chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Culture stool positive, Diarrhoea, Faeces discoloured, Haematochezia, Irritability
Clinical narrative: Information has been received from a nurse practitioner concerning a 8 week old male infant with presumptive milk soy protein intolerance who on 11-JUN-2008 was vaccinated with ROTATEQ. Concomitant vaccination on the same day included PREVNAR, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), poliovirus vaccine inactivated (unspecified) (manufacturer unknown), PEDVAXHIB and RECOMBIVAX HB. It was reported that the patient developed diarrhea and blood in stools following the administration of the vaccine. On 14-JUN-2008 the patient developed loose green stools 3 days after receiving the vaccine. On 17-JUN-2008 the patient had clumps of blood in the stool. There was no fever or vomiting. The patient was just fussy. Medical attention was sought, the physician was contacted. A stool culture was performed. The stool culture was positive for rotavirus and negative for "OMP." It was noted that the patient was being treated with PEDIALYTE. At the time of the report the patient has not recovered. There was no product quality complaint involved. Upon internal review "clumps of blood in the stool" was considered an other important medical event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Rotavirus test positive
Clinical narrative: Information has been received from a nurse practitioner concerning a 8 week old male infant with presumptive milk soy protein intolerance who on 11-JUN-2008 was vaccinated with ROTATEQ. Concomitant vaccination on the same day included PREVNAR, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), poliovirus vaccine inactivated (unspecified) (manufacturer unknown), PEDVAXHIB and RECOMBIVAX HB. It was reported that the patient developed diarrhea and blood in stools following the administration of the vaccine. On 14-JUN-2008 the patient developed loose green stools 3 days after receiving the vaccine. On 17-JUN-2008 the patient had clumps of blood in the stool. There was no fever or vomiting. The patient was just fussy. Medical attention was sought, the physician was contacted. A stool culture was performed. The stool culture was positive for rotavirus and negative for "OMP." It was noted that the patient was being treated with PEDIALYTE. At the time of the report the patient has not recovered. There was no product quality complaint involved. Upon internal review "clumps of blood in the stool" was considered an other important medical event. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning a pregnant 28 year old female who on 03-APR-2007 was vaccinated with a dose of VARIVAX (Oka/Merck).  The patient sought unspecified medical attention.  No adverse reactions were reported.  Follow up information received from the registered nurse indicated that the patient had a positive pregnancy test at home.  Subsequently, the patient experienced some bleedings and had a miscarriage at approximately 4 weeks gestation.  Upon internal review, miscarriage was determined to be an other important medical event.  Additional information is not expected.
Sex: U
Vaccine: HEPA, HEPA, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL and a dose of either Hep A vaccine (MSD) or HAVRIX at the same time as GARDASIL.  The physician reported that this was not the only office to have this happen.  The outcome was unknown.  No additional Adverse Event (AE) information was reported.  Upon internal review seizure was determined to be an other important medical event.  This is one of several reports from the same source.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Blood test, Myelitis transverse
Clinical narrative: Information has been received from a physician concerning a 24 year old female who was vaccinated with a second dose of GARDASIL. In March 2008, the patient experienced generalized numbness and weakness in her body after the vaccination. The patient's condition was described as a transverse myelitis. Laboratory studies performed included "blood work" (result not reported) and magnetic resonance imaging of the brain, neck and spinal cord. Spinal cord lesions were found on the spinal cord magnetic resonance imaging. The patient sought medical attention by the physician. At the time of the report the patient had not recovered. Upon internal review the transverse myelitis was considered to be an important medical event. Additional information has been requested. 7/18/08-records received-6/18-7/14/08 presented with recent onset of arm and leg numbness, electrical shock like sensation with neck flexion. Impression:recent onset of transverse myelitis one week after receiving Gardasil vaccine.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hypoaesthesia, Paraesthesia, Sensation of heaviness
Clinical narrative: Information has been received from a physician concerning a 24 year old female who was vaccinated with a second dose of GARDASIL. In March 2008, the patient experienced generalized numbness and weakness in her body after the vaccination. The patient's condition was described as a transverse myelitis. Laboratory studies performed included "blood work" (result not reported) and magnetic resonance imaging of the brain, neck and spinal cord. Spinal cord lesions were found on the spinal cord magnetic resonance imaging. The patient sought medical attention by the physician. At the time of the report the patient had not recovered. Upon internal review the transverse myelitis was considered to be an important medical event. Additional information has been requested. 7/18/08-records received-6/18-7/14/08 presented with recent onset of arm and leg numbness, electrical shock like sensation with neck flexion. Impression:recent onset of transverse myelitis one week after receiving Gardasil vaccine.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Electromyogram, Hypoaesthesia, Laboratory test, Oedema peripheral, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 24 year old female who was vaccinated with a second dose of GARDASIL. In March 2008, the patient experienced generalized numbness and weakness in her body after the vaccination. The patient's condition was described as a transverse myelitis. Laboratory studies performed included "blood work" (result not reported) and magnetic resonance imaging of the brain, neck and spinal cord. Spinal cord lesions were found on the spinal cord magnetic resonance imaging. The patient sought medical attention by the physician. At the time of the report the patient had not recovered. Upon internal review the transverse myelitis was considered to be an important medical event. Additional information has been requested. 7/18/08-records received-6/18-7/14/08 presented with recent onset of arm and leg numbness, electrical shock like sensation with neck flexion. Impression:recent onset of transverse myelitis one week after receiving Gardasil vaccine.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Sensation of heaviness
