chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: FLUN3
Symptoms: Wrong drug administered
Clinical narrative: A non-serious report of an 18-month old female who received FluMist by accident was received from a consumer.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical history nor concomitant medications were provided.  The patient received FluMist on 14Dec2007.  The 18-month-old patient was inadvertently administered FluMist.  No other events were reported.  No outcome for the event was provided by the reporter.  No dechallenge or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye disorder, Muscle twitching
Clinical narrative: A non-serious report of twitching in eye has been received from a physician concerning a three-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The patient, adopted, had no medical conditions and took no concomitant medications.  The patient received FluMist on 26-Nov-2007.  The physician stated the father reported on the day the patient received FluMist, twitching of the child's eye started.  The twitching continued at the time of this report.  Additional dosing with FluMist is not applicable.  The reporter did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious report of inappropriate dose of vaccine administered was received from a nurse in the concerning a patient of an unknown age.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  No relevant medical or drug history information was reported.  The infant was given FLUMIST on an unknown date.  The patient received one full dose of FLUMIST in each nostril.  No adverse events were reported from this error.  The reporter indicated that there would be no additional information available.  Rechallenge is not applicable.  Causality assessment is not applicable.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  12-Dec-2007: Follow up information obtained and incorporated in above narrative: Availability of information.08-Jan-2008: Follow up information obtained and incorporated in above narrative: Clinical outcome.
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious report of two doses of FluMist given on same day has been received from a nurse concerning a child of unknown age.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for newly indicated population of 2 years to 59 months of age for FluMist.  No medical history no concomitant medications were provided.  The patient received FluMist on an unknown date.  The school age child received one full dose of FluMist in each nostril.  No adverse events were reported.  No outcome was provided by the reporter.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to MEDI-0006238 and MEDI-0006240 which were all received from the same reporter.
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious report of two doses of FluMist given on same day has been received from a nurse in the USA concerning a child of unknown age.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical history nor concomitant medications were provided.  The patient received FluMist on an unknown date.  The school age child received one full dose of FluMist in each nostril.  No adverse events were reported.  No outcome was provided by the reporter.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to MEDI-0006239 and MEDI-0006240 which were all from the same reporter.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: MEDI-0006332 is a non-serious case received from a physician of inadvertent administration of Flumist to a two-year-old female with a history of wheezing.  The patient has a history of recurrent wheezing and no concomitant medications were reported.  On 19 Dec 2007, the patient was inadvertently administered a Flumist vaccine.  The reporter indicated that the patient had not experienced any events at the time of the report.  No further information was provided.  The outcome of the event is unknown.  Rechallenge is not applicable.  The reporter did not provide a causality statement for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Convulsion, Dizziness, Loss of consciousness
