chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning an adolescent female (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided). Concomitant therapy included an unspecified anti malaria medication. Subsequently, on an unspecified date " a few days later" the patient had a seizure. It was reported by the physician that at the time "the patient has a series of tests (NOS) but no diagnosis was found. On another unspecified date the patient received the second dose of Gardasil (lot # not provided) and sixteen days post vaccination, on an unspecified date the patient had seizure. The patient sought unspecified medical attention. The physician reported that it was not known if additional test were completed. The physician reported that the patient had recovered from the seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Flushing, Pruritus generalised
Clinical narrative: Left arm flushing and generalized itching without rash.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Three week pain in right deltoid after vaccine with Gardasil.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Three week pain in right deltoid after vaccine with Gardasil.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Developed hives, urticaria all over body. Did not develop respiratory symptoms responded to Benadryl 50mg after minimal relief with Loratadine 10mg.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Initial and follow up information has been received from a Licensed Practical nurse and a physician concerning a female patient who was vaccinated with a first dose of Gardasil. She developed hives within 2-3 hours of receiving the injection. Unspecified medical attention was sought. The patient was not recovered. The nurse considered hives to be disabling she was not available for follow up, and when the physician was contacted, he could not provide any information regarding why the nurse considered the event disabling. He had not been able to contact the patient. He had no further information regarding her outcome. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, FLUX, PNC, RV5
Symptoms: Abdominal pain, Blood culture, Enema administration, Full blood count, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 7 month old female, with no medical history and no allergies, who was vaccinated with an oral first, second, and third dose of Rotavirus on 11-AUG-2006, 15-NOV-2006, and 16-JAN-2007, respectively. Concomitant vaccines administered on 16-JAN-2007 included a dose of Prevnar, a dose of Influenza (unspecified) and a dose of Pediarix. On 05-Mar-2007 the patient experienced lethargy, abdominal pain, bloody stool, and a prolapsed rectum. The patient was hospitalised for 2 nights. The patient was given a hydrolic enema. No surgery was needed. Subsequent, the patient completely recovered. No product quality complaint was involved. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, FLUX, PNC, RV5
Symptoms: Lethargy, Rectal prolapse
Clinical narrative: Information has been received from a physician concerning a 7 month old female, with no medical history and no allergies, who was vaccinated with an oral first, second, and third dose of Rotavirus on 11-AUG-2006, 15-NOV-2006, and 16-JAN-2007, respectively. Concomitant vaccines administered on 16-JAN-2007 included a dose of Prevnar, a dose of Influenza (unspecified) and a dose of Pediarix. On 05-Mar-2007 the patient experienced lethargy, abdominal pain, bloody stool, and a prolapsed rectum. The patient was hospitalised for 2 nights. The patient was given a hydrolic enema. No surgery was needed. Subsequent, the patient completely recovered. No product quality complaint was involved. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 6 month old Middle Eastern female who was vaccinated with a first and second dose of Rotavirus on 27-OCT-2006 and 29-DEC-2006, respectively. On 03-MAR-2007 the patient was hospitalized for intussusception, which required surgery, but no bowel resection. Subsequently, the patient recovered. No other information was provided. Additional information has been requested. 04/17/07-records received from facility for DOS 3/2-3/5/07 DC DX: Intussusception. Fever. Leukocytosis. 6 day HX of vomiting, has had no stool no diarrhea. Prior to admission fever 103.5. Weight down 14 ounces. Congestion with clear runny nose. Afebrile upon admission. 2nd day of admission passed mucusy stool with streaks of blood. PE: WNL, abdomen soft and nontender.  Surgery reduction ileocecal intussusception and appendectomy
Sex: F
Vaccine: RV5
Symptoms: Barium enema, Intussusception, X-ray
Clinical narrative: Information has been received from a retired physician concerning his granddaughter who was vaccinated with a 2 ml oral dose of Rotateq. Subsequently the patient was treated for intussusception. It was reported that a barium enema was performed. At the time of the report the patient was recovering. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's intussusception was considered to be an other important medical event. Additional information is not expected.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Constipation, Diarrhoea, Gastroenteritis rotavirus
Clinical narrative: Information has been received from a health professional concerning a 6 month old female, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of Rotateq on 19-OCT-2006 and 17-JAN-2007 (Lot# 655866/1110F), respectively. Concomitant vaccinee administered on 17-JAN-2007 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of IPOL, a dose of PedvaxHIB (manufacturer unknown) and a dose of Prevnar. It was reported that, according to the hospital discharge summary, 24 hours prior to presentation at the hospital, on 07-MAR-2007, the patient began with nausea, vomiting, abdominal pain and constipation. The patient was admitted to the hospital on 08-MAR-2007 and had episodes of vomiting, diarrhea, and bloody stools. The patient was diagnosed with ileocolic intussusception, which was initially encountered in the distal transverse colon. It was also noted by the physician on the discharge summary that the patient had rotavirus. The patient did not have surgery and the intussusception was reduced by an air contrast enema. The patient was discharged on 10-MAR-2007 and had recovered. The patient's intussusception and rotavirus were considered to be other important medical events by the reporter. A lot check has been requested. Additional information has been requested.  