chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of ipol, max/low temperature reached: 1.6°CDuration: 6 hours & 21 minutes due to Human error with no reported adverse event; IPOL administered after a temperature excursion, Temp too cold for over 6 hours with no reported adverse event; Initial information received on 20-Nov-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to US-SA-2024SA329623 (master case).  This case involves 8 years old male patient (27 kg) and reporter reported temperature excursion of IPV (VERO) [IPOL], max/low temperature reached: 1.6°cduration: 6 hours & 21 minutes due to human error with no reported adverse event and IPOL administered after a temperature excursion, temp too cold for over 6 hours with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2024, the patient received a dose of 0.5 ml once suspect IPV (VERO) Suspension for injection (lot X1C891M, expiry date-31-OCT-2026) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) which was exposed to temperature excursion, max/low temperature reached: 1.6°cduration: 6 hours & 21 minutes due to human error with no reported adverse event (product storage error) and it was administered after a temperature excursion, temp too cold for over 6 hours with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Temperature excursion not found until 06-Nov-2024.  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.; Sender's Comments:  US-SA-2024SA329623:master case
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event, Product storage error
Clinical narrative: Vaccine given after a temperature excursion. Temp excursion found 11/6/24. Too Cold for 6 hours and 15min with no reported adverse event; Administrated another dose of IPOL with no reported adverse eventAdministrated another dose of IPOL with no reported adverse event; Initial information received on 20-Nov-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 12 years old female patient (48 kg) who received vaccine given after a temperature excursion. temp excursion found 11/6/24. too cold for 6 hours and 15min with no reported adverse event and Administrated another 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.   On an unknown date, the patient received a  dose of 0.5 ml of suspect IPV (VERO) (suspension for injection) lot 1C891M, strength, expiry date was unknown via intramuscular route in unknown administration site for Prophylactic vaccination (Immunization) and vaccine given after a temperature excursion. temp excursion found 11/6/24. too cold for 6 hours and 15min with no reported adverse event (Poor quality product administered) and Administrated another dose of IPV (VERO) [IPOL] (Extra dose 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: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired dose of ActHib  with no reported adverse event; Initial information received on 20-Nov-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 6 months old female patient who was given an expired dose of 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 Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix); Rotavirus vaccine live reassort oral 5v (Rotateq); and Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) for Immunisation.  On 12-Nov-2024, the patient received expired dose of HIB (PRP/T) VACCINE Powder and solvent for solution for injection, dose 0.5 ml 1x(once) lot UJ978AA expiry-08-Nov-2024 via unknown route in the left vastus lateralis for Immunisation (strength unknown) 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: 29.0
Sex: M
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: Nurse accidentally gave a patient YF-VAX with a sterile saline rather than the prepackaged diluent with no reported adverse event; Initial information received on 20-Nov-2024 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 29 years old male patient and reporter stated that nurse accidentally gave a patient yellow fever vaccine - [YF-VAX] with a sterile saline rather than the prepackaged diluent 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 influenza vaccine INACT SPLIT 3V (Fluarix); elasomeran (moderna COVID-19 vaccine); and typhoid vaccine polysacch VI (TYPHIM VI).  On 20-Nov-2024, nurse accidentally gave a patient 0.05 ml of yellow fever vaccine - Solution for injection (unknown strength and expiry date) once with lot UK118AA and expiry date 30-Sep-2025 via subcutaneous route in left arm for Immunization with a sterile saline rather than the prepackaged diluent with no reported adverse event (product preparation error) (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.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Product storage error
Clinical narrative: arm soreness; inappropriate use due to patient reporting a potential FLUZONE HD not stored in the recommended temperatures; Initial information received on 20-Nov-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced arm soreness after inappropriate use of potential Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] not stored in the recommended temperatures.  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 unknown (1x: once) dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site as influenza (influenza immunization) inappropriate use due to patient reporting a potential fluzone hd not stored in the recommended temperatures (poor quality product administered) (same day latency).  On an unknown date the patient developed arm soreness (pain in extremity) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (arm soreness).  At time of reporting, the outcome was Unknown for the event (arm soreness).  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: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired act-hib with no reported adverse event; Initial information received on 21-Nov-2024 regarding an unsolicited valid  non-serious case received from Nurse.  This case involves a 3 years old female patient who was administered an 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 influenza vaccine (influenza).  On 21-Nov-2024, the patient received expired 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength with lot UJ96488 and expiry date 08-NOV-2024 via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (Latency same day).  Reportedly, Nurse called to report that a patient was administered an expired ACT-HIB and asked if the patient needs another vaccine.   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: 26.0
