chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: U
Vaccine: DTAP
Symptoms: Medication error, Wrong drug administered
Clinical narrative: The pharmacy technician pulled the wrong product (Infanrix, DTaP) from the refrigerator to restock the pediatric emergency room refrigerators with Adacel (Tdap).  Pharmacy carries Adacel for Pediatric ED and Pediatric Inpatient.  Pharmacy carries Infanrix only for the off-site practices the hospital stock meds for.  Once discovered by nursing when requesting restock, 3 weeks had passed.  Eight patients were potentially affected.  Upon review of the charts, only one patient actually got the DTaP instead of Tdap.  The patient's parents were notified, no adverse outcome to the patient.  The physicians were writing for the drug as Tdap, DTaP and Td, the medication is not listed in the pharmacy profile or the automated dispensing machines with these designations.  We also noted that Adult physicians were still writing for Tetanus-Diphtheria (TD) for adolescent and not following the updated 2006 CDC guidelines for adolescent patients 11-18 to receive Adacel (Tdap).  Additionally during chart review, we found that the documentation was not consistently in the same place or done completely (drug name, site administered, lot number, expiration date).  And the vaccine information sheets were not routinely given to the patient.  Tdap and DTaP are currently not allowed abbreviation and the policy was bypassed.  Pharmacy segregated the two product in the pharmacy refrigerator.  Pharmacy changed the designation of the products to be consistent with the labeling on the packaging.  Pharmacy requested ED physicians to write ADACEL instead of Tdap; ED evaluating a trigger on the physician order sheet with Adacel preprinted.  Pharmacy to implement bar-coding of the automated dispensing cabinet to reduce stocking errors.  Documentation of the vaccination to be consistent and placed on the Content for immunization form with triggers for the required information and directions to provide the vaccination information sheet to be universal for the hospital and related sites.  The use of Adacel for all patients (11-64) is being evaluated by the ED leadership.  Vaccines are not emergent medications and are being evaluated pharmacy review instead of the override status the vaccines are currently in.  Education to be provided to all staff regarding the updated CDC recommendations the writing the brand name of the medication in the order.  Medication Order writing policy to be enforced regarding the abbreviations.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Pyrexia
Clinical narrative: Fever, cutaneous hypersensitivity
Age: 1.0
Sex: M
Vaccine: HEP, MMR, PNC
Symptoms: Pyrexia
Clinical narrative: Fever MMR reaction.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Severe headache, 36 hours after shot.  Body aches 36 hours after shot.  Flu-like symptoms 36 hours after shot.  Redness, swelling in area of shot.  Serpiginous red line originating from vaccine site.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain
Clinical narrative: Severe headache, 36 hours after shot.  Body aches 36 hours after shot.  Flu-like symptoms 36 hours after shot.  Redness, swelling in area of shot.  Serpiginous red line originating from vaccine site.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Headache, Influenza like illness, Injection site streaking
Clinical narrative: Severe headache, 36 hours after shot.  Body aches 36 hours after shot.  Flu-like symptoms 36 hours after shot.  Redness, swelling in area of shot.  Serpiginous red line originating from vaccine site.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: Severe headache, 36 hours after shot.  Body aches 36 hours after shot.  Flu-like symptoms 36 hours after shot.  Redness, swelling in area of shot.  Serpiginous red line originating from vaccine site.
Age: 72.0
Sex: M
Vaccine: TD
Symptoms: Hemiparesis
Clinical narrative: 1/25/08 Pt reports since getting Tetanus shot in left arm, shoulder has been weak. On exam he has full ROM of the shoulder, but abduction is slightly decreased. No tenderness. Improving.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood pressure normal, Erythema, Nausea, Pruritus, Swelling face
Clinical narrative: Within 15 minutes of receiving Varivax, developed nausea & extreme pruritus of feet, then entire body.  P facial swelling (redness), no airway compromise or SOB.  P mild wheeze, 10x94.  Received Benadryl, Orapred & Epinephrin 0.15 mg IM.  Normal BP's.  Sent to ER after Epi given for observation.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Wheezing
Clinical narrative: Within 15 minutes of receiving Varivax, developed nausea & extreme pruritus of feet, then entire body.  P facial swelling (redness), no airway compromise or SOB.  P mild wheeze, 10x94.  Received Benadryl, Orapred & Epinephrin 0.15 mg IM.  Normal BP's.  Sent to ER after Epi given for observation.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR
Symptoms: Febrile convulsion, Speech disorder developmental
Clinical narrative: Fever induced seizure, speech development appears to have stalled since seizure.
Age: 52.0
Sex: F
Vaccine: TYP
Symptoms: Anaphylactic reaction, Dyspnoea, Paraesthesia
Clinical narrative: Twenty minutes after taking Vivotif, developed facial tingling followed within 5 minutes by shortness of breath (difficulty breathing), anaphylatic event.  Husband is a physician and he treated the problem without hospitalization.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyskinesia, Electroencephalogram normal, Excessive eye blinking, Neurological examination, Tic
Clinical narrative: It began is eye blinking, then turned to facial tics, and now includes the whole head jerking and shoulders moving.  There were NO prior signs of ANY prior tics in my child.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itching around injection site within 5 minutes of administration. Did not progress over next 15 minutes. Patient took 1 dose of Benadryl and reported being "fine" at call at 6pm 1-26-08
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Injection site swelling
Clinical narrative: Large, painful swelling at vaccine site 10 x 13 cm over 3 days with joint pain on L arm & shoulder x >3 days.  Given Benadryl & local ice.