Clinical narrative: HEPATITIS A VACCINE GIVEN. ABOUT 90 SECONDS LATER CLIENT STATES FEELING LIGHT HEADED AND PREVIOUSLY PASSED OUT WHEN SHE HAD BLOOD DRAWN WHEN PREGNANT. APPLIED COLD CLOTH TO BACK OF NECK SUPPORTED HEAD AND OPENED AIRWAY AS CLIENT PASSED OUT AND HAD MILD SEIZURE ACTIVITY. AFTER ABOUT 2 MINUTES BEGAN TO RESPOND TO NAME AND ANSWER YES TO QUESTIONS. CONTINUED TO SUPPORT HEAD AND NECK FOR 5 MINUTES AND APPLY COLD COMPRESSES. BLOOD PRESSURE 76/40 INITIALLY AND FOLLOWUP BLOOD PRESSURE 94/60.  GIVEN GLASS OF ICE COLD WATER. CLIENT STATED SHE HAD NOT EATEN BREAKFAST THIS MORNING. RELEASED AFTER 15 MINUTES WHEN COLOR FULLY RETURNED AND STATES SHE FEELS MUCH BETTER.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: RAISED RASH FROM ABOVE ELBOW BEND TO ABOVE WRISTS OVER BOTH ARMS.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Dyskinesia, Laboratory test, Tremor
Clinical narrative: Received vaccine at 1 PM. At 2:30 AM pt awakened with dry mouth, shaking, and "jerking". Was advised to go to ER wherein the physician drew lab work and stated her symptoms were related to her receiving the vaccine. Symptoms resolved spontaneously.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Nausea, Oedema, Pain
Clinical narrative: ON 01-11-08 PAIN AFTER INJECTION AND LATE AFTERNOON NOTED REDNESS, WARM TO TOUCH, PAINFUL, RAISED AREA SIZE OF HER PALM. NO MEDICATION WAS TAKEN ON 01-11-08.  ON 01-12-08 AREA WORSEN WITH PAIN, REDNESS, EDEMA, AND RED STREAK TOWARDS LEFT BREAST.  PT. WENT TO MEDICAL CENTER AND TREATED WITH DOXYCYCLINE 100MG ONE TABLET EVERY 12 HOURS. PT WITH FEVER, NAUSEA OR VOMITING.  ER MD INFORMED PT TO TAKE OTC BENADRYL. S/S IMPROVED SLIGHTLY AND SEEN BY DR. ON 01-15-08.  PAIN, EDEMA, REDNESS, AND RED STREAK TO LEFT BREAST IMPROVED.  DR. INFORMED PT TO D/C DOXYCYCLINE R/T POSSIBLE ALLERGIC REACTION.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Skin warm, Vomiting
Clinical narrative: ON 01-11-08 PAIN AFTER INJECTION AND LATE AFTERNOON NOTED REDNESS, WARM TO TOUCH, PAINFUL, RAISED AREA SIZE OF HER PALM. NO MEDICATION WAS TAKEN ON 01-11-08.  ON 01-12-08 AREA WORSEN WITH PAIN, REDNESS, EDEMA, AND RED STREAK TOWARDS LEFT BREAST.  PT. WENT TO MEDICAL CENTER AND TREATED WITH DOXYCYCLINE 100MG ONE TABLET EVERY 12 HOURS. PT WITH FEVER, NAUSEA OR VOMITING.  ER MD INFORMED PT TO TAKE OTC BENADRYL. S/S IMPROVED SLIGHTLY AND SEEN BY DR. ON 01-15-08.  PAIN, EDEMA, REDNESS, AND RED STREAK TO LEFT BREAST IMPROVED.  DR. INFORMED PT TO D/C DOXYCYCLINE R/T POSSIBLE ALLERGIC REACTION.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Patient was treated for intussusception on 11/8/07.  02/26/2008 MR received for DOS 11/08-09/2007 with D/C DX:  Intussusception. Infant presented to ER with projectile vomiting, fussiness, drawing up of the legs, and decreased UO.  In ER had bloody stool and RUQ pain.  Reduced by Air Enema. Following reduction, pt tolerated po and d/c next day.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound scan abnormal
Clinical narrative: Patient was treated for intussusception on 11/8/07.  02/26/2008 MR received for DOS 11/08-09/2007 with D/C DX:  Intussusception. Infant presented to ER with projectile vomiting, fussiness, drawing up of the legs, and decreased UO.  In ER had bloody stool and RUQ pain.  Reduced by Air Enema. Following reduction, pt tolerated po and d/c next day.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Patient was treated for intussusception on 11/8/07.  02/26/2008 MR received for DOS 11/08-09/2007 with D/C DX:  Intussusception. Infant presented to ER with projectile vomiting, fussiness, drawing up of the legs, and decreased UO.  In ER had bloody stool and RUQ pain.  Reduced by Air Enema. Following reduction, pt tolerated po and d/c next day.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: R ARM PAIN WITH LOCAL SWELLING IN ABSENCE OF INFECTION  POSITIVE INDURATION
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Eye swelling, Oedema peripheral, Skin warm, Swelling face
Clinical narrative: Arm became swollen and hot to touch, overnight her face became swollen and eyes almost swollen shut.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass
Clinical narrative: REDNESS AND MILD LUMP AND INFLAMMATION.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Throat tightness
Clinical narrative: PATIENT RECEIVED VACCINE AT APPROXIMATELY 11 AM ON 1/11/08 AND CALLED COMPLAINING OF "THROAT CLOSING UP". PATIENT WAS ADVISED TO GO TO THE ER IMMEDIATELY (TO BE DRIVEN BY SOMEONE). SHE TOOK BENADRYL BEFORE LEAVING HER HOME AND ENDED UP LEAVING THE ER AFTER MORE THAN AN HOUR WITHOUT BEING SEEN BECAUSE OF THE LONG WAIT. AT THAT POINT SHE WAS FEELING MUCH BETTER. NO HX OF ADVERSE DRUG OR VACCINE REACTIONS. FIRST DOSE OF GARDASIL. NO COMPLAINTS FOLLOWING EVENT. NO HX OF ASTHMA OR OTHER MEDICAL CONDITIONS.
