chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Haematochezia, Intussusception, Vomiting
Clinical narrative: Information has been received from a physician and a nurse concerning a 3 month old (also reported as 8 week old) female who on 04-MAR-2008 was vaccinated orally with a first dose of ROTATEQ (lot # not provided). On 11-MAR-2008 the patient was seen in the office with vomiting and bloody stools, the patient was diagnosed with intussusception. The patient required a colon resection and recovered. There was no product quality complaint involved. The physician considered the patient's intussusception to be life threatening and serious as an other important medical event. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Colectomy, Haematochezia, Intussusception, Vomiting
Clinical narrative: Information has been received from a physician and a nurse concerning a 3 month old (also reported as 8 week old) female who on 04-MAR-2008 was vaccinated orally with a first dose of ROTATEQ (lot # not provided). On 11-MAR-2008 the patient was seen in the office with vomiting and bloody stools, the patient was diagnosed with intussusception. The patient required a colon resection and recovered. There was no product quality complaint involved. The physician considered the patient's intussusception to be life threatening and serious as an other important medical event. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Surgery, Vomiting
Clinical narrative: Information has been received from a physician and a nurse concerning a 3 month old (also reported as 8 week old) female who on 04-MAR-2008 was vaccinated orally with a first dose of ROTATEQ (lot # not provided). On 11-MAR-2008 the patient was seen in the office with vomiting and bloody stools, the patient was diagnosed with intussusception. The patient required a colon resection and recovered. There was no product quality complaint involved. The physician considered the patient's intussusception to be life threatening and serious as an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder, Heart rate normal, Laboratory test
Clinical narrative: Information has been received from the Merck Pregnancy Registry via a mother concerning her 17 year old daughter with no pertinent medical history who on 21-AUG-2007 was vaccinated with a 0.5ml second dose of GARDASIL. There was no concomitant medication. Subsequently the patient "came to know she was pregnant". A blood test was performed, results unspecified. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Follow up information received from a healthcare professional from an OB/GYN office, indicated that the patient was a 17 year old female with no prior pregnancies, allergic rhinitis, and a past history of depression, obesity and occasional smoking, who on 06-MAR-2007 was vaccinated with the first dose, and on 21-AUG-2007 was vaccinated with the second dose, 0.5ml, of GARDASIL (lot # for both doses: 654510/0962F). The patient's date of LMP was stated as "31-DEC-2007," with an estimated delivery date stated as "29-NOV-2008." On 06-NOV-2007, a vaccination of influenza virus vaccine (FLULAVAL) was administered. During delivery, "fetal intolerance with non-reassuring fetal tracings, brady x 2 - 30's, multiple bradys into 60's" were detected, as well as a "nuchal cord x 1." Active range of motion was monitored for 6 1/2 hours with "NEC." On 03-DEC-2007, at 40 weeks gestation, a Cesarean section was performed due to the symptoms of fetal intolerance, non reassuring fetal tracings and bradycardia. The mother gave birth to a normal female infant (no congenital anomalies or abnormalities), birth weight, 6 lb 15.202 ounces, length 19," head circumference 33cm, and Apgar score of 6 - 9/9. Upon internal review, "fetal intolerance with non reassuring fetal tracings, brady x 2 - 30's" was considered to be serious as an other important medical event (resulted in Cesarean section). Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Dehydration
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated PO with a dose of ROTATEQ. Subsequently the patient became extremely dehydrated and was hospitalized (length of stay unknown). The outcome was unknown. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a certified medical assistant concerning a female co-worker who on 18-MAR-2008 splashed ZOSTAVAX in her eye while administering the vaccine. The patient experienced burning, but it may have been due to flushing it with water. No other symptoms noted. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. The reporter considered the patient events to be an other important medical events. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Cyst, Lymphadenopathy, Tenderness, Ultrasound scan abnormal
Clinical narrative: 3/14/08 received Tdap, IM, left deltoid. 3/17/08 presented with cyst and enlarged lymph  nodes Left axilla approx 70 mm x 40 mm. Soft with slight tenderness. No erythema, drainage.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Dizziness, Nausea, Pyrexia, Rash
Clinical narrative: After Hep B vaccine #3 was given, pt c/o nausea, fever, coughing, and dizziness within 2 min. Pt c/o tightness of throat about 50 min after the vaccine. No SOB. Pt was sent to ER for c/o tightness of throat. He has rash around his neck at the ER. He was given SOLU-MEDROL, BENADRYL, and EPINEPHRINE at ER.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Throat tightness
Clinical narrative: After Hep B vaccine #3 was given, pt c/o nausea, fever, coughing, and dizziness within 2 min. Pt c/o tightness of throat about 50 min after the vaccine. No SOB. Pt was sent to ER for c/o tightness of throat. He has rash around his neck at the ER. He was given SOLU-MEDROL, BENADRYL, and EPINEPHRINE at ER.
