chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain
Clinical narrative: Client states she felt "funny" immediately after vaccination. Returned to clinic to have PPD read, and now client is complaining of fatigue, elevated temp (100-101 degrees F), cough & sore throat. Started by supper time on 1/4/12. Client states she feels this is due to the pertussis part of the vaccine. She has not seen a physician. Encouraged rest, pain/fever reducer & follow up with physician if no improvement in symptoms.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: In the evening after receiving vaccines - pt started to have hives (approx 6) on sides of face & neck sites were also warm & red. Called ER & was instructed to give BENADRYL. Hives resolved. Hives reappeared on 12/31/11. Gave BENADRYL & hive disappeared again. Had 2 more episodes of hives on 1/1/12 & 1/2/12 & started on ZYRTEC.
Age: 0.88
Sex: M
Vaccine: HEP
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Hep B vaccine given on 1/11/12. Call from Mom on 1/13/11 to report fever 100-102 degrees, fussiness, followed by rash on 1/16/12. Rash improved - no fever 24 hours 1/17/12.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Erythema, Feeling hot, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: 12/17/11 - very stiff arm & tricep, decreased movement, dizziness during AM hours. Dizziness ended Monday afternoon (12/19/11). 12/19/11 - redness, warmth, decreased movement. 12/22/11 - no redness, no stiffness, sx's subsided.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ecchymosis, Oedema peripheral
Clinical narrative: Edema (L) thigh with mild ecchymosis.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Screaming
Clinical narrative: Uncontrolled screaming x 3-4 days.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, swelling, severe itching, pain, cellulitis. BENADRYL 50 mg Q 6hrs.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Pt telephoned approximately 24 hours after 1st dose GARDASIL. She stated hives were appearing on her body. No dyspnea or pharyngeal edema. Pt took BENADRYL 50mg PO at home & was advised to go to ED for observation. She went to Hospital, was observed & given more BENADRYL. Hives resolved in several hours.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Pyrexia, Rash generalised, Urticaria
Clinical narrative: - Rash generalized, worse on buttocks since Sunday, U shaped hive on (L) cheek. Fever 101 - 102 Thursday - Sat.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Slight swelling and redness at site of injection. Arm soreness radiating to shoulder - pc patient.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Body temperature increased, Somnolence, Tremor
Clinical narrative: 6 mo vaccine given at noon on 1/9/2012 baby was more "sleepy" per mom that evening woke at 0130/mom took temp which was 104.5 degrees F axillary gave TYLENOL had "tremors" every 20 min until 0500. More "sleepy" today than usual.
Age: 1.31
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMR, VARCEL
Symptoms: Balance disorder, Body temperature increased, Crying, Decreased appetite, Electroencephalogram
Clinical narrative: 2 hours after immunizations, groggy, lethargic, clingy, very fussy, pale, crying, "balance off", stopped eating at supper time. Restless during night. Temperature 101 - 101.6 continuing throughout weekend. Starting vomiting 12/28 (Wed) (day after), continued until Friday at noon 12/30. Sleeping a lot. Doctor called 12/29. Continued fussy, irritable, "red ears" - medication for possible ear infections - 1/1 Very fussy and low grade temp. 1/3 (Tues) eyes redding and mattered eyes. EEG ordered. "Getting better" by mom's report.
Age: 1.31
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMR, VARCEL
Symptoms: Erythema, Eye discharge, Hypersomnia, Irritability, Lethargy
Clinical narrative: 2 hours after immunizations, groggy, lethargic, clingy, very fussy, pale, crying, "balance off", stopped eating at supper time. Restless during night. Temperature 101 - 101.6 continuing throughout weekend. Starting vomiting 12/28 (Wed) (day after), continued until Friday at noon 12/30. Sleeping a lot. Doctor called 12/29. Continued fussy, irritable, "red ears" - medication for possible ear infections - 1/1 Very fussy and low grade temp. 1/3 (Tues) eyes redding and mattered eyes. EEG ordered. "Getting better" by mom's report.