Clinical narrative: Information has been received from a physician concerning a 24 year old female who was vaccinated with a second dose of GARDASIL. In March 2008, the patient experienced generalized numbness and weakness in her body after the vaccination. The patient's condition was described as a transverse myelitis. Laboratory studies performed included "blood work" (result not reported) and magnetic resonance imaging of the brain, neck and spinal cord. Spinal cord lesions were found on the spinal cord magnetic resonance imaging. The patient sought medical attention by the physician. At the time of the report the patient had not recovered. Upon internal review the transverse myelitis was considered to be an important medical event. Additional information has been requested. 7/18/08-records received-6/18-7/14/08 presented with recent onset of arm and leg numbness, electrical shock like sensation with neck flexion. Impression:recent onset of transverse myelitis one week after receiving Gardasil vaccine.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amniotic fluid volume decreased, Caesarean section, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received through the Merck pregnancy registry from a nurse practitioner concerning a 16 year old female who on 07-SEP-2007 was vaccinated with her first dose of GARDASIL IM. On 17-OCT-2007 a positive urine pregnancy test determined patient was pregnant (LMP = 14-AUG-2007). The patient also had prenatal blood work performed. The patient sought medical attention with an exam in the office. The patient's outcome is unknown. Follow-up indicated that the patient had a scheduled caesarean section at term, secondary to a decreased amniotic fluid index. It was reported that the patient "opted" for a caesarean section. The patient delivered a healthy infant with no anomalies and there were no complications. Upon internal review the decreased amniotic fluid index - resulting in a C-section was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Hyperbilirubinaemia neonatal, Pregnancy test positive, Ultrasound scan, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received through the Merck pregnancy registry through a physician concerning a 17 year old female with a reoccurrence of sinusitis headaches who on 24-MAY-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 654535/0960F).  On 24-MAY-2007, the patient was also vaccinated with MENACTRA.  On 24-JUL-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 654535/0960F).  On 22-OCT-2007, the patient had a urine pregnancy test which was positive and on an unspecified date the patient had an ultrasound.  The date of the patient's last menstrual period was 28-JUL-2007 (also reported as 04-AUG-2007).  The patient sought unspecified medical attention in the office.  The estimated date of delivery is 03-MAY-2008.  Follow-up information was received from the physician via telephone on 20-JUN-2008.  The patient delivered a healthy and normal, full-term male, "with no physical anomalies".  The baby did develop transient hyper-bilirubinemia after birth and was transferred to another hospital where the baby was successfully treated and discharged after 3 days.  The physician reported "he's absolutely fine".  Upon internal review transient hyper-bilirubinemia required hospitalization for the baby.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Arrested labour, Caesarean section, Drug exposure during pregnancy, Inappropriate schedule of drug administration
Clinical narrative: Initial and follow up has been received from a health professional for the Pregnancy Registry for GARDASIL concerning a female 18 years old patient with epilepsy, carpal tunnel syndrome, drug hypersensitivity to phenobarbital and a smoker, with a history of no prior pregnancies who on 01-OCT-2007 was vaccinated with her third dose of GARDASIL IM and was subsequently determined to be pregnant. The patient received her first dose of GARDASIL IM on 30-JAN-2007 and her second dose of GARDASIL IM on 20-APR-2007. Concomitant therapy included TEGRETOL, vitamin D (unspecified), folic acid (unspecified) and calcium (unspecified). The patient's estimated LMP was 28-JUL-2007 with an estimated conception date of 07-SEP-2007. The patient's estimated due date is 02-JUN-2008. On 17-OCT-2007 and 18-JAN-2008 the patient had ultrasounds which were normal for screening and to establish a due date. The patient also had a serum alpha-fetoprotein test which was normal. The patient sought medical attention by contacting the office. Follow up information received from a physician reported that on 12-JUN-2008, the patient developed arrest of active labor and required a cesarean section. She delivered a healthy, normal, 7 pound 15 ounce boy with APGAR scores of 9 and 9. There were no congenital anomalies. It was reported that the patient smoked throughout her pregnancy. The patients outcome was not reported. Upon internal review it was determined that the arrest of active labour requiring a cesarean section was an other important medical event. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Initial and follow up has been received from a health professional for the Pregnancy Registry for GARDASIL concerning a female 18 years old patient with epilepsy, carpal tunnel syndrome, drug hypersensitivity to phenobarbital and a smoker, with a history of no prior pregnancies who on 01-OCT-2007 was vaccinated with her third dose of GARDASIL IM and was subsequently determined to be pregnant. The patient received her first dose of GARDASIL IM on 30-JAN-2007 and her second dose of GARDASIL IM on 20-APR-2007. Concomitant therapy included TEGRETOL, vitamin D (unspecified), folic acid (unspecified) and calcium (unspecified). The patient's estimated LMP was 28-JUL-2007 with an estimated conception date of 07-SEP-2007. The patient's estimated due date is 02-JUN-2008. On 17-OCT-2007 and 18-JAN-2008 the patient had ultrasounds which were normal for screening and to establish a due date. The patient also had a serum alpha-fetoprotein test which was normal. The patient sought medical attention by contacting the office. Follow up information received from a physician reported that on 12-JUN-2008, the patient developed arrest of active labor and required a cesarean section. She delivered a healthy, normal, 7 pound 15 ounce boy with APGAR scores of 9 and 9. There were no congenital anomalies. It was reported that the patient smoked throughout her pregnancy. The patients outcome was not reported. Upon internal review it was determined that the arrest of active labour requiring a cesarean section was an other important medical event. No additional information is expected.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Blood culture negative, Culture urine negative, Full blood count normal, Irritability
Clinical narrative: Vaccines given 6-5-08.  Fever 101.8 10:00 pm, seen in ER.  Labs drawn.  Sent home.  Seen here (in office) morning 6-6-08 with fever 102.1 and then admitted to hospital for observation and further evaluation.  Symptoms - fever and irritability.  8/5/08 Reviewed hospital records of 6/6/08. FINAL DX: viral exanthem or fever, secondary to immunizations Records reveal patient experienced fever & irritability later on day of vaccinations.  Seen in ER & d/c to home.  Continued to have fever & irritability w/occasional grunting.  Seen by PCP & admitted for observation.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Vaccines given 6-5-08.  Fever 101.8 10:00 pm, seen in ER.  Labs drawn.  Sent home.  Seen here (in office) morning 6-6-08 with fever 102.1 and then admitted to hospital for observation and further evaluation.  Symptoms - fever and irritability.  8/5/08 Reviewed hospital records of 6/6/08. FINAL DX: viral exanthem or fever, secondary to immunizations Records reveal patient experienced fever & irritability later on day of vaccinations.  Seen in ER & d/c to home.  Continued to have fever & irritability w/occasional grunting.  Seen by PCP & admitted for observation.
Age: 0.02
Sex: M
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Convulsions late evening, following morning 6/23/07 more intense clenching and splitting  of eyes.  Seizures. 7/14/08-records received for DOS 6/23-6/29/07-DC DX:Seizure disorder. presented with 1 day history of sudden jerking twitching episodes, eyes roll back and to side. Did not respond to stimuli by tracking. 10-15 episodes during the night. Fussy, less active, decreased oral intake. Emesis. Decrease in amount of wet diapers. One bowel movement today. 1/25/2010 Nonstop seizure that led to epilepsy, intubated due to seizures, that unfortunately resulted to brain injury. Currently has trachey j tube.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Mom c/o bilateral leg swelling & pain - resolved with TYLENOL - lasted about 12 hrs.  This is second event with ACTHIB.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 105.0.
Age: 44.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: The next morning, at varicella injection site, pt developed 50x80 mm area of induration, erythema, itching.  Feels like needles are poking skin at injection site.  Also complains of headache and joint pain in hands and feet.  Symptoms are diminishing over time.
Age: 44.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site pruritus
Clinical narrative: The next morning, at varicella injection site, pt developed 50x80 mm area of induration, erythema, itching.  Feels like needles are poking skin at injection site.  Also complains of headache and joint pain in hands and feet.  Symptoms are diminishing over time.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Rash macular
Clinical narrative: Lesion "blotch" on abdomen 3 inches wide, 5 inches long, tapering at ends.  Patient applied topical antibiotic, burning upon application.  Site moist.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Erythema, Pruritus, Rash macular
Clinical narrative: Lesion "blotch" on abdomen 3 inches wide, 5 inches long, tapering at ends.  Patient applied topical antibiotic, burning upon application.  Site moist.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Lesion "blotch" on abdomen 3 inches wide, 5 inches long, tapering at ends.  Patient applied topical antibiotic, burning upon application.  Site moist.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Pruritus, Pyrexia, Rash pruritic, Rhinorrhoea
Clinical narrative: Itchy rash (pruritus began 1-2 d after shot, then rash began on Day 5 & got mild fever (temp not taken) & cough & runny nose.  Rash much improved on Day 7.  Used diphenhydramine cream.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Site with 4cm area of redness and tenderness. Hot to touch; symptoms occurred with 24 hours of vaccine; reaction to Varicella
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Musculoskeletal pain, Vaccine positive rechallenge
Clinical narrative: Pain in R shoulder started 3 hours after injection.  Low back pain at same time with worsening pain over past 4 days.  Similar milder sx occurred after 1st injection 2 mo. prior.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after immunization.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Headache, Nausea, Pallor
Clinical narrative: Fever, dizziness, headache, nausea, weakness, paleness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever, dizziness, headache, nausea, weakness, paleness.