04/12/07-records received from facility for DOS 03/08-03/10/2007. DC DX: Ileocolic intussusception. Diagnosed and treated with air contrast enema. Developed abdominal pain 24 hours prior to presentation with decreased PO intake, several episode of vomiting and an episode of diarrhea but no further bowel movements over 24 hours. Febrile to 38.3. PE bowel sounds present soft non distended tender to palpation no masses palpable. Rectal grossly bloody stool in rectal vault.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Intussusception, Nausea, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 6 month old female, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of Rotateq on 19-OCT-2006 and 17-JAN-2007 (Lot# 655866/1110F), respectively. Concomitant vaccinee administered on 17-JAN-2007 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of IPOL, a dose of PedvaxHIB (manufacturer unknown) and a dose of Prevnar. It was reported that, according to the hospital discharge summary, 24 hours prior to presentation at the hospital, on 07-MAR-2007, the patient began with nausea, vomiting, abdominal pain and constipation. The patient was admitted to the hospital on 08-MAR-2007 and had episodes of vomiting, diarrhea, and bloody stools. The patient was diagnosed with ileocolic intussusception, which was initially encountered in the distal transverse colon. It was also noted by the physician on the discharge summary that the patient had rotavirus. The patient did not have surgery and the intussusception was reduced by an air contrast enema. The patient was discharged on 10-MAR-2007 and had recovered. The patient's intussusception and rotavirus were considered to be other important medical events by the reporter. A lot check has been requested. Additional information has been requested.  04/12/07-records received from facility for DOS 03/08-03/10/2007. DC DX: Ileocolic intussusception. Diagnosed and treated with air contrast enema. Developed abdominal pain 24 hours prior to presentation with decreased PO intake, several episode of vomiting and an episode of diarrhea but no further bowel movements over 24 hours. Febrile to 38.3. PE bowel sounds present soft non distended tender to palpation no masses palpable. Rectal grossly bloody stool in rectal vault.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female with "prior isogtry", who in December 2006, was vaccinated with one dose of Zostavax. "Within the past 2 weeks", on approximately 21-FEB-2007, also reported as 3 months after she received Zostavax the patient developed shingles. Medical attention was sought, it was reported that the physician "had to" administer an antiviral to treat the patient. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. The patient's shingles were considered to be an other important important medical event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a medical assistant (also reported as a registered nurse) concerning an immunocompromised female with a history of shingles who on an unspecified date was vaccinated with one dose of Zostavax. Subsequently the patient developed a "serious case of shingles and was hospitalized." The patient was reported to be hospitalized in another country and therefore the length of hospitalization was not known at the time of the report. It was reported that the patient attended the oncology clinic where the medical assistant worked, though the prescribing physician did not work in the clinic. The reason the patient attended the oncology clinic was not provided. There was no product quality complaint involved. No further information was provided. The patient;s shingled were considered serious for hospitalization. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Pt received vaccine/GARDASIL 1/15/07. One week later, developed hives which lasted one week. Pt treated with BENADRYL for symptoms relief. Follow-up information received - Date of vaccination and Adverese event onset date.
Age: 1.1
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMRV, PNC
Symptoms: Pyrexia, Skin discolouration
Clinical narrative: Mom took child to ER for fever 103.9 purple feet. Had given TYLENOL. At ER, (mom told me) given MOTRIN, instructed to give warm bath, massage legs, can't MOTRIN. Left ER about 5:15 PM. Was there about 1 1/2 hours. Follow up 3-1-07 mom says still has fever, no other problems.
Age: 1.66
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: Mom says has little red bumps all over body but child has not scratched them. Mom noticed bumps on 2/26/07 when child woke up. Rash was resolved and was not visible today. Had temp of 99.8.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMRV, PNC
Symptoms: Angioneurotic oedema, Pruritus
Clinical narrative: Mom called morning after shots given said child began itching and breaking out in large hives. AS they were driving home. Took child to ER. Mom says Physician wants allergy testing to determine cause.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Dystonic reaction treated with IV Benadryl then PO Valium in ER. Second ER visit 2/18/07 treated with Cogentin. Symptoms resolved after 12 days. 03/21/07-records received from ER facility for services provided on 3/18 and  3/21/07-DX:Dystonic reaction.  HX: involuntary spasms, seen in ER day prior. DX at that time dystonic reaction. treated with benadryl and valium. Had 5 doses of valium, now spasms with eyes rolling.  Current medications Lexapro.  Allergy: Phenergan (dystonic and psychotic reaction). Neuro exam normal. Spasms observed, eye rolling. DC with cogentin. 2/21/07 seen in ER DX: dystonic medication versus vaccine reaction. Neuro exam normal. No spasm observed. Schedule MRI.  04/11/07-records received from ER for DOS 2/16/07-placed on Lexapro 2 weeks prior to ER visit. C/O erratic jerking moments. Upper body and shoulders. Voluntary control of arms and shoulders, legs and neck intact. HX depression. Additional findings: Facial and left arm muscles contracting spontaneously. DX: Dystonic drug reaction. Discontinue Lexapro.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site TX Cortisone cream, cold compresses.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dysphonia, Injection site pain, Rash, Urticaria
Clinical narrative: Rash all over, hives at 1st, gone by Sat started Thurs, evening, achy joints, hoarseness, injection site tender hoarseness continues today.
