer able to feel much of my body due to the loss of function. Specifically, I could no longer walk or even stand for long periods of time without becoming exhausted as though I would pass out. I went to the emergency room 3 times in 12 months, and I also pursued specialists in cardiology, rheumatology, neurology, orthopedic doctors, vascular surgeons, and so on. All tests performed suggested no pathology despite the
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Feeling abnormal, Feeling cold, Full blood count normal
Clinical narrative: Received vaccine due threat of termination of employment. Felt rush of dizziness and panic after receiving injection within 2 minutes. Sick for about 24 hours after. Life resumed as usual. Approximately 2 months post-vaccination, I developed chest pain, shortness of breath, and head pressure. By 6 months, I had developed numbness and tingling in my hands and feet, purple fingernails, dysautonomia-like symptoms including blood pooling in my hands and feet, heart rate fluctuations greater than 30+ bpm upon standing, and losing the ability to sweat from my arms and legs. I became cold nearly always, and developed panic/adrenaline episodes not triggered by any external stimulus. Previous to vaccination, I was active in my local gym 15+ hours a week with weight training and cardiovascular training, and 3-6 months post vaccination, but exercise ability had become less than a tenth of what I was capable of before. Despite no evident physical injury as measured by MRI, physical therapists, X-Rays, or limited range of mobility, I developed extreme back, leg, neck, and calf tightness/pain, as though there is something poking me or clogging from the inside. The most troubling adverse event was a subjective sense of derealization as though I was not in my own body. This is not a psychological phenomenon, rather it is a transient loss of agency. A sensation of watching another person through my own eyes, especially given that I was no longer able to feel much of my body due to the loss of function. Specifically, I could no longer walk or even stand for long periods of time without becoming exhausted as though I would pass out. I went to the emergency room 3 times in 12 months, and I also pursued specialists in cardiology, rheumatology, neurology, orthopedic doctors, vascular surgeons, and so on. All tests performed suggested no pathology despite the
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Head discomfort, Heart rate irregular, Hypoaesthesia, Hypohidrosis
Clinical narrative: Received vaccine due threat of termination of employment. Felt rush of dizziness and panic after receiving injection within 2 minutes. Sick for about 24 hours after. Life resumed as usual. Approximately 2 months post-vaccination, I developed chest pain, shortness of breath, and head pressure. By 6 months, I had developed numbness and tingling in my hands and feet, purple fingernails, dysautonomia-like symptoms including blood pooling in my hands and feet, heart rate fluctuations greater than 30+ bpm upon standing, and losing the ability to sweat from my arms and legs. I became cold nearly always, and developed panic/adrenaline episodes not triggered by any external stimulus. Previous to vaccination, I was active in my local gym 15+ hours a week with weight training and cardiovascular training, and 3-6 months post vaccination, but exercise ability had become less than a tenth of what I was capable of before. Despite no evident physical injury as measured by MRI, physical therapists, X-Rays, or limited range of mobility, I developed extreme back, leg, neck, and calf tightness/pain, as though there is something poking me or clogging from the inside. The most troubling adverse event was a subjective sense of derealization as though I was not in my own body. This is not a psychological phenomenon, rather it is a transient loss of agency. A sensation of watching another person through my own eyes, especially given that I was no longer able to feel much of my body due to the loss of function. Specifically, I could no longer walk or even stand for long periods of time without becoming exhausted as though I would pass out. I went to the emergency room 3 times in 12 months, and I also pursued specialists in cardiology, rheumatology, neurology, orthopedic doctors, vascular surgeons, and so on. All tests performed suggested no pathology despite the
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Liver function test normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Metabolic function test normal
Clinical narrative: Received vaccine due threat of termination of employment. Felt rush of dizziness and panic after receiving injection within 2 minutes. Sick for about 24 hours after. Life resumed as usual. Approximately 2 months post-vaccination, I developed chest pain, shortness of breath, and head pressure. By 6 months, I had developed numbness and tingling in my hands and feet, purple fingernails, dysautonomia-like symptoms including blood pooling in my hands and feet, heart rate fluctuations greater than 30+ bpm upon standing, and losing the ability to sweat from my arms and legs. I became cold nearly always, and developed panic/adrenaline episodes not triggered by any external stimulus. Previous to vaccination, I was active in my local gym 15+ hours a week with weight training and cardiovascular training, and 3-6 months post vaccination, but exercise ability had become less than a tenth of what I