Age: 1.31
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMR, VARCEL
Symptoms: Ocular hyperaemia, Pallor, Poor quality sleep, Somnolence, Vomiting
Clinical narrative: 2 hours after immunizations, groggy, lethargic, clingy, very fussy, pale, crying, "balance off", stopped eating at supper time. Restless during night. Temperature 101 - 101.6 continuing throughout weekend. Starting vomiting 12/28 (Wed) (day after), continued until Friday at noon 12/30. Sleeping a lot. Doctor called 12/29. Continued fussy, irritable, "red ears" - medication for possible ear infections - 1/1 Very fussy and low grade temp. 1/3 (Tues) eyes redding and mattered eyes. EEG ordered. "Getting better" by mom's report.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Laryngitis, Nasal congestion, Oropharyngeal pain, Rash generalised
Clinical narrative: Flu shot 12-13-11. Nasal congestion, upper respiratory infection cough, sore throat, laryngitis, fatigue, rash small spots covering whole body, mild, sporadic eruptions.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Upper respiratory tract infection
Clinical narrative: Flu shot 12-13-11. Nasal congestion, upper respiratory infection cough, sore throat, laryngitis, fatigue, rash small spots covering whole body, mild, sporadic eruptions.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lacrimation increased, Ocular hyperaemia
Clinical narrative: Pt had redness/watering of eyes. Reaction similar to pt history of allergic reaction to thimerosal (in eye drops). However, thimerosal - free prefilled syringe was used.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye irritation, Ocular hyperaemia, Rash
Clinical narrative: Pt had redness/watering of eyes. Reaction similar to pt history of allergic reaction to thimerosal (in eye drops). However, thimerosal - free prefilled syringe was used.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Muscle spasms, Nuclear magnetic resonance imaging, Pain
Clinical narrative: On 10/8/11 employee started feeling achy all over her body on 10/9 started having mild muscle spasms starting in the arm (R) by 10/10 was having muscle spasms in back, legs, & neck increased severity. Saw several MDs was treated with muscle related, VALIUM, and pain meds, steroids.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPAB, PPV, TDAP
Symptoms: Diarrhoea, Nausea, Pruritus, Throat irritation, Throat tightness
Clinical narrative: 12/6 - 3 pm - received vaccines. 5 pm - (1) Burning throat; "itchy esophagus." (2) Felt like throat was "closing up". 7 pm (3) Nausea & vomiting; diarrhea. Nausea & vomiting lasted 4 days. Throat symptoms lasted overnight.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPAB, PPV, TDAP
Symptoms: Vomiting
Clinical narrative: 12/6 - 3 pm - received vaccines. 5 pm - (1) Burning throat; "itchy esophagus." (2) Felt like throat was "closing up". 7 pm (3) Nausea & vomiting; diarrhea. Nausea & vomiting lasted 4 days. Throat symptoms lasted overnight.
Age: 8.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Contusion, Full blood count, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Petechiae
Clinical narrative: Bruising and petechia on limbs, torso and oropharynx. Platelet count of 1. Hospitalized x2 in 3 wks. Received IVIG x2 to treat ITP. Bruising began 2 wks after vaccines.
Age: 8.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Platelet count decreased
Clinical narrative: Bruising and petechia on limbs, torso and oropharynx. Platelet count of 1. Hospitalized x2 in 3 wks. Received IVIG x2 to treat ITP. Bruising began 2 wks after vaccines.
Age: 0.66
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Within 1 degrees of administration of vaccine pt's Mom states dime sized hives appeared on abdomen for approx 1-2 degrees - Mon states no SOB, no itching, "didn't seem to bother her." No other reactions noted as parent states.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Disorientation, Dizziness, Headache, Hypoacusis
Clinical narrative: Started tunnel-vision with muffled hearing; lost feeling from neck down; got lightheaded with headache. He had loss of direction and weakness, and felt like he was going to blackout. He looked pale and felt cool to the touch. The shot giver (nurse?) took him to back room, had him lie down, and elevated his legs. Within about 5 minutes he started recovering. He was completely recovered in 20 minutes.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Hypoaesthesia, Pallor, Peripheral coldness, Tunnel vision
Clinical narrative: Started tunnel-vision with muffled hearing; lost feeling from neck down; got lightheaded with headache. He had loss of direction and weakness, and felt like he was going to blackout. He looked pale and felt cool to the touch. The shot giver (nurse?) took him to back room, had him lie down, and elevated his legs. Within about 5 minutes he started recovering. He was completely recovered in 20 minutes.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Constipation, Decreased appetite, Dyskinesia, Dyspnoea, Electroencephalogram normal
Clinical narrative: Reported to be irritable evening vaccine received. After going to sleep he gasped, stiffened and was jerking look "out of it." Jerking lasted only a few seconds. However "out of it" look lasted an hour. Color good. Afebrile. Appetite decreased. No BM in few days eating. No vomit.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability postvaccinal, Malaise, Musculoskeletal stiffness, Ultrasound scan normal, Ultrasound skull
Clinical narrative: Reported to be irritable evening vaccine received. After going to sleep he gasped, stiffened and was jerking look "out of it." Jerking lasted only a few seconds. However "out of it" look lasted an hour. Color good. Afebrile. Appetite decreased. No BM in few days eating. No vomit.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Convulsion, Electroencephalogram normal, Neurological symptom, Ultrasound scan normal
Clinical narrative: Reported to be irritable evening vaccine received. After going to sleep he gasped, stiffened and was jerking look "out of it." Jerking lasted only a few seconds. However "out of it" look lasted an hour. Color good. Afebrile. Appetite decreased. No BM in few days eating. No vomit.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, heat, soreness at injection site - red area under shot location. Patient reacted to PNEUMOVAX shot in (R) deltoid.
