chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Pyrexia, Swelling
Clinical narrative: Right deltoid - swelling, erythema, edema, fever
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Rash, Swelling face
Clinical narrative: Mom called - states child awoke her this am with c/o lips swollen, rash on body - no difficulty breathing per mom. Went to ER and seen by ER physician. Mom states given prednisone and benadryl at ER and has Rx for meds to take at home. Mom states pt is better now. On prednisone for 5 days per mom.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dry skin, Eye oedema, Pruritus, Rash
Clinical narrative: Child given imms. Mother returned with child complaining of feet itching and rash on back. Child had no problem swallowing. Two nurses removed his shirt and saw dry skin and no evidence of a rash. No swelling or redness at injection sites. However, eyes were somewhat puffy. Mother had purchased benadryl and gave child 1 teaspoon. 10/26/05 Follow up call to mother. She related she left clinic and called MD. He instructed her to give one more teaspoon benadryl. As of 10/26/05 11am child is feeling fine, no itching.
Age: 6.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Moderately severe local reaction - redness, soreness, swelling around injection site
Age: 66.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Swelling
Clinical narrative: Right arm swollen and red within 3 minutes of vaccine
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Gait disturbance, Pain, Petechiae, Pyrexia
Clinical narrative: Pt received 1 shot in right leg, 2 in left leg in the morning. Later on at dinner time did not feel well, not tired. Pt then developed a fever to 103 slight above as well as a petechial rash mostly over lower extremities. Seen in ER with normal lab tests, Also with pain in left leg and limping for most than 24 hours on left leg. After blood draw, petechial rash over forearm of left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: 3cm area of erythema and mild warmth left deltoid
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Temp 103. Rash on back and stomach (itching)
Age: 12.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on neck and back. Treatment: Zovirax 800mg 1 tab tid times 5 days.
Age: 1.04
Sex: F
Vaccine: HBHEPB, VARCEL
Symptoms: Rash
Clinical narrative: Rash all over body, Treatment Zovirax 1 1/2 tsp, QID x 5 Days.
Age: 0.24
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Decreased appetite, Irritability, Pyrexia, White blood cell count increased
Clinical narrative: Fever, extreme irritability, poor feeding, Septic work up including CBC, UA, LP.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye irritation, Eye swelling, Ocular hyperaemia, Rhinitis
Clinical narrative: Vaccine given 11/16 at 9:15am. By 1pm, patient had cough and would eat ice.  3 hours later, patient's eyes burning, red and puffy.  Nasal airway swollen - "no air"; back of tongue swollen.  Patient has no known allergies. She took Benadryl 25mg three times that day and went to sleep.  The next day patient okay.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue oedema
Clinical narrative: Vaccine given 11/16 at 9:15am. By 1pm, patient had cough and would eat ice.  3 hours later, patient's eyes burning, red and puffy.  Nasal airway swollen - "no air"; back of tongue swollen.  Patient has no known allergies. She took Benadryl 25mg three times that day and went to sleep.  The next day patient okay.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Myalgia, Night sweats, Oedema
Clinical narrative: 48 hrs following influenza vaccination left deltoid developed erythema, edema and she noted all over muscle & joint pain and chills/night sweats. Sought her PCP's attention and was placed on a steroid dose pack and instructed to take anti-inflamatory of her choice (per phone conversation with nurse). As of today she is feeling much better, steroid tx is completed and she has no interest in taking another influenza vaccination in the future.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Serum sickness
Clinical narrative: 48 hrs following influenza vaccination left deltoid developed erythema, edema and she noted all over muscle & joint pain and chills/night sweats. Sought her PCP's attention and was placed on a steroid dose pack and instructed to take anti-inflamatory of her choice (per phone conversation with nurse). As of today she is feeling much better, steroid tx is completed and she has no interest in taking another influenza vaccination in the future.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Approximately 9 hours after receiving MCV4 and Tdap vaccines my son began vomiting and continued vomiting hourly for ten hours, then it tapered off over the next 8 hours.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Balance disorder, Cerebrovascular accident, Confusional state, Coordination abnormal
