chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.28
Sex: M
Vaccine: MMR, DTAP, HIBV, IPV, MMR
Symptoms: Convulsion, Epilepsy, Hypersensitivity, Medication error, Mental retardation severity unspecified
Clinical narrative: Information has been received concerning a case in litigation, via medical records, concerning an approx 2 year old male with an unremarkable neonatal course and no known drug allergies with a family history of demyelinating process (brother)revealed via MRI who on 1/28/1989 was vaccinated with the first dose of MMR II 9lot 631641/0917J) was given on 9/3/1999. In approx Oct 1989, the pt was noted to have speech delay as he was no longer saying distinct words and could only be heard to utter jargon in a sing song manner. He was also noted to have stopped developing. In approx April 1990, a diagnosis of autism was made. on 5/10/1992 the pt was hospitalized in a pediatric ward for reactive air way disease, developmental delays and to rule out pervasive developmental delay. At that time, the pt was noted to have poor speech with a vocabulary of approx 15 words. He was evaluated by a developmental pediatrician who noted that the pt appeared to be showing very stereotypical behavior consistent with Pervasive developmental delay (PPD), in particular, autism, The physician noted that the pt had a severe verbal and non verbal communication disorder with some deviant social interactions. In additional, the pt had chromosomes which were also sent for fragile X, which were negative, High resolution chromosomes that were done revealed that the pt was a 46 xy normal male by chromosome appearance. The pt also had a normal EEG and audiological evaluation. A speech evaluation concluded that the pt had a severe speech delay pattern. Discharge diagnosis included PPD, probably moderate to severe mental retardation and reactive airway disease. On 7/10/1992, the pt was seen by a developmental pediatrician who confirmed a diagnosis of PPD, but was unclear of the specific etiology of the pts developmental difficulties. On 9/15/1992 and MRI of the brain was normal. On 3/19/2001, the pt developed a seizure disorder for which he was hospitalized. ON 3/20/01, a cranial CT scan was normal (no mass lesion and fluid space normal). The pt was also noted to have ADHD and neurobehavioral problems for which he was treated with multiple medications. As of 7/12/2001, the pt was becoming more violent, screaming all the time and hitting family members especially his mother, he had learned some single word slight vocabulary and spelling and numbers, but continued to converse in a single words at best and his verbal reasoning was rudimentary at best. The pt was currently taking lorazepam (Ativan) 4mg BID, divalproex NA (Depakote) 500 mg in the morning and clonidine 2 mg at night. Upon internal review, autism and moderate to severe mental retardation were determined to be an other important medical events (OMIC). Medical records received on 9/12/06 contained the following adverse experienced reactive airway disease requiring hospitalization. Ethmoideral and sphnoid sinus disease, revealed via cranial CT scan. No further information is available. All available medical records will be provided upon request.
Age: 1.28
Sex: M
Vaccine: MMR, DTAP, HIBV, IPV, MMR
Symptoms: Psychomotor hyperactivity, Rhinitis allergic, Sinusitis, Speech disorder
Clinical narrative: Information has been received concerning a case in litigation, via medical records, concerning an approx 2 year old male with an unremarkable neonatal course and no known drug allergies with a family history of demyelinating process (brother)revealed via MRI who on 1/28/1989 was vaccinated with the first dose of MMR II 9lot 631641/0917J) was given on 9/3/1999. In approx Oct 1989, the pt was noted to have speech delay as he was no longer saying distinct words and could only be heard to utter jargon in a sing song manner. He was also noted to have stopped developing. In approx April 1990, a diagnosis of autism was made. on 5/10/1992 the pt was hospitalized in a pediatric ward for reactive air way disease, developmental delays and to rule out pervasive developmental delay. At that time, the pt was noted to have poor speech with a vocabulary of approx 15 words. He was evaluated by a developmental pediatrician who noted that the pt appeared to be showing very stereotypical behavior consistent with Pervasive developmental delay (PPD), in particular, autism, The physician noted that the pt had a severe verbal and non verbal communication disorder with some deviant social interactions. In additional, the pt had chromosomes which were also sent for fragile X, which were negative, High resolution chromosomes that were done revealed that the pt was a 46 xy normal male by chromosome appearance. The pt also had a normal EEG and audiological evaluation. A speech evaluation concluded that the pt had a severe speech delay pattern. Discharge diagnosis included PPD, probably moderate to severe mental retardation and reactive airway disease. On 7/10/1992, the pt was seen by a developmental pediatrician who confirmed a diagnosis of PPD, but was unclear of the specific etiology of the pts developmental difficulties. On 9/15/1992 and MRI of the brain was normal. On 3/19/2001, the pt developed a seizure disorder for which he was hospitalized. ON 3/20/01, a cranial CT scan was normal (no mass lesion and fluid space normal). The pt was also noted to have ADHD and neurobehavioral problems for which he was treated with multiple medications. As of 7/12/2001, the pt was becoming more violent, screaming all the time and hitting family members especially his mother, he had learned some single word slight vocabulary and spelling and numbers, but continued to converse in a single words at best and his verbal reasoning was rudimentary at best. The pt was currently taking lorazepam (Ativan) 4mg BID, divalproex NA (Depakote) 500 mg in the morning and clonidine 2 mg at night. Upon internal review, autism and moderate to severe mental retardation were determined to be an other important medical events (OMIC). Medical records received on 9/12/06 contained the following adverse experienced reactive airway disease requiring hospitalization. Ethmoideral and sphnoid sinus disease, revealed via cranial CT scan. No further information is available. All available medical records will be provided upon request.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Generalized erythematous rash trunk, arms, legs, back with pruritus.  Patient seen by medical doctor 9/18/06.
