chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Accidental exposure, Hypoaesthesia, Laboratory test, Lumbar puncture, Muscle spasms
Clinical narrative: 8 Sep 07 - drew 15-20 syringes of Anthrax for shot line - vaccine aerolized. 8 Oct 07 - Sx started of muscle spasm (L) shoulder - hand with numbness (L) hand. Rx Prednisone taper x2, physical therapy and chiropractic care. Symptoms did not get better but worsened. 3 Dec 07 - MRI C spine = transverse myelitis, C3-C6 (swelling in spinal column (L) eccentric). Hospitalized for high dose IV Solumedrol. Sx better but not better as of 3 May 08.  5/9/08 Reviewed hospital medical records of 12/5-12/11/2007. FINAL DX: transverse myelitis & GERD. Records reveal patient experienced left neck & shoulder pain & stiffness upon awakening 10/8/07 & fingers were numb.  Also had sensation of muscle spasm in forearm & biceps.  Tx w/steroids & muscle relaxant w/o relief.  PCP then prescribed additional steroids & PT w/worsening s/s.  Developed URI symptoms & tx w/antibiotics & developed blister on left buttock that was painful.  Neuro & ID consults done.  During admission tx w/IV high dose steroids w/improvement.  D/C to home on tapering oral steroids & to f/u w/neuro & ID.  5/23/08 Reviewed neurologist medical records of 12/13/07-4/7/08. FINAL DX: transverse myelitis Records reveal patient experienced HA s/p hospitalization for transverse myelitis.  Had HA since LP on 12/6 when ever upright.  Dx w/post LP HA.  Referred for blood patch.  Originally seen in office 12/5/08 w/left arm numbness, weakness & weakness in legs.  Sent for MRI of c-spine which was c/w transverse myelitis & was hospitalized.  Office vs of 1/4/08 revealed pt w/residual numbness of fifth digit, ulnar surface & palm of hand but w/improved dexterity & slow steady progress.  Left hand pain interfered w/sleep.  Meds adjusted.  4/7/08 still contined w/dyesthesias & pain of left hand.  Continued to make slow steady progress & referred for repeat MRI.  Hospital consults & labs included w/records. Follow-up: Still have surface numbness of L hand, palm side of hand and fingers. Increase numbness with increase activity / stress with pain in L palm and hand around finger tips of index, middle and ring fingers. Also, some light paresthesia in L arm during that time as well.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging abnormal, Paraesthesia, Swelling
Clinical narrative: 8 Sep 07 - drew 15-20 syringes of Anthrax for shot line - vaccine aerolized. 8 Oct 07 - Sx started of muscle spasm (L) shoulder - hand with numbness (L) hand. Rx Prednisone taper x2, physical therapy and chiropractic care. Symptoms did not get better but worsened. 3 Dec 07 - MRI C spine = transverse myelitis, C3-C6 (swelling in spinal column (L) eccentric). Hospitalized for high dose IV Solumedrol. Sx better but not better as of 3 May 08.  5/9/08 Reviewed hospital medical records of 12/5-12/11/2007. FINAL DX: transverse myelitis & GERD. Records reveal patient experienced left neck & shoulder pain & stiffness upon awakening 10/8/07 & fingers were numb.  Also had sensation of muscle spasm in forearm & biceps.  Tx w/steroids & muscle relaxant w/o relief.  PCP then prescribed additional steroids & PT w/worsening s/s.  Developed URI symptoms & tx w/antibiotics & developed blister on left buttock that was painful.  Neuro & ID consults done.  During admission tx w/IV high dose steroids w/improvement.  D/C to home on tapering oral steroids & to f/u w/neuro & ID.  5/23/08 Reviewed neurologist medical records of 12/13/07-4/7/08. FINAL DX: transverse myelitis Records reveal patient experienced HA s/p hospitalization for transverse myelitis.  Had HA since LP on 12/6 when ever upright.  Dx w/post LP HA.  Referred for blood patch.  Originally seen in office 12/5/08 w/left arm numbness, weakness & weakness in legs.  Sent for MRI of c-spine which was c/w transverse myelitis & was hospitalized.  Office vs of 1/4/08 revealed pt w/residual numbness of fifth digit, ulnar surface & palm of hand but w/improved dexterity & slow steady progress.  Left hand pain interfered w/sleep.  Meds adjusted.  4/7/08 still contined w/dyesthesias & pain of left hand.  Continued to make slow steady progress & referred for repeat MRI.  Hospital consults & labs included w/records. Follow-up: Still have surface numbness of L hand, palm side of hand and fingers. Increase numbness with increase activity / stress with pain in L palm and hand around finger tips of index, middle and ring fingers. Also, some light paresthesia in L arm during that time as well.