Age: 0.9
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Autoimmune disorder, Feeling hot, Laboratory test normal, Pyrexia, Skin discolouration
Clinical narrative: After administration of Hep B 3 + DTaP. Her body temperature remained excessively hot for several years. 2007 she developed a viral and could not break fever for 3 1/2 weeks. When she finally, recovered she developed large white spots on face and body. She was diagnosed with Vitiligo and auto immune disorder.  4/11/08-records received for office visits-10/7/00-C/O crying, TM erythematous, dull. Left OM. Poor appetite. 10/23/00-nasal congestion, TMs right injected. 12/4/00-Fever, runny nose. 12/7/00-diaper rash.12/9/00-Fever times 2 days. TM with fluid bilateral. . 1/15/01-congested times 5-6 days. 4/1/01-L TM erythematous, dull with pus.6/5/01-C/O rash on arms and stomach, fever times 4 days. 9/1/01-C/O abnormal gait, falling a lot while walking. Referred to neurologist, patient has not returned to PCP since referral.  5/22/08-records received for office visit 11/14/07-for evaluation and treatment of vitiligo which was diagnosed a few months ago. White spots began around 8 months ago. DX: Vitiligo with depigmented macules limited to right periorbital area, right abdomen and right upper extremity.
Age: 0.9
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Viral infection, Vitiligo
Clinical narrative: After administration of Hep B 3 + DTaP. Her body temperature remained excessively hot for several years. 2007 she developed a viral and could not break fever for 3 1/2 weeks. When she finally, recovered she developed large white spots on face and body. She was diagnosed with Vitiligo and auto immune disorder.  4/11/08-records received for office visits-10/7/00-C/O crying, TM erythematous, dull. Left OM. Poor appetite. 10/23/00-nasal congestion, TMs right injected. 12/4/00-Fever, runny nose. 12/7/00-diaper rash.12/9/00-Fever times 2 days. TM with fluid bilateral. . 1/15/01-congested times 5-6 days. 4/1/01-L TM erythematous, dull with pus.6/5/01-C/O rash on arms and stomach, fever times 4 days. 9/1/01-C/O abnormal gait, falling a lot while walking. Referred to neurologist, patient has not returned to PCP since referral.  5/22/08-records received for office visit 11/14/07-for evaluation and treatment of vitiligo which was diagnosed a few months ago. White spots began around 8 months ago. DX: Vitiligo with depigmented macules limited to right periorbital area, right abdomen and right upper extremity.
Age: 31.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Chest X-ray normal, Chest discomfort, Electrocardiogram normal
Clinical narrative: 03/21/08 patient came to clinic, complained of mid-sternal chest discomfort.  Sent to hospital ER for evaluation.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: 3 days splotchy red dot rash appeared on extremities only, none on face that went away with BENADRYL.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site pain, Injection site swelling, Otitis media, Pharyngitis, Pyrexia
Clinical narrative: R thigh swelling/tenderness pain (mild to moderate) fever. all after 2 days of imm.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antinuclear antibody positive, Arthralgia, Dizziness, Injection site pain, Pallor
Clinical narrative: 1st shot - 8/27/2007 - felt like nurse put needle in bone, light headed, turned white, pain at injection site for 3 days.  2nd shot - 10/31/2007 - sore at injection site.  3rd shot - 2/20/2008 - site severe pain in muscles, joints, arm hurt for 3 days.4/10/08-office records received- 5/2/08-records received for DOS 3/11/08- Chief complaint: abnormal Positive ANA, high sed rate, after shots, achy joints, pain has increased since fall 2007, put on Prednisone 3/18/2008. Presented with recurring stress fractures, four since high school.  Chronic pain increasing since last fall. 12/2/09 Other correspondence and medical records received.   Medical records DOS 3/4/09: Final DX: Abnormal weight loss, arthralgias and joint stiffness, elevated sed rate, and positive ANA consistent with polyarthralgia blotchy rash, urticarial rash, HLA B27 positive, back pain out of proportion to other joint pains--suspicious for spondyloarthritis in setting of seronegative arthritis, Lymphocele is seen at T12 through L2 and MR lumbosacral area.  Pulmonary nodules, previous Gardasil immunization prior to onset of rheumatologic symptoms, positive SSA, multiple stress fractures, mostly asymptomatic, abnormal bone scan, bone biopsy pending after tetracycline loading.  Gardasil vaccine questionnaire noting the following sx beginning after vaccine #1 and continuing throughout vaccine series: dizziness, numbness, tingling, joint pain, muscle pain at inj site, rashes, blisters or skin disorders,  extreme fatigue, weight loss,  joint stiffness, night sweats, fevers, back pain, chest pain. All increasing over time. Short term steroid therapy no help. Unable to complete ADLs some days, often debilitating.  C/O Ankylosing spondylitis and connective tissue disorder s/p vaccines.   ICD9 Codes:  Noted as indication for MRI of spine 721.90, 724.5
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: 1st shot - 8/27/2007 - felt like nurse put needle in bone, light headed, turned white, pain at injection site for 3 days.  2nd shot - 10/31/2007 - sore at injection site.  3rd shot - 2/20/2008 - site severe pain in muscles, joints, arm hurt for 3 days.4/10/08-office records received- 5/2/08-records received for DOS 3/11/08- Chief complaint: abnormal Positive ANA, high sed rate, after shots, achy joints, pain has increased since fall 2007, put on Prednisone 3/18/2008. Presented with recurring stress fractures, four since high school.  Chronic pain increasing since last fall. 12/2/09 Other correspondence and medical records received.   Medical records DOS 3/4/09: Final DX: Abnormal weight loss, arthralgias and joint stiffness, elevated sed rate, and positive ANA consistent with polyarthralgia blotchy rash, urticarial rash, HLA B27 positive, back pain out of proportion to other joint pains--suspicious for spondyloarthritis in setting of seronegative arthritis, Lymphocele is seen at T12 through L2 and MR lumbosacral area.  Pulmonary nodules, previous Gardasil immunization prior to onset of rheumatologic symptoms, positive SSA, multiple stress fractures, mostly asymptomatic, abnormal bone scan, bone biopsy pending after tetracycline loading.  Gardasil vaccine questionnaire noting the following sx beginning after vaccine #1 and continuing throughout vaccine series: dizziness, numbness, tingling, joint pain, muscle pain at inj site, rashes, blisters or skin disorders,  extreme fatigue, weight loss,  joint stiffness, night sweats, fevers, back pain, chest pain. All increasing over time. Short term steroid therapy no help. Unable to complete ADLs some days, often debilitating.  C/O Ankylosing spondylitis and connective tissue disorder s/p vaccines.   ICD9 Codes:  Noted as indication for MRI of spine 721.90, 724.5