Sex: F
Vaccine: RAB
Symptoms: Injection site rash, Urticaria
Clinical narrative: hives on their legs, chest; area around the injection site was a little blotchy; Initial information received on 25-Nov-2024 (with live follow up on 25-Nov-2024) regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 26 years old female patient who had hives on their legs, chest and area around the injection site was a little blotchy after receiving vaccine rabies (HDC) vaccine [Imovax rabies].  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 25-Nov-2024, the patient received a Dose 3 of 1 ml of suspect rabies (HDC) vaccine Powder and solvent for suspension for injection of standard strength once with lot X1B611M and expiry date 31-JUL-2026 via intramuscular route in the right deltoid for immunization.   On 25-Nov-2024 the patient developed hives on their legs, chest (urticaria) and area around the injection site was a little blotchy (rash macular) (Latency same day) following the administration of rabies (HDC) vaccine.  Reportedly, Nurse from health department reported that a patient had been scratched by a stray cat and received doses of RABIVERT at the hospital. Nurse administered IMOVAX Rabies as the third dose in the series at the health department. Caller contacted nurse after administration and reported hives on their legs, chest, and noted that the area around the injection site was a little blotchy. Nurse confirmed the patient did not have any reaction to the doses of RABIVERT she received in the emergency room. discussed Precautions section from PI and referred caller to patient's healthcare provider for assistance in determining which product the patient should receive based on her reaction post administration and medical history.  Action taken was 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.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Influenza, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: *I don?t know the brand of flu shot and didn?t want to guess* got two shots in the same arm, went home and raked leaves. By the time I went inside flu symptoms started (fine, as expected). By The next morning my arm was bright red, warm to the touch, raised, and hard/painful (not sore). Flu symptoms went away within 18 hours but ?Covid arm? (near perfect circle, diameter between 4-5?) went from pain to itchy. It?s been more than a week and it?s still red and itchy. Less red, but still visible.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: *I don?t know the brand of flu shot and didn?t want to guess* got two shots in the same arm, went home and raked leaves. By the time I went inside flu symptoms started (fine, as expected). By The next morning my arm was bright red, warm to the touch, raised, and hard/painful (not sore). Flu symptoms went away within 18 hours but ?Covid arm? (near perfect circle, diameter between 4-5?) went from pain to itchy. It?s been more than a week and it?s still red and itchy. Less red, but still visible.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of expired product with no reported adverse event; Initial information received on 21-Nov-2024  (with live follow up received on 21-Nov-2024 ) regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 5 years old female patient and reporter stated that inappropriate use due to administration of expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] 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 varicella zoster vaccine (varicella vaccine), polio vaccine and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunization   On 21-Nov-2024, the patient received expired 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine standard strength (unknown formulation) with lot 2CA28C1 and expiry date 04-Nov-2024 via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (latency same day).  Reportedly, Caller stated that she contacted us this morning regarding the vaccine. Caller stated that a patient was given expired dose of daptacel. and would like to know if there would be any adverse effects or should the patient be reimmunized. Manager from the facility said that the daptacel expired on 04-NOV-2024 but was inadvertently given to twins yesterday, 20-NOV-2024. They wanted to check information about what adverse effects they should look out for and whether they should revaccinate.   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.; Sender's Comments:  US-SA-2024SA344730:
