chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Full blood count, Headache
Clinical narrative: At time of injection for first shot, there was pain at injection site, no swelling I don?t think, but felt like I had the flu for 2-3 days, 99-100 fever, headache, muscle aches, not sure if I had a cough or any nasal issues.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Influenza like illness, Injection site pain, Myalgia, Red blood cell count
Clinical narrative: At time of injection for first shot, there was pain at injection site, no swelling I don?t think, but felt like I had the flu for 2-3 days, 99-100 fever, headache, muscle aches, not sure if I had a cough or any nasal issues.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus arrhythmia, Sinus tachycardia, White blood cell count
Clinical narrative: At time of injection for first shot, there was pain at injection site, no swelling I don?t think, but felt like I had the flu for 2-3 days, 99-100 fever, headache, muscle aches, not sure if I had a cough or any nasal issues.
Age: 1.67
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient received an undiluted dose of vaccine. Received entire vial of Pfizer Covid 19 6mo-4yr vaccine. Did not display any adverse reactions after the 15 minute waiting period in clinic post vaccine administration.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Patient having a Rash "all over body."
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Arthralgia, Injection site reaction, Injection site swelling
Clinical narrative: Pain starting the night of the injection, swelling the next day and redness by the evening of the next day. Swelling is significant and involves nearly the entire left upper  leg. Redness is mild.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Patient developed injection site reaction
Age: 25.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient received vaccine on 12/07/2023, left clinic facility and had a positive pregnancy test on the same day (12/07/2023), patient has history of 5 live births and 1 known spontaneous abortion, patient was unsure of date of LMP when seen for follow up on 03/12/2023 so EDC is unknown, patient referred to and will be followed by Health Center for this pregnancy.  Patient was counseled and informed that she would be placed on VARIVAX pregnancy registry (done 3/13/24)
Age: 25.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient received vaccine on 12/07/2023, left clinic facility and had a positive pregnancy test on the same day (12/07/2023), patient has history of 5 live births and 1 known spontaneous abortion, patient was unsure of date of LMP when seen for follow up on 03/12/2023 so EDC is unknown, patient referred to and will be followed by Health Center for this pregnancy.  Patient was counseled and informed that she would be placed on VARIVAX pregnancy registry (done 3/13/24)
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sudden cardiac death
Clinical narrative: Sudden Cardiac Death
Age: 1.58
Sex: F
Vaccine: COVID19, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reactions noted.  Patient vaccine was checked with other staff member, MD, as no other clinical staff available.  Per FDA guidelines, refrigerated state COVID vaccine was expired by one day and administered to patient.  The vaccine was not labeled as expired. Medication was received at the clinic on 11/20/23. Per Pfizer medical team consult and internal pharmacy and risk investigation: patient received the vaccine outside of the EUA Guided 10-week refrigerated expiration dating upon removing from ultra cold temperatures (Expired 1/29/2024, Administered 1/30/2024). This recommendation was made based on stability testing which confirmed COVID vaccine to be stable at refrigerated temp for up to 72 days (10 weeks + 2 days) which would adjust the TRUE expiration date to 1/31/2024.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial flutter, Cardiac ablation, Echocardiogram, Laboratory test abnormal
Clinical narrative: Atrial flutter.  Had to have a catheter ablation and TEE on 4/26/23
Age: 79.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: Swollen arm with large area of redness surrounding the injection site on the left arm
Age: 56.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AE. Reporting due to vaccine given to patient who did not meet age requirement
Age: 59.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AE. Reporting due to  vaccine given to patient who did not meet age requirement
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain of skin, Sensitive skin
Clinical narrative: *This has happened with every Covid vaccine she has had. This was her 4th vaccine for Covid. All Pfizer* Her skin hurts all over. The surface is hypersensitive to any touch from anything. She almost blacked out once.
Age: 59.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AD. Reporting due to vaccine was given to patient who did not meet age requirement.
