chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Toothache, Toxic encephalopathy, Urinary tract infection, Urine output decreased
Clinical narrative: Subject presented to ER on 3/29/2024. Subject's son noted since previous hospitalization patient has been experiencing increased confusion at home. Son notes that he has had to stay with his father x 1 week as the patient has been experiencing increased confusion that include: occasional loss of time, difficultly ambulating d/t weakness, bouts of anger and yelling, and hallucinations. Son states that the patient usually ambulates by self but notes he has had to help him ambulate. Son notes he was treated for a UTI while admitted 1 week prior. Son denies any previous AMS hx. Patient states he has been experiencing left upper tooth pain x 1 week. Patient was seen by a dentist a few days ago and was referred to an oral surgeon for f/u April 2nd but notes the pain has become severe. Notes he has been unable to sleep d/t the pain. Patient notes this pain radiates to the left ear and left eye, causing occasional episodes of blurry vision. Patient also he has not experienced a BM x5 days. Patient denies abdominal pain but notes discomfort in his abdomen. Patient also notes decreased urinary output, states when he urinates, he only produces a mild amount of urine, and is very dark. Patient denies fever/chills. Patient received dialysis this morning but did not complete the dialysis treatment due to tooth pain. Patient was given morphine injection 2 mg. On this admission, MRI on (3/29/24) showed no acute pathology but only chronic infarcts. No stigmata of CNS infection or new stroke. Neurology was consulted due to concerns of CNS infection or meningoencephalitis due to previous VZV infection. CT Lumbar puncture on 4/2/24 showed no signs of infectious or inflammatory cause. Most likely a toxic metabolic encephalopathy versus vascular dementia due to medical cormorbidities, hospital acquired delirium, chronic infections, antivirals. Patient's symptom was unlikely secondary to tooth pain. CT Imaging of head and neck (3/13/24) on previous admission was remarkable for tooth infection without signs of abscess. Per patient's family's concern, follow-up with Neurology was set up for possible dementia. A follow-up with Palliative was set up to discuss further care as well. Subject discharged on 4/7/2024 to Rehab facility. Study Principal investigator has assessed the causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Subject presented to ER on 3/29/2024. Subject's son noted since previous hospitalization patient has been experiencing increased confusion at home. Son notes that he has had to stay with his father x 1 week as the patient has been experiencing increased confusion that include: occasional loss of time, difficultly ambulating d/t weakness, bouts of anger and yelling, and hallucinations. Son states that the patient usually ambulates by self but notes he has had to help him ambulate. Son notes he was treated for a UTI while admitted 1 week prior. Son denies any previous AMS hx. Patient states he has been experiencing left upper tooth pain x 1 week. Patient was seen by a dentist a few days ago and was referred to an oral surgeon for f/u April 2nd but notes the pain has become severe. Notes he has been unable to sleep d/t the pain. Patient notes this pain radiates to the left ear and left eye, causing occasional episodes of blurry vision. Patient also he has not experienced a BM x5 days. Patient denies abdominal pain but notes discomfort in his abdomen. Patient also notes decreased urinary output, states when he urinates, he only produces a mild amount of urine, and is very dark. Patient denies fever/chills. Patient received dialysis this morning but did not complete the dialysis treatment due to tooth pain. Patient was given morphine injection 2 mg. On this admission, MRI on (3/29/24) showed no acute pathology but only chronic infarcts. No stigmata of CNS infection or new stroke. Neurology was consulted due to concerns of CNS infection or meningoencephalitis due to previous VZV infection. CT Lumbar puncture on 4/2/24 showed no signs of infectious or inflammatory cause. Most likely a toxic metabolic encephalopathy versus vascular dementia due to medical cormorbidities, hospital acquired delirium, chronic infections, antivirals. Patient's symptom was unlikely secondary to tooth pain. CT Imaging of head and neck (3/13/24) on previous admission was remarkable for tooth infection without signs of abscess. Per patient's family's concern, follow-up with Neurology was set up for possible dementia. A follow-up with Palliative was set up to discuss further care as well. Subject discharged on 4/7/2024 to Rehab facility. Study Principal investigator has assessed the causality as not study related.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Abnormal faeces, Dehydration, Faeces discoloured, Haematochezia, Infantile diarrhoea
