chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Surgery
Clinical narrative: OCTOBER 10, 2007:  Patient completes a routine physical examination from Dr.  Patient is not experiencing any health problems and none are found during this examination.  Dr. recommends patient receive two vaccines due to her age: (1) Meningitis vaccine  (2) Cervical cancer vaccine series.  After discussion with Dr., we decide to receive only the Meningitis Vaccine at this time. One shot of Menactra was administered at this time.  NOVEMBER 18, 2007:  Patient informs me of a small raised bump on the back top of her head approximately 1" in diameter.  I told her to let me know if this bump doesn't go away. JANUARY 24, 2008: My wife is sitting on our couch rubbing patient head when she feels a large mass approximately 4" in diameter contouring to the top back of patient's skull.  Patient said it felt like part of her head when she was washing her hair.  I immediately took patient to Hospital to be examined.  An X-Ray showed a large bone distortion at the site of the mass, and we were advised to seek medical attention promptly at  Hospital in downtown.  An appointment was scheduled with neuro-surgeon on 1-25-08.  January 25, 2008:  Patient sees Dr., who examines patient, and orders a series of tests and scans.  The tests and scans indicate a lesion has developed in the meninges area of her skull, and is destroying a large portion of the skull bone in this area.  Dr. recommends surgery as soon as possible to remove the infected bone and area. FEBRUARY 5, 2008:  Patient has surgery at Hospital in downtown.  A large 4" section of her skull bone is cut out, and replaced with a temporary metal plate. FEBRUARY 25, 2008:  Patient has appointment with Dr. to evaluate her recovery.  Scan performed to size opening in patient's skull for fitting a permanent plastic covering for this area.  Surgery scheduled for May 2008, to insert plastic covering into opening. MAY 5, 2008:  Patient's pre-op work at Hospital. MAY 13, 2008: Patient has skull reconstruction surgery completed.  She will need to be seen annaully for evaluations.  1/20/09 Reviewed hospital medical records of 5/13-5/14/2008 & additional clinic records of 1/24-5/27/2008. FINAL DX: intraosseous calavarial meningioma, s/p cranioplasty Records revela patient experienced bony & scalp occipital lump.  Had been initially noted appro 3 mos earlier & thought to be secondary to trauma.  Thought to be resolved until 1/24/08.  Seen in Urgent Care.  Suspicious for osteosarcoma & referred to Heme/Onc clinic.  Seen in clinic 1/25/08 & sent for neurosurgery eval.  Craniectomy for mass excision done 2/5/08 & the resulting calavarial defect was repaired 5/13/08. Follow-up: Meninges lining shows abnormalities and has affected over laying skull bone. Surgical removed of this bone was necessary (cranioplasty) in 2008. See pictures a large plastic implant has replaced skull bone, however the meninge lining could not be removed.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: My Arm became red and swollen and painful.  This occurred 48 hours after flu shot.  After three weeks my arm did recover mostly, but is still a little red.  I continue to put cortisone cream on it.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site pruritus, Injection site rash
Clinical narrative: Itchy rash around site of vaccine administration beginning 4 days after administration and continuing to spread outward at time of this form being filled out.  Also, "hot" sensation generally throughout bones in the evenings.