Age: 6.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Aspiration tracheal, Blood culture negative, CSF culture negative, Culture urine negative, Endotracheal intubation
Clinical narrative: Febrile seizure requiring hospitalization with intubation/IO line.  15 month old previously healthy female with new onset twitching movements with fever.  She had her well child visit today and received her MMR, DTaP, and HIB.  Later that evening, she awakened from a nap and felt subjectively very warm.  She also was repeatedly touching her neck with her right hand.  She then developed twitching of her left eyelid and right hand/wrist.  She was not responsive to her parents attempts to break her from this spell.  Her father picked her up and noted that the rest of her body was limp except for the arm that was twitching.  She was taken by her father to the local ED.  Her movements spread to all extremities during the 5 minutes it took to arrive at the ED.  In the ED, she was given rectal diazepam 1.25mg and the seizure abated.  She then had saturations in the 70s and several attempts were made at intubation.  The 9th attempt was successful but was in the right mainstream by CXR.  The ETT was withdrawn to better position.  Importantly, in between intubation attempts she was successfully bagged to saturations in the 90's.  Several attempts were made for an IV and ultimately an IO was placed.  Patient had two more twitching episodes and received diazepam 1.25mg via IO.  Total time with the twitching was estimated by the family to be about 30 minutes.  NS was started through the IO.  Saturations were in the 90s and transfer to UIHC was done.  5/9/08 Case closed w/medical records that accompanied report. Reviewed hospital medical records of 4/24-4/26/2008. FINAL DX: complex febrile seizure Records reveal patient experienced fever, new onset twitching movements, unresponsive, limpness beginning on day of vaccination.  Taken to ER where arrived seizing.  Tx w/antiseizure meds.  O2 saturations were 70%.  Difficult intubation but O2 sats w/bagging remained in the 90% range.  Seizures recurred in ER x 2.  Transferrd to higher level of care.  Admitted to PICU.  Extubated following day.  Tx w/IV antibiotics x 2 days.  Remained afebrile.  Tx w/steroids for airway edema due to repeated intubation attempts. No further seizure activity while hospitalized.
Age: 6.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Febrile convulsion, Gram stain negative, Hypotonia, Muscle twitching, Oxygen saturation decreased
Clinical narrative: Febrile seizure requiring hospitalization with intubation/IO line.  15 month old previously healthy female with new onset twitching movements with fever.  She had her well child visit today and received her MMR, DTaP, and HIB.  Later that evening, she awakened from a nap and felt subjectively very warm.  She also was repeatedly touching her neck with her right hand.  She then developed twitching of her left eyelid and right hand/wrist.  She was not responsive to her parents attempts to break her from this spell.  Her father picked her up and noted that the rest of her body was limp except for the arm that was twitching.  She was taken by her father to the local ED.  Her movements spread to all extremities during the 5 minutes it took to arrive at the ED.  In the ED, she was given rectal diazepam 1.25mg and the seizure abated.  She then had saturations in the 70s and several attempts were made at intubation.  The 9th attempt was successful but was in the right mainstream by CXR.  The ETT was withdrawn to better position.  Importantly, in between intubation attempts she was successfully bagged to saturations in the 90's.  Several attempts were made for an IV and ultimately an IO was placed.  Patient had two more twitching episodes and received diazepam 1.25mg via IO.  Total time with the twitching was estimated by the family to be about 30 minutes.  NS was started through the IO.  Saturations were in the 90s and transfer to UIHC was done.  5/9/08 Case closed w/medical records that accompanied report. Reviewed hospital medical records of 4/24-4/26/2008. FINAL DX: complex febrile seizure Records reveal patient experienced fever, new onset twitching movements, unresponsive, limpness beginning on day of vaccination.  Taken to ER where arrived seizing.  Tx w/antiseizure meds.  O2 saturations were 70%.  Difficult intubation but O2 sats w/bagging remained in the 90% range.  Seizures recurred in ER x 2.  Transferrd to higher level of care.  Admitted to PICU.  Extubated following day.  Tx w/IV antibiotics x 2 days.  Remained afebrile.  Tx w/steroids for airway edema due to repeated intubation attempts. No further seizure activity while hospitalized.
