chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Fatigue, Hypoaesthesia oral
Clinical narrative: Numbness in tougne; Cancker sores; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (Numbness in tougne), APHTHOUS ULCER (Cancker sores) and FATIGUE (Tiredness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (she does has drugs allergies.).   On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2023, the patient experienced HYPOAESTHESIA ORAL (Numbness in tougne) (seriousness criterion medically significant), APHTHOUS ULCER (Cancker sores) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA ORAL (Numbness in tougne), APHTHOUS ULCER (Cancker sores) and FATIGUE (Tiredness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had taken three vaccinations and received side affects as numbness in tougne, cancker sores and tiredness. Patient had concern about taking fourth vaccination.   Treatment information was not reported.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Neuropathy peripheral, Respiratory failure
Clinical narrative: PERIPHERAL NEUROPATHY CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient came into the clinic for family planning services. Patient had not missed a period and wasn't due for a period for a few more weeks. Menquadfi was due and was administered before the patient was seen by the practitioner. Once the patient was seen by the practitioner, the practitioner ordered a pregnancy test because she was going to place a Nexplanon in the patient. The pregnancy test came back positive. Patient's last period was June 2, 2023 and menquadfi was administered June 27, 2023. Patient tolerated the vaccine well. Patient's due date is determined to be 3/8/24.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired dose administered
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram pulmonary abnormal, Computerised tomogram abdomen, Computerised tomogram neck, Computerised tomogram thorax abnormal, Cough
Clinical narrative: Relatively quick development of flu like symptoms, cough, and and subsequent more persistent cough and increasing dyspnea on exertion, ultimately diagnosed is bilateral moderate pulmonary emboli.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea exertional, Echocardiogram, Influenza like illness, Laboratory test abnormal, Pulmonary embolism
Clinical narrative: Relatively quick development of flu like symptoms, cough, and and subsequent more persistent cough and increasing dyspnea on exertion, ultimately diagnosed is bilateral moderate pulmonary emboli.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired dose administered
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angina pectoris, Symptom recurrence
Clinical narrative: STABLE ANGINA ACUTE NON ST ELEVATION MI 2/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose given
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 14.0
Sex: M
Vaccine: DTAP, HEPA, HPV9
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: INDIVIDUAL THAT ADMINISTERED VACCINE DID NOT MIX IT PER MANUFACTURER INSTRUCTIONS. THE MEN A (ORANGE CAP) WAS NOT MIXED WITH MENCYW(GREY CAP) BUT RATHER WITH THE DILUENT FOR THE LIVE VACCINE SOLUTION. PATIENT DID NOT GET THE COMPLETE DOSE OF MENVEO. MOTHER INFORMED PATIENT WILL NEED DOSE REPEATED .
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose given
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: INDIVIDUAL THAT GAVE VACCINE DID NOT MIX IT ACCORDING TO THE MANUFACTURERS GUIDELINES. MENA (ORANGE CAP) WAS NOT MIXED WITH THE MENCYW (GREY CAP) INSTEAD IT WAS MIXED WITH THE LIVE VIRUS DILUENT SO PATIENT DID NOT RECEIVE THE ENTIRE MENVEO DOSE. MOTHER WAS INFORMED THAT THE DOSE IS INVALID AND PATIENT WILL NEED DOSE REPEATED.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Upon receiving covid vaccine client started feeling dizzy upon exiting clinic door to sit down in the lobby for 15 min wait. but did notify nurse. At 9:25am  clients spouse seeked help from nurse due to client still feeling dizzy. Nurse took client in a wheelchair into a clinic room. Client mentioned breakfast had been consumed and had drank water prior to coming to todays appointment. Two nurses assisted client in laying down on exam room table. Placed a pillow under clients head. Blood pressure was 124/68. Client also complained of still feeling numbness and tingling in both hands. After 5min. assisted client in sitting up on exam table. Gave client a cup of water. By that time client said numbness & tingling was very minimum and only sensation she had was cold hands. Client mentioned dizziness had improved and was mild. Client felt comfortable in walking out to go home and rest. Clients spouse & nurse walked client to car with no difficulties. Client was in clinic room 10 min total.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: 2.5 inch diameter swelling, heat, redness, significant pain and soreness. Site is very hard to the touch. Edematous, erythematous, circular.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: 2.5 inch diameter swelling, heat, redness, significant pain and soreness. Site is very hard to the touch. Edematous, erythematous, circular.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Epilepsy, Obstructive sleep apnoea syndrome, Partial seizures
Clinical narrative: SIMPLE PARTIAL EPILEPSY, INTRACTABLE EPILEPSY, UNSPECIFIED OBSTRUCTIVE SLEEP APNEA
Age: 41.0
Sex: M
Vaccine: HPV9
Symptoms: Pain, Vaccination site pain
