chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: Started breaking out in hives; Initial information received on 13-Jan-2025 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-healthcare professional. This case was received from Pfizer Inc.  This case involves a 81 years old female patient (173 cm and 72.57 kg) who started breaking out in hives after receiving Influenza USP trival a-b high dose subvirion vaccine [Fluzone HD] and Comirnaty (Tozinameran).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via intramuscular route in the left arm (strength and expiration date: not provided) for immunization and received a dose of suspect Comirnaty not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for immunization.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence cannot be requested.  On an unknown date the patient started breaking out in hives (urticaria) (unknown latency).  Action taken- not applicable.  The patient was treated with Fexofenadine hydrochloride (Allegra).  At time of reporting, the outcome was Recovering / Resolving for the event.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: This situation is pre-assessed as a medication error/an inappropriate use due to administration of ADACEL after a shipping excursion with no reported adverse event; This situation is pre-assessed as a medication error/an inappropriate use due to administration of ADACEL after a shipping excursion with no reported adverse event; Initial information received on 13-Jan-2025 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves, this situation is pre-assessed as a medication error/an inappropriate use due to administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] to the unspecified number of patients after a shipping excursion 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, this situation is pre-assessed as a medication error/an inappropriate use due to administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot 2CA94C1, expiry date:31-Aug-2025) (unknown strength, dosage, and route) via unknown administration site for prophylactic vaccination on 13-Jan-2025 to the unspecified number of patients after a shipping excursion with no reported adverse event (product storage error) (unknown latency).  Reportedly, They said that they realized it after administering the vaccine to some patients. They were unsure of whether the vaccine is still suitable for use and wanted to know what to do. Nurse said that they administered Adacel post-excursion to three patients. They also said that the administered vaccines were from the same package.  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: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: red, raised, warm area  8x8 cm, soreness
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given a Spikevax Covid vaccine after it was refrozen and thawed
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given Spikevax covid vaccine that was refrozen and thawed
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given a spikeax covid vaccine that was refrozen and thawed
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given Spikevax Covid vaccine that was refrozen and thawed
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given a Spikevax Covid vaccine that was refrozen and thawed
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given a Spikevax Covid vaccine that was refrozen and thawed
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given a Spikevax Covid vaccine that had been refrozen and thawed
Age: 0.2
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Underdose
Clinical narrative: 0 adverse reaction lower dose was administered (50)
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Delayed (4 days) localized urticarial reaction left forearm (arm received vaccine)
Age: 72.0
Sex: M
Vaccine: PNC13, RSV
Symptoms: Arthralgia
Clinical narrative: Very severe pain in right shoulder where the injection of vaccine was administered.  3 days after and the pain is still present
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Illness, Pain in extremity, Surgery
Clinical narrative: Severe sore arm for 2-3 days, Progressed to illness and hospitalization. Patient stated had surgery and discharged on iv antibiotics
Age: 45.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pruritus, Musculoskeletal discomfort
Clinical narrative: Varivax - client states approximately 20 minutes after receiving vaccine, below R arm site was itchy and a knot developed. Client left voicemail for us on Monday but we were closed. I spoke with client Tuesday approx 8:15 am and that issue was resolved.          Engerix B and MMR - Client states that had difficulty raising L arm and neck was uncomfortable. RN forgot to ask when this started. Client said that today (1/21/25) range of motion was much better of left arm and neck discomfort very little at this point. Instructed client to call her pcp if her symptoms do not improve or she is not satisfied with how she feels. Client had already called PCP yesterday and was instructed by that office to call us.