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: CSF culture, Full blood count, Haematocrit decreased, Haemoglobin decreased, Mean cell volume decreased
Clinical narrative: Fever, poor feeding x1, hospitalization and sepsis work up. 01/28/2008 Hib Lot # confirmed 0820U. 02/01/2008 MR received from CDC for DOS 1/27-29/2008 with D/C DX:  Fever post-immunization. Infant presented to ER with fever, decresed activity, and decreased po intake. PE WNL except temp 101.3'F. Pt had received recalled Pedvax HIB vaccine. Admitted for sepsis w/u. Txd with abx. Afebrile remainder of hospital stay. Per 60 day follow up: Patient most likely had an incidental viral infection at the time of vaccination.
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Fever, poor feeding x1, hospitalization and sepsis work up. 01/28/2008 Hib Lot # confirmed 0820U. 02/01/2008 MR received from CDC for DOS 1/27-29/2008 with D/C DX:  Fever post-immunization. Infant presented to ER with fever, decresed activity, and decreased po intake. PE WNL except temp 101.3'F. Pt had received recalled Pedvax HIB vaccine. Admitted for sepsis w/u. Txd with abx. Afebrile remainder of hospital stay. Per 60 day follow up: Patient most likely had an incidental viral infection at the time of vaccination.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea, Vomiting, Arm pain, Headache x 1 day.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blood pressure increased, Dizziness, Heart rate increased, Tremor
Clinical narrative: Increased blood pressure, increased pulse rate, shakiness, dizziness, feeling of uneasiness for about 20 minutes.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PPV
Symptoms: Convulsion, Pyrexia, Rash
Clinical narrative: My daughter had the MMR Vaccine Mon Jan 14, 2008.  On Wed Jan 16, 2008 she broke out in a rash.  I spoke to the dr on call at medical center and she said it was probably nothing.  On Wed Jan 23, 2008 my daughter was rushed to the hospital due to seizure and high fever.  She had a second seizure at the hospital.  It falls right in the timeline of the risks of the MMR shot.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain, Alcohol problem, Amnesia, Arthralgia, Asthma
Clinical narrative: Got flu shot Nov. 1991. I've been 100 disabled ever since. Atty filled out papers for reporting system years ago! We've heard nothing. The doctors was suppose to fill this out when it happened. 1/19/2009 Multiple chemical sensitivity syndrome (I just found out I have this and probably had it then) reaction to vaccines, sun, alcohol, estrogen, caffeine, recourant yeast infections, reactions to sulfa drugs certain antibiotics, asthma illness and difficulty breathing, insoomnia, concentration, delerium, some paranoia, memory loss, migraines, nausea, abdominal pain, chronic fatigue syndrome, aching joints, muscles, irritating eyes, nose, ears, throat, skin, impaired balance, increased sensitivites to odors and loud noises bright lights, touch, fibromyalgia, heat and cold, liver has trouble getting rid of toxins.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Balance disorder, Chronic fatigue syndrome, Delirium, Disability, Disturbance in attention
Clinical narrative: Got flu shot Nov. 1991. I've been 100 disabled ever since. Atty filled out papers for reporting system years ago! We've heard nothing. The doctors was suppose to fill this out when it happened. 1/19/2009 Multiple chemical sensitivity syndrome (I just found out I have this and probably had it then) reaction to vaccines, sun, alcohol, estrogen, caffeine, recourant yeast infections, reactions to sulfa drugs certain antibiotics, asthma illness and difficulty breathing, insoomnia, concentration, delerium, some paranoia, memory loss, migraines, nausea, abdominal pain, chronic fatigue syndrome, aching joints, muscles, irritating eyes, nose, ears, throat, skin, impaired balance, increased sensitivites to odors and loud noises bright lights, touch, fibromyalgia, heat and cold, liver has trouble getting rid of toxins.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Drug hypersensitivity, Dyspnoea, Eye irritation, Feeling of body temperature change, Fibromyalgia
Clinical narrative: Got flu shot Nov. 1991. I've been 100 disabled ever since. Atty filled out papers for reporting system years ago! We've heard nothing. The doctors was suppose to fill this out when it happened. 1/19/2009 Multiple chemical sensitivity syndrome (I just found out I have this and probably had it then) reaction to vaccines, sun, alcohol, estrogen, caffeine, recourant yeast infections, reactions to sulfa drugs certain antibiotics, asthma illness and difficulty breathing, insoomnia, concentration, delerium, some paranoia, memory loss, migraines, nausea, abdominal pain, chronic fatigue syndrome, aching joints, muscles, irritating eyes, nose, ears, throat, skin, impaired balance, increased sensitivites to odors and loud noises bright lights, touch, fibromyalgia, heat and cold, liver has trouble getting rid of toxins.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fungal infection, Insomnia, Liver disorder, Migraine, Multiple chemical sensitivity