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antinuclear antibody positive, Arthralgia, Borrelia burgdorferi serology negative, DNA antibody negative, Pain in extremity
Clinical narrative: 1st shot - 8/27/2007 - felt like nurse put needle in bone, light headed, turned white, pain at injection site for 3 days.  2nd shot - 10/31/2007 - sore at injection site.  3rd shot - 2/20/2008 - site severe pain in muscles, joints, arm hurt for 3 days.4/10/08-office records received- 5/2/08-records received for DOS 3/11/08- Chief complaint: abnormal Positive ANA, high sed rate, after shots, achy joints, pain has increased since fall 2007, put on Prednisone 3/18/2008. Presented with recurring stress fractures, four since high school.  Chronic pain increasing since last fall. 12/2/09 Other correspondence and medical records received.   Medical records DOS 3/4/09: Final DX: Abnormal weight loss, arthralgias and joint stiffness, elevated sed rate, and positive ANA consistent with polyarthralgia blotchy rash, urticarial rash, HLA B27 positive, back pain out of proportion to other joint pains--suspicious for spondyloarthritis in setting of seronegative arthritis, Lymphocele is seen at T12 through L2 and MR lumbosacral area.  Pulmonary nodules, previous Gardasil immunization prior to onset of rheumatologic symptoms, positive SSA, multiple stress fractures, mostly asymptomatic, abnormal bone scan, bone biopsy pending after tetracycline loading.  Gardasil vaccine questionnaire noting the following sx beginning after vaccine #1 and continuing throughout vaccine series: dizziness, numbness, tingling, joint pain, muscle pain at inj site, rashes, blisters or skin disorders,  extreme fatigue, weight loss,  joint stiffness, night sweats, fevers, back pain, chest pain. All increasing over time. Short term steroid therapy no help. Unable to complete ADLs some days, often debilitating.  C/O Ankylosing spondylitis and connective tissue disorder s/p vaccines.   ICD9 Codes:  Noted as indication for MRI of spine 721.90, 724.5
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Red blood cell sedimentation rate normal, Thyroid function test normal, Urine analysis normal
Clinical narrative: 1st shot - 8/27/2007 - felt like nurse put needle in bone, light headed, turned white, pain at injection site for 3 days.  2nd shot - 10/31/2007 - sore at injection site.  3rd shot - 2/20/2008 - site severe pain in muscles, joints, arm hurt for 3 days.4/10/08-office records received- 5/2/08-records received for DOS 3/11/08- Chief complaint: abnormal Positive ANA, high sed rate, after shots, achy joints, pain has increased since fall 2007, put on Prednisone 3/18/2008. Presented with recurring stress fractures, four since high school.  Chronic pain increasing since last fall. 12/2/09 Other correspondence and medical records received.   Medical records DOS 3/4/09: Final DX: Abnormal weight loss, arthralgias and joint stiffness, elevated sed rate, and positive ANA consistent with polyarthralgia blotchy rash, urticarial rash, HLA B27 positive, back pain out of proportion to other joint pains--suspicious for spondyloarthritis in setting of seronegative arthritis, Lymphocele is seen at T12 through L2 and MR lumbosacral area.  Pulmonary nodules, previous Gardasil immunization prior to onset of rheumatologic symptoms, positive SSA, multiple stress fractures, mostly asymptomatic, abnormal bone scan, bone biopsy pending after tetracycline loading.  Gardasil vaccine questionnaire noting the following sx beginning after vaccine #1 and continuing throughout vaccine series: dizziness, numbness, tingling, joint pain, muscle pain at inj site, rashes, blisters or skin disorders,  extreme fatigue, weight loss,  joint stiffness, night sweats, fevers, back pain, chest pain. All increasing over time. Short term steroid therapy no help. Unable to complete ADLs some days, often debilitating.  C/O Ankylosing spondylitis and connective tissue disorder s/p vaccines.   ICD9 Codes:  Noted as indication for MRI of spine 721.90, 724.5
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Skin laceration, Suture insertion, Syncope
Clinical narrative: Patient received Gardasil in left deltoid.  Upon standing, patient collapsed, hit back of head on stool to exam table.  Patient loss consciousness for 30-40 seconds.  Patient was treated by nurse (RN) and sent to hospital for staples for scalp laceration.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: -administered 4 mo vaccinations when he got them at another facility. Mom did not notify us at time of vaccines-called 2 hrs later to let us know. Also not imm alert
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying
Clinical narrative: On 3-10-08 the mother returned with the child for additional immunization. She stated the child had inconsolable crying, lasting 12 hours, following the 1-7-08 immunization. No medical attention sought for this reaction no residual effect
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Within 48 hours of immunization began with hives on abdomen and legs.  Spread to face.  Responded to Benadryl but now 5 days out still flares when Benadryl wears off.  Chest clear, BS o.k.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pain in extremity
Clinical narrative: 3x3 redness, painful to touch on right deltoid area and down.  3x3 redness to lower right arm.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: Severe pain with certain arm movements in arm muscle at the site of the vaccination.  The pain began the first evening of the vaccination, and lasted for about five (5) months.