Sex: F
Vaccine: RSV
Symptoms: Foetal exposure during pregnancy, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
Clinical narrative: Mother had the Abrysvo vaccine when she was pregnant. Date of vaccine: 10/16/2024. Infant was born. Infant was diagnosed with RSV on 1/16/25.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Balance disorder, Chills, Diplopia, Fatigue
Clinical narrative: pt says his arm was a little sore after the vaccine but he also experienced double vision, numbness in both arms,  had severe low back pain with pain that went down both legs. He had profound tiredness and the feeling of being unsteady. These symtoms were very similar to GBS and lasted about 10 days. Within the past couple of days has had an episode of shivering that lasted a couple of hours and another espisode of sweating that lasted about a couple of hours. Today is still not sleeping well but is feeling some better. He will contact his PCP to discuss future covid vaccines.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Neurological symptom, Pain in extremity, Poor quality sleep
Clinical narrative: pt says his arm was a little sore after the vaccine but he also experienced double vision, numbness in both arms,  had severe low back pain with pain that went down both legs. He had profound tiredness and the feeling of being unsteady. These symtoms were very similar to GBS and lasted about 10 days. Within the past couple of days has had an episode of shivering that lasted a couple of hours and another espisode of sweating that lasted about a couple of hours. Today is still not sleeping well but is feeling some better. He will contact his PCP to discuss future covid vaccines.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: pt says his arm was a little sore after the vaccine but he also experienced double vision, numbness in both arms,  had severe low back pain with pain that went down both legs. He had profound tiredness and the feeling of being unsteady. These symtoms were very similar to GBS and lasted about 10 days. Within the past couple of days has had an episode of shivering that lasted a couple of hours and another espisode of sweating that lasted about a couple of hours. Today is still not sleeping well but is feeling some better. He will contact his PCP to discuss future covid vaccines.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia
Clinical narrative: pt says his arm was a little sore after the vaccine but he also experienced double vision, numbness in both arms,  had severe low back pain with pain that went down both legs. He had profound tiredness and the feeling of being unsteady. These symtoms were very similar to GBS and lasted about 10 days. Within the past couple of days has had an episode of shivering that lasted a couple of hours and another espisode of sweating that lasted about a couple of hours. Today is still not sleeping well but is feeling some better. He will contact his PCP to discuss future covid vaccines.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Illness, Myalgia, Myocardial infarction, Myocarditis
Clinical narrative: pt says his arm was a little sore after the vaccine but he also experienced double vision, numbness in both arms,  had severe low back pain with pain that went down both legs. He had profound tiredness and the feeling of being unsteady. These symtoms were very similar to GBS and lasted about 10 days. Within the past couple of days has had an episode of shivering that lasted a couple of hours and another espisode of sweating that lasted about a couple of hours. Today is still not sleeping well but is feeling some better. He will contact his PCP to discuss future covid vaccines.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pneumonia, Post-acute COVID-19 syndrome, Productive cough, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: pt says his arm was a little sore after the vaccine but he also experienced double vision, numbness in both arms,  had severe low back pain with pain that went down both legs. He had profound tiredness and the feeling of being unsteady. These symtoms were very similar to GBS and lasted about 10 days. Within the past couple of days has had an episode of shivering that lasted a couple of hours and another espisode of sweating that lasted about a couple of hours. Today is still not sleeping well but is feeling some better. He will contact his PCP to discuss future covid vaccines.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: pt says his arm was a little sore after the vaccine but he also experienced double vision, numbness in both arms,  had severe low back pain with pain that went down both legs. He had profound tiredness and the feeling of being unsteady. These symtoms were very similar to GBS and lasted about 10 days. Within the past couple of days has had an episode of shivering that lasted a couple of hours and another espisode of sweating that lasted about a couple of hours. Today is still not sleeping well but is feeling some better. He will contact his PCP to discuss future covid vaccines.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: pt says his arm was a little sore after the vaccine but he also experienced double vision, numbness in both arms,  had severe low back pain with pain that went down both legs. He had profound tiredness and the feeling of being unsteady. These symtoms were very similar to GBS and lasted about 10 days. Within the past couple of days has had an episode of shivering that lasted a couple of hours and another espisode of sweating that lasted about a couple of hours. Today is still not sleeping well but is feeling some better. He will contact his PCP to discuss future covid vaccines.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 9 year old was administered an adult dose (Moderna 12y & older).  No adverse reactions/symptoms noted.
