chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Myalgia, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a nurse concerning her daughter, a 18 year old female patient with a history of supraventricular tachycardia, who on 08-JUL-2008 was vaccinated with a dose of GARDASIL (lot# 660555/0279X) I.M. into left arm.  Concomitant therapy included MENACTRA.  On 22-JUL-2008, the patient developed numbness and tingling of her left arm and fingers.  She then developed fever, nausea, headache, widespread myalgia and cervical lymphadenopathy.  On 26-JUL-2008, the patient experienced tightness in her chest and shortness of breath.  The patient was examined by the physician on 28-JUL-2008 and was prescribed a "Z-pack" ZITHROMAX.  A mono test and complete blood count were normal.  On 01-AUG-2008, a MEDROL dose pack and PROVENTIL inhaler were added.  The patient began to experience extreme fatigue and bilateral lower extremity muscle weakness.  She was unable to participate in team sports and a soccer competition because of her incapacity.  The patient was examined by an unspecified physician at the college on 22-AUG-2008.  A repeat mono test and complete blood count were normal.  The patient has a follow-up appointment scheduled for 05-SEP-2008.  The patient's numbness and tingling of her left arm and fingers, tightness in her chest, shortness of breath, fever, nausea, headache, widespread myalgia, cervical lymphadenopathy, extreme fatigue and bilateral lower extremity muscle weakness persisted.  Numbness and tingling of her left arm and fingers, tightness in her chest, shortness of breath, fever, nausea, headache, widespread myalgia and cervical lymphadenopathy, extreme fatigue and bilateral lower extremity muscle weakness were considered to be disabling by the nurse.  No further information is available.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Pt reported "Throat closing up," and "difficulty breathing." Pt was monitored and 50 mg Benadryl IM administered. Pt reported no throat swelling and ability to breathe freely, vital signs stable. Pt treated at Hospital.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Convulsion, Pallor, Respiratory arrest, Syncope, Urinary incontinence
Clinical narrative: Approx. 5 mins post-vaccination, pt became pale, diaphoretic.  She was positioned with head down.  She then became unresponsive.  Assisted to floor with feet elevated, resp. WNL-she was somewhat responsive & talking.  A few seconds later her eyes rolled back, no resp., no response to painful stimuli, posturing (arms drawn up or in towards trunk) face turned blue.  Pt gasped and resumed normal breathing within 30-40 seconds.  She also lost urinary continence.  Patient quickly became alert, oriented x3 and drank a coke.  Mom reported one other episode previously that she called "passing out" 6 years ago where patient passed out at school.  Mom took her directly to E.R.  Only thing identified then was +strep.  CT scan was done & normal at that time.  Patient was referred to her doctor.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Cyanosis, Dyspnoea, Eye rolling, Hyperhidrosis, Pallor
Clinical narrative: Approx. 5 mins post-vaccination, pt became pale, diaphoretic.  She was positioned with head down.  She then became unresponsive.  Assisted to floor with feet elevated, resp. WNL-she was somewhat responsive & talking.  A few seconds later her eyes rolled back, no resp., no response to painful stimuli, posturing (arms drawn up or in towards trunk) face turned blue.  Pt gasped and resumed normal breathing within 30-40 seconds.  She also lost urinary continence.  Patient quickly became alert, oriented x3 and drank a coke.  Mom reported one other episode previously that she called "passing out" 6 years ago where patient passed out at school.  Mom took her directly to E.R.  Only thing identified then was +strep.  CT scan was done & normal at that time.  Patient was referred to her doctor.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Posturing, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Approx. 5 mins post-vaccination, pt became pale, diaphoretic.  She was positioned with head down.  She then became unresponsive.  Assisted to floor with feet elevated, resp. WNL-she was somewhat responsive & talking.  A few seconds later her eyes rolled back, no resp., no response to painful stimuli, posturing (arms drawn up or in towards trunk) face turned blue.  Pt gasped and resumed normal breathing within 30-40 seconds.  She also lost urinary continence.  Patient quickly became alert, oriented x3 and drank a coke.  Mom reported one other episode previously that she called "passing out" 6 years ago where patient passed out at school.  Mom took her directly to E.R.  Only thing identified then was +strep.  CT scan was done & normal at that time.  Patient was referred to her doctor.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Amniocentesis normal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Live birth
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning an 18 year old female who on 02-JUL-2007 was vaccinated with the first dose of GARDASIL (655205/1426F).  On 24-SEP-2007 the patient was vaccinated with the second dose of GARDASIL (657617/0384U).  The patient was seen in the emergency room on approximately 27-NOV-2007 with stomach aches and had a positive blood pregnancy test (LMP = 14-OCT-2007).  On 04-DEC-2007 the patient was seen in the physician's office and had a positive urine pregnancy test.  Concomitant therapy included pre-natal vitamins + Vitamin C.  On 28-FEB-2008, the patient had an amnio test done, and the results were within normal limits.  On approximately 17-MAR-2008, the patient experienced urinary tract infection and was treated with MACROBID, 100mg, BID during 5 days.  On 21-JUL-2008, at 40 weeks from LMP, the patient had a male liveborn infant normal who weighed 7lbs 5 ounces, length 21.5 inches, and had a head circumference of 14 inches.  There were no complications, infections or illnesses during the pregnancy or the labor/delivery.  The registered nurse reported that the patient had heavy bleeding post partum and required transfusion x 2.  The patient sought medical attention.  Upon internal review heavy bleeding post partum requiring blood transfusions x 2 was determined to be an other important medical event.