chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Warm to touch.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain
Clinical narrative: Patient states that she has had biceps pain since she received her flu shot on 11/10/2023.  She states that the pain feels like a constant, annoying, dull ache.  She notes pain is a 6-7/10 in intensity at rest, but can increase up to a 10/10 at night when she is going to bed.  She notes that certain movements cause increased pain like putting her dishes away in the cabinet or pulling weeds.  She has tried tylenol and ibuprofen with some improvement but not resolution in symptoms.  She feels the pain has gotten worse since it started.  She denies peripheral paresthesias.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: MMR vaccine expired 6/20/2024 given on 6/25/2024
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given MMRV & Varicella instead of MMR & Varicella.  Provider and nurse manager notified.  Provider notified parent.  Nurse manager followed up with State Immunization Program for vaccine validity and no need to revaccinate as these vaccines are acceptable for this age group, and recommended watch for fever, irritability.   Parent told to call with any concerns.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: It is recommended for pediatric immunization of rotarix as a 2- dose series at 2 months and 4 months. This RN administered a 3rd dose during the 6 month appointment. Previously, the clinic had the other version of the vaccine, Rotateq and that is given in a 3-dose form. I was moving quickly to complete tasks in the clinic and thought that rotarix was given during 2,4, and 6 month visits. Parents report no issues with any of the previous vaccines given during 4 month visit. patient tolerated all well.  parents did give consent for rotavirus vaccine at the time. Patient tolerated well with no issues. Reporting as this is a 3rd (extra) dose of the oral vaccine. Consulted with MD, who stated they had no concerns of the additional dose of oral vaccine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Groin pain, Mobility decreased, Myalgia
Clinical narrative: Severe muscle and bone pain including arms, legs, and joints, groin area.  Could not get out of bed for a couple days. It is still lingering with pain but relieved by taking ibuprofen and acetaminophen
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe muscle and bone pain including arms, legs, and joints, groin area.  Could not get out of bed for a couple days. It is still lingering with pain but relieved by taking ibuprofen and acetaminophen
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient has already received this vaccine in December, however no adverse events reported.
Age: 50.0
Sex: M
Vaccine: HEP, HEPA, VARZOS
Symptoms: Chest discomfort, Lacrimation increased, Ocular hyperaemia, Throat tightness, Urticaria
Clinical narrative: Patient experienced: hives, red/watery eyes and reported chest and throat "constriction".  Monitored patient by completing vital signs and their symptoms.  Approximately, 1 and 1/2 hours after vaccinations, the patient was dismissed after symptoms were resolving.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Biopsy muscle abnormal, Dyskinesia, Fibromuscular dysplasia, Gait disturbance
Clinical narrative: I was diagnosed with FMD... I am not sure how long it was there as I had been dealing with myopathy. I was very healthy when I first started getting Covid Vaccines. in the end of August 2023 I had to stop working as I couldnt walk without a walker. I was sent to a rheumatologist. I could'nt shower, look up, get out of a chair, I had FOG or freeze of motion. My body just wouldnt move. It happened quite frequently. I was started on prednisone. I was referred to neurologist and I did'nt have PT becuase the inflammation was high. I did a muscle biopsy to see what exactly i had. It showed I had inactive inflammation. I was tapered off of the prednisone because of the results of the muscle biopsy. Then I had OT an dPT for the weakness due to the myopathy. I noticed at the end of March I was having some uncontrolled movements. At the end of April I saw the neurologist again and he referred me to my current doctor notes in this report. She diagnosed me with FMD on May 28th of 2024.