chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Dyspnoea, Face oedema, Hypoxia, Lacrimation increased
Clinical narrative: Influenza vaccine, Lot #U1747AA, 0.5cc administered I.M. to R Deltoid at approx. 3:35pm on 1/27/06.  Had pt wait x 15 min (1st time receiving flu vaccine).  At 3:45pm, pt was standing, leaning against wall and appeared distressed (staring straight ahead, furrowed brow) and via interpreter pt c/o sensation of lips swelling and throat closing, and mild difficulty breathing. Pt's skin warm to touch, had hand tremors, but no diaphoresis and no rash or c/o itching.  Pt was given 3 tsp (15cc) of liquid diphenhydramine HCl (12.5mg/5cc)at this time and was moved to a sitting position.  At 3:50pm condition was no better, and per interpreter, sensation of throat closing was slightly worse. Pulse=64 BPM,Reg Rate, BP 124/84. 0.3 ml of Epinepherine 1:1,000 was given S.C. in L arm at this time. At 4:00pm, pt clutched chest and throat, was gasping for breath, tears rolling down face.  He was lowered to lying position on floor and 911 was called.  BP was 110/82, pulse 82, lungs auscultated from front only-no wheezing heard, no rash or hives or c/o itching. One more tsp. of diphenhydramine was given. Pt breathing eased with movement to lying position, he remained alert, anxious,skin, warm and dry (though shivering), stated tightness in throat was no worse, but no better. Pt was covered with blankets and EMS arrived within 5 minutes, administered Oxygen via face mask and pt was transported to E.R. with interpreter for further eval. Per the pt's employer, he was felt to be recovered and was released at about 8:00 pm that evening.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Skin warm, Staring, Throat tightness, Tremor
Clinical narrative: Influenza vaccine, Lot #U1747AA, 0.5cc administered I.M. to R Deltoid at approx. 3:35pm on 1/27/06.  Had pt wait x 15 min (1st time receiving flu vaccine).  At 3:45pm, pt was standing, leaning against wall and appeared distressed (staring straight ahead, furrowed brow) and via interpreter pt c/o sensation of lips swelling and throat closing, and mild difficulty breathing. Pt's skin warm to touch, had hand tremors, but no diaphoresis and no rash or c/o itching.  Pt was given 3 tsp (15cc) of liquid diphenhydramine HCl (12.5mg/5cc)at this time and was moved to a sitting position.  At 3:50pm condition was no better, and per interpreter, sensation of throat closing was slightly worse. Pulse=64 BPM,Reg Rate, BP 124/84. 0.3 ml of Epinepherine 1:1,000 was given S.C. in L arm at this time. At 4:00pm, pt clutched chest and throat, was gasping for breath, tears rolling down face.  He was lowered to lying position on floor and 911 was called.  BP was 110/82, pulse 82, lungs auscultated from front only-no wheezing heard, no rash or hives or c/o itching. One more tsp. of diphenhydramine was given. Pt breathing eased with movement to lying position, he remained alert, anxious,skin, warm and dry (though shivering), stated tightness in throat was no worse, but no better. Pt was covered with blankets and EMS arrived within 5 minutes, administered Oxygen via face mask and pt was transported to E.R. with interpreter for further eval. Per the pt's employer, he was felt to be recovered and was released at about 8:00 pm that evening.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Cough, Diarrhoea, Hypotonia, Irritability
Clinical narrative: 2 hours after vaccination: diarrhea began followed by vomiting, fever, dehydration, abdominal cramping, extreme lethargy, limpness, irritability, runny nose, cough. Is still continuing 6 days later although symptoms have improved somewhat.  Diagnosis from doctor was viral and treat with pain reliever and fluids.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Pyrexia, Rhinorrhoea, Viral infection, Vomiting
Clinical narrative: 2 hours after vaccination: diarrhea began followed by vomiting, fever, dehydration, abdominal cramping, extreme lethargy, limpness, irritability, runny nose, cough. Is still continuing 6 days later although symptoms have improved somewhat.  Diagnosis from doctor was viral and treat with pain reliever and fluids.
Age: 45.0
Sex: F
Vaccine: IPV, TDAP, IPV, TDAP
Symptoms: Erythema, Hypoaesthesia, Pruritus, Rash macular
Clinical narrative: Client complains of a mildly itchy macular red rash. A numbness of small red spots on her neck and torso approx. 24 hours after receiving vaccines. No other symptoms. Rash is improved at time of this report.
Age: 45.0
Sex: F
Vaccine: IPV, TDAP, IPV, TDAP
Symptoms: Erythema, Rash macular, Rash pruritic
Clinical narrative: Client complains of a mildly itchy macular red rash. A numbness of small red spots on her neck and torso approx. 24 hours after receiving vaccines. No other symptoms. Rash is improved at time of this report.