Clinical narrative: encephalitis/short term memory difficulty multiple lesions on mri treated with iv steroids 12/2/05 Per review of medical records the following additional symptoms were noted: distorted vision, confusion, loss of balance, falls, unusual smells, "roaring" in ears, increased urinary frequency, and weakness L leg. 12/22/05 Review of medical record indicates stroke in occipital lobe and ataxia.  Follow-up: 12/02/2005 - VERBAL REPORT FROM REPORTER: Date of admission was 11/22/05. Pt. likely to be discharged today or tomorrow. Final diagnosis is ADEM s/p influenza vaccine. Additional symptoms not mentioned on original VAERS report include left-sided weakness, gait disturbance. While in hospital the patient has exhibited intermittent sundowning. 12-2-05 Verbal report from vaccine provider: Lot # not recorded. Syncope and dizziness do not appear to be pre-existing to receipt of flu vaccine. Apparently patient had not had any previous flu vaccines.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Delirium, Encephalitis, Fall, Gait disturbance, Hemiparesis
Clinical narrative: encephalitis/short term memory difficulty multiple lesions on mri treated with iv steroids 12/2/05 Per review of medical records the following additional symptoms were noted: distorted vision, confusion, loss of balance, falls, unusual smells, "roaring" in ears, increased urinary frequency, and weakness L leg. 12/22/05 Review of medical record indicates stroke in occipital lobe and ataxia.  Follow-up: 12/02/2005 - VERBAL REPORT FROM REPORTER: Date of admission was 11/22/05. Pt. likely to be discharged today or tomorrow. Final diagnosis is ADEM s/p influenza vaccine. Additional symptoms not mentioned on original VAERS report include left-sided weakness, gait disturbance. While in hospital the patient has exhibited intermittent sundowning. 12-2-05 Verbal report from vaccine provider: Lot # not recorded. Syncope and dizziness do not appear to be pre-existing to receipt of flu vaccine. Apparently patient had not had any previous flu vaccines.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Memory impairment, Metamorphopsia, Muscular weakness, Parosmia, Pollakiuria
Clinical narrative: encephalitis/short term memory difficulty multiple lesions on mri treated with iv steroids 12/2/05 Per review of medical records the following additional symptoms were noted: distorted vision, confusion, loss of balance, falls, unusual smells, "roaring" in ears, increased urinary frequency, and weakness L leg. 12/22/05 Review of medical record indicates stroke in occipital lobe and ataxia.  Follow-up: 12/02/2005 - VERBAL REPORT FROM REPORTER: Date of admission was 11/22/05. Pt. likely to be discharged today or tomorrow. Final diagnosis is ADEM s/p influenza vaccine. Additional symptoms not mentioned on original VAERS report include left-sided weakness, gait disturbance. While in hospital the patient has exhibited intermittent sundowning. 12-2-05 Verbal report from vaccine provider: Lot # not recorded. Syncope and dizziness do not appear to be pre-existing to receipt of flu vaccine. Apparently patient had not had any previous flu vaccines.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Skin ulcer, Tinnitus
Clinical narrative: encephalitis/short term memory difficulty multiple lesions on mri treated with iv steroids 12/2/05 Per review of medical records the following additional symptoms were noted: distorted vision, confusion, loss of balance, falls, unusual smells, "roaring" in ears, increased urinary frequency, and weakness L leg. 12/22/05 Review of medical record indicates stroke in occipital lobe and ataxia.  Follow-up: 12/02/2005 - VERBAL REPORT FROM REPORTER: Date of admission was 11/22/05. Pt. likely to be discharged today or tomorrow. Final diagnosis is ADEM s/p influenza vaccine. Additional symptoms not mentioned on original VAERS report include left-sided weakness, gait disturbance. While in hospital the patient has exhibited intermittent sundowning. 12-2-05 Verbal report from vaccine provider: Lot # not recorded. Syncope and dizziness do not appear to be pre-existing to receipt of flu vaccine. Apparently patient had not had any previous flu vaccines.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Pain
Clinical narrative: L-deltoid continues to be sore two weeks after injection. After five weeks, soreness has decreased, but is still tender and difficult to move. Instructed the mother to call or bring her back to the office if symptoms did not improve or to call back and inform us of her progress in one month.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Pain, Urticaria
Clinical narrative: Headache, generalized body aches, hives and joint pain.
Age: 0.77
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Bradycardia, Breath holding, Coma, Crying
Clinical narrative: Pediarix given into Rt. Thigh - pt held breath, stiffened, arched back, seemed unable to respond to voice or focus.  Experienced decreased muscle toned -color pale.  Recovered in 60-90 seconds.  Doctor examined and decision made to give Hib and Prevnar.  After these 2 vaccines given pt again immediately started crying, became apneic, dusky, bradycardic.  She had an opisthotonic - like rection, arched her back This episode lasted 1-2 minutes  The baby's exam then returned to normal with normal vital signs.