was capable of before. Despite no evident physical injury as measured by MRI, physical therapists, X-Rays, or limited range of mobility, I developed extreme back, leg, neck, and calf tightness/pain, as though there is something poking me or clogging from the inside. The most troubling adverse event was a subjective sense of derealization as though I was not in my own body. This is not a psychological phenomenon, rather it is a transient loss of agency. A sensation of watching another person through my own eyes, especially given that I was no longer able to feel much of my body due to the loss of function. Specifically, I could no longer walk or even stand for long periods of time without becoming exhausted as though I would pass out. I went to the emergency room 3 times in 12 months, and I also pursued specialists in cardiology, rheumatology, neurology, orthopedic doctors, vascular surgeons, and so on. All tests performed suggested no pathology despite the
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle tightness, Nail discolouration, Neck pain, Nervous system disorder
Clinical narrative: Received vaccine due threat of termination of employment. Felt rush of dizziness and panic after receiving injection within 2 minutes. Sick for about 24 hours after. Life resumed as usual. Approximately 2 months post-vaccination, I developed chest pain, shortness of breath, and head pressure. By 6 months, I had developed numbness and tingling in my hands and feet, purple fingernails, dysautonomia-like symptoms including blood pooling in my hands and feet, heart rate fluctuations greater than 30+ bpm upon standing, and losing the ability to sweat from my arms and legs. I became cold nearly always, and developed panic/adrenaline episodes not triggered by any external stimulus. Previous to vaccination, I was active in my local gym 15+ hours a week with weight training and cardiovascular training, and 3-6 months post vaccination, but exercise ability had become less than a tenth of what I was capable of before. Despite no evident physical injury as measured by MRI, physical therapists, X-Rays, or limited range of mobility, I developed extreme back, leg, neck, and calf tightness/pain, as though there is something poking me or clogging from the inside. The most troubling adverse event was a subjective sense of derealization as though I was not in my own body. This is not a psychological phenomenon, rather it is a transient loss of agency. A sensation of watching another person through my own eyes, especially given that I was no longer able to feel much of my body due to the loss of function. Specifically, I could no longer walk or even stand for long periods of time without becoming exhausted as though I would pass out. I went to the emergency room 3 times in 12 months, and I also pursued specialists in cardiology, rheumatology, neurology, orthopedic doctors, vascular surgeons, and so on. All tests performed suggested no pathology despite the
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Panic reaction, Peripheral vascular disorder, Sensory disturbance, Thyroid function test normal
Clinical narrative: Received vaccine due threat of termination of employment. Felt rush of dizziness and panic after receiving injection within 2 minutes. Sick for about 24 hours after. Life resumed as usual. Approximately 2 months post-vaccination, I developed chest pain, shortness of breath, and head pressure. By 6 months, I had developed numbness and tingling in my hands and feet, purple fingernails, dysautonomia-like symptoms including blood pooling in my hands and feet, heart rate fluctuations greater than 30+ bpm upon standing, and losing the ability to sweat from my arms and legs. I became cold nearly always, and developed panic/adrenaline episodes not triggered by any external stimulus. Previous to vaccination, I was active in my local gym 15+ hours a week with weight training and cardiovascular training, and 3-6 months post vaccination, but exercise ability had become less than a tenth of what I was capable of before. Despite no evident physical injury as measured by MRI, physical therapists, X-Rays, or limited range of mobility, I developed extreme back, leg, neck, and calf tightness/pain, as though there is something poking me or clogging from the inside. The most troubling adverse event was a subjective sense of derealization as though I was not in my own body. This is not a psychological phenomenon, rather it is a transient loss of agency. A sensation of watching another person through my own eyes, especially given that I was no longer able to feel much of my body due to the loss of function. Specifically, I could no longer walk or even stand for long periods of time without becoming exhausted as though I would pass out. I went to the emergency room 3 times in 12 months, and I also pursued specialists in cardiology, rheumatology, neurology, orthopedic doctors, vascular surgeons, and so on. All tests performed suggested no pathology despite the
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Burning sensation, Gastrointestinal inflammation, Muscle spasms, Vaccine positive rechallenge
Clinical narrative: With each does I have had worsening symptoms of bowel inflammation, muscle spasms, and burning sensation in extremities.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Blood pressure increased, Hypertension, Therapy change
Clinical narrative: Blood Pressure spike, primary care physician doubled amloipine dosage.