Age: 21.0
Sex: F
Vaccine: JEV
Symptoms: Hypersensitivity, Rash
Clinical narrative: Pt work for CDC came for first dose's Japanese Encephalitis #1 given about 8:30 am. Developed rash was seen Emergency Department.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Balance disorder, Gait disturbance
Clinical narrative: Pt runs everyday, since vaccine, stride is off, knees don't come up, looks like speed walking rather than running. Balance is off, strength in legs has decreased joint pain. Condition has improved but very slowly still far from recovery. Has been seen by doctors at college 3 times and by the family doctor, test results for blood test are pending as well as an MRI.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Pallor, Skin discolouration
Clinical narrative: On Mon 01/3/06 10:00 found injection site red ring and pale flesh colored center.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Fontanelle bulging, White blood cell count increased
Clinical narrative: Bulging fontanel 18 hours after vaccine, CBC showed WBC 20,700. Required spinal tap (normal) and overnight hospitalization for IV antibiotic.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Febrile convulsion, Hypersensitivity, Hypoxia
Clinical narrative: Received 4 Prevnar vaccines as proscribed, 06/15/04, 08/13/04, 10/22/04 and 04/13/05, had invasive Pneumococcal DX. These vaccines were vaccines for children (program), some power loss during hurricane but not deemed replaceable by VFC. Discharge summary states latex allergy developed. msv Medical records states Upper respiratory infection, febrile seiaure, vomiting, hypoxic. msv
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Leukocytosis, Pneumonia, Sepsis, Upper respiratory tract infection, Vomiting
Clinical narrative: Received 4 Prevnar vaccines as proscribed, 06/15/04, 08/13/04, 10/22/04 and 04/13/05, had invasive Pneumococcal DX. These vaccines were vaccines for children (program), some power loss during hurricane but not deemed replaceable by VFC. Discharge summary states latex allergy developed. msv Medical records states Upper respiratory infection, febrile seiaure, vomiting, hypoxic. msv
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Coma, Hypotonia, Pallor, Stupor
Clinical narrative: Patient reportedly became limp, pale and unresponsive. This episode lasted about 20-30 minutes and self resolved. She was seen in the ER then admitted overnight for observation. No further episodes noted. 2/10/06 - Review of d/c summary indicates final diagnosis of hypotonic-hyporesponsive episode.
Age: 1.27
Sex: M
Vaccine: DTPHIB, MMR, OPV
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: Diagnosed Autism-developmental delay. No speech.  Not potty trained. 2/7/06  Review of medical records done. By 3/3/97 (prior to vax) there were developmental delays (language & social) and these continued to increase until autism was suspected by age 4.5.  2/7/06  Review of medical records done. Immunization record shows Tetramune, Lederle, 4400-744, site not specified, and 3 previous doses. Oral polio 4/27/06-reviewed medical records confirmed pre-existing developmental delay and autism by 1/7/99.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Dysuria, Encephalitis, Laboratory test abnormal, Nausea
Clinical narrative: Vomiting for 2 days post vaccine. Went to doctor weakness in legs, unable to urinate or defecate. Admitted to hospital 6 days later with progressive weakness in legs and body. Was hospitalized for 7 days. Diagnosed with acute disseminating encephalomyelitis. Discharge summary states paresthesia, nausea, vomiting, tremors. msv
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Paraesthesia, Tremor, Vomiting
Clinical narrative: Vomiting for 2 days post vaccine. Went to doctor weakness in legs, unable to urinate or defecate. Admitted to hospital 6 days later with progressive weakness in legs and body. Was hospitalized for 7 days. Diagnosed with acute disseminating encephalomyelitis. Discharge summary states paresthesia, nausea, vomiting, tremors. msv
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Anorexia, Chills, Cough, Headache, Pyrexia
Clinical narrative: Fever, chills, temp, headache, dry cough, anorexia, weight loss.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Weight decreased
Clinical narrative: Fever, chills, temp, headache, dry cough, anorexia, weight loss.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Medication error
Clinical narrative: While Administering Adacel injection the needle was loose and approx 1/2 the vaccine was injected. Discuss with MD about this. We will administer Adacel at next visit at no charge.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site reaction
Clinical narrative: Mild swelling of right thigh at injection site (MMR). Seen by DR. Benadryl 125/5 1tsp PO given and Tylenol 240mg PO given at 11:25, mild redness and swelling left thigh inj site.
Age: 1.11
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Rash morbilliform, Viral infection
Clinical narrative: Pt had measles rash 10 days after vaccine administered. PCP told mom that child had measles from vaccine.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Alopecia, Alopecia areata
Clinical narrative: On 08/04/2005 went to physician for football physical. He was given the Menactra vaccination. On 10/13/2005 was seen back at her office where at least a dime size circle in lower region of the back of his head had hair loss. he then had to wait for a dermatologist appointment in Nov. The circle of hair loss continued to progress. Doctor tested it for fungus which took an additional six weeks. During this time he was placed on cream and cortisone. Returned back on 01/4/2006 confirmed no fungus then diagnosed with Alopecia Areta.