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis vaccine reaction L arm.
Age: 1.09
Sex: M
Vaccine: HEPA, HIBV, MMRV
Symptoms: Crying, Injection site erythema, Injection site papule, Pyrexia
Clinical narrative: Fever 4-5 days after MMRV shot 2/28/07. Excessive crying intermittently x 24 hours. 3 Erythematous papular at injection site.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Heart rate increased, Heart rate normal, Hyperhidrosis
Clinical narrative: 3/12/07 at 4:40 pm experienced rapid heartbeat and sweating. Took blood pressure 97/80 pulse 112. Duration of rapid heartbeat approx 1 1/2 hrs. Took 1/2 of my 0.125 mg Digoxin. 2 hours later pulse came down to normal. The next day I experienced extreme discomfort in my lower bowels before I evacuated them.
Age: 0.62
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: No adverse effect
Clinical narrative: NONE
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Eye swelling, Rhinorrhoea, Sneezing
Clinical narrative: Immediately after immunization the child began sneezing and having a runny nose. His eyes became swollen. Gave Benadryl immediately.
Age: 1.26
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Lt arm induration about 2 CM in diameters erythematous tender to palpation. 2 days after vaccination for 2 days and resolved, given Motrin alternation with Tylenol and compresses.
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Injection site reaction
Clinical narrative: Patient had local reaction to L arm.
Age: 0.42
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Medication error, Wrong drug administered
Clinical narrative: NONE
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Convulsion, Depressed level of consciousness, Electrocardiogram, Tardive dyskinesia
Clinical narrative: At about 3am on day following administration of shots developed lip smacking, with altered level of consciousness. Taken to ER abnormal EKG likely a true neuro onset seizure disorder, reporting only due to time frame.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, RV5
Symptoms: Convulsion, Electroencephalogram normal, Scan brain
Clinical narrative: Admitted to hospital through ER for suspected seizure episode without fever and no other symptoms/problems-EEG=WNL, Brain CT scan=WNL.  05/14/2007 MR received for an o/n ER admit (3/16/07) for parental report of a generalized shaking seizure-like episode which lasted ~ 1 min.  Pt's eyes were looking straight forward and child became sleepy after episode. Pt. (+) for diarrhea.   PE: (+) nasal congestion and perianal rash.  Temp 99.8'F. Otherwise WNL. Discharge DX:  Seizure 2' to immunization.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: Patient developed intussusception 3/15/07 sent to hospital - reduced with barium air enema. 03/28/07-DC summary received. DC DX: Intussusception. Confirmed by ultrasound and successfully reduced with air contrast barium enema.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laboratory test
Clinical narrative: Patient developed intussusception 3/15/07 sent to hospital - reduced with barium air enema. 03/28/07-DC summary received. DC DX: Intussusception. Confirmed by ultrasound and successfully reduced with air contrast barium enema.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Barium enema, Intussusception
Clinical narrative: Patient developed intussusception 3/15/07 sent to hospital - reduced with barium air enema. 03/28/07-DC summary received. DC DX: Intussusception. Confirmed by ultrasound and successfully reduced with air contrast barium enema.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Dehydration, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: Pt admitted to ED c/o fever, nausea, vomiting, dehydration and fatigue. Dr ordered 3 liters of IVF and 2 injections of compazine, DR from ED with prescription (Compazine). 3/19 spoke with pt she c/o mild lightheadness.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Vomiting
Clinical narrative: Pt admitted to ED c/o fever, nausea, vomiting, dehydration and fatigue. Dr ordered 3 liters of IVF and 2 injections of compazine, DR from ED with prescription (Compazine). 3/19 spoke with pt she c/o mild lightheadness.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: C-reactive protein normal, Full blood count normal, Unevaluable event
Clinical narrative: None Stated 04/02/07-records received from facility. Developed rash around injection site, pulse 100, felt shaky, tightness in chest and heart felt like it was racing. Feels anxious, agitated, lightheaded. PE:WNL. DX: Anxiety disorder.
Age: 1.71
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Pruritus, Skin disorder
Clinical narrative: Shots given around 11:00 am, 12:00 pm one hour later patient felt, pokes and itchiness all over body was given prescription for Benadryl, patient came at 3:30 to let us know.