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired daptacel as the second dose in the immunization series with no adverse event; Initial information received on 21-Nov-2024 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 6 months old male patient who received expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] as the second dose in the immunization series with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine, influenza vaccine and pneumococcal vaccine CONJ 7V (CRM197) (Prevnar).  On 21-Nov-2024, the patient received expired 0.5 ml of suspect DIphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection of standard strength with lot 2CA28C1 and expiry date 04-Nov-2024 via intramuscular route in the right thigh for immunization as the second dose in the immunization series with no adverse event (expired product administered) (latency same day)  Reportedly, Nurse stated one of the pediatric patients was given a daptacel that was a couple of weeks beyond the expiration date. The vaccine was given today and the expiration date was on 04-Nov-2024.   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: 26.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Computerised tomogram head normal, Confusional state, Electroencephalogram normal, Unresponsive to stimuli
Clinical narrative: mother went in to give medication at 9 pm. Found patient confused and not responding or answering questions. EMS was called and patient was taken to ED. About 3 am, patient came back to himself and was acting normally. Had CT head which was negative and had EEG that was normal.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient already received in 2023 & completed Shingrix. Office error to have given another series
Age: 92.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect OFFICE error: duplicate vaccine
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Noted nickel sized hard knot under skin @ injection site. Week prior exestinsive reddness and swelling at area about the size of a half dollar.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Notified by nurse that the correct COVID (6mo-4y) vaccine was aministered but was given undiluted rather than after diluaent was added. This led to teh administration fo the entire 3 dose vial to patient rather than just one dose as ordered. Parents were notified right away and advised to watch for side effects. Spoke with parent by phone several days later and no adverse effects were noted.
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: 10069327---PRODUCT QUALITY ISSUE^ 10069892---SYRINGE LEAK From JPSR: "Nurse was giving Flu Vaccine High Dose and vaccine leaked out of syringe Lot# UT8437DA Exp 2025/06 Influenza Vaccine FluZone High dose 0.5ml single dose Sanofi Pasteur Inc Lot# 4326210 Exp 2027/08/30 Hypo Needle Pro 25Gx1inc".
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Insomnia, Lymph node pain, Lymphadenopathy
Clinical narrative: lymph node swollen and painful, large swelling at injection site, flu-like symptoms, sleeplessness cut to severe nerve pain
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: lymph node swollen and painful, large swelling at injection site, flu-like symptoms, sleeplessness cut to severe nerve pain
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female
Clinical narrative: I am a retired pediatric nurse practitioner currently working in Public Health. I am deeply concerned about the Covid 19 mRNA vaccines and its potential association with TP53 mutations. I am informing you of a family cluster (my own) that in my professional opinion needs to be further investigated to rule out an association in susceptible individuals. Over the past 24 months, my first cousin (age 75) and her son (age 53) were both diagnosed with Glioblastomas and have since passed away. My sister was diagnosed with AML (roughly 1 yr ago) and has recently passed away. She was found to have an acquired TP53 mutation . 1 month ago, I was diagnosed with breast cancer. All of us received the mRNA vaccine (2 only Pfizer, 1 mixed Pfizer and Moderna and 1 Moderna only.) ALL of these cancers are associated with TP53 mutations. As we do not fully understand what stressors trigger and acquired mutation, I am pleading with you to investigate the cluster more closely. There may be other reports of similar family clusters. If there is a potential signal here, then the public should be alerted to the risk/benefit of getting any further mRNA vaccines until proper research/data analysis can be performed. Since cancer is not reported in the VAERS system, I worry that this uptick is being overlooked. Please let me know if this concern should be reported elsewhere. I am happy to speak.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure decreased, Echocardiogram, Loss of consciousness, Scan with contrast
Clinical narrative: Lumason contrast iv during echocardiogram caused anaphylaxis, unconsciousness, severe drop in blood pressure...rapid response team intervention and hospitalization. Had previous injection three months earlier with no known reaction. Had covid  shot 2-3 weeks before this injection.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration, Sleep disorder
Clinical narrative: I have been suffering from SIRVA by FLU vaccine injection since over a year ago. I had two vaccine injections on the same day in September 2023. I had pneumonia vaccine on my left arm and Flu on my right arm. The pain on my left arm disappeared in a few days but the pain on my right shoulder have gotten worse and I still have one. I think a nurse put a needle too high on my shoulder. I also have been diabetic last several years and I had Ozempic injections now and then. For over last 2 months I had 2mm injection per week. And I noticed that every time I had Ozempic injection my shoulder pain increase after a few hours or so and lasts a few days. I could not sleep because of the shoulder pain or could not move my arm freely. I am wondering if you have any information or recommendation about SIRVA and Ozempic.