Age: 1.28
Sex: F
Vaccine: DTAPH, PNC
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: Fever 4 hours after shots 103 and screaming and crying for several hours. Fever lasted 4 days, per mom.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Agitation, Crying, Decreased appetite, Pyrexia
Clinical narrative: Immunization given at 5:00 pm on 11/29/2005. the next morning woke up crying for 2 hours, which was very unusual. Temp as high as 105 and never below 101 with Tylenol given every 4 hours. This lasted almost 48 hours. Ate only two times those days rather than her normal 4 times.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Agitation, Crying, Pyrexia
Clinical narrative: Immunization given at 5:00 pm on 11/29/2005. the next morning woke up crying for 2 hours, which was very unusual. Temp as high as 105 and never below 101 with Tylenol given every 4 hours. This lasted almost 48 hours. Ate only two times those days rather than her normal 4 times.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Rash on left arm that spread to chest, trunk, back. Rash is maculopapular confluent. Treated with Medrol dose pack rash began day after TD given.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Tenderness
Clinical narrative: Left upper arm pain, swelling, Erythema and tenderness 2 days after immunization.
Age: 44.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Fatigue, Lymphadenopathy, Nausea
Clinical narrative: Fatigue x one week, left side of neck swollen gland and nausea.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Mild to light red rash to arms, thighs, sides and neck. Non vesicular. Itches.
Age: 3.0
Sex: M
Vaccine: HEP, MMR, PNC
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Pt had localized reaction to MMR vaccination. Temperature 101.2 (ear probe) treating fever with Tylenol/Motrin initially treated site with ice and warm compresses.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Medication error
Clinical narrative: Client was given varicella vaccine using Act Hib diluent.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Erythema, Oedema
Clinical narrative: Right arm red and swollen.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: Left thigh red, swollen and hard.
Age: 0.53
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Agitation, Crying, Irritability
Clinical narrative: Crying, irritability.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dizziness, Injection site oedema, Pain, Throat tightness
Clinical narrative: Possible reaction to Adacel, Tdap, vaccine given on 12/19/2005. Approximately 18-20 hours after receiving vaccine had sudden onset dizziness, chest and throat tightness and pain. She had swelling at injection site but no erythema or itching. No rash was present. She had wheezing which resolved after 2 nebulizer treatments of Albuterol (1 with Pulmicort), Prednisone and Zyrtec. No prior history of wheezing. All symptoms resolved by 48 hours after injection.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Wheezing
Clinical narrative: Possible reaction to Adacel, Tdap, vaccine given on 12/19/2005. Approximately 18-20 hours after receiving vaccine had sudden onset dizziness, chest and throat tightness and pain. She had swelling at injection site but no erythema or itching. No rash was present. She had wheezing which resolved after 2 nebulizer treatments of Albuterol (1 with Pulmicort), Prednisone and Zyrtec. No prior history of wheezing. All symptoms resolved by 48 hours after injection.
Age: 1.23
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Joint range of motion decreased, Oedema, Rash
Clinical narrative: Pt examined on 1/19/06 per request of mother.  Developed fine rash on trunk and extremities.  R leg injection site slight edematous mom reported baby could not stand.  Upon exam by physician baby able to bear weight and move all extremities full range of motion with difficulty.  Instructed to use Tylenol/ Ibupropren as needed.  Mom took baby to local ER with visit in office of same symptoms.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Broke out in rash over most of body 1-24-06 thru 1-25-06. Diagnosed with chicken pox by the CFNP. 1-25-06 Pt received varicella vaccine 11-15-1996
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site swelling
Clinical narrative: Occurred at injection site red, slight swollen.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site swelling
Clinical narrative: Redness and swelling at site right leg. Tx ice to site-Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Swelling, pain, itching - Benadryl.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Scalp/chest/arms/legs some vesicles, some papules. Some papules with degree of puss.
Age: 64.0
Sex: M
Vaccine: TD
Symptoms: Dry skin, Oedema peripheral, Rash, Skin exfoliation
Clinical narrative: Swelling on both hands - more so on left hand - small bumps like measles on hands and arms. Dry skin on face with cracking and peeling.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Temp of 102 degrees;cranky.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Petechiae, Skin burning sensation, Swelling
Clinical narrative: Numerous discrete, purpuric lesions noted on lower extremities no itch and burning. Assoc with ankle/knee swelling and pain. Pt had concomitant URI - afeb, no NAD, O2 Sat: 92, plus coarse rules.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Anorexia, Irritability
Clinical narrative: Irritability time 48 hours;refusal to nurse x 48 hours.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Injection site induration, Injection site pain
Clinical narrative: Hard area ( 1 1/2 in in diameter) to injection site. Pain and discomfort to injection site (left deltoid) that radiated to left leg on night of immunization then following day to right leg. No fever.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Eye swelling, Swelling face
Clinical narrative: 1:30 pm Mother noted swelling around eyes. 2:00 pm eyes shut swelling continued; 2:15 pm facial swelling went to ER for treatment. Treatment in ER - Cortisone and Benadryl by mouth administered. Prescription for cortisone to give one daily for 2-3 days Benadryl as needed.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Erythema, Injection site inflammation, Pyrexia
Clinical narrative: Noted some redness on the thigh right;inflammatory morning after immunization. Low grade temp 48 hours after immunization.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash macular
Clinical narrative: Erythematous, macular papular rash no vesicles.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Pt got 9 spots on body 14 days after vac was given. Red ring with a white head on the middle.
Age: 1.01
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Vaccine failure, dx with varicella 1/24/06 total of 5 crusted vesicles 3 on thighs, 1 on pubis, 1 adjacent to clitoris.