Clinical narrative: Got flu shot Nov. 1991. I've been 100 disabled ever since. Atty filled out papers for reporting system years ago! We've heard nothing. The doctors was suppose to fill this out when it happened. 1/19/2009 Multiple chemical sensitivity syndrome (I just found out I have this and probably had it then) reaction to vaccines, sun, alcohol, estrogen, caffeine, recourant yeast infections, reactions to sulfa drugs certain antibiotics, asthma illness and difficulty breathing, insoomnia, concentration, delerium, some paranoia, memory loss, migraines, nausea, abdominal pain, chronic fatigue syndrome, aching joints, muscles, irritating eyes, nose, ears, throat, skin, impaired balance, increased sensitivites to odors and loud noises bright lights, touch, fibromyalgia, heat and cold, liver has trouble getting rid of toxins.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Myalgia, Nausea, Paranoia, Photosensitivity reaction, Skin irritation
Clinical narrative: Got flu shot Nov. 1991. I've been 100 disabled ever since. Atty filled out papers for reporting system years ago! We've heard nothing. The doctors was suppose to fill this out when it happened. 1/19/2009 Multiple chemical sensitivity syndrome (I just found out I have this and probably had it then) reaction to vaccines, sun, alcohol, estrogen, caffeine, recourant yeast infections, reactions to sulfa drugs certain antibiotics, asthma illness and difficulty breathing, insoomnia, concentration, delerium, some paranoia, memory loss, migraines, nausea, abdominal pain, chronic fatigue syndrome, aching joints, muscles, irritating eyes, nose, ears, throat, skin, impaired balance, increased sensitivites to odors and loud noises bright lights, touch, fibromyalgia, heat and cold, liver has trouble getting rid of toxins.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Throat irritation
Clinical narrative: Got flu shot Nov. 1991. I've been 100 disabled ever since. Atty filled out papers for reporting system years ago! We've heard nothing. The doctors was suppose to fill this out when it happened. 1/19/2009 Multiple chemical sensitivity syndrome (I just found out I have this and probably had it then) reaction to vaccines, sun, alcohol, estrogen, caffeine, recourant yeast infections, reactions to sulfa drugs certain antibiotics, asthma illness and difficulty breathing, insoomnia, concentration, delerium, some paranoia, memory loss, migraines, nausea, abdominal pain, chronic fatigue syndrome, aching joints, muscles, irritating eyes, nose, ears, throat, skin, impaired balance, increased sensitivites to odors and loud noises bright lights, touch, fibromyalgia, heat and cold, liver has trouble getting rid of toxins.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Activities of daily living impaired
Clinical narrative: Got flu shot Nov. 1991. I've been 100 disabled ever since. Atty filled out papers for reporting system years ago! We've heard nothing. The doctors was suppose to fill this out when it happened. 1/19/2009 Multiple chemical sensitivity syndrome (I just found out I have this and probably had it then) reaction to vaccines, sun, alcohol, estrogen, caffeine, recourant yeast infections, reactions to sulfa drugs certain antibiotics, asthma illness and difficulty breathing, insoomnia, concentration, delerium, some paranoia, memory loss, migraines, nausea, abdominal pain, chronic fatigue syndrome, aching joints, muscles, irritating eyes, nose, ears, throat, skin, impaired balance, increased sensitivites to odors and loud noises bright lights, touch, fibromyalgia, heat and cold, liver has trouble getting rid of toxins.
Age: 62.0
Sex: M
Vaccine: HEPA, IPV, TDAP, TYP, YF
Symptoms: Arteriosclerosis, Death, Myocardial infarction, Pain in extremity
Clinical narrative: A 62-year-old male patient, with a history of hyperlipidemia, had received an intramuscular injection of Adacel, lot number not reported; an intramuscular injection of IPOL, lot number not reported; a subcutaneous injection of YF-VAX, lot number not reported; an intramuscular injection of Typhim VI, lot number not reported; and an intramuscular injection of Havrix, lot number not reported; on 17 November 2006. Ten days post-immunization, the patient was found dead in his home as a result of myocardial infarction due to artherosclerotic disease. The patient's son had reported that the patient had been feeling fine, "only had a sore arm after shots." An autopsy was not performed.
Age: 21.0
Sex: M
Vaccine: HEPA, IPV, TD, TYP, YF
Symptoms: Blood test normal, Blood urine present, Chest X-ray, Cystoscopy normal, Full blood count normal
Clinical narrative: Initial report received from a nurse on 08 June 2007.  A 21 year old, male patient (with a medical history of no known allergies) developed blood in the urine and burning with urination after he received IPOL (lot number Z0547-2) intramuscularly in the right arm,  Typhim VI (lot number Z0443-2) intramuscularly in the left arm, YF-VAX (lot number UE945AA) intramuscularly in the left arm, TD vaccine (Massachusetts Biologics Labs, lot number TD151) intramuscularly in the left arm and Havrix (GSK, lot number AHAB115CA) intramuscularly in the right arm, on 20 March 2007.  He went to his local MD (name not available to reporter) and had "tests" done.  The reporter was not sure of the date of the onset of the symptoms, information of the treating physician or tests done.  The patient did not have any illness at the time of the vaccinations.  At the time of the report, the patient's recovery status was unknown.  Follow-up information received on 02 July 2007.  The patient received IPOL subcutaneously.  The onset of the symptoms was 08 May 2007.  He did not have burning with urination.  At the time of the vaccinations, he was not on any medications.  He had a cystoscope, MRI, bladder and kidney X-rays, CBC and other blood work - all were within normal limits.  It was reported that his symptoms have subsided, he had no further problems and he recovered.