Age: 0.77
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Hypotonia, Musculoskeletal stiffness, Opisthotonus, Pallor
Clinical narrative: Pediarix given into Rt. Thigh - pt held breath, stiffened, arched back, seemed unable to respond to voice or focus.  Experienced decreased muscle toned -color pale.  Recovered in 60-90 seconds.  Doctor examined and decision made to give Hib and Prevnar.  After these 2 vaccines given pt again immediately started crying, became apneic, dusky, bradycardic.  She had an opisthotonic - like rection, arched her back This episode lasted 1-2 minutes  The baby's exam then returned to normal with normal vital signs.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy, Myopathy, Vision blurred
Clinical narrative: Flu vaccine given 11.18.2005; bell's palsy noted 11.28.2005. Terms added from Discharge summary rec'd 01/08/2006: Blurred vision, myopathy, facial asymmetry/sr
Age: 5.0
Sex: F
Vaccine: DTAP, FLUX, IPV, MMR
Symptoms: Headache, Injection site erythema, Injection site warmth, Pruritus, Swelling
Clinical narrative: She had 4 injections, 2 in each arm.  Flu and MMR in her right arm and IPV and DTaP in her left.  Today 2 days after her immunizations, the site of her left arm became 50% more swollen than before, very hot red and itchy.  It has spread around the arm like an arm band.  She had a very bad headache the day after her immunization.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site inflammation, Injection site mass, Injection site warmth, Ocular hyperaemia
Clinical narrative: --palpitation for nearly two hours after shot --blood shot eyes couple hours after shot --tightness in left shoulder --left arm inflamed, hot, w/ a knot in the center of an area about 1" in diameter--palpitation and blood shot eyes were short-lived, redness w/ heat, knot, and tightness in shoulder are still evident.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: --palpitation for nearly two hours after shot --blood shot eyes couple hours after shot --tightness in left shoulder --left arm inflamed, hot, w/ a knot in the center of an area about 1" in diameter--palpitation and blood shot eyes were short-lived, redness w/ heat, knot, and tightness in shoulder are still evident.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Malaise, Oedema, Pain
Clinical narrative: Patient states 1 Hour after flu vaccine. She was not feeling well. She hurt redness and swelling at the left upper arm. She started Benadryl 11/20. Presented 11/21/2005 no symptoms of cellulitis.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Unevaluable event
Clinical narrative: None noted at this time
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctivitis, Dyspnoea, Nasal congestion, Productive cough
Clinical narrative: Received vaccine Fluzone 10/13/2005 at 12pm. Symptoms started at 3:30pm. Reported nasal congestion, over production of sputum, conjunctivitis, Shortness of breath.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Heavy sweating, shortness of breath, chills, and very weak also light headed with headache, and upset stomach.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Stomach discomfort
Clinical narrative: Heavy sweating, shortness of breath, chills, and very weak also light headed with headache, and upset stomach.
Age: 1.48
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Cyanosis, Febrile convulsion, Postictal state, Psychomotor hyperactivity, Pyrexia
Clinical narrative: Per daycare provider fever 103, got light blue around lips, increased motor activity then brief post ictal phase. ambulance called taken to ER where they were intercepted by parents who signed him out AMH and took him to another ER by private car. He was seen and diagnosed with febrile seizure and URI.
Age: 1.48
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Upper respiratory tract infection
Clinical narrative: Per daycare provider fever 103, got light blue around lips, increased motor activity then brief post ictal phase. ambulance called taken to ER where they were intercepted by parents who signed him out AMH and took him to another ER by private car. He was seen and diagnosed with febrile seizure and URI.
Age: 1.1
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Irritability, Rash maculo-papular
Clinical narrative: Extreme irritability, maculo papular rash.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site mass, Pyrexia
Clinical narrative: Telephone call 11/15/05 from child's grandmother; c/o "golf ball sized lumps with pus" coming from immunization injection sites, bilateral thighs. States child currently on antibiotic for croup and PCP observed injection sites at last PCP visit and was not concerned. A febrile encourage grandmother and for mother to telephone PCP for follow-up appt. Mom took child to local ER. Administered antibiotic Bactrim.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Dysgeusia
Clinical narrative: Pt stated after Hep B immunization given, I have a plastic taste in my mouth, 12/01/2005 12:10 TC to Pt the plastic taste lasted 15-20 mins. I had a drink the taste went away.
Age: 1.56
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site hypersensitivity, Rash, Urticaria
Clinical narrative: Immediate wheal and redness at vaccine site, no resp symp. Baby did fine and rash was gone by next day.
Age: 1.45
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: parent reported to school nurse child had fever 1/02/2005, developed lesions 11/4/2005 (x 6 days) not DR confirmed.
Age: 17.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Abdominal pain upper, Erythema, Feeling hot, Headache, Hypokinesia
Clinical narrative: Arm was really sore,could'nt pick up over chest area the day of the shot-next day was really sore had a fever of 102.8-head hurt really bad for two days-arm was red and swollen and hot w/redness-lung area hurt- went into ER-was really dehydrated was given 1 bag of fluid & 1 bag of antibiotics through the vein-next day went back in to ER I was vomiting was weak there in the ER they gave me 2more bags of fluid & a bag of antibiotics-Lost two days of work and have not been the same still can not eat I have a loss of appitite, and have been on antibiotics sense then cause I keep getting sick with colds or coughs!! I do have asthma and it has made it harder for me to breath!!
Age: 17.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Oedema, Pyrexia, Vomiting
Clinical narrative: Arm was really sore,could'nt pick up over chest area the day of the shot-next day was really sore had a fever of 102.8-head hurt really bad for two days-arm was red and swollen and hot w/redness-lung area hurt- went into ER-was really dehydrated was given 1 bag of fluid & 1 bag of antibiotics through the vein-next day went back in to ER I was vomiting was weak there in the ER they gave me 2more bags of fluid & a bag of antibiotics-Lost two days of work and have not been the same still can not eat I have a loss of appitite, and have been on antibiotics sense then cause I keep getting sick with colds or coughs!! I do have asthma and it has made it harder for me to breath!!