Age: 1.02
Sex: F
Vaccine: HEP, IPV
Symptoms: Loss of consciousness, Urticaria
Clinical narrative: Hepatitis B and IPV given and within seconds passed out- unconscious x 30 sec. then immediately broke out in hives all over.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Dysphonia, Pallor
Clinical narrative: Paleness, Weakness, Dizziness, Hoarseness.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Dermatitis bullous, Viral infection
Clinical narrative: 25 lesions at various stages--some crusted over. Tx--symptomatic.
Age: 33.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Meningitis, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, nausea/vomiting, fever.  Admitted to hospital with questionable meningitis diagnosis on 01/20/06.  Released from hospital on 01/23/06.  ???vaccine related???
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Flushing, Full blood count, Lethargy, Lumbar puncture, Lymphadenopathy
Clinical narrative: My son was hospitalized this past weekend for what has been determined a reaction to the MMR vaccine he received on 1/20.  I had taken him to his pediatrician on 1/24 because he had red dots all over him (which I later found out is called petechiae), and was acting unlike himself.  They did a CBC which supposedly came back normal the next day.  Friday morning I took him back to his pediatrician because the petechiae was worse, his face was bright red, he had fever of 103.3, and was lethargic.  She did a strep test and mono test which were both negative.  Since it was Friday, she wanted us to go to the hospital for more blood work to rule out potential dangerous illnesses.  We went to the ER, and they did a CBC, spinal tap, and started an IV for antibiotics in case it was a bacterial infection.  They admitted him and kept us there until Sunday afternoon.  The first CBC showed low platelets, and low white blood cells (which terrified me), but the second one on Saturday showed the levels had increased.  The cultures on the blood and spinal fluid were normal (no growth), but the hematologist said he was definately fighting something.  She called it Pancytopenia, which apparently means abnormal blood readings across the board.  They dischared him Sunday with the assumption that he had a bad reaction to the MMR.  He hasn't had fever since yesterday morning and seems to be feeling a lot better, but my fear now is that there could be permanent damage that leads to something more severe. 2/2/06 -  Discharge summary reviewed. D/C diagnosis was listed as: pancytopenia resolving, rash resolving, petechiae stable, adenopathy resolving, question of whether the above is secondary to viral illness or reaction to MMR. Child was treated with IV Ceftriaxone. He had temp of 103.3 at home prior to admission and gradually became afebrile during his hospital stay.  Per 60 day follow up patient has been continuall ill since the vaccine episode. He had rotavirus. C-Diff, sinus infections (including MSRA) and a number of respiratory viruses. It seems that his immune system is not very strong. I just wonder if his poor health has to do with the vaccines or not. I stay home with him, and the only time he is around other kids is when I take him to the child care at my gym 4 X/week. That's probably where he catches everything. Other than the illnesses he is thriving & hitting all his milestones.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Pancytopenia, Personality change, Petechiae, Platelet count decreased, Pyrexia
Clinical narrative: My son was hospitalized this past weekend for what has been determined a reaction to the MMR vaccine he received on 1/20.  I had taken him to his pediatrician on 1/24 because he had red dots all over him (which I later found out is called petechiae), and was acting unlike himself.  They did a CBC which supposedly came back normal the next day.  Friday morning I took him back to his pediatrician because the petechiae was worse, his face was bright red, he had fever of 103.3, and was lethargic.  She did a strep test and mono test which were both negative.  Since it was Friday, she wanted us to go to the hospital for more blood work to rule out potential dangerous illnesses.  We went to the ER, and they did a CBC, spinal tap, and started an IV for antibiotics in case it was a bacterial infection.  They admitted him and kept us there until Sunday afternoon.  The first CBC showed low platelets, and low white blood cells (which terrified me), but the second one on Saturday showed the levels had increased.  The cultures on the blood and spinal fluid were normal (no growth), but the hematologist said he was definately fighting something.  She called it Pancytopenia, which apparently means abnormal blood readings across the board.  They dischared him Sunday with the assumption that he had a bad reaction to the MMR.  He hasn't had fever since yesterday morning and seems to be feeling a lot better, but my fear now is that there could be permanent damage that leads to something more severe. 2/2/06 -  Discharge summary reviewed. D/C diagnosis was listed as: pancytopenia resolving, rash resolving, petechiae stable, adenopathy resolving, question of whether the above is secondary to viral illness or reaction to MMR. Child was treated with IV Ceftriaxone. He had temp of 103.3 at home prior to admission and gradually became afebrile during his hospital stay.  Per 60 day follow up patient has been continuall ill since the vaccine episode. He had rotavirus. C-Diff, sinus infections (including MSRA) and a number of respiratory viruses. It seems that his immune system is not very strong. I just wonder if his poor health has to do with the vaccines or not. I stay home with him, and the only time he is around other kids is when I take him to the child care at my gym 4 X/week. That's probably where he catches everything. Other than the illnesses he is thriving & hitting all his milestones.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash, White blood cell count decreased