Clinical narrative: 9 week old baby got intusussception from Mercks RotaTeq vaccine 6 days after first dose. She initially had a change in color and smell of her stool starting 3 days after vaccine, then over the next several days she then started having diarrhea and vomiting for multiple days. On 7/2 she had red jelly like stool and doctor advised to go to ER. ER confirmed via ultrasound intususception in small intestine, and via stool sample there was blood present. Baby was dehydrated and had lost half a pound since getting the vaccine and doctors admitted her for overnight observation to see if the intususception corrects itself. Thankfully it resolved itself and baby was discharged next afternoon.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Infantile vomiting, Intussusception, Stool analysis abnormal, Ultrasound abdomen abnormal, Weight decreased
Clinical narrative: 9 week old baby got intusussception from Mercks RotaTeq vaccine 6 days after first dose. She initially had a change in color and smell of her stool starting 3 days after vaccine, then over the next several days she then started having diarrhea and vomiting for multiple days. On 7/2 she had red jelly like stool and doctor advised to go to ER. ER confirmed via ultrasound intususception in small intestine, and via stool sample there was blood present. Baby was dehydrated and had lost half a pound since getting the vaccine and doctors admitted her for overnight observation to see if the intususception corrects itself. Thankfully it resolved itself and baby was discharged next afternoon.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: N/A -  Expired
Age: 1.17
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting, Diarrhea, 103 Fever, chills
Age: 55.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Wrong product administered
Clinical narrative: I AM REQUESTING THAT THE FDA INVESTIGATE WHY I WAS GIVEN THE WRONG COVID-19 VACCINE AND SHARE FINDINGS WITH ME.  I made an appointment on Pharmacy website for a flu shot but not a COVID-19 vaccine injection. This is because the Pharmacy "Schedule Vaccine" web page for the Novamax vaccine stated that appointments are not required. Upon arrival at this store pharmacy, I requested twice to receive the Novavax vaccine in addition to the flu shot. Later that day, I received an email/alert informing me that COVID vaccine "COMIRNATY" PFIZER was injected into me. To date, Pharmacy has been uncooperative in sharing details of this mistake and addressing my needs to remove this vaccine, that I never wanted, from my body.
Age: 0.17
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Had redness and swelling at the site. Resolved in 24 hours.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Antinuclear antibody, Blood creatine phosphokinase, Full blood count, Headache, Inflammation
Clinical narrative: SPLITTING HEADACHE, INFLAMMATION, MUSCLE AND TENDON PAIN X 1 MONTH
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Metabolic function test, Myalgia, Tendon pain
Clinical narrative: SPLITTING HEADACHE, INFLAMMATION, MUSCLE AND TENDON PAIN X 1 MONTH
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Culture wound, Impaired healing, Injection site discharge, Injection site erythema, Injection site pain
Clinical narrative: Two to three days after receiving the vaccine area was red and painful, about two weeks in the area felt like a million bee stings burning and painful at the injection site for about 4 days. The area then blistered and blisters erupted drained and scabbed over.  This happened a few times over next two weeks with blistering and erupting then scabbing over. Each time the area burned and itching more and more.  Area has developed as an ulceration not healing.  Patient denies fevers or chills. Denies any hx of MRSA or recurrent unhealing wounds. Not diabetic.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site reaction, Injection site scab, Injection site ulcer, Injection site vesicles
Clinical narrative: Two to three days after receiving the vaccine area was red and painful, about two weeks in the area felt like a million bee stings burning and painful at the injection site for about 4 days. The area then blistered and blisters erupted drained and scabbed over.  This happened a few times over next two weeks with blistering and erupting then scabbing over. Each time the area burned and itching more and more.  Area has developed as an ulceration not healing.  Patient denies fevers or chills. Denies any hx of MRSA or recurrent unhealing wounds. Not diabetic.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Underdose
Clinical narrative: vaccine administration error. incomplete administration of the vaccine. vaccine dose was labeled as invalid and will need to be repeated in 3 months.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, itching, mild edema and warmth at injection site
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events reported, this was an administration error. The patient received a dose of Arexvy from pharmacy on 10/12/2023. Only one dose is indicated per patient. The patient got a second dose by error on 4/3/2024 at our pharmacy. Patient is aware of the error, patient's doctor has been notified. Patient said he did not notice any symptoms from revaccination.
