chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Hypertension, Hypoaesthesia, Insomnia, Irritability, Memory impairment
Clinical narrative: 1.Bronchitis 2. Insomnia 3. High Blood Pressure 4. Agitation, Anxiety, Depression 5. Joints and Muscles Aches 6. Abdominal pain/burning sensation 7. Conjunctivitis 8. Asthma 9. Constipation and Diarrhea 10. Hemorrhoids, Rectal bleeding 11. Angry, Irritable Mood 12. Pain on my groin, knees and hip, lower back, legs 13. Cysts developed 14. Blurred Vision, pain eye 15. Walking with difficulty 16. Numbness and tingling on legs and arms 17. Trouble remembering recent information, bad memory 18. Unable to perform multiple tasks simultaneously, confusion, disorientation 19. Inappropriately sweating 20. Respiratory problems
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia, Paraesthesia, Rectal haemorrhage, Respiratory disorder, Skin burning sensation
Clinical narrative: 1.Bronchitis 2. Insomnia 3. High Blood Pressure 4. Agitation, Anxiety, Depression 5. Joints and Muscles Aches 6. Abdominal pain/burning sensation 7. Conjunctivitis 8. Asthma 9. Constipation and Diarrhea 10. Hemorrhoids, Rectal bleeding 11. Angry, Irritable Mood 12. Pain on my groin, knees and hip, lower back, legs 13. Cysts developed 14. Blurred Vision, pain eye 15. Walking with difficulty 16. Numbness and tingling on legs and arms 17. Trouble remembering recent information, bad memory 18. Unable to perform multiple tasks simultaneously, confusion, disorientation 19. Inappropriately sweating 20. Respiratory problems
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Vision blurred
Clinical narrative: 1.Bronchitis 2. Insomnia 3. High Blood Pressure 4. Agitation, Anxiety, Depression 5. Joints and Muscles Aches 6. Abdominal pain/burning sensation 7. Conjunctivitis 8. Asthma 9. Constipation and Diarrhea 10. Hemorrhoids, Rectal bleeding 11. Angry, Irritable Mood 12. Pain on my groin, knees and hip, lower back, legs 13. Cysts developed 14. Blurred Vision, pain eye 15. Walking with difficulty 16. Numbness and tingling on legs and arms 17. Trouble remembering recent information, bad memory 18. Unable to perform multiple tasks simultaneously, confusion, disorientation 19. Inappropriately sweating 20. Respiratory problems
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Tetanus shot given 1/31/06. Donor stated arm redness and rash appeared to upper right arm starting on 2/1/06. States area itches. Small open area to upper right arm, unk if it was the injection site. Rash is just above antecubital area and appears to be rectangular in shape and doesn't extend into deltoid area.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Cerebrovascular accident, Hypersensitivity, Hypoaesthesia, Throat tightness, Tongue disorder
Clinical narrative: Had Hep B at 3:30 pm.  At 9:15pm tongue thick feeling, right side face numb feeling and throat felt like closing up. Went to ER and Dr. said didn't think allergic reaction but neuro or mini stroke.  Pt was given IV and 4 baby aspirin.  Another ER doctor said possible allergic reaction.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Mom reports fever 105 within 24hrs after receiving DTap, IPV, Hep B-Pediarix, Prevnar & Hib vaccines.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Erythema L arm.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Possible chicken pox after vaccination.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Injection site rash, Rash macular
Clinical narrative: Macular papular rash on chest, collar area and upper arm, at deltoid area.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Unevaluable event
Clinical narrative: none
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt referred for eval of smallpox vaccine site. Vaccinated approximately 9 days ago. Positive erythema, warmth, induration approximately 2 in around site. Negative for pus/discharge.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Hypokinesia, Pain
Clinical narrative: Left Deltoid. Arm was very sore and hard to move. Area where vaccine administered was "size of a grapefruit" according to home nurse.  Area was bruised and remained bruised at the 10 day mark.  Pt was seen by her PCP who stated it was fine and no treatment needed.  Area resolved itself.  Pt stated was not on coumadin.
Age: 64.0
Sex: F
Vaccine: HEP, HEPA, TTOX, YF
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Severe allergic reaction including widespread hives starting immediately after vaccines and increasing in intensity.