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait inability, Impaired work ability, Inflammation, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: I was diagnosed with FMD... I am not sure how long it was there as I had been dealing with myopathy. I was very healthy when I first started getting Covid Vaccines. in the end of August 2023 I had to stop working as I couldnt walk without a walker. I was sent to a rheumatologist. I could'nt shower, look up, get out of a chair, I had FOG or freeze of motion. My body just wouldnt move. It happened quite frequently. I was started on prednisone. I was referred to neurologist and I did'nt have PT becuase the inflammation was high. I did a muscle biopsy to see what exactly i had. It showed I had inactive inflammation. I was tapered off of the prednisone because of the results of the muscle biopsy. Then I had OT an dPT for the weakness due to the myopathy. I noticed at the end of March I was having some uncontrolled movements. At the end of April I saw the neurologist again and he referred me to my current doctor notes in this report. She diagnosed me with FMD on May 28th of 2024.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mobility decreased, Movement disorder, Myopathy, Walking aid user
Clinical narrative: I was diagnosed with FMD... I am not sure how long it was there as I had been dealing with myopathy. I was very healthy when I first started getting Covid Vaccines. in the end of August 2023 I had to stop working as I couldnt walk without a walker. I was sent to a rheumatologist. I could'nt shower, look up, get out of a chair, I had FOG or freeze of motion. My body just wouldnt move. It happened quite frequently. I was started on prednisone. I was referred to neurologist and I did'nt have PT becuase the inflammation was high. I did a muscle biopsy to see what exactly i had. It showed I had inactive inflammation. I was tapered off of the prednisone because of the results of the muscle biopsy. Then I had OT an dPT for the weakness due to the myopathy. I noticed at the end of March I was having some uncontrolled movements. At the end of April I saw the neurologist again and he referred me to my current doctor notes in this report. She diagnosed me with FMD on May 28th of 2024.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Pt previously received Hepatitis B Vaccine 4/18/2018 and 3/12/2009. Provider ordered the Hepatis B adult 3 dose formulation to complete the series, however the Medical Assistant administered Heplisav-B. Provider made aware and advised no need to repeat dose. Pt made aware as well.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chest pain, Diarrhoea, Dizziness, Enterocolitis
Clinical narrative: Hospitalized 3/4/23-3/10/23 Vomiting, Diarrhea, Dizziness, chest pain, UTI, entercolitis, acute respiratory failure
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vomiting
Clinical narrative: Hospitalized 3/4/23-3/10/23 Vomiting, Diarrhea, Dizziness, chest pain, UTI, entercolitis, acute respiratory failure
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Cardiac dysfunction, Carditis, Computerised tomogram thorax, Dyspnoea
Clinical narrative: One day after second injection flu-like symptoms for three days, then subsided. But six weeks later I experienced the first of a series of respiratory/cardiac stress events.   These events at first were over periods of a week, and lasting for a day.    However, these attacks became both more severe in breathing/heart function ability and in frequency.    Living in remote area w/o transport prevented me from routine access to medical, but events became so severe that in February 2022 I went to local ER clinic for relief.   This began several months of in/out ER visits with no certain diagnosis.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Influenza like illness, Respiratory disorder
Clinical narrative: One day after second injection flu-like symptoms for three days, then subsided. But six weeks later I experienced the first of a series of respiratory/cardiac stress events.   These events at first were over periods of a week, and lasting for a day.    However, these attacks became both more severe in breathing/heart function ability and in frequency.    Living in remote area w/o transport prevented me from routine access to medical, but events became so severe that in February 2022 I went to local ER clinic for relief.   This began several months of in/out ER visits with no certain diagnosis.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Blood albumin decreased, Blood alkaline phosphatase normal, Blood calcium, Blood creatinine normal, Blood magnesium
Clinical narrative: At 11:40pm mother noticed the baby stiffening and shaking uncontrollably.  No fever was noted.  Mother called EMS who responded after the seizure resolved.  The seizure lasted about 2 minutes.  The patient was taken to Hospital for evaluation and was observed over night.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Blood potassium increased, Blood sodium normal, Blood urea normal, Carbon dioxide, Haematocrit decreased
Clinical narrative: At 11:40pm mother noticed the baby stiffening and shaking uncontrollably.  No fever was noted.  Mother called EMS who responded after the seizure resolved.  The seizure lasted about 2 minutes.  The patient was taken to Hospital for evaluation and was observed over night.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Haemoglobin, Liver function test normal, Musculoskeletal stiffness, Platelet count normal, Protein total decreased