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Postpartum haemorrhage, Transfusion, Urinary tract infection, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning an 18 year old female who on 02-JUL-2007 was vaccinated with the first dose of GARDASIL (655205/1426F).  On 24-SEP-2007 the patient was vaccinated with the second dose of GARDASIL (657617/0384U).  The patient was seen in the emergency room on approximately 27-NOV-2007 with stomach aches and had a positive blood pregnancy test (LMP = 14-OCT-2007).  On 04-DEC-2007 the patient was seen in the physician's office and had a positive urine pregnancy test.  Concomitant therapy included pre-natal vitamins + Vitamin C.  On 28-FEB-2008, the patient had an amnio test done, and the results were within normal limits.  On approximately 17-MAR-2008, the patient experienced urinary tract infection and was treated with MACROBID, 100mg, BID during 5 days.  On 21-JUL-2008, at 40 weeks from LMP, the patient had a male liveborn infant normal who weighed 7lbs 5 ounces, length 21.5 inches, and had a head circumference of 14 inches.  There were no complications, infections or illnesses during the pregnancy or the labor/delivery.  The registered nurse reported that the patient had heavy bleeding post partum and required transfusion x 2.  The patient sought medical attention.  Upon internal review heavy bleeding post partum requiring blood transfusions x 2 was determined to be an other important medical event.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Guillian Barre Syndrome - symptoms started 8/20/08 - diagnosed by MRI and lumbar puncture.  1/12/09 Reviewed hospital d/c summary for 8/26-9/1/2008 admission. FINAL DX: GBS; head concussion.  9/16/08 Reviewed hospital medical records of 8/26-9/1/2008.  FINAL DX: no discharge summary dictated Records reveal patient experienced progressive worsening of ascending weakness & heaviness of legs, tingling of feet, myalgias & HA since sports collision, difficulty walking, then tingling of hands, fatigue, weight loss, decreased appetite, intermittent nausea, abdominal pain, ataxia over 5-6 days prior to admit.  Seen by PCP when had continued dizziness & lower abdominal pain.  UA showed large amount of RBCs & sent for US.  Admit exam revealed areflexia of LEs & had abnormal gait, trouble lifting LEs.  Tx w/IVIG x 3 days.  Peds neuro, pulm  consult done.  Improved & d/c to home w/neuro & PCP f/u along w/EMG/NCS as outpatient.  9/12/08 Reviewed ER records of 8/23/2008. FINAL DX: s/p concussion syndrome w/no LOC, multiple contusions from sports collision. Records reveal patient experienced sports injury 5 days prior.  Had immediate HA but no LOC.  Dx w/concussion w/o LOC.  Returned to ER 8/23 after developed intermittent numbness in hands & had continued HA.  Had c-spine muscle tenderness & lower abdominal & CVA tenderness.  Also had intermittent leg heaviness & tingling in feet.  Neuro exam was completely WNL at that time.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Concussion, Dyspnoea, Gait disturbance, Guillain-Barre syndrome, Headache
Clinical narrative: Guillian Barre Syndrome - symptoms started 8/20/08 - diagnosed by MRI and lumbar puncture.  1/12/09 Reviewed hospital d/c summary for 8/26-9/1/2008 admission. FINAL DX: GBS; head concussion.  9/16/08 Reviewed hospital medical records of 8/26-9/1/2008.  FINAL DX: no discharge summary dictated Records reveal patient experienced progressive worsening of ascending weakness & heaviness of legs, tingling of feet, myalgias & HA since sports collision, difficulty walking, then tingling of hands, fatigue, weight loss, decreased appetite, intermittent nausea, abdominal pain, ataxia over 5-6 days prior to admit.  Seen by PCP when had continued dizziness & lower abdominal pain.  UA showed large amount of RBCs & sent for US.  Admit exam revealed areflexia of LEs & had abnormal gait, trouble lifting LEs.  Tx w/IVIG x 3 days.  Peds neuro, pulm  consult done.  Improved & d/c to home w/neuro & PCP f/u along w/EMG/NCS as outpatient.  9/12/08 Reviewed ER records of 8/23/2008. FINAL DX: s/p concussion syndrome w/no LOC, multiple contusions from sports collision. Records reveal patient experienced sports injury 5 days prior.  Had immediate HA but no LOC.  Dx w/concussion w/o LOC.  Returned to ER 8/23 after developed intermittent numbness in hands & had continued HA.  Had c-spine muscle tenderness & lower abdominal & CVA tenderness.  Also had intermittent leg heaviness & tingling in feet.  Neuro exam was completely WNL at that time.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Guillian Barre Syndrome - symptoms started 8/20/08 - diagnosed by MRI and lumbar puncture.  1/12/09 Reviewed hospital d/c summary for 8/26-9/1/2008 admission. FINAL DX: GBS; head concussion.  9/16/08 Reviewed hospital medical records of 8/26-9/1/2008.  FINAL DX: no discharge summary dictated Records reveal patient experienced progressive worsening of ascending weakness & heaviness of legs, tingling of feet, myalgias & HA since sports collision, difficulty walking, then tingling of hands, fatigue, weight loss, decreased appetite, intermittent nausea, abdominal pain, ataxia over 5-6 days prior to admit.  Seen by PCP when had continued dizziness & lower abdominal pain.  UA showed large amount of RBCs & sent for US.  Admit exam revealed areflexia of LEs & had abnormal gait, trouble lifting LEs.  Tx w/IVIG x 3 days.  Peds neuro, pulm  consult done.  Improved & d/c to home w/neuro & PCP f/u along w/EMG/NCS as outpatient.  9/12/08 Reviewed ER records of 8/23/2008. FINAL DX: s/p concussion syndrome w/no LOC, multiple contusions from sports collision. Records reveal patient experienced sports injury 5 days prior.  Had immediate HA but no LOC.  Dx w/concussion w/o LOC.  Returned to ER 8/23 after developed intermittent numbness in hands & had continued HA.  Had c-spine muscle tenderness & lower abdominal & CVA tenderness.  Also had intermittent leg heaviness & tingling in feet.  Neuro exam was completely WNL at that time.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: CSF test normal, Convulsion, Electroencephalogram abnormal