Age: 18.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Wrong product administered
Clinical narrative: I AM REQUESTING THAT THE FDA INVESTIGATE WHY I WAS GIVEN THE WRONG COVID-19 VACCINE AND SHARE FINDINGS WITH ME.  My father made an appointment on pharmacy website for a flu shot but not a COVID-19 vaccine injection. This is because the Pharmacy "Schedule Vaccine" web page for the Novamax vaccine stated that appointments are not required. Upon arrival at this store pharmacy, he requested twice that I receive the Novavax vaccine in addition to the flu shot. Later that day, I received an email/alert informing me that COVID vaccine "COMIRNATY" PFIZER was injected into me. To date, Pharmacy has been uncooperative in sharing details of this mistake and addressing my needs to remove this vaccine, that I never wanted, from my body.
Age: 5.0
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Medical Assistant vaccinated the Child with both a Proquad and a Varivax.  She thought the Proquad was a MMR.
Age: 5.0
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Medical Assistant vaccinated the Child with both a Proquad and a Varivax.  She thought the Proquad was a MMR.
Age: 82.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Patient reports he had redness and soreness at the injection site. He later developed a lump under the injection site. He went to an urgent care, where they diagnosed him with cellulitis. Patient was treated with antibiotics. The patient notified the pharmacy today 7/10/2024 of his diagnosis and treatment, and said his antibiotics appeared to be effective and he is healed.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Feeling abnormal, Nausea, Pallor
Clinical narrative: At approx. 1405, patient received HPV vaccine and was given instructions to wait in the lobby for 15min before leaving and to notify staff if she felt funny/bad. At approx. 1412 this nurse checked on the patient, who at that time looked pale and their eyes were slight rolling back. The nurse asked the patient if she was feeling okay, the patient stated that they were feeling dizzy and like they needed to throw up. This nurse then attempted to help the patient to the immunization chair to lay them back and elevate their feet but when the patient stood up they fainted. This nurse gently lowered the patient to the floor, patient was breathing but not responding to verbal stimuli. This nurse asked the receptionist to call for help, while this nurse performed the sternum rub from which the patient awoke immediately and stood up. This nurse assisted the patient back to the chair and two other nurses and the DON arrived to help. Another nurse and this nurse then attempted to assist the patient to the immunization chair, we walked approx. 6ft and the patient fainted again, patient was gently lowered to the floor. The patient?s vitals were assessed, BP was low, a small children?s chair was placed under the patient?s leg to elevate them while they continued to lay in the floor for approx.. 5min. When it was safe the DON gave the patient a soda to sip on. We then were able to assist the patient to the immunization chair and elevate their legs while laying back. The vital signs were assessed again and show BP in normal range. Patient was encouraged to sit and drink the soda and eat a piece of candy. Approx. 15min later the patient stated that they were feeling better. This nurse assessed vital signs, all in normal range, had the patient stand up and in place for 1-2mins and then had the patient walk around the room for 1-2mins. Patient stated that they were no longer dizzy and would like to go home.  Patient was allowed to leave, instructions were give if they felt dizzy or lightheaded again to seek medical assistance immediately.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: At approx. 1405, patient received HPV vaccine and was given instructions to wait in the lobby for 15min before leaving and to notify staff if she felt funny/bad. At approx. 1412 this nurse checked on the patient, who at that time looked pale and their eyes were slight rolling back. The nurse asked the patient if she was feeling okay, the patient stated that they were feeling dizzy and like they needed to throw up. This nurse then attempted to help the patient to the immunization chair to lay them back and elevate their feet but when the patient stood up they fainted. This nurse gently lowered the patient to the floor, patient was breathing but not responding to verbal stimuli. This nurse asked the receptionist to call for help, while this nurse performed the sternum rub from which the patient awoke immediately and stood up. This nurse assisted the patient back to the chair and two other nurses and the DON arrived to help. Another nurse and this nurse then attempted to assist the patient to the immunization chair, we walked approx. 6ft and the patient fainted again, patient was gently lowered to the floor. The patient?s vitals were assessed, BP was low, a small children?s chair was placed under the patient?s leg to elevate them while they continued to lay in the floor for approx.. 5min. When it was safe the DON gave the patient a soda to sip on. We then were able to assist the patient to the immunization chair and elevate their legs while laying back. The vital signs were assessed again and show BP in normal range. Patient was encouraged to sit and drink the soda and eat a piece of candy. Approx. 15min later the patient stated that they were feeling better. This nurse assessed vital signs, all in normal range, had the patient stand up and in place for 1-2mins and then had the patient walk around the room for 1-2mins. Patient stated that they were no longer dizzy and would like to go home.  Patient was allowed to leave, instructions were give if they felt dizzy or lightheaded again to seek medical assistance immediately.