Sex: U
Vaccine: TDAP, TDAP
Symptoms: Radiculitis brachial, X-ray
Clinical narrative: brachial neuritis
Sex: U
Vaccine: TDAP, TDAP
Symptoms: Insomnia, Neck pain, Pain in extremity, Radiculitis brachial
Clinical narrative: brachial neuritis
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Full blood count normal, Injection site erythema, Injection site streaking, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling and streaking at injection site. Area of swelling increase over time, approx 7" by 5" wide. Low grade fever.  Zpack given, symptoms resolved.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Hyperhidrosis, Inflammation, Oedema peripheral, Pain in extremity
Clinical narrative: PPV administered @ 3 PM.  By 6 PM pt. reports arm swollen and very painful.  By 9 PM pt. reports she felt feverish, chills, vomited, diaphoretic. Seen by PCP 11/24/08.  Prescribed 6 day course of steroids to reduce inflammation and swelling.  Pt. reports each day the arm is improving.  Last conversation with patient 11/26/08.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: PPV administered @ 3 PM.  By 6 PM pt. reports arm swollen and very painful.  By 9 PM pt. reports she felt feverish, chills, vomited, diaphoretic. Seen by PCP 11/24/08.  Prescribed 6 day course of steroids to reduce inflammation and swelling.  Pt. reports each day the arm is improving.  Last conversation with patient 11/26/08.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Crying, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Child cried afer immunizations were administered in thighs bilaterally.  Grandmother gave child tylenol before shots were given. Instructed grandmother to put cool washclothes  on childs legs to help with the soreness.  She called back today and said that the child got a very high fever and stated having seizures Saturday night. Stated that baby would not sleep unless someone was walking around with him.  His skin was bright red from the waist down.  Grandmother stated that he had approx. 10-15 seizures.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Day following vaccination area was swollen and red, slightly itchy.  On Rt upper thigh had a large fading giant macule, 19.5x13 cm in size.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Persistent but improving pain to site of injection. Still has pain after 10/17/08 administration. Pain increases with adduction motion. No other complaints.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection swollen, warm, reddened, and tender.  Site very itchy, reddness measuring approximately 2 to 3 inches in diameter.  Site improving with application of hydrocortisone creme for inflammation and warm moist compresses.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site mass, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: PM on 11/7/08 - Site sore with small lump felt AM on 11/8/08 - 1 1/2 by 2 inch hard lump at injection site and arm sore, PM on 11/8/08 - Same size area, but arm hurt from elbow to neck with Rt shoulder sore.  11/10/08 - area smaller and arm less sore by 11/14/08 almost gone, arm achy, arm remains swollen and sore.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: - Break out pruritic rash on hands, right eye, back of neck and head, and red rash around angiogram site. Patient was given cortisone injection and was told to take benadryl at night.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Areflexia, Blood pressure decreased, Blood product transfusion, Blood test, Computerised tomogram
Clinical narrative: Extreme nausea, dizziness along with bouncing vision  and double vision.There also was a loss of reflexes in many extremities.There also was a drop in blood pressure.Had eye drooping. paralysis of eyes.Treatments included plasmaphresis and Ivig treatments.There was also many medicines after discharge from hospital.This was an horrible time in our families lifes. 1/7/09-records received for DOS 10/16-10/22/08-DX DC: Blurred vision probably related to Miller Fisher variant of Guillain-Barre syndrome. Vertigo. Mild leukocytosis without clear source. Admitted with C/O increased blurred vision. Left eye ptosis, nausea. Dizziness began 12 days prior.Plasmapheresis. Transferred to tertiary care center.  2/17/09-records received for DOS 10/22-11/4/08-transferred to rehab facility with IVIG.  02/01/2010 I still experience dizziness and double vision at times. My left side of my face is also still affected at times.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Dizziness, Facial palsy, IIIrd nerve paralysis, Lumbar puncture