Age: 1.45
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Erythematous, maculopapular rash on face, trunk, extremities. Also, an indurated, erythematous area at injection site right thigh.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site pain, Injection site warmth
Clinical narrative: No c/o severe: swelling at injection site with bruising and slight warmth to touch and pain.
Age: 36.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Local swelling, Nodule, Pain
Clinical narrative: Localized swelling and pain with underlying nodule. (L) arm.
Age: 55.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dysphagia, Hypersensitivity, Pharyngeal oedema
Clinical narrative: Severe allergic reaction after 1 hour of administration (throat swelling and difficulty swallowing-911 activated-to local ER for epinephrine and Benadryl-client recovered fully.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site pain
Clinical narrative: Diffuse arthralgias beginning the day after the injection and lasting of one week.  Redness and pain at the injection site and distally along the arm.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Blood pressure, Immediate post-injection reaction, Injection site pain, Loss of consciousness, Pallor
Clinical narrative: Nurse noted few minutes after shot - Pallor, Shaking, LOC for 40 seconds - syncope. Called doctor and had patient lay down. Given oxygen by mask. BP normal, no bronchospasm or respiratory distress on examination. Responsive to name and able to answer questions. Felt better with improved color and able to ambulate on own w/in minutes. F/U call in few hours, patient had low grade fever, soreness in arm where other shot given, but felt well w/o dizziness.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Pyrexia, Syncope, Tremor
Clinical narrative: Nurse noted few minutes after shot - Pallor, Shaking, LOC for 40 seconds - syncope. Called doctor and had patient lay down. Given oxygen by mask. BP normal, no bronchospasm or respiratory distress on examination. Responsive to name and able to answer questions. Felt better with improved color and able to ambulate on own w/in minutes. F/U call in few hours, patient had low grade fever, soreness in arm where other shot given, but felt well w/o dizziness.
Age: 51.0
Sex: F
Vaccine: HEPAB, JEV
Symptoms: Arthralgia, Dizziness, Limb discomfort
Clinical narrative: One hour after recieving twinrix and japanese encephalitis this patient felt dizzy and lightheaded this lasted 45 min. For the next 24 hrs she felt joint aches and discomfort in lt upper arm.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Myoclonus
Clinical narrative: Patient stated having myoclonic jerks on 3/28/05.  After her 4 month vaccinations, she had uncontrolable seizures that resulted in hospitalization for about six months.  She has had numerous testing done at Hospital and results have remained, no known cause.  4/30/2008 MR received for >10 admissions from 3/29/2005 to 3/09/2008.  Initially admitted 3/29/2005 in status epilepticus, progressive in nature since 2pm. Episode started with arm and leg twitching, which progressed to myoclonic jerking of upper and lower extremities with LOC.  Admitted multiple times subsequent to this even with DX: Myoclonus for DOS 4/10-22/05.  Pt developed refractory seizures of multiple types including generalized tonic-clonic seizures, complex partial seizures as well as myoclonic jerks, eye deviations. Frequent admissions for increased seizures as well as various infections (Candida, Mycobacterium, C.diff). Developmental delay noted by 5/2005 with regression. Hypertrophic cardiomyopathy dxd 6/2005. Suspect metabolic or mitochondrial disorder. G-tube placed after failed swallow study. Ketogenic diet started 2007 with good control of seizure. Poor muscle tone and head control. Assessment 3/11/08 Status epilepticus, Global Developmental Delay, Possible mitochondrial disorder.  4/17/09 F/u received reporting pt's death in December 2008. 5/14/09 Genetics note recd dated 11/20/08 for eval of genetic testing done. W/U  (-) for known disorders.  Most likely a mitochondrial d/o, unproven.  6/24/09 Verbal report from ME's office with COD -hypoxic ischemic encephalopathy complicating probable viral myocarditis in a child with developmental disorder of uncertain etiology. manner of death natural. 8/3/09 Autopsy report received with above COD.  Final Dx:  Lymphocytic Myocarditis with hypoxic/ischemic encephalopathy.  Chronic Bronchopneumonia. Blunt impact injury of the torso-contusion of back. Follow-up: seizures, developmental delay - severe.
Age: 0.12
Sex: M
Vaccine: RV5
Symptoms: Blood gases normal, Diarrhoea, Faeces discoloured, Haematochezia, Mucous stools
Clinical narrative: Gave rotavirus vaccine  2-3 days later there was a rash without fever and loose greenish stool. The stool then improved over 3 days but then got slight mucous and some blood. Was referred to ER to see Dr who is Pediatric GI specialist. Abdominal sonogram and X-ray neg. Baby alert and gaining weight. Discharged from ER. Dr. did not think it was intussuception. His opinion is that it could have been unrelated virus, it could be the vaccine, and maybe an outside chance that it is a protein sensit. (I do not think it is protein sens--mom is 95% breast feeding)Baby as of 3 days ago still had tiny amt of blood and mucous--they followed up with GI and he is not worried.