Clinical narrative: Seizure activity.  On call physician aware upon transfer to hospital on 7-21-08.  09/10/2008 MR received for DOS 7/29-8/4/2008 with DX: New onset seizures. Pt transferred from local facility after several episodes of twitching of arms & legs, eyes rolling, unresponsiveness and pallor on 7/28/08. Takes ~ 3 minutes to recover. Witnessed episode at 1st hospital. Ophth consult due to poor tracking. Initially poor blink to light, repeated with indirect ophthalmascope with good blink.  Possible cortical etiology to decreased visual function. Started on phosphenytoin.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray normal, Chest pain, Chills, Choking, Dysphagia
Clinical narrative: Pt got PNEUMOVAX on 8.26.08. Six hours later developed chills, fever, severe headache, lips swelling, SOB and chest pains, difficulty swallowing-choking. Also having reaction local-erythema 10x10 cm with induration. Seen in the office on 8.28.08. When most of the sx already resolved-still had fever, HA, SOB on exertion. Given Prednisone 60 mg x 5 days. Benadryl, Albuterol inh. 9/22/08-records received-office visit 8/26/08-seen to discuss problems, despondent, slight temp. Office visit 8/28/08-C/O fever, shortness of breath for two days. Chills, headache, spine pain. Two days prior difficulty breathing, unable to drink without choking. Swollen lips. Assessment: allergic reaction to Pneumovax. Local reaction right upper arm with circular erythema with slight induration, skin warm.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Electrocardiogram normal, Erythema, Full blood count, Headache
Clinical narrative: Pt got PNEUMOVAX on 8.26.08. Six hours later developed chills, fever, severe headache, lips swelling, SOB and chest pains, difficulty swallowing-choking. Also having reaction local-erythema 10x10 cm with induration. Seen in the office on 8.28.08. When most of the sx already resolved-still had fever, HA, SOB on exertion. Given Prednisone 60 mg x 5 days. Benadryl, Albuterol inh. 9/22/08-records received-office visit 8/26/08-seen to discuss problems, despondent, slight temp. Office visit 8/28/08-C/O fever, shortness of breath for two days. Chills, headache, spine pain. Two days prior difficulty breathing, unable to drink without choking. Swollen lips. Assessment: allergic reaction to Pneumovax. Local reaction right upper arm with circular erythema with slight induration, skin warm.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Lip swelling, Local reaction, Pyrexia
Clinical narrative: Pt got PNEUMOVAX on 8.26.08. Six hours later developed chills, fever, severe headache, lips swelling, SOB and chest pains, difficulty swallowing-choking. Also having reaction local-erythema 10x10 cm with induration. Seen in the office on 8.28.08. When most of the sx already resolved-still had fever, HA, SOB on exertion. Given Prednisone 60 mg x 5 days. Benadryl, Albuterol inh. 9/22/08-records received-office visit 8/26/08-seen to discuss problems, despondent, slight temp. Office visit 8/28/08-C/O fever, shortness of breath for two days. Chills, headache, spine pain. Two days prior difficulty breathing, unable to drink without choking. Swollen lips. Assessment: allergic reaction to Pneumovax. Local reaction right upper arm with circular erythema with slight induration, skin warm.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache
Clinical narrative: headaches. has been under treatment for headaches, parent feels headaches were under more control before vaccine, headaches started to get intensified after receiving vaccine
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Eye movement disorder, Partial seizures, Posturing
Clinical narrative: 16 y/o female at office for well child care.  Received varicella; MENACTRA; GARDASIL & Hep A.  20 mins after vaccine focal seizure in office lasting <1 min.  Eye deviation to left & posturing of L hand.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Pain
Clinical narrative: Pain 8/10 pain scale/noticed 8/27/08 after 12pm.  No redness.  No induration.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Excoriation, Immunisation reaction, Infection, Lymph node pain, Lymphadenopathy
Clinical narrative: Varivax administered right arm 8/13/08; returned to office with complaints of scattered excoriated papules/vesicules on right arm and scalp; few scattered enlarged tender nodes-neck.  Varicella vaccine rx + 1-2 inch infection.  Tx: keep clean and dry.  Altabax Bid x 5 days, Keflex x 500mg BID x 10 days.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Rash papular
Clinical narrative: Varivax administered right arm 8/13/08; returned to office with complaints of scattered excoriated papules/vesicules on right arm and scalp; few scattered enlarged tender nodes-neck.  Varicella vaccine rx + 1-2 inch infection.  Tx: keep clean and dry.  Altabax Bid x 5 days, Keflex x 500mg BID x 10 days.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Blood urine present, Body temperature increased, Chest X-ray normal, Crying, Neurological examination normal
Clinical narrative: Mother wonders if she had a vaccine reaction. Two days ago, in office, she received the following vaccines: PENTACEL, PREVNAR and ROTATEQ. This was late afternoon. At about 5:30 at home, she developed temperature of 99.0E to 100.0E. At 6:00 p.m., she began crying and she cried almost continually for 2 1/2 to 3 hours. Mother cenies her being limp or any color changes. At 8:30 p.m., she vomited. Mother brought her to the ER. She vomited a few times in the ER that night. Mother has been giving her PEDIALYTE since yesterday which she is tolerating. Mother tried soy formula twice today which she vomited. She has had no diarrhea. She has been acting fine since yesterday.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Urine analysis, Vomiting, pH urine increased
Clinical narrative: Mother wonders if she had a vaccine reaction. Two days ago, in office, she received the following vaccines: PENTACEL, PREVNAR and ROTATEQ. This was late afternoon. At about 5:30 at home, she developed temperature of 99.0E to 100.0E. At 6:00 p.m., she began crying and she cried almost continually for 2 1/2 to 3 hours. Mother cenies her being limp or any color changes. At 8:30 p.m., she vomited. Mother brought her to the ER. She vomited a few times in the ER that night. Mother has been giving her PEDIALYTE since yesterday which she is tolerating. Mother tried soy formula twice today which she vomited. She has had no diarrhea. She has been acting fine since yesterday.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid oedema, Swelling face
Clinical narrative: Swelling right eyelid and cheek bone area.  Prescription provided 8-23-08 by Dr. 21 tablets famciclovir 500mg.