Clinical narrative: At 11:40pm mother noticed the baby stiffening and shaking uncontrollably.  No fever was noted.  Mother called EMS who responded after the seizure resolved.  The seizure lasted about 2 minutes.  The patient was taken to Hospital for evaluation and was observed over night.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Red blood cell count decreased, Seizure, Tremor, White blood cell count increased
Clinical narrative: At 11:40pm mother noticed the baby stiffening and shaking uncontrollably.  No fever was noted.  Mother called EMS who responded after the seizure resolved.  The seizure lasted about 2 minutes.  The patient was taken to Hospital for evaluation and was observed over night.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Balance disorder, Burning sensation, Coordination abnormal, Dizziness
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dysphonia, Electric shock sensation, Electromyogram, Fall
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Laboratory test, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Muscle spasms, Muscular weakness, Musculoskeletal disorder, Musculoskeletal stiffness
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, Restless legs syndrome, Sleep disorder, Slow speech
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Temperature intolerance, Tremor, Urinary tract disorder, Vertigo, X-ray
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Aphasia, Balance disorder, Burning sensation, COVID-19
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coordination abnormal, Dizziness, Drug ineffective, Dysphonia, Fall
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Limb discomfort, Muscle spasms, Muscular weakness
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Pain, Paraesthesia, SARS-CoV-2 test, Shock
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Slow speech, Temperature intolerance, Urinary tract disorder, Vertigo
Clinical narrative: muscle cramps, muscle spasms, difficulty walking, difficulty with balance, muscle weakness, slow speech, difficulty finding words, inability to quickly change motion, tremor, coordination issues, stiffness, severe fatigue, vertigo, dizziness, difficulty swallowing, severe sleep issues, sporadic shocks, burning and tingling, difficulty finding words, heat intolerance, severe urinary issues, voice changes, falls, foot issues, severe restless leg, severe widespread pain
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15
Symptoms: Injection site discharge, Injection site erythema, Injection site induration, Injection site infection, Injection site pustule
Clinical narrative: Mother reports on the 6th day after receiving vaccines a red and hardened rash on injection site appeared with tactile fever. One day ago puss started draining. Patient was prescribed cephALEXin 250 mg/5mL oral suspenion 3 mL 3 times a day by oral route as directed for 7 days , for skin infection & ibuprofen 100 mg/5mL oral suspention 4 mL by mouth every 6-8 hours as needed for pain or fever. Patient will be brought back for an office visit follow up on 06/25/2024.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15
Symptoms: Injection site rash, Skin warm
Clinical narrative: Mother reports on the 6th day after receiving vaccines a red and hardened rash on injection site appeared with tactile fever. One day ago puss started draining. Patient was prescribed cephALEXin 250 mg/5mL oral suspenion 3 mL 3 times a day by oral route as directed for 7 days , for skin infection & ibuprofen 100 mg/5mL oral suspention 4 mL by mouth every 6-8 hours as needed for pain or fever. Patient will be brought back for an office visit follow up on 06/25/2024.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Vomiting
Clinical narrative: Dad called the health dept. at approximately 2:45 and advised Pt called and was vomiting and had chills. He wanted to know if this was possible after receiving the vaccine she got. I retrieved the VIS for Men B and read off the most common reactions and nausea was listed. Dad said she will be fine and that it sounds like it was from the shot. I read off signs of anaphylaxis to the dad and he said she doesn't have any of that. I advised if any of these should occur she would need to go to the ER. Patient left this office at approximately 2:05pm after receiving Trumenba with no complaints of nausea or any signs of adverse reactions. This RN called Pt at 3:25pm to check on her and she said she threw up her lunch and was now feeling ok. Laying down with her cat. She sounded good on the phone. She denied any swelling of face or difficulty breathing.
