chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Arthralgia, Back pain, Gait disturbance, Hypokinesia, Lethargy
Clinical narrative: In less than 24 hrs pt was lethargic and had pain on joints. Taken to the doctor who prescribed Motrin. On Thursday was barely able to lift legs and admitted to Intensive Care at Hospital. Pt was released from hospital on Saturday and continued to take Motrin for pain. Readmitted to hospital on Monday. Currently is barely able to move, can't lift legs, has back pain. Pt is a football player. Doctors at hospital have not given a diagnosis yet, but confident that vax caused problems. For more details you may contact parents via cell phone.
Age: 0.72
Sex: M
Vaccine: HIBV, PNC
Symptoms: Anorexia, Dehydration, Insomnia, Irritability, Lethargy
Clinical narrative: My son was lethargic for three days after receiving the Hib (0655R) and PCV 7 (Prevnar B08635H) vaccines.  He ran a fever of 102.5 degrees.  He lost his appetite, became dehyrated, fussy, had trouble sleeping and appeared to be in constant pain.  Most side effects appeared to subside after three days.
Age: 0.72
Sex: M
Vaccine: HIBV, PNC
Symptoms: Pain, Pyrexia
Clinical narrative: My son was lethargic for three days after receiving the Hib (0655R) and PCV 7 (Prevnar B08635H) vaccines.  He ran a fever of 102.5 degrees.  He lost his appetite, became dehyrated, fussy, had trouble sleeping and appeared to be in constant pain.  Most side effects appeared to subside after three days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Marked erythema, warmth, and edema of the left deltoid. Motin 200 mg q 6 hrs ordered X 2 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling, Tenderness
Clinical narrative: Markedly swollen and tender left deltoid.
Age: 1.92
Sex: M
Vaccine: FLU3
Symptoms: Brain oedema, Diarrhoea, Encephalopathy, Irritability, Lip ulceration
Clinical narrative: Death on 10/26/2005 (found deceased in bedroom), flu vaccination given 10/13/05.  Patient also seen at that time for low-grade fever, crankiness, diarrhea, diagnosed with viral stomatitis given finding of ulcers inside lower lip. 6/20/06 Received medical records from PCP which reveal that on day of vax patient had fever, crankiness, sleep difficulties, diarrhea, decreased oral intake & cold sores of lower lip.  Dx: viral illness & stomatitis.  6/21/06 Received autopsy report which revealed COD as complications of viral infection.  Histology of lungs showed atypical interstitial pneumonitis & brain showed perivascular inflammation consistent with viral infection.  Bacterial & viral cultures were neg.  Neuropath exam revealed focal privascular chronic inflammation consistent with viral encephalopathy./ss
Age: 1.92
Sex: M
Vaccine: FLU3
Symptoms: Pneumonitis, Pyrexia, Stomatitis, Viral infection
Clinical narrative: Death on 10/26/2005 (found deceased in bedroom), flu vaccination given 10/13/05.  Patient also seen at that time for low-grade fever, crankiness, diarrhea, diagnosed with viral stomatitis given finding of ulcers inside lower lip. 6/20/06 Received medical records from PCP which reveal that on day of vax patient had fever, crankiness, sleep difficulties, diarrhea, decreased oral intake & cold sores of lower lip.  Dx: viral illness & stomatitis.  6/21/06 Received autopsy report which revealed COD as complications of viral infection.  Histology of lungs showed atypical interstitial pneumonitis & brain showed perivascular inflammation consistent with viral infection.  Bacterial & viral cultures were neg.  Neuropath exam revealed focal privascular chronic inflammation consistent with viral encephalopathy./ss
Age: 35.0
Sex: M
Vaccine: HEP, SMALL
Symptoms: Cellulitis, Chills, Fatigue, Injection site pain, Nausea
Clinical narrative: Patient was given smallpox vaccine 6/02/06. 6/9/06 patient started having pain around where he received his vaccination. Patient starting having symptoms chills, nausea, fever. 6/11/06 Patient felt fatigued. Patient went to local urgent care. Patient was diagnosed with cellulitis on left arm. Patient was prescribed Bactrim 800mg. Doctor discharged with Bactrim and gave patient Augmentin.