Age: 21.0
Sex: M
Vaccine: HEPA, IPV, TD, TYP, YF
Symptoms: Nuclear magnetic resonance imaging normal, Urinary system X-ray
Clinical narrative: Initial report received from a nurse on 08 June 2007.  A 21 year old, male patient (with a medical history of no known allergies) developed blood in the urine and burning with urination after he received IPOL (lot number Z0547-2) intramuscularly in the right arm,  Typhim VI (lot number Z0443-2) intramuscularly in the left arm, YF-VAX (lot number UE945AA) intramuscularly in the left arm, TD vaccine (Massachusetts Biologics Labs, lot number TD151) intramuscularly in the left arm and Havrix (GSK, lot number AHAB115CA) intramuscularly in the right arm, on 20 March 2007.  He went to his local MD (name not available to reporter) and had "tests" done.  The reporter was not sure of the date of the onset of the symptoms, information of the treating physician or tests done.  The patient did not have any illness at the time of the vaccinations.  At the time of the report, the patient's recovery status was unknown.  Follow-up information received on 02 July 2007.  The patient received IPOL subcutaneously.  The onset of the symptoms was 08 May 2007.  He did not have burning with urination.  At the time of the vaccinations, he was not on any medications.  He had a cystoscope, MRI, bladder and kidney X-rays, CBC and other blood work - all were within normal limits.  It was reported that his symptoms have subsided, he had no further problems and he recovered.
Age: 41.0
Sex: M
Vaccine: DT, FLU3, HEPA, IPV, MEN, TYP
Symptoms: Dark circles under eyes, Eye swelling, Skin wrinkling
Clinical narrative: Initial report received on 15 August 2007 from a health care provider.  A 41-year-old male patient had received an injection of Decavac, lot number not reported; an injection of IPOL, lot number not reported; an injection of Menomune, lot number not reported; an injection of Typhim VI, lot number not reported; an injection of Fluzone SV 2006-2007, lot number not reported; and an injection of Havrix, manufacturer GSK, lot number not reported; on 20 December 2006.  Routes and sites of administration were not reported.  The patient had received the vaccinations for travel out of the country where he visited for two weeks.  Illness at the time of vaccination was unknown.  "Almost immediately" post-vaccination, the patient complained of dark circles under his eyes, bags under his eyes, and a permanent tired line in his face.  Per a letter from the patient dated 13 August 2007, "These side effects have not improved or diminished to date."  At the time of this report, the patient had not recovered.  A new version was created for this case on 31 August 2007 to add that the reporter for this case is the same as for case 2007-03017.  No relevant medically significant information was added.  Follow-up information was received from the health professional on 24 September 2007.  Decavac (lot number U1880DA) was given in the left deltoid; Fluzone (lot number A203BA) was given in the left deltoid; IPOL (lot number Z0306) was given subcutaneously in the right arm; Menomune (lot number UE766AA) was given subcutaneously in the left arm; Typhim (lot number Z0572) was given in the right deltoid; and Havrix (GSK, lot number AHAVB109CB) was given in the right deltoid.  The patient's date of birth was provided as 28 May 1965.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA, VARCEL
Symptoms: Discomfort, Injection site urticaria, Pain, Skin warm, Swelling
Clinical narrative: Very swollen, red, warm to touch, very tender, size 2 inches in left thigh injection site.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Very swollen, red, warm to touch, very tender, size 2 inches in left thigh injection site.
Age: 1.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Basophil count normal, Convulsion, Eosinophil count normal, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Office visit 1/4/08 patient was diagnosed with ITP.  Mom read side effects of MMR could be ITP.
Age: 1.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Lymphocyte count decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count decreased
Clinical narrative: Office visit 1/4/08 patient was diagnosed with ITP.  Mom read side effects of MMR could be ITP.
Age: 1.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Neutrophil count, Platelet count decreased, Polymerase chain reaction, Pyrexia, Red blood cell count decreased
Clinical narrative: Office visit 1/4/08 patient was diagnosed with ITP.  Mom read side effects of MMR could be ITP.
Age: 1.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Red blood cell microcytes, Red cell distribution width increased, White blood cell count normal
Clinical narrative: Office visit 1/4/08 patient was diagnosed with ITP.  Mom read side effects of MMR could be ITP.