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3, HPV9, TDAP
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Mild rhinorrhea and congestion after the vaccine. No fever. No other symptoms. Follow up at 2 weeks with some symptoms, mild, feeling better.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from regulatory authority and refers to a female adult patient (55-59-years-old) (origin). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023, the patient experienced Pneumococcal infection. On an unknown date in 2023, Streptococcus pneumoniae serotyping showed not available. At the time of reporting, the outcome of the event Pneumococcal infection was not known. The action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) regarding Pneumococcal infection was reported not applicable.   The causal relationship between Pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported. Upon internal review, the event pneumococcal infection was determined to be medically significant.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain, Pain in extremity
Clinical narrative: Left thigh dull pain upper
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient is 9 years old. He was given the DTap dose for children ages 6weeks to 6years. There was confusion as to what dose the patient was to receive as he had never received the 2nd dose of the series. There were no side effects.
Age: 77.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Acute respiratory distress syndrome, Acute respiratory failure, Angiogram abnormal, Computerised tomogram, Confusional state
Clinical narrative: 1/10/24 Seen by primary care provider (Dr.) Provider recommended that she get the RSV shot. She drove herself to the Pharmacy nearest her home. On recommendation of pharmacy staff, she received ABRYSVO powder for injection (for RSV) and Prevnar 20 suspension for injection (for pneumonia). After receiving the injections, she was walking in the store and felt lightheaded and nauseous. She sat down and apparently fainted. EMS was called by store staff. She was taken by ambulance to Medical Center. Presented to ER with near syncopal event after negative reaction to RSV and pneumonia vaccine. Admitted to hospital with diagnosis of sepsis due to pneumonia, SVC syndrome and ppm thrombosis. 1/18/24 Rehab Center  Discharged from Medical for syncope and collapse.   1/20/24 Medical Center Taken to (redacted) with acute respiratory distress with tachypnea. Did CT scan, ECG, lab work, ultrasound. Admitted to ICU.   1/22/24 Dr. Patient's cardiologist, Dr., reports that signs and symptoms not suggestive of acute SVC syndrome but instead more chronic process. Suggests more conservative treatment for now (OAC). Reasonable to assess with venogram.   1/22/24, 2 pm Medical Center Had angiography and successful revascularization of chronically occluded SVC.   1/23/24 Medical Center Recovering well from angiography.   1/24 Medical Center Patient very confused to place, person, surroundings, trying to leave the hospital. Patient was given Ativan, Haldol and restrained.   1/25/24 Rehab Center  Discharged from Medical Center, transported to rehab via medical transport. Presenting with acute respiratory failure with hypercapnia, pneumonia from unspecified organism and other diagnoses.   2/11/24 Discharged to  Discharged to home with home health and oxygen, wheelchair delivered to home. Transported by friend.   More detailed information from Medical Center and Rehab Center are available from the patient or the facility.