Clinical narrative: My son was hospitalized this past weekend for what has been determined a reaction to the MMR vaccine he received on 1/20.  I had taken him to his pediatrician on 1/24 because he had red dots all over him (which I later found out is called petechiae), and was acting unlike himself.  They did a CBC which supposedly came back normal the next day.  Friday morning I took him back to his pediatrician because the petechiae was worse, his face was bright red, he had fever of 103.3, and was lethargic.  She did a strep test and mono test which were both negative.  Since it was Friday, she wanted us to go to the hospital for more blood work to rule out potential dangerous illnesses.  We went to the ER, and they did a CBC, spinal tap, and started an IV for antibiotics in case it was a bacterial infection.  They admitted him and kept us there until Sunday afternoon.  The first CBC showed low platelets, and low white blood cells (which terrified me), but the second one on Saturday showed the levels had increased.  The cultures on the blood and spinal fluid were normal (no growth), but the hematologist said he was definately fighting something.  She called it Pancytopenia, which apparently means abnormal blood readings across the board.  They dischared him Sunday with the assumption that he had a bad reaction to the MMR.  He hasn't had fever since yesterday morning and seems to be feeling a lot better, but my fear now is that there could be permanent damage that leads to something more severe. 2/2/06 -  Discharge summary reviewed. D/C diagnosis was listed as: pancytopenia resolving, rash resolving, petechiae stable, adenopathy resolving, question of whether the above is secondary to viral illness or reaction to MMR. Child was treated with IV Ceftriaxone. He had temp of 103.3 at home prior to admission and gradually became afebrile during his hospital stay.  Per 60 day follow up patient has been continuall ill since the vaccine episode. He had rotavirus. C-Diff, sinus infections (including MSRA) and a number of respiratory viruses. It seems that his immune system is not very strong. I just wonder if his poor health has to do with the vaccines or not. I stay home with him, and the only time he is around other kids is when I take him to the child care at my gym 4 X/week. That's probably where he catches everything. Other than the illnesses he is thriving & hitting all his milestones.
Age: 1.28
Sex: M
Vaccine: FLU3, MMR, PNC
Symptoms: Laboratory test abnormal, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Had MMR given along with Prevnar and flu vaccine (NOS on 10/15/2005). Office visit: 11/1/05 C/O runny nose 1 weep rash 3>2 days, fever on 2 week
Age: 0.77
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye swelling, Hypersensitivity, Rash macular, Skin disorder
Clinical narrative: 10/26/05 9:30pm Mother called stating daughter had flu shot today. Now c/o eyes red and swollen, skin is slightly blotchy. Mother feels child is having allergic reaction to vaccine. Benadryl given. 10/27/05 10:30 am Mother called back, states child is much better. Subsequent immunocap allergy testing plus egg white allergy.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Injection site red, tender, swollen arthralgia left arm. F/U visit 01/11/2006 pt C/O tenderness, slight redness.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Feeling hot, Urticaria
Clinical narrative: 5 mins after admin of vaccine, client developed approximately 10 cm in diameter over Left clavicle, also stated she felt hot. Administered liquid Benadryl 50 mg PO x1. By 3 PM hive was faded and pt stated felt better. At 2:40 pm BP was at 162/88. At 4:50 BP 142/84 with pulse of 88.
Age: 16.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pruritus
Clinical narrative: Pt took 1st Vivotif capsule 01/28/2006, In am of 01/29/2006 pt noticed itchy rash on knees. Monday 01/30/2006 pt had rash on elbows and knees. Pt took capsule #2 01/30/2006 and on 01/31/2006 has itchy rash on ankles and elbows. Stated rash on ankles is very bothersome. Benadryl given 01/31/2006 in AM for rash.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Right thigh erythematous, mildly itchy, superficial 8cm x 8cm injection site.
Age: 23.0
Sex: F
Vaccine: MEN, YF
Symptoms: Injection site rash, Pruritus, Rash macular, Skin ulcer
Clinical narrative: Rash around yellow fever injection site spreading extensively down back, legs, and to ankles and arms.  Maculopapular lesions slightly itchy. 1/27/06 Telephone call to patient rash mostly resolved took Benadryl.
Age: 0.17
Sex: M
Vaccine: PNC
Symptoms: Candidiasis, Hepatitis, Hepatosplenomegaly, Laboratory test abnormal, Lymphadenopathy
Clinical narrative: This is a 67 day old, HIV positive, male infant enrolled in protocols CIPRA SA 004, "Evaluation of quantitative and qualitative antibody response to streptococcus pneumoniae and haemophilus influenzae type B conjugate vaccines amongst HIV-1 exposed infected children that are receiving vs those not receiving antiretroviral therapy, as well as among HIV-1-exposed-uninfected children and HIV-1 unexposed-uninfected children," on 12/15/2005 who died of an unknown cause. The subject was also enrolled in the delayed antiretroviral therapy treatment arm of protocol CIPRA SA 002 "A Phase III, randomized, open-label trial to evaluate strategies for providing antiretroviral therapy to infants shortly after primary infection in a resource poor setting." The subject was born by vaginal breech delivery at 37 weeks gestation. Mother had apgar scores of 2 and 4 with no prenatal problems. The mother received zidovudine for an estimated 3 weeks prior to delivery and nevirapine at delivery. The subject received one dose of nevirapine at birth 7 days of zidovudine after birth. The subject has been solely formula fed since birth. The subject received one dose of Prevnar on 12/19/2005. He was evaluated on 01/03/2006 and his weight was in the 5th percentile, length just below 6th percentile, head circumference in the 10th percentile and his weight for height 1-score was 0.20. The subject had generalized lymphadenopathy (size 0-0 5cm), mild oral thrush, hepatosplenomegaly (4cm live span, 2cm palpable spleen), and no signs of respiratory distress. He was sent home on Vidaylin syrup, Ferro, drops, Bactrim, oral Mycostatin drops, and oral Daktarin gel. The mother reported no cough, no diarrhea or vomiting, no fever and no other complaints prior to 01/09/2006. At 18:00 on 01/09/2006 the mother noticed that the subject was breathing fast and at 22:00 the subject looked pale. The mother took the subject to the local hospital at 23:00. The subject was dead on arrival at 23:30 on 01/09/2006. Differential diagnoses of sepsis or pneumonia have been made. A post-mortem exam was performed on 01/17/2006 and results are pending. This site investigator believes this event is not related to study agent. The DAIDS medical officer believes this event is probably not related, but cannot rule out a relationship to study agent. 3/2/06 Received medical records which revealed UTI, oral thrush, hepatomegaly & splenomegaly. Received Autopsy Report 3/6/06 which revealed COD as pneumocystis carinii pneumonia & granulomatous hepatitis.