Age: 1.27
Sex: M
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Local rx to varicella open vesicle Left thigh at documented injection site no induration and no erythema.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Injection site warmth
Clinical narrative: Left upper arm inferiously with 11.0 X 9.0 C erythema with mild increased warmth, only slight induration at superior aspect.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Bronchitis, Irritability, Pneumonia, Somnolence
Clinical narrative: Patient received 5 shots at routine well child visit on 10/27/05. She was fussy the rest of the day and slept all day on the 25th awakening only to eat, The mother treated the child with Tylenol cold drops for infants. 2/23/06 Received medical records from PCP.  2/23/06 Received Autopsy Report which states COD is Acute bronchopneumonia./ss
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Dizziness, Infection, Myalgia, Neck pain
Clinical narrative: Pt. complained of achy pain in back and neck on day following vaccine.  No headache, no fever, no sore throat, no weakness, no numbness. +/- dizzy only on awakening. Exam negative except for mild paraspinous. Muscle tenderness in lumbar region both. DTR 1-2t/=B, MS B/S throughout.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Epilepsy, Laboratory test abnormal
Clinical narrative: 1-3-06 seizure in mild duration seen in office 1-4-06, 1-10-06 EEG done-abnormal EEG findings potentially epileptiform
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chills, Erythema, Headache, Influenza like illness, Injection site pustule
Clinical narrative: 6 days after Smallpox vaccine was given pt returned c/o flu like symptoms.  Symptoms included fevers/chills, nausea, body aches, headache and mild rhinorrhea.  No sore throat, cough.  Pt had fever of 100.9 and HR of 120.  Other VS wnl.  Normal exam exam white pustule at vaccination site.  Small axillary node on vaccination arm.  Mild tonsillar erythema.  Normal neuro exam and resp and cards exam.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Nausea, Pain, Pyrexia, Rhinorrhoea, Skin nodule
Clinical narrative: 6 days after Smallpox vaccine was given pt returned c/o flu like symptoms.  Symptoms included fevers/chills, nausea, body aches, headache and mild rhinorrhea.  No sore throat, cough.  Pt had fever of 100.9 and HR of 120.  Other VS wnl.  Normal exam exam white pustule at vaccination site.  Small axillary node on vaccination arm.  Mild tonsillar erythema.  Normal neuro exam and resp and cards exam.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pericarditis
Clinical narrative: 6 days after Smallpox vaccine was given pt returned c/o flu like symptoms.  Symptoms included fevers/chills, nausea, body aches, headache and mild rhinorrhea.  No sore throat, cough.  Pt had fever of 100.9 and HR of 120.  Other VS wnl.  Normal exam exam white pustule at vaccination site.  Small axillary node on vaccination arm.  Mild tonsillar erythema.  Normal neuro exam and resp and cards exam.
Age: 1.03
Sex: M
Vaccine: MU, VARCEL
Symptoms: Pyrexia, Skin ulcer, Viral infection
Clinical narrative: >25 lesions various stages, temp>100. Diagnosis: Varicella  Treatment: none
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Viral infection
Clinical narrative: "Clear blisters, now cloudy with erythematous bases." Diagnosis: Varicella Treatment: None
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Pyrexia, Viral infection
Clinical narrative: Temp 101.3, widespread vesicles.  Diagnosis: Varicella Treatment: Acyclovir
Age: 1.01
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: About 12 lesions, trunk mostly.  One on head.  Diagnosis: Varicella  Treatment: Symptomatic
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Skin ulcer, Viral infection
Clinical narrative: Fever > 100 degrees.  Vesicular lesion all over body including scalp and ear canal in varying stages of development.  Diagnosis: Varicella; Treatment: Acyclovir
Age: 50.0
Sex: F
Vaccine: HIBV
Symptoms: Balance disorder, Dyspnoea, Palpitations
Clinical narrative: dysebeuilibrium, palpitations, shortness of breath- lasted 10minutes
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL, FLU3, MMR, PNC, VARCEL
Symptoms: Blood gases abnormal, Candidiasis, Dermatitis bullous, Eye discharge, Haematocrit decreased
Clinical narrative: Information has been received from a physician concerning a 12 month old male with an allergy to amoxicillin (+) clavulanate potassium (Augmentin) who on 21-Oct-2005 was vaccinated in the right thigh with a first dose of varicella virus vaccine live. Concomitant vaccinations administered that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a dose of influenza virus split virion 3v vaccine inactivated (Fluzone), and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. Subsequently, the patient developed a small amount of lesions on the body and a fever elevated to 105 degrees Fahrenheit. The patient was taken to the hospital and administered antibiotics. Laboratory studies were performed (results not provided). The patient subsequently recovered. It was noted that it was not known what vaccine caused the events. A product quality complaint was not involved. Follow-up information from the physician indicated that on 01-Nov-2005 papulopustular lesions developed around the injection site. The patient's fever started three days ago, on 04-Nov-2005. It was to 102 F. The patient also had gunky eyes. On 04-Nov-2005 and 05-Nov-2005 the patient's temperature was at 103.5 F. On 06-Nov-2005 the patient's fever was 105.2 F. He was then sent to the emergency room and started on azithromycin (Zithromax). It was noted that the patient was on therapy with cetirizine hydrochloride (Zyrtec). Laboratory test were performed, abnormal results were as follows: C reactive protein was 12.4 mg/dl (high), white blood cell count was 20.7 (high), red blood cell count was 3.79 (low), hemoglobin was 10.2 (low), hematocrit was 29.8 (low), and RDW was 15.6 (high). A strep scream was negative. On 07-Nov-2005 the patient was seen in the physician's office. He had a cluster of lesions at the injection site of the vaccine on the right thigh "x 1 week," and one pustule on neck "x several days. Upon exam the patient had thrush on the buccal mucosa (both sides) and on the left tonsil. It was noted that he had been on amoxicillin (+) clavulanate potassium (Augmentin) since 28-Oct-2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. Assessment of the patient indicated fever, vaccine -type varicella and thrush. The plan from the physician included reassurance, "flu for fever > 5 days," and nystatin. There was no mention of hospitalization. The patient's adverse events were determined to be other important medical events by the physician (OMIC). Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL, FLU3, MMR, PNC, VARCEL