Age: 77.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Dizziness, Electrocardiogram, Hypercapnia, Intensive care, Laboratory test
Clinical narrative: 1/10/24 Seen by primary care provider (Dr.) Provider recommended that she get the RSV shot. She drove herself to the Pharmacy nearest her home. On recommendation of pharmacy staff, she received ABRYSVO powder for injection (for RSV) and Prevnar 20 suspension for injection (for pneumonia). After receiving the injections, she was walking in the store and felt lightheaded and nauseous. She sat down and apparently fainted. EMS was called by store staff. She was taken by ambulance to Medical Center. Presented to ER with near syncopal event after negative reaction to RSV and pneumonia vaccine. Admitted to hospital with diagnosis of sepsis due to pneumonia, SVC syndrome and ppm thrombosis. 1/18/24 Rehab Center  Discharged from Medical for syncope and collapse.   1/20/24 Medical Center Taken to (redacted) with acute respiratory distress with tachypnea. Did CT scan, ECG, lab work, ultrasound. Admitted to ICU.   1/22/24 Dr. Patient's cardiologist, Dr., reports that signs and symptoms not suggestive of acute SVC syndrome but instead more chronic process. Suggests more conservative treatment for now (OAC). Reasonable to assess with venogram.   1/22/24, 2 pm Medical Center Had angiography and successful revascularization of chronically occluded SVC.   1/23/24 Medical Center Recovering well from angiography.   1/24 Medical Center Patient very confused to place, person, surroundings, trying to leave the hospital. Patient was given Ativan, Haldol and restrained.   1/25/24 Rehab Center  Discharged from Medical Center, transported to rehab via medical transport. Presenting with acute respiratory failure with hypercapnia, pneumonia from unspecified organism and other diagnoses.   2/11/24 Discharged to  Discharged to home with home health and oxygen, wheelchair delivered to home. Transported by friend.   More detailed information from Medical Center and Rehab Center are available from the patient or the facility.
Age: 77.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Medical device site thrombosis, Nausea, Patient restraint, Pneumonia, Presyncope
Clinical narrative: 1/10/24 Seen by primary care provider (Dr.) Provider recommended that she get the RSV shot. She drove herself to the Pharmacy nearest her home. On recommendation of pharmacy staff, she received ABRYSVO powder for injection (for RSV) and Prevnar 20 suspension for injection (for pneumonia). After receiving the injections, she was walking in the store and felt lightheaded and nauseous. She sat down and apparently fainted. EMS was called by store staff. She was taken by ambulance to Medical Center. Presented to ER with near syncopal event after negative reaction to RSV and pneumonia vaccine. Admitted to hospital with diagnosis of sepsis due to pneumonia, SVC syndrome and ppm thrombosis. 1/18/24 Rehab Center  Discharged from Medical for syncope and collapse.   1/20/24 Medical Center Taken to (redacted) with acute respiratory distress with tachypnea. Did CT scan, ECG, lab work, ultrasound. Admitted to ICU.   1/22/24 Dr. Patient's cardiologist, Dr., reports that signs and symptoms not suggestive of acute SVC syndrome but instead more chronic process. Suggests more conservative treatment for now (OAC). Reasonable to assess with venogram.   1/22/24, 2 pm Medical Center Had angiography and successful revascularization of chronically occluded SVC.   1/23/24 Medical Center Recovering well from angiography.   1/24 Medical Center Patient very confused to place, person, surroundings, trying to leave the hospital. Patient was given Ativan, Haldol and restrained.   1/25/24 Rehab Center  Discharged from Medical Center, transported to rehab via medical transport. Presenting with acute respiratory failure with hypercapnia, pneumonia from unspecified organism and other diagnoses.   2/11/24 Discharged to  Discharged to home with home health and oxygen, wheelchair delivered to home. Transported by friend.   More detailed information from Medical Center and Rehab Center are available from the patient or the facility.