Age: 1.95
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema
Clinical narrative: Left thigh with redness and 10 by 7 cm area.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth
Clinical narrative: Red, warm area size of silver dollar left arm.
Age: 1.26
Sex: F
Vaccine: HBHEPB, IPV, MMR
Symptoms: Irritability, Pyrexia, Rash, Rash erythematous
Clinical narrative: Low grade fever (100.3) for 3 days, irritable, overall rash, lacy, erythematous rash, especially prominent on trunk.  Seen in office 9/18/06.
Age: 32.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Injection site reaction
Clinical narrative: Right deltoid developed local reaction, Post pneumococcal, which required physician evaluation, cephalosporin antibiotic and Aleve, and off work until 9/18/06. Recheck 9/18/06 and improved released to work. Stated mother informed her on 9/15/06 that she had previous reaction in childhood to Pneumococcal vaccine.
Age: 23.0
Sex: M
Vaccine: HEPAB, SMALL, TYP
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: Soldier presented on 8/18/06 with c/o light headedness, blurred vision, and nausea. Diagnosed as probable mild reaction to multiple vaccinations. No evidence suggesting smallpox vaccine reaction. Reassurance given.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, Rheumatoid arthritis
Clinical narrative: Severe joint pain and stiffness upon waking, peaking approximately 20 days post-vaccination but still persistent.  Diagnosed with rheumatoid arthritis 9/22/06.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: WARM SWELLING TO LEFT DELTOID WHERE VACCINE WAS RECEIVED  AREA ALSO RED AND TENDER.   TOLD TO APPLY ICE TO AREA AND GIVEN MEDROL DOSE PACK TO TAKE AS DIRECTED.  PATIENT FOLLOWED UP IN ONEDAY AND WAS IMPROVING.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The patient experienced localized erythema and edema on the vaccinated thigh beginning approximately 24 hrs after vaccination which began to resolve itself approximately 48 hrs after vaccination.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Pt. presented w/ extensive rash(4X6 ")redness,edema at injection site (right deltoid).  Father reports swelling, itching and pain within 8 hours of injection. Parent reports temp of 100.6 orally resolved with Motrin given.
Age: 21.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain upper, Dizziness, Headache, Vomiting
Clinical narrative: Approximately 2 minutes after receiving the vaccine (Tuesday, September 19), the client stated he vomited.  VIS sheet and package insert were reviewed with him.  Was instructed if symptoms worsen to seek medical care.  On Friday, September 22, spoke with clients supervisor who stated client had been sent home from work on Thursday, September 21 because of dizziness.  Also spoke with client on same day and he stated that on Thursday, September 22, he had vomiting and dizziness.  He also stated, he fell at his home and cut his head.    By Friday, September 22, he stated he continued to have mild dizziness, but it was improving, he also was having a head ache and stomach ache.    As it was three days since the vaccine was administered and was late Friday afternoon when the conversation took place, client was instructed to follow up with a physician for evaluation.  While doctor visit may not have been necessary, as a safety measure, he was instructed to follow up with a physician.    Unsure if doctor visit was made.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Information related Health Department via client's supervisor.  Client stated to her supervisor that following administration of the Rabies vaccine on Tuesday, September 19, she felt fine the rest of the day.  She did relate to her supervisor that on Wednesday, September 20 she was dizzy, had nausea, head ache, and fatigue.    On Friday, September 22, client stated to her supervisor that she no longer had the nausea but continued to be light headed and felt tired.  Client had previously received a Rabies vaccine on June 6, 2006 but failed to return at the appropriate time to continue the series.  Because of this, was required to begin series again on Aug. 29, 2006
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Face oedema, Urticaria
Clinical narrative: Hives and extremely swollen lips.  Hives off and on for 7 days.  Swollen lips subsided in 2 days. Prednisone taper from 60 mg-10 mg, ranitidine 150 mg twice a day, Benadryl 50 mg every 4 hrs.  1st vaccine 8-21-2006 2nd vaccine 8-24-2006 3rd vaccine8-28-2006
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Pain, Rash
Clinical narrative: Rubor, warmth, edema of injection site, pain on touch.
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Lethargy, Neck pain, Night sweats, Pyrexia
Clinical narrative: C/O LEFT neck sore and swollen day after received Hep.A IM in RIGHT Deltoid muscle.  3 days after Hep A C/O fever 101, lethargy,extremely tired with night swets. Fever subsided and symptoms cleared Sunday day 4 after injection.  Referred to her physician.  Doubt related to Hep A given in opposite arm from complaints of swelling, tenderness.