Sex: M
Vaccine: MMR
Symptoms: Autopsy, Death, Infection
Clinical narrative: Information has been received from a lawyer concerning a male child with a history of febrile convulsion who on an undisclosed date was vaccinated with MMR II. Ten days after being vaccinated with MMR II the child was found dead in his cot. It was reported that the general practitioner immunized the child when he had a fever and history of febrile convulsion. The post mortem found "MV" in his lungs and various other infections. No further details were provided.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 75 year old male with diabetes, hypertension, gastroesophageal reflux disease and benign prostatic hyperplasia who on 14-DEC-2007 was vaccinated with 0.5 ml of Pneumovax 23 vaccine (Lot #659150/1384U) subcutaneously. Concomitant therapy included sitagliptin phosphate, tablet (MSD) (duration, dose and indication not reported). Other concomitant therapy included Metformin, rosuvastatin calcium (CRESTOR) and omeprazole (PRILOSEC). The next day,on 15-DEC-2007, the patient developed swelling and redness from the injection site down to his hand with pain in his thumb. The patient was hospitalized on 17-DEC-2007 for about 2 days and was treated with diphenhydramine hydrochloride (BENADRYL) and hydroxyzine hydrochloride (ATARAX) and was released. Laboratory diagnostics included a white blood cell count of 13,000 All symptoms were resolved in 10 days. The swelling and redness from the injection site down to his hand with pain in his thumb was considered to be an other important medical event. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 75 year old male with diabetes, hypertension, gastroesophageal reflux disease and benign prostatic hyperplasia who on 14-DEC-2007 was vaccinated with 0.5 ml of Pneumovax 23 vaccine (Lot #659150/1384U) subcutaneously. Concomitant therapy included sitagliptin phosphate, tablet (MSD) (duration, dose and indication not reported). Other concomitant therapy included Metformin, rosuvastatin calcium (CRESTOR) and omeprazole (PRILOSEC). The next day,on 15-DEC-2007, the patient developed swelling and redness from the injection site down to his hand with pain in his thumb. The patient was hospitalized on 17-DEC-2007 for about 2 days and was treated with diphenhydramine hydrochloride (BENADRYL) and hydroxyzine hydrochloride (ATARAX) and was released. Laboratory diagnostics included a white blood cell count of 13,000 All symptoms were resolved in 10 days. The swelling and redness from the injection site down to his hand with pain in his thumb was considered to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Confusional state, Headache
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin M decreased, CSF culture negative, CSF glucose normal, CSF lymphocyte count normal
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: CSF monocyte count, CSF neutrophil count increased, CSF protein increased, CSF white blood cell count increased, Demyelination
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Encephalitis, Polymerase chain reaction, Virus serology test positive
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Blood folate normal, Blood immunoglobulin G normal, Borrelia burgdorferi serology negative, CSF culture negative
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: CSF glucose normal, CSF immunoglobulin increased, CSF lymphocyte count normal, CSF monocyte count, CSF myelin basic protein increased
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: CSF neutrophil count increased, CSF protein increased, CSF test abnormal, CSF white blood cell count increased, Cognitive disorder
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Demyelination, Drug screen negative, Encephalitis, HIV test negative, Hypokinesia
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction, Respiratory failure, Syphilis test negative, Viral infection
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Viral test negative, Virus serology test positive, Vitamin B12 normal
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided).  The physician noted that the patient experienced confusion and headaches.  He added that the patient was not vaccinated at his office, but at an OB/GYN office.  At the time of this report, the outcome of the events was unknown.  The reporting physician considered encephalomyelitis to be disabling.  Additional information has been requested.  2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination.  Seen by pcp & dx w/UTI, tx w/antibiotics.  No improvement & went to ER.  Quickly developed mental status changes & was unresponsive to stimuli.  Transferred to ICU & intubated.  Failed extubation & was re-intubated.  Able to progress & successfully extubated.  Tx w/antibiotics, antivirals & high dose steroids.  Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine.  Transferred to inpatient rehab center.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Confusional state, Headache
Clinical narrative: Pt presented with mengingoencephalitis of uncertain etiology 11 days after Gardasil vaccine. Her evaluation suggested a demyelinating process.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin M decreased, CSF culture negative, CSF glucose normal, CSF lymphocyte count normal
Clinical narrative: Pt presented with mengingoencephalitis of uncertain etiology 11 days after Gardasil vaccine. Her evaluation suggested a demyelinating process.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: CSF monocyte count, CSF neutrophil count increased, CSF protein increased, CSF white blood cell count increased, Demyelination
Clinical narrative: Pt presented with mengingoencephalitis of uncertain etiology 11 days after Gardasil vaccine. Her evaluation suggested a demyelinating process.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Encephalitis, Polymerase chain reaction, Virus serology test positive