Age: 77.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Revascularisation procedure, Sepsis, Superior vena cava occlusion, Syncope, Tachypnoea
Clinical narrative: 1/10/24 Seen by primary care provider (Dr.) Provider recommended that she get the RSV shot. She drove herself to the Pharmacy nearest her home. On recommendation of pharmacy staff, she received ABRYSVO powder for injection (for RSV) and Prevnar 20 suspension for injection (for pneumonia). After receiving the injections, she was walking in the store and felt lightheaded and nauseous. She sat down and apparently fainted. EMS was called by store staff. She was taken by ambulance to Medical Center. Presented to ER with near syncopal event after negative reaction to RSV and pneumonia vaccine. Admitted to hospital with diagnosis of sepsis due to pneumonia, SVC syndrome and ppm thrombosis. 1/18/24 Rehab Center  Discharged from Medical for syncope and collapse.   1/20/24 Medical Center Taken to (redacted) with acute respiratory distress with tachypnea. Did CT scan, ECG, lab work, ultrasound. Admitted to ICU.   1/22/24 Dr. Patient's cardiologist, Dr., reports that signs and symptoms not suggestive of acute SVC syndrome but instead more chronic process. Suggests more conservative treatment for now (OAC). Reasonable to assess with venogram.   1/22/24, 2 pm Medical Center Had angiography and successful revascularization of chronically occluded SVC.   1/23/24 Medical Center Recovering well from angiography.   1/24 Medical Center Patient very confused to place, person, surroundings, trying to leave the hospital. Patient was given Ativan, Haldol and restrained.   1/25/24 Rehab Center  Discharged from Medical Center, transported to rehab via medical transport. Presenting with acute respiratory failure with hypercapnia, pneumonia from unspecified organism and other diagnoses.   2/11/24 Discharged to  Discharged to home with home health and oxygen, wheelchair delivered to home. Transported by friend.   More detailed information from Medical Center and Rehab Center are available from the patient or the facility.
Age: 77.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Ultrasound scan, Wheelchair user
Clinical narrative: 1/10/24 Seen by primary care provider (Dr.) Provider recommended that she get the RSV shot. She drove herself to the Pharmacy nearest her home. On recommendation of pharmacy staff, she received ABRYSVO powder for injection (for RSV) and Prevnar 20 suspension for injection (for pneumonia). After receiving the injections, she was walking in the store and felt lightheaded and nauseous. She sat down and apparently fainted. EMS was called by store staff. She was taken by ambulance to Medical Center. Presented to ER with near syncopal event after negative reaction to RSV and pneumonia vaccine. Admitted to hospital with diagnosis of sepsis due to pneumonia, SVC syndrome and ppm thrombosis. 1/18/24 Rehab Center  Discharged from Medical for syncope and collapse.   1/20/24 Medical Center Taken to (redacted) with acute respiratory distress with tachypnea. Did CT scan, ECG, lab work, ultrasound. Admitted to ICU.   1/22/24 Dr. Patient's cardiologist, Dr., reports that signs and symptoms not suggestive of acute SVC syndrome but instead more chronic process. Suggests more conservative treatment for now (OAC). Reasonable to assess with venogram.   1/22/24, 2 pm Medical Center Had angiography and successful revascularization of chronically occluded SVC.   1/23/24 Medical Center Recovering well from angiography.   1/24 Medical Center Patient very confused to place, person, surroundings, trying to leave the hospital. Patient was given Ativan, Haldol and restrained.   1/25/24 Rehab Center  Discharged from Medical Center, transported to rehab via medical transport. Presenting with acute respiratory failure with hypercapnia, pneumonia from unspecified organism and other diagnoses.   2/11/24 Discharged to  Discharged to home with home health and oxygen, wheelchair delivered to home. Transported by friend.   More detailed information from Medical Center and Rehab Center are available from the patient or the facility.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Resident was given a Spikevax on 11-20-24 at 0600  to the left deltoid and the resident was then given a 2nd dose of Spikevax to right deltoid on 11-21-24@ 1226 inadvertenly. Resident exhibited no signs or symptoms of any adverse effects following incident. Vital signs remain stable with no complaints voiced or observed.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Condition aggravated, Dry mouth, Ear pain
Clinical narrative: A couple hours after injection begin to have severe dry mouth. Can?t seem to get enough water to fix the problem. I drink plenty of water and am well hydrated but still horrible dry mouth.  Then woke up in the middle of the night with shoulder pain, which I know is normal, but then it moved to my right ear and neck, then it moved to my elbows and head, then it moved my right hip and toes. I have some arthritis in some of those areas and it seems to have triggered my arthritis horribly. The next morning still have a headache and I feel worse than I did the four times that I actually got Covid.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: A couple hours after injection begin to have severe dry mouth. Can?t seem to get enough water to fix the problem. I drink plenty of water and am well hydrated but still horrible dry mouth.  Then woke up in the middle of the night with shoulder pain, which I know is normal, but then it moved to my right ear and neck, then it moved to my elbows and head, then it moved my right hip and toes. I have some arthritis in some of those areas and it seems to have triggered my arthritis horribly. The next morning still have a headache and I feel worse than I did the four times that I actually got Covid.