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Tenderness
Clinical narrative: C/O LEFT neck sore and swollen day after received Hep.A IM in RIGHT Deltoid muscle.  3 days after Hep A C/O fever 101, lethargy,extremely tired with night swets. Fever subsided and symptoms cleared Sunday day 4 after injection.  Referred to her physician.  Doubt related to Hep A given in opposite arm from complaints of swelling, tenderness.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pain in jaw, Pyrexia, Swelling
Clinical narrative: C/o achiness, fever, pain/swelling in jaw area.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood calcium increased, Convulsion, Leukocytosis
Clinical narrative: Seizure, convulsive movement lasting a few seconds. No color change. DC Summary received for DOS 9/16-9/18/06. DC DX: Seizure. Presented to ER after seizure activity noted at home. Mom states she was sleeping with patient and awakened to find her eyes dilated and rolled back in her head, arms and legs flexed and she reports three jerks. Patient then started crying. No color changed associated with that, no HX of any fever, no HX of previous seizures. Mom states she had mild upper respiratory symptoms for 3 days prior to visit also received 12 month well child vaccinations 6 1/2 hours prior to episode. Medication for vesicoureteral reflux had changed from Bactrim to nitrofurantoin which she received 2 hours prior to episode. Also received cold medication including active ingredients of acetaminophen , dextromethorphan and phenylephrine 1 1/2 hours prior to seizure. Mom denied any postictal symptoms.  PE unremarkable, afebrile.  DC on Keflex changed from nitrofurantoin due to possible adverse reaction of elevated liver enzymes. Follow up with neurologist.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC
Symptoms: Liver function test abnormal, White blood cell count increased
Clinical narrative: Seizure, convulsive movement lasting a few seconds. No color change. DC Summary received for DOS 9/16-9/18/06. DC DX: Seizure. Presented to ER after seizure activity noted at home. Mom states she was sleeping with patient and awakened to find her eyes dilated and rolled back in her head, arms and legs flexed and she reports three jerks. Patient then started crying. No color changed associated with that, no HX of any fever, no HX of previous seizures. Mom states she had mild upper respiratory symptoms for 3 days prior to visit also received 12 month well child vaccinations 6 1/2 hours prior to episode. Medication for vesicoureteral reflux had changed from Bactrim to nitrofurantoin which she received 2 hours prior to episode. Also received cold medication including active ingredients of acetaminophen , dextromethorphan and phenylephrine 1 1/2 hours prior to seizure. Mom denied any postictal symptoms.  PE unremarkable, afebrile.  DC on Keflex changed from nitrofurantoin due to possible adverse reaction of elevated liver enzymes. Follow up with neurologist.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blister, Erythema, Hypersensitivity, Rash erythematous
Clinical narrative: Raised erythematous patchy rash of left shoulder (Behind left deltoid muscle) with slight vesicles. Also similar linear rash on left leg (appearance of delayed hypersensitivity) rash began 1 week after injection.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Raised erythematous patchy rash of left shoulder (Behind left deltoid muscle) with slight vesicles. Also similar linear rash on left leg (appearance of delayed hypersensitivity) rash began 1 week after injection.
Age: 15.0
Sex: F
Vaccine: MNQ, TTOX
Symptoms: Anaemia, Chills, Headache, Hypoaesthesia, Pruritus
Clinical narrative: Pt received meningococcal and tetanus shots on 9/11 she developed itchiness after vaccines were given, Ha started on 9/13 had a temp of 100.9 and chills had numbness of feet since 9/13/2006. 02/20/2007-records received and reviewed for DOS 09/20-09/26/06.Complained of chills, nausea and numbness in feet no trouble ambulating, complained of headache and migraine headache. Continues to have numbness  and feels weak but doing better as of 9/22/06. 9/23/06 numbness decreasing, less tired from the Atarax, 9/25/06 feeling better parent unable to bring patient in for labs. To see neurologist is no improvement.
Age: 15.0
Sex: F
Vaccine: MNQ, TTOX
Symptoms: Pyrexia
Clinical narrative: Pt received meningococcal and tetanus shots on 9/11 she developed itchiness after vaccines were given, Ha started on 9/13 had a temp of 100.9 and chills had numbness of feet since 9/13/2006. 02/20/2007-records received and reviewed for DOS 09/20-09/26/06.Complained of chills, nausea and numbness in feet no trouble ambulating, complained of headache and migraine headache. Continues to have numbness  and feels weak but doing better as of 9/22/06. 9/23/06 numbness decreasing, less tired from the Atarax, 9/25/06 feeling better parent unable to bring patient in for labs. To see neurologist is no improvement.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, hot, a Knot in muscle of left deltoid.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, hot, knot in muscle left deltoid.
Age: 1.26
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Rash
Clinical narrative: Rash noted on trunk and abd, red, flat, no itchy reported on fever reported. Mother stated rash 2 days after immunization.
Age: 1.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Erythema, Rash erythematous
Clinical narrative: Received MMR vaccine 9/13/06. Rash began 9/24/06 seen in office 9/26/06. Diffuse erythematous raised rash on abdomen and eyes.