Clinical narrative: Pt presented with mengingoencephalitis of uncertain etiology 11 days after Gardasil vaccine. Her evaluation suggested a demyelinating process.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Blood folate normal, Blood immunoglobulin G normal, Borrelia burgdorferi serology negative, CSF culture negative
Clinical narrative: Pt presented with mengingoencephalitis of uncertain etiology 11 days after Gardasil vaccine. Her evaluation suggested a demyelinating process.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: CSF glucose normal, CSF immunoglobulin increased, CSF lymphocyte count normal, CSF monocyte count, CSF myelin basic protein increased
Clinical narrative: Pt presented with mengingoencephalitis of uncertain etiology 11 days after Gardasil vaccine. Her evaluation suggested a demyelinating process.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: CSF neutrophil count increased, CSF protein increased, CSF test abnormal, CSF white blood cell count increased, Cognitive disorder
Clinical narrative: Pt presented with mengingoencephalitis of uncertain etiology 11 days after Gardasil vaccine. Her evaluation suggested a demyelinating process.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Demyelination, Drug screen negative, Encephalitis, HIV test negative, Hypokinesia
Clinical narrative: Pt presented with mengingoencephalitis of uncertain etiology 11 days after Gardasil vaccine. Her evaluation suggested a demyelinating process.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction, Respiratory failure, Syphilis test negative, Viral infection
Clinical narrative: Pt presented with mengingoencephalitis of uncertain etiology 11 days after Gardasil vaccine. Her evaluation suggested a demyelinating process.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Viral test negative, Virus serology test positive, Vitamin B12 normal
Clinical narrative: Pt presented with mengingoencephalitis of uncertain etiology 11 days after Gardasil vaccine. Her evaluation suggested a demyelinating process.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Drug exposure during pregnancy, Laboratory test
Clinical narrative: Information has been received from a 20 year old female with no pertinent medical history who on 01-Nov-2007 was vaccinated with a 0.5 ml dose of Gardasil.  Concomitant therapy included prenatal vitamins.  On 05-Jan-2008 the patient was dehydrated.  She was hospitalized where she found out that she was pregnant with twins.  The patient's last menstrual period was approximately 22-Oct-2007 and estimated date of delivery was 28-Jun-2008.  On 07-Jan-2008, the patient was released from the hospital.  The patient's outcome was not reported.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Dyspnoea, Pharyngeal oedema, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female with no medical history and no drug allergies, who on 04-JAN-2008 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 658488/1264U). There was no concomitant medication. On 04-JAN-2008 four or five hours post vaccination the patient experienced difficulty in breathing, shortness of breath, and a swollen throat. The symptoms lasted about 6 hours and then the patient developed a "high fever" and a cough that lasted about 2 days. The patient called the office. The patient was not hospitalized. No laboratory diagnostics were performed. On 06-JAN-2008 the patient recovered. No product quality complaint was involved. The physician considered the difficulty breathing, shortness of breath, swollen throat, "high fever", and cough to be life threatening. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Head injury, Loss of consciousness, Syncope, X-ray
Clinical narrative: Information has been received from a mother concerning her 15 year old daughter who has had a liver transplant.  There were multiple concomitant medications but none were specified.  On 31-DEC-2007 the patient was vaccinated with her first dose of Gardasil.  The mother reported that her daughter fainted within 10 minutes after receiving the vaccination.  She passed out for about 1 minute after hitting her head.  She was seen in the emergency room and required 7 staples in her head to close the wound she received.  A CT of the head and neck was performed, as well as X-rays.  No results were reported.  Her head injury was considered to be immediately life-threatening and disabling.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: DTAP, HPV4, VARCEL
Symptoms: Abortion spontaneous, Blood gonadotrophin decreased, Drug exposure during pregnancy, Pregnancy test positive, Vaginal haemorrhage
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with no pertinent medical history, seasonal allergies and allergies to nickel and penicillin who on 02-AUG-2007 was vaccinated intramuscularly (site not reported) with the 1st dose of the 0.5 ml Gardasil (lot#655620/0171U). The patient was concomitantly vaccinated with Varivax (MSD) and DTaP (manufacturer unknown). On 15-AUG-2007, the patient was seen in the emergency room with lowering hcg levels and some vaginal bleeding. On 16-AUG-2007 and 17-AUG-2007, the patient returned to the emergency room with continuing decreasing hcg levels and later had a spontaneous abortion (exact date not reported). On 01-OCT-2007, the patient was vaccinated intramuscularly (site not reported) with the 2nd dose of the 0.5 ml Gardasil (lot#658094/0524U) while pregnant (WAES#0801USA01237). Follow-up information was received from the nurse stating that the exact date of the spontaneous abortion and LMP after the 2nd dose of the Gardasil vaccine is unknown. Upon internal review spontaneous abortion was considered to be an other important medical events. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: C/O NAUSEA AND HEADACHE APPROX 2 HOURS AFTER ZOSTAVAX WAS GIVEN. SYMPTOMS LASTED APPROX 2 HOURS.