Age: 22.0
Sex: F
Vaccine: HPV4, SMALL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Bumps, reactions on stomach, back, neck, chest, breast, arms, underarms.  Itchy, red, noticeable.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: First PEDIARIX given at age 2 m - 4/16/2008.  Cried high pitch cry with fever & irritability same night & with irritability > 24 hours after.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Initial report received on 06 March 2008 from a health care professional.  An 18-year-old female patient, who was taking TOPAMAX and PREVACID, and who had no past obstetrical history, but did have past medical history of migraines, acne, "GERD", and allergic rhinitis, had received a right arm booster dose of ADACEL, a dose of GARDASIL (Manufacturer Merck), and a dose of "Hep A" vaccine (manufacturer Merck) on 12 February 2008.  The lot numbers, routes and sites of administration for the GARDASIL and "Hep A" vaccines were not provided.  The route of administration for the ADACEL was also not provided.  The patient then "conceived 14 February 2008", and had a positive pregnancy test on 02 March 2008.  The date of the patient's last menstrual period was not provided.  It was not reported whether the patient had experienced any adverse events since vaccination with ADACEL, GARDASIL, and "Hep A".
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ataxia, Condition aggravated
Clinical narrative: Progressive ataxia since prior to 3/07 in pt with remote hx Langerhans histiocytosis; during this time, starting 8/21/07, received GARDASIL series with significant worsening of ataxia. 9/30/2008 Office notes received from PCP. Gardasil series given 8/21/07, 10/22/07 and 3/5/08 with no reported problems initially.  WCC 6/20/08 with worsening ataxia.  Has gait disturbance, slowed and slurred speech. PE (+) for above as well as R facial droop, pallor, reflexes 4+ with 3 beat clonus, Babinski (+). DX:  Cerebellar Ataxia, unclear etiology. Neurology referral. Seen by heme/onc consult for tx for histiocytosis 8/8/08. Worsening of balance and tremor with tx.  Chest pain resolved with reposition of PICC. Pt anorexic with wt loss. Neuro exam (+) for mild tremor, ataxia and imbalance with gait, slurred speech.  Impression:  CNS involvement with acute Langerhans cell histiocytosis causing ataxia and dysmetria Labs and Diagnostics: MRI brain (+) for atrophic corpus collosum, cortical gray matter abnormalities of the frontal lobe, and T2 signal abnormalities of the cerebellum. 10/13/08 Neuro consult received dated 6/24/2008 with DX:  Progressive Cerebellar Ataxia.  Hx of Histiocytosis X.  Anemia, presumed iron deficient. Abnormal MRI.  Pt presented with worsening gait difficulties, falling, difficulty using arms and progressive dysarthria.  Neuro exam (+) for minimal coarse nystagmus, eye tracking difficulty, brisk reflexes, dysdiadochokinesis, dysmetria, tremor, and profound ataxia. Pt emotional and tearful-?encephalopathy/frontal release syndrome. Referred to Heme/Onc.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site swelling, Pain, Vomiting
Clinical narrative: Pt. had 4 year IZS on 6/18/08.  Started 6/19/08 in AM with mild swelling of R arm, which progressed.  Temp 100.4.  Vomited x1.  TYLENOL for pain, ice to area.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Vaccines given 6/17/08.  Slight swelling and warmth of right upper arm.  No drainage.  Advised TYLENOL, and cool compress.
Sex: U
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Small red area at site of varicella vaccine 1st noticed 6/21 + enlarging.  12.5 cm diameter red, tender, slightly indurated area L deltoid surrounding varicella vaccine injection.
