chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Parkinson's disease, Physical examination
Clinical narrative: Patient developed symptoms of Parkinsonism less than 2 months after vaccination
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Pyrexia
Clinical narrative: mildly high fever, headache.  We called the pediatrician, they claim it was not from vaccination.
Age: 92.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Coordination abnormal, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: A 91 yr old presented to the ER with painful paresthesia of both feet, abrupt onset of difficulty with ambulation, subjective weakness and incoordination of both lower extremities and back pain. Neurology felt abrupt onset of symptoms precluded a diagnosis of Guillain Barre syndrome. Patient received a flu shot in late January and the timing suggests that was the initiating source of GBS.  5/1/07 Received medical records from hospital which reveal patient experienced painful paresthesia of both feet up to ankles, intrascapular back pain, weakness & difficulty walking for 1-2 days.  Admitted 2/10/07-2/22/07 for ataxia.  Had persistent HTN while hospitalized & a heart murmur.  Consults by neuro, pulmonary, surgery, nephrology, physical med.  Tx w/plasma phoresis x 5 which did improve sensorimotor function & was able to ambulate w/walker at d/c to inpatient rehab facility where she stayed from 2/22-3/16/07 when she was d/c to home with continued home health care.  FINAL DX: Guillain Barre Syndrome.
Age: 92.0
Sex: F
Vaccine: FLUX
Symptoms: Neurological examination abnormal, Pain in extremity, Paraesthesia
Clinical narrative: A 91 yr old presented to the ER with painful paresthesia of both feet, abrupt onset of difficulty with ambulation, subjective weakness and incoordination of both lower extremities and back pain. Neurology felt abrupt onset of symptoms precluded a diagnosis of Guillain Barre syndrome. Patient received a flu shot in late January and the timing suggests that was the initiating source of GBS.  5/1/07 Received medical records from hospital which reveal patient experienced painful paresthesia of both feet up to ankles, intrascapular back pain, weakness & difficulty walking for 1-2 days.  Admitted 2/10/07-2/22/07 for ataxia.  Had persistent HTN while hospitalized & a heart murmur.  Consults by neuro, pulmonary, surgery, nephrology, physical med.  Tx w/plasma phoresis x 5 which did improve sensorimotor function & was able to ambulate w/walker at d/c to inpatient rehab facility where she stayed from 2/22-3/16/07 when she was d/c to home with continued home health care.  FINAL DX: Guillain Barre Syndrome.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Patient received PPD .5cc IM left deltoid - was to have received Tdap instead. Called for recommendations told that "no adverse effect was expected.
Age: 1.03
Sex: M
Vaccine: HIBV, IPV, MMRV, PNC
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Patient was given IPV.
Age: 1.11
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Gave IPV#4 that isn't due til age 4 years of age didn't give MMR or Varivax, Hep B and were out of Hep A.
Age: 1.16
Sex: M
Vaccine: HIBV, IPV, MMRV
Symptoms: Injection site induration, Rash papular, Varicella
Clinical narrative: 3cm injection site induration with papular eruption consistent with attenuated poor Varicella.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Itchy skin at injection site gave her Benadryl 25mg PO x 1 dose.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Itchy skin at injection site gave her Benadryl 25mg PO x 1 dose.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Clinical narrative: Sudden death while sleeping at night. Post mortem pending.  7/3/07 Received autopsy report which reveals COD as Sudden unexplained death of infancy while co-sleeping w/adult & manner of death as undetermined.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria rash all over the body
Age: 1.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swollen red tender 2x3 cm Rt thigh.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2"x2 1/2" swelling, redness and hot to touch area over LT upper arm.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site red, epidemetis, hot to touch and achy from shoulder down to elbow after 24 hrs.
Age: 56.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Injection site pain, Injection site warmth, Musculoskeletal pain, Pain in extremity
Clinical narrative: R shoulder and site of injection (R delt) pain, sharp pain, radiates down arm, warm to the touch. Pt's in home supportive care giver was interviewed on 4-6-07. Unknown if pt has used any treatment, i.e. cold compress or Tylenol.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4-6-07 8:45 AM parents present with child at PH services questioning the red swollen arm of PT L deltoid.