Age: 73.0
Sex: M
Vaccine: TDAP
Symptoms: Limb mass, Pain in extremity, Tenderness
Clinical narrative: Pt reported that he had a lump for about 1 week and now he has soreness that comes and goes, especially when he touches his arm.
Age: 7.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A TD vaccine was inadvertently given to a 7-year-old client instead of the appropriate TDAP that should have been given. The TDVAX that was given is for ages 7 and older but was not the appropriate vaccine for this client at this visit.  No adverse reactions were reported as a result of the vaccine error.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Injection site reaction, Injection site swelling, Pain
Clinical narrative: Severe, throbbing pain on injection site for 2 days and swelling. Patient applied ice pack on 7/10, and used Icy Hot Cream on 7/9
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Asthenia, Balance disorder, Blood phosphorus decreased, Blood pressure increased
Clinical narrative: Guillan Barre syndrome.  Symptoms include heart palpitations, elevated blood pressure, elevated heart rate, arrhythmia, dizziness, shortness of breath, vision focus problems, reaction time problems, weakness, fatigue, difficulty moving legs, brain fog, unsteadiness/lack of coordination and balance.   Admitted to ER. blood work showed low phosphorous.  Given phosphorous via IV.  Prescribed metaprolol 25mg for heart palpitations by cardiologist.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain fog, Coordination abnormal, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: Guillan Barre syndrome.  Symptoms include heart palpitations, elevated blood pressure, elevated heart rate, arrhythmia, dizziness, shortness of breath, vision focus problems, reaction time problems, weakness, fatigue, difficulty moving legs, brain fog, unsteadiness/lack of coordination and balance.   Admitted to ER. blood work showed low phosphorous.  Given phosphorous via IV.  Prescribed metaprolol 25mg for heart palpitations by cardiologist.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Guillain-Barre syndrome, Heart rate increased, Mobility decreased, Palpitations
Clinical narrative: Guillan Barre syndrome.  Symptoms include heart palpitations, elevated blood pressure, elevated heart rate, arrhythmia, dizziness, shortness of breath, vision focus problems, reaction time problems, weakness, fatigue, difficulty moving legs, brain fog, unsteadiness/lack of coordination and balance.   Admitted to ER. blood work showed low phosphorous.  Given phosphorous via IV.  Prescribed metaprolol 25mg for heart palpitations by cardiologist.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Scan myocardial perfusion, Slow response to stimuli, Vision blurred
Clinical narrative: Guillan Barre syndrome.  Symptoms include heart palpitations, elevated blood pressure, elevated heart rate, arrhythmia, dizziness, shortness of breath, vision focus problems, reaction time problems, weakness, fatigue, difficulty moving legs, brain fog, unsteadiness/lack of coordination and balance.   Admitted to ER. blood work showed low phosphorous.  Given phosphorous via IV.  Prescribed metaprolol 25mg for heart palpitations by cardiologist.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: MA accidentally administered a Dtap and Tdap to a 10yr old patient at the same office visit.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Detoxification, Echocardiogram, Electrocardiogram, Immunisation reaction
Clinical narrative: JNJ #1 5/3/2021 MODERNA #1 11/2/2021 DEVELOPED CHEST PAIN, PALPITATIONS, DIAGNOSED WITH COVID-19 SUBCLINICAL VACCINE MYOPERICARDITIS.   TREATED WITH COLCHICINE AND PROTOCOL BASE SPIKE PROTEIN DETOXIFICATION.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Myopericarditis, Palpitations