Age: 1.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: Office visit 1/4/08 patient was diagnosed with ITP.  Mom read side effects of MMR could be ITP.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old patient who was vaccinated po with a first dose of Rotateq. Subsequently the patient developed rotavirus and was admitted to the hospital. The patient was still in the hospital and it was unknown for how long . Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune hepatitis, Biopsy liver, Hepatic enzyme increased, Hepatic function abnormal, Liver function test abnormal
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot# unknown). On an unspecified date the patient developed an autoimmune hepatitis. Medical attention was sought. No further information is available. The outcome was not reported. Follow-up information was received. The patient was vaccinated with a first, second and third dose of Gardasil (lot # 657622/0388U, 658094/0524U and 658282/1263U) IM respectively. In August 2007 the patient was seen with a rash on the upper arms and chest. The patient also had elevated liver enzymes. The liver "bx was c/w" autoimmune hepatitis. The reporter felt that autoimmune hepatitis was related to Gardasil. At the time of reporting the patient had not recovered. Additional information is not expected.  02/05/2008 MR received from reporter/vax provider.  Pt reported fatigue following 1st Gardasil.  Several weeks after #2 pt reported rash on upper arm and chest as well as LFTs elevated c/w autoimmune hepatitis.  Txd with steroids.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot# unknown). On an unspecified date the patient developed an autoimmune hepatitis. Medical attention was sought. No further information is available. The outcome was not reported. Follow-up information was received. The patient was vaccinated with a first, second and third dose of Gardasil (lot # 657622/0388U, 658094/0524U and 658282/1263U) IM respectively. In August 2007 the patient was seen with a rash on the upper arms and chest. The patient also had elevated liver enzymes. The liver "bx was c/w" autoimmune hepatitis. The reporter felt that autoimmune hepatitis was related to Gardasil. At the time of reporting the patient had not recovered. Additional information is not expected.  02/05/2008 MR received from reporter/vax provider.  Pt reported fatigue following 1st Gardasil.  Several weeks after #2 pt reported rash on upper arm and chest as well as LFTs elevated c/w autoimmune hepatitis.  Txd with steroids.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 17 year old female with no medical history, and no drug reactions/allergies, who on 20-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot#655154/1210U). There was no concomitant medications. Subsequently, the patient was determined to be pregnant. No adverse experience was related to this event. A urine pregnancy test was positive. The patients last menstrual period was 9-Nov-2007 and her estimated delivery date was 15-AUG-2007. The patient's mother contacted the office by phone. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow-up information indicated that the patient had an elective termination on an unspecified date. It was reported that the termination was not due to exposure to the vaccine. It was reported to be unknown if the products of conception were examined. Upon internal review elective termination was considered to be an other important medical event. Additional information is not expected.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Amnesia, Apnoea, Blood test, Bradyphrenia, Headache
Clinical narrative: Stopped breathing while asleep - 2 sep. occasions. Numbness in hands/arms, feet/lets scalp - random other places. Blurred vision occas., extreme headaches, reduced thought processes, short term memory loss. Motor skills decreased.  3/7/08 Reviewed PCP medical records of 11/6/2007-1/14/2008 which reveal patient experienced numbness & tingling of arms & legs x 2 weeks prior to 11/6 visit with trouble sleeping.  Also had fatigue, joint stiffness, muscle pain & muscle weakness. Referred to neuro for NCS.   PCP FINAL DX: suspect Guillian Barre syndrome resulting from immunization but difficult to prove. NEURO FINAL DX: possible post immune encephalopathy w/underlying neuropathy in patient w/(+) West Nile titers all occuring approx 1 wk s/p hepatitis & sleep deprivation seconday to meds.  Seen by neuro 11/8/2007 & NCS revealed mod to severe bilat CTS, worse on right.  Returned to PCP on 11/14 anxious w/same complaints. Referred for labs & MRI, all WNL.  Referred to 2nd neuro & seen on 11/26.  EMG/NCS at that visit revealed evidence of an underlying ensory motor polyneuropathy, demyelinative greater than axonal in nature.  Referred for additional lab studies for West Nile & spinal MRI.  Returned to PCP 12/4/07 for labs & 12/10 for med changes & LP.  Returned to PCP 12/17 w/right side weakness, forgetful, impaired memory & concentration, back & muscle pain, numbness of hands, insomnia, anxiety/depression.  Referred to neuro for neuro-psych testing.  Seen by neuro 12/20 for underlying encephalopathy.  Neuropathy of feet improved but still having intermittent confusion.  Referred for neuro-psych testing & additional MRI scans.  Returned to PCP 1/14/2008 very frustrated as no improvement & unable to perform work duties.  Referred to Clinic.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Hypokinesia, Lumbar puncture, Nuclear magnetic resonance imaging, Urine analysis