Age: 20.0
Sex: M
Vaccine: CHIK, YF
Symptoms: Hyperhidrosis, Syncope, Vision blurred
Clinical narrative: AFTER 5 MINUTES PATIENT BECAME DIAPHORETIC, BLURRY VISION THEN FAINTED. PATIENT RESPONDED WHEN I SHOOK HIM AND CALLED HIS NAME. I ELEVATED HIS FEET AND HE DRANK WATER. HE FELT BETTER IN ABOUT 10 MINUTES, I MADE STAY SEATED FOR ABOUT 50 MINUTES. HE STATED , HE FELT FINE AND LEFT.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash
Clinical narrative: A very local reaction appearing as a rash on the left thigh to the Proquad (MMR V) vaccine, does not appear to be infected, does not appear to be warm to the touch
Age: 0.67
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: ADVERSE EVENT- Extra dose of Vaxelis given to patient when not needed. No reactions/ side effects from extra dose given.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 9 year old child given Dtap after age 7. Child had 5 previous doses documented in medical record.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase increased, Blood bicarbonate normal
Clinical narrative: Immediately after vaccination and overnight he felt well.  However the following morning he noted that he had muscle aches and an anterior precordial discomfort which did not resolve.    He describes the chest discomfort as being a palm sized area near the left lower sternal border.  His description of the actual discomfort is quite vague.  He states that he did feel somewhat more comfortable propped up on a few pillows.  But he does not describe much shortness of breath.  The pain did not worsen with deep inspiration.  He was seen in the emergency room  For these complaints on the 29th.  Parents report a history of fever, although I do not have a specific maximum temperature.  By the time he was seen in the emergency room his temperature had normalized.   He was  noted to have a fine, lacy appearing rash diffusely over all of his chest and neck.  This was not itchy or raised.  During the emergency room visit he was slightly tachycardic with a heart rate of about 110 and showed a mildly elevated blood pressure.  There was no description of any irregular rhythm.  Concern was raised regarding possible post COVID vaccine  myocarditis in the number of laboratory studies were performed.  Troponin T at baseline was mildly elevated at 20 and after 2 hours increased to 36 prompting a formal diagnosis of early myocarditis.  Chest x-ray was normal as was a limited bedside echocardiogram.   He was given a one week course of colchicine after the initial  ED visit.  Within about 24-48 hours of the emergency room visit pt states that he felt normal again.  He was seen by me about 10 days after presentation and he was asymptomatic.  Echocardiogram, cardiac MRI and Holter monitor were all normal.  There was no evidence of ongoing inflammation or myocardial scarring by cMR.  He was instructed to avoid strenuous exercise for 3 months and will have ongoing evaluation in our cardiology clinic
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: Immediately after vaccination and overnight he felt well.  However the following morning he noted that he had muscle aches and an anterior precordial discomfort which did not resolve.    He describes the chest discomfort as being a palm sized area near the left lower sternal border.  His description of the actual discomfort is quite vague.  He states that he did feel somewhat more comfortable propped up on a few pillows.  But he does not describe much shortness of breath.  The pain did not worsen with deep inspiration.  He was seen in the emergency room  For these complaints on the 29th.  Parents report a history of fever, although I do not have a specific maximum temperature.  By the time he was seen in the emergency room his temperature had normalized.   He was  noted to have a fine, lacy appearing rash diffusely over all of his chest and neck.  This was not itchy or raised.  During the emergency room visit he was slightly tachycardic with a heart rate of about 110 and showed a mildly elevated blood pressure.  There was no description of any irregular rhythm.  Concern was raised regarding possible post COVID vaccine  myocarditis in the number of laboratory studies were performed.  Troponin T at baseline was mildly elevated at 20 and after 2 hours increased to 36 prompting a formal diagnosis of early myocarditis.  Chest x-ray was normal as was a limited bedside echocardiogram.   He was given a one week course of colchicine after the initial  ED visit.  Within about 24-48 hours of the emergency room visit pt states that he felt normal again.  He was seen by me about 10 days after presentation and he was asymptomatic.  Echocardiogram, cardiac MRI and Holter monitor were all normal.  There was no evidence of ongoing inflammation or myocardial scarring by cMR.  He was instructed to avoid strenuous exercise for 3 months and will have ongoing evaluation in our cardiology clinic
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium normal, Blood pressure increased, Blood sodium normal, Blood urea normal, C-reactive protein normal