Age: 17.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling with redness from deltoid to elbow, accompanied by fever.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: (L) arm with 2 x 1 1/2 cm area of erythema & hyperpigmentation.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Chills, Dyspnoea, Laboratory test, Pyrexia
Clinical narrative: Difficulty breathing (wheezing); chest pain; chills; shortness of breath; vomiting; fever.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting, Wheezing
Clinical narrative: Difficulty breathing (wheezing); chest pain; chills; shortness of breath; vomiting; fever.
Age: 0.62
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: CSF test normal, Computerised tomogram normal, Convulsion, Drug screen, Endotracheal intubation
Clinical narrative: Seizure/status epilepticus. Received multiple medications and intubation; airlifted to regional hospital. Afebrile at presentation in ER.
Age: 0.62
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Full blood count normal, Laboratory test normal, Nuclear magnetic resonance imaging, Status epilepticus, Urine analysis normal
Clinical narrative: Seizure/status epilepticus. Received multiple medications and intubation; airlifted to regional hospital. Afebrile at presentation in ER.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal pain, Blood electrolytes, Full blood count, Hypersomnia, Screaming
Clinical narrative: Approximately 5 hrs after vaccination, child woke up screaming. He screamed for about 6 hours, maybe longer. He seemed to have pain in his abdm so a KUB was done which was read as ? obstruction. He was sent to hospital, but no other test was done. He went home & slept the next 36 hrs except for brief moments when mom fed him.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Urinary system X-ray
Clinical narrative: Approximately 5 hrs after vaccination, child woke up screaming. He screamed for about 6 hours, maybe longer. He seemed to have pain in his abdm so a KUB was done which was read as ? obstruction. He was sent to hospital, but no other test was done. He went home & slept the next 36 hrs except for brief moments when mom fed him.
Age: 1.02
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Otitis media acute, Pyrexia
Clinical narrative: Sudden onset of high fever (104 degrees F), fussy, acute otitis media diagnosed the next day and started on amoxicillin. Still having high fevers 3 days later.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Warm/Red/Non-tender induration measuring 6.7cm wide and 10.5cm long in oval shape on right upper arm.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 3 1/2 days of moderate-severe redness and tenderness. Starting an inch below sight and stopping 8 inches below by 3-4 inches wide. Hot to the touch.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chest X-ray, Chest pain, Electrocardiogram, Pain in extremity
Clinical narrative: Pain in right arm to chest and back.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pruritus, Rash erythematous
Clinical narrative: Back started itching, noticed red bumps all over back, sore throat tried oatmeal baths, Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARZOS, VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Child was given Zostavax instead of regular childhood vaccine for chickenpox. Patient was told not to be around pregnant women and infants for 3 months. Told to watch for fever and rash.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARZOS, VARCEL, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Child was given Zostavax instead of regular childhood vaccine for chickenpox. Patient was told not to be around pregnant women and infants for 3 months. Told to watch for fever and rash.
Age: 31.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chest discomfort, Cyanosis, Loss of consciousness, Respiratory distress
Clinical narrative: Respiratory distress, chest tightness, cyanosis of lips and face, loss of consciousness started <2min after administration of vaccine and lasted until Epinephrine was administered. Approximate duration <7min.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral
Clinical narrative: Patient had severe swelling of arm.
Age: 39.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Bursa injury, Immediate post-injection reaction, Injection site reaction, Malaise, Muscular weakness
Clinical narrative: This is the short version: As soon as she administered the shot I felt severe pain. When I tried to move it is was very heavy. She said it was normal. When I left the store, I had no strength to push open the door. I was heading to dinner with my boss and co-worker. They asked me what was wrong as soon as they saw me. I also began feeling feverish. I ended up being sick for weeks. The pain in my arm continued to get worse. I did Physical Therapy, went to a Chiropractor and then my Orthopedic Doc requested I get surgery. The needle nicked my bursa sac.
Age: 39.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Pyrexia, Sensation of heaviness, X-ray
Clinical narrative: This is the short version: As soon as she administered the shot I felt severe pain. When I tried to move it is was very heavy. She said it was normal. When I left the store, I had no strength to push open the door. I was heading to dinner with my boss and co-worker. They asked me what was wrong as soon as they saw me. I also began feeling feverish. I ended up being sick for weeks. The pain in my arm continued to get worse. I did Physical Therapy, went to a Chiropractor and then my Orthopedic Doc requested I get surgery. The needle nicked my bursa sac.