Symptoms: Haemoglobin decreased, Injection site reaction, Laboratory test abnormal, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 12 month old male with an allergy to amoxicillin (+) clavulanate potassium (Augmentin) who on 21-Oct-2005 was vaccinated in the right thigh with a first dose of varicella virus vaccine live. Concomitant vaccinations administered that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a dose of influenza virus split virion 3v vaccine inactivated (Fluzone), and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. Subsequently, the patient developed a small amount of lesions on the body and a fever elevated to 105 degrees Fahrenheit. The patient was taken to the hospital and administered antibiotics. Laboratory studies were performed (results not provided). The patient subsequently recovered. It was noted that it was not known what vaccine caused the events. A product quality complaint was not involved. Follow-up information from the physician indicated that on 01-Nov-2005 papulopustular lesions developed around the injection site. The patient's fever started three days ago, on 04-Nov-2005. It was to 102 F. The patient also had gunky eyes. On 04-Nov-2005 and 05-Nov-2005 the patient's temperature was at 103.5 F. On 06-Nov-2005 the patient's fever was 105.2 F. He was then sent to the emergency room and started on azithromycin (Zithromax). It was noted that the patient was on therapy with cetirizine hydrochloride (Zyrtec). Laboratory test were performed, abnormal results were as follows: C reactive protein was 12.4 mg/dl (high), white blood cell count was 20.7 (high), red blood cell count was 3.79 (low), hemoglobin was 10.2 (low), hematocrit was 29.8 (low), and RDW was 15.6 (high). A strep scream was negative. On 07-Nov-2005 the patient was seen in the physician's office. He had a cluster of lesions at the injection site of the vaccine on the right thigh "x 1 week," and one pustule on neck "x several days. Upon exam the patient had thrush on the buccal mucosa (both sides) and on the left tonsil. It was noted that he had been on amoxicillin (+) clavulanate potassium (Augmentin) since 28-Oct-2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. Assessment of the patient indicated fever, vaccine -type varicella and thrush. The plan from the physician included reassurance, "flu for fever > 5 days," and nystatin. There was no mention of hospitalization. The patient's adverse events were determined to be other important medical events by the physician (OMIC). Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL, FLU3, MMR, PNC, VARCEL
Symptoms: Candidiasis, Eye discharge, Haematocrit decreased, Haemoglobin decreased, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 12 month old male with an allergy to amoxicillin (+) clavulanate potassium (Augmentin) who on 21-Oct-2005 was vaccinated in the right thigh with a first dose of varicella virus vaccine live. Concomitant vaccinations administered that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a dose of influenza virus split virion 3v vaccine inactivated (Fluzone), and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. Subsequently, the patient developed a small amount of lesions on the body and a fever elevated to 105 degrees Fahrenheit. The patient was taken to the hospital and administered antibiotics. Laboratory studies were performed (results not provided). The patient subsequently recovered. It was noted that it was not known what vaccine caused the events. A product quality complaint was not involved. Follow-up information from the physician indicated that on 01-Nov-2005 papulopustular lesions developed around the injection site. The patient's fever started three days ago, on 04-Nov-2005. It was to 102 F. The patient also had gunky eyes. On 04-Nov-2005 and 05-Nov-2005 the patient's temperature was at 103.5 F. On 06-Nov-2005 the patient's fever was 105.2 F. He was then sent to the emergency room and started on azithromycin (Zithromax). It was noted that the patient was on therapy with cetirizine hydrochloride (Zyrtec). Laboratory test were performed, abnormal results were as follows: C reactive protein was 12.4 mg/dl (high), white blood cell count was 20.7 (high), red blood cell count was 3.79 (low), hemoglobin was 10.2 (low), hematocrit was 29.8 (low), and RDW was 15.6 (high). A strep scream was negative. On 07-Nov-2005 the patient was seen in the physician's office. He had a cluster of lesions at the injection site of the vaccine on the right thigh "x 1 week," and one pustule on neck "x several days. Upon exam the patient had thrush on the buccal mucosa (both sides) and on the left tonsil. It was noted that he had been on amoxicillin (+) clavulanate potassium (Augmentin) since 28-Oct-2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. Assessment of the patient indicated fever, vaccine -type varicella and thrush. The plan from the physician included reassurance, "flu for fever > 5 days," and nystatin. There was no mention of hospitalization. The patient's adverse events were determined to be other important medical events by the physician (OMIC). Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL, FLU3, MMR, PNC, VARCEL