Age: 56.0
Sex: U
Vaccine: FLU3
Symptoms: Inflammation, Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Left arm painful and inflamed since injection; could not lift arm above level of shoulder nor rotate arm; called PCP and was advised ice, ibuprofen and later added massage therapy.  Pain moved up arm and into shoulder by this time.  Massage therapy X 4-5 weeks with improvement but still having problems lifting arm or full range of motion.  Has improved but not returned to normal levels of activity at this time 1/15/2008.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye swelling, Ocular hyperaemia, Oedema mouth, Pharyngeal oedema
Clinical narrative: Throat and mouth was swollen eye were red and had discharge coming from them. 4/21/08-office notes received for 12/13/07-C/O tongue and throat swelling. Dyspnea. DX: Anaphylaxis uncertain exact allergen. Symptoms began 3 hours after vaccination.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Depressed level of consciousness, Pyrexia
Clinical narrative: Pt received immunization on 11/26/07 approx. 6PM at time of admin. Parent report period of decreased responsiveness starting approx 0300 11/27/07, lasted about 3 hrs. No seizure activity. Started with fever, T101 late on 11/27/07. Brought to hospital where was hospitalised 11/28 - 11/30/07.  2/1/2008 MR received for DOS 11/28-30/2008 with D/C Dx Viral Gastroenteritis. Infant presented to ER with 3 day hx of fevers and vomiting which began day of admission.  Parent also reported episode of chest convulsions/dry heaves followed by lethargy.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bronchitis, Dyspnoea, Fluid retention, Surgery, X-ray abnormal
Clinical narrative: Shortness of breath started on Dec 7th, on 8th went to walk in clinic - diagnosed Bronchitis - given Z-pack. Started Z-Pack on 8th. Saw family Dr on the 11th - took X-ray water in lung - sent to hospital - had to have surgery about 12:12 am for water around heart and lungs. 1/16/08-records received for DOS 12/11-12/14/07- DC DX: Tamponade (pericardial effusion, resolved), bilateral plueral effusion (resolved), pneumonia, hypertension, leukocytosis (improved) and dyslipidemia. Presented to ER with acute shortness of breath for 3 days and chest pain in sternal area worsening with movement and lying down, was diagnosed with large pleural effusion and pericaridal effusion. Pericardial window placed
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chest X-ray abnormal, Dyspnoea, Intensive care, Laboratory test abnormal
Clinical narrative: Shortness of breath started on Dec 7th, on 8th went to walk in clinic - diagnosed Bronchitis - given Z-pack. Started Z-Pack on 8th. Saw family Dr on the 11th - took X-ray water in lung - sent to hospital - had to have surgery about 12:12 am for water around heart and lungs. 1/16/08-records received for DOS 12/11-12/14/07- DC DX: Tamponade (pericardial effusion, resolved), bilateral plueral effusion (resolved), pneumonia, hypertension, leukocytosis (improved) and dyslipidemia. Presented to ER with acute shortness of breath for 3 days and chest pain in sternal area worsening with movement and lying down, was diagnosed with large pleural effusion and pericaridal effusion. Pericardial window placed
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pulmonary oedema, Surgery, Viral infection
Clinical narrative: Shortness of breath started on Dec 7th, on 8th went to walk in clinic - diagnosed Bronchitis - given Z-pack. Started Z-Pack on 8th. Saw family Dr on the 11th - took X-ray water in lung - sent to hospital - had to have surgery about 12:12 am for water around heart and lungs. 1/16/08-records received for DOS 12/11-12/14/07- DC DX: Tamponade (pericardial effusion, resolved), bilateral plueral effusion (resolved), pneumonia, hypertension, leukocytosis (improved) and dyslipidemia. Presented to ER with acute shortness of breath for 3 days and chest pain in sternal area worsening with movement and lying down, was diagnosed with large pleural effusion and pericaridal effusion. Pericardial window placed
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt came into ER. Symptoms: 1. Fever, 2. Nausea Vomiting (3) malaise. Treatment Drug # 1: Ceftriaxone Dose: 1 Units: GM Freq: ONCE Router IV. Treatment Drug # 2 ACETAMINOPHEN Dose: 1 Units: GM Freq: ONCE Route: PO. Treatment Drug # # METHYLPREDNISOLONE Dose: 125 Units: MG Freq: ONCE Route: IV. Pt discharged with Augentin 875 mg, and medrol dose pack.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dysgeusia