Age: 6.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Skin warm, Unresponsive to stimuli
Clinical narrative: Febrile seizure requiring hospitalization with intubation/IO line.  15 month old previously healthy female with new onset twitching movements with fever.  She had her well child visit today and received her MMR, DTaP, and HIB.  Later that evening, she awakened from a nap and felt subjectively very warm.  She also was repeatedly touching her neck with her right hand.  She then developed twitching of her left eyelid and right hand/wrist.  She was not responsive to her parents attempts to break her from this spell.  Her father picked her up and noted that the rest of her body was limp except for the arm that was twitching.  She was taken by her father to the local ED.  Her movements spread to all extremities during the 5 minutes it took to arrive at the ED.  In the ED, she was given rectal diazepam 1.25mg and the seizure abated.  She then had saturations in the 70s and several attempts were made at intubation.  The 9th attempt was successful but was in the right mainstream by CXR.  The ETT was withdrawn to better position.  Importantly, in between intubation attempts she was successfully bagged to saturations in the 90's.  Several attempts were made for an IV and ultimately an IO was placed.  Patient had two more twitching episodes and received diazepam 1.25mg via IO.  Total time with the twitching was estimated by the family to be about 30 minutes.  NS was started through the IO.  Saturations were in the 90s and transfer to UIHC was done.  5/9/08 Case closed w/medical records that accompanied report. Reviewed hospital medical records of 4/24-4/26/2008. FINAL DX: complex febrile seizure Records reveal patient experienced fever, new onset twitching movements, unresponsive, limpness beginning on day of vaccination.  Taken to ER where arrived seizing.  Tx w/antiseizure meds.  O2 saturations were 70%.  Difficult intubation but O2 sats w/bagging remained in the 90% range.  Seizures recurred in ER x 2.  Transferrd to higher level of care.  Admitted to PICU.  Extubated following day.  Tx w/IV antibiotics x 2 days.  Remained afebrile.  Tx w/steroids for airway edema due to repeated intubation attempts. No further seizure activity while hospitalized.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Barium double contrast, Blood culture negative, Intussusception, Urinary system X-ray
Clinical narrative: Rotateq administered 4/4/08. Pt hospitalized 4/25/08 with intussusception which was reduced nonsurgically. Hospitalized x 3 days. 5/13/08-clinic notes received for DOS 4/4/08-well baby visit. DOS 5/5/08-F/U visit for past hospitalization for intussusception. Successfully reduced with 2 air contrast enemas which demonstrated successful reduction of intussusception. In clinic no C/O.  5/22/08-records received for DOS 4/23/08-Impression: Intussusception status post reduction air contrast barium enema. Presented to ED with vomiting began on day of seen in ED, vomitus is bilious and blood stained. Some bloody diarrhea. Lethargic and tired, decreased oral intake and normal urine output.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Rash pruritic, Throat irritation, Wheezing
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from a health care professional on 02 May 2008.  A 14-year-old male patient with a medical history of allergies to Augmentin and peaches, as well as seasonal allergies, had received an intramuscular injection of Menactra, lot number U2613AA, on 01 May 2008 at 4:00 PM.  60 minutes later, the patient called the physician's office to report symptoms of scratchy throat and an itchy rash on his abdomen.  He also experienced wheezing, but his breathing was not labored.  He was seen in the emergency room and was treated with IV steroids (unspecified).  He was discharged to home with an Epi-Pen and prescriptions for prednisone and Zyrtec.  The physician's office followed up with the patient on 02 May 2008 and reported that he was doing well and had recovered from the events.
Age: 61.0
Sex: F
Vaccine: TTOX
Symptoms: Shock
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 02 May 2008 from a consumer.  A 61-year-old female patient, whose medical history was not provided, had received a tetanus immunization (trade name, manufacturer's name, route and site of administration not provided) on an unknown date.  At an unspecified amount of time later, the patient experienced shock.  Treatments received and diagnostic tests performed were not provided.  Recovery status of the patient was not provided.  No other relevant medically significant information was provided.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Asthenia, Asthma exercise induced, Back pain, Chest X-ray
Clinical narrative: Initial report received on 28 April 2008 from another manufacturer, report# WAES 0804USA04043.  The initial reporter to this manufacturer had been a health care professional.  Verbatim from the report: "Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of Gardasil (Lot# 659653/1448U) and a dose of MENACTRA, administered in the other arm.  On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash.  The rash was predominantly on the neck and the face.  The rash was diffuse, macular, itchy, and was hive-like in some areas.  The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort.  On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat.  The patient was diagnosed with allergic reaction and/or exercise induced asthma.  The patient was treated with albuterol and an unspecified steroid.  On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler for two days and the steroid for one day.  The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX.  