Age: 39.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Hypoaesthesia, Oedema peripheral, Pain, Skin warm
Clinical narrative: Patient had HEP A, TDAP & TYPHOID vaccines on 8/25/08.  She reports minimal soreness only on 8/26 & 8/27 then pain went away.  Patient reports falling asleep in a recliner in the am of 8/30/08 and waking up with right arm swollen and warm to the touch in right deltoid area with whole arm feeling numb.  States she was sleeping on right arm.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle tightness, Myalgia
Clinical narrative: Patient reported muscle pain/tightness in her legs only. Starting AM of 8/22/08. Upon speaking with her again on 8/25/08, she noticed that her conditioned had improved, and felt the residual pain was due to standing for a long period of time on 08/24/08.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on face and legs 3 days after receiving vaccines, and still has Sx as of today.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Urticaria
Clinical narrative: 4-5 cm erythematous circular rash with central 1 cm welt
Age: 14.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: none
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse reaction.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Convulsion, Pain in extremity, Somnolence, Syncope
Clinical narrative: Client fainted.  Client's mother stated client had a seizure not witnessed by staff.  Client stated after hepatitis A, she felt pain in Lt arm.  After MENACTRA she felt like she had to sleep.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: syncopal episode after Gardasil injection. Awakened in seconds after feet elevated. c/o lightheadedness. Given crackers and soda and monitored x 1 hr. BP 108/72. Left with parent and walked out on own and started felt fine. Client was very nervous before vaccination.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Client waited approximately 15 minutes at clinic after receiving vaccine and felt fine.  Experienced onset of headache and nausea on way home.  Called doctor's office from home and advised to take 2 Tylenol and rest.  Client had relief of symptoms approximately 5 hours after receiving vaccine.  No symptoms 9/5 except some soreness at Gardasil injection site.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema, Irritability
Clinical narrative: Redness at site, irritability. BENADRYL and TYLENOL given.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Fatigue, Hypoaesthesia facial, Muscle spasms
Clinical narrative: (1) numb face - half on face after vaccine. (? which of 3); (2) per parent, -> Resolved. Seemed tired, leg cramps, abdominal cramps, fatigue (Lost 10# in 1 month -> per parent but notes she gained 10# in 6 months 1st and 3rd shot; after series.  9/16/08 Reviewed PCP medical records of 5/2/07-9/2/08. FINAL DX: Records reveal patient c/o abdominal pain x 6 mo on 5/2/07 vs.  Exam revealed right ear hearing loss, bilateral eye problems, gynecomastia.  Dx w/non-specific abdominal pain.  Was in good health w/o complaint on 7/2 visit.  Next vs 11/2/07 showed pt had gained 10# in 6 mo but had no complaints after first 2 HPV vax.  RTC on 12/26/07 with somach pain, constipation & low back pain x 2 weeks esp when drinking milk.  Dx with r/o milk allergy.  RTC 1/17/08 w/chronic abdomen pain, anxiety & HA.  RTC 2/8/08 w/lump on right side of neck, cold s/s, heartburn & lower abdominal pain.  Dx w/URI, cervical lymphadenopathy, GE reflux/gastritis.  RTC 3/12/08 w/heartburn, nausea, epigastric pain.  Dx w/gastritis/GE reflux.   Labs done, results not reported.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Dizziness, severe headache, emesis (x5), resolved the following day.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Skin warm, Tenderness
Clinical narrative: 8/11/08 Received vaccine arm pain from shoulder to elbow with radiation to the fingers. 8/25/08 Arm pain persisted, moderate tenderness, warm to touch and treated with Cephalexin for possible cellulitis. 9/4/08 No change in arm pain, swelling and warmth not present.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Developed muscle aches, low grade temperature, still with same aches and pains when last seen.  A detailed summary is noted in doctor's consult note attached.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: According to ME office next day after 7 AM bottle baby found dead. Post showed no trauma.  10/24/08 Autopsy report states COD as sudden unexpected death in infancy.  Manner of death is undetermined.  Report also states patient found unresponsive supine in bassinet.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Deafness neurosensory
Clinical narrative: Previously undiagnosed, sensorineural hearing loss - symmetric.  Specialist thinks pattern is consistent with congenital insert, however, mom feels child's hearing was excellent before Gardasil series.  09/10/2008 PCP records received including 2 ENT and audiological evals with DX:  Sensorineural hearing loss-symmetric.  Deafness. WCC 6/4/07 with normal exam. RTO 7/2/08 with c/o hearing problems after failing school hearing test. Did not pass audiogram given in office.  Refered to ENT.  ENT visit 7/15/08. Pt states first noticed a change in hearing approx 2 yrs ago. Occasional ringing in ears. ENT PE WNL. 1/26/2010 Had hearing loss-possibly due to GARDASIl hearing has not recovered.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Deafness
Clinical narrative: Previously undiagnosed, sensorineural hearing loss - symmetric.  Specialist thinks pattern is consistent with congenital insert, however, mom feels child's hearing was excellent before Gardasil series.  09/10/2008 PCP records received including 2 ENT and audiological evals with DX:  Sensorineural hearing loss-symmetric.  Deafness. WCC 6/4/07 with normal exam. RTO 7/2/08 with c/o hearing problems after failing school hearing test. Did not pass audiogram given in office.  Refered to ENT.  ENT visit 7/15/08. Pt states first noticed a change in hearing approx 2 yrs ago. Occasional ringing in ears. ENT PE WNL. 1/26/2010 Had hearing loss-possibly due to GARDASIl hearing has not recovered.