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Medication error
Clinical narrative: No event. TDAP administered instead of DTAP on 8/2/06. Error reported. Spec connected-vaccine valid as 5th under DTAP.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Bronchitis, Heat stroke, Immune system disorder, Neurological symptom, Pain
Clinical narrative: I was inoculated with the small pox vaccine during training, in that I had a reaction to, and become infected with eczema vaccination in 1989.  I was in ICU isolation for ever 6 weeks and almost died.  They used an unknown test drug that was under investigation at that time to expedite the healing.  I have permanent scarring all around my face and will never forget the pain.  This has caused me permanent and ongoing immune problems as well as neurological damage in my brain.  From the smallpox, a string of health conditions evolved while on duty.  I was diagnosed with Rheumatoid Arthritis, triggered by the virus, just two years later in 1991 at 25 years old.  I was treated with long-term use of prednisone for 3 years; a combination of eczema vaccination and prednisone zapped my immune system indefinitely.  In 1994, I suffered a severe heat stroke while on active duty, and was hospitalized.  My fever peaked 107 degrees F while over seas in 1995, I had severe bronchitis and developed walking pneumonia; was hospitalized.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Pneumonia, Pyrexia, Rheumatoid arthritis
Clinical narrative: I was inoculated with the small pox vaccine during training, in that I had a reaction to, and become infected with eczema vaccination in 1989.  I was in ICU isolation for ever 6 weeks and almost died.  They used an unknown test drug that was under investigation at that time to expedite the healing.  I have permanent scarring all around my face and will never forget the pain.  This has caused me permanent and ongoing immune problems as well as neurological damage in my brain.  From the smallpox, a string of health conditions evolved while on duty.  I was diagnosed with Rheumatoid Arthritis, triggered by the virus, just two years later in 1991 at 25 years old.  I was treated with long-term use of prednisone for 3 years; a combination of eczema vaccination and prednisone zapped my immune system indefinitely.  In 1994, I suffered a severe heat stroke while on active duty, and was hospitalized.  My fever peaked 107 degrees F while over seas in 1995, I had severe bronchitis and developed walking pneumonia; was hospitalized.
Age: 1.24
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Initial report received on 14/Sep/2006 from another manufacturer, who received the initial report from a physician.  the other manufacturer's reference number is listed.  An eight year old female with no known allergies and a past medical history of acute dermatitis had received a fourth intra-muscular dose of ACT-HIB, lot number 0998390, in the left thigh, and a first subcutaneous dose of VARIVAX (manufacturer mentioned), lot number 627336/1056H, in the right thigh on 12/MAR/1999.  Seven years post-immunization, the patient developed strep throat which was treated with amoxicillin for ten days.  Nine days later, she developed full blown chicken pox with over 500 lesions, "the worst case of chicken pox that the office has ever seen".  The patient also developed a secondary infection which was treated with KEFLEX.  No testing was done on the lesions to determine if the lesions were wild type versus vaccine strain of chicken pox.  The physician reported this adverse events as vaccine failure.  The patient recovered from these  adverse events on 03/AUG/2006, 19 days after onset of symptoms.  Reportedly,  the patient's father, who had no known allergies, or medical history, died after one month of hospitalization in the intensive care unit of pneumonia secondary to varicella which he developed on 25/Jul/2006.  The patient and her father were exposed to a one year old infant who developed chicken pox at the day care the family operated.  The patient's father never had chicken pox and had not been vaccinated with varicella virus vaccine live.  The patient's sibling received varicella vaccination on 30/Jan/2001, and did not develop varicella.  The patient's mother developed shingles just prior to the patient developing the chicken pox.  The secondary infection was considered to be an other important medical event by the other manufacturer. (OMIC)
Age: 1.24
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL
Symptoms: Bacterial infection, Drug ineffective, Pharyngolaryngeal pain, Rash vesicular, Skin ulcer
Clinical narrative: Initial report received on 14/Sep/2006 from another manufacturer, who received the initial report from a physician.  the other manufacturer's reference number is listed.  An eight year old female with no known allergies and a past medical history of acute dermatitis had received a fourth intra-muscular dose of ACT-HIB, lot number 0998390, in the left thigh, and a first subcutaneous dose of VARIVAX (manufacturer mentioned), lot number 627336/1056H, in the right thigh on 12/MAR/1999.  Seven years post-immunization, the patient developed strep throat which was treated with amoxicillin for ten days.  Nine days later, she developed full blown chicken pox with over 500 lesions, "the worst case of chicken pox that the office has ever seen".  The patient also developed a secondary infection which was treated with KEFLEX.  No testing was done on the lesions to determine if the lesions were wild type versus vaccine strain of chicken pox.  The physician reported this adverse events as vaccine failure.  The patient recovered from these  adverse events on 03/AUG/2006, 19 days after onset of symptoms.  Reportedly,  the patient's father, who had no known allergies, or medical history, died after one month of hospitalization in the intensive care unit of pneumonia secondary to varicella which he developed on 25/Jul/2006.  The patient and her father were exposed to a one year old infant who developed chicken pox at the day care the family operated.  The patient's father never had chicken pox and had not been vaccinated with varicella virus vaccine live.  The patient's sibling received varicella vaccination on 30/Jan/2001, and did not develop varicella.  The patient's mother developed shingles just prior to the patient developing the chicken pox.  The secondary infection was considered to be an other important medical event by the other manufacturer. (OMIC)
Age: 1.24
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL
Symptoms: Viral infection