On 15-FEB-2008 the patient was seen for back pain and "choleretic pain."  The shortness of breath had resolved.  The patient's chest x-ray had no change.  The patient had positive convalescent mycoplasma.  On 04-MAR-2008 the patient followed up at the office to recheck the pneumonia and upper respiratory infection, which were resolved.  It was reported that the patient's back pain was 80% better.  The blood counts were normal.  On 07-MAR-2008 the patient was seen by her primary pediatrician.  It was reported that the patient may have used ALEVE during the week for relief of pain.  It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist.  The patient was started on FLOVENT.  On 11-MAR-2008 there was a call to the office for an unspecified reason.  The patient was prescribed an EPIPEN.  On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal.  The allergist did not think that the patient required respiratory medications.  On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo.  The patient had no other neurological conditions.  The patient had experienced persistent malaise and fatigue since the onset of the rash.  At the time of the report, the patient was not recovered from all events.  No product quality complaint was involved.  Upon internal review the allergic reaction, exercise induce asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events.  Additional information has been requested."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Conversion disorder, Dizziness, Dyspnoea, Fatigue, Full blood count normal
Clinical narrative: Initial report received on 28 April 2008 from another manufacturer, report# WAES 0804USA04043.  The initial reporter to this manufacturer had been a health care professional.  Verbatim from the report: "Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of Gardasil (Lot# 659653/1448U) and a dose of MENACTRA, administered in the other arm.  On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash.  The rash was predominantly on the neck and the face.  The rash was diffuse, macular, itchy, and was hive-like in some areas.  The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort.  On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat.  The patient was diagnosed with allergic reaction and/or exercise induced asthma.  The patient was treated with albuterol and an unspecified steroid.  On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler for two days and the steroid for one day.  The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX.  On 15-FEB-2008 the patient was seen for back pain and "choleretic pain."  The shortness of breath had resolved.  The patient's chest x-ray had no change.  The patient had positive convalescent mycoplasma.  On 04-MAR-2008 the patient followed up at the office to recheck the pneumonia and upper respiratory infection, which were resolved.  It was reported that the patient's back pain was 80% better.  The blood counts were normal.  On 07-MAR-2008 the patient was seen by her primary pediatrician.  It was reported that the patient may have used ALEVE during the week for relief of pain.  It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist.  The patient was started on FLOVENT.  On 11-MAR-2008 there was a call to the office for an unspecified reason.  The patient was prescribed an EPIPEN.  On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal.  The allergist did not think that the patient required respiratory medications.  On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo.  The patient had no other neurological conditions.  The patient had experienced persistent malaise and fatigue since the onset of the rash.  At the time of the report, the patient was not recovered from all events.  No product quality complaint was involved.  Upon internal review the allergic reaction, exercise induce asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events.  Additional information has been requested."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Headache, Hypersensitivity, Malaise, Mycoplasma infection, Mycoplasma serology positive
Clinical narrative: Initial report received on 28 April 2008 from another manufacturer, report# WAES 0804USA04043.  The initial reporter to this manufacturer had been a health care professional.  Verbatim from the report: "Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of Gardasil (Lot# 659653/1448U) and a dose of MENACTRA, administered in the other arm.  On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash.  The rash was predominantly on the neck and the face.  The rash was diffuse, macular, itchy, and was hive-like in some areas.  The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort.  On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat.  The patient was diagnosed with allergic reaction and/or exercise induced asthma.  The patient was treated with albuterol and an unspecified steroid.  On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler for two days and the steroid for one day.  The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX.  On 15-FEB-2008 the patient was seen for back pain and "choleretic pain."  The shortness of breath had resolved.  The patient's chest x-ray had no change.  The patient had positive convalescent mycoplasma.  On 04-MAR-2008 the patient followed up at the office to recheck the pneumonia and upper respiratory infection, which were resolved.  It was reported that the patient's back pain was 80% better.  The blood counts were normal.  On 07-MAR-2008 the patient was seen by her primary pediatrician.  It was reported that the patient may have used ALEVE during the week for relief of pain.  It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist.  The patient was started on FLOVENT.  On 11-MAR-2008 there was a call to the office for an unspecified reason.  The patient was prescribed an EPIPEN.  On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal.  The allergist did not think that the patient required respiratory medications.  On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo.  The patient had no other neurological conditions.  The patient had experienced persistent malaise and fatigue since the onset of the rash.  At the time of the report, the patient was not recovered from all events.  No product quality complaint was involved.  Upon internal review the allergic reaction, exercise induce asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events.  Additional information has been requested."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash macular, Rash pruritic, Red blood cell sedimentation rate normal, Vertigo, Wheezing