Clinical narrative: Immediately after vaccination and overnight he felt well.  However the following morning he noted that he had muscle aches and an anterior precordial discomfort which did not resolve.    He describes the chest discomfort as being a palm sized area near the left lower sternal border.  His description of the actual discomfort is quite vague.  He states that he did feel somewhat more comfortable propped up on a few pillows.  But he does not describe much shortness of breath.  The pain did not worsen with deep inspiration.  He was seen in the emergency room  For these complaints on the 29th.  Parents report a history of fever, although I do not have a specific maximum temperature.  By the time he was seen in the emergency room his temperature had normalized.   He was  noted to have a fine, lacy appearing rash diffusely over all of his chest and neck.  This was not itchy or raised.  During the emergency room visit he was slightly tachycardic with a heart rate of about 110 and showed a mildly elevated blood pressure.  There was no description of any irregular rhythm.  Concern was raised regarding possible post COVID vaccine  myocarditis in the number of laboratory studies were performed.  Troponin T at baseline was mildly elevated at 20 and after 2 hours increased to 36 prompting a formal diagnosis of early myocarditis.  Chest x-ray was normal as was a limited bedside echocardiogram.   He was given a one week course of colchicine after the initial  ED visit.  Within about 24-48 hours of the emergency room visit pt states that he felt normal again.  He was seen by me about 10 days after presentation and he was asymptomatic.  Echocardiogram, cardiac MRI and Holter monitor were all normal.  There was no evidence of ongoing inflammation or myocardial scarring by cMR.  He was instructed to avoid strenuous exercise for 3 months and will have ongoing evaluation in our cardiology clinic
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Dyspnoea, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Immediately after vaccination and overnight he felt well.  However the following morning he noted that he had muscle aches and an anterior precordial discomfort which did not resolve.    He describes the chest discomfort as being a palm sized area near the left lower sternal border.  His description of the actual discomfort is quite vague.  He states that he did feel somewhat more comfortable propped up on a few pillows.  But he does not describe much shortness of breath.  The pain did not worsen with deep inspiration.  He was seen in the emergency room  For these complaints on the 29th.  Parents report a history of fever, although I do not have a specific maximum temperature.  By the time he was seen in the emergency room his temperature had normalized.   He was  noted to have a fine, lacy appearing rash diffusely over all of his chest and neck.  This was not itchy or raised.  During the emergency room visit he was slightly tachycardic with a heart rate of about 110 and showed a mildly elevated blood pressure.  There was no description of any irregular rhythm.  Concern was raised regarding possible post COVID vaccine  myocarditis in the number of laboratory studies were performed.  Troponin T at baseline was mildly elevated at 20 and after 2 hours increased to 36 prompting a formal diagnosis of early myocarditis.  Chest x-ray was normal as was a limited bedside echocardiogram.   He was given a one week course of colchicine after the initial  ED visit.  Within about 24-48 hours of the emergency room visit pt states that he felt normal again.  He was seen by me about 10 days after presentation and he was asymptomatic.  Echocardiogram, cardiac MRI and Holter monitor were all normal.  There was no evidence of ongoing inflammation or myocardial scarring by cMR.  He was instructed to avoid strenuous exercise for 3 months and will have ongoing evaluation in our cardiology clinic
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory normal, Immediate post-injection reaction, Magnetic resonance imaging heart abnormal, Myalgia, Myocarditis
Clinical narrative: Immediately after vaccination and overnight he felt well.  However the following morning he noted that he had muscle aches and an anterior precordial discomfort which did not resolve.    He describes the chest discomfort as being a palm sized area near the left lower sternal border.  His description of the actual discomfort is quite vague.  He states that he did feel somewhat more comfortable propped up on a few pillows.  But he does not describe much shortness of breath.  The pain did not worsen with deep inspiration.  He was seen in the emergency room  For these complaints on the 29th.  Parents report a history of fever, although I do not have a specific maximum temperature.  By the time he was seen in the emergency room his temperature had normalized.   He was  noted to have a fine, lacy appearing rash diffusely over all of his chest and neck.  This was not itchy or raised.  During the emergency room visit he was slightly tachycardic with a heart rate of about 110 and showed a mildly elevated blood pressure.  There was no description of any irregular rhythm.  