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Chills, Muscle spasms, Muscle twitching, Stomach discomfort
Clinical narrative: chills, muscular vibrating, stomach vibrating
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Blood test, Chills, Diagnostic procedure, Frequent bowel movements, Stomach discomfort
Clinical narrative: chills, muscular vibrating, stomach vibrating
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Thyroid function test, Tremor
Clinical narrative: chills, muscular vibrating, stomach vibrating
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Fever > 100.5, tiredness, achy - reaction at injection site: pain, redness, warm to touch, induration of 4cm X 6 cm
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Fever > 100.5, tiredness, achy - reaction at injection site: pain, redness, warm to touch, induration of 4cm X 6 cm
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Pyrexia, Rash, Rash papular
Clinical narrative: Presented to ER with fever and vesiculo-papular rash on trunk, spreading to thighs.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Dizziness, Headache, Laboratory test, Loss of consciousness
Clinical narrative: SYMPTOMS: o Groin/hip, knee, ankle pain (began following Gardasil Vaccine Shot #1 12/18/06; severely worsened following Gardasil Vaccine Shot #2 2/2/07) o Light-headedness, increased headaches (began following Gardasil Vaccine Shot #1; increased following Gardasil Vaccine Shot #2) o Episodes of blurred vision (occasional episodes Jan thru present 2007) o One episode of "blacking out"  while in shower (Feb 2007) o Swelling in knees  TREATMENT: o Been under the care of orthopaedic sports medicine doctor since 2/2/07 o Had series of Xrays hips, knees, ankles  --- nothing out of the ordinary shown o Participated in 6 weeks physical therapy --- pain increased to point of discontinuing PT at suggestion of physical therapist and orthopaedic doctor o Had blood work done --- nothing out of the ordinary shown o Met with Dr. neurologist 3/20/07 --- office tests show nothing out of the ordinary prescribed change in diet and charting of headaches follow-up appt in early May o Began Ibuprofen therapy (4x per day for 2 weeks) for swelling and hips/knees/ankles as prescribed by orthopaedic doctor on 3/21/07 follow-up appt 4/6/07. o Next step:  schedule appointment with rheumatologist; begin physical therapy again as prescribed by orthopaedic doctor
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: SYMPTOMS: o Groin/hip, knee, ankle pain (began following Gardasil Vaccine Shot #1 12/18/06; severely worsened following Gardasil Vaccine Shot #2 2/2/07) o Light-headedness, increased headaches (began following Gardasil Vaccine Shot #1; increased following Gardasil Vaccine Shot #2) o Episodes of blurred vision (occasional episodes Jan thru present 2007) o One episode of "blacking out"  while in shower (Feb 2007) o Swelling in knees  TREATMENT: o Been under the care of orthopaedic sports medicine doctor since 2/2/07 o Had series of Xrays hips, knees, ankles  --- nothing out of the ordinary shown o Participated in 6 weeks physical therapy --- pain increased to point of discontinuing PT at suggestion of physical therapist and orthopaedic doctor o Had blood work done --- nothing out of the ordinary shown o Met with Dr. neurologist 3/20/07 --- office tests show nothing out of the ordinary prescribed change in diet and charting of headaches follow-up appt in early May o Began Ibuprofen therapy (4x per day for 2 weeks) for swelling and hips/knees/ankles as prescribed by orthopaedic doctor on 3/21/07 follow-up appt 4/6/07. o Next step:  schedule appointment with rheumatologist; begin physical therapy again as prescribed by orthopaedic doctor
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Blood test normal, Dizziness, Groin pain, Headache
Clinical narrative: SYMPTOMS: o Groin/hip, knee, ankle pain (began following Gardasil Vaccine Shot #1 12/18/06; severely worsened following Gardasil Vaccine Shot #2 2/2/07) o Light-headedness, increased headaches (began following Gardasil Vaccine Shot #1; increased following Gardasil Vaccine Shot #2) o Episodes of blurred vision (occasional episodes Jan thru present 2007) o One episode of "blacking out"  while in shower (Feb 2007) o Swelling in knees  TREATMENT: o Been under the care of orthopaedic sports medicine doctor since 2/2/07 o Had series of Xrays hips, knees, ankles  --- nothing out of the ordinary shown o Participated in 6 weeks physical therapy --- pain increased to point of discontinuing PT at suggestion of physical therapist and orthopaedic doctor o Had blood work done --- nothing out of the ordinary shown o Met with Dr. neurologist 3/20/07 --- office tests show nothing out of the ordinary prescribed change in diet and charting of headaches follow-up appt in early May o Began Ibuprofen therapy (4x per day for 2 weeks) for swelling and hips/knees/ankles as prescribed by orthopaedic doctor on 3/21/07 follow-up appt 4/6/07. o Next step:  schedule appointment with rheumatologist; begin physical therapy again as prescribed by orthopaedic doctor
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Pain, Physiotherapy, Vision blurred, X-ray limb normal