Clinical narrative: JNJ #1 5/3/2021 MODERNA #1 11/2/2021 DEVELOPED CHEST PAIN, PALPITATIONS, DIAGNOSED WITH COVID-19 SUBCLINICAL VACCINE MYOPERICARDITIS.   TREATED WITH COLCHICINE AND PROTOCOL BASE SPIKE PROTEIN DETOXIFICATION.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase normal, Blood sodium normal, Chest X-ray abnormal, Feeling abnormal
Clinical narrative: 6:30 at night mom gave her 1.25mg of Tylenol as she felt warm Then bathed. Looked a bit fussy. At 915pm mom noted her to be "stiff", said "a a a ", few seconds, eyes open wide, when Mom petted her, she relaxed and stopped. Fever checked at the time fever up to 102.0 Started cooling her off and undressed and cooling cloth. Was baby was responsive and eating afterwards.    At 10pm, was given more tylenol.  Around 11pm mom noticed the episode again, lasted few seconds.  Mom picked her up and she was fine. Taken to ED. On arrival, fever was 102.2.  Given Motrin and all was well. Fever last for 2 days only Brother had a fever a few hours afterwards.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Full blood count normal, Lung opacity, Musculoskeletal stiffness, Pyrexia, Urine analysis normal
Clinical narrative: 6:30 at night mom gave her 1.25mg of Tylenol as she felt warm Then bathed. Looked a bit fussy. At 915pm mom noted her to be "stiff", said "a a a ", few seconds, eyes open wide, when Mom petted her, she relaxed and stopped. Fever checked at the time fever up to 102.0 Started cooling her off and undressed and cooling cloth. Was baby was responsive and eating afterwards.    At 10pm, was given more tylenol.  Around 11pm mom noticed the episode again, lasted few seconds.  Mom picked her up and she was fine. Taken to ED. On arrival, fever was 102.2.  Given Motrin and all was well. Fever last for 2 days only Brother had a fever a few hours afterwards.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Myalgia, Somnolence, Vision blurred
Clinical narrative: by 2pm day of shot, fatigue and sleepiness.  Next day having vision problems/blurry, muscle pains, more fatigue/general malaise
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient suffered redness and swelling of the left arm still present a week after injection.  Reports pain from day of initial injection that she thought was expected. On day 5 family tried to touch her arm and they could not touch her.  They lifted her sleeve to find redness, heat and swelling to the are.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: PT CALLED TO REPORT THAT LAST NIGHT HE STARTED EXPERIENCING RASH AND ITCHING STARTING ON THE BOTTOM OF HIS LEGS. HE SAID THAT IT HAS STARTED TO SPREAD TO HIS TORSO AND ARMS AS OF TODAY. HE STATED THAT HE WAS WORRIED THAT THE VACCINE GAVE HIM CHICKEN POX SOMEHOW. HE IS GOING TO CALL MD/GO TO URGENT CARE FOR TREATMENT. PATIENT WAS INFORMED OF POSSIBILITY OF ALLERGIC REACTION AND INSTRUCTED TO SEEK MEDICAL ATTENTION.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, PNC15
Symptoms: Abdominal pain upper, Feeling abnormal, Pallor
Clinical narrative: Patient came into clinic to receive catch up vaccinations , child received, DTAP, P15 and HIB, pt initially tolerated vaccines well, waiting approx 15 mins in lobby as instructed after vaccines, when mother got up to leave, pt told her mother she didnt not feel good, that her stomach hurt, mom states she then was pale and mother yell stating she was having a reaction, child was immediately brought to exam room child , Mom was holding child in her arms, was pale, eyes open, child was placed on exam table child was awake and talking, B/P @1200 84/51 HR59. Child was able to sit up and eat peanut butter crackers and drink  B/p rechecked around 1205 107/65 HR 91. Child stated she felt better and wanted to go home. 1210 BP 92/61 HR89  after a few minutes child was able to stand and B/p rechecked  92/60 HR 89. I attempted to Contact Dr on cell phone with no answer, Contacted, RND who stated to call APN who was covering for Dr. APN notified of the event detail, APN stated if patient feeling back to normal child free to leave clinic, Mom states that child was back to normal at approx 1240. Encouraged mom if child had any more issues she should call 911 or report to her nearest ER. Mom verbalized understanding.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Contusion, Injected limb mobility decreased, Pain in extremity, X-ray