Sex: U
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Local reaction, Tenderness
Clinical narrative: Small red area at site of varicella vaccine 1st noticed 6/21 + enlarging.  12.5 cm diameter red, tender, slightly indurated area L deltoid surrounding varicella vaccine injection.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Induration, Pallor, Swelling, Urticaria
Clinical narrative: Indurated wheal - 3 cm diameter around injection site and surrounding pale, pink swelling approximately 10 cm diameter.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count normal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt presented ~46 hours post PNEUMOVAX 23 c/o severe pain, redness & swelling L deltoid.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Rash papular
Clinical narrative: Febrile seizure, low grade temp, papulovesicular rash 11 days after vaccines.  T max 100.3. Seen in ER - MD office following day.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Eye disorder, Lip blister, Nausea, Rash
Clinical narrative: Pt received MMR as school requirement on Tues 6-16-08.  Nausea 6-17-08 - increased N/V 6-18-08 - hives 6-19-08 to date confluent hives L face - blister on lip.  Discomfort with L eye - rash R shoulder & L lower ribcage.  Has had hives both arms.  C/O feels like face is on fire today unable to take BENADRYL & work.  Advised to see MD - no insurance.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria, Vomiting
Clinical narrative: Pt received MMR as school requirement on Tues 6-16-08.  Nausea 6-17-08 - increased N/V 6-18-08 - hives 6-19-08 to date confluent hives L face - blister on lip.  Discomfort with L eye - rash R shoulder & L lower ribcage.  Has had hives both arms.  C/O feels like face is on fire today unable to take BENADRYL & work.  Advised to see MD - no insurance.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Depressed level of consciousness, Tremor, Unresponsive to stimuli
Clinical narrative: Shaking/tremors of arms and legs.  Frequent apnea episodes.  Does not respond to verbal stimuli.  Obtunded.  911 called.  Patient sent to ER. 8/1/08-records received for DOS 6/20-6/22/08-Assessment:complex febrile seizure, presenting in status epilepticus. Morning of admission developed tactile fever, runny nose and increased drooling and later that same day received his vaccinations. Soon after began to experience generalized tonic-clonic activity lasting 45 minutes. Temp in ED 101.5.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Chest X-ray normal, Computerised tomogram normal, Full blood count normal, Grand mal convulsion, Status epilepticus
Clinical narrative: Shaking/tremors of arms and legs.  Frequent apnea episodes.  Does not respond to verbal stimuli.  Obtunded.  911 called.  Patient sent to ER. 8/1/08-records received for DOS 6/20-6/22/08-Assessment:complex febrile seizure, presenting in status epilepticus. Morning of admission developed tactile fever, runny nose and increased drooling and later that same day received his vaccinations. Soon after began to experience generalized tonic-clonic activity lasting 45 minutes. Temp in ED 101.5.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Gait disturbance, Skin discolouration, X-ray normal
Clinical narrative: Patient complained of left leg limping/notice indention/white pigmentation on June 25, grandmother states a trauma/a injury.  History CP on dad sided/rtn on 07-30-07 - grandmother states notice when started walking and child walked at 13 months dragging of left leg.  States CP-Aunt-Dad side and son at 4 years.  Notice indention on 06-25-07 - x-ray normal.  09-14-07 left leg indention - lighter in color - not limping much.  Stopped dragging leg - recovered.  Small lipoatrophy left thigh - present.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site rash, Rash generalised
Clinical narrative: Smallpox site inflamed causing a dark, red, bumpy appearance around it.  Approximately 1 to 2 inches around the site.  Small, red bumps appeared about 3 weeks after the vaccination.  They appeared on my face, arms, legs, and starting of the back.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Anxiety, Dyspnoea, Immediate post-injection reaction, Screaming, Wheezing
Clinical narrative: After vaccines given immediately started wheezing & short of breath.  Pt felt anxious & screamed - gave 1.25 XOPENEX through nebulizer to treat wheezing - pt left 15 mins after treatment - sounded good.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Site with redness + tenderness 2 1/2cm diameter.  S/S with in 24h of vaccine site hot to touch.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Erythema, Mass, Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: Severe lump in leg and very red and swollen.  Fever & vomiting.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 14 1/2 yr old male with history of reaction to varicella.  6 cm x 3 cm red swollen area - Rx BACTRIM x10 days.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Activities of daily living impaired, Arthralgia, Computerised tomogram normal, Headache, Migraine
Clinical narrative: 51 y/o male, retired, who contracted the health center due to persistent headaches and polyarthralgia onset following receipt of AVA #3 Sep 2004 during deployment out of the country. 1) Headaches were reported as frequent, on the order of 3-4 times per week, associated with nausea/photophobia, and often interfering with his functional capacity. Review of available medical records substantiated this history, indicating he received medical evaluation through both primary care and a neurologist beginning in May 2005, at which time he was diagnosed with migraines following a normal head CT and brain MRI. 2) Joint pain was reported as involving bilateral fingers and bilateral knees; denied history of trauma or overuse; joint pain was to accompanied by erythema, swelling, warmth, or joint deformity; no underlying history of rheumatoid disease; no medical evaluation of joint pain to date. Symptoms: Headache-Migraine, Joint Pain- multiple joints.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Nuclear magnetic resonance imaging brain normal, Photophobia
Clinical narrative: 51 y/o male, retired, who contracted the health center due to persistent headaches and polyarthralgia onset following receipt of AVA #3 Sep 2004 during deployment out of the country. 1) Headaches were reported as frequent, on the order of 3-4 times per week, associated with nausea/photophobia, and often interfering with his functional capacity. Review of available medical records substantiated this history, indicating he received medical evaluation through both primary care and a neurologist beginning in May 2005, at which time he was diagnosed with migraines following a normal head CT and brain MRI. 2) Joint pain was reported as involving bilateral fingers and bilateral knees; denied history of trauma or overuse; joint pain was to accompanied by erythema, swelling, warmth, or joint deformity; no underlying history of rheumatoid disease; no medical evaluation of joint pain to date. Symptoms: Headache-Migraine, Joint Pain- multiple joints.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase normal, Anorexia, Arthralgia, Dizziness, Fatigue
Clinical narrative: Arthralgia, myalgia, dizziness, flu-like symptoms, anorexia, fatigue, malaise, nausea, sweating-onset approx 24 hours after vaccine administration
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis C positive, Hyperhidrosis, Influenza like illness, Malaise, Myalgia
Clinical narrative: Arthralgia, myalgia, dizziness, flu-like symptoms, anorexia, fatigue, malaise, nausea, sweating-onset approx 24 hours after vaccine administration
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: Arthralgia, myalgia, dizziness, flu-like symptoms, anorexia, fatigue, malaise, nausea, sweating-onset approx 24 hours after vaccine administration
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: Kindergarten shots were given that were given 1 yr ago.No adverse effects noted at this time. parents and physician notified of event.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash erythematous, Rash vesicular
Clinical narrative: The patient recieved Zostavax on 6/2/08 and presented to the Emergency Department on 6/4/08 complaining of pain. Upon examination, erythematous vesicular lesions were noticed. She was diagnosed with herpes zoster and discharge with Valtrex and Lidoderm patch. She followed up with her primary care physician, who gave her pain medications. As of 6/23/08, the pain is still present.