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Diarrhoea, Respiratory tract congestion, Vomiting
Clinical narrative: Vomiting, diarrhea, congestion
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Induration, Product administered at inappropriate site, Skin warm
Clinical narrative: Patient received vaccination by EMT who placed vaccine in patients left arm which later became red, warm and partially hardened. Director of Nursing visited the patient at his school the day following administration to observe the arm. The shot was given too low on the left arm, below the deltoid muscle. However, upon consultation with the vaccination coordinator and Pediatrician, it was determined that the body was responding to the vaccination and that a repeat administration was not necessary. Follow up education was provided to EMT regarding proper placement of vaccinations that are intramuscular.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Balance disorder, Blood test normal, Cardiac function test normal, Computerised tomogram head normal
Clinical narrative: significant pain and immobility  in neck, shoulders for first two months with headache on right side, then chronic continuing signicant immobility in right shoulder with pain, muscle atrophy, pain radiating to neck and significant headache on right side, facial numbness, radiating pain down spine to right eg and difficulty walking, passing out and dizziness,.  two emergency room visits, visit to rheunatologist and full workup with blood tests etc, visits to neurologist with full CT scan of head and spine, visits to primary with shown deficits in balance and referrals to another neurologist/PT/cardiologist.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Computerised tomogram spine normal, Dizziness, Gait disturbance, Headache, Hypoaesthesia
Clinical narrative: significant pain and immobility  in neck, shoulders for first two months with headache on right side, then chronic continuing signicant immobility in right shoulder with pain, muscle atrophy, pain radiating to neck and significant headache on right side, facial numbness, radiating pain down spine to right eg and difficulty walking, passing out and dizziness,.  two emergency room visits, visit to rheunatologist and full workup with blood tests etc, visits to neurologist with full CT scan of head and spine, visits to primary with shown deficits in balance and referrals to another neurologist/PT/cardiologist.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Loss of consciousness, Mobility decreased, Muscle atrophy, Neck pain
Clinical narrative: significant pain and immobility  in neck, shoulders for first two months with headache on right side, then chronic continuing signicant immobility in right shoulder with pain, muscle atrophy, pain radiating to neck and significant headache on right side, facial numbness, radiating pain down spine to right eg and difficulty walking, passing out and dizziness,.  two emergency room visits, visit to rheunatologist and full workup with blood tests etc, visits to neurologist with full CT scan of head and spine, visits to primary with shown deficits in balance and referrals to another neurologist/PT/cardiologist.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity, Spinal pain
Clinical narrative: significant pain and immobility  in neck, shoulders for first two months with headache on right side, then chronic continuing signicant immobility in right shoulder with pain, muscle atrophy, pain radiating to neck and significant headache on right side, facial numbness, radiating pain down spine to right eg and difficulty walking, passing out and dizziness,.  two emergency room visits, visit to rheunatologist and full workup with blood tests etc, visits to neurologist with full CT scan of head and spine, visits to primary with shown deficits in balance and referrals to another neurologist/PT/cardiologist.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient reports redness, swelling and pain at injection site starting within 24hours of administration, so she marked the outline of the redness on Tuesday 3/12/24. She then noticed a significant worsening in pain, swelling, and redness so presented to clinic for evaluation 3/13/24.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Erythema, warmth and mild edema to injection site
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain upper, Hypotonia, Pallor
Clinical narrative: Patient stated his stomach hurt, turned very pale and was limp after receiving the vaccine. Patient was kept in clinic until 3:30. Provider checked on patient and then RN checked on patient prior to leaving.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fall, Pallor
Clinical narrative: Patient became dizzy, pale. Asked to go to the bathroom. While in the bathroom, pt fell. Was given cool rag for forehead and popsicle. Laid down in clinic on exam table for several minutes.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: Dizziness, and weakness, pain, redness, and swelling, myalgia, fatigue, headache, shivering. There were a large amount of tiny painful aggregations of blisters on the inside part of the lower lip, that appeared along with other adverse events, and they disappeared when other adverse events were gone.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lip blister, Myalgia, Pain, Swelling
Clinical narrative: Dizziness, and weakness, pain, redness, and swelling, myalgia, fatigue, headache, shivering. There were a large amount of tiny painful aggregations of blisters on the inside part of the lower lip, that appeared along with other adverse events, and they disappeared when other adverse events were gone.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given a PPSV23 when he should have been given a PCV20. Patient will need to come back into clinic in 1 year to receive a PCV20. Pt did not have a reaction, rather the incorrect vaccine was given.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Swelling
Clinical narrative: Patient presents to pharmacy, 5 days after vaccine, showing a red swollen shoulder. It looked like a red band across of deltoid.