Age: 0.64
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Convulsion, Pyrexia
Clinical narrative: Had 6 month shots and influenza on 12/2/11. That evening at 6pm went to the ER with fever of 104.3 and seizure, released a short while later, told to give Tylenol for fever.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Human chorionic gonadotropin positive
Clinical narrative: Positive HCG while deployed abroad.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Aphonia, Back pain, Chest pain, Dyspnoea, Headache
Clinical narrative: The same day as injection started with severe swelling on (R)-det and neck, and severe headache. Pn across back, entire arm and across chest by Thursday night. Itch that started on Friday down entire (R) arm. By Sunday morning woke up with rash and swelling on face by Sunday afternoon had to go to ER with difficulty breathing and loss of voice. I had a fever from 1-12-12 until currently. Blurry vision.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Local swelling, Pain in extremity, Pruritus
Clinical narrative: The same day as injection started with severe swelling on (R)-det and neck, and severe headache. Pn across back, entire arm and across chest by Thursday night. Itch that started on Friday down entire (R) arm. By Sunday morning woke up with rash and swelling on face by Sunday afternoon had to go to ER with difficulty breathing and loss of voice. I had a fever from 1-12-12 until currently. Blurry vision.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash, Swelling face, Vision blurred
Clinical narrative: The same day as injection started with severe swelling on (R)-det and neck, and severe headache. Pn across back, entire arm and across chest by Thursday night. Itch that started on Friday down entire (R) arm. By Sunday morning woke up with rash and swelling on face by Sunday afternoon had to go to ER with difficulty breathing and loss of voice. I had a fever from 1-12-12 until currently. Blurry vision.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Gait disturbance, Limb discomfort, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: About 3 hrs after injection left arm hurt. Next day left thigh hurt - next day pain was so severe I could hardly walk. Visit to chiropractor - no relief - visit to doctor - referred to ortho Dr. - diagnosed as bursitis. Shot was ineffective. Finally had MRI, meanwhile living on VICODIN 24/7. MRI results attached. Physical therapy recommended and continued to date. Still some discomfort in thigh. In discussing this with many medical personnel, some have suggested the problem was caused by the needle, not necessarily the vaccine.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: States (L) deltoid started swelling and became painful after the vaccine was given 1/16/12. (L) deltoid tender and swollen.
Age: 1.23
Sex: F
Vaccine: HEP, HIBV, VARCEL
Symptoms: Bite, Cellulitis, Skin infection, Skin lesion
Clinical narrative: Varicella vaccine admin 1/4/12 RUA, sq. Pt presented at clinic 01/15/12 for "bites" on buttocks & LA, started on KEFLEX for cellulitis. Infected pox lesion (L) upper arm - onset 1-14-12, pox lesion perineum on 1-4-11
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Charlie horse like soreness initially. This progressed to severe pain and limited range of motion only in the shoulder receiving the injection. This has persisted since the injection on 1/5/12 - she is taking Ibuprofen at night (2 other family members also were vaccinated w/o reaction).
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP, JEV1, ANTH, JEVX, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin increased
Clinical narrative: Substernal chest pain, with radiation to left arm which presented at rest, approx 10:00am. Notified physician at approx 12:00pm at which time vitals, physical done. Taken to local hospital where EKG findings consistent with pericarditis, elevated troponins indicated myocarditis. Admitted to hospital, discharged after 4 days.
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP, JEV1, ANTH, JEVX, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: Substernal chest pain, with radiation to left arm which presented at rest, approx 10:00am. Notified physician at approx 12:00pm at which time vitals, physical done. Taken to local hospital where EKG findings consistent with pericarditis, elevated troponins indicated myocarditis. Admitted to hospital, discharged after 4 days.
Age: 21.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Pallor
Clinical narrative: Patient had just finished with her plasma donation, to RN for tetanus vaccine, after 15 minute mandatory wait time donor was feeling fine and cleared to go.  She remained in center and approx 35 mins after her shot she started experiencing dizziness and pallor and came to see RN, she admitted to not having eaten in the past 4 hours prior to donating and had just smoked a cigarette.  Stayed with RN for approx 25 mins, rested, gave 12 oz water and crackers, BP and pulse WNL at this time, recovered fully in approx 25 mins and was cleared to leave center with friend.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Abasia, CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Guillain-Barre Syndrome, pain, numbness, tingling in feet and legs, inability to walk, numbness in fingers. Hospitalized in ICU and rehab, treated with IVIG, pain medication, muscle relaxants.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Intensive care, Lumbar puncture abnormal, Pain in extremity, Paraesthesia
Clinical narrative: Guillain-Barre Syndrome, pain, numbness, tingling in feet and legs, inability to walk, numbness in fingers. Hospitalized in ICU and rehab, treated with IVIG, pain medication, muscle relaxants.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Pt was given flu vaccine using pharmajet and caught the flu in January.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Moderate swelling around the injection site, bright red, hot to the touch, and moderate fever.  Child is always extremely healthy and is not a "complainer," but feels limited due to the amount of pain.