Age: 35.0
Sex: M
Vaccine: HEP, SMALL
Symptoms: Pyrexia
Clinical narrative: Patient was given smallpox vaccine 6/02/06. 6/9/06 patient started having pain around where he received his vaccination. Patient starting having symptoms chills, nausea, fever. 6/11/06 Patient felt fatigued. Patient went to local urgent care. Patient was diagnosed with cellulitis on left arm. Patient was prescribed Bactrim 800mg. Doctor discharged with Bactrim and gave patient Augmentin.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Reported body aches "a few hours after the shot" with a 99.5F fever that night and 100.2F temperature the following morning with c/o nausea. Took Tylenol with relief and applied, cold compresses. Tolerating foods/fluids 24 hrs after injection. Symptoms lasted for about 36 after injection.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Eye oedema, Pruritus
Clinical narrative: Hepatitis B given (1st ) dose. Employee called about 1 hour later. Eyes swelling and itching. Benadryl 50mg PO and Prednisone 50mg PO given.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Muscle spasms, Pruritus
Clinical narrative: Initial report received from a physician on 18/May/2006. An 18 year old male patient with no pre-existing medical history had received an intramuscular left deltoid injection of MENACTRA, lot number U2050AA, on 15/May/2006. Three days later, the patient was examined by a physician and was experiencing generalized itching and significant spasms of the neck bilaterally. The patient was treated with muscle relaxants and anti inflammatories. At the time of this report the patient had not recovered.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site reaction, Purpura
Clinical narrative: Purpuric rash A 12 year old male patient with a history of environmental allergies had received an intramuscular left deltoid injection of Menactra, lot number U1995AA on 24/MAR/2006. Four days later, the patient developed a purpuric rash over his left should and upper arm around the site of vaccination. Per the reported, tests included the following, "CBC, diff, platelets, PT/PTT-normal". At the time of this report the patient had recovered. Follow-up information received on 05/May/2006 from a health care provider. The patient was examined by the physician on 31Mar/2006 and 10/Apr/2006. Per the reported "CBC, platelets, and PT/PTT performed on 31/Mar/2006 were all normal". The patient had no respiratory or GI illness at the time of vaccination or within the weeks preceding and following the vaccination. The case was reviewed by the reporter and no additional information was available.
Age: 17.0
Sex: F
Vaccine: DTP, MNQ
Symptoms: Laboratory test abnormal, Myositis
Clinical narrative: Myositis Generalized muscle aches CPK increased Post licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra), trail cod MTA30. Subject #62363047 Initial report received on 17/Jan/2006 from an investigator participating in the above mention trail in the U.S.A. under the reference number MTA30. A 17 year old female subject developed muscle aches one day after she had received an injection of Menactra lot not reported. The same day she was concomitantly vaccinated with the DTaP (manufacturer and lot number not reported). Concomitant medication included adapalane and a topical form of retinoic acid. The subject was seen in an emergency room. Her CPK was 345. She was treated with Naprosyn and discharged to home. The discharge diagnosis from ER was myositis. Her recovery status was not reported. As per the investigator, the events are considered to be non-serious, but possibly related to the vaccinations. Documents held by sender: emergency department record.
Sex: F
Vaccine: MNQ
Symptoms: Mononucleosis syndrome
Clinical narrative: Mononucleosis infectious Initial report received from a health care provider on 24/Mar/2006. A female patient (age not specified), had received an injection of Menactra, manufacturer sanofi pasteur, lot number not reported on an unspecified date. Route and site of administration were not reported. At an unspecified period of time following vaccination, the patient "tested positive for mono". Additional information was not provided. At the time of this report, the recovery was not reported.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Hyperventilation, Hypoaesthesia
Clinical narrative: Hyperventilation Shortness of breath Numbness Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra), trail Code MTA30 Subject #23300291 Initial report received on 20/Mar/2006 from an investigator participating in the above mentioned trail in the USA under the reference number MTA30. A 15 year old female subject developed hyperventilation the same day as she received a dose of Menactra. The lot number was not reported. The event was considered to be non-serious. No treatment or recover status information was provided. Follow-up information on 29/Mar/2006. Five minutes post-vaccination, the subject began complaining of a feeling of shortness of breath and as if her throat felt "heaving". She began to hyperventilate and experienced perioral and fingertip numbness. She remained alert with normal speech, and her lungs were clear bilaterally. The symptoms lasted approximately 30 minutes. The subject was diagnosed with hyperventilation and at the time of this report, the subject had recovered. According to the investigator the event was related to the study vaccine.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Syphilis test false positive
Clinical narrative: Initial report received on April 10,2006, from a health care professional. An 18-year-old female patient with a history of allergy to bees, had received an administration of Menactra, on January 06,2006. The lot number, route and site of administration were not reported. Seventy days post vaccination, the patient donated blood and the blood tested positive for syphilis. The patient spoke with her physician, and she was subsequently tested for GBS, Lyme Disease, Mono, Hepatitis A, B, C and MMR to rule out other possible causes for a positive syphilis test. The results of the laboratory testing was not provided. Per the reporter, the syphilis test was thought to be a false positive. The patient's status at the time of this report was reported as "unknown".