Age: 46.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Pain in extremity
Clinical narrative: After receiving shots for travel purposes, I was told my left arm would be sore for a few days.  It has been 28 days and my arm still hurts.  No swelling or redness was ever visable, however the pain for the first two weeks was excruciating.  It is not as bad now but it is still very much present.
Age: 26.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: PT C/O REDNESS AND SWELLING TO LEFT ARM. LEFT TRICEPT AREA RED, WARM TO TOUCH, 70 W X SSL. PT DENIES ANY PAIN TO AREA. PT DID NOT APPLY ICE TO AREA OR TAKE ANTI-INFLAMATORY AT ONSET OF REACTION. INSTRUCTED PT: TO APPLY ICE TO AREA 20 MINS ON/20 MINS OFF AT LEAST 3X A DAY X 3 DAYS, TAKE 200-400 MG (1-2 TABLETS) OF ADVIL OR ALEVE 2X'S A DAY X 3 DAYS. IF REDNESS SWELLING OR PAIN INCREASES SEEK MED CARE IMMEDIATELY.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Immunisation reaction
Clinical narrative: immunization reaction ldt redden area. mom advised to put cool packs on affected area. return to clinic if worsens.
Age: 24.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Erythema, Hyperaesthesia, Oedema peripheral, Pain in extremity
Clinical narrative: PT C/O REDNESS AND SWELLING TO RIGHT ARM. RIGHT TRICEP AREA RED, SWOLLEN, WARM AND PAINFUL TO TOUCH, 70W X 296. PT DID NOT APPLY ICE TO AREA. LEFT TRICEP AREA RED, AND SWOLLEN, 50WX201. PT DID NOT APPLY ICE TO AREA. INSTRUCTED PT TO APPLY ICE TO AREA 20 MINS ON/20 MINS OFF AT LEAST 3X A DAY X3 DAYS. TAKE 200-400 MG (1-2 TABLETS) OF ADVIL 2X1S A DAY X 3 DAYS. IF REDNESS , SWELLING, OR PAIN INCREASES SEEK MEDICAL CARE IMMEDIATELY.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Dyskinesia, Dyspnoea, Hyperhidrosis
Clinical narrative: Within 5 minutes of receiving HPV vaccine, patient c/o dizziness and passed out.  Was aroused in seconds, jumped up violently and thrashed about then passed out a second time.  Trouble breathing, blood pressure dropped from 110/76 to 90/62 and broke out in hives over all of torso.  Very pale, sweaty and very shallow breathing.  911 was then contacted.  Just prior to their arrival (about 7 minutes) pt aroused and was able to sit up at take in a dose of liquid Benadryl.  She was stable at time of departure on ambulance, but hives were worsening.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoventilation, Loss of consciousness, Pallor, Urticaria
Clinical narrative: Within 5 minutes of receiving HPV vaccine, patient c/o dizziness and passed out.  Was aroused in seconds, jumped up violently and thrashed about then passed out a second time.  Trouble breathing, blood pressure dropped from 110/76 to 90/62 and broke out in hives over all of torso.  Very pale, sweaty and very shallow breathing.  911 was then contacted.  Just prior to their arrival (about 7 minutes) pt aroused and was able to sit up at take in a dose of liquid Benadryl.  She was stable at time of departure on ambulance, but hives were worsening.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Local reaction
Clinical narrative: RIGHT DELTOID 7 X 3 1/2 CM AREA OF ERYTHEMA. POSSIBLE LARGE LOCAL REACTION US. EARLY CELLULITIS.