Clinical narrative: Extreme nausea, dizziness along with bouncing vision  and double vision.There also was a loss of reflexes in many extremities.There also was a drop in blood pressure.Had eye drooping. paralysis of eyes.Treatments included plasmaphresis and Ivig treatments.There was also many medicines after discharge from hospital.This was an horrible time in our families lifes. 1/7/09-records received for DOS 10/16-10/22/08-DX DC: Blurred vision probably related to Miller Fisher variant of Guillain-Barre syndrome. Vertigo. Mild leukocytosis without clear source. Admitted with C/O increased blurred vision. Left eye ptosis, nausea. Dizziness began 12 days prior.Plasmapheresis. Transferred to tertiary care center.  2/17/09-records received for DOS 10/22-11/4/08-transferred to rehab facility with IVIG.  02/01/2010 I still experience dizziness and double vision at times. My left side of my face is also still affected at times.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Miller Fisher syndrome, Nausea, Ocular myasthenia, Ophthalmoplegia, Plasmapheresis
Clinical narrative: Extreme nausea, dizziness along with bouncing vision  and double vision.There also was a loss of reflexes in many extremities.There also was a drop in blood pressure.Had eye drooping. paralysis of eyes.Treatments included plasmaphresis and Ivig treatments.There was also many medicines after discharge from hospital.This was an horrible time in our families lifes. 1/7/09-records received for DOS 10/16-10/22/08-DX DC: Blurred vision probably related to Miller Fisher variant of Guillain-Barre syndrome. Vertigo. Mild leukocytosis without clear source. Admitted with C/O increased blurred vision. Left eye ptosis, nausea. Dizziness began 12 days prior.Plasmapheresis. Transferred to tertiary care center.  2/17/09-records received for DOS 10/22-11/4/08-transferred to rehab facility with IVIG.  02/01/2010 I still experience dizziness and double vision at times. My left side of my face is also still affected at times.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Extreme nausea, dizziness along with bouncing vision  and double vision.There also was a loss of reflexes in many extremities.There also was a drop in blood pressure.Had eye drooping. paralysis of eyes.Treatments included plasmaphresis and Ivig treatments.There was also many medicines after discharge from hospital.This was an horrible time in our families lifes. 1/7/09-records received for DOS 10/16-10/22/08-DX DC: Blurred vision probably related to Miller Fisher variant of Guillain-Barre syndrome. Vertigo. Mild leukocytosis without clear source. Admitted with C/O increased blurred vision. Left eye ptosis, nausea. Dizziness began 12 days prior.Plasmapheresis. Transferred to tertiary care center.  2/17/09-records received for DOS 10/22-11/4/08-transferred to rehab facility with IVIG.  02/01/2010 I still experience dizziness and double vision at times. My left side of my face is also still affected at times.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: 20 minutes after administration of vaccine client became faint and diaphoretic.
Age: 0.92
Sex: F
Vaccine: UNK
Symptoms: Anorexia, Restlessness, Vomiting
Clinical narrative: Loss of appetite, Vomiting, Restlessness
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Neuralgia, Pain in extremity
Clinical narrative: Patient said that she could tell after her shot that something was wrong, although she did not inform the pharmacist.  She said that she felt sick the next day after the shot. Now her arm has been hurting since 11/3/08 that she received the shot.  She saw a doctor on the 14 and he said that it was nerve pain.
Age: 37.0
Sex: F
Vaccine: FLUN3
Symptoms: Burning sensation, Ear, nose and throat examination normal, Epstein-Barr virus test, Headache, Neuralgia
Clinical narrative: First had flu mist 2007 and started having severe symptoms of severe headache on back of head and then left side of head and neck.  Burning, painful sensation along occipital nerve area on left side. Symptoms lasted 4-6 months.  2007 received flu shot and had minor symptoms.  Had flu mist again 2008 and started symptoms all over again same area and type but not as severe as first year.  Saw 2 neurologists and ear-nost-throat specialist who could not find cause.  Did suggest occipital neuralgia.