Concern was raised regarding possible post COVID vaccine  myocarditis in the number of laboratory studies were performed.  Troponin T at baseline was mildly elevated at 20 and after 2 hours increased to 36 prompting a formal diagnosis of early myocarditis.  Chest x-ray was normal as was a limited bedside echocardiogram.   He was given a one week course of colchicine after the initial  ED visit.  Within about 24-48 hours of the emergency room visit pt states that he felt normal again.  He was seen by me about 10 days after presentation and he was asymptomatic.  Echocardiogram, cardiac MRI and Holter monitor were all normal.  There was no evidence of ongoing inflammation or myocardial scarring by cMR.  He was instructed to avoid strenuous exercise for 3 months and will have ongoing evaluation in our cardiology clinic
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, Protein total normal, Pyrexia, Rash, Tachycardia
Clinical narrative: Immediately after vaccination and overnight he felt well.  However the following morning he noted that he had muscle aches and an anterior precordial discomfort which did not resolve.    He describes the chest discomfort as being a palm sized area near the left lower sternal border.  His description of the actual discomfort is quite vague.  He states that he did feel somewhat more comfortable propped up on a few pillows.  But he does not describe much shortness of breath.  The pain did not worsen with deep inspiration.  He was seen in the emergency room  For these complaints on the 29th.  Parents report a history of fever, although I do not have a specific maximum temperature.  By the time he was seen in the emergency room his temperature had normalized.   He was  noted to have a fine, lacy appearing rash diffusely over all of his chest and neck.  This was not itchy or raised.  During the emergency room visit he was slightly tachycardic with a heart rate of about 110 and showed a mildly elevated blood pressure.  There was no description of any irregular rhythm.  Concern was raised regarding possible post COVID vaccine  myocarditis in the number of laboratory studies were performed.  Troponin T at baseline was mildly elevated at 20 and after 2 hours increased to 36 prompting a formal diagnosis of early myocarditis.  Chest x-ray was normal as was a limited bedside echocardiogram.   He was given a one week course of colchicine after the initial  ED visit.  Within about 24-48 hours of the emergency room visit pt states that he felt normal again.  He was seen by me about 10 days after presentation and he was asymptomatic.  Echocardiogram, cardiac MRI and Holter monitor were all normal.  There was no evidence of ongoing inflammation or myocardial scarring by cMR.  He was instructed to avoid strenuous exercise for 3 months and will have ongoing evaluation in our cardiology clinic
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin T increased
Clinical narrative: Immediately after vaccination and overnight he felt well.  However the following morning he noted that he had muscle aches and an anterior precordial discomfort which did not resolve.    He describes the chest discomfort as being a palm sized area near the left lower sternal border.  His description of the actual discomfort is quite vague.  He states that he did feel somewhat more comfortable propped up on a few pillows.  But he does not describe much shortness of breath.  The pain did not worsen with deep inspiration.  He was seen in the emergency room  For these complaints on the 29th.  Parents report a history of fever, although I do not have a specific maximum temperature.  By the time he was seen in the emergency room his temperature had normalized.   He was  noted to have a fine, lacy appearing rash diffusely over all of his chest and neck.  This was not itchy or raised.  During the emergency room visit he was slightly tachycardic with a heart rate of about 110 and showed a mildly elevated blood pressure.  There was no description of any irregular rhythm.  Concern was raised regarding possible post COVID vaccine  myocarditis in the number of laboratory studies were performed.  Troponin T at baseline was mildly elevated at 20 and after 2 hours increased to 36 prompting a formal diagnosis of early myocarditis.  Chest x-ray was normal as was a limited bedside echocardiogram.   He was given a one week course of colchicine after the initial  ED visit.  Within about 24-48 hours of the emergency room visit pt states that he felt normal again.  He was seen by me about 10 days after presentation and he was asymptomatic.  Echocardiogram, cardiac MRI and Holter monitor were all normal.  There was no evidence of ongoing inflammation or myocardial scarring by cMR.  He was instructed to avoid strenuous exercise for 3 months and will have ongoing evaluation in our cardiology clinic
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Blood creatinine increased, Blood glucose normal, Blood urea increased, Chest X-ray normal, Full blood count
Clinical narrative: Patient reported shortly after receiving the shingles vaccination he began experiencing severe arm pain, inablitity to raise his arm, tremors and feeling unwell. Planned discharge hom 1/21/2025.