Clinical narrative: Initial report received on 28 April 2008 from another manufacturer, report# WAES 0804USA04043.  The initial reporter to this manufacturer had been a health care professional.  Verbatim from the report: "Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of Gardasil (Lot# 659653/1448U) and a dose of MENACTRA, administered in the other arm.  On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash.  The rash was predominantly on the neck and the face.  The rash was diffuse, macular, itchy, and was hive-like in some areas.  The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort.  On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat.  The patient was diagnosed with allergic reaction and/or exercise induced asthma.  The patient was treated with albuterol and an unspecified steroid.  On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler for two days and the steroid for one day.  The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX.  On 15-FEB-2008 the patient was seen for back pain and "choleretic pain."  The shortness of breath had resolved.  The patient's chest x-ray had no change.  The patient had positive convalescent mycoplasma.  On 04-MAR-2008 the patient followed up at the office to recheck the pneumonia and upper respiratory infection, which were resolved.  It was reported that the patient's back pain was 80% better.  The blood counts were normal.  On 07-MAR-2008 the patient was seen by her primary pediatrician.  It was reported that the patient may have used ALEVE during the week for relief of pain.  It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist.  The patient was started on FLOVENT.  On 11-MAR-2008 there was a call to the office for an unspecified reason.  The patient was prescribed an EPIPEN.  On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal.  The allergist did not think that the patient required respiratory medications.  On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo.  The patient had no other neurological conditions.  The patient had experienced persistent malaise and fatigue since the onset of the rash.  At the time of the report, the patient was not recovered from all events.  No product quality complaint was involved.  Upon internal review the allergic reaction, exercise induce asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events.  Additional information has been requested."
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician, via the Merck pregnancy registry, concerning a 25 year old female patient who on 22-MAR-2007 was vaccinated with a dose, 0.5ml, IM, of GARDASIL (Lot # 655503/0012U). The physician stated that on 24-MAR-2007, the patient had a positive pregnancy test (over the counter), and added that the patient was pregnant at the time of vaccination. The LMP date was 25-FEB-2007, with an estimated date of delivery of 02-DEC-2007. Follow up information from a nurse at the physician's office, indicated that on 12-DEC-2007, the patient delivered a "normal and healthy baby girl," via a C-section. Attempts for a vaginal delivery included PITOCIN, and "resulted in spontaneous decreases on the baby's heart rate." The infant weighed 8 lb 6 oz, with an Apgar score of 9/9. No further information was reported. Upon internal review, "resulted in decrease in the baby's heart rate" (led to a C-section) was determined to be serious as an other important medical event. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Pregnancy test positive
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 26 year old female with no medical history, who on 04-JUN-2007 was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  The patient was pregnant.  The pregnancy was confirmed by a pregnancy test.  At the time of the report, the patient was 8 weeks pregnant and her outcome was unknown.  The patient's last menstrual period was 20-MAY-2007 and her estimated delivery date was 27-FEB-2008.  The patient had one previous pregnancy and one full term delivery.  No product quality complaint was involved.  Follow-up information indicated that on 07-AUG-2007 the patient went to the emergency room due to bleeding.  The patient experienced a spontaneous abortion.  Upon internal review spontaneous abortion was considered to be an other important medical event.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with a third dose of Gardasil.  Subsequently the patient may have been pregnant when she received the third dose of Gardasil.  The doses of Gardasil were administered at another physician's office.  Unspecified medical attention was sought.  On an unspecified date the patient had a positive beta-human chorionic gonadotropin test (unspecified).  The patient's LMP date was 13-FEB-2008.  The patient's estimated date of delivery is 19-NOV-2008.  Follow-up information was received from the physician's office.  On an unspecified date the patient had terminated her pregnancy.  The patient's outcome was unknown.  Upon internal review abortion induced is considered to be an other medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Paralysis