Age: 37.0
Sex: F
Vaccine: FLUN3
Symptoms: Neurological examination normal, Occipital neuralgia, Vaccine positive rechallenge
Clinical narrative: First had flu mist 2007 and started having severe symptoms of severe headache on back of head and then left side of head and neck.  Burning, painful sensation along occipital nerve area on left side. Symptoms lasted 4-6 months.  2007 received flu shot and had minor symptoms.  Had flu mist again 2008 and started symptoms all over again same area and type but not as severe as first year.  Saw 2 neurologists and ear-nost-throat specialist who could not find cause.  Did suggest occipital neuralgia.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Fluid intake reduced, Pneumonia, Pyrexia, Unresponsive to stimuli
Clinical narrative: This case was reported by a pharmacist and described the occurrence of fever in a 55-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 10 November 2008 at 08:00, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 10 November 2008, less than one day after vaccination with FLULAVAL, the subject experienced fever. The pharmacist received a call from the subject's husband, who reported that his wife experienced a "very high fever" since receiving the FLULAVAL vaccination. The husband noted that the fever had worsened to 104 degrees. The pharmacist did not have any further details. Relevant test results included body temperature of 104 degrees. At the time of reporting the event was worse. Follow-up information was received on 01 December 2008, via pharmacist, who reported he spoke with the subject's son. He reported the subject's temperature rose to 106.7 the next day. She was not drinking and was unresponsive. She went to the emergency room and the physician ran tests, but it showed nothing. She was hospitalized and developed pneumonia. The subject was discharged and is doing better. It was reported that the onset date was 10 October 2008, which conflicts with previously reported date of 10 November 2008. The subject was hospitalised and the pharmacist considered the events were disabling. At the time of reporting the events were improved. The pharmacist considered the events were possibly related to vaccination with FLULAVAL.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site pain, Injection site reaction, Monoplegia
Clinical narrative: This case was reported by a pharmacist (also the subject's sister) and described the occurrence of injection site redness in a 41-year-old female subject who was vaccinated with FLULAVAL, GlaxoSmithKline.  Concurrent medications included Fluoxetine.  On 27 September 2008 at 22:00 the subject received a dose of FLULAVAL at 0.5 ml in the left arm.  Several days following administration of FLULAVAL, the subject experienced injection site redness, injection site soreness, numbness at the injection site and injection site tingling.  It was also reported that the subject was experiencing arm paralysis which also began several days following FLULAVAL injection.  She has to move the affected arm with her other arm, however, she does have feeling in the affected arm.  The pharmacist considered the events were clinically significant (or requiring intervention).  The subject was treated with Ibuprofen.  At the time of reporting the events seemed to be worsening and becoming disabling.  The pharmacist considered the events were possibly related to vaccination with FLULAVAL.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a pharmacist (also the subject's sister) and described the occurrence of injection site redness in a 41-year-old female subject who was vaccinated with FLULAVAL, GlaxoSmithKline.  Concurrent medications included Fluoxetine.  On 27 September 2008 at 22:00 the subject received a dose of FLULAVAL at 0.5 ml in the left arm.  Several days following administration of FLULAVAL, the subject experienced injection site redness, injection site soreness, numbness at the injection site and injection site tingling.  It was also reported that the subject was experiencing arm paralysis which also began several days following FLULAVAL injection.  She has to move the affected arm with her other arm, however, she does have feeling in the affected arm.  The pharmacist considered the events were clinically significant (or requiring intervention).  The subject was treated with Ibuprofen.  At the time of reporting the events seemed to be worsening and becoming disabling.  The pharmacist considered the events were possibly related to vaccination with FLULAVAL.
Sex: U
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Nausea, Pain, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an elderly subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved, but the outcome of nausea was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that there outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758822A, A0758823A, A0758824A, and A0758825A.
Sex: U
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an elderly subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved, but the outcome of nausea was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that there outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758822A, A0758823A, A0758824A, and A0758825A.
Sex: U
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Pain, Pharmaceutical product complaint, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved, but the outcome of nausea was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758823A, A0758824A and A0758825A.
Sex: U
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Nausea, Pain, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL(GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. Dehydration was also reported. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was hospitalized. At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758822A, A0758824A and A0758825A.
Sex: U
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL(GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. Dehydration was also reported. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was hospitalized. At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758822A, A0758824A and A0758825A.
Sex: U
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Nausea, Pain, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline).  On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml.  On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain.  Dehydration was also reported.  The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL.  This was considered to be a product complaint.  The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention).  The subject was hospitalized.  At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.  A health educator requested information for a specific lot of FLULAVAL.  A retirement home vaccinated a number of adults and elderly subjects on two different dates.  On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea.  Body aches were also documented.  The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL.  Three of the subjects developed dehydration and were also hospitalized.  The facility was ruling out viral causes also. Linked cases numbers include:  A0758812A, A0758823A, A0758823A and A0758825A.