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Dyspnoea, Productive cough
Clinical narrative: ADVERSE EVENTS: Extreme congestion and coughing from 8/12/2023 to 12/20/2023.  Mild congestion 12/21/2023 to 2/2/2024.  Cough up yellow sputum 8/12/2023 to 12/20/2023.  Shortness of breath 9/15/2023 to 12/20/2023  TREATMENT: Amoxicillin 8/20/2023 to 9/6/2023 Clavulanate Potassium 8/20/2023 to 9/6/2023 Methylprednisolone 9/7/2023 to 9/13/2023 and 9/18/2023 to 9/24/2023 Singulair 9/14/2023 to 9/18/2023 Prednisone 9/20/2023 to 9/28/2023 and 11/2/2023 to 11/14/2023 Albuterol 9/23/2023 to 12/20/2023 Fluticasone-Salmeterol 10/17/2023 to 11/17/2023 Nasonex 10/17/2023 to 11/17/2023 Levofloxacin 11/2/2023 to 11/9/2023  OUTCOME: It took 6 months to get over the problem.
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Respiratory tract congestion, Spirometry, Sputum culture, Sputum discoloured
Clinical narrative: ADVERSE EVENTS: Extreme congestion and coughing from 8/12/2023 to 12/20/2023.  Mild congestion 12/21/2023 to 2/2/2024.  Cough up yellow sputum 8/12/2023 to 12/20/2023.  Shortness of breath 9/15/2023 to 12/20/2023  TREATMENT: Amoxicillin 8/20/2023 to 9/6/2023 Clavulanate Potassium 8/20/2023 to 9/6/2023 Methylprednisolone 9/7/2023 to 9/13/2023 and 9/18/2023 to 9/24/2023 Singulair 9/14/2023 to 9/18/2023 Prednisone 9/20/2023 to 9/28/2023 and 11/2/2023 to 11/14/2023 Albuterol 9/23/2023 to 12/20/2023 Fluticasone-Salmeterol 10/17/2023 to 11/17/2023 Nasonex 10/17/2023 to 11/17/2023 Levofloxacin 11/2/2023 to 11/9/2023  OUTCOME: It took 6 months to get over the problem.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperglycaemia, Type 1 diabetes mellitus
Clinical narrative: Developed IDD Type 1 - insulin dependent 6 weeks after vaccination.  Parent feels related and would like it reported.  Clinically stable.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: redness and itchy on L thigh started 1 day after. 4" x 3" - gave Benadryl - less itchy, red
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient received 3 vaccines, stated she felt fine after vaccine administration, patient left with no signs or symptoms of feeling ill. When she got to the elevator around 10:40am, she said blacked out for a few seconds, mom grabbed her.  Patient did not fall to the floor. Alert was called, vitals stable. Patient did not have breakfast this morning, juice and crackers given. Dr. examined at bedside and discharged in stable condition.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Chest pain, Echocardiogram abnormal, Electrocardiogram, Immunisation reaction
Clinical narrative: CHEST PAIN, PALPITATIONS, TACHY CARDIA WARRANTING SEVERAL EMERGENCY ROOM VISITS, TREATMENT WITH BETA-BLOCKERS. DIAGNOSIS COVID MRNA VACCINE INDUCED POTS.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Palpitations, Postural orthostatic tachycardia syndrome, Sinus tachycardia, Tachycardia
Clinical narrative: CHEST PAIN, PALPITATIONS, TACHY CARDIA WARRANTING SEVERAL EMERGENCY ROOM VISITS, TREATMENT WITH BETA-BLOCKERS. DIAGNOSIS COVID MRNA VACCINE INDUCED POTS.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: CHEST PAIN, PALPITATIONS, TACHY CARDIA WARRANTING SEVERAL EMERGENCY ROOM VISITS, TREATMENT WITH BETA-BLOCKERS. DIAGNOSIS COVID MRNA VACCINE INDUCED POTS.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Tinnitus
Clinical narrative: I've had ringing in my ears since the vaccine. I'm not sure exactly when it started. I felt bad for a few days after the injection and at some point I noticed I had ringing in my ears. It's been constant since then though I notice it more sometimes than others
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, Underdose
Clinical narrative: Patient jumped and vaccine went all over her arm. I doubt any made into into the muscle so I advised the parent to repeat the dose later.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Product preparation error