Age: 48.0
Sex: M
Vaccine: TD, TDAP
Symptoms: Incorrect dose administered, Malaise, Wound
Clinical narrative: Patient has not felt well since vaccines given on 3/1/07 he can not be specific about symptoms. He received an extra dose .5ml of TD.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Allergy to vaccine, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient c/o L deltoid pain, the night of the immunization. Patient was seen in the office the following day. His left arm was swelling and erythema. DX with allergic reaction to ProQuad. Given RX for Keflex and OTC Benadryl. Return in 1 week.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncopal episode after dose #2 of Gardasil vaccine.
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site rash, Injection site vesicles, Pyrexia
Clinical narrative: Broke out at injection site (left leg) with fluid-filled blisters on 3-15-2007, low fever, think it is at injection site of Varicella.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Colitis, Haematochezia
Clinical narrative: Colitis, Blood in stool.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itching, swelling, redness.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Blister, Dermatitis contact, Injection site rash, Rash
Clinical narrative: DTaP 2-28-07 Developed blistering rash on back the next day, then 2 days later developed rash on right leg (Leg DTaP was given) diagnosis contact dermatitis given Arapored. 3-12-07 rechecked and given Keflex and Cutivate for infected area on buttocks.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Palpitations, Syncope, Vision blurred
Clinical narrative: Received hepatitis B vaccine Saturday evening 3-17-07 at approximately 6:30pm. Between 9:00 and 9:30p started having heart palpitation Sunday morning at approximately 7:00 am blurred vision, fainted. Transported to medical center - lab work, chest x-ray and EKG obtained - some PVCS noted (did not admit). Syncope episode around 1:30pm 3-19-07.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: L upper arm reddened, warm swollen and painful. Pt states started last night.
Age: 51.0
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue
Clinical narrative: Severe fatigue, joint pain for 1 month after Adacel.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Patient called day of shot to report pain, swelling and redness on right arm that extends from shoulder to about 2 inches from elbow. "It's hard as a rock". No complaints of headache or fever but says feels kind of "fluish". Spoke to my supervisor who said suggest ice and ibuprofen. If no improvement or if swelling extends to fingers seek medical care
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Blood test normal, Body temperature decreased, Feeling cold, Pyrexia, Screaming
Clinical narrative: Within one week of receiving his one-year vaccines (MMR, Chicken pox) my son developed a fever (102 F) for two days, and the fourth night woke up screaming and unable/unwilling to open his eyes.  The baby felt cold, so we took his temperature rectally and it was 95 F.  We called the pediatrician and he directed us to the hospital emergency room.  They ran blood tests, and found no evidence of bacterial infection per conversations with the attending physician.  His temperature warmed to 98 F while at the hospital and we went home.  Over the next week his temperature dropped again (twice), but levelled out at ~96 F, but with no hospital visit.  He had blood culture work done the following week, but again they found nothing.  He has since been fine, and appears normal.  A friend who has a 2 year old boy, said the same exact symptoms happened within 1 week of her son recieving his one year vaccines (MMR + chicken pox), but the temperature drop was more excessive (93 F taken at the hospital).  04/27/2007 MR received for ER visit of 03/06/2007 for C/o infant waking up screaming and feeling cold to touch and hx. of cough x 3 weeks.  Initial rectal temp 94.9'F up to 99.7 2 hours later. PE: WNL except bilteral hyperemic TMs and clear rhinorrhea. DX:  Bilateral otitis Media. URI.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient given smallpox vaccine on 6 Mar 07.  Patient came to emergency room at Medical Center on 16 Mar 07 complaining of left upper arm redness and swelling. Patient was educated on keeping site clean and covered.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Pain in extremity
Clinical narrative: pain left arm progressively getting more sore/more painful, lump at site of injection, pink at injsection site
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Guillain-Barre syndrome, Headache, Paraesthesia
Clinical narrative: Weakness, tingling, requiring hospitalization and IV gammaglobulin , severe headache from gammaglobulin, transfer hospital, Final diagnosis Guiallian Barret syndrome.  04/02/2007 MR received from a 6 day hospital admission for worsening progressive weakening and paresthesias. Seen twice prior on 2/28/07 and 3/1/07, but discharged home. PE WNL except 4/5 motor strength. 1+elbow and wrist reflexes. 2+ankle reflexes. Weakness noted, especially getting out of a chair. Fatigued appearance.  Slightly wide-based gait. Tx'd with IVIG.  Increasing problems with blurry vision, weakness, SOB, and pelvic muscle difficulty during hospitalization. Transfered to another facility for further care.  Awaiting those records. Primary Discharge DX: 1) Paresthesias with weakness.  Probable Guillain-Barre Syndrome.  2) Chest Pain episode believed 2' to gammaglobulin. (-) CAT scan for PE. 3) Visual Blurriness. Secondary Discharge DX:  1)Increased liver tests 2' to gamma globulin, resolved. 2) Increased D-dimer.  3)Increased CRP.  4)Hypoxia.   04/09/2007 MR received from transferring facility for admission 3/8-12/07 for further evaluation of 1 week of paresthesias, headache and vomiting.  IM and Neuro. evals not entirely c/w GBS (no objective weakness and preserved reflexes). However, repeat EMG was c/w GBS.  DX:  Partially treated Guillian Barre Syndrome.  Status migrainosis vs. chemical meningitis induced by IVIG.