Age: 53.0
Sex: M
Vaccine: HEP, MNQ, YF
Symptoms: Anorexia, Dizziness, Myalgia, Nausea, Vomiting
Clinical narrative: Initial report received from a healthcare professional on May 18, 2006. A 53-year-old male patient, with a medical history of hypertension, had received a left deltoid injection of Menactra, lot number U2004AA; a subcutaneous, left arm injection of YF-Vax, lot number UE813AA; and a right deltoid injection of Hepatitis B vaccine, lot number 1121R; on May 16, 2006. Thirteen hours later, the patient developed nausea, vomiting, muscle aches and lightheadedness. One day after that, the patient was unable to eat and continued to have some muscle aches. The event did not require examination by a physician. At the time of this report, the patient had recovered. Follow up information received on 07/Jun/2006 from a health care professional. The patient had not received any other vaccinations within four weeks of the 26/May/2006 vaccinations. He had not had an adverse event following any prior vaccinations. The patient did not have any relevant testing performed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Erythematous surrounding injection site with vesicles. Benadryl.
Age: 20.0
Sex: F
Vaccine: HEPA, TD, YF
Symptoms: Hypersensitivity, Pharyngolaryngeal pain, Swelling face, Tachycardia
Clinical narrative: Approx 30 mins after leaving health dept lips started swelling. Took shower. Lips continued to swell, then throat started hurting. Called health dept approx 4:25pm. Advised to go to ER. Left about 4:30pm to go to hospital. 7/10/06-ED and DC summary received from facility. DC DX: Allergic Reaction. ED report:PE revealed mild edema to upper lip, oropharynx clear, HR 114 tachycardia without murmur. Respirations 24. Afebrile.  RX with IM Decadron and Benadryl, oral Tagamet and prednisone. No further complaints, swelling resolved. DC home on Prednisone for 3 days.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Constipation, Crying, Diarrhoea, Irritability, Screaming
Clinical narrative: Information has been received from a pharmacist concerning a 17 week old female who on 5/31/2006 was vaccinated with a regular one time oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (Human bovine). There was no concomitant medication. It was reported that from 6/2/2006 to 6/4/2006 the patient was experiencing constipation and had no bowel movements. On 6/4/2006 diarrhea started. The diarrhea was described as mucousy. It was noted that the patient had been irritable. The patient had episodes of crying and screaming. The patients parents could settle her down for little while and then she would start again. It was noted that she was a normally happy baby. AT the time of the report the patient had not recovered. There were no laboratory or diagnostic tests performed. The patient was treated with Cefdinir (Omnicef). No product quality complaint was involved. No other information was provided. The patients reaction was considered to be an other important medical event and to involve significant disability or incapacity by the reporter (OMIC).
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Acute respiratory distress syndrome, Apnoea, Cardiac failure, Cough, Diastolic dysfunction
Clinical narrative: Pneumonia, ARDS, Pulmonary edema, not necessarily related. Pt transferred to hospital so unknown at this time what evaluation has shown. Discharge summary states dyspnea, fever, cough, apnea, ARDS, cardiac diastolic disfunction. msv Follow-up: Vaccinated as part of State wide effort after out-weaks.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Hepatic enzyme abnormal, Laboratory test abnormal, Pneumonia, Pulmonary oedema
Clinical narrative: Pneumonia, ARDS, Pulmonary edema, not necessarily related. Pt transferred to hospital so unknown at this time what evaluation has shown. Discharge summary states dyspnea, fever, cough, apnea, ARDS, cardiac diastolic disfunction. msv Follow-up: Vaccinated as part of State wide effort after out-weaks.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Pneumonia, ARDS, Pulmonary edema, not necessarily related. Pt transferred to hospital so unknown at this time what evaluation has shown. Discharge summary states dyspnea, fever, cough, apnea, ARDS, cardiac diastolic disfunction. msv Follow-up: Vaccinated as part of State wide effort after out-weaks.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Dyspnoea, Lacrimal disorder, Rash, Wheezing
Clinical narrative: Increased Lacrimation, SOB, wheezing, rash and shortness of breath. Tx'ed with Benadryl, Xopenex, Pulmicort and hospitalized for IV steroids. 07/05/2006-9 page medical record received from hospital for overnight hospitalization. Admitting DX: anaphylaxis. H&P by pediatrician revealed that 2-3 minutes after vaccine of MMR he developed tearing, redness in face and some rhinorrhea and cough, developed some petechial rash on face and morbilliform red rash all over chest and extremities. Wheezing and distress RX in office with 25mg Benadryl po, Xopenex 1.2mg nebulizer treatment, pulse oximetry was above 92% throughout the episode. Did not require epinephrine injection. After 20 minutes rash remained. Admitted for observation. PMH includes surgery for polydactyly of the upper and lower extremities, Asthma. Current medications included albuterol. Hospital course included IV Solu-Medrol and Ventolin inhaler. Ambulating and eating well during observation. RX @DC included oral prednisone.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Blister, Hypoxia, Medication error, Rash pruritic