Clinical narrative: Stopped breathing while asleep - 2 sep. occasions. Numbness in hands/arms, feet/lets scalp - random other places. Blurred vision occas., extreme headaches, reduced thought processes, short term memory loss. Motor skills decreased.  3/7/08 Reviewed PCP medical records of 11/6/2007-1/14/2008 which reveal patient experienced numbness & tingling of arms & legs x 2 weeks prior to 11/6 visit with trouble sleeping.  Also had fatigue, joint stiffness, muscle pain & muscle weakness. Referred to neuro for NCS.   PCP FINAL DX: suspect Guillian Barre syndrome resulting from immunization but difficult to prove. NEURO FINAL DX: possible post immune encephalopathy w/underlying neuropathy in patient w/(+) West Nile titers all occuring approx 1 wk s/p hepatitis & sleep deprivation seconday to meds.  Seen by neuro 11/8/2007 & NCS revealed mod to severe bilat CTS, worse on right.  Returned to PCP on 11/14 anxious w/same complaints. Referred for labs & MRI, all WNL.  Referred to 2nd neuro & seen on 11/26.  EMG/NCS at that visit revealed evidence of an underlying ensory motor polyneuropathy, demyelinative greater than axonal in nature.  Referred for additional lab studies for West Nile & spinal MRI.  Returned to PCP 12/4/07 for labs & 12/10 for med changes & LP.  Returned to PCP 12/17 w/right side weakness, forgetful, impaired memory & concentration, back & muscle pain, numbness of hands, insomnia, anxiety/depression.  Referred to neuro for neuro-psych testing.  Seen by neuro 12/20 for underlying encephalopathy.  Neuropathy of feet improved but still having intermittent confusion.  Referred for neuro-psych testing & additional MRI scans.  Returned to PCP 1/14/2008 very frustrated as no improvement & unable to perform work duties.  Referred to Clinic.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: Stopped breathing while asleep - 2 sep. occasions. Numbness in hands/arms, feet/lets scalp - random other places. Blurred vision occas., extreme headaches, reduced thought processes, short term memory loss. Motor skills decreased.  3/7/08 Reviewed PCP medical records of 11/6/2007-1/14/2008 which reveal patient experienced numbness & tingling of arms & legs x 2 weeks prior to 11/6 visit with trouble sleeping.  Also had fatigue, joint stiffness, muscle pain & muscle weakness. Referred to neuro for NCS.   PCP FINAL DX: suspect Guillian Barre syndrome resulting from immunization but difficult to prove. NEURO FINAL DX: possible post immune encephalopathy w/underlying neuropathy in patient w/(+) West Nile titers all occuring approx 1 wk s/p hepatitis & sleep deprivation seconday to meds.  Seen by neuro 11/8/2007 & NCS revealed mod to severe bilat CTS, worse on right.  Returned to PCP on 11/14 anxious w/same complaints. Referred for labs & MRI, all WNL.  Referred to 2nd neuro & seen on 11/26.  EMG/NCS at that visit revealed evidence of an underlying ensory motor polyneuropathy, demyelinative greater than axonal in nature.  Referred for additional lab studies for West Nile & spinal MRI.  Returned to PCP 12/4/07 for labs & 12/10 for med changes & LP.  Returned to PCP 12/17 w/right side weakness, forgetful, impaired memory & concentration, back & muscle pain, numbness of hands, insomnia, anxiety/depression.  Referred to neuro for neuro-psych testing.  Seen by neuro 12/20 for underlying encephalopathy.  Neuropathy of feet improved but still having intermittent confusion.  Referred for neuro-psych testing & additional MRI scans.  Returned to PCP 1/14/2008 very frustrated as no improvement & unable to perform work duties.  Referred to Clinic.
Age: 2.0
Sex: F
Vaccine: OPV, IPV
Symptoms: Back pain, Body temperature increased, Fatigue, Muscle contractions involuntary, Muscular weakness
Clinical narrative: After first administration of vaccine had high fever. Second vaccine caused full blown poliomyelitis, effected from waist down with contractions of legs rt and left with therapy recovered till reoccurrence of post polio syndrome in 2006 - with extreme fatigue - severe back and neck pain, muscle weakness. Unknown what future holds now. 2/12/08-records received-for multiple dates of service 8/30/26-5/1/07-with C/O back and leg pain and liver hemangioma.
Age: 2.0
Sex: F
Vaccine: OPV, IPV
Symptoms: Neck pain, Poliomyelitis, Post polio syndrome, Pyrexia
Clinical narrative: After first administration of vaccine had high fever. Second vaccine caused full blown poliomyelitis, effected from waist down with contractions of legs rt and left with therapy recovered till reoccurrence of post polio syndrome in 2006 - with extreme fatigue - severe back and neck pain, muscle weakness. Unknown what future holds now. 2/12/08-records received-for multiple dates of service 8/30/26-5/1/07-with C/O back and leg pain and liver hemangioma.
Age: 2.0
Sex: F
Vaccine: OPV, IPV
Symptoms: Post polio syndrome, Pyrexia, Tooth loss
Clinical narrative: After first administration of vaccine had high fever. Second vaccine caused full blown poliomyelitis, effected from waist down with contractions of legs rt and left with therapy recovered till reoccurrence of post polio syndrome in 2006 - with extreme fatigue - severe back and neck pain, muscle weakness. Unknown what future holds now. 2/12/08-records received-for multiple dates of service 8/30/26-5/1/07-with C/O back and leg pain and liver hemangioma.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Immediate post-injection reaction, Lethargy, Pallor
Clinical narrative: Approximately 5 minutes after receiving vaccines became pale and lethargic after crying.  4/8/08 Reviewed hospital birth medical records of 9/23-10/27/2007.  4/15/08 Reviewed vax record which corrects date of vax to 1/22/2008, lot #s correct as reported.  Office note of 1/22 revealed patient experienced severe crying immediately after vax & then pale w/vasovagal response.  Sent to hospital for overnight observation & patient recovered well.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Haematochezia, Intussusception, Surgery
Clinical narrative: Child received immunizations 1/11/08. Went to ER on 1/12/08 - bloody stools - diagnosed with intussusception (surgical reduction required).  01/31/2008 MR received from CDC including vax record confirming vax as reported and hospital records from DOS 1/12-15/2008 with DX: Ileocolic Intussusception. Infant presented to ER with progressive nausea, vomiting and bloody diarrhea.  PO intake decreased. Surgical consult PE (+) for lethargy,  abdominal tenderness and a RUQ density on deep palpation. IS was not reducible by BE so pt had surgical reduction of IS and appendectomy.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Diabetes mellitus, Dysstasia, Guillain-Barre syndrome, Hepatic lesion, Lumbar puncture