Sex: U
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline).  On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml.  On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain.  Dehydration was also reported.  The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL.  This was considered to be a product complaint.  The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention).  The subject was hospitalized.  At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.  A health educator requested information for a specific lot of FLULAVAL.  A retirement home vaccinated a number of adults and elderly subjects on two different dates.  On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea.  Body aches were also documented.  The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL.  Three of the subjects developed dehydration and were also hospitalized.  The facility was ruling out viral causes also. Linked cases numbers include:  A0758812A, A0758823A, A0758823A and A0758825A.
Sex: U
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Nausea, Pain, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. Dehydration was also reported. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was hospitalized. At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758822A, A0758823A and A0758824A.
Sex: U
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in an adult (possibly elderly) subject of unspecified gender who was vaccinated with FLULAVAL, (GlaxoSmithKline). On 05 or 21 November 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 26 November 2008, the subject developed severe nausea, vomiting, diarrhea and body pain. Dehydration was also reported. The nursing supervisor of the facility was concerned that the outbreak was related to vaccination with FLULAVAL. This was considered to be a product complaint. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was hospitalized. At the time of reporting the events were unresolved, but the outcome of nausea and dehydration was not specifically reported. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. A health educator requested information for a specific lot of FLULAVAL. A retirement home vaccinated a number of adults and elderly subjects on two different dates. On 26 November 2008, approximately 40 of these individuals (staff and residents) developed severe nausea, vomiting and diarrhea. Body aches were also documented. The nursing supervisor of the facility was concerned that these outbreaks were related to vaccination with FLULAVAL. Three of the subjects developed dehydration and were also hospitalized. The facility was ruling out viral causes also. Linked cases numbers include: A0758812A, A0758822A, A0758823A and A0758824A.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Grand mal convulsion, Influenza like illness, Malaise, Oropharyngeal pain
Clinical narrative: We received from a physician the following information on 19 NOV 2008: A 12-year-old boy, born on 11 AUG 1996, received FLUVIRIN, batch-no. 89976, on 13 NOV 2008. "Over the weekend the patient developed influenza-like symptoms (weakness, aches, sore throat)". It is reported that on 18 NOV 2008 he had a tonic-clonic seizure lasting for 5 minutes. The seizure did not require a treatment. At the time of report the patient has malaise and is still ill. An EEG is planned.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: We received from a physician the following information on 19 NOV 2008: A 12-year-old boy, born on 11 AUG 1996, received FLUVIRIN, batch-no. 89976, on 13 NOV 2008. "Over the weekend the patient developed influenza-like symptoms (weakness, aches, sore throat)". It is reported that on 18 NOV 2008 he had a tonic-clonic seizure lasting for 5 minutes. The seizure did not require a treatment. At the time of report the patient has malaise and is still ill. An EEG is planned.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Leukocytosis, Pain in extremity, Pyrexia, White blood cell count increased
Clinical narrative: 3 hours after vaccine, severe arm pain, unable to move left arm. Fever 102. Leukocytosis 12/2/08. Still with severe arm pain and unable to perform active range of motion.  12/19/2008 MR received for DOS 11/25-26/2008 with DX: L shoulder myositis s/p pneumonia vaccine.  Pt presented severe, worsening L arm pain. PE (+) for elevated BP 214/88, T=101.9'F, decreased ROM of L shoulder with (+) tenderness. Tx with abx, anti-inflammatories and pain meds and d/c to f/u w/ PCP.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Grip strength decreased, Injected limb mobility decreased, Injection site pain