Age: 38.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Asthenia, Chills, Dizziness, Erythema, Hyperhidrosis
Clinical narrative: Patient developed lightheadedness, felt weak, had sweats/chills but no fevers.  Received vaccines on Monday morning 1/9/12, developed symptoms on Tuesday morning (1/10/12).  Symptoms continued through Wednesday, had resolved by Thurs 1/12/12.  Had Hepatitis B/Hepatitis A (Twinrix) and Pneumonia vaccines on Monday morning.   Both given in the same arm.  One of the vaccines had local reaction of erythema and swelling - not sure which vaccine it was that caused the localized reaction.
Age: 38.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Local reaction, Swelling
Clinical narrative: Patient developed lightheadedness, felt weak, had sweats/chills but no fevers.  Received vaccines on Monday morning 1/9/12, developed symptoms on Tuesday morning (1/10/12).  Symptoms continued through Wednesday, had resolved by Thurs 1/12/12.  Had Hepatitis B/Hepatitis A (Twinrix) and Pneumonia vaccines on Monday morning.   Both given in the same arm.  One of the vaccines had local reaction of erythema and swelling - not sure which vaccine it was that caused the localized reaction.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Anticonvulsant drug level, Full blood count, Grand mal convulsion, Metabolic function test
Clinical narrative: Reported to Employee Health - had 2 grand mal epileptic seizures & was treated in ED. Had had TD in past without incident & unsure if related to Tdap. Seizures about 40 min after injection.
Sex: U
Vaccine: UNK
Symptoms: Arthritis infective, Injection site warmth, Pain, Pain in extremity, X-ray limb normal
Clinical narrative: Pt. had injection on 11-13-2011 and pain started 11-14-2011. Injection site felt a little hot but no real swelling. Pain radiating down into hand. Took Ibuprofen & NAPROSYN to rule out infection. Did not help. Dr. took X-ray came out normal. Pt told to make appt with hand surgeon. Was told he had infection in joint and got steroid shot. Also starting physical therapy for a few weeks.
Sex: F
Vaccine: DTAP, HEP, HIBV, RVX
Symptoms: Central venous catheterisation, Computerised tomogram, Electroencephalogram, Gastrointestinal tube insertion, Grand mal convulsion
Clinical narrative: 2 month vaccinations - received at (11AM-12PM) Hep B, DTaP, Hib, Rota started with grand mal seizures at 5pm, took to ER, transported in ambulance to ER, admitted to PICU, upgraded to status epilepsy, was on breathing tube, feeding tube, central line, artery line, meds - VERSED, KEPPRA, Phenobarb, TOPAMAX, Vit B6, stayed in hospital 11/7/11-11/17/11. Also had a blood transfusion.
Sex: F
Vaccine: DTAP, HEP, HIBV, RVX
Symptoms: Intensive care, Nuclear magnetic resonance imaging, Status epilepticus, Transfusion
Clinical narrative: 2 month vaccinations - received at (11AM-12PM) Hep B, DTaP, Hib, Rota started with grand mal seizures at 5pm, took to ER, transported in ambulance to ER, admitted to PICU, upgraded to status epilepsy, was on breathing tube, feeding tube, central line, artery line, meds - VERSED, KEPPRA, Phenobarb, TOPAMAX, Vit B6, stayed in hospital 11/7/11-11/17/11. Also had a blood transfusion.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal distension, Alanine aminotransferase increased, Barium enema abnormal, Blood albumin decreased, Blood calcium decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old female patient with Gastrooesophageal reflux disease (GERD), neonatal jaundice and history of otitis, with no know drug allergies and no previous illnesses was vaccinated by mouth with the second dose of ROTATEQ (lot number: 669763/1311AA). No other medications included. Concomitant vaccines given on the same day included the second dose IM of PREVNAR 13 (lot number: 916599) into the right leg, the second dose of IM of PENTACEL (lot number: C4026AA) into the left leg and the second dose IM of ENGERIX-B (lot number: AHBVB982BB) into the left leg. The patient developed intussusception diagnosed on 19-OCT-2011 that required surgical resection with loss of some small bowel. The patient had seven day of admission. On 23-NOV-2011, hospital records DOS 10/19-26/2011. The patient was diagnosed with intussusception and small bowel obstruction (SBO). Concurrent conditions included: fever, cold symptoms, vomiting, decreased urine output, irritability, abdominal distension, red currant jelly stools and oral thrush. In the physical exam was diagnosed with taut and distended abdomen. It was unable to reduce intussusception in radiology. The patient underwent laparotomy for reduction with bowel resection. The patient was observed in Intensive Care Unit (ICU). On unspecified date, the patient recovered with uncomplications. The patient was discharged in stable condition to follow up with Primary care Physician (PCP), surgeon. In hospital records, kidney, ureter, bladder (KUB) findings suggested obstruction involving mid small bowel. Laboratory test included: Blood platelet count 554 (High), serum blood urea nitrogen (BUN) 26 (High), serum alanine aminotransferase (ALT) 80 (High), total urine ketones 2+ (High). Barium enema intussusception with unsuccessful reduction, white blood cell count (WBC) 7.7 (High); blood neutrophil count  25 (L), blood lymphocyte count 57 (High), serum calcium test 8.1 (Low), total serum protein 4.2 (L), serum albumin 2.8 (Low). The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening and serious by the agency. The original reporting source was not provided. The VAERS ID# is 441867. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669763/1311A in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot 669763/1311AA met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood urea increased, Haematochezia, Intensive care, Intussusception, Irritability