Clinical narrative: Initial report received on 14/Sep/2006 from another manufacturer, who received the initial report from a physician.  the other manufacturer's reference number is listed.  An eight year old female with no known allergies and a past medical history of acute dermatitis had received a fourth intra-muscular dose of ACT-HIB, lot number 0998390, in the left thigh, and a first subcutaneous dose of VARIVAX (manufacturer mentioned), lot number 627336/1056H, in the right thigh on 12/MAR/1999.  Seven years post-immunization, the patient developed strep throat which was treated with amoxicillin for ten days.  Nine days later, she developed full blown chicken pox with over 500 lesions, "the worst case of chicken pox that the office has ever seen".  The patient also developed a secondary infection which was treated with KEFLEX.  No testing was done on the lesions to determine if the lesions were wild type versus vaccine strain of chicken pox.  The physician reported this adverse events as vaccine failure.  The patient recovered from these  adverse events on 03/AUG/2006, 19 days after onset of symptoms.  Reportedly,  the patient's father, who had no known allergies, or medical history, died after one month of hospitalization in the intensive care unit of pneumonia secondary to varicella which he developed on 25/Jul/2006.  The patient and her father were exposed to a one year old infant who developed chicken pox at the day care the family operated.  The patient's father never had chicken pox and had not been vaccinated with varicella virus vaccine live.  The patient's sibling received varicella vaccination on 30/Jan/2001, and did not develop varicella.  The patient's mother developed shingles just prior to the patient developing the chicken pox.  The secondary infection was considered to be an other important medical event by the other manufacturer. (OMIC)
Age: 1.24
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL
Symptoms: Drug ineffective, Infection, Pneumonia, Skin ulcer, Viral infection
Clinical narrative: Initial report received on 14/Sep/2006 from another manufacturer, who received the initial report from a physician.  the other manufacturer's reference number is listed.  An eight year old female with no known allergies and a past medical history of acute dermatitis had received a fourth intra-muscular dose of ACT-HIB, lot number 0998390, in the left thigh, and a first subcutaneous dose of VARIVAX (manufacturer mentioned), lot number 627336/1056H, in the right thigh on 12/MAR/1999.  Seven years post-immunization, the patient developed strep throat which was treated with amoxicillin for ten days.  Nine days later, she developed full blown chicken pox with over 500 lesions, "the worst case of chicken pox that the office has ever seen".  The patient also developed a secondary infection which was treated with KEFLEX.  No testing was done on the lesions to determine if the lesions were wild type versus vaccine strain of chicken pox.  The physician reported this adverse events as vaccine failure.  The patient recovered from these  adverse events on 03/AUG/2006, 19 days after onset of symptoms.  Reportedly,  the patient's father, who had no known allergies, or medical history, died after one month of hospitalization in the intensive care unit of pneumonia secondary to varicella which he developed on 25/Jul/2006.  The patient and her father were exposed to a one year old infant who developed chicken pox at the day care the family operated.  The patient's father never had chicken pox and had not been vaccinated with varicella virus vaccine live.  The patient's sibling received varicella vaccination on 30/Jan/2001, and did not develop varicella.  The patient's mother developed shingles just prior to the patient developing the chicken pox.  The secondary infection was considered to be an other important medical event by the other manufacturer. (OMIC)
Age: 1.24
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL
Symptoms: Bacterial infection, Skin ulcer, Viral infection
Clinical narrative: Initial report received on 14/Sep/2006 from another manufacturer, who received the initial report from a physician.  the other manufacturer's reference number is listed.  An eight year old female with no known allergies and a past medical history of acute dermatitis had received a fourth intra-muscular dose of ACT-HIB, lot number 0998390, in the left thigh, and a first subcutaneous dose of VARIVAX (manufacturer mentioned), lot number 627336/1056H, in the right thigh on 12/MAR/1999.  Seven years post-immunization, the patient developed strep throat which was treated with amoxicillin for ten days.  Nine days later, she developed full blown chicken pox with over 500 lesions, "the worst case of chicken pox that the office has ever seen".  The patient also developed a secondary infection which was treated with KEFLEX.  No testing was done on the lesions to determine if the lesions were wild type versus vaccine strain of chicken pox.  The physician reported this adverse events as vaccine failure.  The patient recovered from these  adverse events on 03/AUG/2006, 19 days after onset of symptoms.  Reportedly,  the patient's father, who had no known allergies, or medical history, died after one month of hospitalization in the intensive care unit of pneumonia secondary to varicella which he developed on 25/Jul/2006.  The patient and her father were exposed to a one year old infant who developed chicken pox at the day care the family operated.  The patient's father never had chicken pox and had not been vaccinated with varicella virus vaccine live.  The patient's sibling received varicella vaccination on 30/Jan/2001, and did not develop varicella.  The patient's mother developed shingles just prior to the patient developing the chicken pox.  The secondary infection was considered to be an other important medical event by the other manufacturer. (OMIC)
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Unintended pregnancy, Uterine haemorrhage
Clinical narrative: Pt is a 16 year old single, student who claimed she was not sexually active but has dysfunctional uterine bleeding Pelvic ultrasound given for above complaint and confirmed pregnancy of 16th weeks, Tdap, Menactra, PPD given at 16 y/o unknown effect to fetus.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pruritus, Skin ulcer
Clinical narrative: Patient developed shingles 9/20/06 (4 months after receiving Varicella vaccine).  Shingles were in a dermatomal pattern involving T9 dermatome.  Also had concommitent ear infection as same time.  Was evaluated in ER and by PMD.  No treatment was given.  One week later, lesions are starting to resolve.  Did have mild pruritis from lesions, but does not seem to have neuralgia.