Age: 40.0
Sex: M
Vaccine: COVID19, FLU4, HEP, TDAP
Symptoms: Extra dose administered
Clinical narrative: Duplicate IMZ for Flu shot...received 02/26/2024 already and then again 03/26/2024
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: RASH AND ITCHING ON BOTH ARMS AND SPREAD TO CHEST
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE REACTION. PT WAS GIVEN THE VACCINE THIS MORNING 3/26 AND IT EXPIRED 3/25.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Loss of consciousness
Clinical narrative: patient stood up then sat down, then he stood up walked a couple steps and passed out
Age: 16.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Immediate post-injection reaction, Posture abnormal, Seizure like phenomena, Staring
Clinical narrative: Administered both vaccines in left deltoid as requested. Patient said that she felt fine immediately after receiving vaccines. I was answering questions Mom had about HPV vaccine when we noted that patients head had rolled back and was rolling from right side to left side while her arms were straightening out at her sides. Her Mom called her name and I held on to her left shoulder, calling her name. She then picked her head up and looked at both of us and asked... " What? Did I pass out?" Then she said that she felt fine and gave a laugh. I asked her when last she ate and she said around 1:00PM. I gave her a sucker for some sugar. We sat and monitored her for about 10-15 minutes. She said she felt fine, and I asked her to stand up slowly and not move too fast. She did and said she felt fine. She started walking towards to door with her Mom at her side with no issues. She walked about 25 steps and then stopped, did not move. Her Mom called her name and I went to them. She was still just standing still. I grabbed her and made her sit back down on a chair. She was staring off into space for about 20 seconds then blinked and said that she felt fine. She was talking appropriately and stood back up unassisted. I put her in a wheelchair to take her to the car and she was talking throughout our walk. She was able to get into the car without assistance.
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Deafness, Ocular hyperaemia, Pneumonia
Clinical narrative: Relative called back next day saying pt. could not hear and eyes were bloodshot and suspected it might be from the vaccine. Pharmacist on duty told them to go to the ER and call us back to update us.  Today (03/26/24) relative came in and picked up medications that were sent over this morning for oral antibiotics and antibiotic eyedrop.  Pt. was diagnosed with pneumonia per relative consulted with counseling notes on the medications.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Condition aggravated, Dizziness, Fatigue, Feeling cold
Clinical narrative: Prior to vaccination, pt stated the fear of needle. pt stated she has a history of seizures but has been getting vaccines with no complications. rph reviewed the VARS with pt but pt still wanted to get the vaccine irrespective of her history of seizures. however, after vaccination, pt was very lethargic and complained of coldness and almost passed out. pt was closely monitored for almost 15 minutes in the vaccination room and then at the waiting area in the lobby. Pt was still feeling tired and weak for almost 20 minutes and stated she had a mild  incident  of seizure after 20 minutes.  After 30 minutes of monitoring, pt was feeling ok and left the pharmacy. a follow-up call was made an hour later and pt stated she is feeling ok. no adverse reaction was reported.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Seizure
Clinical narrative: Prior to vaccination, pt stated the fear of needle. pt stated she has a history of seizures but has been getting vaccines with no complications. rph reviewed the VARS with pt but pt still wanted to get the vaccine irrespective of her history of seizures. however, after vaccination, pt was very lethargic and complained of coldness and almost passed out. pt was closely monitored for almost 15 minutes in the vaccination room and then at the waiting area in the lobby. Pt was still feeling tired and weak for almost 20 minutes and stated she had a mild  incident  of seizure after 20 minutes.  After 30 minutes of monitoring, pt was feeling ok and left the pharmacy. a follow-up call was made an hour later and pt stated she is feeling ok. no adverse reaction was reported.