Age: 0.12
Sex: M
Vaccine: RV5
Symptoms: Rash, Ultrasound abdomen normal
Clinical narrative: Gave rotavirus vaccine  2-3 days later there was a rash without fever and loose greenish stool. The stool then improved over 3 days but then got slight mucous and some blood. Was referred to ER to see Dr who is Pediatric GI specialist. Abdominal sonogram and X-ray neg. Baby alert and gaining weight. Discharged from ER. Dr. did not think it was intussuception. His opinion is that it could have been unrelated virus, it could be the vaccine, and maybe an outside chance that it is a protein sensit. (I do not think it is protein sens--mom is 95% breast feeding)Baby as of 3 days ago still had tiny amt of blood and mucous--they followed up with GI and he is not worried.
Age: 17.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Physician ordered Tdap but patient was administered DTaP.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Eye infection, Meningitis bacterial, Pyrexia
Clinical narrative: 1-11-09 fever 104F, crying all time, wouldn't lay down.  1/12/08 - ER hospital, transferred to hospital - spinal meningitis, bacterial.  Bacteria not identified.  tx - IV antibiotics.  D/cd 1/16/08 No residual effects.  Mom stated Dr. said could be from shots or eye infection.  4/1/08 Reviewed ER medical records of 01/12/08. FINAL ER DX: meningitis Records reveal patient w/fever x 4 days.  Seen by PCP, dx w/URI & tx w/oral antibiotics.  Excessive crying x 1 day whenever laid down.  Exam revealed left eye irritation, drainage & edema.  LP done.  Admitted & tx w/IV antibiotics  5/1/08 Reviewed hospital medical records of 1/12-1/16/2008. FINAL DX: meningitis Records reveal patient w/fever.  Seen by PCP & dx w/URI, tx w/antibiotics.  Fever continued, screaming/crying unconsolable.  Took to ER where admitted for febrile illness.  When LP (+), transferred to higher level of care.  On admit, had green drainage left eye w/swelling, tachycardia & poor perfusion.  Tx w/IVF & multi IV antibiotics Progressed & d/c w/home health to continue IV antibiotcs via PICC line & f/u w/PCP.
Age: 27.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: 3/06/08 - wrist and hand warm yesterday last pm started to swell and painful.  No soreness at vaccination site.  3/07/08 Painful this date right hand and wrist with shooting pain up to right elbow.  Continues to be swollen - no heat or redness noted.  No soreness, redness, or swelling at vaccination site referred to physician.
Age: 71.0
Sex: M
Vaccine: PPV, TD, VARZOS
Symptoms: Disorientation, Headache, Impaired driving ability, Malaise, Pain in extremity
Clinical narrative: PT STATES SORENESS IN ARM THAT RECEIVED PNUEMOVAX.  MENTAL DISORIENTATION FOR 2 DAYS, VERTIGO, HEADACHE, GENERAL MALAISE, UNABLE TO DRIVE VEHICLE.
Age: 71.0
Sex: M
Vaccine: PPV, TD, VARZOS
Symptoms: Vertigo
Clinical narrative: PT STATES SORENESS IN ARM THAT RECEIVED PNUEMOVAX.  MENTAL DISORIENTATION FOR 2 DAYS, VERTIGO, HEADACHE, GENERAL MALAISE, UNABLE TO DRIVE VEHICLE.
Age: 72.0
Sex: F
Vaccine: HEPAB, TD, TYP
Symptoms: Erythema, Oedema peripheral, Rash, Skin warm
Clinical narrative: Patient returned for second Twinrix, and stated that after her last immunizations given on 1/24/08, her right arm developed redness and swelling and was warm to touch.  She then stated she developed a rash that lasted 2 weeks.  Did not seek medical attention at the time of the symptoms.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Dizziness, Headache, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pt received smallpox vaccine in left shoulder on 17 Mar 08. He Presented to day c/o dizziness, nausea, vomiting, frontal headaches pain level #4 for the past two days. Denies visual changes, and tinnitis. Vaccine site is tender and warm to touch. Firm underlying tissue circum: 50 mm around the injection site. Sites appears within normal variances according to smallpox trifold VIS dated 1 Aug 07. Physician ordered anti inflammatory meds. Pt is instructed to return to clinic on 31 Mar 2008 and or  to ER if symptons worsen over the weekend.  PT recieved Anthrax, Typhoid, PPD and Smallpox on 17 Mar 2008.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Nausea, Vomiting
Clinical narrative: Pt received smallpox vaccine in left shoulder on 17 Mar 08. He Presented to day c/o dizziness, nausea, vomiting, frontal headaches pain level #4 for the past two days. Denies visual changes, and tinnitis. Vaccine site is tender and warm to touch. Firm underlying tissue circum: 50 mm around the injection site. Sites appears within normal variances according to smallpox trifold VIS dated 1 Aug 07. Physician ordered anti inflammatory meds. Pt is instructed to return to clinic on 31 Mar 2008 and or  to ER if symptons worsen over the weekend.  PT recieved Anthrax, Typhoid, PPD and Smallpox on 17 Mar 2008.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Oedema peripheral, Pruritus
Clinical narrative: Whole arm swelled 2 days after injection. 3" below injection sight had severe knot and 2" redness and hot temperatures. Upper arm very tender to slightest touch. Arm was itchy. Low grade fever under control with proper dosage of ibuprofen 3 times a day.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tenderness
Clinical narrative: Whole arm swelled 2 days after injection. 3" below injection sight had severe knot and 2" redness and hot temperatures. Upper arm very tender to slightest touch. Arm was itchy. Low grade fever under control with proper dosage of ibuprofen 3 times a day.