Clinical narrative: SYMPTOMS: o Groin/hip, knee, ankle pain (began following Gardasil Vaccine Shot #1 12/18/06; severely worsened following Gardasil Vaccine Shot #2 2/2/07) o Light-headedness, increased headaches (began following Gardasil Vaccine Shot #1; increased following Gardasil Vaccine Shot #2) o Episodes of blurred vision (occasional episodes Jan thru present 2007) o One episode of "blacking out"  while in shower (Feb 2007) o Swelling in knees  TREATMENT: o Been under the care of orthopaedic sports medicine doctor since 2/2/07 o Had series of Xrays hips, knees, ankles  --- nothing out of the ordinary shown o Participated in 6 weeks physical therapy --- pain increased to point of discontinuing PT at suggestion of physical therapist and orthopaedic doctor o Had blood work done --- nothing out of the ordinary shown o Met with Dr. neurologist 3/20/07 --- office tests show nothing out of the ordinary prescribed change in diet and charting of headaches follow-up appt in early May o Began Ibuprofen therapy (4x per day for 2 weeks) for swelling and hips/knees/ankles as prescribed by orthopaedic doctor on 3/21/07 follow-up appt 4/6/07. o Next step:  schedule appointment with rheumatologist; begin physical therapy again as prescribed by orthopaedic doctor
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: X-ray normal, X-ray of pelvis and hip normal
Clinical narrative: SYMPTOMS: o Groin/hip, knee, ankle pain (began following Gardasil Vaccine Shot #1 12/18/06; severely worsened following Gardasil Vaccine Shot #2 2/2/07) o Light-headedness, increased headaches (began following Gardasil Vaccine Shot #1; increased following Gardasil Vaccine Shot #2) o Episodes of blurred vision (occasional episodes Jan thru present 2007) o One episode of "blacking out"  while in shower (Feb 2007) o Swelling in knees  TREATMENT: o Been under the care of orthopaedic sports medicine doctor since 2/2/07 o Had series of Xrays hips, knees, ankles  --- nothing out of the ordinary shown o Participated in 6 weeks physical therapy --- pain increased to point of discontinuing PT at suggestion of physical therapist and orthopaedic doctor o Had blood work done --- nothing out of the ordinary shown o Met with Dr. neurologist 3/20/07 --- office tests show nothing out of the ordinary prescribed change in diet and charting of headaches follow-up appt in early May o Began Ibuprofen therapy (4x per day for 2 weeks) for swelling and hips/knees/ankles as prescribed by orthopaedic doctor on 3/21/07 follow-up appt 4/6/07. o Next step:  schedule appointment with rheumatologist; begin physical therapy again as prescribed by orthopaedic doctor
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Headache, Pain
Clinical narrative: FRONTAL HEADACHE 6/10 PAIN.  LIGHTHEADED.  TX'D C/ OBSERVATION AND TYLENOL.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: LIGHTHEADED, HEADACHE 5/10 FRONTAL/TEMPORAL, WEAK
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Urticaria
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 5 year old white male who on 04, Dec 2006 at 11:30 was vaccinated SC in the right lower thigh with a first dose of measles virus vaccine live (Enders-Edmonston) (-) mumps virus vaccine live (Jeryl Lynn) (-) rubella virus vaccine live (Wistar Ra 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 655746/1093F). Concomitant vaccination on the same day at the same time included a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (-) tetanus toxoid (INFANRIX) lot # AC14B035AA) given IM in the left upper thigh, a fourth dose of poliovirus vaccine inactivated (vero) (IPOL) (lot # A0240) given SC in the left lower thigh and a second dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) lot 3 U2244AA) given IM in the right upper thigh. The next day, on the evening of 05, Dec 2006 at 21:51 the patient woke up with hives on his face and neck. Medical attention was sought and the patient was treated with diphenhydramine hydrochloride (BENADRYL). The patient's mother also reported that his left thigh had redness which lasted two days. Subsequently, on 13, Dec 2006 the patient also broke out on his left thigh with a 2-3 inch area of confluent lesions that appeared as a pink red bumpy rash with a raised border. The patient was reported to have a similar rash on his right thigh that was "about 1x1 inch." It was reported that the patient was vaccinated in the past with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) without experiencing any adverse reactions. The patient's records also indicated that he was previously vaccinated with diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX), poliovirus vaccine inactivated (Vero) (IPOL) and influenza virus split virion 3v vaccine inactivated (Fluzone with no adverse reaction. There was no product quality complaint involved. No additional information was provided.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Flushing, Pruritus, Urticaria
Clinical narrative: Information has been received form a nurse concerning a 12 month old male who on 11, Dec 2006 was vaccinated with a 0.5 ml dose of measles virus vaccine live (Enders- Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 655746/1093F). Concomitant vaccination included a dose of Hib conj vaccine (OMPC) (MSD). On 11, Dec 2006, following the vaccination, the patient experienced flushing, itchiness and hives on his entire body. The patient was seen in an ER and he was treated with diphenhydramine hydrochloride (BENADRYL). Subsequently, the patient recovered as of 12, Dec 2006. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye oedema, Oedema peripheral, Pain, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning an 18 year old white female with an allergy to erythromycin ethylsuccinate (+) sulfisoxazole acetyl (Pediazole) who on 26, Dec 2006 was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) lot # 653735/0688F). The patient had no illnesses at the time of vaccination. On 27, Dec 2006 rash. By 28, Dec 2006, the patient developed severe urticarial rash requiring oral steroids and antihistamines. By 31-Dec 2006 the patient developed edema of hands, feet, and eyes and respiratory symptoms. The patient was seen in the emergency room. Treatment included intravenous dexamethasone (Decadron) with relief. Subsequently,  the patient recovered. Additional information has been requested