Age: 17.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: The client was present at a special mass vaccination event on 2-24-2024 at the Church. She received a Fluzone Quadrivalent vaccine (LOT# U8200CA) and a Havrix Hepatitis A vaccine (LOT# ADU-T9TL9) to the RD at 1617.   A documentation review later revealed that the client received a 1 ML dose of the Havrix vaccine, but the age-appropriate dose for her was actually 0.5 ML. This writer spoke with provider Dr. to apprise her of the situation and seek her response and recommendation. Dr. reported that this vaccination was not a medical concern, that this writer should focus on any side effects the client may have experienced, and that the client should proceed with her next age-appropriate dose per the standard vaccination schedule.   This writer also spoke with the vaccination team (RN, RN, and MA) who were present at the special event to determine the context surrounding the error. The vaccination event was held at the Church in order to serve a large encampment of refugees that have settled there. The vaccinators were prepared to see only clients aged 19 years and older, with a separate organization about 20 feet away providing vaccinations to clients aged 18 and younger. They report that they were working with the client through a interpreter, had conducted the standard screening and education per procedure, and had believed at the time that she was eligible for the vaccination, but now believe that she had accidentally gotten in the wrong line with her family.  This writer has provided verbal and written education to all staff members outlining the importance of verifying a client's age and using that information to determine their eligibility for their requested vaccine(s). The education highlighted that many vaccines can only be administered to certain age ranges and some have different doses depending on the age of the client (including Havrix) and that this creates a risk for medication errors. Staff were directed to review any available documentation and to directly confirm the client's DOB with the client before proceeding to vaccination.  There are significant challenges to reaching the client due to a lack of contact information s/t her living situation, but this writer is using all contact methods available to him and is hopeful that they will be successful in time. Once contact is made, this writer will explain the situation, the reporting process, and will relay the provider?s response and recommendations.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count normal, Echocardiogram normal, Electrocardiogram normal, Feeling of body temperature change, Full blood count normal
Clinical narrative: hand tremor, muscle weakness, excessive sweating, night sweats, neuropathic pain, sensation of body throbbing, pounding heart, headaches, loss of ability to thermoregulate (periods of always feeling too hot or too cold), burning and tingling sensations of the skin. Symptoms were debilitating for approximately three months, improved over the course of a year.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Magnetic resonance imaging normal, Metabolic function test normal, Muscular weakness
Clinical narrative: hand tremor, muscle weakness, excessive sweating, night sweats, neuropathic pain, sensation of body throbbing, pounding heart, headaches, loss of ability to thermoregulate (periods of always feeling too hot or too cold), burning and tingling sensations of the skin. Symptoms were debilitating for approximately three months, improved over the course of a year.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Neurological examination normal, Night sweats, Palpitations, Paraesthesia
Clinical narrative: hand tremor, muscle weakness, excessive sweating, night sweats, neuropathic pain, sensation of body throbbing, pounding heart, headaches, loss of ability to thermoregulate (periods of always feeling too hot or too cold), burning and tingling sensations of the skin. Symptoms were debilitating for approximately three months, improved over the course of a year.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count normal, Sensory disturbance, Skin burning sensation, Tremor
Clinical narrative: hand tremor, muscle weakness, excessive sweating, night sweats, neuropathic pain, sensation of body throbbing, pounding heart, headaches, loss of ability to thermoregulate (periods of always feeling too hot or too cold), burning and tingling sensations of the skin. Symptoms were debilitating for approximately three months, improved over the course of a year.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Feeling of body temperature change, Hyperaesthesia teeth, Muscular weakness, Nausea
Clinical narrative: hand tremor, muscle weakness, excessive sweating, night sweats, neuropathic pain, sensation of body throbbing, pounding heart, headaches, loss of ability to thermoregulate (periods of always feeling too hot or too cold), burning and tingling sensations of the skin. Symptoms were debilitating for approximately three months, improved over the course of a year.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Night sweats, Pain, Paraesthesia, Skin burning sensation
Clinical narrative: hand tremor, muscle weakness, excessive sweating, night sweats, neuropathic pain, sensation of body throbbing, pounding heart, headaches, loss of ability to thermoregulate (periods of always feeling too hot or too cold), burning and tingling sensations of the skin. Symptoms were debilitating for approximately three months, improved over the course of a year.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Tinnitus, Tremor, Vomiting
Clinical narrative: hand tremor, muscle weakness, excessive sweating, night sweats, neuropathic pain, sensation of body throbbing, pounding heart, headaches, loss of ability to thermoregulate (periods of always feeling too hot or too cold), burning and tingling sensations of the skin. Symptoms were debilitating for approximately three months, improved over the course of a year.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Vaccination failure, Varicella, Varicella virus test positive
Clinical narrative: Diagnosed with chicken pox by Varicella Zoster Virus PCR 3-11-24. 2 yr old sister had chicken pox, unvaccinated, approx 2-3 wks earlier as well as 6 yr old brother who was vaccinated for chicken pox x one yr. Mom wanted Vaers informed vaccines failed.