Age: 4.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Staff noticed when entering COVID vaccine in EHR that wrong age group was given. Patient is 4 yrs old and a Pfizer 5-11 yrs dose was administered. Attempted to reach parent to inform, unsuccessful in contacting.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Nausea, Pain in extremity
Clinical narrative: AFTER ADMINISTERING THE VACCINES, THE PATIENT ARRIVES AT THE EMERGENCY ROOM 20 MINUTES LATER AND THE MOTHER VERBALIZES THAT THE PATIENT IS PRESENTING NAUSEA AND PAIN IN HER RIGHT ARM AFTER VACCINES WERE ADMINISTERED.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Feeling abnormal, Heart rate increased, Hypotension
Clinical narrative: Postural Orthostatic Tachycardia Syndrome (POTS) diagnosis - symptoms include fainting, dizziness, lightheadedness, brain fog, low blood pressure, uncharacteristically high heart rates, etc. (overall feeling horrible 24/7). Treatments included over 2 years of trail and error and lifestyle change to get it to a manageable place (MANY different medications, diets, lifestyle changes, CBT therapy). Took about 2 years since symptoms began to feel like myself again.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Postural orthostatic tachycardia syndrome, Syncope, Tilt table test positive
Clinical narrative: Postural Orthostatic Tachycardia Syndrome (POTS) diagnosis - symptoms include fainting, dizziness, lightheadedness, brain fog, low blood pressure, uncharacteristically high heart rates, etc. (overall feeling horrible 24/7). Treatments included over 2 years of trail and error and lifestyle change to get it to a manageable place (MANY different medications, diets, lifestyle changes, CBT therapy). Took about 2 years since symptoms began to feel like myself again.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Nausea, Pyrexia
Clinical narrative: Hospitalized 3/4/23-3/8/23 chest pain, fever, cough, dysonea, nausea, PE,
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait disturbance, Urticaria
Clinical narrative: CHIEF COMPLAINT / HPI Chief Complaint Patient presents with ? Imm/Inj     Pt has hives from vaccine yesterday after swimming in pool.  Pt is limping from RT. TH  Tylenol yesterday for his shots - chicken pox and Dtap/IPV Was refusing to walk yesterday, was fine in the pool but when out, starting having hives in contact areas  No new foods
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Induration, Inflammation, Joint swelling, Peripheral swelling
Clinical narrative: Patient had swelling in the right wrist that was red, painful, inflamed, hard to touch originally in September (about 2 months after vaccine). About 6 weeks later it spread to his fingers/knuckles. It has remained and never gone away, gradually worsening over 2 years. Started in the left hand about 2 months after original right hand issue.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Patient had swelling in the right wrist that was red, painful, inflamed, hard to touch originally in September (about 2 months after vaccine). About 6 weeks later it spread to his fingers/knuckles. It has remained and never gone away, gradually worsening over 2 years. Started in the left hand about 2 months after original right hand issue.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: patient lost consciousness twice within 45 minutes after vaccine. pt was supported throughout duration post-vaccine. was provided water, juice, and a protein bar. pt reported dizziness and nausea.
Age: 0.67
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events noted
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Gaze palsy, Pallor, Seizure like phenomena, Syncope
Clinical narrative: Patient was vaccinated at 1:04 pm . At 1:10 pm Patient fainted, eyes rolled back, had seizure-like activity, and pale lips. Called 911 and transferred care over to paramedics.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dysphagia, Dyspnoea, Flushing, Hyperventilation, Swollen tongue
Clinical narrative: Patient and grandmother/guardian returned to clinic at 1518 stating that patient was having difficulty breathing and swallowing after they went to the store and they were closer to the health department than the ER. Patient had flushing of the face, redness, and swelling of the tongue. Hyperventilating. Patient was taken to exam room and emergency protocol initiated with 911 called and delegating physician - Dr. Patient vital signs 141/88 and HR 73 at 1519; Pulse ox 88 initially with HR 73, notified per Dr. to withhold epinephrine as long as Pulse ox 88 or above. Patient alert, oriented to her current location, name, date of birth and address. Able to answer questions. Encouraged patient to breathe through nose and out of mouth. Breathing regulated, Pulse ox 98 on room air. 1527 bp 132/85 and HR 99. EMS arrived and offered to take patient to ER. Grandmother and patient declined as patient stated that she was feeling better. Per MD notification, administered diphenhydramine 25mg by mouth; swallowed without difficulty. (1525); Patient to remain at HD for 45 minutes per MD instructions and given diphenhydramine 25mg to take in 4 hours with lexicomp information. 1536 BP 135/90 HR 99; 98% oxygen on room air. Patient is laughing and joking with grandmother and staff.