Age: 17.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Anorexia, Cellulitis, Cough, Dehydration, Erythema
Clinical narrative: Arm was really sore,could'nt pick up over chest area the day of the shot-next day was really sore had a fever of 102.8-head hurt really bad for two days-arm was red and swollen and hot w/redness-lung area hurt- went into ER-was really dehydrated was given 1 bag of fluid & 1 bag of antibiotics through the vein-next day went back in to ER I was vomiting was weak there in the ER they gave me 2more bags of fluid & a bag of antibiotics-Lost two days of work and have not been the same still can not eat I have a loss of appitite, and have been on antibiotics sense then cause I keep getting sick with colds or coughs!! I do have asthma and it has made it harder for me to breath!!
Age: 17.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Injection site warmth, Pain, Pharyngitis, Pyrexia
Clinical narrative: Arm was really sore,could'nt pick up over chest area the day of the shot-next day was really sore had a fever of 102.8-head hurt really bad for two days-arm was red and swollen and hot w/redness-lung area hurt- went into ER-was really dehydrated was given 1 bag of fluid & 1 bag of antibiotics through the vein-next day went back in to ER I was vomiting was weak there in the ER they gave me 2more bags of fluid & a bag of antibiotics-Lost two days of work and have not been the same still can not eat I have a loss of appitite, and have been on antibiotics sense then cause I keep getting sick with colds or coughs!! I do have asthma and it has made it harder for me to breath!!
Age: 17.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Rhinitis, Swelling
Clinical narrative: Arm was really sore,could'nt pick up over chest area the day of the shot-next day was really sore had a fever of 102.8-head hurt really bad for two days-arm was red and swollen and hot w/redness-lung area hurt- went into ER-was really dehydrated was given 1 bag of fluid & 1 bag of antibiotics through the vein-next day went back in to ER I was vomiting was weak there in the ER they gave me 2more bags of fluid & a bag of antibiotics-Lost two days of work and have not been the same still can not eat I have a loss of appitite, and have been on antibiotics sense then cause I keep getting sick with colds or coughs!! I do have asthma and it has made it harder for me to breath!!
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Grand mal seizure about 8-12 hours after vaccination with Pediarix, Hib, PCV7, no fever recorded.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Grand mal convulsion
Clinical narrative: Grand mal seizure about 8-12 hours after vaccination with Pediarix, Hib, PCV7, no fever recorded.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Anaemia, Asthenia, Bacterial infection, Bradycardia, CSF test abnormal
Clinical narrative: Oct 30 breathing problems, Tingling in fingers, toes, weakness in legs, lower back pain, total inability to move by Nov 2nd. Diagnosed as acute infective polyneuritis, treated with plasmapheresis, breathing improved. No in long term therapy. Arms, fingers still numb. Trouble walking still in therapy Nov 25.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Leukocytosis, Nausea
Clinical narrative: Oct 30 breathing problems, Tingling in fingers, toes, weakness in legs, lower back pain, total inability to move by Nov 2nd. Diagnosed as acute infective polyneuritis, treated with plasmapheresis, breathing improved. No in long term therapy. Arms, fingers still numb. Trouble walking still in therapy Nov 25.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Urinary tract infection
Clinical narrative: Oct 30 breathing problems, Tingling in fingers, toes, weakness in legs, lower back pain, total inability to move by Nov 2nd. Diagnosed as acute infective polyneuritis, treated with plasmapheresis, breathing improved. No in long term therapy. Arms, fingers still numb. Trouble walking still in therapy Nov 25.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Back pain, Difficulty in walking, Dyspnoea, Hypokinesia
Clinical narrative: Oct 30 breathing problems, Tingling in fingers, toes, weakness in legs, lower back pain, total inability to move by Nov 2nd. Diagnosed as acute infective polyneuritis, treated with plasmapheresis, breathing improved. No in long term therapy. Arms, fingers still numb. Trouble walking still in therapy Nov 25.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Laboratory test abnormal, Paraesthesia
Clinical narrative: Oct 30 breathing problems, Tingling in fingers, toes, weakness in legs, lower back pain, total inability to move by Nov 2nd. Diagnosed as acute infective polyneuritis, treated with plasmapheresis, breathing improved. No in long term therapy. Arms, fingers still numb. Trouble walking still in therapy Nov 25.
Age: 1.07
Sex: M
Vaccine: FLU3, MMR, VARCEL, FLU3, HIBV, MMR, VARCEL
Symptoms: Apnoea, Malaise, Upper respiratory tract infection
Clinical narrative: Patient became ill within 24 hours of vaccine administration with URI symptoms, He was then discovered by parents to have stopped breathing.