Clinical narrative: Information has been received from a nurse within the doctor's office concerning a female patient who was vaccinated with a second dose of GARDASIL.  The nurse reported that she heard from her aunt that a patient received the GARDASIL injection and experienced paralysis and could not even cut her own dinner after the injection was administered.  The patient had to walk with a cane and also went to physical therapy.  She did not receive the vaccine at the reporting nurse's office.  No further information was known.  The paralysis was considered to be disabling.  Additional information is not available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Impaired driving ability, Muscle disorder
Clinical narrative: Information has been received from a physician concerning an approximate 17 year old female who in April 2007 ("within the past 2-3 weeks") was vaccinated with a first dose of Gardasil 0.5 mL IM.  In April 2007, "couple of weeks" later the patient developed "muscular problems to the point where she couldn't drive".  Unspecified medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  When asked if it was a significant disability/incapacity, "she said that she thinks it was because the patient could not drive a car".  Additional information has been requested.  8/19/08 To be linked to 311859 and 316857.  8/21/2008 Neurology consults received dated 5/2/2008 and 5/27/2008 with Assessment: Myalgias-began 3 weeks after the Gardasil shot and has continued for 3 weeks.  Not weak; doubt Guillain-Barre syndrome.  PCP refered pt with sx of fatigue, pain upon pulling legs and need to use handrail to pull self climbing stairs, also affects the joints. PCP ? latent virus, restless legs, or rxn to Gardasil (most likely).  PE WNL except 4+ DTRs in the lower extremities.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome, Limb discomfort
Clinical narrative: Information has been received from a physician concerning an approximate 17 year old female who in April 2007 ("within the past 2-3 weeks") was vaccinated with a first dose of Gardasil 0.5 mL IM.  In April 2007, "couple of weeks" later the patient developed "muscular problems to the point where she couldn't drive".  Unspecified medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  When asked if it was a significant disability/incapacity, "she said that she thinks it was because the patient could not drive a car".  Additional information has been requested.  8/19/08 To be linked to 311859 and 316857.  8/21/2008 Neurology consults received dated 5/2/2008 and 5/27/2008 with Assessment: Myalgias-began 3 weeks after the Gardasil shot and has continued for 3 weeks.  Not weak; doubt Guillain-Barre syndrome.  PCP refered pt with sx of fatigue, pain upon pulling legs and need to use handrail to pull self climbing stairs, also affects the joints. PCP ? latent virus, restless legs, or rxn to Gardasil (most likely).  PE WNL except 4+ DTRs in the lower extremities.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Band neutrophil percentage, Basophil count normal, Blood creatine phosphokinase, Eosinophil count normal
Clinical narrative: Information has been received from a physician concerning an approximate 17 year old female who in April 2007 ("within the past 2-3 weeks") was vaccinated with a first dose of Gardasil 0.5 mL IM.  In April 2007, "couple of weeks" later the patient developed "muscular problems to the point where she couldn't drive".  Unspecified medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  When asked if it was a significant disability/incapacity, "she said that she thinks it was because the patient could not drive a car".  Additional information has been requested.  8/19/08 To be linked to 311859 and 316857.  8/21/2008 Neurology consults received dated 5/2/2008 and 5/27/2008 with Assessment: Myalgias-began 3 weeks after the Gardasil shot and has continued for 3 weeks.  Not weak; doubt Guillain-Barre syndrome.  PCP refered pt with sx of fatigue, pain upon pulling legs and need to use handrail to pull self climbing stairs, also affects the joints. PCP ? latent virus, restless legs, or rxn to Gardasil (most likely).  PE WNL except 4+ DTRs in the lower extremities.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count normal, Mean cell haemoglobin concentration normal, Mean cell volume normal
Clinical narrative: Information has been received from a physician concerning an approximate 17 year old female who in April 2007 ("within the past 2-3 weeks") was vaccinated with a first dose of Gardasil 0.5 mL IM.  In April 2007, "couple of weeks" later the patient developed "muscular problems to the point where she couldn't drive".  Unspecified medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  When asked if it was a significant disability/incapacity, "she said that she thinks it was because the patient could not drive a car".  Additional information has been requested.  8/19/08 To be linked to 311859 and 316857.  8/21/2008 Neurology consults received dated 5/2/2008 and 5/27/2008 with Assessment: Myalgias-began 3 weeks after the Gardasil shot and has continued for 3 weeks.  Not weak; doubt Guillain-Barre syndrome.  PCP refered pt with sx of fatigue, pain upon pulling legs and need to use handrail to pull self climbing stairs, also affects the joints. PCP ? latent virus, restless legs, or rxn to Gardasil (most likely).  PE WNL except 4+ DTRs in the lower extremities.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Mean platelet volume normal, Monocyte count normal, Muscular weakness, Myalgia, Neurological examination