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician concerning an 18 year old white female with an allergy to erythromycin ethylsuccinate (+) sulfisoxazole acetyl (Pediazole) who on 26, Dec 2006 was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) lot # 653735/0688F). The patient had no illnesses at the time of vaccination. On 27, Dec 2006 rash. By 28, Dec 2006, the patient developed severe urticarial rash requiring oral steroids and antihistamines. By 31-Dec 2006 the patient developed edema of hands, feet, and eyes and respiratory symptoms. The patient was seen in the emergency room. Treatment included intravenous dexamethasone (Decadron) with relief. Subsequently,  the patient recovered. Additional information has been requested
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye oedema, Neutrophil count normal, Oedema peripheral, Platelet count increased, Rash
Clinical narrative: Information has been received from a physician concerning an 18 year old white female with an allergy to erythromycin ethylsuccinate (+) sulfisoxazole acetyl (Pediazole) who on 26, Dec 2006 was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) lot # 653735/0688F). The patient had no illnesses at the time of vaccination. On 27, Dec 2006 rash. By 28, Dec 2006, the patient developed severe urticarial rash requiring oral steroids and antihistamines. By 31-Dec 2006 the patient developed edema of hands, feet, and eyes and respiratory symptoms. The patient was seen in the emergency room. Treatment included intravenous dexamethasone (Decadron) with relief. Subsequently,  the patient recovered. Additional information has been requested
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Respiratory disorder, Urticaria, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning an 18 year old white female with an allergy to erythromycin ethylsuccinate (+) sulfisoxazole acetyl (Pediazole) who on 26, Dec 2006 was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) lot # 653735/0688F). The patient had no illnesses at the time of vaccination. On 27, Dec 2006 rash. By 28, Dec 2006, the patient developed severe urticarial rash requiring oral steroids and antihistamines. By 31-Dec 2006 the patient developed edema of hands, feet, and eyes and respiratory symptoms. The patient was seen in the emergency room. Treatment included intravenous dexamethasone (Decadron) with relief. Subsequently,  the patient recovered. Additional information has been requested
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC, FLU3, HEPA, MMRV, PNC
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with a history of bilateral ear tube insertion (12, Dec 2006) with no known drug allergies or reactions, who on 02, Jan 2007 was vaccinated subcutaneously in the right arm with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 655847/1386F). Concomitant therapy included the fourth dose of pneumococcal 4 6B 9V 16 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot# B08670K)  intramuscularly in the left thigh, the first dose of hepatitis A vaccine (inactive) (MSD) (lot #  656497/1213F) intramuscularly in the right thigh and the second dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) (influenza virus split virion 3v vaccine inactivated ) (lot # UT2174LA) intramuscularly in the right thigh on 10, Jan 2007. the patient had a fever of 101; noted to last two days (onset of symptoms also noted as 11, Jan 2007. Medical attention was sought on 12, Jan 2007, during a doctor's office visit loss of appetite, loose stools, and three vesicular lesions (one hard, one on his back, and one on his trunk) were noted; the diagnosis was mild chicken pox secondary to vaccine. No additional information to report. There was no product quality complaint.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC, FLU3, HEPA, MMRV, PNC
Symptoms: Anorexia, Body temperature, Diarrhoea, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with a history of bilateral ear tube insertion (12, Dec 2006) with no known drug allergies or reactions, who on 02, Jan 2007 was vaccinated subcutaneously in the right arm with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 655847/1386F). Concomitant therapy included the fourth dose of pneumococcal 4 6B 9V 16 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot# B08670K)  intramuscularly in the left thigh, the first dose of hepatitis A vaccine (inactive) (MSD) (lot #  656497/1213F) intramuscularly in the right thigh and the second dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) (influenza virus split virion 3v vaccine inactivated ) (lot # UT2174LA) intramuscularly in the right thigh on 10, Jan 2007. the patient had a fever of 101; noted to last two days (onset of symptoms also noted as 11, Jan 2007. Medical attention was sought on 12, Jan 2007, during a doctor's office visit loss of appetite, loose stools, and three vesicular lesions (one hard, one on his back, and one on his trunk) were noted; the diagnosis was mild chicken pox secondary to vaccine. No additional information to report. There was no product quality complaint.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC, FLU3, HEPA, MMRV, PNC