Age: 22.0
Sex: F
Vaccine: FLUC4, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: CLIENT STATES THE VACCINATION SITE STARTED ITCHING ON 6/24/24 BUT IS NO LONGER ITCHING TODAY 6/25/24BUT HURTS TO THE TOUCH. THE SITE WAS RED AND RAISED, ABOUT 2-3 CM IN SIZE. DENIES ANY OTHER S/S.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Throat irritation
Clinical narrative: lightheaded, dizziness, scratchy throat, EMS called, patient not transported to hospital
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Joint range of motion decreased, Loss of personal independence in daily activities, Pain
Clinical narrative: Acute pain of left shoulder s/p Tdap vaccine. Etiology unclear. Unusual that Pt also developed acute right shoulder pain though this has resolved quickly. Left shoulder issues concerning for acute inflammation vs RTC pathology. No symptoms to suggest underlying inflammatory disorder. Chiropractic care has helped.  Back to 80% of ROM - but painful rotation, adduction and extension causes pain.  Working on stretches.  Able to work with her hands but unable to do forceful movements.   Not really interested in steroid injection or oral steroids.   Had to cancer some events.  Took some ibuprofen.  Used lidocaine rub.  Will continue to go the chiropractor.
Age: 62.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Nausea, Vomiting
Clinical narrative: NAUSEA AND VOMITING
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Kidney ablation, Renal mass
Clinical narrative: Kidney mass
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Student received vaccines at student health office on Thursday, June 20, 2024,  at approx. 1:30 pm. Parent states when they got home at about 3:00 pm her son was very fatigued and fell asleep. Student started to experience pain to the right upper arm along with a headache, nausea and vomiting that evening at around 8:30 pm. Parent gave student some Tylenol for some pain relief.  Student and parent noticed his right upper arm getting more red and swollen the next day in the morning. Parent states the swelling and redness was about the size of a small orange.  Headache was also getting worse and so was the nausea and vomiting so she took him to Hospital ER.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Somnolence, Vomiting
Clinical narrative: Student received vaccines at student health office on Thursday, June 20, 2024,  at approx. 1:30 pm. Parent states when they got home at about 3:00 pm her son was very fatigued and fell asleep. Student started to experience pain to the right upper arm along with a headache, nausea and vomiting that evening at around 8:30 pm. Parent gave student some Tylenol for some pain relief.  Student and parent noticed his right upper arm getting more red and swollen the next day in the morning. Parent states the swelling and redness was about the size of a small orange.  Headache was also getting worse and so was the nausea and vomiting so she took him to Hospital ER.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Dyspnoea, Electrocardiogram, Vascular graft
Clinical narrative: Breathing difficulties began approximately 6 months after 2nd vaccine. Have gone through different heart tests such as ECG?s , stress, blood work.  March 5th was date of bypass surgery. Currently going through cardiac rehab.  Breathing difficulties currently still being worked on.
Age: 49.0
Sex: F
Vaccine: PNC15, PPV
Symptoms: Vaccination site cellulitis
Clinical narrative: Vaccination site cellulitis; This spontaneous report has been received from a 49-year-old female patient, referring to herself.  The patient's concurrent conditions included secondary pulmonary arterial hypertension. Concomitant therapies included hydroxychloroquine sulfate (PLAQUENIL), colecalciferol (VITAMIN D3), pyridoxine hydrochloride (VITAMIN B6), vitamin B12 not otherwise specified (NOS), desvenlafaxine succinate monohydrate (PRISTIQ), folic acid, ibuprofen, paracetamol (TYLENOL), butalbital (+) caffeine (+) paracetamol (FIORICET), naloxone hydrochloride (NARCAN), hydrocodone bitartrate (+) paracetamol (HYDROCODONE/ACETAMINOPHEN), loperamide hydrochloride (IMODIUM A-D), ascorbic acid (+) ergocalciferol (+) folic acid (+) retinol (+) tocopherol (+) vitamin b nos (MULTIPLE VITAMINS), modafinil (PROVIGIL), prednisone, oxygen, diphenhydramine hydrochloride (BENADRYL ALLERGY), pregabalin (LYRICA), valaciclovir hydrochloride (VALTREX), ascorbic acid (+) biotin (+) calcium carbonate (+) cupric oxide (+) calcium pantothenate (+) chromium nicotinate (+) colecalciferol (+) cyanocobalamin (+) ferrous fumarate (+) folic acid (+) magnesium hydroxide (+) manganese gluconate (+) nicotinamide (+) phytomenadione (+) potassium iodide (+) pyridoxine hydrochloride (+) tocopheryl acetate (+) retinol (+) riboflavin (+) selenomethionine (+) sodium molybdate (+) thiamine hydrochloride (+) zinc gluconate (MULTIVITAMIN FOR WOMEN). The information regarding the patient's medical history was not reported.  On an unspecified date in 2024, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) or pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), administered for prophylaxis (dose, route of administration, anatomical location, lot# and expiry date were not reported).  On an unspecified date in 2024, the patient experienced vaccination site cellulitis, due to which she started antibiotic (unspecified) on 13-MAY-2024.  The outcome of the event was unknown.  