Age: 0.17
Sex: M
Vaccine: PNC
Symptoms: Pneumonia, Respiratory rate increased, Sepsis, Urinary tract infection
Clinical narrative: This is a 67 day old, HIV positive, male infant enrolled in protocols CIPRA SA 004, "Evaluation of quantitative and qualitative antibody response to streptococcus pneumoniae and haemophilus influenzae type B conjugate vaccines amongst HIV-1 exposed infected children that are receiving vs those not receiving antiretroviral therapy, as well as among HIV-1-exposed-uninfected children and HIV-1 unexposed-uninfected children," on 12/15/2005 who died of an unknown cause. The subject was also enrolled in the delayed antiretroviral therapy treatment arm of protocol CIPRA SA 002 "A Phase III, randomized, open-label trial to evaluate strategies for providing antiretroviral therapy to infants shortly after primary infection in a resource poor setting." The subject was born by vaginal breech delivery at 37 weeks gestation. Mother had apgar scores of 2 and 4 with no prenatal problems. The mother received zidovudine for an estimated 3 weeks prior to delivery and nevirapine at delivery. The subject received one dose of nevirapine at birth 7 days of zidovudine after birth. The subject has been solely formula fed since birth. The subject received one dose of Prevnar on 12/19/2005. He was evaluated on 01/03/2006 and his weight was in the 5th percentile, length just below 6th percentile, head circumference in the 10th percentile and his weight for height 1-score was 0.20. The subject had generalized lymphadenopathy (size 0-0 5cm), mild oral thrush, hepatosplenomegaly (4cm live span, 2cm palpable spleen), and no signs of respiratory distress. He was sent home on Vidaylin syrup, Ferro, drops, Bactrim, oral Mycostatin drops, and oral Daktarin gel. The mother reported no cough, no diarrhea or vomiting, no fever and no other complaints prior to 01/09/2006. At 18:00 on 01/09/2006 the mother noticed that the subject was breathing fast and at 22:00 the subject looked pale. The mother took the subject to the local hospital at 23:00. The subject was dead on arrival at 23:30 on 01/09/2006. Differential diagnoses of sepsis or pneumonia have been made. A post-mortem exam was performed on 01/17/2006 and results are pending. This site investigator believes this event is not related to study agent. The DAIDS medical officer believes this event is probably not related, but cannot rule out a relationship to study agent. 3/2/06 Received medical records which revealed UTI, oral thrush, hepatomegaly & splenomegaly. Received Autopsy Report 3/6/06 which revealed COD as pneumocystis carinii pneumonia & granulomatous hepatitis.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Hypertension, Hypokinesia, Influenza like illness
Clinical narrative: Initial report received on 11/3/2005 from a consumer. A 77 year old female patient who was currently taking Zestoretic, Toprol XL, 200 mg, Tricor, 160 mg and Synthroid 0.1mg at the time of the vaccination had received an administration (route site not reported) of Fluzone SV 2005-2006 USP lot number not reported on 9/21/2005. The next day she complained of muscle soreness, weakness and joint pain. The patient fells it is very severe in nature. She was evaluated by a physician and was prescribed methylprednisolone which slightly improved her conditions. The patient had some unspecified diagnostic testing completed to rule out rheumatoid arthritis. The patient had not recovered from these events at the time of the report. Follow up information received on 1/13/2006 from the patient. Per the reporter, the patient stated she developed muscle weakness and soreness the day after receiving an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1806AA, in the left deltoid on 9/21/2005 at 15:30. After seeing three doctors she was diagnosed with polymyalgia rheumatica. The patient was taking Norvasc at the time of the vaccination. It is unknown if the patient recovered from these events at the time of this report. Follow up information received on 1/24/2006 from the patient. The patient reported that the day after receiving an injection of Fluzone, she woke up aching like she had the flu. She traveled and a pre planned trip from 10/13/2005 to 10/20/2005 and reported that she was in great pain and could not sleep at night. She was seen by a physician who prescribed Advil, which did not improve her symptoms. She reported that she had to be assisted out of chairs, the bus, etc. and that by the time she returned home she was home bound until she saw a rheumatologist and received the diagnosis of poly myalgia rheumatica. She reports that she is now taking prednisone and had had to add Norvasc to control her high blood pressure. It was not reported whether she has recovered from the events. Due to the new information provided on 1/24/2006, this case is being upgraded to serious (OMIC).