Symptoms: Injection site reaction, Laboratory test abnormal, Pyrexia, Rash papular, Rash pustular
Clinical narrative: Information has been received from a physician concerning a 12 month old male with an allergy to amoxicillin (+) clavulanate potassium (Augmentin) who on 21-Oct-2005 was vaccinated in the right thigh with a first dose of varicella virus vaccine live. Concomitant vaccinations administered that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a dose of influenza virus split virion 3v vaccine inactivated (Fluzone), and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. Subsequently, the patient developed a small amount of lesions on the body and a fever elevated to 105 degrees Fahrenheit. The patient was taken to the hospital and administered antibiotics. Laboratory studies were performed (results not provided). The patient subsequently recovered. It was noted that it was not known what vaccine caused the events. A product quality complaint was not involved. Follow-up information from the physician indicated that on 01-Nov-2005 papulopustular lesions developed around the injection site. The patient's fever started three days ago, on 04-Nov-2005. It was to 102 F. The patient also had gunky eyes. On 04-Nov-2005 and 05-Nov-2005 the patient's temperature was at 103.5 F. On 06-Nov-2005 the patient's fever was 105.2 F. He was then sent to the emergency room and started on azithromycin (Zithromax). It was noted that the patient was on therapy with cetirizine hydrochloride (Zyrtec). Laboratory test were performed, abnormal results were as follows: C reactive protein was 12.4 mg/dl (high), white blood cell count was 20.7 (high), red blood cell count was 3.79 (low), hemoglobin was 10.2 (low), hematocrit was 29.8 (low), and RDW was 15.6 (high). A strep scream was negative. On 07-Nov-2005 the patient was seen in the physician's office. He had a cluster of lesions at the injection site of the vaccine on the right thigh "x 1 week," and one pustule on neck "x several days. Upon exam the patient had thrush on the buccal mucosa (both sides) and on the left tonsil. It was noted that he had been on amoxicillin (+) clavulanate potassium (Augmentin) since 28-Oct-2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. Assessment of the patient indicated fever, vaccine -type varicella and thrush. The plan from the physician included reassurance, "flu for fever > 5 days," and nystatin. There was no mention of hospitalization. The patient's adverse events were determined to be other important medical events by the physician (OMIC). Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL, FLU3, MMR, PNC, VARCEL
Symptoms: Skin disorder, Skin ulcer, Viral infection, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 12 month old male with an allergy to amoxicillin (+) clavulanate potassium (Augmentin) who on 21-Oct-2005 was vaccinated in the right thigh with a first dose of varicella virus vaccine live. Concomitant vaccinations administered that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a dose of influenza virus split virion 3v vaccine inactivated (Fluzone), and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. Subsequently, the patient developed a small amount of lesions on the body and a fever elevated to 105 degrees Fahrenheit. The patient was taken to the hospital and administered antibiotics. Laboratory studies were performed (results not provided). The patient subsequently recovered. It was noted that it was not known what vaccine caused the events. A product quality complaint was not involved. Follow-up information from the physician indicated that on 01-Nov-2005 papulopustular lesions developed around the injection site. The patient's fever started three days ago, on 04-Nov-2005. It was to 102 F. The patient also had gunky eyes. On 04-Nov-2005 and 05-Nov-2005 the patient's temperature was at 103.5 F. On 06-Nov-2005 the patient's fever was 105.2 F. He was then sent to the emergency room and started on azithromycin (Zithromax). It was noted that the patient was on therapy with cetirizine hydrochloride (Zyrtec). Laboratory test were performed, abnormal results were as follows: C reactive protein was 12.4 mg/dl (high), white blood cell count was 20.7 (high), red blood cell count was 3.79 (low), hemoglobin was 10.2 (low), hematocrit was 29.8 (low), and RDW was 15.6 (high). A strep scream was negative. On 07-Nov-2005 the patient was seen in the physician's office. He had a cluster of lesions at the injection site of the vaccine on the right thigh "x 1 week," and one pustule on neck "x several days. Upon exam the patient had thrush on the buccal mucosa (both sides) and on the left tonsil. It was noted that he had been on amoxicillin (+) clavulanate potassium (Augmentin) since 28-Oct-2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. Assessment of the patient indicated fever, vaccine -type varicella and thrush. The plan from the physician included reassurance, "flu for fever > 5 days," and nystatin. There was no mention of hospitalization. The patient's adverse events were determined to be other important medical events by the physician (OMIC). Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Information has been received from a registered pharmacist concerning a 51 year old male with history of psychiatric issues, history of seizures "that occurred a long time ago" who "one week ago" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5 ml), intramuscularly. Subsequently, the patient experienced seizures. The patient was treated with levetiracetam (KEPRA), and "is much better now." The reporter considered seizures to be other important medical event (OMIC). Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Bacterial infection, Drug ineffective, Immunoglobulins decreased, Laboratory test abnormal, Meningitis