Clinical narrative: Information has been received from a physician concerning an approximate 17 year old female who in April 2007 ("within the past 2-3 weeks") was vaccinated with a first dose of Gardasil 0.5 mL IM.  In April 2007, "couple of weeks" later the patient developed "muscular problems to the point where she couldn't drive".  Unspecified medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  When asked if it was a significant disability/incapacity, "she said that she thinks it was because the patient could not drive a car".  Additional information has been requested.  8/19/08 To be linked to 311859 and 316857.  8/21/2008 Neurology consults received dated 5/2/2008 and 5/27/2008 with Assessment: Myalgias-began 3 weeks after the Gardasil shot and has continued for 3 weeks.  Not weak; doubt Guillain-Barre syndrome.  PCP refered pt with sx of fatigue, pain upon pulling legs and need to use handrail to pull self climbing stairs, also affects the joints. PCP ? latent virus, restless legs, or rxn to Gardasil (most likely).  PE WNL except 4+ DTRs in the lower extremities.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Neutrophil count normal, Platelet count normal, Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal
Clinical narrative: Information has been received from a physician concerning an approximate 17 year old female who in April 2007 ("within the past 2-3 weeks") was vaccinated with a first dose of Gardasil 0.5 mL IM.  In April 2007, "couple of weeks" later the patient developed "muscular problems to the point where she couldn't drive".  Unspecified medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  When asked if it was a significant disability/incapacity, "she said that she thinks it was because the patient could not drive a car".  Additional information has been requested.  8/19/08 To be linked to 311859 and 316857.  8/21/2008 Neurology consults received dated 5/2/2008 and 5/27/2008 with Assessment: Myalgias-began 3 weeks after the Gardasil shot and has continued for 3 weeks.  Not weak; doubt Guillain-Barre syndrome.  PCP refered pt with sx of fatigue, pain upon pulling legs and need to use handrail to pull self climbing stairs, also affects the joints. PCP ? latent virus, restless legs, or rxn to Gardasil (most likely).  PE WNL except 4+ DTRs in the lower extremities.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: White blood cell count normal
Clinical narrative: Information has been received from a physician concerning an approximate 17 year old female who in April 2007 ("within the past 2-3 weeks") was vaccinated with a first dose of Gardasil 0.5 mL IM.  In April 2007, "couple of weeks" later the patient developed "muscular problems to the point where she couldn't drive".  Unspecified medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  When asked if it was a significant disability/incapacity, "she said that she thinks it was because the patient could not drive a car".  Additional information has been requested.  8/19/08 To be linked to 311859 and 316857.  8/21/2008 Neurology consults received dated 5/2/2008 and 5/27/2008 with Assessment: Myalgias-began 3 weeks after the Gardasil shot and has continued for 3 weeks.  Not weak; doubt Guillain-Barre syndrome.  PCP refered pt with sx of fatigue, pain upon pulling legs and need to use handrail to pull self climbing stairs, also affects the joints. PCP ? latent virus, restless legs, or rxn to Gardasil (most likely).  PE WNL except 4+ DTRs in the lower extremities.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Inappropriate schedule of drug administration, Laboratory test
Clinical narrative: Information has been received from a 27 year old female with an allergic reaction to antibiotics who on 13-MAR-2007 was vaccinated with a first dose of GARDASIL.  On an unspecified date the patient was vaccinated with a second and third dose of GARDASIL.  There was no concomitant medication.  It was reported that the patient had three shots of GARDASIL and experienced a seizure disorder during sleep on 27-OCT-2007, 10-NOV-2007, 01-JAN-2008, 31-JAN-2008, 23-FEB-2008 and 03-APR-2008.  Unspecified medical attention was sought.  The patient had a computed axial tomography, diagnostic laboratory tests, electroencephalography and a magnetic resonance imaging performed.  The results were unknown.  At the time of reporting the patient had not recovered.  Upon internal review the event seizure disorder was considered to be an other medical event.  No additional information is available.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a 27 year old female with an allergic reaction to antibiotics who on 13-MAR-2007 was vaccinated with a first dose of GARDASIL.  On an unspecified date the patient was vaccinated with a second and third dose of GARDASIL.  There was no concomitant medication.  It was reported that the patient had three shots of GARDASIL and experienced a seizure disorder during sleep on 27-OCT-2007, 10-NOV-2007, 01-JAN-2008, 31-JAN-2008, 23-FEB-2008 and 03-APR-2008.  Unspecified medical attention was sought.  The patient had a computed axial tomography, diagnostic laboratory tests, electroencephalography and a magnetic resonance imaging performed.  The results were unknown.  At the time of reporting the patient had not recovered.  Upon internal review the event seizure disorder was considered to be an other medical event.  No additional information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Muscular weakness, Nerve injury, Pain in extremity, Physiotherapy