Age: 1.07
Sex: M
Vaccine: FLU3, MMR, VARCEL, FLU3, HIBV, MMR, VARCEL
Symptoms: Abnormal sleep-related event, Coma, Lethargy, Pyrexia, Respiratory disorder
Clinical narrative: Patient became ill within 24 hours of vaccine administration with URI symptoms, He was then discovered by parents to have stopped breathing.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Meningitis
Clinical narrative: A physician reported that an 18 year old male study participant experienced headache and diagnosed with viral meningitis 14 days after receipt of study vaccine on Oct 24 2005. He complained of headache on Nov 7 2005. On 11/08/2005, he went to the Emergency department where a spinal tap confirmed a diagnosis of viral meningitis. He was treated with unspecified medications and was discharged on Nov 11 2005. The patient recovered without sequelae. He went back to school on Nov 16 2005 and wad advised to follow up with his physician in a few weeks. No further information is available as the study participant refused to sign release of medical records. The investigator assessed the adverse events as possibly related to study vaccine.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Complex regional pain syndrome, Contusion, Muscle twitching, Pain
Clinical narrative: Initial report received on Nov 23 2005 from a health care professional. A 15 year old female patient who was born with weakness on her right side had received an intra muscular injection of Menactra, lot number U1782AA, expiration date 2/11/2007, in the right deltoid on Oct 18 2005. The next day she had a deep aching bruise sensation in her right arm, third, fourth and fifth fingers on her right hand. She was seen by a neurologist and was treated with prednisone for five days. Her diagnosis was complex regional pain syndrome with reflex sympathetic dystrophy. At the time of this report the patient had not recovered.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Agitation, Aphasia, Crying, Eye disorder, Fontanelle bulging
Clinical narrative: 1st symptom that was noticed was vomiting and bulging fontanel (anterior) brought to pediatrician, who stated bulging fontanel was due to vomiting. 2 weeks later she was brought to neurosurgeon due to continued bulging fontanel, sundowning eyes, high pitch screams, lack of vocalization and excessive sleeping. 1/31/06 Review of 9-page d/c summary confirms pre-existing hydrocephalus. Draining of 3rd ventricle of brain was successfully done 1 month s/p vax.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Somnolence, Vomiting
Clinical narrative: 1st symptom that was noticed was vomiting and bulging fontanel (anterior) brought to pediatrician, who stated bulging fontanel was due to vomiting. 2 weeks later she was brought to neurosurgeon due to continued bulging fontanel, sundowning eyes, high pitch screams, lack of vocalization and excessive sleeping. 1/31/06 Review of 9-page d/c summary confirms pre-existing hydrocephalus. Draining of 3rd ventricle of brain was successfully done 1 month s/p vax.
Age: 15.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Tenderness
Clinical narrative: 11/08/2005 received flu shot and pneumo vaccine in left deltoid and PPD left forearm. Pain in left deltoid within 1/2 hour of recd shot. Swelling started by that evening and grew larger within 24 hours. Approx 4-5 inches from injection site dime size, non blanching erythema that was tender to palp started 24 hours later. By 48 hours erythema increased to about 4x3.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling hot, Hypersensitivity, Injection site swelling, Pain
Clinical narrative: left deltoid with red, raised area approx 7 cm in diameter. Hot to touch and painful c/o shortness of breath more than usual. Pt is 1PPD smoker.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Received vaccine in am about 10am mother called me about 3pm patient had total body fine red rash some itching. Suggested Benadryl 5 mg PO and to see MD if not resolved.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Urticaria
Clinical narrative: Hives, SOB, pressure in chest, spoke with her pharmacist told to go to the ER, went was treated and sent home after a few hours. Given a shot in ER and oral med for hives.
Age: 1.11
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Seen in ER on night of 11/28/2005 for high fever, had 3 short febrile seizures, labs drawn.
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Heart rate increased, Paraesthesia
Clinical narrative: Patient has never had a flu vaccine in the past. Patient received flu vaccine after denying allergies to anything, but Iodine. Stated, she has worn contacts and had no irritation to solution. Denies allergy to eggs or latex. Nurse administered flu vaccine 2-3 min later patient state "I can't breath. My arms tingle." 1 pm B/P 168/110 P 170 R 30. Squad called. EPI administered per directions. 1:50 patient state "I feel better. B/P 160/50 P 100 R 20. Alert, oriented. Squad arrived 2:00 pm transported to ER. 11-22-05 5 pm discharged from hospital with 2 more epi pins. 11/23/05 reported she had fully recovered to and went out Christmas shopping 11/23/05.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Pt reported sob, tight chest, difficult breathing before leaving store. I was called to service desk where I advised customer service to call 911. I administered epi pen 0.3mg to pt's right thigh after getting her in a chair (approx 1:57pm). Pt felt breathing was easier after approx 1 min post epi. EMSA administered O2 approx 10 min did not transport. Pt stayed here approx 20 min longer and drove to Dr office. Dr called and said she appeared ok and released her to go home.
Age: 0.65
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Marked edematous swelling of extremity developing over 48 hr. Non painful. Treatment Benadryl.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Lacrimation increased, Pain, Pyrexia, Swelling face
Clinical narrative: Off site flu clinic, school RN alerted us of reaction. Pt received shot and began to feel achy, feverish and have chills approx 1 hr after receiving shot. Approx 6:30 pm he told the RN his face swelled and felt like a lump in his throat. Also experienced watery eyes though out evening until Tuesday. He never saw an MD. His wife is a pharmacist and she gave him Claritin -symptoms began to resolve. 11/23/05 pt was feeling fine.