Clinical narrative: Shingrix was diluted with sterile dilutent and not the dilutent provided in manufacturer box. There was one full dose remaining in the package, when nurse opened the package the package insert was covering the cap of the other vial, nurse did not identify that the two vials had different colored caps. Patient reported headache the night of administration that resolved by the next morning. Also reported mild L arm pain where vaccine was administered.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood creatine phosphokinase, C-reactive protein, Full blood count, Metabolic function test
Clinical narrative: Myalgias and Joint Pain currently lasting 1 month
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Urine analysis
Clinical narrative: Myalgias and Joint Pain currently lasting 1 month
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Cough, Respiratory tract congestion
Clinical narrative: ADVERSE EVENTS: extreme congestion and coughing from 12/8/2023 to 1/17/2024  TREATMENT:  Ipratropium 1/2/2024 to 1/19/2024 Methylprednisolone 1/2/2024 to 1/8/2024 Dimetapp 1/2/2024 to 1/19/2024  OUTCOME: It took 6 weeks to overcome the problem.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abnormal loss of weight, Arthralgia, Back pain, Dizziness, Fatigue
Clinical narrative: Fever, migraines, arthralgia, lower back and neck pain, stiffness, fatigue, malaise, hives/rash on legs (2 separate episodes), heart palpitations, numbness of hands and face, sciatic pain, hip pain, syncopal episodes, lightheaded/dizziness, severe unintentional weight loss, rosacea
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Laboratory test, Malaise, Migraine, Musculoskeletal stiffness
Clinical narrative: Fever, migraines, arthralgia, lower back and neck pain, stiffness, fatigue, malaise, hives/rash on legs (2 separate episodes), heart palpitations, numbness of hands and face, sciatic pain, hip pain, syncopal episodes, lightheaded/dizziness, severe unintentional weight loss, rosacea
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neck pain, Palpitations, Pyrexia, Rash, Rosacea
Clinical narrative: Fever, migraines, arthralgia, lower back and neck pain, stiffness, fatigue, malaise, hives/rash on legs (2 separate episodes), heart palpitations, numbness of hands and face, sciatic pain, hip pain, syncopal episodes, lightheaded/dizziness, severe unintentional weight loss, rosacea
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sciatica, Syncope, Urticaria
Clinical narrative: Fever, migraines, arthralgia, lower back and neck pain, stiffness, fatigue, malaise, hives/rash on legs (2 separate episodes), heart palpitations, numbness of hands and face, sciatic pain, hip pain, syncopal episodes, lightheaded/dizziness, severe unintentional weight loss, rosacea
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Injection site hypoaesthesia, Injection site reaction, Muscular weakness
Clinical narrative: c/o weakness/numbness in deltoid area where shot was given
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Shingle vaccine was administrated instead of varicella vaccine
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Crying, Gait disturbance, Injection site cellulitis, Injection site erythema, Injection site infection
Clinical narrative: Mother reported to nurse during telephone triage patient with larger than golf ball swelling to left leg 3/6/2024 morning. Affected area with calor, redness, and tenderness to the touch.  Cried if affected area palpated. Gait change reported. Provider diagnosed patient with Skin infection (cellulitis) on 3/6/2024. Patient instructed to begin antibiotic cephalexin (250mg/5mL) oral suspension 8.2mL tid x 7 days.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother reported to nurse during telephone triage patient with larger than golf ball swelling to left leg 3/6/2024 morning. Affected area with calor, redness, and tenderness to the touch.  Cried if affected area palpated. Gait change reported. Provider diagnosed patient with Skin infection (cellulitis) on 3/6/2024. Patient instructed to begin antibiotic cephalexin (250mg/5mL) oral suspension 8.2mL tid x 7 days.