Clinical narrative: Flu vaccine administered November 10, 2008, left deltoid.  Pt has experienced pain (8 on scale 1-10) from site of injection to elbow.  Hurts to rotate arm.  Decreased strength for holding items.  Unable to left arm above elbow height.  Symptoms have occured X 3 wks and continue.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Ultrasound scan normal
Clinical narrative: (L) arm sore since receiving FLUZONE 10/28/08. Started getting sore the evening she got shot. No redness or swelling. Ultrasound negative for hematoma. Prednisone gave little relief. Ibuprofen takes edge off.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: Started 3 weeks ago, improving now. 2 months of joint and muscle aches, weakness, fatigue, migraines, sinus pressure. nausea, vomiting, and diarrhea began 2 weeks after injection and resolved. nausea, vomiting, diarrhea again 3 weeks ago. Intermittent chest pain and shortness of breath 3 weeks ago. Bloody nasal discharge. 1/15/09-records received-6/13/08-did  not follow up with referral due to lack of insurance. Pevlic pain now resolved. Changed pills now C/O circumoral rash and increased headaches. 7/8/08-Gardasil given C/O feeling tired. 9/10/08-Gardasil given.12/1/08-C/O fatigue, nausea, vomiting,diarrhea, dizziness, migraines, since last gardasil shot, 2 months of  joint and muscle  aches, weak, exhaustion.Hair loss improving. PE:normal  hair pattern. 1/27/09-records received-on 11/10/08 C/O nausea, vomiting, diarrhea since night prior, increased malaise, joint pain, epigastric pain. Stressed regarding complaints related to Gardasil. Assessment:anxiety, gastritis. 11/19/08-weight loss of 15 pounds. Loose stools and constipation. Tired. Assessment:fatigue, muscle ache, diarrhea/constipation. 11/26/08-diarrhea continues intermittently, mucle aches, joint pain intermittent. Assessment: symptoms related to anxiety and sedentary lifestyle and poor dieting with numerous somatic complaints.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Migraine, Myalgia, Nausea, Rhinorrhoea
Clinical narrative: Started 3 weeks ago, improving now. 2 months of joint and muscle aches, weakness, fatigue, migraines, sinus pressure. nausea, vomiting, and diarrhea began 2 weeks after injection and resolved. nausea, vomiting, diarrhea again 3 weeks ago. Intermittent chest pain and shortness of breath 3 weeks ago. Bloody nasal discharge. 1/15/09-records received-6/13/08-did  not follow up with referral due to lack of insurance. Pevlic pain now resolved. Changed pills now C/O circumoral rash and increased headaches. 7/8/08-Gardasil given C/O feeling tired. 9/10/08-Gardasil given.12/1/08-C/O fatigue, nausea, vomiting,diarrhea, dizziness, migraines, since last gardasil shot, 2 months of  joint and muscle  aches, weak, exhaustion.Hair loss improving. PE:normal  hair pattern. 1/27/09-records received-on 11/10/08 C/O nausea, vomiting, diarrhea since night prior, increased malaise, joint pain, epigastric pain. Stressed regarding complaints related to Gardasil. Assessment:anxiety, gastritis. 11/19/08-weight loss of 15 pounds. Loose stools and constipation. Tired. Assessment:fatigue, muscle ache, diarrhea/constipation. 11/26/08-diarrhea continues intermittently, mucle aches, joint pain intermittent. Assessment: symptoms related to anxiety and sedentary lifestyle and poor dieting with numerous somatic complaints.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Sinus headache, Vomiting
Clinical narrative: Started 3 weeks ago, improving now. 2 months of joint and muscle aches, weakness, fatigue, migraines, sinus pressure. nausea, vomiting, and diarrhea began 2 weeks after injection and resolved. nausea, vomiting, diarrhea again 3 weeks ago. Intermittent chest pain and shortness of breath 3 weeks ago. Bloody nasal discharge. 1/15/09-records received-6/13/08-did  not follow up with referral due to lack of insurance. Pevlic pain now resolved. Changed pills now C/O circumoral rash and increased headaches. 7/8/08-Gardasil given C/O feeling tired. 9/10/08-Gardasil given.12/1/08-C/O fatigue, nausea, vomiting,diarrhea, dizziness, migraines, since last gardasil shot, 2 months of  joint and muscle  aches, weak, exhaustion.Hair loss improving. PE:normal  hair pattern. 1/27/09-records received-on 11/10/08 C/O nausea, vomiting, diarrhea since night prior, increased malaise, joint pain, epigastric pain. Stressed regarding complaints related to Gardasil. Assessment:anxiety, gastritis. 11/19/08-weight loss of 15 pounds. Loose stools and constipation. Tired. Assessment:fatigue, muscle ache, diarrhea/constipation. 11/26/08-diarrhea continues intermittently, mucle aches, joint pain intermittent. Assessment: symptoms related to anxiety and sedentary lifestyle and poor dieting with numerous somatic complaints.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Prostatic disorder, Urticaria