The reporter considered vaccination site cellulitis to be related to pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) or pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  This is one of two reports referring to the same patient.  Additional information is not expected. ; Sender's Comments:  US-009507513-2405USA008886:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; TE where patients have received the product; This spontaneous report was received from a Licensed Practical Nurse (LPN) referring to a 4 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 20-JUN-2024 , the patient was vaccinated with an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter, lot # Y003881 (strength, route, expiration date and anatomical location were not provided) for prophylaxis.   The temperature excursion was as follow: -14°C up to -10°C for 8 hours 0 minutes 0 seconds and -10°C up to -8°C for 6 hours 0 minutes 0 seconds.  No symptoms reported. No previous excursions reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Nurse calling to report inadvertently administered expired dose of MMRII to a patient. Caller stated product did not undergo any temperature excursions and was supported Per Post-Expiry Memo. Permission to contact HCP was granted. No additional infor; This spontaneous report was received from a nurse and refers to a unspecified age and gender patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.   On 21-JUN-2024, the patient started was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA)(M-M-R II) injection, lot #W039972, expiration date: 02-JUN-2024 (who had been verified to be a valid lot number), administered for prophylaxis (strength, and route of administration were not provided) (expired product administered).  No additional adverse event.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: did not reconstitute it with the adjuvant/mixed it with a sterile diluent; did not reconstitute it with the adjuvant/mixed it with a sterile diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number X5J23, expiry date 25-JAN-2026) for prophylaxis.   On 14-JUN-2024, the patient received the 2nd dose of Shingrix. On 14-JUN-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: did not reconstitute it with the adjuvant/mixed it with a sterile diluent) and inappropriate dose of vaccine administered (Verbatim: did not reconstitute it with the adjuvant/mixed it with a sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-JUN-2024 The reporter was a office manager. The reporter reported that a medical assistant (patient) administered Shingrix on Friday and they did not reconstituted it with the adjuvant and mixed it with a sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consent to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient waited longer than 6 months after the 1st dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient waited longer than 6 months after the 1st dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 17-JUN-2024 A reporter reported that he/she had a question about Shingrix dosing schedule. What to do if the patient waited longer than 6 months after the 1st dose. This was identified as a potential error medication, as the reporter was asking for how to proceed instructions.  However, the reporter ended the chat abruptly so no more information could be gathered. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Syringe issue, Underdose
Clinical narrative: Engerix-B under dose maladministration/received half of the dose; syringe began to leak from the luer lock area of the syringe; Pharmaceutical product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 60-year-old female patient who received HBV (Engerix B adult) (batch number 9LK2G, expiry date 21-AUG-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received the 1st dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced underdose (Verbatim: Engerix-B under dose maladministration/received half of the dose), syringe leak (Verbatim: syringe began to leak from the luer lock area of the syringe) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the underdose, syringe leak and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 17-JUN-2024 While a medical assistant was administering ENGERIX-B, the syringe began to leak from the luer lock area of the syringe. Because of this, the patient did not receive the full dose, received half dose which led underdose. The reporter confirms that, the needle was screwed on correctly, and that a Luer lock compatible needle was used. The defect was discovered, during administration, after partial use. The box from which the suspect syringe came from has been flagged by the health care professional in order to focus on any other syringe issues from this lot. The size gauge needle was used either a 23 g or 25 g (1 inch). The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 18-JUN-2024 Healthcare professional was the reporter who stated a patient told her a friend had the complete Shingrix series in 2018 and the friend got shingles 7 later. No further information was known such as initials, date of administration, lot number, location vaccine administered or any patient demographics.  The reporter noted that the timeline does not add up, as 7 years later would be year 2025 but this was how it was reported to the Healthcare professional. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Menstruation irregular