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Muscular weakness, Myalgia, Pain, Polymyalgia rheumatica
Clinical narrative: Initial report received on 11/3/2005 from a consumer. A 77 year old female patient who was currently taking Zestoretic, Toprol XL, 200 mg, Tricor, 160 mg and Synthroid 0.1mg at the time of the vaccination had received an administration (route site not reported) of Fluzone SV 2005-2006 USP lot number not reported on 9/21/2005. The next day she complained of muscle soreness, weakness and joint pain. The patient fells it is very severe in nature. She was evaluated by a physician and was prescribed methylprednisolone which slightly improved her conditions. The patient had some unspecified diagnostic testing completed to rule out rheumatoid arthritis. The patient had not recovered from these events at the time of the report. Follow up information received on 1/13/2006 from the patient. Per the reporter, the patient stated she developed muscle weakness and soreness the day after receiving an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1806AA, in the left deltoid on 9/21/2005 at 15:30. After seeing three doctors she was diagnosed with polymyalgia rheumatica. The patient was taking Norvasc at the time of the vaccination. It is unknown if the patient recovered from these events at the time of this report. Follow up information received on 1/24/2006 from the patient. The patient reported that the day after receiving an injection of Fluzone, she woke up aching like she had the flu. She traveled and a pre planned trip from 10/13/2005 to 10/20/2005 and reported that she was in great pain and could not sleep at night. She was seen by a physician who prescribed Advil, which did not improve her symptoms. She reported that she had to be assisted out of chairs, the bus, etc. and that by the time she returned home she was home bound until she saw a rheumatologist and received the diagnosis of poly myalgia rheumatica. She reports that she is now taking prednisone and had had to add Norvasc to control her high blood pressure. It was not reported whether she has recovered from the events. Due to the new information provided on 1/24/2006, this case is being upgraded to serious (OMIC).
Age: 0.5
Sex: M
Vaccine: HBHEPB
Symptoms: Drug ineffective, Meningitis
Clinical narrative: Information has been received from a physician concerning a 2 year old male with an inability to develop immunity after exposure to disease or vaccination who on 1/28/2004 was vaccinated with th first dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot 646074/0369N). On 3/26/2004 the patient was vaccinated with the second dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot 646074/0369N). On 05/28/2004 the patient was vaccinated with the third dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot 646446/0730N). It was reported that the child had not developed an immunity to Haemophilus influenza. The child had developed Haemophilus influenza meningitis in July 2004 and did not develop immunity even after that disease. the patient sough unspecified medical attention. The patient was hospitalized (dates unknown). The patient underwent serologic titers (date unknown). The physician believed that the child had a deficiency which prevented him from developing immunity. At the time of this report, the patient has not recovered from the event. The reporting physician considered the event to be serious (OMIC), due to hospitalization, immediately life threatening and disabling. additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Information has been received from a physician concerning a 71 year old female with hypertension 7/28/1999, hyperlipidaemia06/26/2001 and pneumoconiosis  1989 who on 1/7/2005 at approximately 11:00am, was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included benidipine hydrochloride (Coniel), pravastatin NA (mevalotin), vitamin E nicotinate (juvela N) and Clotiazepam (Rize). 11/7/2005, in the evening, the patient developed injection site swelling, warmth and redness with dull pain. on 11/08/2005 (previously reported as 11/7/2005) the patient developed general malaise.  On 11/10/2005 the injection site swelling, warmth, redness and dull pain and malaise were relieved. On that same day, the patient developed itching. On 11/18/2005, the patient recovered from the itching. The reporter felt that the injection site swelling, injection site warmth, injection site redness, dull pain and malaise were considered to be other important medical events (OMIC). he reporter felt that the injection site swelling, injection site warmth, injection site redness, dull pain and malaise were related to therapy with pneumococcal 23v polysaccharide vaccine. Additional information has been requested. Other business partner numbers include E200600132.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Information has been received from a physician concerning a 71 year old female with hypertension 7/28/1999, hyperlipidaemia06/26/2001 and pneumoconiosis  1989 who on 1/7/2005 at approximately 11:00am, was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included benidipine hydrochloride (Coniel), pravastatin NA (mevalotin), vitamin E nicotinate (juvela N) and Clotiazepam (Rize). 11/7/2005, in the evening, the patient developed injection site swelling, warmth and redness with dull pain. on 11/08/2005 (previously reported as 11/7/2005) the patient developed general malaise.  On 11/10/2005 the injection site swelling, warmth, redness and dull pain and malaise were relieved. On that same day, the patient developed itching. On 11/18/2005, the patient recovered from the itching. The reporter felt that the injection site swelling, injection site warmth, injection site redness, dull pain and malaise were considered to be other important medical events (OMIC). he reporter felt that the injection site swelling, injection site warmth, injection site redness, dull pain and malaise were related to therapy with pneumococcal 23v polysaccharide vaccine. Additional information has been requested. Other business partner numbers include E200600132.