Clinical narrative: brusing, pain, burning, decreased range of motion left arm
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The organization pharmacy sent the covid vaccine with a bright yellow expiration date of 7/11/24 as usual. But when it was given today, we realized the vial's expiration date was 7/2/24
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Death, Laboratory test
Clinical narrative: Patient developed symptoms of ALS shortly after the shot and died 8/22/2023.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Loss of consciousness, Pyrexia, Seizure, Syncope
Clinical narrative: Patient had a syncope episode the night of 6/24/2024 that lasted for 3 seconds and was witnessed by her sister. After losing consciousness the patient began to shake according to sister. Patient did not lose bladder/bowel control and did not remember it once she was coherent again. This is the first time patient has experienced convulsions and there is a family history of epilepsy. Mom called the office on 6/25/2024 and informed the nurse line that patient had a slight fever the day before and dizziness after eating. I informed mom that the fever could be due to vaccine but since patient has a history of of dizziness after eating then that symptom could be unrelated. I advised mom to schedule an appointment due to the symptoms patient had experienced. Mom did not schedule an appointment with us and I had front desk reach out on 2 more different occasions. Mom never answered or returned our voice mails for scheduling. Patients sibling had an appointment at our office on 7/5/2024 and during that time, mom stopped by the front desk to ask if we could add on patient to our schedule for the dizziness and shaking symptoms she experienced on 6/24/2024. Patient was seen by both Dr. and PA-C on 7/5/2024. The providers found that patient has a history of passing out, hot flashes after eating, and becoming light headed when really hot or standing up. The providers have low suspicion for the symptoms being due to a seizure. At this time Dr. and PA-C are referring to Neurology, speaking to patients Endocrinologist, and also ordering an EKG and EEG.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Incorrect vaccine given.  Adolescent vaccines given in error.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Within less than 12 hours after receiving the flu vaccine in my left arm, erythema had occurred. It was moderately painful and very hot to the touch. It persisted for about 4 days.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient came to the office today for immunizations.  I printed his immunization record before his appointment and it showed he needed his 2nd HPV, 2nd Hep A, and meningococcal vaccine.  He called his mom before I gave him his vaccines and his mom said she thought he had received his meningitis vaccine at Facility.  I called the clinic and was told patient had received the meningitis vaccine on 8/11/2017.  I didn't inquire if he had received both does of the HPV vaccine.  I asked patient to fax me a copy of the record.  I gave the vaccines before receiving the record and when I did receive the record it showed that he had already had his 2nd HPV vaccine.  Therefore, an extra dose of HPV was given today.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Antibody test, Rash, Varicella post vaccine
Clinical narrative: Pt was seen in Emergency Room for sudden onset rash.  Was diagnosed with  Varicella and returned home, with directions for care.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: FEELS DIZZY LEFT SIDE FACE NUMBNESS AND TINGLING, ABLE TO SPEAK CLEARLY ,SMILE NO DROOPING, HOLD ARMS UP .