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old female patient with Gastrooesophageal reflux disease (GERD), neonatal jaundice and history of otitis, with no know drug allergies and no previous illnesses was vaccinated by mouth with the second dose of ROTATEQ (lot number: 669763/1311AA). No other medications included. Concomitant vaccines given on the same day included the second dose IM of PREVNAR 13 (lot number: 916599) into the right leg, the second dose of IM of PENTACEL (lot number: C4026AA) into the left leg and the second dose IM of ENGERIX-B (lot number: AHBVB982BB) into the left leg. The patient developed intussusception diagnosed on 19-OCT-2011 that required surgical resection with loss of some small bowel. The patient had seven day of admission. On 23-NOV-2011, hospital records DOS 10/19-26/2011. The patient was diagnosed with intussusception and small bowel obstruction (SBO). Concurrent conditions included: fever, cold symptoms, vomiting, decreased urine output, irritability, abdominal distension, red currant jelly stools and oral thrush. In the physical exam was diagnosed with taut and distended abdomen. It was unable to reduce intussusception in radiology. The patient underwent laparotomy for reduction with bowel resection. The patient was observed in Intensive Care Unit (ICU). On unspecified date, the patient recovered with uncomplications. The patient was discharged in stable condition to follow up with Primary care Physician (PCP), surgeon. In hospital records, kidney, ureter, bladder (KUB) findings suggested obstruction involving mid small bowel. Laboratory test included: Blood platelet count 554 (High), serum blood urea nitrogen (BUN) 26 (High), serum alanine aminotransferase (ALT) 80 (High), total urine ketones 2+ (High). Barium enema intussusception with unsuccessful reduction, white blood cell count (WBC) 7.7 (High); blood neutrophil count  25 (L), blood lymphocyte count 57 (High), serum calcium test 8.1 (Low), total serum protein 4.2 (L), serum albumin 2.8 (Low). The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening and serious by the agency. The original reporting source was not provided. The VAERS ID# is 441867. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669763/1311A in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot 669763/1311AA met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Laparotomy, Lymphocyte percentage increased, Nasopharyngitis, Neutrophil percentage decreased, Oral candidiasis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old female patient with Gastrooesophageal reflux disease (GERD), neonatal jaundice and history of otitis, with no know drug allergies and no previous illnesses was vaccinated by mouth with the second dose of ROTATEQ (lot number: 669763/1311AA). No other medications included. Concomitant vaccines given on the same day included the second dose IM of PREVNAR 13 (lot number: 916599) into the right leg, the second dose of IM of PENTACEL (lot number: C4026AA) into the left leg and the second dose IM of ENGERIX-B (lot number: AHBVB982BB) into the left leg. The patient developed intussusception diagnosed on 19-OCT-2011 that required surgical resection with loss of some small bowel. The patient had seven day of admission. On 23-NOV-2011, hospital records DOS 10/19-26/2011. The patient was diagnosed with intussusception and small bowel obstruction (SBO). Concurrent conditions included: fever, cold symptoms, vomiting, decreased urine output, irritability, abdominal distension, red currant jelly stools and oral thrush. In the physical exam was diagnosed with taut and distended abdomen. It was unable to reduce intussusception in radiology. The patient underwent laparotomy for reduction with bowel resection. The patient was observed in Intensive Care Unit (ICU). On unspecified date, the patient recovered with uncomplications. The patient was discharged in stable condition to follow up with Primary care Physician (PCP), surgeon. In hospital records, kidney, ureter, bladder (KUB) findings suggested obstruction involving mid small bowel. Laboratory test included: Blood platelet count 554 (High), serum blood urea nitrogen (BUN) 26 (High), serum alanine aminotransferase (ALT) 80 (High), total urine ketones 2+ (High). Barium enema intussusception with unsuccessful reduction, white blood cell count (WBC) 7.7 (High); blood neutrophil count  25 (L), blood lymphocyte count 57 (High), serum calcium test 8.1 (Low), total serum protein 4.2 (L), serum albumin 2.8 (Low). The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening and serious by the agency. The original reporting source was not provided. The VAERS ID# is 441867. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669763/1311A in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot 669763/1311AA met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Platelet count increased, Protein total decreased, Pyrexia, Small intestinal obstruction, Small intestinal resection