Age: 1.41
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling noted to Left thigh two days after vaccine was given.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site irritation, Injection site pain, Injection site warmth
Clinical narrative: Patient called to pharmacy with concerns regarding tetanus vaccine received 3/20/07.  Per patient she is still having soreness in the deltoid muscle.  There is no redness and only a small mark at the injection site.  Patient states that she was sore the day of the injection and the day after.  The soreness then went away and returned two days ago.  Patient also states that the injection site feels warm.  Instructed patient to contact her physician to determine if she should be seen.  Patient said she would contact her doctor.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Erythema, Rash pruritic
Clinical narrative: Child had Tdap vaccine in RD and HPV vaccine in LD on 3/24/08 between 3pm and 5pm. By bedtime that evening, GMA reported to me that a red and itching rash developed over left arm above and below injection site and that rash spread to front and back torso by 3/25/08. Gma reports that rash is still present today 3/28/08.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema
Clinical narrative: Redness started Wed. 3/26/08 and spread to about 3.5x5.5 inches diameter. Denies fever, but c/o body aches. Treated 3/28/08 with Bactrim DS 160/800mg 1 po bid x 7 days.
Age: 1.46
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Dyspnoea, Irritability, Pneumonia, Pyrexia, Respiratory rate increased
Clinical narrative: Parent phoned facility on 03/12/2008 at approximately 11am. Parent reported that child had been "crabby" but did not have a fever on 03/11/2008 in the morning but by 12 noon on that same day began having trouble breathing, sounding "congested", and was breathing faster. Parent reported this happened within 12 hours and stated that the child had previously had a slight cold. The child was taken into an Urgent Care center "last night" (03/11/2008). The parent stated that the child has a "fast moving pneumonia" and later stated clinician speculation of a "superbug". The parent stated that the child was "almost admitted" and is now on steroids.
Age: 1.46
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Respiratory tract congestion, Superinfection
Clinical narrative: Parent phoned facility on 03/12/2008 at approximately 11am. Parent reported that child had been "crabby" but did not have a fever on 03/11/2008 in the morning but by 12 noon on that same day began having trouble breathing, sounding "congested", and was breathing faster. Parent reported this happened within 12 hours and stated that the child had previously had a slight cold. The child was taken into an Urgent Care center "last night" (03/11/2008). The parent stated that the child has a "fast moving pneumonia" and later stated clinician speculation of a "superbug". The parent stated that the child was "almost admitted" and is now on steroids.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: PATIENT DEVELOPED ERYTHEMA AT INJECTION SITE POST VACCINATION. LEFT ANTEROLATERAL THIGH APPROX 6 CM IN DIAMETER. PREVIOUS VAERS WEB SUBMISSION INCORRECT DOCUMENTATION OF SITE. PLEASE USE THIS VAERS WEB SUBMISSION.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Computerised tomogram, Convulsion, Laboratory test normal
Clinical narrative: PATIENT WAS GIVEN PDRX AND PREVNAR ON 3/11/2008 AT 11:00 AM AND ON 3/13/2008 MOM CALLED OFFICE AT 4:00 PM STATING THAT PATIENT WAS HAVING SEIZURE LIKE SYMPTOMS WITH NO FEVER. ADVISED MOTHER TO CALL EMS. PATIENT WAS TRANSPORTED TO  HOSPITAL VIA PERSONAL AUTOMOBILE.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Provider administered Tdap Boostrix to this adult client instead of Adacel Tdap.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Pallor, Tonic clonic movements
Clinical narrative: Patient's lips, toes and fingers turned white in color and had tonic-clonic seizure lasting approximately 20-30 seconds.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Dermatitis contact, Dry skin, Erythema, Pruritus, Rash
Clinical narrative: Immunizations provided 03/10/08; client with father into clinic on 3/14/08 reporting symptoms occurred on 03/11/08 of redness, itching, rough, dry rash, worsening each day.  Referred to PMD. Contacted client's mother on Monday, 3/17/08 who reports client seen by PMD on 3/17/08 who prescribed topical cream. Says dr dx poison oak.
Age: 45.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TDAP, TYP
Symptoms: Rash generalised
Clinical narrative: Localized, large Rash developed apprx 5-7 days after smallpox vaccination was administered.  Rash was around parts of chest, but mostly located in the deltoid & armpit area of the vaccinated arm on the 7th day after vax was given. Rash was generalized, not one large rash, but several small outbreaks. Rash wasn't raised.