Age: 1.02
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Mother called day after vaccines were given states child is breaking out in heat type rash oven face and entire body. Mother has child shopping advised to go to the Emergency Room. Seen at EOR Dx with possible reaction to the vaccines. (Mother feels it was from a new car seat she had started using that day) Follow up was attempted unable to locate until she came to clinic 9/26/06.
Age: 1.56
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives at vaccination site and all over the body.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Pain, Vertigo
Clinical narrative: On 9/26/2006, patient felt dizzy. She described her head as "swimming".  She complained of headache.  She stated that her right arm hurt and was stiff.  On 9/27/06 patient dizziness had improved, but arm pain persisted.
Age: 9.0
Sex: M
Vaccine: MMR, PPV
Symptoms: Cellulitis, Injection site reaction, Pain, Pyrexia
Clinical narrative: CELLULITIS AT INJECTION SITE, FEVER, ARM PAIN TX: KEFLEX X10 DAYS, ICE, TYLENOL/MOTRIN
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Had a severe local reaction to left thigh.  She was seen on 09/07/06.  Left upper thigh red and indurated with increased warmth to area about 9x8 in.  It covered entire anterior thigh and spread to post. thigh.  No vesicles noted.
Age: 65.0
Sex: F
Vaccine: DTAP, HEPAB, PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Left arm became red and swollen, tender to touch.  Examined today.  Instructed to take Ibuprofen 600 mg Q 6 hours and ice.  RTC tomorrow for further evaluation.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Patient left, ten minutes later returned and said he was light headed. Took his blood pressure it was 60/40 for 3 times.  Called 911 and took his blood pressure and it was 80/nothing. Emergency techs took him to the hospital.
Age: 1.34
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: A day after administering the vaccine, the patient came back to the office with left arm swelling and pain on site of immunization. Doctor recommended Benadryl, Ibuprofen and cold compresses.  We call the patient a few days after reaction and the symptoms had disappeared.
Age: 67.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 15cm x 8cm erythema induration in L upper arm.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RIGHT LEG WHERE DTaP WAS GIVEN BECAME VERY RED AND SWOLLEN, WARM TO THE TOUCH, AFEBRILE.  TO BE TREATED WITH MOTRIN AND BENADRYL, RTC IF SX DO NOT RESOLVE.
Age: 5.0
Sex: F
Vaccine: DTOX, MMR, OPV, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Developed Varicella on 9/25/06.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Swelling
Clinical narrative: RT upper arm swollen x1 day, freely movable, no discharge.
Age: 2.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Bacterial infection, Pneumonia, Pyrexia
Clinical narrative: 6 days after - high fever fever continues, low grade for additional 9 days pneumonia diagnosed 9-27-2006
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Death. SIDS death? Under coroner's investigation.  03/05/07-Autopsy report received:cause of death Sudden Infant Death Syndrome. Toxicology report received. None detected. Records copied and sent to FDA.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cough, Pharyngitis, Pyrexia, Rhinitis, Vaccine positive rechallenge
Clinical narrative: Death. SIDS death? Under coroner's investigation.  03/05/07-Autopsy report received:cause of death Sudden Infant Death Syndrome. Toxicology report received. None detected. Records copied and sent to FDA.