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old female patient with Gastrooesophageal reflux disease (GERD), neonatal jaundice and history of otitis, with no know drug allergies and no previous illnesses was vaccinated by mouth with the second dose of ROTATEQ (lot number: 669763/1311AA). No other medications included. Concomitant vaccines given on the same day included the second dose IM of PREVNAR 13 (lot number: 916599) into the right leg, the second dose of IM of PENTACEL (lot number: C4026AA) into the left leg and the second dose IM of ENGERIX-B (lot number: AHBVB982BB) into the left leg. The patient developed intussusception diagnosed on 19-OCT-2011 that required surgical resection with loss of some small bowel. The patient had seven day of admission. On 23-NOV-2011, hospital records DOS 10/19-26/2011. The patient was diagnosed with intussusception and small bowel obstruction (SBO). Concurrent conditions included: fever, cold symptoms, vomiting, decreased urine output, irritability, abdominal distension, red currant jelly stools and oral thrush. In the physical exam was diagnosed with taut and distended abdomen. It was unable to reduce intussusception in radiology. The patient underwent laparotomy for reduction with bowel resection. The patient was observed in Intensive Care Unit (ICU). On unspecified date, the patient recovered with uncomplications. The patient was discharged in stable condition to follow up with Primary care Physician (PCP), surgeon. In hospital records, kidney, ureter, bladder (KUB) findings suggested obstruction involving mid small bowel. Laboratory test included: Blood platelet count 554 (High), serum blood urea nitrogen (BUN) 26 (High), serum alanine aminotransferase (ALT) 80 (High), total urine ketones 2+ (High). Barium enema intussusception with unsuccessful reduction, white blood cell count (WBC) 7.7 (High); blood neutrophil count  25 (L), blood lymphocyte count 57 (High), serum calcium test 8.1 (Low), total serum protein 4.2 (L), serum albumin 2.8 (Low). The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening and serious by the agency. The original reporting source was not provided. The VAERS ID# is 441867. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669763/1311A in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot 669763/1311AA met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urine ketone body present, Urine output decreased, Vomiting, White blood cell count normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 weeks old female patient with Gastrooesophageal reflux disease (GERD), neonatal jaundice and history of otitis, with no know drug allergies and no previous illnesses was vaccinated by mouth with the second dose of ROTATEQ (lot number: 669763/1311AA). No other medications included. Concomitant vaccines given on the same day included the second dose IM of PREVNAR 13 (lot number: 916599) into the right leg, the second dose of IM of PENTACEL (lot number: C4026AA) into the left leg and the second dose IM of ENGERIX-B (lot number: AHBVB982BB) into the left leg. The patient developed intussusception diagnosed on 19-OCT-2011 that required surgical resection with loss of some small bowel. The patient had seven day of admission. On 23-NOV-2011, hospital records DOS 10/19-26/2011. The patient was diagnosed with intussusception and small bowel obstruction (SBO). Concurrent conditions included: fever, cold symptoms, vomiting, decreased urine output, irritability, abdominal distension, red currant jelly stools and oral thrush. In the physical exam was diagnosed with taut and distended abdomen. It was unable to reduce intussusception in radiology. The patient underwent laparotomy for reduction with bowel resection. The patient was observed in Intensive Care Unit (ICU). On unspecified date, the patient recovered with uncomplications. The patient was discharged in stable condition to follow up with Primary care Physician (PCP), surgeon. In hospital records, kidney, ureter, bladder (KUB) findings suggested obstruction involving mid small bowel. Laboratory test included: Blood platelet count 554 (High), serum blood urea nitrogen (BUN) 26 (High), serum alanine aminotransferase (ALT) 80 (High), total urine ketones 2+ (High). Barium enema intussusception with unsuccessful reduction, white blood cell count (WBC) 7.7 (High); blood neutrophil count  25 (L), blood lymphocyte count 57 (High), serum calcium test 8.1 (Low), total serum protein 4.2 (L), serum albumin 2.8 (Low). The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening and serious by the agency. The original reporting source was not provided. The VAERS ID# is 441867. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669763/1311A in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot 669763/1311AA met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Abdominal pain, Barium enema abnormal, Blood creatinine decreased, Blood potassium increased, Carbon dioxide decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 month old male patient with history of otitis media was vaccinated orally with a third dose of ROTATEQ (lot number 670237/0919AA) on 11-NOV-2011. Concomitant vaccination given on the same date included DAPTACEL (IM, site unknown, third dose, lot number C3944AA) and IPOL (IM, site unknown, third dose, lot number G1500). There were no other concomitant medications. It was reported that on 15-NOV-2011, the patient experienced intussusception. The following information was obtained through follow-up and/or provided by the government on 05-DEC-2011: ER, Hospital records and discharge summary from 15-NOV-2011 to 16-NOV-2011. The patient diagnosis was Intussusception. The patient presented with fever, vomiting, diarrhea with streaks of mucous/dark blood tinge, and abdominal pain. The patient was fussy and had bilateral hydrocele. Barium enema was administered with reduction of intussusception upon third attempt. The patient was discharged. At the time of the report the patient's outcome was unknown. Labs and diagnostics tests included abdominal ultrasound (Abnormal), testicular ultrasound (Abnormal), barium enema (Abnormal), potassium 5.8, CO2 18.4, creatinine <0.25, CBC - 4.80, platelets 500 and monocytes 21.0%. The events were serious due hospitalization and were considered by agency to be immediately life-threatening. The original reporting source was not provided. The VAERS ID number is 442968. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question 670237/0919AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Enema administration, Full blood count abnormal, Hydrocele
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 month old male patient with history of otitis media was vaccinated orally with a third dose of ROTATEQ (lot number 670237/0919AA) on 11-NOV-2011. Concomitant vaccination given on the same date included DAPTACEL (IM, site unknown, third dose, lot number C3944AA) and IPOL (IM, site unknown, third dose, lot number G1500). There were no other concomitant medications. It was reported that on 15-NOV-2011, the patient experienced intussusception. The following information was obtained through follow-up and/or provided by the government on 05-DEC-2011: ER, Hospital records and discharge summary from 15-NOV-2011 to 16-NOV-2011. The patient diagnosis was Intussusception. The patient presented with fever, vomiting, diarrhea with streaks of mucous/dark blood tinge, and abdominal pain. The patient was fussy and had bilateral hydrocele. Barium enema was administered with reduction of intussusception upon third attempt. The patient was discharged. At the time of the report the patient's outcome was unknown. Labs and diagnostics tests included abdominal ultrasound (Abnormal), testicular ultrasound (Abnormal), barium enema (Abnormal), potassium 5.8, CO2 18.4, creatinine <0.25, CBC - 4.80, platelets 500 and monocytes 21.0%. The events were serious due hospitalization and were considered by agency to be immediately life-threatening. The original reporting source was not provided. The VAERS ID number is 442968. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question 670237/0919AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Intussusception, Irritability, Laboratory test abnormal, Monocyte percentage increased, Platelet count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 month old male patient with history of otitis media was vaccinated orally with a third dose of ROTATEQ (lot number 670237/0919AA) on 11-NOV-2011. Concomitant vaccination given on the same date included DAPTACEL (IM, site unknown, third dose, lot number C3944AA) and IPOL (IM, site unknown, third dose, lot number G1500). There were no other concomitant medications. It was reported that on 15-NOV-2011, the patient experienced intussusception. The following information was obtained through follow-up and/or provided by the government on 05-DEC-2011: ER, Hospital records and discharge summary from 15-NOV-2011 to 16-NOV-2011. The patient diagnosis was Intussusception. The patient presented with fever, vomiting, diarrhea with streaks of mucous/dark blood tinge, and abdominal pain. The patient was fussy and had bilateral hydrocele. Barium enema was administered with reduction of intussusception upon third attempt. The patient was discharged. At the time of the report the patient's outcome was unknown. Labs and diagnostics tests included abdominal ultrasound (Abnormal), testicular ultrasound (Abnormal), barium enema (Abnormal), potassium 5.8, CO2 18.4, creatinine <0.25, CBC - 4.80, platelets 500 and monocytes 21.0%. The events were serious due hospitalization and were considered by agency to be immediately life-threatening. The original reporting source was not provided. The VAERS ID number is 442968. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question 670237/0919AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.