Age: 2.0
Sex: F
Vaccine: FLU3, PNC, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Pt received Varivax and Prevnar on 11/9/05. Mom noticed bumps a week later after staying at aunts. Aunt had a dog with fleas so attributed spot to flea bite. She noticed a scab (pt was itching) with bumps around it (not sure if fluid filled). Took her to ER and was told had infection related to vaccine site and started on Keflex to pt tid times 10 days. Mom brought her to office to be rechecked. Yellow scab with erythema and surrounding dry pustules on right upper thigh.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness postural, Loss of consciousness
Clinical narrative: No adverse events until 10:30 pm next day. Got up from relaxing position suddenly felt dizzy, laid down on floor - proceeded to passed out momentarily - tried to get up and momentarily passed out again. Rested for approximately 3/4 hours and then was ok. No events since.
Age: 1.35
Sex: M
Vaccine: FLU3
Symptoms: Pharyngitis, Rhinitis, Rhinorrhoea, Skin discolouration, Urticaria
Clinical narrative: Pt received the vaccine on Wed 11/23/2005 at approximately 11am. Mom called clinic to report pt had awoken from nap at 3pm with large white welts on left leg, arm, and abdomen. No fever had slight cold with runny nose. Had received vaccine in left leg. Mom called physician who ordered Benadryl. No shortness of breath reported. Call mom today reported hives continued through Friday 11/25, used Benadryl with relief. Pt has had previous dose for vaccine 02/08 no apparent allergy to eggs.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash macular
Clinical narrative: Returned approximately 90 minutes after getting injection stating her arm was itching. Arm where it was given is blotchy. No hives.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Redness and swelling at site of influenza injection.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Rash all over body and then progressed to hives (ears, neck, trunk, arms, legs).
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Cough, Drug ineffective, Pneumonia, Pyrexia
Clinical narrative: Cough, Phlegm, Fever, DX pneumonia and staph infection.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Rhinorrhoea
Clinical narrative: Cough, Phlegm, Fever, DX pneumonia and staph infection.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Approx 4 Hours after receiving flu shot felt achy, which lasted thru the night. Face was red, on 11/18/2005 called Dr told to take Benadryl. She did so and redness went away. No redness on 11/19/2005. Did have facial redness on 11/20 and 11/21. Called Dr on 11/22. Told to take Benadryl. Do so and no redness since.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Decreased appetite, Pyrexia
Clinical narrative: Had flu shot about 10am 10/31/05. Approx 3pm experienced chills, fever, felt weak, decreased appetite. Reports no fever or chills next day 11/01/05 but continued to have low energy and low appetite. Episode lasted 2 1/2 days did not consult a doctor.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Myalgia, Pruritus
Clinical narrative: Local erythema, edema, induration about 8cm in diameter at site. Within 24 hours of vaccine, she had a temp of 100.4, myalgias, pruritus, rash on upper chest, neck and upper back that is slightly raised, papular. 11/30/2005 no pruritus, erythema gone, mild induration.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash papular
Clinical narrative: Local erythema, edema, induration about 8cm in diameter at site. Within 24 hours of vaccine, she had a temp of 100.4, myalgias, pruritus, rash on upper chest, neck and upper back that is slightly raised, papular. 11/30/2005 no pruritus, erythema gone, mild induration.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Pain
Clinical narrative: Very sore left arm since shot. It has not gone away. Pain wakes him up at night. Pain is located over left deltoid. It does not radiate. Is not associated with loss of function or numbness.
Age: 60.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis infection on left arm. Emergency room visit and private doctor visit.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Swelling
Clinical narrative: Cellulitis infection - swelling on arm. Visit to doctor.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Nausea, Pyrexia, Rash
Clinical narrative: Fatigue, nausea, low grade fever and rash on hands, arms and face
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A nurse practitioner reported that a 6 year old female experienced profuse bloody nose within 10 minutes of FluMist administration on Oct 17 2005. Bleeding resolved with ice pack and maintaining patient on a supine position. No other information was available at the time of the report. The reporter causality is not provided. A nurse practitioner reported that a 5-year-old female experienced profuse bloody nose within 10 minutes of receiving FLUMIST on 17Oct2005. The bleeding was resolved with ice pack and placing her in a supine position. On March 28, 2006 the nurse reported the event has completely resolved. Additional information date of birth and adverse event onset date/time and outcome.