Clinical narrative: Immediately after receiving 2nd dose of Engerix B, patient experienced metallic taste in mouth. 45 minutes later metallic taste remained, accompanied by feeling of lightheadedness.  BP 140/90, pulse 90, resp 14. States feeling like she "inhaled bug spray."  Given 400 mg ibuprofen.  Symptoms continued for 1 hr, 15 min.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death
Clinical narrative: Pt. died in bed approx. 48 hours after receiving 1st set of 3  immunizations. Records received 3/31/08-final autopsy report. COD: Probably Sudden Infant Death Syndrome. Petechial hemorrhages, epicardial, pleural.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 7 cm x 3 cm erythema, swelling from injection site.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Bedridden, Contusion, Inflammation
Clinical narrative: For 48 hours after immunization, patient was bedridden both mentally and physically very weak.  Arm showed bruising and inflammation.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Injection site pain, Nausea, Photophobia, Pyrexia
Clinical narrative: Pt. feels nauseated, headache is ongoing, sensitive to light, fever of 102.0, pain in arm & leg (injection sites).
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood glucose normal, Blood pressure, Syncope
Clinical narrative: After injection of Varivax #2 in R arm and HPV #1 in L arm she fainted.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Headache, Hypoaesthesia, Musculoskeletal stiffness, Neck pain
Clinical narrative: 2 days after receiving Menactra, had numbness, tightness, and stiffness of fingers on right hand.  The night before had headache, sacral pain, hip and neck pain.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Skin tightness
Clinical narrative: 2 days after receiving Menactra, had numbness, tightness, and stiffness of fingers on right hand.  The night before had headache, sacral pain, hip and neck pain.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Pain, Swelling
Clinical narrative: Swelling over golf ball size, pain ever since.  Now having skin pigment change at vaccination site.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Chest pain, Chills, Cough, Dizziness
Clinical narrative: 1st day, evening sore throat, cough continuing with headache chills and ear ache.  2nd day with body ache.  3rd day all symptoms continuing with temperature 99.3 and increasing, difficulty breathing, wheezing and heart missing beats and some fast beats and chest pains and dizziness in the evening.  Tool Tylenol and albuterol for breathing.  4th day, breathing and heart better, sore throat, cough and head congestion.  8th day, doctor gave amoxicillin for next 7 days and nasal decongestant.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Ear pain, Headache, Heart rate irregular, Nasal congestion
Clinical narrative: 1st day, evening sore throat, cough continuing with headache chills and ear ache.  2nd day with body ache.  3rd day all symptoms continuing with temperature 99.3 and increasing, difficulty breathing, wheezing and heart missing beats and some fast beats and chest pains and dizziness in the evening.  Tool Tylenol and albuterol for breathing.  4th day, breathing and heart better, sore throat, cough and head congestion.  8th day, doctor gave amoxicillin for next 7 days and nasal decongestant.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngolaryngeal pain, Wheezing
Clinical narrative: 1st day, evening sore throat, cough continuing with headache chills and ear ache.  2nd day with body ache.  3rd day all symptoms continuing with temperature 99.3 and increasing, difficulty breathing, wheezing and heart missing beats and some fast beats and chest pains and dizziness in the evening.  Tool Tylenol and albuterol for breathing.  4th day, breathing and heart better, sore throat, cough and head congestion.  8th day, doctor gave amoxicillin for next 7 days and nasal decongestant.
Age: 4.0
Sex: M
Vaccine: FLU3, IPV
Symptoms: Agitation, Crying
Clinical narrative: Mom called on 1-2-08 to state that 2 weeks after vaccines he woke crying and seemed startled & "limber".  Stated in '05 he had a fever for 2 days about 2 weeks after his first flu shot.  No documentation.  Child was not seen after either episode.