Age: 1.33
Sex: M
Vaccine: FLU3, HBHEPB, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 16 month old male  with a history of osteomyelitis in the left leg who on 11/18/2005 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 646669/0626R). Concomitant vaccination that day included a third dose of Hib conj hepatitis B vaccine (lot 652710/0695R) given IM in the right thigh and a first dose of influenza virus split virion 3v vaccine inactivated (Fluzone) given IM in the left thigh. Illness at the time of vaccination was resolved OM. On 11/30/2005 the patients mother noted a marble size lump at the varicella virus vaccine live  injection site and a  swollen gland in his groin. The child was seen by the physician on 12/02/2005 with induration and redness at the injection site. The patient was treated with cephalexin (Keflex). At the time of the report the patient was recovering. There was no product quality complaint involved. Follow up information indicated that on 11/30/2005 the patient developed a lump at the injection site and swollen lymph node in the right groin without redness. On 12/01/2005 the lump at the injection site was red. On 12/02/2005 the patient had a 1x1 cm area of erythema with papule and 2-3 cm long x 1-2 cm wide induration and inguinal adenopathy. The patient had no temperature and was  treated with Keflex 250 TID x 10 days. No work up was done. On approximately 12/12/2005 the patient recovered. The patients events were considered to be other important medical events (OMIC). No further information is expected.
Age: 1.33
Sex: M
Vaccine: FLU3, HBHEPB, VARCEL
Symptoms: Lymphadenopathy, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 16 month old male  with a history of osteomyelitis in the left leg who on 11/18/2005 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 646669/0626R). Concomitant vaccination that day included a third dose of Hib conj hepatitis B vaccine (lot 652710/0695R) given IM in the right thigh and a first dose of influenza virus split virion 3v vaccine inactivated (Fluzone) given IM in the left thigh. Illness at the time of vaccination was resolved OM. On 11/30/2005 the patients mother noted a marble size lump at the varicella virus vaccine live  injection site and a  swollen gland in his groin. The child was seen by the physician on 12/02/2005 with induration and redness at the injection site. The patient was treated with cephalexin (Keflex). At the time of the report the patient was recovering. There was no product quality complaint involved. Follow up information indicated that on 11/30/2005 the patient developed a lump at the injection site and swollen lymph node in the right groin without redness. On 12/01/2005 the lump at the injection site was red. On 12/02/2005 the patient had a 1x1 cm area of erythema with papule and 2-3 cm long x 1-2 cm wide induration and inguinal adenopathy. The patient had no temperature and was  treated with Keflex 250 TID x 10 days. No work up was done. On approximately 12/12/2005 the patient recovered. The patients events were considered to be other important medical events (OMIC). No further information is expected.
Age: 0.5
Sex: M
Vaccine: MMR
Symptoms: Anger, Depression, Hepatocellular damage, Hypersensitivity, Irritability
Clinical narrative: MMR shot caused severe allergic reaction and extreme high fever of 105 degrees. Baby had permanent damage. Took too long to get fever down. Had reaction in Dr office. This was a happy baby, after shot was overly fussy, high fever, rash and became chronicly angry. Suffered liver damage. 60 Day Follow-up Information 16-MAY-2006: Physically yes. Mentally NO. This was a happy child. Now he is ANGRY. Easily upset, depressed. He is smart but has difficulty with reading. Why wasn't I informed of the RISKS BEFORE he was given shots? It should be a requirement to be educated on vaccines BEFORE the child is given any - say during pregnancy. Follow-up: He has liver damage, and his brain was affected. We hope he will learn to be happy. Even though some thing we did to his body without his permission (the shots) have caused permanent damage.
Age: 0.5
Sex: M
Vaccine: MMR
Symptoms: Nervous system disorder, Pyrexia, Rash, Reading disorder
Clinical narrative: MMR shot caused severe allergic reaction and extreme high fever of 105 degrees. Baby had permanent damage. Took too long to get fever down. Had reaction in Dr office. This was a happy baby, after shot was overly fussy, high fever, rash and became chronicly angry. Suffered liver damage. 60 Day Follow-up Information 16-MAY-2006: Physically yes. Mentally NO. This was a happy child. Now he is ANGRY. Easily upset, depressed. He is smart but has difficulty with reading. Why wasn't I informed of the RISKS BEFORE he was given shots? It should be a requirement to be educated on vaccines BEFORE the child is given any - say during pregnancy. Follow-up: He has liver damage, and his brain was affected. We hope he will learn to be happy. Even though some thing we did to his body without his permission (the shots) have caused permanent damage.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: CSF test abnormal, Coordination abnormal, Guillain-Barre syndrome, Hyporeflexia, Laboratory test abnormal
Clinical narrative: 12/17/2005 1st signs of nerve damage, 12/19/05 Dr visit no diagnosis, 12/21/05 Dr visit referred to neurologist, 12/22/05 Neurologist diagnosed GBS, 12/23/05 EMG Spinal Tap confirmed Guillain Barre Syndrome, 01/24/06 partially recovered. Information from medical records includes paresthesis, decreased reflexes, ataxia. msv