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with a history of bilateral ear tube insertion (12, Dec 2006) with no known drug allergies or reactions, who on 02, Jan 2007 was vaccinated subcutaneously in the right arm with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 655847/1386F). Concomitant therapy included the fourth dose of pneumococcal 4 6B 9V 16 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot# B08670K)  intramuscularly in the left thigh, the first dose of hepatitis A vaccine (inactive) (MSD) (lot #  656497/1213F) intramuscularly in the right thigh and the second dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) (influenza virus split virion 3v vaccine inactivated ) (lot # UT2174LA) intramuscularly in the right thigh on 10, Jan 2007. the patient had a fever of 101; noted to last two days (onset of symptoms also noted as 11, Jan 2007. Medical attention was sought on 12, Jan 2007, during a doctor's office visit loss of appetite, loose stools, and three vesicular lesions (one hard, one on his back, and one on his trunk) were noted; the diagnosis was mild chicken pox secondary to vaccine. No additional information to report. There was no product quality complaint.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient vomited the day after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sought medical attention. Subsequently, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient vomited the day after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sought medical attention. Subsequently, the patient recovered. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA02792. This manufacturer received the original report from a registered nurse. Verbatim from report: "Information has been received from a registered nurse concerning a 4-year-old male with no pre-existing allergies, birth defects, or medical conditions who on 01-MAR-2007 at 9:00 AM was vaccinated SC in the right arm with a second dose of Varivax (Lot # 656079/1306F). Suspect therapy that day at 9:00 AM included a second dose of MMR II (Lot# "D697F"). There was no illness at the time of the vaccinations. Concomitant therapy that day at 9:00 AM included a first dose of Infanrix (Lot# AC14B042BA) administered in the left deltoid, and a forth dose of Ipol (Lot # 20306) (not a valid manufacturer lot number) administered SC in the left arm. On 01-MAR-2007 at 9: AM the patient experienced urticaria. It was noted that the urticaria was first at the right arm, at the site of both the Varivax and MMR II. However, the event occurred immediately after the Varivax administration. Within a 1/2 hour, urticaria expanded to the anterior and posterior trunk. BENADRYL 19mg was administered, and the patient was observed in the office for 1 hour. He was discharged from the office to continue BENADRYL 1 and 1/2 tsp q6 hours for hives and itching. subsequently, on 07-MAR-2007, the patient recovered. There were no adverse events following prior vaccinations. The event was considered another important medical event by the reporter. The reporter for this case is the same as for case 2007-00771 where a 7-year-old female experienced wheezing, eye swelling, urticaria, pruritus, skin warm, and generalized erythema.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA02792. This manufacturer received the original report from a registered nurse. Verbatim from report: "Information has been received from a registered nurse concerning a 4-year-old male with no pre-existing allergies, birth defects, or medical conditions who on 01-MAR-2007 at 9:00 AM was vaccinated SC in the right arm with a second dose of Varivax (Lot # 656079/1306F). Suspect therapy that day at 9:00 AM included a second dose of MMR II (Lot# "D697F"). There was no illness at the time of the vaccinations. Concomitant therapy that day at 9:00 AM included a first dose of Infanrix (Lot# AC14B042BA) administered in the left deltoid, and a forth dose of Ipol (Lot # 20306) (not a valid manufacturer lot number) administered SC in the left arm. On 01-MAR-2007 at 9: AM the patient experienced urticaria. It was noted that the urticaria was first at the right arm, at the site of both the Varivax and MMR II. However, the event occurred immediately after the Varivax administration. Within a 1/2 hour, urticaria expanded to the anterior and posterior trunk. BENADRYL 19mg was administered, and the patient was observed in the office for 1 hour. He was discharged from the office to continue BENADRYL 1 and 1/2 tsp q6 hours for hives and itching. subsequently, on 07-MAR-2007, the patient recovered. There were no adverse events following prior vaccinations. The event was considered another important medical event by the reporter. The reporter for this case is the same as for case 2007-00771 where a 7-year-old female experienced wheezing, eye swelling, urticaria, pruritus, skin warm, and generalized erythema.