Clinical narrative: Called to report hives to his chest, back and face.  Breathing DK at 6:30 pm 12-2-8.  No reaction at injection sites.  Pt. stated he has severe prostate issues.  I told him to call his PCP.  MD told him to take a few doses of BENADRYL & go to ER if no improvement.  Phoned Pt wife 9 pm she gave 1 dose BENDRYL.  He is improving quickly.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Choking, Cyanosis, Respiratory distress, Vomiting
Clinical narrative: Vomited, choked, resp. distress-cyanosis in evening after injection. Went to ER where she had 2-3 more episodes with vomiting. Pt stabilized and was discharged.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hot flush, Rash, Skin warm
Clinical narrative: EE received FLUZONE on 10/30 around 12 noon. EE states noted "hot flashes" to face with 3 hrs of injection, noted rash on neck and cheeks 2 days after injection 11/1/08. Reported this to nurse on 11/2/08 rash felt hot, self treated with cold compresses. States rash took 1 1/2 weeks to dissipate.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Full blood count, Henoch-Schonlein purpura, Metabolic function test, Urine analysis
Clinical narrative: Onset of symptoms 11/20/08 - Present seen in ER 11/28/08 diagnosed with Henoch Schonlein purpura. Symptoms included small papable purpura on legs and buttocks. 12/30/2008 MR received for ER visitfor c/o rash. Dx:  Henoch-Schonlein Purpura. Pt presented with 1 wk hx of macular rash on legs and buttocks.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. states she noticed a "brown spot" on arm when she removed the bandaide 4 hours after GARDASIL injection. Area started itching 2-3 days later and has not stopped- (has been scratching). Redness at site started 2 weeks later and then started having pain radiating out 4 inches diameter around site- minor swelling noted. No treatment done. Reported on 12/2/08 to CCHD- Instructed to see PMD immediately.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Headache, Nausea, Pain, Restlessness
Clinical narrative: With in 2 hours of receiving vaccine, felt like a "tight vice around my waist, and abd. large and distended; very achy. Restless night, mild nausea, H/A this AM, mild".
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Condition aggravated, Cough, Influenza like illness
Clinical narrative: At 1:30pm three hours after flu shot was administered I began to wheeze and cough (similar to asthma attack) I went to speak to head nurse form hospital who was still at my place of employment. She said if I was not allergic to eggs or chicken to call my doctor.  I called doctor's office and explained.  They called in a prescription for ALBUTAROL (haven't needed it for two yrs.)  In the evening I had a temp of 101, shivering, flu like symptoms (severe)
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: At 1:30pm three hours after flu shot was administered I began to wheeze and cough (similar to asthma attack) I went to speak to head nurse form hospital who was still at my place of employment. She said if I was not allergic to eggs or chicken to call my doctor.  I called doctor's office and explained.  They called in a prescription for ALBUTAROL (haven't needed it for two yrs.)  In the evening I had a temp of 101, shivering, flu like symptoms (severe)
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dyspnoea, Livedo reticularis, Pyrexia
Clinical narrative: Healthy 3 1/2 month female infant received immunization PEDIARIX, ACTHIB, PREVNAR and ROTATEQ and dev. low grade fever with mottling of extremities and problems breathing 12 hrs later.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Asthma, Condition aggravated, Erythema, Headache, Myalgia
Clinical narrative: Fercrisness, headache, muscle ache, arm pain, redness. Asthma symptoms
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fercrisness, headache, muscle ache, arm pain, redness. Asthma symptoms
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: 20 minutes post injection. 5-6 cm redness around injection site where VARIVAX was administered. Advised mom to monitor. Spoke with mom this AM. Pt last PM developed a nodule. Mom did warm compresses. Gave Benadryl. Afebrile per mom. Pt has no other symptoms today.