Age: 50.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Medication error
Clinical narrative: A nurse reported that a 49 year old male received FluMist vaccine at an inappropriate site. At approximately 3:45pm on Oct 15 05, a nurse administered FluMist vaccine to the patient via intramuscular injection. The nurse reported that he was unfamiliar with FluMist and was unaware that it is approved for intra nasal use only. Not noticing the label that said for intra nasal use only, he broke off the tip of the FluMist syringe and aspirated the 0.5ml content using a different syringe with needle and injected it to the patient. As of Oct 24 2005, the patient did not report any adverse events but was advised to inform the nurse or call for emergency help if there need be. The reporter causality is not provided. Information received 06/23/2006. Lot # not available. Lost during act of nature.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood glucose increased
Clinical narrative: MEDI-003745 is not a serious spontaneous case from a consumer or other non health professional involving elevated blood glucose (unlabelled). The reporter causality is not provided to FluMist. A medical assistant from a physician's office reported that a 7 year old male, with history of new onset juvenile diabetes, experienced elevated blood glucose levels ranging from 300-500 mg/dl, 2 days after receiving FluMist vaccine on 05Oct05. Per the reporter, the patient's mother has since brought the patient to his pediatric endocrinologist for management of the elevated blood glucose. The patient is also receiving insulin (dosage and frequency not specified). He has not recovered. The reporter causality is not provided.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A nurse reported that an expired FluMist vaccine was administered to a 39 year old male patient on Oct 19 2005. There was no adverse event reported following vaccine administration, No other information is available. The reporter causality is not provided.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Immediate post-injection reaction, Nasal congestion, Sneezing
Clinical narrative: A nurse reported that a 9 year old male experienced left nare closed. and multiple violent sneezing of about 15-20 times immediately after FluMist vaccine on 10/19/2005. There was no additional information at the time of report. The patients clinical outcome in unknown. Reporter causality is not provided. A nurse reported that a 9-year-old male experienced "left rare clomire" and multiple episodes of violent sneezing approximately 15-20 times immediately after receiving FLUMIST vaccine on 18Oct2005. The patient's clinical outcome is unknown. Reporter causility is not provided. 26Apr2006: Additional information received include date of birth, lot number and expiration date of vaccine.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A nurse reported that an adult female received expired FluMist vaccine on an unspecified date. There were no adverse advents reported. No other information was available at the time of report. The reporter causality is not provided. Information received 06/23/2006. Adverse Event onset date/time, lot number of vaccine, and vaccine administration date/time are unavailable.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye disorder, Medication error, Photosensitivity reaction
Clinical narrative: A 7 year old female had FluMist accidentally sprayed on her left eye on Oct 25 2005, when she moved her head back as a nurse was spraying the vaccine into her left nostril. As a result, the child experienced left eye photosensitivity. The affected eye was flushed with normal saline. On Oct 26 2005 the patients mother called the doctors office to inform them that the patient has fully recovered. The reported assessed the adverse event as possibly related to FluMist.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A physician reported that a 3 year old boy received FluMist vaccine by mistake on Oct 25 2005. No adverse event occurred at the time of report. The reporter causality is not provided.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A physician reported that a 3 year old female received FLUMIST vaccine in error. No adverse event was reported to have occurred at the time of this report. The reporter causality is not provided.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A nurse reported that an adult female received FluMist on Oct 26 2005 an accidentally sprayed the vaccine to her right eye. The patient flushed her right eye with liquigel and water. The patient also reported that she thinks her eyelashes caught most of the sprayed liquid. On Oct 27 2005, the reporter was informed by the patient that she is doing great and has completely recovered. The reporter causality is not provided. Additional information: date of birth, age at time of vaccination and lot number of vaccine.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A nurse reported that a 40 year old female experienced FluMist vaccine accidentally sprayed on her eye when she received the vaccine on Oct 28 2005. No adverse event was reported. The reporter also stated that one third of the vaccine was administered on one nostril and the remaining two thirds to the other nostril, possibly due to been a problem with the divider dosing clip. No other information is available at the time of report. The patient completely recovered. The reporter causality is not provided.
Age: 6.0
Sex: U
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: A nurse reported that a 6 year old child experienced nausea, vomiting and stomach pain. Three days after receiving FluMist on Oct 28 2005. the patient is being taken cared of at home. The patients clinical outcome is unknown. The reporter causality is not provided. No other information was available at the time of the report. Additional information has been requested. Follow up information - Patient DOB and vaccine lot number received.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Pharyngolaryngeal pain
Clinical narrative: MEDI-0003805 is not serious spontaneous case from a consumer involving sore throat. The reporter causality is not provided to FluMist. An office manager in a physician's office reported that a 33 year old female and 3 other office staff experienced headache and sore throat 2 days after receiving FluMist vaccine on 26Oct05. The patient recovered. The reporter causality is not provided. Follow up - Patient's  DOB received.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: MEDI-003806 is not a serious spontaneous case from a consumer in the USA  involving sore throat. The reporter causality is not provided to FLUMIST. An office manager in a physician's office reported that a 33 year old female and 3 other staff experienced headache and sore throat 2 days after receiving FLUMIST vaccine on 26Oct05. After taking Tylenol Ibuprofen, she completely recovered. The reporter causality is not provided.