Age: 1.25
Sex: F
Vaccine: FLU3, PNC, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: MOM REPORTED "HIVES ON LEFT THIGH." RESOLVED UPON ARRIVAL TO OFFICE. LEFT THIGH SOFT WITHOUT HIVES OR REDNESS PER MD.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Fall, Gaze palsy, Joint injury, Loss of consciousness, Pallor
Clinical narrative: about 5 minutes after administration of vaccines his eyes rolled back in his head, he got pale and lost consciousness. He fell to the ground. The whole episode lasted less than one minute but was frightening.  He hurt his right knee because the the way he fell (crumpled)but it was more of a soft tissue injury.  We watched him for 30 minutes in the office after and he was fine.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Body temperature increased, Dysphonia
Clinical narrative: Mother states client hoarse since shortly after receipt of vaccine.  Temp 99+ last pm.  Denies hives, pain, weakness, shortness of breath. Recommended client be seen by physician if no improvement.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Erythema, Grand mal convulsion, Malaise, Nausea
Clinical narrative: SYMPTOMS 09/05/08 A.M. NAUSEA, VOMITING, ACHINESS AND PETIT MAL SEIZURES, SOME BETTER IN EVENING.  09/06/08 AGAIN BECAME ILL AND HAD GRAND MAL SEIZURE. TO E.R. ABOUT 12 NOON. RELEASED BACK HOME. HAD TO RETURN TO THE E.R. ON 09/07/08 BECAUSE STILL ILL.  WAS GIVEN I.V. FUIDS, PHENERGAN, AND TORADOL. T-99 P-86 B/P 138/74. ADVISE REST, EAT, AND DRINK. LEFT ARM ALSO HAD SWELLING, REDNESS, SL PAIN TO AREA.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity, Petit mal epilepsy, Vomiting
Clinical narrative: SYMPTOMS 09/05/08 A.M. NAUSEA, VOMITING, ACHINESS AND PETIT MAL SEIZURES, SOME BETTER IN EVENING.  09/06/08 AGAIN BECAME ILL AND HAD GRAND MAL SEIZURE. TO E.R. ABOUT 12 NOON. RELEASED BACK HOME. HAD TO RETURN TO THE E.R. ON 09/07/08 BECAUSE STILL ILL.  WAS GIVEN I.V. FUIDS, PHENERGAN, AND TORADOL. T-99 P-86 B/P 138/74. ADVISE REST, EAT, AND DRINK. LEFT ARM ALSO HAD SWELLING, REDNESS, SL PAIN TO AREA.
Age: 76.0
Sex: M
Vaccine: TTOX
Symptoms: Bradycardia, Dizziness, Heart rate decreased, Hyperhidrosis, Pallor
Clinical narrative: Approximately 15 minutes after the shot was given, the patient began shaking, stated he felt faint, then was unresponsive for approximately 30 seconds.  He was pale and diaphoretic.  His blood pressure and respirations remained stable.  He became bradycardic (HR=47-50 BPM).  He was also noted to have a rash on the arm where he received the shot.  Patient received 12.5 mg IV Benadryl, and 125 mg IV solu-medrol and symptoms resolved.
Age: 76.0
Sex: M
Vaccine: TTOX
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Approximately 15 minutes after the shot was given, the patient began shaking, stated he felt faint, then was unresponsive for approximately 30 seconds.  He was pale and diaphoretic.  His blood pressure and respirations remained stable.  He became bradycardic (HR=47-50 BPM).  He was also noted to have a rash on the arm where he received the shot.  Patient received 12.5 mg IV Benadryl, and 125 mg IV solu-medrol and symptoms resolved.
Age: 16.0
Sex: M
Vaccine: DTAP
Symptoms: Electroencephalogram, Full blood count, Grand mal convulsion, Inappropriate schedule of drug administration, Nuclear magnetic resonance imaging
Clinical narrative: A Dtap vaccination was administered at approx 4:00 pm July 31, 2008.  At approx 11:15 on August 1, 2008 patient collapsed in a grand mal seizure.  He was transported by ambulance to the emergency room where he underwent a full blood panel and urinalysis, MRI and observation.  Patient's case was referred to a local neurologist and underwent an EEG.  As of September 8, 2008 we have been advised to not allow patient to drive for three months from the incident, and observe him for further indicators.  No medication was prescribed.
Age: 16.0
Sex: M
Vaccine: DTAP
Symptoms: Urine analysis
Clinical narrative: A Dtap vaccination was administered at approx 4:00 pm July 31, 2008.  At approx 11:15 on August 1, 2008 patient collapsed in a grand mal seizure.  He was transported by ambulance to the emergency room where he underwent a full blood panel and urinalysis, MRI and observation.  Patient's case was referred to a local neurologist and underwent an EEG.  As of September 8, 2008 we have been advised to not allow patient to drive for three months from the incident, and observe him for further indicators.  No medication was prescribed.