Clinical narrative: 98-83-18 150/104 VS on adm. Pt arrived in ER with complaints of sunburn Left shoulder pain/itching with yellow exudate inside blistered areas. Physician ordered tetanus vaccine. Nurse administered Adacel and then recalled pt stated childhood allergy to pertussis. Called poison control and followed recommendations per doctor order. No reaction. Pt observed x 2 hrs with cont O2 sat x 1. VS dismissed 97.8-68-18 122/48 O2 Sat 100%.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Similar reaction on previous exposure to drug, Skin discolouration, Sunburn
Clinical narrative: 98-83-18 150/104 VS on adm. Pt arrived in ER with complaints of sunburn Left shoulder pain/itching with yellow exudate inside blistered areas. Physician ordered tetanus vaccine. Nurse administered Adacel and then recalled pt stated childhood allergy to pertussis. Called poison control and followed recommendations per doctor order. No reaction. Pt observed x 2 hrs with cont O2 sat x 1. VS dismissed 97.8-68-18 122/48 O2 Sat 100%.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Myalgia, Pyrexia
Clinical narrative: Back pain localized to paraspinal muscles; lower thoracic with low-grade temperatures.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: TDAP given IM, R deltoid 5/31/06. Pt developed hard raised spot at injection site on 6/1/06. Slowly progressed to enlarging area of swelling and erythema, no pain. Became 4" X 2" area and pt was treated 6/6/06 with Cephalexin and topical cream.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Difficulty in walking, Muscular weakness
Clinical narrative: 6/8/06 Telephone call from pt's mother who expressed concerns of pt having chills and weak legs with difficulty walking. To MD for evaluation.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Headache, Malaise, Nasal congestion, Pain
Clinical narrative: 30 min. after getting vaccines, pt didn't feel well, laid down, after 2 hrs, headache, body aches, very stuffy head and nose. Felt bad for 2-3 days then symptoms cleared up.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red, raised rash to trunk, arms and legs. Pt c/o pruritus only. No fever. Mom stated pt has had appt. to see physician tomorrow. Instructed mom to give pt Children's Benadryl. As of today, 6/9/06, pt's mom reports that the pt has been seen by a pediatrician who does not feel the rash is vaccine related. A cream prescription has made a slight improvement to rash. Physician may refer pt to a dermatologist.
Age: 1.04
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Patient presented with fever of 104.4 x 4 days, rash appeared first on one shoulder then the other. Vaccine administered on 5/30/06. Fever started day 4 after vaccine.
Age: 1.26
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Facial palsy
Clinical narrative: Bell's Palsy
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Pink vesicles on face, torso, legs.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pt received DTAP on 5/30/06, was seen in the office on 6/1/06 for severe local reaction. L thigh and knee were swollen and painful. Started on Zyrtec and has had gradual improvement and nearly resolved.
Age: 1.23
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Subcutaneous nodule
Clinical narrative: 2.5cm sub-nodule ///, red, not tender, left anterior thigh.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Mood altered, Rash
Clinical narrative: Rash suddenly appeared all over body about 24 hours after vaccine administration and child was not acting himself per mom.
Age: 1.2
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives developed on leg where Prevnar given and spread to feet and soles of feet. Denies swollen lips, SOB, wheeze. No F/C/S, no N/v/D. Reaction occurred same day as injection time frame unknown. Started on Benadryl 9mg q6 prn. Report to ER is SOB, wheeze, swollen lips or tongue.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Pt was inconsolable and excessively crying for approximately 3 hours. Pt came into office, ibuprofen was administered and pt left the office in stable condition.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Pain
Clinical narrative: Skin hurts chills no fever, symptoms started 11:00 pm 12:00 am
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation
Clinical narrative: Cried inconsolably for 1 hour and 15 min.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Varicella vaccine breakthrough. Pt developed rash 5/26/06 on trunk, extremities and palate. Had fever of 104 by ear for 12 hrs on 5/26/06. Seen in our office 5/30/06 with over 100 pinpoint vesicles and diagnosed by MD with atypical varicella.
Age: 70.0
Sex: F
Vaccine: DTAP
Symptoms: Blister, Erythema
Clinical narrative: Patient received DTAP IM in left deltoid. Patient developed 2.5x5 inch redness on deltoid with warmth. Small blisters also developed.