Age: 0.3
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No symptoms and no asthma/ findings on exam. Plan to f/u in 7 days/ MOC was advise to call or go to ED if fever, rash or any reactions.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: 11/21/08-"Pain began evening of 11/21/08 (several hours after receiving injection).  Swelling, reddness warmth began 11/22/08 above & below elbow on right arm.  Saw primary MD 11/24/08.  Symptoms subsided that evening.  No antibiotics needed".
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Conjunctivitis, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: 15 year old female LMP 9/2/08 urine HCG negative 9/28/08. GARDASIL given 9/30/08.  Urine HCG positive 10/17/08 with positive exam HCG(126.7) on same day. status post spontaneous abortion 10/22/08.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: 15 year old female LMP 9/2/08 urine HCG negative 9/28/08. GARDASIL given 9/30/08.  Urine HCG positive 10/17/08 with positive exam HCG(126.7) on same day. status post spontaneous abortion 10/22/08.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Caesarean section, Cephalo-pelvic disproportion, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a 24 year old female consumer for the Pregnancy Registry for GARDASIL concerning herself with a history of methicillin-resistant staphylococcal aureus infection in August 2007 who on 24-DEC-2007 was vaccinated with her first dose of GARDASIL (lot# not reported). On 03-MAR-2008 the patient was vaccinated with her second dose of GARDASIL (lot# not reported). There was no concomitant medication. On 10-MAR-2008 the patient found out she was pregnant with 3 positive home pregnancy tests. She also had an examine with the nurse practitioner to confirm she was 9 weeks pregnant. Her estimated LMP was 05-JAN-2008 and her outcome was not reported. Follow-up information was received from a physician concerning the 24 year old female patient with a history of eczema, carpal tunnel and anemia. No previous pregnancies. On 15-APR-2008, ultrasound was performed with result within normal limits. On an unspecified date, the patient developed anemia during pregnancy. On 13-NOV-2008, the patient delivered a liveborn male infant by cesearean section due to cephalo-pelvic disproportion. Infant weighed 9 pounds 11 ounces. The infant's apgar score was 9/9. The infant was normal, with no congenital anomalies. There was no infection or illness during pregnancy. The infant's delivery by cesearean section due to cephalo-pelvic disproportion was considered an other important medical event. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Information has been received from a 24 year old female consumer for the Pregnancy Registry for GARDASIL concerning herself with a history of methicillin-resistant staphylococcal aureus infection in August 2007 who on 24-DEC-2007 was vaccinated with her first dose of GARDASIL (lot# not reported). On 03-MAR-2008 the patient was vaccinated with her second dose of GARDASIL (lot# not reported). There was no concomitant medication. On 10-MAR-2008 the patient found out she was pregnant with 3 positive home pregnancy tests. She also had an examine with the nurse practitioner to confirm she was 9 weeks pregnant. Her estimated LMP was 05-JAN-2008 and her outcome was not reported. Follow-up information was received from a physician concerning the 24 year old female patient with a history of eczema, carpal tunnel and anemia. No previous pregnancies. On 15-APR-2008, ultrasound was performed with result within normal limits. On an unspecified date, the patient developed anemia during pregnancy. On 13-NOV-2008, the patient delivered a liveborn male infant by cesearean section due to cephalo-pelvic disproportion. Infant weighed 9 pounds 11 ounces. The infant's apgar score was 9/9. The infant was normal, with no congenital anomalies. There was no infection or illness during pregnancy. The infant's delivery by cesearean section due to cephalo-pelvic disproportion was considered an other important medical event. Additional information is not expected.