Age: 48.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood bilirubin normal, Cytomegalovirus antibody negative
Clinical narrative: Patient received hepatitis B recombinant vaccine 20 mcg IM to right deltoid on 8/14/08 at an acute care facility.  Patient was admitted to our outpatient substance abuse treatment rogram and had LFTs on 8/26/08 as follows:  AST 1516, ALT 390, alk phos 59 and total bilirubin 0.8.  Only medication change in time period was administration of the vaccine. LFTs normal prior to the vaccination.
Age: 48.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Cytomegalovirus antibody positive, Hepatitis B surface antigen negative, Liver function test abnormal
Clinical narrative: Patient received hepatitis B recombinant vaccine 20 mcg IM to right deltoid on 8/14/08 at an acute care facility.  Patient was admitted to our outpatient substance abuse treatment rogram and had LFTs on 8/26/08 as follows:  AST 1516, ALT 390, alk phos 59 and total bilirubin 0.8.  Only medication change in time period was administration of the vaccine. LFTs normal prior to the vaccination.
Age: 48.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Cytomegalovirus antibody positive, Hepatic enzyme increased, Hepatitis B surface antigen negative
Clinical narrative: Patient received hepatitis B recombinant vaccine 20 mcg IM to right deltoid on 8/14/08 at an acute care facility.  Patient was admitted to our outpatient substance abuse treatment rogram and had LFTs on 8/26/08 as follows:  AST 1516, ALT 390, alk phos 59 and total bilirubin 0.8.  Only medication change in time period was administration of the vaccine. LFTs normal prior to the vaccination.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, Full blood count normal, Laboratory test normal, Pyrexia
Clinical narrative: Patient was given pneumovax on 6/20/08 and developed a fever on 6/21/08.  He was on antibiotics previously and they were restarted.  He was afebrile the night of 6/21/08.  He had no other signs or symptoms associated.  9/23/08 Reviewed hospital medical records of 6/18-6/23/08. FINAL DX: acute CHF; chronic atrial fib; CAD; HTN; anemia; gout;  mild dementia; & cellulits LUE. Records reveal patient experienced SOB & LE edema.  Improved w/diuresis & anticoagulant meds.  Had thoracentesis for 770 cc fluid.  Developed LUE swelling & redness s/p vaccination.
Age: 33.0
Sex: M
Vaccine: HEPAB, TDAP, YF
Symptoms: Anorexia, Asthenia, Diarrhoea, Pyrexia
Clinical narrative: day after shots -fever- did not take temp- lost appetite- very weak- lasted about one week- little bit of diarrhea- did not go to MD- still has not gone to MD- I encouraged client to go to MD
Age: 36.0
Sex: F
Vaccine: HEPAB, TDAP, YF
Symptoms: Nasopharyngitis, Nausea, Rhinorrhoea
Clinical narrative: day of shots- nausea- one week later cold and runny nose
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left Deltoid swollen, warm to the touch, itching, red
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, YF
Symptoms: Cough, Increased upper airway secretion, Pyrexia
Clinical narrative: fever day of shots- temp never taken- week later coughing- still has cough- lots of phlegm- almost vomited, but did not- did not go to MD- still has not gone to MD- I encouraged client's mother to go to MD
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, YF
Symptoms: Anorexia, Cough, Diarrhoea, Increased upper airway secretion, Pyrexia
Clinical narrative: slight cough day of shot & next day- fever- no temp taken- cough became phlegmy- vomiting & diarrhea 09-01-08 to 09-06-08-loss of appetite 08-14-08 to 09-05-08-fever 08-27-08 to 08-28-08- coughs day and night- client never went to MD- still has not gone to MD- I encouraged client's mother to go to MD
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, YF
Symptoms: Vomiting
Clinical narrative: slight cough day of shot & next day- fever- no temp taken- cough became phlegmy- vomiting & diarrhea 09-01-08 to 09-06-08-loss of appetite 08-14-08 to 09-05-08-fever 08-27-08 to 08-28-08- coughs day and night- client never went to MD- still has not gone to MD- I encouraged client's mother to go to MD
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, YF
Symptoms: Anorexia, Body temperature increased, Cough, Diarrhoea, Increased upper airway secretion
Clinical narrative: 08-14-08 had high temp- did not take temp- loss of appetite, languid, sleeplessness, 08-14-08 to 08-17-08-08-22-08 phlegmy cough started & still has- diarrhea 09-03-08 ti 09-04-08- fever 09-07-08 still no temp taken- did not go to MD- still has not gone to MD- I encouraged client's mother to go to MD
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, YF
Symptoms: Insomnia, Listless, Pyrexia
Clinical narrative: 08-14-08 had high temp- did not take temp- loss of appetite, languid, sleeplessness, 08-14-08 to 08-17-08-08-22-08 phlegmy cough started & still has- diarrhea 09-03-08 ti 09-04-08- fever 09-07-08 still no temp taken- did not go to MD- still has not gone to MD- I encouraged client's mother to go to MD
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Cough, Increased upper airway secretion, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: 08-14-08 fever- no temp taken- phlegmy cough started- 08-25-08- breastfeeding ok- coughs at night & vomits at night- today runny nose started- client never went to MD- still has not gone to MD- I encouraged client's mother to go to MD
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: Pt. vomiting several hours after vaccine administration.  No intervention necessary.