Age: 18.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Unevaluable event
Clinical narrative: Patient voluntarily went to the emergency room.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was vaccinated 3/26.  She noticed her injection site was sore and warm on 3/27.  She happened to come in today and the injection site was red, swollen (raised) and warm to the touch.  The area was apporoximately 2X3 inches.  Referred patient to her MD for further f/u if needed.  No other s/s reported.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Within 5-10 minutes of receiving MMR #2, pt. developed erythema and induration of approximately 4-5cm surrounding vaccination site.  Pt. received 3 other vaccinations at the same time, none of which developed this rxn.  Pt was given 12.5mg diphenhydramine po and within 20 minutes, her symptoms had improved.  Pt. was discharged home 30 minutes after receiving diphenhydramine.  No further need for medical tx has been reported since.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Angioedema, Malaise, Nausea, Rash generalised, Rash papular
Clinical narrative: Patient received yellow fever vaccine 2 weeks prior to visit. Co of vague malaise and nausea 3 days after vaccine followed by large hives. When seen on 3/26/08, patient had fine papular ithcy rash on trunk, face and limbs.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Rash pruritic
Clinical narrative: Patient received yellow fever vaccine 2 weeks prior to visit. Co of vague malaise and nausea 3 days after vaccine followed by large hives. When seen on 3/26/08, patient had fine papular ithcy rash on trunk, face and limbs.
Age: 1.52
Sex: F
Vaccine: DTPIPV, PPV
Symptoms: Anorexia, Local swelling, Pyrexia, Somnolence
Clinical narrative: The child developed a fever of 102 degrees by Friday, March 28 at 4:00 p.m., she had no appetite, she seemed extremely sleepy and kept pulling at her ear.  By Saturday morning, at 11:00 A.M. her neck was observed to be swollen--the first time this has ever happened to this child.  At the time this report is being filed, this previously healthy child has no appetite, is whimpering as if in severe pain and is being taken to the hospital emergency room again.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Dyskinesia, Electroencephalogram, Fall
Clinical narrative: The Patient was sitting on a chair when Vaccine Gardasil was Administered. Then immediately her eyes rolled back, she lost consciousness and her body fell forward. After which the patients upper body started to shake and her arms were jerking. This lasted for 45 seconds- 1 min and then she regained consciousness. She complained of a headache, weakness and dizziness. I checked her pulse which was 76 bpm. We had her lay down for 30 min and drink some water after which she felt better.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Gaze palsy, Headache, Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: The Patient was sitting on a chair when Vaccine Gardasil was Administered. Then immediately her eyes rolled back, she lost consciousness and her body fell forward. After which the patients upper body started to shake and her arms were jerking. This lasted for 45 seconds- 1 min and then she regained consciousness. She complained of a headache, weakness and dizziness. I checked her pulse which was 76 bpm. We had her lay down for 30 min and drink some water after which she felt better.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: I was given Tdap booster shot.  Initial pain at site of injection which has persisted for 4 days.  Redness at injection site with diameter about 30 millimeters. There was also swelling. I have put ice on the area and taking Motrin for pain.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Patient received IPV and Varicella vaccines in right deltoid region at two separate sites.  On 3/27 patient returned to office with erythema, swelling, and mild warmth to right deltoid area. Area also indurated.  Affected area is 23 cm in diameter and 7 cm in length.  Treated with cool compresses and Benadryl for itching.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Erythema, Induration, Pain in extremity, Pyrexia
Clinical narrative: WAS VACCINATED 03/27/2008.  24 HOURS LATER DEVELOPED FEVER OF 103F.  TODAY A 2 X 2.5 OF ERYTHEMOUS, INDURATED, PAINFUL AREA NOTED ON RIGHT UPPER ARM (DELTOID AREA).
Age: 0.75
Sex: M
Vaccine: FLU3
Clinical narrative: The patient developed autism symptoms from absolutely healthy. He was diagnosed "moderate autism" on 03/28/2008.  9/5/08 Reviewed PCP office records of 2/6/06-8/2/07. FINAL DX: none provided Records reveal patient experienced excellent health in 2006.  RTC 1/07 w/pharyngitis, 3/20/07 w/URI & 4/07 w/pharyngitis & OM.  May, 2007 parent expressed concern re development.  8/07 noted to have atopic dermatitis.  9/16/08 Received psychological report from parent for 3/28/2008. FINAL DX:Autism spectrum disorder Records reveal patient experienced communication, play, motor/sensory & socialization delays as well as stereotyped behaviors.
Sex: U
Vaccine: VARCEL
Symptoms: Death, Lymphohistiocytosis
Clinical narrative: It was reported in a published article that a patient was vaccinated with a dose of VARIVAX (Oka/Merck). After vaccination, the patient died two months after receiving a diagnosis of familial hemophagocytic lymphohistioicytosis. An autopsy was not performed. It was reported that the patient's older sibling died after vaccination with VARIVAX (Oka/Merck) (WAES # 0803USA04484). The article also discussed the experiences of two other patients while on therapy with VARIVAX (Oka/Merck) (WAES numbers 0803USA03578 and 0803USA04453). Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 52.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Differential white blood cell count normal, International normalised ratio, Metabolic function test normal, Pain in extremity, Palpitations
Clinical narrative: Report writes that subject received his #1 anthrax injection on 12/18/2006, #2 on 1/22/07, and #3 on 4/11/07. In addition, the subject received botulinum vaccine on 2/20/07 and 3/6/07 without incident. The subject reportedly experienced a deep dull left arm pain (on 4/23/07) distal to injection site starting in left elbow and extending to left wrist. 3 days later (4/26/07) he noted a small scaly lesion on his left posterior thigh. The subject was evaluated by a occupational health MD and exam reported revealed a 1.5 cm light hyperpigmented flat, circumscribed lesion on right anterior thigh; and a 1.5 cm raised, pink textured, scaly lesion on left posterior thigh. No fever, chills or systemic S/Sx. Exam negative for lymphadenopathy, increased extremity diameter - No redness or swelling of extremities with full ROM bilaterally. Some diffuse tenderness with palpation of left elbow and forearm - C/V and resp. negative. No other skin lesions noted. Subsequently, the informant reported that subject states he has a second lesion on his leg (R medial thigh) and a lesion on his abdomen. He was seen in the clinic where lab tests were performed and results were negative. Reportedly, the abdominal lesion was evaluated to be from ibuprofen taken for arm pain. As of 5/22/07 all events were resolved, but subject currently anthrax vaccine ineligible. This report is linked to Manufacturers report #07AV00146SP. The subject is the same for both reports, however the report reflect different doses of the vaccine.