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA02792. This manufacturer received the original report from a registered nurse. Verbatim from report: "Information has been received from a registered nurse concerning a 4-year-old male with no pre-existing allergies, birth defects, or medical conditions who on 01-MAR-2007 at 9:00 AM was vaccinated SC in the right arm with a second dose of Varivax (Lot # 656079/1306F). Suspect therapy that day at 9:00 AM included a second dose of MMR II (Lot# "D697F"). There was no illness at the time of the vaccinations. Concomitant therapy that day at 9:00 AM included a first dose of Infanrix (Lot# AC14B042BA) administered in the left deltoid, and a forth dose of Ipol (Lot # 20306) (not a valid manufacturer lot number) administered SC in the left arm. On 01-MAR-2007 at 9: AM the patient experienced urticaria. It was noted that the urticaria was first at the right arm, at the site of both the Varivax and MMR II. However, the event occurred immediately after the Varivax administration. Within a 1/2 hour, urticaria expanded to the anterior and posterior trunk. BENADRYL 19mg was administered, and the patient was observed in the office for 1 hour. He was discharged from the office to continue BENADRYL 1 and 1/2 tsp q6 hours for hives and itching. subsequently, on 07-MAR-2007, the patient recovered. There were no adverse events following prior vaccinations. The event was considered another important medical event by the reporter. The reporter for this case is the same as for case 2007-00771 where a 7-year-old female experienced wheezing, eye swelling, urticaria, pruritus, skin warm, and generalized erythema.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Myalgia, Pharyngolaryngeal pain, Streptococcal serology, Swelling
Clinical narrative: Information has been received form a registered nurse concerning a 17 year old female, with no pertinent medical history who on 23, Feb 2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 656049/0187U). On 24, Feb 2007. the patient experienced arthralgia, myalgia and sore throat. Patient outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Myalgia, Pharyngolaryngeal pain
Clinical narrative: Information has been received form a registered nurse concerning a 17 year old female, with no pertinent medical history who on 23, Feb 2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 656049/0187U). On 24, Feb 2007. the patient experienced arthralgia, myalgia and sore throat. Patient outcome was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Pruritus, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 26, Feb 2007 was vaccinated IM with a 0.5 mL first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no  concomitant medication. The nurse reported that 15 minutes after she had her first vaccination. she came back to the office with generalized hives all over the body where she touched and scratched. The nurse confirmed that there was no reaction at the injection site and she had no problems breathing. The patient was given diphenhydramine hydrochloride and the reaction was gone, but then she had headaches. The patient was reported to have gone home, recovered, after an hour of observation on 26, Feb 2007. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 26, Feb 2007 was vaccinated IM with a 0.5 mL first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no  concomitant medication. The nurse reported that 15 minutes after she had her first vaccination. she came back to the office with generalized hives all over the body where she touched and scratched. The nurse confirmed that there was no reaction at the injection site and she had no problems breathing. The patient was given diphenhydramine hydrochloride and the reaction was gone, but then she had headaches. The patient was reported to have gone home, recovered, after an hour of observation on 26, Feb 2007. Additional information has been requested.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received from another manufacturer on 28 March 2007, report number WAES0703USA03353. Verbatim from the report: "Information has been received concerning a female with congenital Dacryostenosis who on 25-JAN-2007, at 1130, was vaccinated PO with the first dose of Rotateq (Lot #656103/1166F). Concomitant vaccinations administered on the same day and time included the first IM dose in the left leg of DAPTACEL (Lot #C2521AA), the first IM dose in the left leg of Comvax (Lot #654993/1158F), the first IM dose in the right leg of Prevnar (Lot #B08670F) and the first IM dose in the right leg of Ipol (Lot #Z0324). There was no illness at the time of vaccination. Other concomitant drug therapy included POLYTRIM. On 10-MAR-2007, the patient was taken to the Emergency Room (ER). An air-contrast barium enema was positive for intussusception. A diagnosis of intussusception was made by the hospital. In March 2007, the patient recovered. Upon internal review, intussusception was determined to be an other important medical event. No further information is available."
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Barium double contrast, Emergency care examination abnormal, Intussusception
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received from another manufacturer on 28 March 2007, report number WAES0703USA03353. Verbatim from the report: "Information has been received concerning a female with congenital Dacryostenosis who on 25-JAN-2007, at 1130, was vaccinated PO with the first dose of Rotateq (Lot #656103/1166F). Concomitant vaccinations administered on the same day and time included the first IM dose in the left leg of DAPTACEL (Lot #C2521AA), the first IM dose in the left leg of Comvax (Lot #654993/1158F), the first IM dose in the right leg of Prevnar (Lot #B08670F) and the first IM dose in the right leg of Ipol (Lot #Z0324). There was no illness at the time of vaccination. Other concomitant drug therapy included POLYTRIM. On 10-MAR-2007, the patient was taken to the Emergency Room (ER). An air-contrast barium enema was positive for intussusception. A diagnosis of intussusception was made by the hospital. In March 2007, the patient recovered. Upon internal review, intussusception was determined to be an other important medical event. No further information is available."