Clinical narrative: A few weeks to a month after stated vaccination, period would last for the entire month or go two months with no period; Miscarriage; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C214) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Birth control (Patient has taken birth control since 15yo and reported consistent periods).    On 23-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In August 2022, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). In September 2022, the patient experienced MENSTRUATION IRREGULAR (A few weeks to a month after stated vaccination, period would last for the entire month or go two months with no period). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) outcome was unknown and MENSTRUATION IRREGULAR (A few weeks to a month after stated vaccination, period would last for the entire month or go two months with no period) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was unknown if the patient experienced any additional symptoms/events or medication details and reason for taking the medicine. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. There were no lab data/results available.    Company Comment: This is a spontaneous case concerning a 29-year-old, female patient with medical history of birth control since she was 15 years-old (no details provided) who experienced the serious (due to medically significant) unexpected event of Abortion spontaneous, and the non-serious unexpected event of Menstruation irregular. The events occurred approximately 1 year 3 months and 1 year 4 months, respectively, after a dose of mRNA-1273 vaccine (dose number was not provided). Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the event Abortion spontaneous was not reported, and the outcome of the event Menstruation irregular was reported as not recovered. The events were considered as not related to the vaccine due to long latency. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: symptoms as Bell's Palsy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2024 and was forwarded to Moderna on 19-Jun-2024.      This spontaneous case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (symptoms as Bell's Palsy) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (symptoms as Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (symptoms as Bell's Palsy) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The suspect product dosage text was reported as unknown. It was reported that the patient took Moderna vaccine in 3 years ago and have symptoms as Bell's Palsy. Reporter causality was not reported.  No treatment medication was reported.  Company Comment: This is a Spontaneous case concerning a 58-year-old male patient with no medical history reported, who experienced the serious (per medically significant) expected AESI of Bell's palsy. The event occurred on an unknown date and onset latency after an unspecified dose of mRNA-1273 received for COVID-19 Vaccination schedule. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine, Endometrial disorder, Investigation, Mammogram, Mammogram abnormal
Clinical narrative: My body is slowly being destroyed by the poison; Currently, I have developed endometrial cells even though I had a hysterectomy; I have not been sexually active; My urine came back with blood in it; My Cologuard just came back abnormal; my mammogram came back abnormal for the first time ever; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EP6955) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy" (unspecified if ongoing); "HPA", start date: 2000 (unspecified if ongoing); "leep procedure" (unspecified if ongoing); "c-section" (unspecified if ongoing); "appendectomy" (unspecified if ongoing); "known allergies penicillin" (unspecified if ongoing). Concomitant medication(s) included: XANAX. Vaccination history included: pfizer COVID-19 vaccine-purple (DOSE 1, SINGLE, Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: ENDOMETRIAL DISORDER (non-serious) with onset Jan2023, outcome "unknown", described as "Currently, I have developed endometrial cells even though I had a hysterectomy"; NON-CONSUMMATION (non-serious) with onset Jan2023, outcome "unknown", described as "I have not been sexually active"; STOOL ANALYSIS ABNORMAL (non-serious) with onset Jan2023, outcome "unknown", described as "My Cologuard just came back abnormal"; POISONING (medically significant) with onset Jan2023, outcome "unknown", described as "My body is slowly being destroyed by the poison"; BLOOD URINE (non-serious) with onset Jan2023, outcome "unknown", described as "My urine came back with blood in it"; MAMMOGRAM ABNORMAL (non-serious) with onset Jan2023, outcome "unknown", described as "my mammogram came back abnormal for the first time ever". The events "my body is slowly being destroyed by the poison", "currently, i have developed endometrial cells even though i had a hysterectomy", "i have not been sexually active", "my urine came back with blood in it", "my cologuard just came back abnormal" and "my mammogram came back abnormal for the first time ever" required physician office visit. The patient underwent the following laboratory tests and procedures: Cologuard: abnormal, notes: My Cologuard just came back abnormal and my mammogram came back abnormal for the first time ever. Every time I go for something it is abnormal; Mammogram: abnormal; Urine analysis: with blood in it. It was unknown if therapeutic measures were taken as a result of poisoning, endometrial disorder, non-consummation, blood urine, stool analysis abnormal, mammogram abnormal. Clinical course: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.