Age: 1.67
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Death, Pyrexia, Skin warm, Unresponsive to stimuli
Clinical narrative: pt was feeling warm on Sunday Sept 22, On Monday Sept 23 at around 1AM the parents returned from a wedding  to pick child up from his grandmothers house and they found him unresponsive facing down in the bed. He was dead.  His last time awake was a few hours earlier the grandmother heard him crying and she came into the room and gave him his pacifier and he went back to sleep.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: rash started on torso about 10 days after receiving the flu vaccine and then spread to a full body rash over the next 5 days. She saw her PCP on 11/30 via telehealth
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already received Prevnar 20 one year prior to receiving this dose. Patient was not due at time of administration. Duplicate vaccine on record, no adverse reaction occurred.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: I have had a migraine since the flu shot.  It has been 2 weeks of a non stop migraine in which my medication prescribed after the same issue with the covid 19 vaccine occurred is not working.  I was instructed to report
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Right arm pain in deltoid muscle, weakness in arm, ongoing pain x months
Age: 41.0
Sex: F
Vaccine: CHIK, CHOL, TYP
Symptoms: Pain, Pyrexia, Rash, Rash macular
Clinical narrative: Within 4 days after vaccination developed fever, body aches; complaining of macular rash hands, back and spreading over body last few days
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Hypertension, Injection site bruising, Injection site erythema, Injection site haemorrhage
Clinical narrative: pt says the person that gave her the injection hit a vain. It turned red at the injection site and bled and then her arm turned black and blue the next day after the vaccine.  She applied ice to help with the pain. She bled alot and has  never bled after getting a flu shot before. It took over a week for the swelling and pain to go away. She developed a swollen tonsil about 5 days after the shot. Her throat was a little sore. She went to see her Doctor. It was 12/2/24 before she could get in to see him. Her BP was high. He prescribed her antibiotics and sent for blood work. She is to follow up on 12/16 after blood work results to come back.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Oropharyngeal pain, Tonsillar hypertrophy
Clinical narrative: pt says the person that gave her the injection hit a vain. It turned red at the injection site and bled and then her arm turned black and blue the next day after the vaccine.  She applied ice to help with the pain. She bled alot and has  never bled after getting a flu shot before. It took over a week for the swelling and pain to go away. She developed a swollen tonsil about 5 days after the shot. Her throat was a little sore. She went to see her Doctor. It was 12/2/24 before she could get in to see him. Her BP was high. He prescribed her antibiotics and sent for blood work. She is to follow up on 12/16 after blood work results to come back.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site
Age: 1.08
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given a Vaxelis at their visit instead of the varivax that was supposed to be given at that visit.  Parent was notified and has been addressed with the nurse that gave the injection and noted in the patient's chart. No adverse symptoms noted per MD and parent.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction. In Error Pt was given an extra dose of Pentacel outside of normal vaccine schedule
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient received Dtap/IPV (Quadracel) vaccine. Due to patient being 7 years of age patient needed to received Tdap instead of Dtap. Physician and nurse aware of this error.  Currently in the process of reaching out to parents to have child come back in 4 weeks from dtap vaccination for revaccination with Tdap vaccine for adequate protection.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: Adhesive capsulitis of left shoulder