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Erythema, Nausea, Oedema peripheral, Vomiting
Clinical narrative: Information has been received from a 24 year old female who on 06, Mar 2007 was vaccinated intramuscularly with a 0.5 mL third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). The patient mentioned that she did not have any problems with dose 1 or 2 and that these doses were were given in the outer part of her arm. She reported that the third dose was given less in the outer area and more towards the inner arm but still in the muscle. On 06, Mar 2007, the patient started to throw up. and she developed a fever. On 09, Mar 2007, the patient went to the emergency room due to continued vomiting and dizziness. She was treated with intravenous fluid and was released at approximately 04:00 pm. As of 12, Mar 2007, the patient continued to experience dizziness and nausea.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fluid replacement, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a 24 year old female who on 06, Mar 2007 was vaccinated intramuscularly with a 0.5 mL third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). The patient mentioned that she did not have any problems with dose 1 or 2 and that these doses were were given in the outer part of her arm. She reported that the third dose was given less in the outer area and more towards the inner arm but still in the muscle. On 06, Mar 2007, the patient started to throw up. and she developed a fever. On 09, Mar 2007, the patient went to the emergency room due to continued vomiting and dizziness. She was treated with intravenous fluid and was released at approximately 04:00 pm. As of 12, Mar 2007, the patient continued to experience dizziness and nausea.
Age: 7.0
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL
Symptoms: Erythema, Eye swelling, Pruritus, Skin warm, Urticaria
Clinical narrative: Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA02777. This manufacturer received the original report from a nurse. Verbatim from the report: "Information has been received from a registered nurse concerning a 7-year-old female with asthma and allergies to Zithromax, cyprohetadine, beef, corn, soy, and milk, chronic gastric paresis, eosinophilic, and esophagitis who on 26-FEB-2007 at 4:30 PM was vaccinated SC in the right arm with a second dose of Varivax (Lot # 656079/1306F). Concomitant therapy that day at 4:30 PM included a forth dose of Fluzone (Lot # U62271AA) (not a valid lot number) administered in the right deltoid. Additional concomitant therapy included montelukast sodium, Flovent, Prevacid, Miralax, and vitamins (unspecified). On 26-FEB-2007 at 5:45 PM, the patient's whole body became bright red, and the child became itchy and warm with hives. In addition, the patient's eyes started to swell. After talking to the doctor, 25mg Benadryl was given and was told to go to the ER. The patient began wheezing on the way to the ER. Epinephrine was given in the ER and the patient was discharged on prednisone. Subsequently, the patient recovered. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested." The reporter for this case is the same as for case 2007-00972. Where a 4-year-old male experienced urticaria.
Age: 7.0
Sex: F
Vaccine: FLU3, VARCEL, FLU3, VARCEL
Symptoms: Wheezing
Clinical narrative: Initial report received on 28 March 2007 from an other manufacturer, reference number WAES 0703USA02777. This manufacturer received the original report from a nurse. Verbatim from the report: "Information has been received from a registered nurse concerning a 7-year-old female with asthma and allergies to Zithromax, cyprohetadine, beef, corn, soy, and milk, chronic gastric paresis, eosinophilic, and esophagitis who on 26-FEB-2007 at 4:30 PM was vaccinated SC in the right arm with a second dose of Varivax (Lot # 656079/1306F). Concomitant therapy that day at 4:30 PM included a forth dose of Fluzone (Lot # U62271AA) (not a valid lot number) administered in the right deltoid. Additional concomitant therapy included montelukast sodium, Flovent, Prevacid, Miralax, and vitamins (unspecified). On 26-FEB-2007 at 5:45 PM, the patient's whole body became bright red, and the child became itchy and warm with hives. In addition, the patient's eyes started to swell. After talking to the doctor, 25mg Benadryl was given and was told to go to the ER. The patient began wheezing on the way to the ER. Epinephrine was given in the ER and the patient was discharged on prednisone. Subsequently, the patient recovered. There was no product quality complaint. The events were considered to be immediately life-threatening and other important medical events by the reporter. Additional information has been requested." The reporter for this case is the same as for case 2007-00972. Where a 4-year-old male experienced urticaria.