Age: 35.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Pharyngolaryngeal pain
Clinical narrative: MEDI-0003807 is a not serious spontaneous case from a consumer involving sore throat. The reporter causality is not provided to FluMist. An office manager in a physician's office reported that a 35 year old male and 3 other office staff experienced headache and sore throat 2 days after receiving FluMist vaccine on 26Oct05. This patient completely recovered. The reporter causality is not provided.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Pharyngolaryngeal pain
Clinical narrative: MEDI-00068085 is not serious spontaneous case from a consumer involving sore throat. The reporter causality is not provided to FluMist. An 36 year old female office manager in a physician's office reported that she and 3 other office staff experienced headache and sore throat 2 days after receiving FluMist vaccine on 26Oct05. This patient recovered from the headache but sore throat continued. The reporter causality is not provided. A 36 year old female officer manager in a physician's office reported that she and 1 other staff experienced headache and sore throat 2 days after receiving FLUMIST vaccine on 26Oct05. SHe took TYLENOL and MOTRIN. She recovered from the headache but sore throat continued. The reporter causality is not provided. 12April2006: Additional information obtained: Patient's date of Birth.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Acne, Erythema
Clinical narrative: MEDI-0003810 is a non serious spontaneous case from a consumer involving red pimple like dots around nose. The reporter causality is not provided to FluMist. A 34 year old female reported that she experienced red pimple like non-pruritic dots around the nose 2 weeks after receiving FluMist on 12Oct05. There was no medical intervention. The patient has not yet recovered. The patient's husband also experienced the same red pimple like dots a week after they both received the FluMist at their children's pediatrician's office. The reporter causality is not provided. This case is linked to MEDI-0003816.
Age: 38.0
Sex: M
Vaccine: FLUN3
Symptoms: Acne, Erythema
Clinical narrative: MEDI-0003816 is a non serious spontaneous case from a consumer involving red pimple like dots around the nose. The reporter causality is not proved to FluMist. A consumer reported that her 38 year old husband developed red pimple like, non-pruritic, dots around the nose one week after receipt of FluMist vaccine on 12Oct05 from his children's pediatrician's office. As of 08Nov05, the dots persisted, but are now less and brownish in color. The reporter causality is not provided. The reporter also reported that she experience the same adverse event two weeks after receiving FluMist vaccine. This case is linked to AER # MEDI-0003810.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Received menactra LA 11/29/05. Large swelling and redness covering completely upper left arm. 6 inch local reaction to vaccine. Seen by us 11:50 am 12/01/05 child received 2 tap benadryl, warm compress and tylenol.
Age: 35.0
Sex: F
Vaccine: HEP, TD
Symptoms: Chills, Erythema, Injection site swelling, Injection site vesicles, Pain
Clinical narrative: Presented to Family Medicine for another reason. Site of Td was evaluated per patients request 4 inch area of erythema noted. Mild tenderness. Pt is afebrile bodyaches, chills. Pt reports in 1996 had reaction to Td with swelling and blisters at site
Age: 35.0
Sex: F
Vaccine: HEP, TD
Symptoms: Tenderness
Clinical narrative: Presented to Family Medicine for another reason. Site of Td was evaluated per patients request 4 inch area of erythema noted. Mild tenderness. Pt is afebrile bodyaches, chills. Pt reports in 1996 had reaction to Td with swelling and blisters at site
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: 11/30/05 Soreness left shoulder, evening- developed fever 101.5; red area around inj site 12/01/05: Increased soreness left shoulder, fever
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin reaction
Clinical narrative: Pt received varricella vaccine 1995 "Classic" outbreak with approx 50 pox on day 2 of illness no fever
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Chills, Contusion, Diarrhoea, Pyrexia, Rash erythematous
Clinical narrative: 11/15/05 fever, chills, diarrhea, .5 inch round raised area red and hot to touch. 11/16/05 3cm bruise 10cm red and warm to touch at area
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Skin warm
Clinical narrative: 11/15/05 fever, chills, diarrhea, .5 inch round raised area red and hot to touch. 11/16/05 3cm bruise 10cm red and warm to touch at area
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Mom notices large 15 x 15 cm red induction at site of IPV and DTaP on 11/25/05
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Erythema, Myalgia, Nausea, Pain in jaw
Clinical narrative: Large redness left arm/chest and myalgria, nausea, jaw pain, short of breath
Age: 1.84
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Erythema, Gait disturbance, Injection site mass
Clinical narrative: 2 days post immunization child developed lump with erythema to right thigh and limping of affected leg given Rx for antibiotic
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Medication error, Rash
Clinical narrative: 05/18/05 client was given an expired dose of vaccine. 11/16/05 - client recevied repeat v2v vaccine. 11/28/05 client's mother and grandmother called to report a rash all over the body. Has seen the Dr. Thought it was an amoxicillin reaction. Child on coladryl. Not taking the prednisone. To see Dr at 4:15.
Age: 0.41
Sex: M
Vaccine: HIBV
Symptoms: Irritability, Lethargy, Pyrexia, Stupor, Vomiting
Clinical narrative: About 2.5 hours after HIB #2 - pt noted to be lethargic, irritable, temp 102.2 - gave tylenol became hyporesponsive - vomited several times. EMS was called and evaluated. Sent back to office. Normal exam