Age: 1.42
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blister, Pyrexia
Clinical narrative: Pt started with a fever 09/05/08.  Pt has multiple blisters in trunk and a few on face and legs noted 09/07/08
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Anger, Attention deficit/hyperactivity disorder, Autism, Communication disorder, Developmental delay
Clinical narrative: AT AGE 3YR TO 5YR CORE SYMPTOMS: CONTINUOUS SCREAMING TO COMMUNICATE -NON VERBAL WITH WORDS, ECHOLITHC, SLOWED DEVELOPEMENT IN SPEECH AND MOTOR SKILLS,UNABLE TO EXPRESS EMOTION (excited,happy,sad etc.,)AND UNCONTROLLED ANGER.SERVERAL TEST WERE RAN BY A NEUOROLIST, PSYCOLOGIST AND DOCTOR-HE WAS ALSO TESTED THROUGH SCHOOL PSYCOLOGIST  AND SPECIALIST-WITH COMBINE RESULTS FROM SCHOOL AND PERSONAL TESTING IT WAS DETERMINE PATIENT IS AUTISTIC AND HAS ADHD** ALSO A VACCINE CALLED PREVNAR WAS GIVEN IN 9-12-03 1TIME  9/26/08 MR received from parent including psych evals and care plans. Eval 10/29/2003 (+) for developmental delays in cognitive and verbal abilities. Psych eval 1/14/2006 which report sleep disturbances and ADHD. Neuropsych eval 6/6/06 with sx suggestive of Pervasive Developmental Delay and Autism. School eval with DX: Communication d/o 2' to Autism Spectrum Disorder. MR received from PCP. 1st visit 3/13/2001 with normal growth and dev.  Exam (+) for ezcema and congestion. Rocking behavior noted 12/3/02. Speech noted to be delayed at 4yr check 9/9/03.  1/27/2010 Follow-up: As of date, my child still experiences mental disfunctions and abnormalities.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Echolalia, Neurological examination, Psychomotor skills impaired, Screaming
Clinical narrative: AT AGE 3YR TO 5YR CORE SYMPTOMS: CONTINUOUS SCREAMING TO COMMUNICATE -NON VERBAL WITH WORDS, ECHOLITHC, SLOWED DEVELOPEMENT IN SPEECH AND MOTOR SKILLS,UNABLE TO EXPRESS EMOTION (excited,happy,sad etc.,)AND UNCONTROLLED ANGER.SERVERAL TEST WERE RAN BY A NEUOROLIST, PSYCOLOGIST AND DOCTOR-HE WAS ALSO TESTED THROUGH SCHOOL PSYCOLOGIST  AND SPECIALIST-WITH COMBINE RESULTS FROM SCHOOL AND PERSONAL TESTING IT WAS DETERMINE PATIENT IS AUTISTIC AND HAS ADHD** ALSO A VACCINE CALLED PREVNAR WAS GIVEN IN 9-12-03 1TIME  9/26/08 MR received from parent including psych evals and care plans. Eval 10/29/2003 (+) for developmental delays in cognitive and verbal abilities. Psych eval 1/14/2006 which report sleep disturbances and ADHD. Neuropsych eval 6/6/06 with sx suggestive of Pervasive Developmental Delay and Autism. School eval with DX: Communication d/o 2' to Autism Spectrum Disorder. MR received from PCP. 1st visit 3/13/2001 with normal growth and dev.  Exam (+) for ezcema and congestion. Rocking behavior noted 12/3/02. Speech noted to be delayed at 4yr check 9/9/03.  1/27/2010 Follow-up: As of date, my child still experiences mental disfunctions and abnormalities.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Anorexia, Chills, Injection site swelling, Pyrexia
Clinical narrative: FEVER 102; CHILLS; LOSS OF APPETITE; MILD SWELLING AT INJECTION SITE
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: none- client given expired vaccine.  Telephone call to parent - reported that child was not experiencing illness the next day.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT RECIEVED PNEUMOVAX ON 8/20/08 AT 1900.  PT REPORTED ITCHING TO SITE TO RN.  RN ASSESSMENT NOTED SWELLING AND SLIGHT REDNESS.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Patient reported she had a transient urticarial rash on her back 4 hours after receiving immunization.  The rash resolved after 24 hours with treatment with antihistamines.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Appendicitis, Colonoscopy normal, Computerised tomogram abnormal, Diarrhoea
Clinical narrative: I have received the 3 vaccines, first one 1-22-08,4-1-2008 and 8-21-2008  I became ill in February 2008, had bloody stools, diarrhea, nausea, cbc was done at that time i had a wbc of 13.0 a colonoscopy was done in April 2008 this was negative.  i have had headaches(migraines) that have occured more often.  I received my 3rd shot on 8-22-08 i had a bruise and swelling from this. I started to feel ill, lightheaded, nausea and vomiting as well as diarrhea and stomach pains times 1 week before , i ended up in the ER on 9-4-8 with excruitiating abdominal pain, painful urination.  My WBC at that time was 17.5, my urinalysis was within normal limits and the CT confirmed an appendicitis. I had surgery that evening. 9/22/08-records received for DOS 9/4-9/5/08-DC DX: Appendicitis. Presented with C/O abdominal pain times one day and diarrhea times one week. Surgery, laparoscopic appendectomy.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysuria, Haematochezia, Headache, Injection site bruising
Clinical narrative: I have received the 3 vaccines, first one 1-22-08,4-1-2008 and 8-21-2008  I became ill in February 2008, had bloody stools, diarrhea, nausea, cbc was done at that time i had a wbc of 13.0 a colonoscopy was done in April 2008 this was negative.  i have had headaches(migraines) that have occured more often.  I received my 3rd shot on 8-22-08 i had a bruise and swelling from this. I started to feel ill, lightheaded, nausea and vomiting as well as diarrhea and stomach pains times 1 week before , i ended up in the ER on 9-4-8 with excruitiating abdominal pain, painful urination.  My WBC at that time was 17.5, my urinalysis was within normal limits and the CT confirmed an appendicitis. I had surgery that evening. 9/22/08-records received for DOS 9/4-9/5/08-DC DX: Appendicitis. Presented with C/O abdominal pain times one day and diarrhea times one week. Surgery, laparoscopic appendectomy.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Malaise, Migraine, Nausea, Surgery