Age: 36.0
Sex: M
Vaccine: HEP, TDAP, TYP, YF
Symptoms: Headache, Night sweats, Pyrexia
Clinical narrative: Client States that he got Adacel, Hep B, Typhoid, and Yellow fever on 3/1/07. He developed a fever of 100 24 hours after the immunization night sweats, headache which lasted for 1/2 day. He did not see a Dr.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Blood amylase increased, Computerised tomogram normal, Lipase increased, Pancreatitis acute
Clinical narrative: Initial information received from a health care professional on 02 April 2007. A 17-year-old male patient received a dose of Menactra, lot number U2171AA, administered intramuscularly on 16 March 2007. The patient had no reported past medical history. Approximately three to five days later, the patient developed chronic, intermittent abdominal pain. He was diagnosed with acute pancreatitis and was hospitalized on 29 March 2007. A CT scan of the abdomen was normal. Ultrasound of the gallbladder and pancreas was normal. Amylase was 400 on admission and lipase elevated at 2,500. MRCP was pending. At the time of this report, the patient remained hospitalized and had not recovered from the events. 05/02/07-records received from facility for DOS 4/9-4/13/07-DC DX:Resolving Diarrhea and Dehydration. Previously admitted one week prir for pancreatitis which resolved itself. Possible immunologic reaction to a possible Menactra shot administered five days before initial onset of abdominal pain and pancreatitis. Dehydration elevated lipases and amylases. 10 pound weight loss. Current medication includes Protonix.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Ultrasound scan normal
Clinical narrative: Initial information received from a health care professional on 02 April 2007. A 17-year-old male patient received a dose of Menactra, lot number U2171AA, administered intramuscularly on 16 March 2007. The patient had no reported past medical history. Approximately three to five days later, the patient developed chronic, intermittent abdominal pain. He was diagnosed with acute pancreatitis and was hospitalized on 29 March 2007. A CT scan of the abdomen was normal. Ultrasound of the gallbladder and pancreas was normal. Amylase was 400 on admission and lipase elevated at 2,500. MRCP was pending. At the time of this report, the patient remained hospitalized and had not recovered from the events. 05/02/07-records received from facility for DOS 4/9-4/13/07-DC DX:Resolving Diarrhea and Dehydration. Previously admitted one week prir for pancreatitis which resolved itself. Possible immunologic reaction to a possible Menactra shot administered five days before initial onset of abdominal pain and pancreatitis. Dehydration elevated lipases and amylases. 10 pound weight loss. Current medication includes Protonix.
Sex: M
Vaccine: DTAP, HIBV, MMR, MMR, DTAP, HEP, HIBV, IPV, MMR
Symptoms: Autism, Autism spectrum disorder, Bruxism, DNA test for fragile X, Developmental delay
Clinical narrative: This case was considered medically important. Additional information has been received pertaining to the reported product, patient demographics, medical history, additional adverse events, laboratory tests, immunizations and dates of administration. Information regarding Hib-Titer Vaccine was received from an attorney regarding an 18-month-old male patient who experienced bruxism, pica, PDD, autism, neurodevelopmental disorder, developmental incapacity, mental  and intellectual incapacity, permanent neurological damage, mercury poisoning and learning disabilities. The patient also received the fourth of DTaP on 29-Mar-1996. On 06-Nov-1997 the patient developed PDD, bruxism and pica. On unknown dates the patient also experienced neurodevelopmental disorder, developmental incapacity, autism, mental and intellectual incapacity, permanent neurological damage, mercury poisoning and learning disabilities. The outcome is unknown. DNA test for fragile X (results: negative) was done on 07-Jul-1997. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAP, HIBV, MMR, MMR, DTAP, HEP, HIBV, IPV, MMR
Symptoms: Learning disability, Mental impairment, Metal poisoning, Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: This case was considered medically important. Additional information has been received pertaining to the reported product, patient demographics, medical history, additional adverse events, laboratory tests, immunizations and dates of administration. Information regarding Hib-Titer Vaccine was received from an attorney regarding an 18-month-old male patient who experienced bruxism, pica, PDD, autism, neurodevelopmental disorder, developmental incapacity, mental  and intellectual incapacity, permanent neurological damage, mercury poisoning and learning disabilities. The patient also received the fourth of DTaP on 29-Mar-1996. On 06-Nov-1997 the patient developed PDD, bruxism and pica. On unknown dates the patient also experienced neurodevelopmental disorder, developmental incapacity, autism, mental and intellectual incapacity, permanent neurological damage, mercury poisoning and learning disabilities. The outcome is unknown. DNA test for fragile X (results: negative) was done on 07-Jul-1997. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAP, HIBV, MMR, MMR, DTAP, HEP, HIBV, IPV, MMR
Symptoms: Pica
Clinical narrative: This case was considered medically important. Additional information has been received pertaining to the reported product, patient demographics, medical history, additional adverse events, laboratory tests, immunizations and dates of administration. Information regarding Hib-Titer Vaccine was received from an attorney regarding an 18-month-old male patient who experienced bruxism, pica, PDD, autism, neurodevelopmental disorder, developmental incapacity, mental  and intellectual incapacity, permanent neurological damage, mercury poisoning and learning disabilities. The patient also received the fourth of DTaP on 29-Mar-1996. On 06-Nov-1997 the patient developed PDD, bruxism and pica. On unknown dates the patient also experienced neurodevelopmental disorder, developmental incapacity, autism, mental and intellectual incapacity, permanent neurological damage, mercury poisoning and learning disabilities. The outcome is unknown. DNA test for fragile X (results: negative) was done on 07-Jul-1997. No additional information was available at the time of this report.