Sex: F
Vaccine: HEPA
Symptoms: Liver function test abnormal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of increased liver function test in a female subject of unspecified age who was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. Previous vaccination included hepatitis B vaccine (manufacturer unspecified) which was administered on an unspecified date prior to 18 July 2006. On 18 July 2006, the subject received an unspecified dose of Havrix. At an unspecified time prior to 25 September 2006, after vaccination with Havrix, the subject experienced increased liver function test. No additional information was provided at the time of reporting. This case was assessed as medically serious by the manufacturer (OMIC). At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEPA
Symptoms: Liver function test abnormal
Clinical narrative: This case was reported by a health care professional and described the occurrence of elevated liver enzymes in a female subject of unspecified age who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. The subject's medical history and concurrent conditions were not reported. Concurrent medications included Atorvastatin calcium. On an unspecified date, the subject received unspecified dose of Havrix. The lot number and expiration date were not provided. At an unspecified time after vaccination with Havrix, the subject experienced elevated liver enzymes. This case was assessed as medically serious (OMIC). At the time of reporting the outcome of the event was unspecified. No additional details are available.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: CSF test abnormal, Chills, Headache, Herpes simplex serology negative, Nuclear magnetic resonance imaging
Clinical narrative: 9/17 & 18 fever and chills, 9/19/06 developed lesions (15 lesions oh shoulder, flank, ankle), 9/23 headache, 9/24 admitted to hosp with r/o viral meningitis, CSF neg varicella. 10/5/06 Received medical records from PCP which reveal patient seen on 9/20/06 varicella zoster virus by rapid PCR test same day was positive.  MD noted rash on arm for approx 2 days after having had vaccine approx 2 weeks prior to visit due to being recently found to be nonimmune serologically.  Hard itch lesions on back of neck & left deltoid approx 4 days prior to visit & now with lesion on right anterior chest wall & chills.  MD punctured left deltoid lesion to obtain specimen for testing. 10/5/06 Received medical records from hospital which reveal patient admitted 9/24/06-9/27/06 after developing severe frontal HA day before admit.  Continued to have significant pain, nuchal rigidity & scarring on shoulder & ankle where had previous lesions.  Started on IV antiviral med.  Final Dx: Meningitis, varicella vs enterovirus.  Patient was to continue antiviral IV upon d/c./ss Per 60 day follow up: No adverse effects. - varicella test
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Pain, Polymerase chain reaction, Protein total, Pyrexia, Rash
Clinical narrative: 9/17 & 18 fever and chills, 9/19/06 developed lesions (15 lesions oh shoulder, flank, ankle), 9/23 headache, 9/24 admitted to hosp with r/o viral meningitis, CSF neg varicella. 10/5/06 Received medical records from PCP which reveal patient seen on 9/20/06 varicella zoster virus by rapid PCR test same day was positive.  MD noted rash on arm for approx 2 days after having had vaccine approx 2 weeks prior to visit due to being recently found to be nonimmune serologically.  Hard itch lesions on back of neck & left deltoid approx 4 days prior to visit & now with lesion on right anterior chest wall & chills.  MD punctured left deltoid lesion to obtain specimen for testing. 10/5/06 Received medical records from hospital which reveal patient admitted 9/24/06-9/27/06 after developing severe frontal HA day before admit.  Continued to have significant pain, nuchal rigidity & scarring on shoulder & ankle where had previous lesions.  Started on IV antiviral med.  Final Dx: Meningitis, varicella vs enterovirus.  Patient was to continue antiviral IV upon d/c./ss Per 60 day follow up: No adverse effects. - varicella test
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Rash pruritic, Skin ulcer, Varicella, White blood cell count
Clinical narrative: 9/17 & 18 fever and chills, 9/19/06 developed lesions (15 lesions oh shoulder, flank, ankle), 9/23 headache, 9/24 admitted to hosp with r/o viral meningitis, CSF neg varicella. 10/5/06 Received medical records from PCP which reveal patient seen on 9/20/06 varicella zoster virus by rapid PCR test same day was positive.  MD noted rash on arm for approx 2 days after having had vaccine approx 2 weeks prior to visit due to being recently found to be nonimmune serologically.  Hard itch lesions on back of neck & left deltoid approx 4 days prior to visit & now with lesion on right anterior chest wall & chills.  MD punctured left deltoid lesion to obtain specimen for testing. 10/5/06 Received medical records from hospital which reveal patient admitted 9/24/06-9/27/06 after developing severe frontal HA day before admit.  Continued to have significant pain, nuchal rigidity & scarring on shoulder & ankle where had previous lesions.  Started on IV antiviral med.  Final Dx: Meningitis, varicella vs enterovirus.  Patient was to continue antiviral IV upon d/c./ss Per 60 day follow up: No adverse effects. - varicella test
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Fatigue, Headache, Laboratory test abnormal, Meningitis, Nausea
Clinical narrative: 9/17 & 18 fever and chills, 9/19/06 developed lesions (15 lesions oh shoulder, flank, ankle), 9/23 headache, 9/24 admitted to hosp with r/o viral meningitis, CSF neg varicella. 10/5/06 Received medical records from PCP which reveal patient seen on 9/20/06 varicella zoster virus by rapid PCR test same day was positive.  MD noted rash on arm for approx 2 days after having had vaccine approx 2 weeks prior to visit due to being recently found to be nonimmune serologically.  Hard itch lesions on back of neck & left deltoid approx 4 days prior to visit & now with lesion on right anterior chest wall & chills.  MD punctured left deltoid lesion to obtain specimen for testing. 10/5/06 Received medical records from hospital which reveal patient admitted 9/24/06-9/27/06 after developing severe frontal HA day before admit.  Continued to have significant pain, nuchal rigidity & scarring on shoulder & ankle where had previous lesions.  Started on IV antiviral med.  Final Dx: Meningitis, varicella vs enterovirus.  Patient was to continue antiviral IV upon d/c./ss Per 60 day follow up: No adverse effects. - varicella test