Clinical narrative: I have received the 3 vaccines, first one 1-22-08,4-1-2008 and 8-21-2008  I became ill in February 2008, had bloody stools, diarrhea, nausea, cbc was done at that time i had a wbc of 13.0 a colonoscopy was done in April 2008 this was negative.  i have had headaches(migraines) that have occured more often.  I received my 3rd shot on 8-22-08 i had a bruise and swelling from this. I started to feel ill, lightheaded, nausea and vomiting as well as diarrhea and stomach pains times 1 week before , i ended up in the ER on 9-4-8 with excruitiating abdominal pain, painful urination.  My WBC at that time was 17.5, my urinalysis was within normal limits and the CT confirmed an appendicitis. I had surgery that evening. 9/22/08-records received for DOS 9/4-9/5/08-DC DX: Appendicitis. Presented with C/O abdominal pain times one day and diarrhea times one week. Surgery, laparoscopic appendectomy.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: I have received the 3 vaccines, first one 1-22-08,4-1-2008 and 8-21-2008  I became ill in February 2008, had bloody stools, diarrhea, nausea, cbc was done at that time i had a wbc of 13.0 a colonoscopy was done in April 2008 this was negative.  i have had headaches(migraines) that have occured more often.  I received my 3rd shot on 8-22-08 i had a bruise and swelling from this. I started to feel ill, lightheaded, nausea and vomiting as well as diarrhea and stomach pains times 1 week before , i ended up in the ER on 9-4-8 with excruitiating abdominal pain, painful urination.  My WBC at that time was 17.5, my urinalysis was within normal limits and the CT confirmed an appendicitis. I had surgery that evening. 9/22/08-records received for DOS 9/4-9/5/08-DC DX: Appendicitis. Presented with C/O abdominal pain times one day and diarrhea times one week. Surgery, laparoscopic appendectomy.
Age: 1.92
Sex: M
Vaccine: HEPA
Symptoms: Rash pruritic
Clinical narrative: No problems until approximately 2 days later when he broke out in an itchy rash on chest which moved to shoulders then arms and finally the back.  The rash lasted only 2 to 3 days and no fever or other Signs or Sx.
Age: 62.0
Sex: F
Vaccine: DPP, HEPA, VARZOS
Symptoms: Pruritus
Clinical narrative: Prolonged, severe itching began 4 days following vaccination. Antihistamines not effective.
Age: 15.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Blood creatinine, Blood urea, Full blood count, Injection site swelling, Laboratory test
Clinical narrative: Patient describes swelling at vaccine site and lip,hand and lower extremities with in days of vaccine and persisting through Urgent Care visit 9/8/08
Age: 15.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Lip swelling, Oedema peripheral, Urine analysis
Clinical narrative: Patient describes swelling at vaccine site and lip,hand and lower extremities with in days of vaccine and persisting through Urgent Care visit 9/8/08
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Autism
Clinical narrative: This case was reported by a physician and described the occurrence of autism in a 3-year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), and ENGERIX B (GlaxoSmithKline). On unspecified dates in December 2005 and February 2006, the subject received unspecified doses of PEDIARIX (.5 ml, unknown, left thigh). On an unspecified date in September 2006, the subject received an unspecified dose of ENGERIX B (unknown). On an unspecified date in May 2008, approximately 20 months after vaccination with ENGERIX B, and 27 and 29 months after vaccination with PEDIARIX doses, the subject experienced autism. A physician evaluating a claim reported that the mother of the vaccination subject stated that her child has autism due to exposure to thimerosal in ENGERIX B and PEDIARIX. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Menstruation irregular
Clinical narrative: Parents report hair loss and irregular menses at 1/28/08 PE visit.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Arthralgia, Dizziness, Feeling abnormal, Headache
Clinical narrative: Parents report hair loss and irregular menses at 1/28/08 PE visit.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Menstruation irregular
Clinical narrative: Parents report hair loss and irregular menses at 1/28/08 PE visit.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Blurred vision, dizziness, redness and swelling and pain at injection site, headache, fast-heart beat, chills, very tired.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vision blurred
Clinical narrative: Blurred vision, dizziness, redness and swelling and pain at injection site, headache, fast-heart beat, chills, very tired.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Has 1/2 cm raised area where GARDASIL vaccine was given on 5-13-08.  Extreme itching still.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Has 1/2 cm raised area where GARDASIL vaccine was given on 5-13-08.  Extreme itching still.
Age: 33.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Contusion, Head injury, Syncope
Clinical narrative: Fainted approximately 10 minutes after receiving injections.  Sustained bump on head and left bruised shoulder.  Patient called next day for follow-up.  No abnormal signs or symptoms related to head trauma - patient at work.  Patient stated "he was fine".
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Erythema, Pain, Pain in extremity, Skin nodule, Skin warm
Clinical narrative: Mother called, child complaining left arm hurts.  3" x 5" erythemateous area, mid deltoid.  Slight nodule underneath.  Very warm to touch and painful.  Doctor stated a mild reaction from the preservative.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Allergy to vaccine, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Red, swollen spot and hot and hard to touch on left upper arm.