Age: 15.0
Sex: U
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: GAVE DTAP INSTEAD TDAP
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood pressure, Cardiac stress test, Pain, Palpitations, Pruritus
Clinical narrative: Itching then swelling as large as baseball hard and painful and then heart palpatations.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: Itching then swelling as large as baseball hard and painful and then heart palpatations.
Age: 66.0
Sex: U
Vaccine: PNC
Symptoms: Biopsy lung abnormal, Neoplasm malignant, Nuclear magnetic resonance imaging abnormal, Positron emission tomogram abnormal
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was scheduled with PCP visit. PCP ordered PET scan and MRI; results showed abnormalities in R lung. Lung specialist performed biopsy and Stage 3A carcinoma was diagnosed. No hospitalization or emergency department visit associated with this event. We would be happy to forward the Study's SAE Report Form upon request.
Age: 51.0
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was admitted to the general medical service. Vaccination took place on 1/28/2008 and admission was on 4/7/2008. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Condition aggravated, Full blood count, Metabolic function test, Pain in extremity
Clinical narrative: I took the first Hep B injection on January 16th, 2007. Approximately 1 1/2 weeks after that I began to experience joint pain in my right arm. The second injection was given on February 13th, 2007. The pain in my arm had increased from the elbow area to my shoulder and finally my entire arm. I went to the doctor on 2/19/07 and was diagnosed with what seemed to be 'tendonitis'. I wore a brace on my right arm for over 2 months. The pain lasted much longer than the doctor had initially suspected it would. Thereafter I began to experience additional joint pains that would last from 2-3 days in one area and then move to another area. The joints affected were my knees, shoulders, arms, hands. The third and final Hep B injection was administered on June 14th 2007. Still experiencing intense joint pain that finally became unbearable, I ended up back in the doctor's office on October 19th, 2007. Lab work was ordered and it was discovered that I had a high Rheumatoid Factor. I began to see a Rheumatologist shortly thereafter and I was diagnosed with full blown Rheumatoid Arthritis. I began Plaquenil treatment with no success. Methotrexate was added, with a steady dosage increase, with still no success. My test results are higher each month than they were the month before. I am about to add a third medication to the treatment program which is 'injectable' Humira. I am also on Prednisone therapy. I have always been very healthy. This disease attacked my body very suddenly, very unexpectedly, and is progressing at a rapid pace. There is NO genetic history of Rheumatoid Arthritis on either side of my family. I had often wondered if the Hep B vacination could have had anything to do with the sudden onset of Rheumatoid Arthritis, but did not mention it to my doctor until two days ago. Since that time I have learned of the case studies and possible links between immunizations and Rheumatic disease.  7/31/2008 MR received from rheumatology consult dated 3/20/08-7/9/08 with DX:  Seropositive RA.  Pt reports onset of joint pain, stiffness and inflammation beginning 10/2007.  Pt dx with RA based on earlier labs. PE (+) for limited ROM of the R shoulder. Swelling of MCP, MTP & PIP joints with dusky color/redness and warmth. Joints are tender. Knees show swelling and effusion. F/U 7/9/08 with continued pain, swelling and stiffness in hands, ankles, and feet.  PE (+) for joint synovitis, tenderness and effusion.  Only partial resolution of sx with meds.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Rheumatoid arthritis, Rheumatoid factor increased, Tendonitis
Clinical narrative: I took the first Hep B injection on January 16th, 2007. Approximately 1 1/2 weeks after that I began to experience joint pain in my right arm. The second injection was given on February 13th, 2007. The pain in my arm had increased from the elbow area to my shoulder and finally my entire arm. I went to the doctor on 2/19/07 and was diagnosed with what seemed to be 'tendonitis'. I wore a brace on my right arm for over 2 months. The pain lasted much longer than the doctor had initially suspected it would. Thereafter I began to experience additional joint pains that would last from 2-3 days in one area and then move to another area. The joints affected were my knees, shoulders, arms, hands. The third and final Hep B injection was administered on June 14th 2007. Still experiencing intense joint pain that finally became unbearable, I ended up back in the doctor's office on October 19th, 2007. Lab work was ordered and it was discovered that I had a high Rheumatoid Factor. I began to see a Rheumatologist shortly thereafter and I was diagnosed with full blown Rheumatoid Arthritis. I began Plaquenil treatment with no success. Methotrexate was added, with a steady dosage increase, with still no success. My test results are higher each month than they were the month before. I am about to add a third medication to the treatment program which is 'injectable' Humira. I am also on Prednisone therapy. I have always been very healthy. This disease attacked my body very suddenly, very unexpectedly, and is progressing at a rapid pace. There is NO genetic history of Rheumatoid Arthritis on either side of my family. I had often wondered if the Hep B vacination could have had anything to do with the sudden onset of Rheumatoid Arthritis, but did not mention it to my doctor until two days ago. Since that time I have learned of the case studies and possible links between immunizations and Rheumatic disease.  