Clinical narrative: Great pain in both legs moving upward, difficulty getting up and down out of chair, bed, etc.  02/12/2008 MR received for DOS 11/29-12/03/2007 with Final DX:  Guillain-Barre Syndrome 2' to influenza vaccination.  HTN. DM. Stable 4 mm noncalcified LLL nodule per CT abd/pelvis.  Stable hepatic lesions c/w proteinaceous cyst. Pt presented to MD with pain in legs, weakness and inability to get out of a chair w/o using arms and ambulation. Pain noted in upper limb girdle/shoulder.  PE (+) for 1+ DTRs with normal strength noted. Txd with IVIG. x 5 days with good response. 2/15/2008 Pt improved to date, but not 100%. Follow-up Information 09-MAY-2008: I have not regained the total use of my legs that I had before the flu shot. I still have great difficulty getting up and down from a chair. I cannot drive long distances. My shoulders are in pain from the effort it takes to get my legs up from a seated position. There has not been one day free of pain or any way normal since that horrible shot. The only good thing is that I voluntarily did it; I would hate someone if I had been forced to have had it. It has been six months, I am now trying accupuncture and deep massage. I am thousands of dollars in debt from this.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Mobility decreased, Pain in extremity, Transfusion
Clinical narrative: Great pain in both legs moving upward, difficulty getting up and down out of chair, bed, etc.  02/12/2008 MR received for DOS 11/29-12/03/2007 with Final DX:  Guillain-Barre Syndrome 2' to influenza vaccination.  HTN. DM. Stable 4 mm noncalcified LLL nodule per CT abd/pelvis.  Stable hepatic lesions c/w proteinaceous cyst. Pt presented to MD with pain in legs, weakness and inability to get out of a chair w/o using arms and ambulation. Pain noted in upper limb girdle/shoulder.  PE (+) for 1+ DTRs with normal strength noted. Txd with IVIG. x 5 days with good response. 2/15/2008 Pt improved to date, but not 100%. Follow-up Information 09-MAY-2008: I have not regained the total use of my legs that I had before the flu shot. I still have great difficulty getting up and down from a chair. I cannot drive long distances. My shoulders are in pain from the effort it takes to get my legs up from a seated position. There has not been one day free of pain or any way normal since that horrible shot. The only good thing is that I voluntarily did it; I would hate someone if I had been forced to have had it. It has been six months, I am now trying accupuncture and deep massage. I am thousands of dollars in debt from this.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Asthenia, Blood product transfusion, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Great pain in both legs moving upward, difficulty getting up and down out of chair, bed, etc.  02/12/2008 MR received for DOS 11/29-12/03/2007 with Final DX:  Guillain-Barre Syndrome 2' to influenza vaccination.  HTN. DM. Stable 4 mm noncalcified LLL nodule per CT abd/pelvis.  Stable hepatic lesions c/w proteinaceous cyst. Pt presented to MD with pain in legs, weakness and inability to get out of a chair w/o using arms and ambulation. Pain noted in upper limb girdle/shoulder.  PE (+) for 1+ DTRs with normal strength noted. Txd with IVIG. x 5 days with good response. 2/15/2008 Pt improved to date, but not 100%. Follow-up Information 09-MAY-2008: I have not regained the total use of my legs that I had before the flu shot. I still have great difficulty getting up and down from a chair. I cannot drive long distances. My shoulders are in pain from the effort it takes to get my legs up from a seated position. There has not been one day free of pain or any way normal since that horrible shot. The only good thing is that I voluntarily did it; I would hate someone if I had been forced to have had it. It has been six months, I am now trying accupuncture and deep massage. I am thousands of dollars in debt from this.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypokinesia, Hypotonia, Muscle atrophy, Muscular weakness, Musculoskeletal pain
Clinical narrative: Great pain in both legs moving upward, difficulty getting up and down out of chair, bed, etc.  02/12/2008 MR received for DOS 11/29-12/03/2007 with Final DX:  Guillain-Barre Syndrome 2' to influenza vaccination.  HTN. DM. Stable 4 mm noncalcified LLL nodule per CT abd/pelvis.  Stable hepatic lesions c/w proteinaceous cyst. Pt presented to MD with pain in legs, weakness and inability to get out of a chair w/o using arms and ambulation. Pain noted in upper limb girdle/shoulder.  PE (+) for 1+ DTRs with normal strength noted. Txd with IVIG. x 5 days with good response. 2/15/2008 Pt improved to date, but not 100%. Follow-up Information 09-MAY-2008: I have not regained the total use of my legs that I had before the flu shot. I still have great difficulty getting up and down from a chair. I cannot drive long distances. My shoulders are in pain from the effort it takes to get my legs up from a seated position. There has not been one day free of pain or any way normal since that horrible shot. The only good thing is that I voluntarily did it; I would hate someone if I had been forced to have had it. It has been six months, I am now trying accupuncture and deep massage. I am thousands of dollars in debt from this.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity
Clinical narrative: Great pain in both legs moving upward, difficulty getting up and down out of chair, bed, etc.  02/12/2008 MR received for DOS 11/29-12/03/2007 with Final DX:  Guillain-Barre Syndrome 2' to influenza vaccination.  HTN. DM. Stable 4 mm noncalcified LLL nodule per CT abd/pelvis.  Stable hepatic lesions c/w proteinaceous cyst. Pt presented to MD with pain in legs, weakness and inability to get out of a chair w/o using arms and ambulation. Pain noted in upper limb girdle/shoulder.  PE (+) for 1+ DTRs with normal strength noted. Txd with IVIG. x 5 days with good response. 2/15/2008 Pt improved to date, but not 100%. Follow-up Information 09-MAY-2008: I have not regained the total use of my legs that I had before the flu shot. I still have great difficulty getting up and down from a chair. I cannot drive long distances. My shoulders are in pain from the effort it takes to get my legs up from a seated position. There has not been one day free of pain or any way normal since that horrible shot. The only good thing is that I voluntarily did it; I would hate someone if I had been forced to have had it. It has been six months, I am now trying accupuncture and deep massage. I am thousands of dollars in debt from this.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPAB, IPV, TD, YF, FLUN3, HEPAB, IPV, TD, YF, FLUN3, HEPAB, IPV, TD, YF
Symptoms: CSF culture negative, CSF glucose increased, CSF protein normal, Cognitive disorder, Dysarthria
Clinical narrative: Patient admitted for Acute disseminated encephalomyelitis.   1/29/08 Case closed w/medical records that accompanied report which reveal that patient experienced sore throat, congestion & persistent cough when seen 10/8/07.  Treated symptomatically & improved initially.  Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener & resolved with change.  Then received multiple vax on 10/16/07.  Returned to clinic 10/19/07 w/worsening cough, fever, sore throat & nasal discharge.  Tx symptomatically & improved.  On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine & falling asleep on his feet.  Taken to ER & transferred to higher level of care.  Temp in ER 103.2.  Had LP in ER which showed CSF WBC 2240 w/82% polys.  Admitted 10/26-11/5/2007 in ICU.  Was stiff, unresponsive to stimuli, wringing his hands & shaking.  Tx w/IV antibiotics, antivirals & steroids & placed in isolation.  ID & neuro consults done.  Gradually improved & was d/c to home w/ID & Neuro outpatient f/u.  ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory & concentration problems.  Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognitive function.  Referred for neuropsych & congnitive rehab.  As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue & some difficulty w/memory & concentration. FINAL DX: ADEM.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPAB, IPV, TD, YF, FLUN3, HEPAB, IPV, TD, YF, FLUN3, HEPAB, IPV, TD, YF
Symptoms: Enterovirus serology test negative, Fatigue, Haematocrit, Haemoglobin, Laboratory test normal
Clinical narrative: Patient admitted for Acute disseminated encephalomyelitis.   1/29/08 Case closed w/medical records that accompanied report which reveal that patient experienced sore throat, congestion & persistent cough when seen 10/8/07.  Treated symptomatically & improved initially.  Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener & resolved with change.  Then received multiple vax on 10/16/07.  Returned to clinic 10/19/07 w/worsening cough, fever, sore throat & nasal discharge.  Tx symptomatically & improved.  On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine & falling asleep on his feet.  Taken to ER & transferred to higher level of care.  Temp in ER 103.2.  Had LP in ER which showed CSF WBC 2240 w/82% polys.  Admitted 10/26-11/5/2007 in ICU.  Was stiff, unresponsive to stimuli, wringing his hands & shaking.  Tx w/IV antibiotics, antivirals & steroids & placed in isolation.  ID & neuro consults done.  Gradually improved & was d/c to home w/ID & Neuro outpatient f/u.  ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory & concentration problems.  Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognitive function.  Referred for neuropsych & congnitive rehab.  As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue & some difficulty w/memory & concentration. FINAL DX: ADEM.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPAB, IPV, TD, YF, FLUN3, HEPAB, IPV, TD, YF, FLUN3, HEPAB, IPV, TD, YF
Symptoms: Leukoencephalomyelitis, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction, Protein total
Clinical narrative: Patient admitted for Acute disseminated encephalomyelitis.   1/29/08 Case closed w/medical records that accompanied report which reveal that patient experienced sore throat, congestion & persistent cough when seen 10/8/07.  Treated symptomatically & improved initially.  Returned to clinic on 10/16/07 w/urticarial rash thought to be caused by fabric softener & resolved with change.  Then received multiple vax on 10/16/07.  Returned to clinic 10/19/07 w/worsening cough, fever, sore throat & nasal discharge.  Tx symptomatically & improved.  On 10/26/07 patient had HA, neck stiffness, slurred speech, confusion, collapsed, was stuporous, incontinent of urine & falling asleep on his feet.  Taken to ER & transferred to higher level of care.  Temp in ER 103.2.  Had LP in ER which showed CSF WBC 2240 w/82% polys.  Admitted 10/26-11/5/2007 in ICU.  Was stiff, unresponsive to stimuli, wringing his hands & shaking.  Tx w/IV antibiotics, antivirals & steroids & placed in isolation.  ID & neuro consults done.  Gradually improved & was d/c to home w/ID & Neuro outpatient f/u.  ID outpatient vs of 11/20 revealed patient quite weak w/mild stiff neck, numbness of hands, weak grip, memory & concentration problems.  Neuro outpatient vs of 11/21 revealed patient continued to improve but concerned about cognitive function.  Referred for neuropsych & congnitive rehab.  As of 11/30, had weakness of bilateral extremities, more in legs, weak hand grasp, decreased sensation in fingers, easy fatigue & some difficulty w/memory & concentration. FINAL DX: ADEM.