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Vision blurred
Clinical narrative: FEVER, CHILLS, HEADACHE, BLURRY VISION
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: pt describe to have rash on both arms about 4-5 days after receiving vaccination. ruled out sunburn, but pt described to have rash and itchiness on left, then right arm. the only thing she can attribute it to is the vaccination from a few days earlier. pt states that searched for covid related reactions and found covid arm pictures to be consistent with what she experienced. symptoms seems to subside a week later but still feels some sporadic itching. pt states that she's been treating it as if it is poison ivy rash.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, Wrong patient received product
Clinical narrative: Received order through data via databasefor Meningococcal A,C,W,Y and Meningococcal B vaccine. Prepared discharge paperwork and reviewed immunizations for Meningitis vaccines. Prepared vaccinations within the med room along with discharge paperwork. Wrote the lot numbers of the vaccinations on the vaccination consent form. Headed towards patient room. Before entering the patient's room, I received another order from the doctor that Hep A was added. Did not clarify order nor was the immunization report rechecked for Hep A past vaccinations. Proceeded back to med room. Prepared Hep A vaccine and verified that vaccine fits patient age. Proceeded once again to patient's room. Notified of 3 vaccinations to parent and obtained signed consent from parent. Administered vaccinations and discharged patients and parent. Documented vaccinations and noticed Hep A order was missing. Asked provider to add Hep A order. Provider reports a miscommunication, in which Hep A was ordered for a different patient and not current patient. Provider asked for patient's immunization record. Nurse provided immunization record and confirmed that patient already received 2 doses of Hep A vaccination prior current Hep A vaccine administration.
Age: 6.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist reports this patient is now 15 years old and came to their pharmacy to complete the series; No additional AE reported; patient who received a first dose of GARDASIL 9 at 6 years of age.; This spontaneous report has been received from a pharmacist, referring to a 6-year-old patient of an unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 06-MAR-2015, the patient was vaccinated with 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiry date were not reported) (product administered to patient of inappropriate age).  At the time of reporting, the patient was 15-year-old and came to the pharmacy to complete the series (inappropriate schedule of product administration). No additional adverse event reported (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP did not report any side effects regarding the administration of the expired vaccine; HCP reported that a patient was inadverntly administered an expired dose of the VARIVAX vaccine on 06/18/2024. HCP stated that the VARIVAX vaccine expired on 06/01/2024.; This spontaneous report was received from a registered nurse referring to a patient of unknown age. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 18-JUN-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number W017552, expiration date 01-JUN-2024 (dose and route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP called to report PROQUAD was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; HCP called to report PROQUAD was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot number X022920, expiration date 12-MAR-2025, 0.5 milliliter (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Office manager confirmed that patient has not reported any other AEs since administration.; Office manager reported that a dose of vaccine was administered on 28JUN2024 after it experienced a temperature excursion on 24JUN2024.; This spontaneous report was received from an office manager and refers to a patient of unknown and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 28-JUN-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #X023875, which had been verified to be a valid lot number, expiration date reported and confirmed as 27-MAR-2025, administered for prophylaxis (strength, route of administration, and anatomical location were not provided) (Product storage error), which underwent a temperature excursion (on 24-JUN-2024) of 13.92 degrees Fahrenheit (also reported as between 6 degrees Fahrenheit [°F] to 14 F) for 45 minutes. It was confirmed that patient had not reported any other adverse events (no adverse event). No previous temperature excursion nor additional information provided.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE where the product has been administered to one patient. No further information provided. No additional AE/PQC.     VARIVAX: X028613   EXP: 12/13/2025   39F for 1392 hours 0 minutes 0 seconds- CURRENT  NO PREVIOUS EXCURSIONS; This spontaneous report has been received from a pharmacist, concerning a 23-years-old male patient. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 06-JUN-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at the dose of 0.5 milliliter (mL) as prophylaxis after a temperature excursion (strength, dose number, frequency, route of administration, and anatomical locations of application were not reported; lot number X028613 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), with expiration date reported as 15-DEC-2025 and 13-DEC-2025 and established upon internal review as 13-DEC-2025)(product storage error). No additional adverse event (AE) was reported (no adverse event).  Administered dose of vaccine experienced temperature excursion of 39 degrees Fahrenheit for 1392 hours 0 minutes and 0 seconds. There was no previous temperature excursion.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported. Consent to contact is yes. No additional AE/No PQC.; HCP called to report a TE with MMR II.  Administered after being improperly stored.; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 02-JUL-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, 0.5 milliliter, lot #W030848, which had been verified to be a valid lot number, expiration date reported and confirmed as 27-SEP-2024, administered as prophylaxis by a health professional (strength, route of administration, and anatomical location were not provided) after being improperly stored (product storage error). No adverse effected were reported (no adverse event).