Clinical narrative: Information has been received from a published literature article concerning a 7/12 year old male who was vaccinated with Pneumococcal 23v polysaccharide vaccine and varicella virus vaccine live (date unknown). On an unspecified date, the patient developed neutropenia, x linked agammaglobulinemia, streptococcus pneumonia (serotype 18F) meningitis, pneumonia, varicella titer was negative and he did not developed antibody responses to diphtheria, tetanus and pneumococcal antigens. At the time of this report, the outcome of the events were unknown. the literature article reads as follows A well developed, well nourished 7 1/2 year old male was diagnosed with X linked agammaglobulinemia XLA in 2003 by mutation analysis. He was brought to us for follow up and intravenous immunoglobulin IVIG therapy. He had streptococcus pneumonia serotype 18F meningitis at 4 years of age, He had only 2 confirmed episodes of pneumonia, in different areas of the lung at 5 years of age. immunization are up to date including pneumococcal polysaccharide vaccine. Family history was negative for immunological disorders. IVIG was started in NOV 2002 and discontinued due to family relocation in July 2004. He remained free of infections although his IVIG replacement was discontinued for the last 8 months. The patient has been effectively prevented from opportunistic infections with prophylactic TMP SMX. In contrast to the literature, his constant neutropenia was not associated with infections and moreover, neutropenia persisted under IVIG therapy. White blood cell was 3500 ul and absolute neutrophil count ANC was 1200 ul in the last visit. However, he had at least two documented ANC of lest than 1000ul. The patient has low IgG, IgA, IgG1, IgG2 levels and B cell count 1%, but normal IgM, IgE, IgG3, IgG4 levels and T/NK cell counts. Lymphocyte responses to mitogens PHA and Con A and Candida were absent, but response to PWM and tetanus was normal. He did not develop antibody responses to diphtheria, tetanus and pneumococcal antigens. Varicella titer was negative after immunization. BTK mutation BTK Exon 5, G 503T, Trp 124 Leu affecting the PH domain was identified on platelets by flow cytometry. Upon internal review, the streptococcus pneumonia serotype 18F meningitis was considered to be an other important medical event (OMIC). No further information is available. A copy of the published literature article is attached as further documentation of the patients experience.
Age: 7.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Neutropenia, Pneumonia, White blood cell count decreased
Clinical narrative: Information has been received from a published literature article concerning a 7/12 year old male who was vaccinated with Pneumococcal 23v polysaccharide vaccine and varicella virus vaccine live (date unknown). On an unspecified date, the patient developed neutropenia, x linked agammaglobulinemia, streptococcus pneumonia (serotype 18F) meningitis, pneumonia, varicella titer was negative and he did not developed antibody responses to diphtheria, tetanus and pneumococcal antigens. At the time of this report, the outcome of the events were unknown. the literature article reads as follows A well developed, well nourished 7 1/2 year old male was diagnosed with X linked agammaglobulinemia XLA in 2003 by mutation analysis. He was brought to us for follow up and intravenous immunoglobulin IVIG therapy. He had streptococcus pneumonia serotype 18F meningitis at 4 years of age, He had only 2 confirmed episodes of pneumonia, in different areas of the lung at 5 years of age. immunization are up to date including pneumococcal polysaccharide vaccine. Family history was negative for immunological disorders. IVIG was started in NOV 2002 and discontinued due to family relocation in July 2004. He remained free of infections although his IVIG replacement was discontinued for the last 8 months. The patient has been effectively prevented from opportunistic infections with prophylactic TMP SMX. In contrast to the literature, his constant neutropenia was not associated with infections and moreover, neutropenia persisted under IVIG therapy. White blood cell was 3500 ul and absolute neutrophil count ANC was 1200 ul in the last visit. However, he had at least two documented ANC of lest than 1000ul. The patient has low IgG, IgA, IgG1, IgG2 levels and B cell count 1%, but normal IgM, IgE, IgG3, IgG4 levels and T/NK cell counts. Lymphocyte responses to mitogens PHA and Con A and Candida were absent, but response to PWM and tetanus was normal. He did not develop antibody responses to diphtheria, tetanus and pneumococcal antigens. Varicella titer was negative after immunization. BTK mutation BTK Exon 5, G 503T, Trp 124 Leu affecting the PH domain was identified on platelets by flow cytometry. Upon internal review, the streptococcus pneumonia serotype 18F meningitis was considered to be an other important medical event (OMIC). No further information is available. A copy of the published literature article is attached as further documentation of the patients experience.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Dysphagia, Pharyngeal oedema
Clinical narrative: Information has been received from a physician concerning a 36 year old female with hypertension, fibromyalgia and questionable allergy to penicillin from childhood who on 1/20/2006 was vaccinated IM in the deltoid with the first 0.5ml dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy included labetalol HCL and cyclobenzaprine HCL Flexeril. The physician reported that in the middle of the night on 1/21/2006, the patient awoke with difficulty swallowing. The patient went to the ER, was diagnosed with uvula swelling and was treated with prednisone and amoxicillin. The patient was subsequently discharged from the ER after receiving treatment. On 1/23/2006, the patients uvula swelling resolved. The reporting physician considered the uvula swelling to be immediately life threatening and an other important medical event (OMIC). Additional information has been requested.