Age: 43.0
Sex: F
Vaccine: DT
Symptoms: Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: Pain and weakness, limited range of motion in left arm, persisting over a week after immunization.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: Received vaccine 5/25/06 and on day 11, 6/5/06, developed fever 100.4 and broke out in rash. On 6/7/06, seen in our clinic and did have lesions in various stages, 1 clear vesicle on chest, some crusted on face and trunk. (Not numerous)
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 10 X 13cm area of redness on R thigh. Local reaction to DTAP.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Opisthotonus, Posturing, Urinary incontinence
Clinical narrative: Following a demonstration of Hep-A vaccine, pt stood upright arching back in chair. Body went into tonic clonic posturing with incontinence of urine. Episode lasting 10 seconds. Recovery 1-2 minutes. Rescue squad called. Pt referred to ER.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This pt had pneumonia vaccine 11/22/1989 with no reactions. She had /// again 5/15/06 and within 24 hours developed swelling of upper arm in area where she received it. The arm still swelling, 1 week later and there is some residual redness of upper arm as of 6/7/06.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Dizziness, Hypoaesthesia, Nausea, Pallor, Tremor
Clinical narrative: Pt received .5ml, SC, vaccination of Menomune Meningococcal upper R arm. Mother stated that usually 4 nurses need to restrain pt in order for him to get a shot. Pt took the shot without any restraint and pt stayed in room talking with me for 15 minutes and then he and his mother and brother left the office. Brother returned to office stating his brother wasn't feeling well. Pt was sitting in hallway stating he was "dizzy, felt numb all over and slightly nauseated". The pt was pale, slightly tremulous and diaphoretic. Pt's pulse was 64 and regular. Pt was assisted into wheelchair and returned to office where he was assisted onto pt exam couch. Pt was observed for about 15 minutes, in which time he was allowed to sip some water and sit upright. Pt's color returned. Pt's pulse rate remained stable, and his diaphoresis ended. Pt remained sitting and stated he was no longer dizzy, tremulous or nauseated. Pt left office with his mother and brother. Pt and pt's mother were instructed to contact their physician if symptoms returned.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Urticaria
Clinical narrative: Urticaria of lower extremities 10 minutes after administration of Pediarix and Prevnar.
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia oral, Wheezing
Clinical narrative: 45 minutes after shot was given, pt c/o tongue numbness, SOB-wheezing, dizziness. 2 Benadryl 25mg given at onset. 1 dose Adult Epi-pen injected. No loss of consciousness. Seen by her doctor.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: After 10 minutes patient c/o rash red itchy over both arms and chest.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Varicella vesicular papular rash broke out with lesion 6/2/06
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Immunizations given on 6/5/06, right leg became red, swollen and itchy on 6/6/06. DTAP immunization was given in right anterior thigh. DX'd as local reaction to DTAP. Prelone syrup was prescribed on 6/7/06.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Migraine, Vision blurred
Clinical narrative: Migraine headaches lasting 3 days. Beginning within 24 hrs after injection. Also c/o blurred vision. Pt did not see MD. Self medicated with Excedrin Migraine, 2 tabs q 4-6 hrs X 3 days.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Dry throat, Sneezing, Urticaria
Clinical narrative: Sneezing started 1-2 min. after shots. Coughing and rash, itching in throat 5 min. after shots. Rash worsened with hives 10 min. after shots.
Age: 76.0
Sex: U
Vaccine: PPV
Symptoms: Cough, Diarrhoea, Dyspnoea, Vomiting
Clinical narrative: Diarrhea, vomiting, unable to breathe. I was sick for almost 2 weeks. As of today 6/8/06 I'm still coughing.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Pruritus, Rash vesicular, Viral infection
Clinical narrative: Red and pimple like bumps some itchy noticed today June 9, 2006. Treatment Acyclovir 800mg qid x 5 days.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Medication error, Purpura, Rash erythematous, Rhinorrhoea, Roseola
Clinical narrative: Purpura; Inappropriate Schedule of Drug Administration; Rash Erythematous; Roseola; Rhinorrhea: Urticaria Information has been received from a physician concerning a 17 week old teething male with no other medical history and no known drug allergies (NKDA) who on 17-MAR-2006 was vaccinated P) with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot 653754/0139F). Concomitant vaccines administered on that same day included the second IM dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD) (Lot #653524/1192R), the second IM dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine +) tetanus toxoid (Daptacel ) (Lot #C239), the second IM dose of poliovirus vaccine inactivated (Verol) (IPOL) (Lot #Y0576) and the second IM dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (Lot #B08642). There was other concomitant therapy or illness at the time of vaccine. On 19-MAR-2006, the patient developed slightly purpuric rash characterized by bumps and little red spots that were slightly raised on both legs (from thighs down), hands, arms, (from elbow down) and torso which became urticarial. There was no itching or fever. On 21-MAR-2006, the patient was seen in the Emergency Room and was diagnosed with roseola. On 22-MAR-2006 the patient was seen by the physician as his rash persisted. At that time there was no blood in the stool. On 24-MAR-2006, the patient was again seen by the physician to re-check the rash on his hand. On 26-MAR-2006, the patient seen by another physician. At that time the patient had no fever, vomiting, diarrhea or difficulty breathing and appeared to be well hydrated. The patient was noted to have normal skin turgor, no lesions. He had a diffuse red pinpoint rash over his body with areas of hives and urticaria spread over the torso and extremities. The patient had more purple skin lesions and thicker areas of hives. No petechia or purpura was noted at that time. The patient was encouraged to rest and consume fluids. On 11-APR-2006, the patient's purpuric red rash and urticaria resolved.  