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received their second dose 8 months after their first dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old female patient who received HAB (Twinrix adult) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11-SEP-2023).   On 19-JUN-2024, the patient received the 2nd dose of Twinrix adult. On 19-JUN-2024, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: received their second dose 8 months after their first dose). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUL-2024 The pharmacy intern reported that the patient was receiving Twinrix adult and they unfortunately received their second dose 8 months after their first dose.  The reporter asked at this point, should they be restarting their dosing schedule. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow up via postal. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: They have not received Shingrix dose 2 yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix in September 2018).   On an unknown date, the patient did not receive received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: They have not received Shingrix dose 2 yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUL-2024 The patient self-reported this case for herself. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.  The reporter did not wanted to provide any additional information.  The case was linked with case US2024083034 reported by the same reporter for her husband.; Sender's Comments:  US-GSK-US2024083034:Same reporter/Different patient
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: administer an adult dose of Havrix to a patient of 6 years old; administer an adult dose of Havrix to a patient of 6 years old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 6-year-old female patient who received HAV (Havrix adult) (batch number 3S54K, expiry date 18-DEC-2025) for prophylaxis.   On 21-JUN-2024, the patient received Havrix adult. On 21-JUN-2024, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: administer an adult dose of Havrix to a patient of 6 years old) and accidental overdose (Verbatim: administer an adult dose of Havrix to a patient of 6 years old). The outcome of the adult product administered to child and accidental overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUL-2024 The healthcare professional reported to administer an adult dose of Havrix to a child patient, which led to adult product administered to child and accidental overdose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got Positive for covid; got Positive for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Mar2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2024, outcome "recovering" and all described as "got Positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 29Jun2024 to 03Jul2024. Clinical course: It was reported that Patient got Positive for covid 9 days ago took it for five days and he improved. Patient had all the Pfizer covid vaccines, all of them, the most recent was 4 months ago.  Batch/lot number is not provided, and it cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Small fibre neuropathy
Clinical narrative: I developed several small fiber sensory neuropathy; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 19Feb2021 as dose 1, single (Lot number: EL9265) at the age of 37 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SMALL FIBRE NEUROPATHY (disability) with onset 01Aug2021, outcome "not recovered", described as "I developed several small fiber sensory neuropathy". Therapeutic measures were taken as a result of small fibre neuropathy (reported as medication).
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: she may have been allergic to in the Pfizer covid vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 50-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "she may have been allergic to in the Pfizer covid vaccine".  Additional information: the patient had a reaction to the Pfizer Covid vaccine, and she saw the Premarin vaginal cream was made by Pfizer. The patient she is really concerned if she uses the product. Patient could not provide information on what ingredient she may have been allergic to in the Pfizer covid vaccine. Patient stated she had the Pfizer covid vaccine approximately 4 years before this report, it was her first and only covid shot. She has not had any other covid vaccines. Patient stated she was unable to have any coloring or dyes, she got an anaphylaxis reaction. "She had a ton of allergies". The prescribing information of Premarin Vaginal Cream and Comirnaty, no ingredients found to be the same in these products. is unable to say whether or not she may have a reaction to the vaginal cream.  Recommended to share ingredient information for both products with her HCP to determine if there are any potential allergens or risks in using the Premarin Vaginal Cream.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Gait inability, Pyrexia, Swelling
Clinical narrative: swelling; fever; inability to walk for 24 hours; This is a spontaneous report received from a Physician from a sales representative.  An infant patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; WALKING DISABILITY (non-serious), outcome "recovered", described as "inability to walk for 24 hours". It was unknown if therapeutic measures were taken as a result of swelling. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400209979 same drug/event, different patient;US-PFIZER INC-202400209978 same drug/event, different patient;
Sex: U
Vaccine: PNC20
Symptoms: Gait inability, Pyrexia, Swelling
Clinical narrative: swelling; fever; inability to walk for 24 hours; This is a spontaneous report received from a Physician from a sales representative.  An infant patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; GAIT INABILITY (non-serious), outcome "unknown", described as "inability to walk for 24 hours". It was unknown if therapeutic measures were taken as a result of swelling, pyrexia, gait inability. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400209824 same reporter, drug, events, different patient;US-PFIZER INC-202400209979 same reporter, drug, events, different patient;