Age: 1.39
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: 02/1/06, 1 week after vaccines child broke out in blister like rash on hands, feet, mouth & legs. ED visit and treated with Benadryl and Tylenol. Fever.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Crying, Erythema, Feeling hot, Irritability
Clinical narrative: Parents took child to hospital with complaints of increased irritability and high pitched crying since receiving immunization.  Left thigh red and warm.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: 10 days after immunizations patient had FUO and febrile seizure.  We would like recommendations about giving MMR booster at age 5 years.
Age: 48.0
Sex: F
Vaccine: TTOX
Symptoms: Fatigue, Injection site pain, Sleep disorder, Swelling
Clinical narrative: FYI -- tetanus shot made me excessively tired for a couple days and caused mild swelling in my arm. Since then, I have had intermittent deep pain at the injection site. The pain is enough to wake me up, but not enough to necessitate using pain killers (I use a heating pad).
Age: 2.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error
Clinical narrative: Menactra vaccine was administered instead of Flu shot.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Thermal burn, Urticaria
Clinical narrative: ~11;30 Patient was given Dtap, IPV, in her left deltoid and MMR (SQ) in right deltoid by nurse. After the shots the patient complained of "burning" at the injection site.  The nurse noted some redness and rash around the site. 11:35 The nurse notified the doctor who examined the patient who at that point was audibly wheezing, the injection sites were red, and swollen and she had several hives on her body.  MD order a albuterol nebulizer,and  Benadryl Liquid 25mg.  Patient was closely monitored.   ~11:50 Wheezing resolved, redness at sites still present and 1-2 new hives noted on abdomen. 13:00 Patient sent home with instructions to give Benadryl every 6 hours and call if symptoms return or worsen. No wheezing noted when sent home, redness still at injection sites. Patient does have a history of previous reaction to unknow substance several days prior but no history of problems with immunizations. Patient also had nasal congested with cough prior to immunization. No fever noted or reported at home.   Patient also has a history of asthma.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Wheezing
Clinical narrative: ~11;30 Patient was given Dtap, IPV, in her left deltoid and MMR (SQ) in right deltoid by nurse. After the shots the patient complained of "burning" at the injection site.  The nurse noted some redness and rash around the site. 11:35 The nurse notified the doctor who examined the patient who at that point was audibly wheezing, the injection sites were red, and swollen and she had several hives on her body.  MD order a albuterol nebulizer,and  Benadryl Liquid 25mg.  Patient was closely monitored.   ~11:50 Wheezing resolved, redness at sites still present and 1-2 new hives noted on abdomen. 13:00 Patient sent home with instructions to give Benadryl every 6 hours and call if symptoms return or worsen. No wheezing noted when sent home, redness still at injection sites. Patient does have a history of previous reaction to unknow substance several days prior but no history of problems with immunizations. Patient also had nasal congested with cough prior to immunization. No fever noted or reported at home.   Patient also has a history of asthma.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Rash all over body, headache, low-grade fever, all symptoms started 6 days after vaccination.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Lymphadenopathy, Malaise, Myalgia, Pyrexia
Clinical narrative: Patient states that about 12 hours after receiving vaccine she began feeling ill with swollen glands in neck, fatigue, muscle aches, and fever.  States she felt perfectly healthy prior to vaccine, and when she returned to relate this information two and a half days after receiving vaccine she said she still felt ill.