Clinical narrative: Information has been received from a physician concerning an 18 or 19 year old female who in March 2007, was vaccinated with a first dose of Gardasil IM.  In March 2007 the patient experienced nerve impact in her shoulder blade.  The patient went through physical therapy to repair the nerve damage.  The patient was unable to play softball because of the weakness and pain in her arm.  The patient could not fully use her arm.  At the time of reporting the patient was recovering.  The reporter considered the events to be disabling.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Lt arm-back (SC) Zostavax vaccine injected.  2 days later has reddened area 25 mm in circumf.  Swelling slightly today with itching noted.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Electrocardiogram, Full blood count, Laboratory test, Metabolic function test
Clinical narrative: Onset 4-19-08 - X2 episodes of fainting, SOB, palpitations facial & extremity tingling, X1 syncopal episode 5-2-08 with same symptoms -> seen at ER.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Paraesthesia, Spirometry, Syncope
Clinical narrative: Onset 4-19-08 - X2 episodes of fainting, SOB, palpitations facial & extremity tingling, X1 syncopal episode 5-2-08 with same symptoms -> seen at ER.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Epistaxis, Full blood count, Hyperhidrosis, Injection site erythema
Clinical narrative: Pt has an area of redness and swelling the size of a 50 cent piece at injection site: c/o fever, chills and sweats onset 5/1/08. Also nose bleed. Fever on 5/1/08 102.9 now with intermittent fevers.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Pt has an area of redness and swelling the size of a 50 cent piece at injection site: c/o fever, chills and sweats onset 5/1/08. Also nose bleed. Fever on 5/1/08 102.9 now with intermittent fevers.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: The injection site on the back of my right arm became very red, very hard and very hot.  I started getting a reaction late Monday, 4/21.  By Wednesday afternoon, the reaction had gotten the size of a grapefruit, was extremely warm and beet red.  I applied a hydrocortisone cream & started taking Benadryl.  Continued treatment for three days.  I still have a slightly red area that itches.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: On 4/2/08 pt came back to health center to have her arm checked.  There was a 2 inch red raised wheal on arm at site of YF vaccine given 3-28-08.  She states bump started on 4-1-08 around noon & was very itchy.  On 4-2-08 she states the bump is the same size as 4-1-08 & less itchy.  Denies itchiness elsewhere on body, difficulty breathing, swollen throat or other allergy sx.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injection site bruising, Mass, Pain, Pain in extremity
Clinical narrative: 4/4/08 Office visit stating she has hard, sore lump on left arm - no bruising or redness noted.  4/8/08 OV stating arm throbbing from elbow to hand.  4/9/08 OV bruise larger than half dollar at injection site connected by thin bruise line to another bruised area below and left of initial site.
Age: 39.0
Sex: U
Vaccine: ANTH, UNK
Symptoms: Arthralgia, Balance disorder, Dizziness, Headache, Hypertension
Clinical narrative: Headache frequently, nausea, dizziness & vertigo.  Pain in the joints all the body, body aching, losing balance, high blood pressure.
Age: 39.0
Sex: U
Vaccine: ANTH, UNK
Symptoms: Nausea, Pain, Vertigo
Clinical narrative: Headache frequently, nausea, dizziness & vertigo.  Pain in the joints all the body, body aching, losing balance, high blood pressure.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: LD area red, swollen and warm.  X3 days.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: L deltoid redness, swelling, itching.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Body temperature increased, Headache, Nausea, Vomiting
Clinical narrative: Gardasil inj given at 8:30am on 4/30/08.  Pt started feeling nauseous.  By evening pt felt weak, wheezing, vomiting until 5am, temp 104 degrees, & HA.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Wheezing
Clinical narrative: Gardasil inj given at 8:30am on 4/30/08.  Pt started feeling nauseous.  By evening pt felt weak, wheezing, vomiting until 5am, temp 104 degrees, & HA.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Zostavax shot which resulted in an allergic reaction.  Site of administration was swollen, red, warm to touch within 3-4 hours after receiving.  Patient received Benadryl po, cream & cold ice patch the relieved swelling.
Age: 40.0
Sex: M
Vaccine: RAB
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: Donor exper nausea, diarrhea, fever 24 hrs after receiving vaccine.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Erythema wheal on R upper arm, tender to touch.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema, Rash macular
Clinical narrative: Parent reported via phone on 4/18/08 that pt had "red blotches" all over.  Tx with Atavax po.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Dizziness, Injection site induration, Injection site pain, Musculoskeletal pain
Clinical narrative: Area around inj site became hard and sore, got home hardness area expended.  No redness but forearm & shoulder hurts.  Also pt felt some what dizzy.  Cellulitis 5-2-08 Rocephin one gam IM given and Rx for Augmentin bid 875 mg.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Area around inj site became hard and sore, got home hardness area expended.  No redness but forearm & shoulder hurts.  Also pt felt some what dizzy.  Cellulitis 5-2-08 Rocephin one gam IM given and Rx for Augmentin bid 875 mg.
Age: 29.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: 50mm wheal - red - swollen.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash, Injection site scab, Injection site swelling
Clinical narrative: Swelling and redness at site x 2 weeks with rash. Now rash and scabbing at site/discoloration approx 3.5cm.