Age: 1.08
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV, PNC
Symptoms: Abasia, Abscess, Haematoma, Injection site nodule, Mass
Clinical narrative: 3-13-07 Mother took child to Hospital with complaints of high fever and swollen left thigh.  Diagnosis: Otitis Media Treatment: Amoxicillin, follow up with doctor for swelling to left thigh.  Sonogram pending.  3-20-07 Mother walked in stating child unable to ambulate since immunizations administered 2-27-07. Non-tender nickel size nodule noted to left mid thigh. Mother was provided with spanish education regarding the potential adverse effects from childhood immunizations, including exaggerated localized reaction, and sterile abcess. Patient demonstrated ambulation without any hesitation, guarding, jor limited mobility.Mother was instructed to follow thru with Hospital referral with doctor to evaluate swelling of left thigh. Child evaluated by PA-C. He identified mass Lt thigh post vaccination most likely represents a sterile abcess or hematoma.  She was referred to doctor as recommended initally by Hospital.  Mom also advised that this could resolve on its own.  R.N.
Age: 1.08
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV, PNC
Symptoms: Mobility decreased, Oedema peripheral, Otitis media, Pyrexia, Ultrasound scan
Clinical narrative: 3-13-07 Mother took child to Hospital with complaints of high fever and swollen left thigh.  Diagnosis: Otitis Media Treatment: Amoxicillin, follow up with doctor for swelling to left thigh.  Sonogram pending.  3-20-07 Mother walked in stating child unable to ambulate since immunizations administered 2-27-07. Non-tender nickel size nodule noted to left mid thigh. Mother was provided with spanish education regarding the potential adverse effects from childhood immunizations, including exaggerated localized reaction, and sterile abcess. Patient demonstrated ambulation without any hesitation, guarding, jor limited mobility.Mother was instructed to follow thru with Hospital referral with doctor to evaluate swelling of left thigh. Child evaluated by PA-C. He identified mass Lt thigh post vaccination most likely represents a sterile abcess or hematoma.  She was referred to doctor as recommended initally by Hospital.  Mom also advised that this could resolve on its own.  R.N.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed actual shingles approximately 2 weeks after receiving the vaccine 04/04/07-records received from facility for DOS 11/22-11/23/06 DC DX: chest pain syndrome status post coronary angiography which revealed normal coronary anatomy on 11/22/06-HX of pulmonary embolism 2002. Hyperlipidemia. Depression/anxiety. Chronic urticaria. Asthma. Records do not mention shingles. 04/10/07-records received from PCP-note for DOS 11/29/06-rash on left shoulder reddish evidence of healing vesicles.
Age: 16.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Contusion, Fatigue, Skin discolouration
Clinical narrative: 10Mar07 bruise-like skin discolorations began to appear. She had them on her shoulder, forearm, breast and thigh.  They were not painful.  She had no temperature but was extremely tired.
Age: 40.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Arthralgia, Joint swelling, Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Rash on feet, legs, arms, mid section. Swollen feet, swelling in joints, pain in feet, and joints through out the body.
Age: 40.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Arthralgia, Full blood count abnormal, Rash macular, Rash pruritic, White blood cell count increased
Clinical narrative: Rash on feet, legs, arms, mid section. Swollen feet, swelling in joints, pain in feet, and joints through out the body.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Attention deficit/hyperactivity disorder, Autism spectrum disorder, Coordination abnormal, Crying, Dysgraphia
Clinical narrative: The night that patient received his first round of vaccinations he screamed for 4 hours straight- inconsolable.  I called the emergency room that evening and they told me that if he continued to cry for more than 4 hours to bring him in.  He stopped at 4 hours- exhausted.   During his next round of shots (4 months)his leg became so red and inflamed that we took him to the emergency room. We were told this was a site reaction. Patient is now 7 and is facing a myriad of challenges.  He developed language late and we sought speech therapy to bring that along.  His muscle tone and coordination are low.  He has been diagnosed with ADHD- Inattentive type, dysgraphia, dyslexia and PDD NOS (autistic spectrum).
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Dyslexia, Fatigue, Hypotonia, Injection site erythema, Injection site inflammation
Clinical narrative: The night that patient received his first round of vaccinations he screamed for 4 hours straight- inconsolable.  I called the emergency room that evening and they told me that if he continued to cry for more than 4 hours to bring him in.  He stopped at 4 hours- exhausted.   During his next round of shots (4 months)his leg became so red and inflamed that we took him to the emergency room. We were told this was a site reaction. Patient is now 7 and is facing a myriad of challenges.  He developed language late and we sought speech therapy to bring that along.  His muscle tone and coordination are low.  He has been diagnosed with ADHD- Inattentive type, dysgraphia, dyslexia and PDD NOS (autistic spectrum).