Age: 0.19
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Convulsion, Erythema, Haemorrhage intracranial, Rash, Screaming
Clinical narrative: 4 hours after her shots she cried for 12 hours straight!  This was not normal crying but hard screaming.  Her leg was very swollen and beat red.  She developed a rash 2 days later.  Her crying continued for a month straight, she cried all day and all night.  24 hours after the shots she had a seizure.  3 weeks later she had an intracranial bleed.  By this time she had about 6 seizures and the day of the bleed she was having them every 3-6 minutes.  Also her ventricles were swollen.
Age: 0.19
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Swelling
Clinical narrative: 4 hours after her shots she cried for 12 hours straight!  This was not normal crying but hard screaming.  Her leg was very swollen and beat red.  She developed a rash 2 days later.  Her crying continued for a month straight, she cried all day and all night.  24 hours after the shots she had a seizure.  3 weeks later she had an intracranial bleed.  By this time she had about 6 seizures and the day of the bleed she was having them every 3-6 minutes.  Also her ventricles were swollen.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Seen for a 4 month well child care visit on the morning of 3/15/04.  Developed fever and seizure requiring ER visit at 8:30pm on 3/15/04.   Has had subsequent diagnosis of seizure disorder and has required the care of a neurologist.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site warmth, Pain, Swelling
Clinical narrative: Child's arm swelled up, became hot, and painful to touch.  Mother called regarding reaction on Saturday 2/4/06.  RN on call instructed mother to take the child to ER.   RN administering vaccine called mother on Monday, 2/6/06, regarding the ER findings.  Child was placed on Cephalexin and is to see his regular physician on Wednesday, 2/8/06.  Mother was giving the antibiotic, using hot packs, and Tylenol for comfort.
Age: 3.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Feeling hot, Injection site induration, Pain, Tenderness
Clinical narrative: L arm was red and painful the day after shot was given (MMR); 2cm erythema, 1.5 cm induration, warm, tender; no streaks; no increased lymph nodes
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Rash macular
Clinical narrative: Blotchy red skin where shots were received in arms.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Convulsion, Postictal state
Clinical narrative: As soon as the I/M vaccine was administered-within 1-2 seconds Pt became tense and went into a generalized tonic seizure lasting about 3.5 minutes.  Pt vital signs remained stable.  She was post icteal after treatment.  She was sent to ER via paramedics.
Age: 52.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site abscess, Injection site induration
Clinical narrative: Seriousness Criteria: Other - Medically Significant (OMIC). A 53 year old female patient received an intra-muscular injection of Decavac, lot number U1587AA, in the left deltoid on 11/Jan/2006. Five days later, the patient developed a "hard knob" at the injection site. She treated the area with ice. On 18/Jan/2006, the patient was seen in an emergency room. An incision and drainage of the site was done, and the patient was diagnosed with an abscess of the left deltoid. She was treated with IV Zosyn and Keflex for ten days. She subsequently recovered.
Age: 52.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site abscess, Injection site mass
Clinical narrative: Seriousness Criteria: Other - Medically Significant (OMIC). A 53 year old female patient received an intra-muscular injection of Decavac, lot number U1587AA, in the left deltoid on 11/Jan/2006. Five days later, the patient developed a "hard knob" at the injection site. She treated the area with ice. On 18/Jan/2006, the patient was seen in an emergency room. An incision and drainage of the site was done, and the patient was diagnosed with an abscess of the left deltoid. She was treated with IV Zosyn and Keflex for ten days. She subsequently recovered.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Alpha-2 macroglobulin increased, Cast application, Gross motor delay, Injection site joint pain, Injection site swelling
Clinical narrative: Approximately 1 week following immunization patient developed left knee pain, swelling and unable to extend knee fully. Symptoms worsened and she developed severe contractures requiring serial casting to strengthen leg. Currently not ambulating with pain/weakness of left knee. We ruled out neurologic, rheumatologic, ortho causes. She continue with casting and physical therapy. 3/30/06 Received partial medical records from provider which reveal normal labs & x-ray of leg revealed femoral shaft turned more outward.  Referred to ped ortho at another facility.   5/8/06 Received medical records from second facility which revealed patient developed hamstring contracture.  Eval by Rheumatologist, Orthopedics & neurologist as well as PT & serial casting.MRI & x-rays of left leg were WNL.  60 Day Follow-up Information 02-MAY-2006: Persistent knee pain/decreased range of motion. Not ambulating well. Improving minimally with Physical Therapy but unlikely to recover completely. Mild delayed gross motor milestones. Not jumping, but now walking and running appropiate for age.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Joint range of motion decreased, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Rheumatoid factor negative, Spinal X-ray normal