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Injected limb mobility decreased, Lymphocyte percentage decreased
Clinical narrative: Patient reported shortly after receiving the shingles vaccination he began experiencing severe arm pain, inablitity to raise his arm, tremors and feeling unwell. Planned discharge hom 1/21/2025.
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Malaise, Neutrophil percentage increased, Pain in extremity, SARS-CoV-2 test negative, Tremor
Clinical narrative: Patient reported shortly after receiving the shingles vaccination he began experiencing severe arm pain, inablitity to raise his arm, tremors and feeling unwell. Planned discharge hom 1/21/2025.
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Patient reported shortly after receiving the shingles vaccination he began experiencing severe arm pain, inablitity to raise his arm, tremors and feeling unwell. Planned discharge hom 1/21/2025.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Brain fog, Cerebrovascular accident, Confusional state, Diplopia
Clinical narrative: double vision, brain fog, not "feeling right" confusion; MRI of brain on December 9, 2024 confirmed 2 (recent) strokes.  NOTE:  No previous history of any strokes or symptoms of same
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Feeling abnormal, Magnetic resonance imaging head abnormal, Magnetic resonance imaging neck
Clinical narrative: double vision, brain fog, not "feeling right" confusion; MRI of brain on December 9, 2024 confirmed 2 (recent) strokes.  NOTE:  No previous history of any strokes or symptoms of same
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT RECEIVED FLU FOR AGE 3 AND UP BUT PATIENT IS ONLY 6 MONTHS OLD.  PATIENT HAD NO ADVERSE REACTIONS.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event, treatment or outcome. Patient received dose of Arexvy on 1/7/2025 despite already receiving it on 12/21/2023, reporting only.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: right sided facial droop; bells palsy
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Staff member received high dose flu vaccine 9/11/24. Staff member requested and received high dose flu vaccine again today, 1/21/25.  No adverse reaction.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event, treatment or outcome, reporting only. Patient received mResvia on 1/8/2025 despite receiving Arexvy on 12/7/2023.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Borrelia test negative, C-reactive protein normal, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: 2 days later patient had joint pain in hands and feet , stiffness and swelling in hands and feet
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: 2 days later patient had joint pain in hands and feet , stiffness and swelling in hands and feet
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast pain
Clinical narrative: Right side breast hurt, lumps under arm pit, doctor said to come back in 2 weeks if not gone. Gone after a week.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Breast pain, Chest pain, Dark circles under eyes, Eye pain
Clinical narrative: Pt was given the TdaP vaccine in her left deltoid by MA in usual protocol. Approx 30 seconds after vaccine was administered she developed pain at the injection site that progressed to the left breast. Dr came back to the exam room to evaluate patient. She was rocking back and forth holding her left arm with ice pack in place. Dr laid patient back on the exam table with the HOB elevated and asked for EpiPen to be available in the exam room. Patient reported pain progressed up the left side of her chest, neck and head. She then developed HA with pain behind the left eye and jaw tightness. Dr asked for EMS to be called, patient aware. Dr noticed a darkening of the skin of both eyelids and under the eyes. Discoloration then started in the perioral area. Patient then developed some throat tightness. A single dose of EpiPen was administered into the lateral R thigh at 11:51a. Patient reported breathing better approx 2-3 min after Epi was delivered. She denied abdominal pain, nausea, vomiting. Patient was taken to hospital by ambulance. TdaP added to allergy list.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Muscle tightness, Neck pain, Skin discolouration
Clinical narrative: Pt was given the TdaP vaccine in her left deltoid by MA in usual protocol. Approx 30 seconds after vaccine was administered she developed pain at the injection site that progressed to the left breast. Dr came back to the exam room to evaluate patient. She was rocking back and forth holding her left arm with ice pack in place. Dr laid patient back on the exam table with the HOB elevated and asked for EpiPen to be available in the exam room. Patient reported pain progressed up the left side of her chest, neck and head. She then developed HA with pain behind the left eye and jaw tightness. Dr asked for EMS to be called, patient aware. Dr noticed a darkening of the skin of both eyelids and under the eyes. Discoloration then started in the perioral area. Patient then developed some throat tightness. A single dose of EpiPen was administered into the lateral R thigh at 11:51a. Patient reported breathing better approx 2-3 min after Epi was delivered. She denied abdominal pain, nausea, vomiting. Patient was taken to hospital by ambulance. TdaP added to allergy list.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: Pt was given the TdaP vaccine in her left deltoid by MA in usual protocol. Approx 30 seconds after vaccine was administered she developed pain at the injection site that progressed to the left breast. Dr came back to the exam room to evaluate patient. She was rocking back and forth holding her left arm with ice pack in place. Dr laid patient back on the exam table with the HOB elevated and asked for EpiPen to be available in the exam room. Patient reported pain progressed up the left side of her chest, neck and head. She then developed HA with pain behind the left eye and jaw tightness. Dr asked for EMS to be called, patient aware. Dr noticed a darkening of the skin of both eyelids and under the eyes. Discoloration then started in the perioral area. Patient then developed some throat tightness. A single dose of EpiPen was administered into the lateral R thigh at 11:51a. Patient reported breathing better approx 2-3 min after Epi was delivered. She denied abdominal pain, nausea, vomiting. Patient was taken to hospital by ambulance. TdaP added to allergy list.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red itchy skin reaction around the injection area (circle size about 10cm diameter).
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral cyst, Computerised tomogram head, Electroencephalogram, Gene mutation identification test positive, Generalised tonic-clonic seizure
Clinical narrative: 4 months to the day after she received this vaccine she had her first grand Maul Seizure. She had an MRI and it shows Global white matter change calcifications and cyst throughout her brain. She has had genetic testing and was diagnosed with Labrune syndrome however the geneticist stated that she only had 1 of the missing components and that it generally takes 2 to have active disease which she does.  but if the MRNA changed her DNA than that could account for this change and now my child has a terminal diagnosis
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Intracranial calcification, Labrune syndrome, Leukodystrophy, Magnetic resonance imaging head abnormal
Clinical narrative: 4 months to the day after she received this vaccine she had her first grand Maul Seizure. She had an MRI and it shows Global white matter change calcifications and cyst throughout her brain. She has had genetic testing and was diagnosed with Labrune syndrome however the geneticist stated that she only had 1 of the missing components and that it generally takes 2 to have active disease which she does.  but if the MRNA changed her DNA than that could account for this change and now my child has a terminal diagnosis
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site reaction, Muscle twitching, Paraesthesia
Clinical narrative: Systemic: Muscle twitching in area of administration-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: In addition to tinigling in the lower left arm, the patient is experiencing muscle twitching in the area of administation.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction
Clinical narrative: Systemic: Heart Attack-Severe, Systemic: Stroke-Severe, Additional Details: PATIENT SAYS LAST COVID 19 VACCINE HE RECEIVED RESULTED IN HOSPITALIZATION, HE HAD A HEART ATTACK/STROKE ACCORDING TO HIS CARDIOLOGIST.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient will go to urgent care, had the same reaxction with pneuminia vaccine, was given antibiotic , Other Vaccines:  VaccineTypeBrand: Fluzone High dose; Manufacturer: Sanofi; LotNumber: U8527CA; Route: IM; BodySite: Right arm; Dose: ; VaxDate: UNKNOWN
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Headache, Influenza like illness, Lethargy, Malaise
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Systemic: Feeling "not well". Flu-like symptoms.-Mild, Systemic: Headache-Mild
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: flu like symptoms-Mild, Systemic: Headache-Medium, Other Vaccines:  VaccineTypeBrand: Fluzone HD; Manufacturer: Flu Trivalent HD PZF; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Additional Details: Pt claims that she got cellulitis after getting immunization in her left arm which caused her to be hospitalized at 1/7/2025 for 7 days.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeding disorder, Pyrexia
Clinical narrative: Systemic: Fever-Medium, Systemic: Unable to eat-Medium, Systemic: Weakness-Medium, Additional Details: Patient also reported that this happened every time she received the COVID vaccine. The 2 previous doses of COVID 02/05/21 and 03/05/21 were from a place
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Nervousness, Skin abrasion, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Mild abrasion to nose due to fall-Mild, Additional Details: Vaccination log in and adminstration was completed. Patient was nervous throughout the adminstration. Afterwards, patient asked for a few minutes in the vaccination area by herself and was given that. Mins after vac, she fainted. Staff immediately tended to the patient and I called 911.While on the phone with 911, patient gained conscious and was asked if she was fine which she answered yes. She denied EMS dispatch. PharmD cleared pt to leave with caregiver afterwards.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Pallor
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient received both flu and covid at the same time. mom said she got light headed in the aisle and confused. sat her down, gave her some water and chocolate and color returned to her face. sat for a bit and returned to baseline, Other Vaccines:  VaccineTypeBrand: Pfizer COVID; Manufacturer: Pfizer; LotNumber: LN7302; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient received both flu and covid at the same time. mom said she got light headed in the aisle and confused. sat her down, gave her some water and chocolate and color returned to her face. sat for a bit and returned to baseline, Other Vaccines:  VaccineTypeBrand: Pfizer COVID; Manufacturer: Pfizer; LotNumber: LN7302; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pruritus, Rash, Rash pruritic
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Headache-Medium, Additional Details: Patient reports a reaction that she is not certain is linked to the vaccine. She experienced a headache on the day of vaccination and on and off since. She has an itchy rash on her neck and chest that appeared a couple days after. She also mentions experiencing severe pain. Patient has taken Zyrtec.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Systemic: Chills-Severe
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: The incident not happened to patient, but to her toddler that accompanied her. He reached his hand into the sharp container while we were preparing for vaccination. We both tried to stop him as fast as we could. There were about 10 syringes on the bottom of container. Upon examine his hand, there is no sign of cut or blood. Howere, mom was concerning about risk of accidental needle prick. Mom contacted pediatrician, and pharmacy customer will contact mom for further plan of action, Other Vaccines:  VaccineTypeBrand: flucelvax trivalent 2024-2025; Manufacturer: Seqirus, Inc; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Redness, swelling, tenderness at injection site and cover an area of about 3 to 5 inches in diameter.  symptoms have not gone away 6 days post administration.  Pt was advised to seek further care either from his PCP or an urgent care.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Herpes zoster, Injection site bruising, Insomnia, Neuralgia
Clinical narrative: Site: Bruising at Injection Site-Severe, Systemic: Unable to Sleep-Severe, Additional Details: pt describes shingles like severe nerve pain burning/ shooting pain extreme anxiety and difficulty sleeping since vaccinatuion
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Systemic: Unable to Sleep-Severe, Additional Details: pt describes shingles like severe nerve pain burning/ shooting pain extreme anxiety and difficulty sleeping since vaccinatuion
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysphagia, Dyspnoea, Hypoaesthesia, Loss of consciousness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: patient passed out after getting the flu vaccine. After approx 1 minute she became responsive, then several minutes later she passed out a second time. At that time 911 was called and paramedics arrived shortly after. patient became responsive shortly after and reported feeling numbness in her arm and had difficulty taking a deep breath and blurred vision. Paramedics monitored vital signs and stayed until patient was feeling better. Pt's mother came in several days after and said pt was better  , Other Vaccines:  VaccineTypeBrand: moderna spikevax; Manufacturer: moderna; LotNumber: 3043823; Route: intramuscular; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Throat tightness, Unresponsive to stimuli, Vision blurred
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: patient passed out after getting the flu vaccine. After approx 1 minute she became responsive, then several minutes later she passed out a second time. At that time 911 was called and paramedics arrived shortly after. patient became responsive shortly after and reported feeling numbness in her arm and had difficulty taking a deep breath and blurred vision. Paramedics monitored vital signs and stayed until patient was feeling better. Pt's mother came in several days after and said pt was better  , Other Vaccines:  VaccineTypeBrand: moderna spikevax; Manufacturer: moderna; LotNumber: 3043823; Route: intramuscular; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Headache-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Incident occurred 24 hours after vaccine, patient experienced redness, swollen, hot to touch, and pain around the injection area and 4 inches down the arm from the injection site. Additionally, patient experienced headaches and swollen lymph nodes as well. Patient has been icing the area and taking benadryl to help with the reaction at the recommendation of her PCP when she visited also for this reason., Other Vaccines:  VaccineTypeBrand: Prevnar 20; Manufacturer: ; LotNumber: LP8151; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 01/13/2025