Clinical narrative: Patient has had arm soreness in area of vaccine administered x 10 days and pain in that area with picking up his 6 month child since.  No other numbness or radiculopathy.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Hypoacusis
Clinical narrative: Lost most of my hearing in my right ear.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: The day after the 3rd vaccine tinnitus began and continues to this day
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired MMR vaccine during well child clinic visit. No adverse reactions experienced. Provider and parent was notified.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Hypertension
Clinical narrative: high blood pressure , heart feels like it flutters
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blood creatinine increased, Blood glucose abnormal, Body temperature increased, Carbon dioxide abnormal, Chest X-ray normal
Clinical narrative: Pt developed temp 103 and had a "seizure".  Mom did not administer fever reducer for the elevated temp.  She called ambulance and was taken to local emergency department.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Full blood count abnormal, Laboratory test normal, Metabolic function test abnormal, Neutrophil count increased, Seizure
Clinical narrative: Pt developed temp 103 and had a "seizure".  Mom did not administer fever reducer for the elevated temp.  She called ambulance and was taken to local emergency department.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Pt developed temp 103 and had a "seizure".  Mom did not administer fever reducer for the elevated temp.  She called ambulance and was taken to local emergency department.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: Pt is currently pregnant 29+0 weeks. EDD-9/18/23. Pt was given the HPV vaccine, instead of the intended TDAP.  No adverse effects, or symptoms.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Tdap vaccine was given too early to patient at appointment. System showed it as recommended, but it had not been ten years since it was last given and it was not due yet. Patient was informed while still in the office of the error and discussed with PCP during visit.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Hypertrichosis, Injection site discolouration, Injection site granuloma, Injection site nodule, Injection site pruritus
Clinical narrative: Pt. received the Dtap on 5/10/22 and developed a nodule on the right thigh Pt. received the Hep A on 10/14/22 and developed a nodule on the left thigh From that point forward the area where the injections were given became pruritic granulomas with periods of exacerbation continuing now for over a year with areas of blue to brown discoloration (varies), hyperpigmentation and hypertrichosis, sleep disturbances and skin break down from scratching. Treated topically with hydrocortisone ointment and hydrocolliod dressings when flare ups occur. Condition continues to persist daily.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Skin disorder, Skin hyperpigmentation, Sleep disorder
Clinical narrative: Pt. received the Dtap on 5/10/22 and developed a nodule on the right thigh Pt. received the Hep A on 10/14/22 and developed a nodule on the left thigh From that point forward the area where the injections were given became pruritic granulomas with periods of exacerbation continuing now for over a year with areas of blue to brown discoloration (varies), hyperpigmentation and hypertrichosis, sleep disturbances and skin break down from scratching. Treated topically with hydrocortisone ointment and hydrocolliod dressings when flare ups occur. Condition continues to persist daily.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient was given Trumenba to start Men B series and then given Bexsero for 2nd Men B
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypoxia, Respiratory failure, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 1/17/2023 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 1.5
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: Patient was given IPV instead of Dtap. IPV was given to early. Patient didn't have adverse reactions while in clinic. And Dtap was administered.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Embolic stroke
Clinical narrative: ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT, UNSPECIFIED VEIN
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Contusion, Injection site erythema, Injection site swelling, Peripheral swelling, Rash
Clinical narrative: Day 1 after shots, localized redness and swelling at injection sites (sub q, worse than IM).  Day 2 after shots, left leg was swollen from thigh crease to knee. Red blotchy rash covering entire thigh.  Day 3, swelling was subsiding and area was bruised in appearance.  No treatment was needed other than Tylenol and cool compresses.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: Day 1 after shots, localized redness and swelling at injection sites (sub q, worse than IM).  Day 2 after shots, left leg was swollen from thigh crease to knee. Red blotchy rash covering entire thigh.  Day 3, swelling was subsiding and area was bruised in appearance.  No treatment was needed other than Tylenol and cool compresses.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: The diluent was administered to the patient instead of the diluted vaccine. The patient did not have any adverse reaction following the administrations. The patient's parent has been notified. The patient is scheduled to receive the vaccine at their 9-month well-child visit. The RN administering the vaccine has been educated.
Age: 22.0
Sex: F
Vaccine: PNC15
Symptoms: Nausea, Wrong product administered
Clinical narrative: Patient was given vaccine by mistake; she was supposed to get Gardasil 9 shot 3. She experienced nausea on Sunday which was did not suspect was caused by the vaccines.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: CHRONIC HYPOTENSION
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina unstable, Hypotension
Clinical narrative: UNSTABLE ANGINA HYPOTENSION
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Dizziness, Fatigue, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient called the pharmacy this morning claiming to have experienced light headedness, sweating and tiredness before passing out on the floor of her kitchen trying to get a drink of water. She has no memory of passing out or how long she was on the floor! Said she had a sore arm from the shot but felt fine last night. Advised patient to seek medication attention as she had a bump on the back of her head. She was feeling better when she called but told her I would report adverse event online and as well as to my management team.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient called the pharmacy this morning claiming to have experienced light headedness, sweating and tiredness before passing out on the floor of her kitchen trying to get a drink of water. She has no memory of passing out or how long she was on the floor! Said she had a sore arm from the shot but felt fine last night. Advised patient to seek medication attention as she had a bump on the back of her head. She was feeling better when she called but told her I would report adverse event online and as well as to my management team.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angina pectoris
Clinical narrative: ANGINA, UNSPECIFIED ACUTE NON ST ELEVATION MI
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Malaise
Clinical narrative: Patient experienced BALANCE ISSUES resulting in him bumping into things. He also felt very sick. Experienced symptoms for about 24 hours
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Electrocardiogram, Electroencephalogram, Full blood count, Magnetic resonance imaging
Clinical narrative: Focal onset seizure
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Partial seizures
Clinical narrative: Focal onset seizure
Age: 10.0
Sex: M
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a patient over 7 years old
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Cold sweat, Concussion, Dizziness, Fall, Head injury
Clinical narrative: Pt's 11 year old vaccines (HPV, Tdap, MCV4) were administered by RN with him sitting on the end of the exam table at approximately 8:30. Tdap and MCV4 were administered in the left arm, HPV last in the right arm. The RN walked away instantly and pt. fainted instantly, fell face first off the exam table and hit his head extremely hard on the ground feet from the RN?s feet who was throwing things away. Pt then appeared to seize for about 5 seconds according to his pediatrician (but the ER dr. and paramedics later said it was just a reaction to the concussion), and went unconscious for 5-10 seconds.  Dr. Office monitored pt. for over 2 hours on the exam room floor with a pulse that would get faint at times and every time he got up he got dizzy and would sweat profusely and was very clammy. Dr. Office called EMS after 2 hours and he was taken by ambulance to hospital. He was diagnosed with Vasovagal Syncope and a Concussion with loss of consciousness. They never did do a CT Head scan.  The CDC indicates that ?Fainting and related injuries after immunizations can be prevented. Many falls due to fainting can be prevented by having the patient sit or lie down.  For this reason, experts recommend having patients sit in a chair or lay down when they receive a vaccination.  In addition, patients should be observed for 15 minutes after vaccination.?  Clinic did not follow this recommendation. It appears safety protocol was not followed to prevent injury from a possible fainting episode.  They had pt seated upright on the end of the exam table and the nurse walked away immediately after the 3rd poke (which was the HPV vaccination). Dr. had mom engaged in conversation on the computer with their backs turned to pt. I believe clinic should make protocol improvements to prevent this from happening again in the future and that they are responsible for not following simple vaccine safety precautions that could have prevented pt. from getting hurt. As Dr. herself stated that this happened under their watch and she has reported it. Dr. acknowledged that this incident shouldn?t have happened and could have been prevented. She shared that their clinic is going to use it as a learning situation. A nurse whom I spoke with on 7/3/2023 said that as a result of pt.s incident, reminder email went out to remind all staff on what protocol should be followed for positioning of shots. It should be 45 degree angle in bed or in a seated chair with arms. Nurse did say that this was always the protocol, but it was missed that day with pt. and she apologized.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Laboratory test abnormal, Loss of consciousness, Pulse abnormal
Clinical narrative: Pt's 11 year old vaccines (HPV, Tdap, MCV4) were administered by RN with him sitting on the end of the exam table at approximately 8:30. Tdap and MCV4 were administered in the left arm, HPV last in the right arm. The RN walked away instantly and pt. fainted instantly, fell face first off the exam table and hit his head extremely hard on the ground feet from the RN?s feet who was throwing things away. Pt then appeared to seize for about 5 seconds according to his pediatrician (but the ER dr. and paramedics later said it was just a reaction to the concussion), and went unconscious for 5-10 seconds.  Dr. Office monitored pt. for over 2 hours on the exam room floor with a pulse that would get faint at times and every time he got up he got dizzy and would sweat profusely and was very clammy. Dr. Office called EMS after 2 hours and he was taken by ambulance to hospital. He was diagnosed with Vasovagal Syncope and a Concussion with loss of consciousness. They never did do a CT Head scan.  The CDC indicates that ?Fainting and related injuries after immunizations can be prevented. Many falls due to fainting can be prevented by having the patient sit or lie down.  For this reason, experts recommend having patients sit in a chair or lay down when they receive a vaccination.  In addition, patients should be observed for 15 minutes after vaccination.?  Clinic did not follow this recommendation. It appears safety protocol was not followed to prevent injury from a possible fainting episode.  They had pt seated upright on the end of the exam table and the nurse walked away immediately after the 3rd poke (which was the HPV vaccination). Dr. had mom engaged in conversation on the computer with their backs turned to pt. I believe clinic should make protocol improvements to prevent this from happening again in the future and that they are responsible for not following simple vaccine safety precautions that could have prevented pt. from getting hurt. As Dr. herself stated that this happened under their watch and she has reported it. Dr. acknowledged that this incident shouldn?t have happened and could have been prevented. She shared that their clinic is going to use it as a learning situation. A nurse whom I spoke with on 7/3/2023 said that as a result of pt.s incident, reminder email went out to remind all staff on what protocol should be followed for positioning of shots. It should be 45 degree angle in bed or in a seated chair with arms. Nurse did say that this was always the protocol, but it was missed that day with pt. and she apologized.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Seizure, Syncope
Clinical narrative: Pt's 11 year old vaccines (HPV, Tdap, MCV4) were administered by RN with him sitting on the end of the exam table at approximately 8:30. Tdap and MCV4 were administered in the left arm, HPV last in the right arm. The RN walked away instantly and pt. fainted instantly, fell face first off the exam table and hit his head extremely hard on the ground feet from the RN?s feet who was throwing things away. Pt then appeared to seize for about 5 seconds according to his pediatrician (but the ER dr. and paramedics later said it was just a reaction to the concussion), and went unconscious for 5-10 seconds.  Dr. Office monitored pt. for over 2 hours on the exam room floor with a pulse that would get faint at times and every time he got up he got dizzy and would sweat profusely and was very clammy. Dr. Office called EMS after 2 hours and he was taken by ambulance to hospital. He was diagnosed with Vasovagal Syncope and a Concussion with loss of consciousness. They never did do a CT Head scan.  The CDC indicates that ?Fainting and related injuries after immunizations can be prevented. Many falls due to fainting can be prevented by having the patient sit or lie down.  For this reason, experts recommend having patients sit in a chair or lay down when they receive a vaccination.  In addition, patients should be observed for 15 minutes after vaccination.?  Clinic did not follow this recommendation. It appears safety protocol was not followed to prevent injury from a possible fainting episode.  They had pt seated upright on the end of the exam table and the nurse walked away immediately after the 3rd poke (which was the HPV vaccination). Dr. had mom engaged in conversation on the computer with their backs turned to pt. I believe clinic should make protocol improvements to prevent this from happening again in the future and that they are responsible for not following simple vaccine safety precautions that could have prevented pt. from getting hurt. As Dr. herself stated that this happened under their watch and she has reported it. Dr. acknowledged that this incident shouldn?t have happened and could have been prevented. She shared that their clinic is going to use it as a learning situation. A nurse whom I spoke with on 7/3/2023 said that as a result of pt.s incident, reminder email went out to remind all staff on what protocol should be followed for positioning of shots. It should be 45 degree angle in bed or in a seated chair with arms. Nurse did say that this was always the protocol, but it was missed that day with pt. and she apologized.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Cold sweat, Fall, Feeling of body temperature change, Generalised tonic-clonic seizure, Head injury
Clinical narrative: Pt's 11 year old vaccines (HPV, Tdap, MCV4) were administered by RN with him sitting on the end of the exam table at approximately 8:30. Tdap and MCV4 were administered in the left arm, HPV last in the right arm. The RN walked away instantly and pt. fainted instantly, fell face first off the exam table and hit his head extremely hard on the ground feet from the RN?s feet who was throwing things away. Pt then appeared to seize for about 5 seconds according to his pediatrician (but the ER dr. and paramedics later said it was just a reaction to the concussion), and went unconscious for 5-10 seconds.  Dr. Office monitored pt. for over 2 hours on the exam room floor with a pulse that would get faint at times and every time he got up he got dizzy and would sweat profusely and was very clammy. Dr. Office called EMS after 2 hours and he was taken by ambulance to hospital. He was diagnosed with Vasovagal Syncope and a Concussion with loss of consciousness. They never did do a CT Head scan.  The CDC indicates that ?Fainting and related injuries after immunizations can be prevented. Many falls due to fainting can be prevented by having the patient sit or lie down.  For this reason, experts recommend having patients sit in a chair or lay down when they receive a vaccination.  In addition, patients should be observed for 15 minutes after vaccination.?  Clinic did not follow this recommendation. It appears safety protocol was not followed to prevent injury from a possible fainting episode.  They had pt seated upright on the end of the exam table and the nurse walked away immediately after the 3rd poke (which was the HPV vaccination). Dr. had mom engaged in conversation on the computer with their backs turned to pt. I believe clinic should make protocol improvements to prevent this from happening again in the future and that they are responsible for not following simple vaccine safety precautions that could have prevented pt. from getting hurt. As Dr. herself stated that this happened under their watch and she has reported it. Dr. acknowledged that this incident shouldn?t have happened and could have been prevented. She shared that their clinic is going to use it as a learning situation. A nurse whom I spoke with on 7/3/2023 said that as a result of pt.s incident, reminder email went out to remind all staff on what protocol should be followed for positioning of shots. It should be 45 degree angle in bed or in a seated chair with arms. Nurse did say that this was always the protocol, but it was missed that day with pt. and she apologized.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Heart rate irregular, Immediate post-injection reaction, Syncope
Clinical narrative: Pt's 11 year old vaccines (HPV, Tdap, MCV4) were administered by RN with him sitting on the end of the exam table at approximately 8:30. Tdap and MCV4 were administered in the left arm, HPV last in the right arm. The RN walked away instantly and pt. fainted instantly, fell face first off the exam table and hit his head extremely hard on the ground feet from the RN?s feet who was throwing things away. Pt then appeared to seize for about 5 seconds according to his pediatrician (but the ER dr. and paramedics later said it was just a reaction to the concussion), and went unconscious for 5-10 seconds.  Dr. Office monitored pt. for over 2 hours on the exam room floor with a pulse that would get faint at times and every time he got up he got dizzy and would sweat profusely and was very clammy. Dr. Office called EMS after 2 hours and he was taken by ambulance to hospital. He was diagnosed with Vasovagal Syncope and a Concussion with loss of consciousness. They never did do a CT Head scan.  The CDC indicates that ?Fainting and related injuries after immunizations can be prevented. Many falls due to fainting can be prevented by having the patient sit or lie down.  For this reason, experts recommend having patients sit in a chair or lay down when they receive a vaccination.  In addition, patients should be observed for 15 minutes after vaccination.?  Clinic did not follow this recommendation. It appears safety protocol was not followed to prevent injury from a possible fainting episode.  They had pt seated upright on the end of the exam table and the nurse walked away immediately after the 3rd poke (which was the HPV vaccination). Dr. had mom engaged in conversation on the computer with their backs turned to pt. I believe clinic should make protocol improvements to prevent this from happening again in the future and that they are responsible for not following simple vaccine safety precautions that could have prevented pt. from getting hurt. As Dr. herself stated that this happened under their watch and she has reported it. Dr. acknowledged that this incident shouldn?t have happened and could have been prevented. She shared that their clinic is going to use it as a learning situation. A nurse whom I spoke with on 7/3/2023 said that as a result of pt.s incident, reminder email went out to remind all staff on what protocol should be followed for positioning of shots. It should be 45 degree angle in bed or in a seated chair with arms. Nurse did say that this was always the protocol, but it was missed that day with pt. and she apologized.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 52.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Pruritus
Clinical narrative: Patient has redness, warm surrounding injection site. Patient reported has soreness and itchy in the arm. The redness is growing from injeciton site to the lower arm. Pharmacist counseled patient to take Tylenol and benadryl cream/ capsule for the soreness and itching,
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 61.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Influenza like illness, Single component of a two-component product administered, Swelling
Clinical narrative: Nurse thought they had properly prepared shingrix vaccine and then administered to pt. The nurse had the vials in hand still and noticed the vaccine(powder) still in vial.  Thus, she realized only the adjuvant suspension component was administered. This event was reported to unit manager and nurse manager who advised we can still administer shingrix. The patient was called and asked to come back. The situation was explained to the patient who verbalized understanding and the was shingrix administered correctly with a double check.  The nurse manager reports: I called to triage this pt today, to ensure he was not having any unusual symptoms and to inform him verbally of the event. Aside from a couple days of flu-like symptoms and some vaccine site redness and swelling which resolved after a few days, he felt fine. He was very understanding of the error and asked for advice on when to receive his second dose of the Shingrix vaccine. I also asked him to reach out to our office if he noted any new/unusual symptoms.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired dose administered
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Biopsy skin abnormal, Burning sensation, Gait disturbance, Hypoaesthesia
Clinical narrative: Burning tight pain in right calf, toes, and feet. Numbness in feet and legs. Caledonia in her wrists and trunk. Off balance when walking.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Pain in extremity
Clinical narrative: Burning tight pain in right calf, toes, and feet. Numbness in feet and legs. Caledonia in her wrists and trunk. Off balance when walking.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose in series discrepancy. Patient received a 2nd dose in the single dose series. First dose was given on 5/5/23 and second dose was given on 6/6/23. No adverse reaction was reported by patient.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Induration, Injection site discolouration, Injection site rash, Injection site reaction
Clinical narrative: Pain, swelling redness, hot to the touch the first day. Second day - same only the swelling and redness increased to a size of about 4" in diameter swelling site was very hard to the touch. Site was very hot and painful and hard to the touch. Third day - same but the size increased to close to 5" in diameter and began to itch. Fourth day - swelling decreased somewhat but was still hot to the touch. Redness began to turn a purple color. Fifth and following days - redness decreased, but the discoloration remained. Still warm to the touch. Skin is blotchy and has tiny raised bumps like "orange skin." Increased itching. Mild swelling persists. Today is the tenth day after the injection, and there is still itching (sometimes severe), mild swelling of a diameter of about 3-3.5", blotchiness, discoloration, bumpy skin and warmth at the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth, Pain, Pruritus, Rash macular, Skin warm
Clinical narrative: Pain, swelling redness, hot to the touch the first day. Second day - same only the swelling and redness increased to a size of about 4" in diameter swelling site was very hard to the touch. Site was very hot and painful and hard to the touch. Third day - same but the size increased to close to 5" in diameter and began to itch. Fourth day - swelling decreased somewhat but was still hot to the touch. Redness began to turn a purple color. Fifth and following days - redness decreased, but the discoloration remained. Still warm to the touch. Skin is blotchy and has tiny raised bumps like "orange skin." Increased itching. Mild swelling persists. Today is the tenth day after the injection, and there is still itching (sometimes severe), mild swelling of a diameter of about 3-3.5", blotchiness, discoloration, bumpy skin and warmth at the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Pain, swelling redness, hot to the touch the first day. Second day - same only the swelling and redness increased to a size of about 4" in diameter swelling site was very hard to the touch. Site was very hot and painful and hard to the touch. Third day - same but the size increased to close to 5" in diameter and began to itch. Fourth day - swelling decreased somewhat but was still hot to the touch. Redness began to turn a purple color. Fifth and following days - redness decreased, but the discoloration remained. Still warm to the touch. Skin is blotchy and has tiny raised bumps like "orange skin." Increased itching. Mild swelling persists. Today is the tenth day after the injection, and there is still itching (sometimes severe), mild swelling of a diameter of about 3-3.5", blotchiness, discoloration, bumpy skin and warmth at the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling redness, hot to the touch the first day. Second day - same only the swelling and redness increased to a size of about 4" in diameter swelling site was very hard to the touch. Site was very hot and painful and hard to the touch. Third day - same but the size increased to close to 5" in diameter and began to itch. Fourth day - swelling decreased somewhat but was still hot to the touch. Redness began to turn a purple color. Fifth and following days - redness decreased, but the discoloration remained. Still warm to the touch. Skin is blotchy and has tiny raised bumps like "orange skin." Increased itching. Mild swelling persists. Today is the tenth day after the injection, and there is still itching (sometimes severe), mild swelling of a diameter of about 3-3.5", blotchiness, discoloration, bumpy skin and warmth at the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Pain, swelling redness, hot to the touch the first day. Second day - same only the swelling and redness increased to a size of about 4" in diameter swelling site was very hard to the touch. Site was very hot and painful and hard to the touch. Third day - same but the size increased to close to 5" in diameter and began to itch. Fourth day - swelling decreased somewhat but was still hot to the touch. Redness began to turn a purple color. Fifth and following days - redness decreased, but the discoloration remained. Still warm to the touch. Skin is blotchy and has tiny raised bumps like "orange skin." Increased itching. Mild swelling persists. Today is the tenth day after the injection, and there is still itching (sometimes severe), mild swelling of a diameter of about 3-3.5", blotchiness, discoloration, bumpy skin and warmth at the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Pain, swelling redness, hot to the touch the first day. Second day - same only the swelling and redness increased to a size of about 4" in diameter swelling site was very hard to the touch. Site was very hot and painful and hard to the touch. Third day - same but the size increased to close to 5" in diameter and began to itch. Fourth day - swelling decreased somewhat but was still hot to the touch. Redness began to turn a purple color. Fifth and following days - redness decreased, but the discoloration remained. Still warm to the touch. Skin is blotchy and has tiny raised bumps like "orange skin." Increased itching. Mild swelling persists. Today is the tenth day after the injection, and there is still itching (sometimes severe), mild swelling of a diameter of about 3-3.5", blotchiness, discoloration, bumpy skin and warmth at the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: Pain, swelling redness, hot to the touch the first day. Second day - same only the swelling and redness increased to a size of about 4" in diameter swelling site was very hard to the touch. Site was very hot and painful and hard to the touch. Third day - same but the size increased to close to 5" in diameter and began to itch. Fourth day - swelling decreased somewhat but was still hot to the touch. Redness began to turn a purple color. Fifth and following days - redness decreased, but the discoloration remained. Still warm to the touch. Skin is blotchy and has tiny raised bumps like "orange skin." Increased itching. Mild swelling persists. Today is the tenth day after the injection, and there is still itching (sometimes severe), mild swelling of a diameter of about 3-3.5", blotchiness, discoloration, bumpy skin and warmth at the injection site.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pt was injection with a timed-out vial. Vial timed out on 6/23/23 and the pt was mistakenly injection on 6/29/23.
Age: 79.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pt was injected with a timed-out Vial. Vial timed-out on 6/23/23 and the pt was injected on 6/29/23.
Age: 79.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Pt was injected with a timed-out Vial. Vial timed-out on 6/23/23 and the pt was injected on 6/29/23.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test positive
Clinical narrative: One day in January 2023, I woke up with a slight cough and extreme fatigue. I took a home antigen test and got a positive result. I called my doctor, who asked me if I wanted Paxlovid. When she explained the possible side effects to me, I decided not to take it. She instead prescribed me a nasal spray and a steroid. I self-isolated at home for about two weeks. The symptoms were very mild. I never developed any symptoms besides the cough and fatigue, both of which remained mild.
Age: 79.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pt was injected with a timed-out Vial. Vial timed-out on 6/23/23 and the pt was injected on 6/29/23.
Age: 79.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Pt was injected with a timed-out Vial. Vial timed-out on 6/23/23 and the pt was injected on 6/29/23.
Age: 61.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Mistakenly ordered Kinrix when IPOL was not available. Patient was trying to get IPOL before vacation. Through manufacturer it was not indicated that vaccine was age 4-6 and the polio part of vaccination was the same strength as IPOL. Kinrix was mistakenly given when not indicated for patient age.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pt was injected with a timed-out Vial. Vial timed-out on 6/23/23 and the pt was injected on 6/29/23.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: About 6 weeks after the second dose of the COVID-19 vaccine - vitiligo (white patches) started to emerge. The onset was quick and appeared all over my daughter's body.  It is still present
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pt was injected with a timed-out Vial. Vial timed-out on 6/23/23 and the pt was injected on 6/29/23.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pt was injected with a timed-out Vial. Vial timed-out on 6/23/23 and the pt was injected on 6/29/23.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 1/15/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Dyspnoea, Pruritus, Urticaria
Clinical narrative: PATIENT REPORT ON DAY 6/12/23 HAVING HIVES, BURNING, ITCHING ALL OVER BODY. PATIENT REPORT HAVING SHORTNESS OF BREATH TOO. PATIENT REPORT STILL HAVING ITCHING
Age: 60.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Mistakenly ordered Kinrix when IPOL was not available. Patient was trying to get IPOL before vacation. Through manufacturer it was not indicated that vaccine was age 4-6 and the polio part of vaccination was the same strength as IPOL. Kinrix was mistakenly given when not indicated for patient age.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: diarrhea, ongoing
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Angina pectoris
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE STABLE ANGINA ACUTE NON ST ELEVATION MI