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient got a dose of Influnza Fluzone High Dose on 11/27/24 from their provider's office. Fluzone High Dose vaccine was also administered at pharmacy Store on 12/2/24. RN called and stated patient requested vaccine for "over 65 year old" from pharmacy and was meant to get RSV vaccine (Arexvy/Abrysvo) but was given Fluzone High Dose instead which patient already received less than a week earlier. RN stated patient has no symptoms right now that we are aware of.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Acute pain of left shoulder
Age: 25.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Axillary mass, Axillary pain, Ultrasound scan
Clinical narrative: Pt seen in urgent care on 12/3/2024 for bump under L armpit that had started after vaccine administration and present for one week. Pt states developed painful large bump under the L armpit a few hours after receiving the TDAP and Influenza vaccines. Initially bump was larger. At time of assessment pt has a firm palpable mass under L axilla w/o noticeable erythema or external symptoms. VS were normal at time of assessment and pt declined having fever, chills, or body aches, vomiting, nausea or abdominal pain. Advised warm compress, tylenol/IBU for pain and ultrasound ordered for further eval of mass.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given HD flu on 11/9/24 and on 11/26/24. No adverse reactions noted at this time.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Left upper arm pain
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Alopecia, Blood test
Clinical narrative: Child started losing hair in two spots and now hair loss is significant. He recently had a haircut prior to the shot and had no balding.
Age: 10.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Dtap/IPV (Quadracel) vaccination and should have received Tdap instead of Dtap due to being 10 years of age. Physician and nurse aware. Currently trying to get in touch with parents to inform of vaccine error and bring patient back in 4 weeks to revaccinate with Tdap for adequate protection.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Patient received to doses of Hepatitis B vaccine in the same day, within 2-3 hours of each other. Staff gave 2nd dose of Hepatitis B vaccine unknowingly after patient was seen by a previous provider in another office. Staff could not find patient in the immunization data base and unknowingly gave vaccine after parent consent.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient needed TDAP based on being over 7 years of age  but received DTaP instead.  No adverse reaction to vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was accidentally given the Covid vaccine for the 6 month- 11 year age range rather than the 12+ formulation.
Age: 20.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Eyelid rash, Rash
Clinical narrative: Patient got a rash on the arm with the flu shot and she got a slight rash on her face and around eye
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tachycardia
Clinical narrative: Tachycardia and nausea
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB, PNC20, PNC20
Symptoms: Injection site discharge, Injection site haemorrhage, Injection site mass, Injection site swelling, Ultrasound scan abnormal
Clinical narrative: Subcutaneous mass' at injection sites for both 4 month vaccines  & 6 month vaccines  At 6 month injection sites there was a large area of swelling which erupted with blood & pus on right leg leaving a  with remaining scab on right leg from 4 month injection on right leg. On 12/1/24 scab started to have pus discharge from scab. Pt was admitted to Hospial on 12/3/24 for this.   After 6 month injections on the left leg pt developed a mass. Ultrasound was done at Hospital on 11/26/24 , reoprt indicated concern for abscess. Pt was seen at Hospital Emergency room & ultrasound was repeated and thought to be hematoma. Pt is admitted to Hospital 12/3/24 Pt. received 4 month vaccines on 8/30/2024 and 6 month vaccines on 10/25/24. Pt was forst seen in office for reactions on 11/23/2024
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore left arm, severe headache
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was accidentally given the Covid vaccine intended for patients 6 months-11 years rather than the 12+ formulation.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired.