chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 2/2/2023 & 2/7/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-se date.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product administration error
Clinical narrative: Pt received 0.1 mL of the Jynneos smallpox/monkeypox vaccine intradermally in the right forearm. Pt did have a confirmed case of moneypox in July 2022 so he should not have received it.  Pt was monitored post injection - no adverse reaction noted.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cholecystitis acute, Hypotension
Clinical narrative: HYPOTENSION 3/24/2023 ACUTE CHOLECYSTITIS
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MILD
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Hypoxia
Clinical narrative: HYPOXIA 4/18/2023 COVID-19 PNEUMONIA
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, hot to touch at injection site. Symptoms started 12-18 hrs after admin. Treating with cephalexin suspension 250 mg/5ml (7.5 ml PO BID X 7 days) . Diagnosed with cellulitis of left lower limb.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Musculoskeletal stiffness, Myalgia, Pain, Pyrexia
Clinical narrative: Low grade fever, stiff/sore muscles, tightness in spine; feels like in a constant hard bear hug. Painful to move about, reach or lift any objects over 4 lbs.  Diagnosed with an L2 closed fracture on 5/9/23 after initial MMR was given on 5/5/2023. Had second MMR given on 6/28/23 and now having same symptoms and to include diarrhea.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Spinal disorder
Clinical narrative: Low grade fever, stiff/sore muscles, tightness in spine; feels like in a constant hard bear hug. Painful to move about, reach or lift any objects over 4 lbs.  Diagnosed with an L2 closed fracture on 5/9/23 after initial MMR was given on 5/5/2023. Had second MMR given on 6/28/23 and now having same symptoms and to include diarrhea.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, INFERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI 1/13/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram thorax abnormal, Crying, Gait inability, Headache
Clinical narrative: Three weeks later my last vaccine 07MAR2023 I began to feel ill with unusual pain everywhere.  My ankles feet legs and everywhere swelled up, I had pains everywhere, all over my body with real bad headasches.  Sometime in April I was unable to walk, in the middle of the night during this time I would wake up at night crying so bad due to the pain all over my body particularly in my hips.  I am still not well and I being tetsed to determine what is wrong with my bgody.  I have seen a kidney, blood, and lung  doctor, blood doctor.  I have had a CT scan.  I am scheduled to have a lung biopsy on 05JUL2023.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lung disorder, Malaise, Pain, Peripheral swelling
Clinical narrative: Three weeks later my last vaccine 07MAR2023 I began to feel ill with unusual pain everywhere.  My ankles feet legs and everywhere swelled up, I had pains everywhere, all over my body with real bad headasches.  Sometime in April I was unable to walk, in the middle of the night during this time I would wake up at night crying so bad due to the pain all over my body particularly in my hips.  I am still not well and I being tetsed to determine what is wrong with my bgody.  I have seen a kidney, blood, and lung  doctor, blood doctor.  I have had a CT scan.  I am scheduled to have a lung biopsy on 05JUL2023.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Three weeks later my last vaccine 07MAR2023 I began to feel ill with unusual pain everywhere.  My ankles feet legs and everywhere swelled up, I had pains everywhere, all over my body with real bad headasches.  Sometime in April I was unable to walk, in the middle of the night during this time I would wake up at night crying so bad due to the pain all over my body particularly in my hips.  I am still not well and I being tetsed to determine what is wrong with my bgody.  I have seen a kidney, blood, and lung  doctor, blood doctor.  I have had a CT scan.  I am scheduled to have a lung biopsy on 05JUL2023.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebral artery occlusion, Cerebrovascular accident
Clinical narrative: ACUTE STROKE DUE TO OCCLUSION OF LEFT ANTERIOR CEREBRAL ARTERY
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond-use date.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE NON ST ELEVATION MI ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Cellulitis, Injection site erythema, Pyrexia, Rash
Clinical narrative: Patient went to ER the day after the vaccine was administer for fever and rash. Follow up in our office for redness on right thigh today 6/30/23. Patient is being treated with antibiotic for cellulitis
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Lymphadenopathy, Pain, Pharyngeal erythema, Pharyngeal swelling, Pyrexia
Clinical narrative: Body rash, fever, swollen lymph nodes, red/swollen throat, body aches
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Rash
Clinical narrative: Body rash, fever, swollen lymph nodes, red/swollen throat, body aches
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 1/13/2023 & 2/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Scrotal dermatitis
Clinical narrative: Patient's family reports significant rash on face and scrotum
Age: 0.58
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: PedvaxHIB was given by RN without order being present. Patient not due for vax until 12 months.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blister, Cranial nerve disorder, Deafness, Dizziness, Ear pain
Clinical narrative: 1 day after receiving COVID-19 booster vaccine, the patient developed dizziness and headache. Symptoms progressed to right facial droop, right ear pain, and hearing loss. She saw ENT and neurology and was diagnosed with Ramsay Hunt syndrome. She received courses of prednisone and valacyclovir . Symptoms improved with the exception of vertigo, which is ongoing.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Facial paralysis, Headache, Herpes zoster oticus, Hypoacusis, Scab
Clinical narrative: 1 day after receiving COVID-19 booster vaccine, the patient developed dizziness and headache. Symptoms progressed to right facial droop, right ear pain, and hearing loss. She saw ENT and neurology and was diagnosed with Ramsay Hunt syndrome. She received courses of prednisone and valacyclovir . Symptoms improved with the exception of vertigo, which is ongoing.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vertigo
Clinical narrative: 1 day after receiving COVID-19 booster vaccine, the patient developed dizziness and headache. Symptoms progressed to right facial droop, right ear pain, and hearing loss. She saw ENT and neurology and was diagnosed with Ramsay Hunt syndrome. She received courses of prednisone and valacyclovir . Symptoms improved with the exception of vertigo, which is ongoing.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Symptom recurrence
Clinical narrative: ACUTE DVT OF LEFT POPLITEAL VEIN 3/1/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adrenal insufficiency, Blood test, Cardiac stress test, Catheterisation cardiac, Chronic fatigue syndrome
Clinical narrative: No immediate reaction other than typical injection site soreness.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chronic inflammatory response syndrome, Echocardiogram, Electrocardiogram, Gene mutation identification test, General physical health deterioration
Clinical narrative: No immediate reaction other than typical injection site soreness.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypobarism, Hypovolaemia, Injection site pain, Laboratory test, Magnetic resonance imaging heart
Clinical narrative: No immediate reaction other than typical injection site soreness.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Plasma cells decreased, Post viral fatigue syndrome, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Red blood cell count decreased
Clinical narrative: No immediate reaction other than typical injection site soreness.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Renal function test, Stress echocardiogram, Vaccination complication, Volume blood decreased, Wheelchair user
Clinical narrative: No immediate reaction other than typical injection site soreness.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adrenal insufficiency, Chronic fatigue syndrome, Chronic inflammatory response syndrome, Decreased ventricular preload, Hypovolaemia
Clinical narrative: No immediate reaction other than typical injection site soreness.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Post viral fatigue syndrome, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Volume blood
Clinical narrative: No immediate reaction other than typical injection site soreness.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Volume blood decreased
Clinical narrative: No immediate reaction other than typical injection site soreness.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: No immediate reaction other than typical injection site soreness.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G, Vaccination site rash, Vaccination site swelling
Clinical narrative: Pt. reported adverse reaction on 6/30/23. This RN visualized remnants of healing rash at the site where the vaccination was given on 6/1/23. The tissue appeared mildly red and raised in two areas surrounding the vaccination site of right arm.
Age: 61.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Headache, Impaired work ability
Clinical narrative: Pt wife states that husband received twinrix and shingrix yesterday.  Last night, started complaining of headache.  Worsened today and had to leave work early.  Took ibuprofen.  Wife doesn't know if patient has any other symptoms.  I advised her to contact doctor if symptoms worsen or if he develops fever or swelling.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Acute respiratory failure
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE RESPIRATORY FAILURE
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Adjustment disorder, Blood test normal, Chest X-ray normal, Computerised tomogram head normal, Condition aggravated
Clinical narrative: Dizziness/vertigo/lightheadedness beginning/first noted upon waking the morning after (6/23/23) vaccination (approx. 7AM).  Patient/Self was unsteady when walking, and experienced more significant moments of dizziness when changing position from laying to standing (significant), or sitting to standing (lesser).  Patient went to Urgent Care clinic on 6/24 and was diagnosed with benign positional vertigo despite no other incidences of vertigo in the last decade.   Dizziness continued through going to bed on Sunday, 6/25.  Diaphoresis/perspiration/excessive sweating beginning/first noted the morning after (6/23/23) vaccination (approx. 8AM).  Patient/Self was extremely sweaty throughout the day, despite reasonable ambient temperatures (75 degrees) and air conditioned surroundings while indoors or in a vehicle.  Resolved and was not present on 6/24/23.  Shortness of breath beginning/first noted the morning after (6/23/23) vaccination (approx. 8AM).  Patient/Self noticed abnormal shortness of breath upon mild exertion throughout 6/23 & 6/24, and resolved by 6/25/23.  Abnormal hypertension, first noted the evening after (6/23/23) vaccination.  Patient/Self had disregarded other symptoms until developing a headache in the afternoon/evening of 6/23.  Upon arriving home, tested blood pressure and found it above 150/110.  It remained high into 6/24/23, reaching above 160/110 leading to an Urgent Care visit on 6/24/23.  The attending physician diagnosed adjustment disorder as the cause of elevated blood pressure.  Blood pressure was 148/98 prior to leaving the clinic.  Blood pressure has remained elevated since, reaching above 170/120 on 6/27/23.  Patient/Self called their doctor office and was advised to go to the Emergency Room due to the risk of stroke.  The ED conducted blood tests for Troponin to assess organ damage (negative), Chest X-Ray (normal), and CT scan (normal).  After several hours of observation, blood pressure lowered to 137/94 and Patient was discharged.  Blood pressure remains elevated.  Of note - Patient has been treated and well managed for blood pressure using 160 mg/daily dose of Valsartan for more than a decade.  Blood Pressure in office on 6/22/23 prior to vaccination was measured at 130/78.  Prior readings at different office visits over the last 2 years were 110/70 (4/28/23), 129/79 (2/1/23), 116/70 (9/26/22), 120/82 (6/30/22), 128/80 (6/2/22), 130/84 (10/14/21), 126/80 (7/7/21)
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Dizziness postural, Dyspnoea, Dyspnoea exertional, Full blood count
Clinical narrative: Dizziness/vertigo/lightheadedness beginning/first noted upon waking the morning after (6/23/23) vaccination (approx. 7AM).  Patient/Self was unsteady when walking, and experienced more significant moments of dizziness when changing position from laying to standing (significant), or sitting to standing (lesser).  Patient went to Urgent Care clinic on 6/24 and was diagnosed with benign positional vertigo despite no other incidences of vertigo in the last decade.   Dizziness continued through going to bed on Sunday, 6/25.  Diaphoresis/perspiration/excessive sweating beginning/first noted the morning after (6/23/23) vaccination (approx. 8AM).  Patient/Self was extremely sweaty throughout the day, despite reasonable ambient temperatures (75 degrees) and air conditioned surroundings while indoors or in a vehicle.  Resolved and was not present on 6/24/23.  Shortness of breath beginning/first noted the morning after (6/23/23) vaccination (approx. 8AM).  Patient/Self noticed abnormal shortness of breath upon mild exertion throughout 6/23 & 6/24, and resolved by 6/25/23.  Abnormal hypertension, first noted the evening after (6/23/23) vaccination.  Patient/Self had disregarded other symptoms until developing a headache in the afternoon/evening of 6/23.  Upon arriving home, tested blood pressure and found it above 150/110.  It remained high into 6/24/23, reaching above 160/110 leading to an Urgent Care visit on 6/24/23.  The attending physician diagnosed adjustment disorder as the cause of elevated blood pressure.  Blood pressure was 148/98 prior to leaving the clinic.  Blood pressure has remained elevated since, reaching above 170/120 on 6/27/23.  Patient/Self called their doctor office and was advised to go to the Emergency Room due to the risk of stroke.  The ED conducted blood tests for Troponin to assess organ damage (negative), Chest X-Ray (normal), and CT scan (normal).  After several hours of observation, blood pressure lowered to 137/94 and Patient was discharged.  Blood pressure remains elevated.  Of note - Patient has been treated and well managed for blood pressure using 160 mg/daily dose of Valsartan for more than a decade.  Blood Pressure in office on 6/22/23 prior to vaccination was measured at 130/78.  Prior readings at different office visits over the last 2 years were 110/70 (4/28/23), 129/79 (2/1/23), 116/70 (9/26/22), 120/82 (6/30/22), 128/80 (6/2/22), 130/84 (10/14/21), 126/80 (7/7/21)
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Gait disturbance, Headache, Hyperhidrosis, Hypertension, Laboratory test normal
Clinical narrative: Dizziness/vertigo/lightheadedness beginning/first noted upon waking the morning after (6/23/23) vaccination (approx. 7AM).  Patient/Self was unsteady when walking, and experienced more significant moments of dizziness when changing position from laying to standing (significant), or sitting to standing (lesser).  Patient went to Urgent Care clinic on 6/24 and was diagnosed with benign positional vertigo despite no other incidences of vertigo in the last decade.   Dizziness continued through going to bed on Sunday, 6/25.  Diaphoresis/perspiration/excessive sweating beginning/first noted the morning after (6/23/23) vaccination (approx. 8AM).  Patient/Self was extremely sweaty throughout the day, despite reasonable ambient temperatures (75 degrees) and air conditioned surroundings while indoors or in a vehicle.  Resolved and was not present on 6/24/23.  Shortness of breath beginning/first noted the morning after (6/23/23) vaccination (approx. 8AM).  Patient/Self noticed abnormal shortness of breath upon mild exertion throughout 6/23 & 6/24, and resolved by 6/25/23.  Abnormal hypertension, first noted the evening after (6/23/23) vaccination.  Patient/Self had disregarded other symptoms until developing a headache in the afternoon/evening of 6/23.  Upon arriving home, tested blood pressure and found it above 150/110.  It remained high into 6/24/23, reaching above 160/110 leading to an Urgent Care visit on 6/24/23.  The attending physician diagnosed adjustment disorder as the cause of elevated blood pressure.  Blood pressure was 148/98 prior to leaving the clinic.  Blood pressure has remained elevated since, reaching above 170/120 on 6/27/23.  Patient/Self called their doctor office and was advised to go to the Emergency Room due to the risk of stroke.  The ED conducted blood tests for Troponin to assess organ damage (negative), Chest X-Ray (normal), and CT scan (normal).  After several hours of observation, blood pressure lowered to 137/94 and Patient was discharged.  Blood pressure remains elevated.  Of note - Patient has been treated and well managed for blood pressure using 160 mg/daily dose of Valsartan for more than a decade.  Blood Pressure in office on 6/22/23 prior to vaccination was measured at 130/78.  Prior readings at different office visits over the last 2 years were 110/70 (4/28/23), 129/79 (2/1/23), 116/70 (9/26/22), 120/82 (6/30/22), 128/80 (6/2/22), 130/84 (10/14/21), 126/80 (7/7/21)
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Troponin I normal, Vertigo, Vertigo positional
Clinical narrative: Dizziness/vertigo/lightheadedness beginning/first noted upon waking the morning after (6/23/23) vaccination (approx. 7AM).  Patient/Self was unsteady when walking, and experienced more significant moments of dizziness when changing position from laying to standing (significant), or sitting to standing (lesser).  Patient went to Urgent Care clinic on 6/24 and was diagnosed with benign positional vertigo despite no other incidences of vertigo in the last decade.   Dizziness continued through going to bed on Sunday, 6/25.  Diaphoresis/perspiration/excessive sweating beginning/first noted the morning after (6/23/23) vaccination (approx. 8AM).  Patient/Self was extremely sweaty throughout the day, despite reasonable ambient temperatures (75 degrees) and air conditioned surroundings while indoors or in a vehicle.  Resolved and was not present on 6/24/23.  Shortness of breath beginning/first noted the morning after (6/23/23) vaccination (approx. 8AM).  Patient/Self noticed abnormal shortness of breath upon mild exertion throughout 6/23 & 6/24, and resolved by 6/25/23.  Abnormal hypertension, first noted the evening after (6/23/23) vaccination.  Patient/Self had disregarded other symptoms until developing a headache in the afternoon/evening of 6/23.  Upon arriving home, tested blood pressure and found it above 150/110.  It remained high into 6/24/23, reaching above 160/110 leading to an Urgent Care visit on 6/24/23.  The attending physician diagnosed adjustment disorder as the cause of elevated blood pressure.  Blood pressure was 148/98 prior to leaving the clinic.  Blood pressure has remained elevated since, reaching above 170/120 on 6/27/23.  Patient/Self called their doctor office and was advised to go to the Emergency Room due to the risk of stroke.  The ED conducted blood tests for Troponin to assess organ damage (negative), Chest X-Ray (normal), and CT scan (normal).  After several hours of observation, blood pressure lowered to 137/94 and Patient was discharged.  Blood pressure remains elevated.  Of note - Patient has been treated and well managed for blood pressure using 160 mg/daily dose of Valsartan for more than a decade.  Blood Pressure in office on 6/22/23 prior to vaccination was measured at 130/78.  Prior readings at different office visits over the last 2 years were 110/70 (4/28/23), 129/79 (2/1/23), 116/70 (9/26/22), 120/82 (6/30/22), 128/80 (6/2/22), 130/84 (10/14/21), 126/80 (7/7/21)
Age: 33.0
Sex: F
Vaccine: HEP, MMRV, TDAP, VARCEL
Symptoms: No adverse event
Clinical narrative: Patient tolerated all vaccinations well and denied any adverse reaction to receiving vaccinations.  Patient received Measles, Mumps, Rubella, Varicella (MMRV) vaccination and Varicella vaccination on the same date.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pt was given Heplisav-b instead of menveo which was the intended vaccine. patient has had hep b  vaccinations in the past as stated from Provider this is no harm to patient. Provider called patient and patient had no symptoms and was fine.  no treatment was necessary, only that he had to come in a few days later to get the correct vaccine. in which he was evaluated at that time as well.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching on Hands only
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Swollen tongue
Clinical narrative: Patient complained of tongue swelling  about 15 minutes after receiving shot. Vitals taken BP 143/86, then repeated 10 minutes later 120/97. EMS called due to patient having tongue swelling and general feeling of unwell. EMS arrived and patient stated she was feeling better but was still examined by EMS. Patient ended up not going to hospital. No medications were given by pharmacy.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain, Neuralgia, Rash
Clinical narrative: rash on shoulder and chest. nerve pain on neck onto shoulder
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient was given 2nd bivalent vaccination without meeting eligibility requirements.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Worsening of my tinnitus.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was due only for a Dtap vaccine but was given a Pediarix vaccine instead. Patient did not have an adverse reaction to the vaccine but was given the incorrect vaccine. The patient was not due for a Hep B or IPV vaccine at the time.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Two Bivalent Covid Vaccines given in a weeks time period.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received dose of Pfizer Monovalent after 4/18 when the FDA stopped use of this vaccine.    Patient has returned on 5/11/23 for BIVALENT Dose
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received monovalent dose of pfizer after 4/18 when the FDA stopped use of this vaccine.    They have returned on 5/24/23 for BIVALENT dose
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Echocardiogram, Exposure during pregnancy, Fine motor skill dysfunction
Clinical narrative: Pregnancy History: due date 11/23/21, gave birth to healthy baby girl 5lb 12oz. Was induced early due to hypertension leading in to preeclampsia starting at 35 weeks Symptom History: Paresthesia in limbs, noticed weakness and numbness starting in left leg in 8/2021 and assumed it was related to the pregnancy. It spread to left arm around 05/2022. The weakness, numbness, and loss of dexterity was bothersome enough that I started seeing doctors in July 2022. Had MRIs and bloodwork in July with no diagnosis. I saw an ophthalmologist and was checked for neurological eye issues and was cleared. By August it was spread to right side and by October I was experiencing numbness in my lips, tongue, scalp and neck as well as the limbs. I had neuro exams with no diagnosis. By December, on my vsafe checkin (I signed up as a pregnant recipient of the covid vaccine and had been doing regular checkups) I was recommended to file an adverse event to investigate whether the vaccines were related - by that point I had both primary Moderna shots as well as a bivalent booster. I saw a cardiologist in January 2023  and had an echo and a stress test with no diagnosis. I saw an allergist in March 2023 with no diagnosis. As of this submission in June 2023, my symptoms persist without diagnosis. I also noted over that time frame ~8/2021-present I have had small bouts of vertigo on the rough magnitude of a couple times a month.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Hypertension, Hypoaesthesia, Hypoaesthesia oral, Induced labour
Clinical narrative: Pregnancy History: due date 11/23/21, gave birth to healthy baby girl 5lb 12oz. Was induced early due to hypertension leading in to preeclampsia starting at 35 weeks Symptom History: Paresthesia in limbs, noticed weakness and numbness starting in left leg in 8/2021 and assumed it was related to the pregnancy. It spread to left arm around 05/2022. The weakness, numbness, and loss of dexterity was bothersome enough that I started seeing doctors in July 2022. Had MRIs and bloodwork in July with no diagnosis. I saw an ophthalmologist and was checked for neurological eye issues and was cleared. By August it was spread to right side and by October I was experiencing numbness in my lips, tongue, scalp and neck as well as the limbs. I had neuro exams with no diagnosis. By December, on my vsafe checkin (I signed up as a pregnant recipient of the covid vaccine and had been doing regular checkups) I was recommended to file an adverse event to investigate whether the vaccines were related - by that point I had both primary Moderna shots as well as a bivalent booster. I saw a cardiologist in January 2023  and had an echo and a stress test with no diagnosis. I saw an allergist in March 2023 with no diagnosis. As of this submission in June 2023, my symptoms persist without diagnosis. I also noted over that time frame ~8/2021-present I have had small bouts of vertigo on the rough magnitude of a couple times a month.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscular weakness, Neurological examination
Clinical narrative: Pregnancy History: due date 11/23/21, gave birth to healthy baby girl 5lb 12oz. Was induced early due to hypertension leading in to preeclampsia starting at 35 weeks Symptom History: Paresthesia in limbs, noticed weakness and numbness starting in left leg in 8/2021 and assumed it was related to the pregnancy. It spread to left arm around 05/2022. The weakness, numbness, and loss of dexterity was bothersome enough that I started seeing doctors in July 2022. Had MRIs and bloodwork in July with no diagnosis. I saw an ophthalmologist and was checked for neurological eye issues and was cleared. By August it was spread to right side and by October I was experiencing numbness in my lips, tongue, scalp and neck as well as the limbs. I had neuro exams with no diagnosis. By December, on my vsafe checkin (I signed up as a pregnant recipient of the covid vaccine and had been doing regular checkups) I was recommended to file an adverse event to investigate whether the vaccines were related - by that point I had both primary Moderna shots as well as a bivalent booster. I saw a cardiologist in January 2023  and had an echo and a stress test with no diagnosis. I saw an allergist in March 2023 with no diagnosis. As of this submission in June 2023, my symptoms persist without diagnosis. I also noted over that time frame ~8/2021-present I have had small bouts of vertigo on the rough magnitude of a couple times a month.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pre-eclampsia, Vertigo
Clinical narrative: Pregnancy History: due date 11/23/21, gave birth to healthy baby girl 5lb 12oz. Was induced early due to hypertension leading in to preeclampsia starting at 35 weeks Symptom History: Paresthesia in limbs, noticed weakness and numbness starting in left leg in 8/2021 and assumed it was related to the pregnancy. It spread to left arm around 05/2022. The weakness, numbness, and loss of dexterity was bothersome enough that I started seeing doctors in July 2022. Had MRIs and bloodwork in July with no diagnosis. I saw an ophthalmologist and was checked for neurological eye issues and was cleared. By August it was spread to right side and by October I was experiencing numbness in my lips, tongue, scalp and neck as well as the limbs. I had neuro exams with no diagnosis. By December, on my vsafe checkin (I signed up as a pregnant recipient of the covid vaccine and had been doing regular checkups) I was recommended to file an adverse event to investigate whether the vaccines were related - by that point I had both primary Moderna shots as well as a bivalent booster. I saw a cardiologist in January 2023  and had an echo and a stress test with no diagnosis. I saw an allergist in March 2023 with no diagnosis. As of this submission in June 2023, my symptoms persist without diagnosis. I also noted over that time frame ~8/2021-present I have had small bouts of vertigo on the rough magnitude of a couple times a month.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported.; HCP calling to report that PROQUAD was administered after undergoing a TE. No adverse affects reported. Caller stated this occurred in February 2023.          ?    Names of vaccines involved (including lot/exp): PROQUAD (Lot: W019631, Expiration: 1; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   In February 2023, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) (0.5 ml, lot #W019631, expiration date: 19-DEC-2023, strength and route of administration were not provided) for prophylaxis after undergoing a temperature excursion (TE) (Incorrect product storage).  Administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 13.5 degrees Fahrenheit (F) for 3 hours, 5 minutes, 0 seconds. There was no previous temperature excursion reported. No adverse affects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W03; No additional AE.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown date, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot #W031812, expiration date: 05-OCT-2024, strength and route of administration were not provided) for prophylaxis while the vaccine had a temperature excursion (Incorrect product storage).  Administered varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 24.4 degrees Fahrenheit (F) for 5 hours 51 minutes 0 seconds. There was no previous temperature excursion reported. The patient was asymptomatic. No additional adverse event (AE).
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE; HCP calls to report PROQUAD administered to patient after expirations date.  No further AE.  No PQC.; This spontaneous report was received from a nurse, referring to p5-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 16-JUN-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status rHa (1 dosage form, subcutaneously in right upper arm, lot #u039955, expiration date 14-JUN-2023) for prophylaxis (Expired vaccine used). No further adverse event (AE) (No adverse event). No product quality complaints (PQC).
Age: 0.67
Sex: M
Vaccine: RV5
Symptoms: Infantile spitting up, Retching
Clinical narrative: Reported on behalf of HCP who administered ROTATEQ to a patient who gagged and spit up following oral administration. Patient is an 8-month-old healthy male who "gagged and spit up everything" following his third dose of ROTATEQ. Dates of vaccina; Reported on behalf of HCP who administered ROTATEQ to a patient who gagged and spit up following oral administration. Patient is an 8-month-old healthy male who "gagged and spit up everything" following his third dose of ROTATEQ. Dates of vaccina; accidental underdose; This spontaneous report was received from a nurse and refers to an 8-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (dose, frequency, strength, lot #, and expiry date were not provided), then following oral administration, he gagged and spit up. At the reporting time, the outcome of the events was unknown.  Causal assessment between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse outcomes or side effects were reported or observed by the patients who received the administered doses by an experienced HCP; HCP (nurse) called to report TE for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 11-May-2023 and was administered on 15-Jun-2023; This spontaneous report was received from a nurse, concerning a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-MAY-2023, varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot number W031813 was verified to be valid, expiration date reported and confirmed as 05-OCT-2024) suffered a temperature excursion (TE). On 15-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot number W031813, expiration date 05-OCT-2024), administered as prophylaxis (route of administration and anatomical location were not provided) (Product storage error). The reporter made aware of the by the Vaccines Program until 26-JUN-2023 (reported as "today"). The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with a supported stability evaluation, and there were not any previous excursions and 8 doses total were administered. No adverse outcomes or side effects were reported or observed by the patient who received the administered dose by an experienced HCP.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA012318: US-009507513-2306USA012351: US-009507513-2306USA012355: US-009507513-2306USA012362: US-009507513-2306USA012702: US-009507513-2306USA012732: US-009507513-2306USA012753:
Sex: U
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; HCP reports patient was administered  GARDASIL 9 ( not supported ) and VARIVAX ( supported) after TE.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot # W039688, expiration date: 13-DEC-2024 (strength, and route of administration were not provided); and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #w015188, expiration date: 06-JAN-2025 (strength, and route of administration were not provided). Those vaccines were administered for prophylaxis. Before administration those vaccines underwent temperature excuursion for 20 minutes. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in 0 Farenheit (F) and varicella virus vaccine live (oka/merck) (VARIVAX) in 32 Farenheit (F). No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other AE; Physician calling to report inadvertently administering an extra dose of MMR II to a 4 year old patient, one month after the second dose; This spontaneous report was received from a physician refers to a 4-year-old patient unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 28-JUN-2023 the patient was vaccinated with extra dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (exact dose, dose number, route and site of administration, lot# and expiration date were not provided). Other suspect therapies included sterile diluent (STERILE DILUENT) for prophylaxis (extra dose administered and no adverse event).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Nurse calling to ask about what regimen she should follow for GARDASIL 9 for a patient who received her first dose at 12 years old and is now almost 18 years old and has not received any subsequent doses. No additional AE/PQC.; No Adverse Event; This spontaneous report was received from an other health care professional refers to a 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (at 12 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the patient received her first dose at 12 years old and is now almost 18 years old and has not received any subsequent doses. The nurse calling to ask about what regimen she should follow (inappropriate schedule of product administration). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HCP reported VARIVAX was administered to patient after a temperature excursion.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 28-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, once, (valid lot number W039293 [expiration date 11-DEC-2024]) (dose, dose number, strength, vaccination scheme, and route of administration were not provided), administered for prophylaxis, after a temperature excursion of 23 degrees Fahrenheit (F) with a time frame of 2 hours, 17 minutes. No previous temperature excursion.  No additional adverse event (AE) was reported.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE.; Nurse calls to report PNEUMOVAX 23 administered to patient after expiration date  No further AE.  No PQC; This spontaneous report has been received form a nurse, regarding a 65-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 28-JUN-2023, the patient was vaccinated with an expired Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, as prophylaxis (lot number: U027357, which was determined to be valid as syringe, with an expiration date on 25-MAR-2023) (strength, dose, scheme, route and anatomical location of administration were not reported).  No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HCP reported VARIVAX was administered to patient after a temperature excursion.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 27-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, (valid lot number W008904 [expiration date 15-MAR-2024]) (dose, dose number, strength, vaccination scheme, and route of administration were not provided), administered for prophylaxis, after a temperature excursion of 23 degrees Fahrenheit (F) with a time frame of 2 hours, 17 minutes (product storage error). No previous temperature excursion.  No additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013410:same reporter
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HBP calling to report administration of PROQUAD following a temperature excursion. NO other AE and no PQC; NO other AE and no PQC; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (dose, dose number, strength, vaccination scheme, indication, lot number and expiration date were not provided), after a temperature excursion (product storage error).  No additional adverse event (AE) was reported.