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site reaction, Speech disorder developmental
Clinical narrative: The night that patient received his first round of vaccinations he screamed for 4 hours straight- inconsolable.  I called the emergency room that evening and they told me that if he continued to cry for more than 4 hours to bring him in.  He stopped at 4 hours- exhausted.   During his next round of shots (4 months)his leg became so red and inflamed that we took him to the emergency room. We were told this was a site reaction. Patient is now 7 and is facing a myriad of challenges.  He developed language late and we sought speech therapy to bring that along.  His muscle tone and coordination are low.  He has been diagnosed with ADHD- Inattentive type, dysgraphia, dyslexia and PDD NOS (autistic spectrum).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Woke up in am of 3-20-07 with 8 cm redness and swelling on the left deltoid region.  Also complains of some itching.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Swelling, erythema, induration appearing 48 hours following vaccination.
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site vesicles, Pyrexia
Clinical narrative: Broke out at injection site (left leg) with fluid-filled blisters on 3-15-2007.  low fever.  think it is at injection site of Varicella.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site vesicles, Swelling
Clinical narrative: Immediately after varicella injection given, pt had swelling below the injection site.  Patient was back in our office on 3-5-2007 and had acute localized eruption (blisters) at site of varicella injection.
Age: 16.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Medication error, No adverse effect, Wrong drug administered
Clinical narrative: Pregnant adolescent in need of immunizations required for school entry (Hepatitis B and Td).  Vaccines provided in prenatal clinic without adverse event, but Hep B vaccine was an adult formulation rather than the indicated pediatric version.
Age: 17.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Incorrect dose administered, Pregnancy
Clinical narrative: Pregnant adolescent in need of immunizations required for school entry (Hepatitis B and Td).  Vaccines provided in prenatal clinic without adverse event, but Hep B vaccine was an adult formulation rather than the indicated pediatric version.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pain, Pruritus
Clinical narrative: PAINFUL INDURATION AT ADMINISTRATION SITE. PATIENT ALSO FEELS PRURITUS AND "THROBBING".  INDURATION MEASURES 45 MM X 49 MM
Age: 1.24
Sex: M
Vaccine: DTAP, HBHEPB, MMRV, PNC, DTAP, HBHEPB, MMRV, PNC
Symptoms: Autopsy, Death, Mental status changes
Clinical narrative: Initial report received on 12 March 2007 from another manufacturer, report number WAES0702USA03955. The initial reporter to this manufacturer was a health care professional. Verbatim from the report: "This is in follow-up to report (s) previously submitted on 3/2/2007; 3/88/2007. Information has been received from a physician concerning a 15-month-old male with a history of jaundice at birth, who on 24-Jan-2007 was vaccinated with a 05 ml dose of ProQuad (lot# 656160/1396F, expiration date 16-May-2008). Concomitant vaccinations included: Prevnar (lot# B08639A), Tripedia (lot# C2552AA) and PedvaxHIB (lot# reported as 653660/0257F). Subsequently, on 11-Feb-2007, the patient experienced a mental state change and was hospitalized. The patient underwent a CT scan that was non-conclusive at the time of this report. It was reported that the patient experienced unexpected rapid deterioration and died on 12-Feb-2007. An autopsy was performed, however, results were not yet available. The cause of death was unknown at the time of this report. On 01-Mar-2007, a call was placed to the physician's office to verify the lot number reported for PedvaxHIB. It was confirmed that the vaccine given was "Comvax" with a lot umber reported as 0257F. The patient's adverse experiences were considered to be life-threatening and disabling. Additional information has been requested."
Age: 1.24
Sex: M
Vaccine: DTAP, HBHEPB, MMRV, PNC, DTAP, HBHEPB, MMRV, PNC
Symptoms: Computerised tomogram, Death, General physical health deterioration, Mental status changes
Clinical narrative: Initial report received on 12 March 2007 from another manufacturer, report number WAES0702USA03955. The initial reporter to this manufacturer was a health care professional. Verbatim from the report: "This is in follow-up to report (s) previously submitted on 3/2/2007; 3/88/2007. Information has been received from a physician concerning a 15-month-old male with a history of jaundice at birth, who on 24-Jan-2007 was vaccinated with a 05 ml dose of ProQuad (lot# 656160/1396F, expiration date 16-May-2008). Concomitant vaccinations included: Prevnar (lot# B08639A), Tripedia (lot# C2552AA) and PedvaxHIB (lot# reported as 653660/0257F). Subsequently, on 11-Feb-2007, the patient experienced a mental state change and was hospitalized. The patient underwent a CT scan that was non-conclusive at the time of this report. It was reported that the patient experienced unexpected rapid deterioration and died on 12-Feb-2007. An autopsy was performed, however, results were not yet available. The cause of death was unknown at the time of this report. On 01-Mar-2007, a call was placed to the physician's office to verify the lot number reported for PedvaxHIB. It was confirmed that the vaccine given was "Comvax" with a lot umber reported as 0257F. The patient's adverse experiences were considered to be life-threatening and disabling. Additional information has been requested."