Age: 52.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Physical examination normal, Skin hyperpigmentation, Skin lesion, Skin test negative, Tenderness
Clinical narrative: Report writes that subject received his #1 anthrax injection on 12/18/2006, #2 on 1/22/07, and #3 on 4/11/07. In addition, the subject received botulinum vaccine on 2/20/07 and 3/6/07 without incident. The subject reportedly experienced a deep dull left arm pain (on 4/23/07) distal to injection site starting in left elbow and extending to left wrist. 3 days later (4/26/07) he noted a small scaly lesion on his left posterior thigh. The subject was evaluated by a occupational health MD and exam reported revealed a 1.5 cm light hyperpigmented flat, circumscribed lesion on right anterior thigh; and a 1.5 cm raised, pink textured, scaly lesion on left posterior thigh. No fever, chills or systemic S/Sx. Exam negative for lymphadenopathy, increased extremity diameter - No redness or swelling of extremities with full ROM bilaterally. Some diffuse tenderness with palpation of left elbow and forearm - C/V and resp. negative. No other skin lesions noted. Subsequently, the informant reported that subject states he has a second lesion on his leg (R medial thigh) and a lesion on his abdomen. He was seen in the clinic where lab tests were performed and results were negative. Reportedly, the abdominal lesion was evaluated to be from ibuprofen taken for arm pain. As of 5/22/07 all events were resolved, but subject currently anthrax vaccine ineligible. This report is linked to Manufacturers report #07AV00146SP. The subject is the same for both reports, however the report reflect different doses of the vaccine.
Age: 52.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Full blood count normal, International normalised ratio, Pain in extremity, Skin hyperpigmentation, Skin lesion
Clinical narrative: Report writes that subject received his #1 anthrax injection on 12/18/2006, #2 on 1/22/07, and #3 on 4/11/07. In addition, the subject received botulinum vaccine on 2/20/07 and 3/6/07 without incident. The subject reportedly experienced a deep dull left arm pain (on 4/23/07) distal to injection site starting in left elbow and extending to left wrist. 3 days later (4/26/07) he noted a small scaly lesion on his left posterior thigh. The subject was evaluated by a occupational health MD and exam reported revealed a 1.5 cm light hyperpigmented flat, circumscribed lesion on right anterior thigh; and a 1.5 cm raised, pink textured, scaly lesion on left posterior thigh. No fever, chills or systemic S/Sx. Exam negative for lymphadenopathy, increased extremity diameter - No redness or swelling of extremities with full ROM bilaterally. Some diffuse tenderness with palpation of left elbow and forearm - C/V and resp. negative. No other skin lesions noted. Subsequently, the informant reported that subject states he has a second lesion on his leg (R medial thigh) and a lesion on his abdomen. He was seen in the clinic where lab tests were performed and results were negative. Reportedly, the abdominal lesion was evaluated to be from ibuprofen taken for arm pain. As of 5/22/07 all events were resolved, but subject currently anthrax vaccine ineligible. This report is linked to Manufacturers report #07AV00146SP. The subject is the same for both reports, however the report reflect different doses of the vaccine.
Age: 52.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Skin test negative, Tenderness
Clinical narrative: Report writes that subject received his #1 anthrax injection on 12/18/2006, #2 on 1/22/07, and #3 on 4/11/07. In addition, the subject received botulinum vaccine on 2/20/07 and 3/6/07 without incident. The subject reportedly experienced a deep dull left arm pain (on 4/23/07) distal to injection site starting in left elbow and extending to left wrist. 3 days later (4/26/07) he noted a small scaly lesion on his left posterior thigh. The subject was evaluated by a occupational health MD and exam reported revealed a 1.5 cm light hyperpigmented flat, circumscribed lesion on right anterior thigh; and a 1.5 cm raised, pink textured, scaly lesion on left posterior thigh. No fever, chills or systemic S/Sx. Exam negative for lymphadenopathy, increased extremity diameter - No redness or swelling of extremities with full ROM bilaterally. Some diffuse tenderness with palpation of left elbow and forearm - C/V and resp. negative. No other skin lesions noted. Subsequently, the informant reported that subject states he has a second lesion on his leg (R medial thigh) and a lesion on his abdomen. He was seen in the clinic where lab tests were performed and results were negative. Reportedly, the abdominal lesion was evaluated to be from ibuprofen taken for arm pain. As of 5/22/07 all events were resolved, but subject currently anthrax vaccine ineligible. This report is linked to Manufacturers report #07AV00146SP. The subject is the same for both reports, however the report reflect different doses of the vaccine.