7/31/2008 MR received from rheumatology consult dated 3/20/08-7/9/08 with DX:  Seropositive RA.  Pt reports onset of joint pain, stiffness and inflammation beginning 10/2007.  Pt dx with RA based on earlier labs. PE (+) for limited ROM of the R shoulder. Swelling of MCP, MTP & PIP joints with dusky color/redness and warmth. Joints are tender. Knees show swelling and effusion. F/U 7/9/08 with continued pain, swelling and stiffness in hands, ankles, and feet.  PE (+) for joint synovitis, tenderness and effusion.  Only partial resolution of sx with meds.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiomegaly, Death, Passive smoking, Splenomegaly, Toxicologic test normal
Clinical narrative: Death -coroner says enlarged heart & enlarge spleen  7/4/08 Reviewed PCP medical records of 1999-6/2008 which included vax record.  In 8/2007, c/o of tiredness & loss of appetite.  Monospot (-).  On day of vax, patient was well, weight noted as 237, otherwise no complaints. 7/8/08 Autopsy report states COD as arrhythmia due to cardiomyopathy.States anatomic findings of obesity, pulmonary edema, mild & left ventricular hypertrophy w/myocardial nuclear enlargement.  Patient had been found non-responsive by family.  EMS found patient cyanotic w/rigor & no further resuscitation was performed.  Family reported patient had been well earlier in the evening.  Albuterol inhaler was found at scene but no suspicious features at scene.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Death
Clinical narrative: Death -coroner says enlarged heart & enlarge spleen  7/4/08 Reviewed PCP medical records of 1999-6/2008 which included vax record.  In 8/2007, c/o of tiredness & loss of appetite.  Monospot (-).  On day of vax, patient was well, weight noted as 237, otherwise no complaints. 7/8/08 Autopsy report states COD as arrhythmia due to cardiomyopathy.States anatomic findings of obesity, pulmonary edema, mild & left ventricular hypertrophy w/myocardial nuclear enlargement.  Patient had been found non-responsive by family.  EMS found patient cyanotic w/rigor & no further resuscitation was performed.  Family reported patient had been well earlier in the evening.  Albuterol inhaler was found at scene but no suspicious features at scene.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying
Clinical narrative: PT WAS CRYING FOR ABOUT 45MIN NONE STOP.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo, Vision blurred
Clinical narrative: I received the injection about 9:30 AM on June 26.  About one hour later, as I was driving home, I stopped at the grocery store.  As I got out of the car, I felt dizzy and had trouble focusing my eyes.  I went on into the store and as I was shopping, this feeling would come and go.  After I got home I felt things spinning if I would close my eyes.  I called the doctor who told me to check my blood pressure and pulse and if not in the normal range that I should go to an urgent care clinic.  My husband took my BP and pulse when he got home and, by then, everything was beginning to get back to normal.  After approx. 8 hours the dizziness was pretty much gone.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Activities of daily living impaired, Chills, Headache, Pain, Pyrexia
Clinical narrative: Pt c/o low grade fever, body aches, chills, headache. Had to leave school. Pt has hx of + PPD. Seen today here in clinic by Dr., given 600mg Motrin. F/u in 1 week. ER precations given if headache/fever persist, or worsen.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Chills, Confusional state, Fatigue, Feeling abnormal
Clinical narrative: Patient was otherwise healthy, had one small cold in over a year. Vaccine was at 3:30pm on 5/6/08. By that night, patient's vaccine site was swollen, warm and painful. Patient had 100mg. of Ibuprofen and ice on site. When patient woke in morning of 5/7/08 at 5:45am, he complained that he was unusually tired. He seemed a bit spaced out. He went to school. Not recognizing he was not well, he said his legs were really tired through the day, and at Gym class (9:30am)he realized that he kept losing grip of a baseball bat. He ate lunch at 10:30am and still felt a bit tired. By 2:00pm it seems he lost conciousness in the classroom. He said everything turned white and he fainted. At this point he might have hit his head, had symptoms of a concusion. He blacked out a few times in a wheel chair to and at the health office at school. I arrived at the school by 2:30pm. I witnessed his confusion and dazed behavior. He was shaking and had the chills. His temperature was 99, he had a stiff appearence. The most startling event that I witnessed and the EMT said was not typical of a concusion was that his face seemed almost paralyzed. His face was green/greyish and lack of color. He had no muscle tone in his face. One eye was somewhat lower than the other. The EMT checked for signs of a stroke, it was negative. They took him to the Emergency room. He was given glucose and orange juice and by 5:00pm he was more like himself, including color and muscle-tone in his face. His arms and legs were still weak and still had a low fever for another 2 days. The injection site was swollen for another few days. The Doctors denied that this might have been an adverse reaction to the Menactra vaccine. I think it's just too much of a coincidence for it not to be related. Thankfuly he recovered.