Age: 56.0
Sex: M
Vaccine: HEPAB, TDAP, TYP, YF
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: NAUSEA, VOMITING, DIARRHEA
Age: 1.03
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Crying, Insomnia, Irritability, Pyrexia, Screaming
Clinical narrative: Mother reports child "started screaming and crying" Monday night after shots were administered (Shots were admiministered during AM clinic between 9am and 11am). Mother reports child could only be consoled by holding her "24/7". Mother states child slept poorly Monday and Tuesday night and did have a low grade fever Tuesday. By Friday 3/16, Mother reports child continues with crying during the day but will sleep at night. Mother states no previous reactions to immunizations in the past (this is the first time the child has, however, had the MMRV vaccine). Mother states child is also teething (cutting 3 top teeth) and has a HX of ear infection x2 in the past and does sleep poorly with same per Mom. On 3/16 Mother advised to consider having child assessed by Dr. and report results to local health dept. On Monday 3/19, I did leave a message for Mom to call the LHD. On 3/20, I did call Mom again to check on status of child. Mom states has not yet taken child to doctor, but plans to do so "in the next couple of days". Mom states child's fussiness continues.
Age: 1.03
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Teething
Clinical narrative: Mother reports child "started screaming and crying" Monday night after shots were administered (Shots were admiministered during AM clinic between 9am and 11am). Mother reports child could only be consoled by holding her "24/7". Mother states child slept poorly Monday and Tuesday night and did have a low grade fever Tuesday. By Friday 3/16, Mother reports child continues with crying during the day but will sleep at night. Mother states no previous reactions to immunizations in the past (this is the first time the child has, however, had the MMRV vaccine). Mother states child is also teething (cutting 3 top teeth) and has a HX of ear infection x2 in the past and does sleep poorly with same per Mom. On 3/16 Mother advised to consider having child assessed by Dr. and report results to local health dept. On Monday 3/19, I did leave a message for Mom to call the LHD. On 3/20, I did call Mom again to check on status of child. Mom states has not yet taken child to doctor, but plans to do so "in the next couple of days". Mom states child's fussiness continues.
Age: 0.51
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Body temperature increased, Partial seizures
Clinical narrative: Left sided focal seizure 13 hours after recieving vaccine. Presented to ER with temp of 103.  Total time of seizure was 30 minutes. Pt hospitalized for 3 days. 3/30/07 Received medical records from hospital which reveal patient experienced a left sided focal seizure consisting of focal twitching of left arm & leg w/unresponsiveness. 13 hrs s/p vax w/fever of 103.  Seizure lasted approx 30 min & abated w/ER tx.  Transferred from outlying ER to higher level of care.  Admitted 3/13/07-3/16/07.  Admit exam revealed lethargy & slight gen muscle hypotonia. No further fever or seizure activity & muscle tone improved but remained slightly hypotonic at d/c to home w/follow up arranged w/PCP & ped neuro. FINAL DX: Left sided focal seizure associated w/fever occurring s/p 6 mo immunization series.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster, Varicella, Varicella zoster virus serology positive
Clinical narrative: HERPES ZOSTER IN A PREVIOUSLY VACCINATED CHILD INVOLVING Left T5-7 AND C5 DERMATOMES.  THE RASH STARTED 11/30/06 AND RASH LASTED >8 WEEKS.  CHILD WAS TREATED WITH ACYCLOVIR 1/22/07-1/27/07.  LESION SPECIMENS WERE COLLECTED 1/22/07 AND WERE POSITIVE FOR VZV VACCINE STRAIN.  THE RASH RESOLVED WITHOUT FURTHER COMPLICATION.
Age: 22.0
Sex: F
Vaccine: HPVX, TDAP
Symptoms: Injection site swelling, Oedema peripheral, Pharyngolaryngeal discomfort, Swelling face
Clinical narrative: Localized swelling at injection sites,swelling of hands and feet, swelling of face and posterior pharynx
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Parent called the office on 03/19/07 to report a quarter sized red, warm, hard, painful area at the site of Varivax injection.  Reaction began 03/18 PM, was resolving by the time of the phone call.  She was not seen in the office.  Doctor rec. cool compresses to the site.  He requested that VAERS form be completed.
Age: 4.0
Sex: M
Vaccine: DTAP, HPVX, MMRV, OPV
Symptoms: Cellulitis, Gait disturbance, Inappropriate schedule of drug administration, Injection site induration, Shock
Clinical narrative: Developed a severe cellulitis the day after injection given.  Severe swelling and compromised circulation. Mobility effected - limping. Leg dusky colored unless elevated.  Parent called physician for antibiotics, kept leg elevated (mother is RN).  Leg continues with hard lumps felt at injeciton site.