Age: 16.0
Sex: F
Vaccine: HEP, HPV9, MNQ
Symptoms: Crying, Fall, Unresponsive to stimuli
Clinical narrative: 3:05pm Administration of vaccines was completed.  I was charting the encounter and talking to client. (Mother and client had requested that mother sit outside of immunization room.)  I asked client if she thought she could standup and walk to clerical office to checkout.  Client stated "yes".  I turned around to pickup forms.  I heard the chair tun over.  I turned towards client and found her laying in floor face down and unresponsive.  I tried to roll her over without success.  I opened door and got Mom.  Mother came in and started screaming. Mother helped me roll client over, while I am explaining that client may have fainted.  Mother exits the room.  Client sat straight up and was crying.  Mother comes into room again upon my request.  I asked client to lay down so I could elevate her legs.  She stated "no".  I told mother to tell her to lay down and client continued to refuse.  I am in supporting Client in sitting position.  I asked mother to go get help and she did.  2 nurses arrived and we were able to get client into reclining chair.  Client's color is good and she is communicating with mother and nurses.  Client is talking clear and states she does not remember what happened.  A drink is offered and she drank it without any problems. RN stayed with client and I continued with clinic.  There were no redness, lacerations, bleeding or swelling noted to face and head.  Client states she has a headache.  4:00pm   I informed mother to observe and report and changes to us and go to E.R. with any worsening of symptoms.  Mother States she understands.  Immunization record given to mother.  Client states she feels like she can walk.  R.N. assisted client to her vehicle.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Bursa injury, Pain in extremity, Product administered at inappropriate site, X-ray limb abnormal
Clinical narrative: Patient states that after her vaccine, she experienced pain in her arm/shoulder. Her Dr took an xray and believes that the vaccine was given too high and went into the bursa and caused damaged. She has been going to physical therapy and will be following up with orthopedics.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA. Present at evaluation 6 months after the adverse event.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Limb discomfort
Clinical narrative: Patient developed swelling distal to injection site in left arm 2 days after vaccination.  Described arm as heavy and harm in specific area, area is red
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: Soreness in arm since vaccine given. Small lump there as well. No soreness in left arm where he had the covid vaccine.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Loss of personal independence in daily activities
Clinical narrative: Patient stated he woke up the next morning and felt extremely dizzy to the point he could not do anything. He took some Tylenol then took a nap. He felt better after he woke up from his nap.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pt given pediatric dose of Hep B vaccine. No treatment. No harm.
Age: 76.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site swelling
Clinical narrative: day of vaccination  pt reported mild swelling at injection site, days following vaccination pt went to her doctors due to developing a black spot on her skin at the injection site, Dr instructed the pt it was cellulitis and sent in doxycycline for the pt.  At the time of reporting this the black spots on her skin has not gone away and pt was instructed to return to her Dr.
Age: 7.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Physician ordered Dtap, but Tdap was administered.  Patient unharmed.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Acute disseminated encephalomyelitis, Anal incontinence, Bacterial test, Bartonella test negative, Blood pressure abnormal
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Brain stem syndrome, CSF culture negative, CSF glucose normal, CSF lymphocyte count, CSF protein increased
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: CSF white blood cell count increased, Computerised tomogram head abnormal, Cryptococcus test, Enterovirus test negative, Full blood count
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Headache, Herpes simplex test negative, Human metapneumovirus test positive, Hyporesponsive to stimuli, Immunoglobulin therapy
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Laboratory test normal, Lethargy, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Mechanical ventilation
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Mental status changes, Metabolic function test, Metagenomic analysis, Nausea, Nervous system disorder
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Next-generation sequencing, Nitrite urine absent, Plasmapheresis, Pleocytosis, Pyrexia
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Respiratory viral panel, Rubulavirus test negative, Serology negative, Sinusitis, Speech disorder
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Unresponsive to stimuli, Urinary incontinence, Urine analysis normal, Viral test negative, Vomiting
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: West Nile virus test negative, White blood cells urine negative
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Asthenia, Brain injury, Brain oedema, Central nervous system lesion, Coma
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Eating disorder, Feeling abnormal, Headache, Laboratory test normal, Lumbar puncture normal
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Plasmapheresis, Positron emission tomogram normal, Sleep disorder
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, DTAPHEPBIP, DTAPIPV, MMR
Symptoms: Spinal cord disorder, Unresponsive to stimuli, Viral test negative, Vomiting
Clinical narrative: He was in his normal state of health until 2/15 when he began to complain of headache, nausea, and vomiting. Over the course of 2/16-2/19 he became more lethargic. On 2/19 he spoke to his mother and father who reported that he was not responding normally and did not make sense when responding. He presented to hospital on 2/20 after he was "lethargic" at home and had bowel and bladder incontinence. He was hospitalized for some time and transferred to continue management and workup. On 2/27 he was transferred to our facility for treatment with plasmapheresis (PLEX). During hospitalization at hospital, he remains neurologically devastated with minimal improvement.  Overall, he remains unresponsive, on a ventilator and some mild blood pressure control. Infectious workup was negative and he continues to follow with neurology for ADEM of unknown cause.