Medical records also contained the following adverse event: running nose (March 2006). No further information is available.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Purpura; Inappropriate Schedule of Drug Administration; Rash Erythematous; Roseola; Rhinorrhea: Urticaria Information has been received from a physician concerning a 17 week old teething male with no other medical history and no known drug allergies (NKDA) who on 17-MAR-2006 was vaccinated P) with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot 653754/0139F). Concomitant vaccines administered on that same day included the second IM dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD) (Lot #653524/1192R), the second IM dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine +) tetanus toxoid (Daptacel ) (Lot #C239), the second IM dose of poliovirus vaccine inactivated (Verol) (IPOL) (Lot #Y0576) and the second IM dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (Lot #B08642). There was other concomitant therapy or illness at the time of vaccine. On 19-MAR-2006, the patient developed slightly purpuric rash characterized by bumps and little red spots that were slightly raised on both legs (from thighs down), hands, arms, (from elbow down) and torso which became urticarial. There was no itching or fever. On 21-MAR-2006, the patient was seen in the Emergency Room and was diagnosed with roseola. On 22-MAR-2006 the patient was seen by the physician as his rash persisted. At that time there was no blood in the stool. On 24-MAR-2006, the patient was again seen by the physician to re-check the rash on his hand. On 26-MAR-2006, the patient seen by another physician. At that time the patient had no fever, vomiting, diarrhea or difficulty breathing and appeared to be well hydrated. The patient was noted to have normal skin turgor, no lesions. He had a diffuse red pinpoint rash over his body with areas of hives and urticaria spread over the torso and extremities. The patient had more purple skin lesions and thicker areas of hives. No petechia or purpura was noted at that time. The patient was encouraged to rest and consume fluids. On 11-APR-2006, the patient's purpuric red rash and urticaria resolved.  Medical records also contained the following adverse event: running nose (March 2006). No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Vomiting Information has been received from a physician concerning a pediatric patient who in approximately March 2006, was vaccinated PO with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). The physician reported that in approximately March 2006, the patient experienced vomiting for one full week following vaccination with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Unspecified medical attention was sought. Subsequently, the patient's vomiting resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Inappropriate schedule of drug administration; no adverse effect Information has been received from a physician concerning patients who were vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) outside of the indicated age range. It was unknown if medical attention was sought and no complications were reported. No further information is available.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea Information has been received from a physician concerning a 4 month old male who on approximately 17-MAR-2006 and on 03-MAY-2006 was vaccinated PO with the first and second 2.0ml dose respectively of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). There was no concomitant therapy. The physician reported that on approximately 03-MAY-2006, after the second dose, the patient experienced eight days of persistent diarrhea. Unspecified medical attention was sought, but no laboratory/diagnostics tests were performed. At the time of this report the patient was recovering. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Inappropriate schedule of drug administration; no adverse effect Information has been received from a physician concerning two 4 month old patients who were vaccinated PO with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). It was unknown if medical attention was sought and no adverse experiences were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse (RN) concerning a child who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live )human-bovine). The RN reported that the child became quite ill the day after being vaccinated as they experienced vomiting, diarrhea and fever. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Vomiting Information has been received from a registered nurse (RN) concerning a 6 month old male who on approximately 16-MAY-2006 was vaccinated PO with a dose a rotavirus G1 G2 G3 G4 P1 vaccine live (human-bovine). The RN reported that on approximately 16-MAY-2006 the patient experienced vomiting. Unspecified medical attention was sought. At the time of this report, the patient was noted to be recovering. No further information is available.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Inappropriate schedule of drug administration  Information has been received from a pharmacist concerning his 4 month old daughter who was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) when she was four months old. It was unknown if medical attention was sought. It was noted that the patient would get the second dose when she was six month old at the request of the physician. Therefore the patient would only get the total of two doses. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Inappropriate schedule of drug administration; no adverse effect Information has been received from a registered nurse (RN) concerning a 4 month old patient with no pertinent medical history or allergies in approximately May 2006, was vaccinated PO with the first 2.0ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). There was no concomitant therapy. Unspecified medical attention was sought and no laboratory/diagnostic tests were performed. No adverse reaction was reported. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Crying, Medication error, Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 week old male with no medical history and no allergies who on 26-MAY-2006 was vaccinated with a first 2mol oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). There was no concomitant medication. On 27-MAY-2006 the patient experienced vomiting, abdominal pain and crying. It was reported that the patient recovered on 28-MAY-2006. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: TD, DT
Symptoms: Acanthosis, Blister, Cellulitis, Diarrhoea, Eosinophilia
Clinical narrative: This case was reported in a literature article and described the occurrence of Wells syndrome in a 7 year old female subject who was vaccinated with tetanus and diphtheria toxoids absorbed manufacturer unspecified for prophylaxis. Relevant medical history included a similar episode of an itchy, indurated rash on the back of her left foot several months earlier that was treated empirically with antibiotics for presumed bacterial cellulitis. No illness, medication, or immunization preceded that episode. There is a family history of atopy. On an unspecified date the subject received unspecified dose of Absorbed diphtheria and tetanus vaccine unknown. One week after vaccination with absorbed diphtheria + tetanus vaccine, the subject experienced in itchy and indurated rash on her right foot. The induration spread centrifugally forming large plagues that subsequently became oedematous with vesiculation. Similar plaques also appeared on her upper extremities. Her symptoms were only pruritus and mild diarrhea. Physical examination revealed a well appearing child who was vigorously scratching throughout the evaluation. She was afebrile with stable vital signs. Symmetrical, indurated, well demarcated erythematous plaques were present on her upper extremities. Red brown papules coalescing into infiltrated plaques with some focal vesiculation were present on the back of her right foot and medical instep. The remainder of the physical examination was unremarkable. Her laboratory data were notable for a peripheral eosinophilia (976/mm3, 16%) with a normal white blood cell count 6100/mm3, negative stool ova and parasite studies, and negative viral and bacterial cultures from blister fluid. Microscopic examination of hematoxylin and eosin stained sections of a skin punch biopsy specimen revealed acanthosis, spongiosis, and interstitial and perivascular dermal eosinophilic infiltrates with a flam figure, consistent with Wells syndrome or eosinophilic cellulitis. Prednisone was initiated at 1.5 mg/kg and slowly tapered with adjunctive high potency topical steroid. Her condition initially improved, but flared once her oral steroid was tapered. Her steroid course was extended with resolution of her rash. She was continued to have episodic flares that have responded to symptomatic topical therapy. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. The author considered the events were related to vaccination with Absorbed diphtheria + tetanus vaccine.
Age: 7.0
Sex: F
Vaccine: TD, DT
Symptoms: Erythema, Inflammation, Oedema peripheral, Rash papular, Rash pruritic
Clinical narrative: This case was reported in a literature article and described the occurrence of Wells syndrome in a 7 year old female subject who was vaccinated with tetanus and diphtheria toxoids absorbed manufacturer unspecified for prophylaxis. Relevant medical history included a similar episode of an itchy, indurated rash on the back of her left foot several months earlier that was treated empirically with antibiotics for presumed bacterial cellulitis. No illness, medication, or immunization preceded that episode. There is a family history of atopy. On an unspecified date the subject received unspecified dose of Absorbed diphtheria and tetanus vaccine unknown. One week after vaccination with absorbed diphtheria + tetanus vaccine, the subject experienced in itchy and indurated rash on her right foot. The induration spread centrifugally forming large plagues that subsequently became oedematous with vesiculation. Similar plaques also appeared on her upper extremities. Her symptoms were only pruritus and mild diarrhea. Physical examination revealed a well appearing child who was vigorously scratching throughout the evaluation. She was afebrile with stable vital signs. Symmetrical, indurated, well demarcated erythematous plaques were present on her upper extremities. Red brown papules coalescing into infiltrated plaques with some focal vesiculation were present on the back of her right foot and medical instep. The remainder of the physical examination was unremarkable. Her laboratory data were notable for a peripheral eosinophilia (976/mm3, 16%) with a normal white blood cell count 6100/mm3, negative stool ova and parasite studies, and negative viral and bacterial cultures from blister fluid. Microscopic examination of hematoxylin and eosin stained sections of a skin punch biopsy specimen revealed acanthosis, spongiosis, and interstitial and perivascular dermal eosinophilic infiltrates with a flam figure, consistent with Wells syndrome or eosinophilic cellulitis. Prednisone was initiated at 1.5 mg/kg and slowly tapered with adjunctive high potency topical steroid. Her condition initially improved, but flared once her oral steroid was tapered. Her steroid course was extended with resolution of her rash. She was continued to have episodic flares that have responded to symptomatic topical therapy. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. The author considered the events were related to vaccination with Absorbed diphtheria + tetanus vaccine.