Age: 4.0
Sex: M
Vaccine: DTAP, HPVX, MMRV, OPV
Symptoms: Skin discolouration, Swelling, Wrong drug administered
Clinical narrative: Developed a severe cellulitis the day after injection given.  Severe swelling and compromised circulation. Mobility effected - limping. Leg dusky colored unless elevated.  Parent called physician for antibiotics, kept leg elevated (mother is RN).  Leg continues with hard lumps felt at injeciton site.
Age: 63.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Anorexia, Erythema, Headache, Hyperaesthesia, Nausea
Clinical narrative: Received pneumo vaccine in right arm and Hep A vaccine in left arm.  Right arm became red, hot, sensitive to touch and swollen, including bicep and tricep area.  Experienced nausea/headache/loss of appetite/chills/fever up to 101F.  Unable to sleep on vaccine site/throat constricted for a few hours. Symptoms lasted at least 36-48 hours.  Today, swelling & redness is receding but still very sore. MA at physican's office advised Tylenol and ice compresses.
Age: 63.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Pyrexia, Skin warm, Swelling, Throat tightness
Clinical narrative: Received pneumo vaccine in right arm and Hep A vaccine in left arm.  Right arm became red, hot, sensitive to touch and swollen, including bicep and tricep area.  Experienced nausea/headache/loss of appetite/chills/fever up to 101F.  Unable to sleep on vaccine site/throat constricted for a few hours. Symptoms lasted at least 36-48 hours.  Today, swelling & redness is receding but still very sore. MA at physican's office advised Tylenol and ice compresses.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Skin lesion
Clinical narrative: Several hundred lesions on face, trunk and extremities for 24 hours.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: none
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Rash vesicular
Clinical narrative: Patient developed fever of 104 and a 10 minute febrile siezure 12 days after receiving MMR and Varivax.  She also had a mild Varicella rash at that time.  I saw her the day after symptoms began.  She had fever over the next 24 hours but did not have further siezures.  She was fully recovered by 48 hours after onset and only had a resolving Varicella rash at that time.
Age: 9.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Nausea, Pallor, Vomiting
Clinical narrative: Approximately 5 minutes after administration my child complained of nausea and dizziness, she appeared pale.  About 10 min later she vomitted.  About 15 min after administration she felt ok.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Swelling, Tenderness
Clinical narrative: Swelling, Erythema, tenderness and induration appearing 24 hours after the booster varicella vaccine.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Bone pain, Chills, Hypoaesthesia, Neurological examination normal
Clinical narrative: Initial report received on 17 January 2007 from the patient. A female patient (date of birth not reported), who has no concurrent illnesses or pre existing medical conditions, but who had tested positive for egg allergy (date of testing not reported), had received a right arm dose of Fluzone on 08 November 2006. The lot number, route and site of administration was not reported. Three days post-immunization, the patient had chills, numbness, tingling, and shooting pain in her arms that spread to all four extremities over the next month. At an unspecified amount of time later, the patient was evaluated by two neurologists at a hospital (contact information for the hospital was provided) and all tests were normal. Diagnostic testing included a Brain scan, and "ANA" test that were normal. The patient had not received any other vaccinations within four weeks of the vaccination on 08 November 2006. At the time of this report, the patient had not recovered. Follow-up information received on 20 February 2007. There was no additional information . Follow up information received on 15 March 2007 from the patient. The patient reported that she still had "sharp pains in my bones" and the numbness has continued now for four months. treatments received and diagnostic testings performed were not reported. Due to this new information, the seriousness of this case has been upgraded to serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Initial report received on 17 January 2007 from the patient. A female patient (date of birth not reported), who has no concurrent illnesses or pre existing medical conditions, but who had tested positive for egg allergy (date of testing not reported), had received a right arm dose of Fluzone on 08 November 2006. The lot number, route and site of administration was not reported. Three days post-immunization, the patient had chills, numbness, tingling, and shooting pain in her arms that spread to all four extremities over the next month. At an unspecified amount of time later, the patient was evaluated by two neurologists at a hospital (contact information for the hospital was provided) and all tests were normal. Diagnostic testing included a Brain scan, and "ANA" test that were normal. The patient had not received any other vaccinations within four weeks of the vaccination on 08 November 2006. At the time of this report, the patient had not recovered. Follow-up information received on 20 February 2007. There was no additional information . Follow up information received on 15 March 2007 from the patient. The patient reported that she still had "sharp pains in my bones" and the numbness has continued now for four months. treatments received and diagnostic testings performed were not reported. Due to this new information, the seriousness of this case has been upgraded to serious.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Henoch-Schonlein purpura
Clinical narrative: This case was reported by a physician and described the occurrence of Henoch-Schonlein purpura in a 14-year-old female subject who was vaccinated with Boostrix for prophylaxis. Concurrent vaccination included Menactra given on 06 March 2007. On 6 March 2007 the subject received 1st dose of Boostrix at 0.5ml, intramuscularly, in the right arm. On 14 March 2007, 8 days after vaccination with Boostrix, the subject experienced Henoch-Schonlein purpura all over her body. At the time of reporting the event was improved. The physician considered the event was probably related to vaccination with Boostrix.