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Rash vesicular, Rhinorrhoea
Clinical narrative: 9/17 & 18 fever and chills, 9/19/06 developed lesions (15 lesions oh shoulder, flank, ankle), 9/23 headache, 9/24 admitted to hosp with r/o viral meningitis, CSF neg varicella. 10/5/06 Received medical records from PCP which reveal patient seen on 9/20/06 varicella zoster virus by rapid PCR test same day was positive.  MD noted rash on arm for approx 2 days after having had vaccine approx 2 weeks prior to visit due to being recently found to be nonimmune serologically.  Hard itch lesions on back of neck & left deltoid approx 4 days prior to visit & now with lesion on right anterior chest wall & chills.  MD punctured left deltoid lesion to obtain specimen for testing. 10/5/06 Received medical records from hospital which reveal patient admitted 9/24/06-9/27/06 after developing severe frontal HA day before admit.  Continued to have significant pain, nuchal rigidity & scarring on shoulder & ankle where had previous lesions.  Started on IV antiviral med.  Final Dx: Meningitis, varicella vs enterovirus.  Patient was to continue antiviral IV upon d/c./ss Per 60 day follow up: No adverse effects. - varicella test
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Anorexia, Asthenia, CSF test abnormal, Fatigue, Headache
Clinical narrative: 9/17 & 18 fever and chills, 9/19/06 developed lesions (15 lesions oh shoulder, flank, ankle), 9/23 headache, 9/24 admitted to hosp with r/o viral meningitis, CSF neg varicella. 10/5/06 Received medical records from PCP which reveal patient seen on 9/20/06 varicella zoster virus by rapid PCR test same day was positive.  MD noted rash on arm for approx 2 days after having had vaccine approx 2 weeks prior to visit due to being recently found to be nonimmune serologically.  Hard itch lesions on back of neck & left deltoid approx 4 days prior to visit & now with lesion on right anterior chest wall & chills.  MD punctured left deltoid lesion to obtain specimen for testing. 10/5/06 Received medical records from hospital which reveal patient admitted 9/24/06-9/27/06 after developing severe frontal HA day before admit.  Continued to have significant pain, nuchal rigidity & scarring on shoulder & ankle where had previous lesions.  Started on IV antiviral med.  Final Dx: Meningitis, varicella vs enterovirus.  Patient was to continue antiviral IV upon d/c./ss Per 60 day follow up: No adverse effects. - varicella test
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Nausea, Rash pustular, Rhinorrhoea, Viral infection
Clinical narrative: 9/17 & 18 fever and chills, 9/19/06 developed lesions (15 lesions oh shoulder, flank, ankle), 9/23 headache, 9/24 admitted to hosp with r/o viral meningitis, CSF neg varicella. 10/5/06 Received medical records from PCP which reveal patient seen on 9/20/06 varicella zoster virus by rapid PCR test same day was positive.  MD noted rash on arm for approx 2 days after having had vaccine approx 2 weeks prior to visit due to being recently found to be nonimmune serologically.  Hard itch lesions on back of neck & left deltoid approx 4 days prior to visit & now with lesion on right anterior chest wall & chills.  MD punctured left deltoid lesion to obtain specimen for testing. 10/5/06 Received medical records from hospital which reveal patient admitted 9/24/06-9/27/06 after developing severe frontal HA day before admit.  Continued to have significant pain, nuchal rigidity & scarring on shoulder & ankle where had previous lesions.  Started on IV antiviral med.  Final Dx: Meningitis, varicella vs enterovirus.  Patient was to continue antiviral IV upon d/c./ss Per 60 day follow up: No adverse effects. - varicella test
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: Infant developed nasal congestion on 9/17/06 and fever 101. Mother noticed shortness of breath in infant. (/18/06 exam showed nasal congestion with clear nasal discharge. Infant did no require any medication.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Erythema, Feeling hot, Hot flush
Clinical narrative: 8/25 six hours after flu shot received in right deltoid she became hot and her skin was flushed red. She vomited x 1 then went home. She was dizzy and aching across her arms and shoulders. That night she had diarrhea and said to ache, 9/27 she is still feeling achy.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Vomiting
Clinical narrative: 8/25 six hours after flu shot received in right deltoid she became hot and her skin was flushed red. She vomited x 1 then went home. She was dizzy and aching across her arms and shoulders. That night she had diarrhea and said to ache, 9/27 she is still feeling achy.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Mother brought child in with report of swelling and redness to area. Some redness and swelling observed.
Age: 1.69
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Hypotonia, Opisthotonus
Clinical narrative: 02/22/2006 11 am pt went limp in car seat in car. Arched back and made a noise prior to going limp.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash, Rash pruritic
Clinical narrative: Multiple isolated blistery rash some scabbed over, others emerging pruritic.
Age: 11.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Dyspnoea
Clinical narrative: Mom stated about 2-3 hours after immunizations administered, child stated he could not breath. Mom took child to ER. Evaluated by MD. Mom stated child received Epinephrine, Prednisone and Benadryl. Child okay now. Mom states MD advised to repeat imm.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash papular
Clinical narrative: Exposure to unvaccinated child with chicken pox (varicella), papular erythema rash on trunk and spreading to head and extremities, uniform no crusting.
Age: 1.37
Sex: M
Vaccine: MMR, PNC
Symptoms: Rash, Rash maculo-papular, Rash papular
Clinical narrative: Rash raised rounded erythematous papules of various sizes. Some exonated areas of face, hair line no fever.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Epistaxis, Urticaria
Clinical narrative: Hives, epistaxis, 2-3 doses of Benadryl
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Incoherent, Loss of consciousness, Syncope, Vaccine positive rechallenge
Clinical narrative: Fainted, incoherent x 1 minute or less Black out both times.