Age: 7.0
Sex: F
Vaccine: TD, DT
Symptoms: Rash vesicular, Skin discolouration
Clinical narrative: This case was reported in a literature article and described the occurrence of Wells syndrome in a 7 year old female subject who was vaccinated with tetanus and diphtheria toxoids absorbed manufacturer unspecified for prophylaxis. Relevant medical history included a similar episode of an itchy, indurated rash on the back of her left foot several months earlier that was treated empirically with antibiotics for presumed bacterial cellulitis. No illness, medication, or immunization preceded that episode. There is a family history of atopy. On an unspecified date the subject received unspecified dose of Absorbed diphtheria and tetanus vaccine unknown. One week after vaccination with absorbed diphtheria + tetanus vaccine, the subject experienced in itchy and indurated rash on her right foot. The induration spread centrifugally forming large plagues that subsequently became oedematous with vesiculation. Similar plaques also appeared on her upper extremities. Her symptoms were only pruritus and mild diarrhea. Physical examination revealed a well appearing child who was vigorously scratching throughout the evaluation. She was afebrile with stable vital signs. Symmetrical, indurated, well demarcated erythematous plaques were present on her upper extremities. Red brown papules coalescing into infiltrated plaques with some focal vesiculation were present on the back of her right foot and medical instep. The remainder of the physical examination was unremarkable. Her laboratory data were notable for a peripheral eosinophilia (976/mm3, 16%) with a normal white blood cell count 6100/mm3, negative stool ova and parasite studies, and negative viral and bacterial cultures from blister fluid. Microscopic examination of hematoxylin and eosin stained sections of a skin punch biopsy specimen revealed acanthosis, spongiosis, and interstitial and perivascular dermal eosinophilic infiltrates with a flam figure, consistent with Wells syndrome or eosinophilic cellulitis. Prednisone was initiated at 1.5 mg/kg and slowly tapered with adjunctive high potency topical steroid. Her condition initially improved, but flared once her oral steroid was tapered. Her steroid course was extended with resolution of her rash. She was continued to have episodic flares that have responded to symptomatic topical therapy. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. The author considered the events were related to vaccination with Absorbed diphtheria + tetanus vaccine.
Age: 7.0
Sex: F
Vaccine: TD, DT
Symptoms: Bacterial infection, Blister, Cellulitis, Diarrhoea, Eosinophilia
Clinical narrative: This case was reported in a literature article and described the occurrence of Wells syndrome in a 7 year old female subject who was vaccinated with tetanus and diphtheria toxoids absorbed manufacturer unspecified for prophylaxis. Relevant medical history included a similar episode of an itchy, indurated rash on the back of her left foot several months earlier that was treated empirically with antibiotics for presumed bacterial cellulitis. No illness, medication, or immunization preceded that episode. There is a family history of atopy. On an unspecified date the subject received unspecified dose of Absorbed diphtheria and tetanus vaccine unknown. One week after vaccination with absorbed diphtheria + tetanus vaccine, the subject experienced in itchy and indurated rash on her right foot. The induration spread centrifugally forming large plagues that subsequently became oedematous with vesiculation. Similar plaques also appeared on her upper extremities. Her symptoms were only pruritus and mild diarrhea. Physical examination revealed a well appearing child who was vigorously scratching throughout the evaluation. She was afebrile with stable vital signs. Symmetrical, indurated, well demarcated erythematous plaques were present on her upper extremities. Red brown papules coalescing into infiltrated plaques with some focal vesiculation were present on the back of her right foot and medical instep. The remainder of the physical examination was unremarkable. Her laboratory data were notable for a peripheral eosinophilia (976/mm3, 16%) with a normal white blood cell count 6100/mm3, negative stool ova and parasite studies, and negative viral and bacterial cultures from blister fluid. Microscopic examination of hematoxylin and eosin stained sections of a skin punch biopsy specimen revealed acanthosis, spongiosis, and interstitial and perivascular dermal eosinophilic infiltrates with a flam figure, consistent with Wells syndrome or eosinophilic cellulitis. Prednisone was initiated at 1.5 mg/kg and slowly tapered with adjunctive high potency topical steroid. Her condition initially improved, but flared once her oral steroid was tapered. Her steroid course was extended with resolution of her rash. She was continued to have episodic flares that have responded to symptomatic topical therapy. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. The author considered the events were related to vaccination with Absorbed diphtheria + tetanus vaccine.