Age: 29.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse event; Inbound call from a medical assistant who reported an AE. Caller reported that a pediatric dose of VAQTA was administered to a 29 year old adult patient. No symptoms reported by the HCP.; Adult use of a child product; This spontaneous report was received from a medical assistant, referring to a 29-year-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 06-FEB-2024, the adult patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X017317, expiration date: 13-DEC-2024, administered once, administered for prophylaxis (strength, and route of administration were not provided) (Incorrect dose administered; Product administered to patient of inappropriate age). No symptoms reported by the health care professional (HCP). No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Nurse reported patient received dosing schedule of GARDASIL 9 outside of PI. Caller stated 30-year-old patient received first 2 doses of GARDASIL 9 10 years ago and never received 3rd dose.; Caller did not report any symptoms; This spontaneous report has been received from a nurse referring to a patient of unknown gender, who was currently 20 years old. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were no provided.     In 2014 (reported as "10 years ago"), the patient was vaccinated with the first two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route, strength, lot# and expiration date were not provided) for prophylaxis. The patient never received the third dose (inappropriate schedule of product administration). The reporter did not report any symptoms (no adverse event).        Lot# has been requested and will be submitted if received.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No symptomatic adverse events were reported; Patient was inadvertently administered ROTATEQ that was involved in a supported below range temperature excursion; This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 28-FEB-2024, the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliters, lot #1932235, expiration date: 12-APR-2024, administered for prophylaxis (strength and route of administration were not provided) that was involved in a supported belong range temperature excursion at minus 2.2 degrees Celsius for one hour and three minutes. No additional adverse events were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure via eye contact, Eye irrigation, Eye irritation, Occupational exposure to product
Clinical narrative: flushed her eyes immediately at the eye wash station. The caller said it is difficult to distinguish if the irritating or burning; VARIVAX splashed in her eye; staff member was getting ready to administer VARIVAX to a patient, but the VARIVAX splashed in her eye; This spontaneous report as received from a nurse refers to a female patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medications.   It was reported that on 07-MAR-2024, the nurse as getting ready to administer virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, lot number and expiration date were not reported)  and  sterile diluent(STERILE DILUENT) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis  to a patient, but the virus vaccine live (oka/merck)(VARIVAX)  splashed in her eye (accidental exposure to product, occupational exposure to product). The patient did not miss a dose.  The staff member flushed her eyes immediately at the eye wash station. The reporter said it was difficult to distinguish if the irritating or burning, that the staff member was experiencing in her eyes, was because of the eye rinse or because of the varicella virus vaccine live (oka/merck)(VARIVAX) exposure (Eye irritation). The outcome of eye irritation was reported as not recovered. Causality for eye irritation and virus vaccine live (oka/merck)(VARIVAX)   was unspecified.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; HCP called to report that an expired MMR II inadvertently administered after its labeled expiry date to a patient today (3/7/2024).; This spontaneous report was received from a medical assistant referring to a 12-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On 07-MAR-2024 (also reported as today), the patient was inadvertently administered an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #W007181, expiration date: 01-MAR-2024, therapy type: rHA, 1st dose, administered for prophylaxis (dose, strength, and route of administration were not provided) (expired product administered). The health care professional (HCP) confirmed no temperature excursion (T/E) occurred. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AEs; Caller reported PROQUAD was administered after being reconstituted with Normal Saline.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported.  On 08-MAR-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous (SQ) injection, 0.5 milliliter, lot number: X022920, which had been verified to be a valid lot number, expiration date reported and confirmed as 12-MAR-2025 (strength was not provided) administered subcutaneously on the leg as prophylaxis after being reconstituted with 0.5 milliliter of sodium chloride (NORMAL SALINE) (lot/batch number: 6029026, expiry date: September 2024; formulation, strength, and indication were not provided) (Product preparation error). It was stated that the operator of device was a health care professional.  No further information and no additional adverse events reported (No adverse event).
Age: 24.0
Sex: F
Vaccine: PNC15, PNC15
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; one of their patients inadvertently received VAXNEUVANCE twice; This spontaneous report was received from nurse and refers to a 25-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 23-NOV-2022, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (lot #W021510, expiration date: 08-OCT-2023, formulation pre-filled syringe, route of administration and anatomical location were not provided) for prophylaxis. On 27-NOV-2023, the patient was vaccinated with second dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (lot #X020693, expiration date: 18-OCT-2025, formulation pre-filled syringe, route of administration and anatomical location were not provided) for prophylaxis (Extra dose administered). No other information was provided. No additional adverse event (AE) reported (No adverse event). No product quality complaint (PQC) reported.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP called to report that a single dose of PROQUAD was given to a 13 Year old patient on an unspecified date.; no additional AE information; This spontaneous report was received from a nurse and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a single dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported.  Lot # is being requested and will be submitted if received.