Clinical narrative: Approximately 1 week following immunization patient developed left knee pain, swelling and unable to extend knee fully. Symptoms worsened and she developed severe contractures requiring serial casting to strengthen leg. Currently not ambulating with pain/weakness of left knee. We ruled out neurologic, rheumatologic, ortho causes. She continue with casting and physical therapy. 3/30/06 Received partial medical records from provider which reveal normal labs & x-ray of leg revealed femoral shaft turned more outward.  Referred to ped ortho at another facility.   5/8/06 Received medical records from second facility which revealed patient developed hamstring contracture.  Eval by Rheumatologist, Orthopedics & neurologist as well as PT & serial casting.MRI & x-rays of left leg were WNL.  60 Day Follow-up Information 02-MAY-2006: Persistent knee pain/decreased range of motion. Not ambulating well. Improving minimally with Physical Therapy but unlikely to recover completely. Mild delayed gross motor milestones. Not jumping, but now walking and running appropiate for age.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Walking disability, X-ray limb abnormal, X-ray of pelvis and hip abnormal
Clinical narrative: Approximately 1 week following immunization patient developed left knee pain, swelling and unable to extend knee fully. Symptoms worsened and she developed severe contractures requiring serial casting to strengthen leg. Currently not ambulating with pain/weakness of left knee. We ruled out neurologic, rheumatologic, ortho causes. She continue with casting and physical therapy. 3/30/06 Received partial medical records from provider which reveal normal labs & x-ray of leg revealed femoral shaft turned more outward.  Referred to ped ortho at another facility.   5/8/06 Received medical records from second facility which revealed patient developed hamstring contracture.  Eval by Rheumatologist, Orthopedics & neurologist as well as PT & serial casting.MRI & x-rays of left leg were WNL.  60 Day Follow-up Information 02-MAY-2006: Persistent knee pain/decreased range of motion. Not ambulating well. Improving minimally with Physical Therapy but unlikely to recover completely. Mild delayed gross motor milestones. Not jumping, but now walking and running appropiate for age.
Age: 43.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Aldolase normal, Blood creatine phosphokinase normal, Blood folate normal, Blood glucose decreased, Blood thyroid stimulating hormone decreased
Clinical narrative: 1. Cognitive Dysfunction - decreased concentration increased effort to retain and understand when he reads, hard to focus. Now it is also with any exertion like mowing the lawn. Worse when working out. Still trying to run. Increased time to recover. Also after eating associated visual disturbance with the above.  2. Sleep Disturbance - sleeps 8 hours/night  - wakes up - 2x night, has night sweats 2-3x week, does not awaken refreshed. 3. Myalgias - generalized muscles pain effecting thighs, forearms, calf, neck, back. Low level irritating 2-3 constant, works through it.  4. Fatigue - constantly tired, naps during day if able, feels need to sleep early in the evening. 5. Chronic Rhinitis - constant post nasal drip irritating constant flow that sometimes causes. Also sometimes has to sit down in the shower hoarseness. Causes cough if exercising, which leaves him with cough the next day.  6. Paresthesias - mild tingling in fingers and toes that started in last couple months. 7. Tension Headache, mild- manifests in pressure in frontal region, is with problem #! and made worse after exercise and eating. Follow-up Information 09-OCT-2007: Progressive chronic rhinitis, fatigue, myalgias, cognitive dysfunction, scintillating scotomas. Follow-up Information 09-OCT-2007: Diagnosed with Chronic Fatigue Syndrome after extensive workup at a hospital and clinic.
Age: 43.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: C-reactive protein decreased, CSF glucose normal, CSF immunoglobulin increased, CSF protein normal, CSF test normal
Clinical narrative: 1. Cognitive Dysfunction - decreased concentration increased effort to retain and understand when he reads, hard to focus. Now it is also with any exertion like mowing the lawn. Worse when working out. Still trying to run. Increased time to recover. Also after eating associated visual disturbance with the above.  2. Sleep Disturbance - sleeps 8 hours/night  - wakes up - 2x night, has night sweats 2-3x week, does not awaken refreshed. 3. Myalgias - generalized muscles pain effecting thighs, forearms, calf, neck, back. Low level irritating 2-3 constant, works through it.  4. Fatigue - constantly tired, naps during day if able, feels need to sleep early in the evening. 5. Chronic Rhinitis - constant post nasal drip irritating constant flow that sometimes causes. Also sometimes has to sit down in the shower hoarseness. Causes cough if exercising, which leaves him with cough the next day.  6. Paresthesias - mild tingling in fingers and toes that started in last couple months. 7. Tension Headache, mild- manifests in pressure in frontal region, is with problem #! and made worse after exercise and eating. Follow-up Information 09-OCT-2007: Progressive chronic rhinitis, fatigue, myalgias, cognitive dysfunction, scintillating scotomas. Follow-up Information 09-OCT-2007: Diagnosed with Chronic Fatigue Syndrome after extensive workup at a hospital and clinic.
Age: 43.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest X-ray normal, Chronic fatigue syndrome, Cognitive disorder, Cognitive disorder, Cough
Clinical narrative: 1. Cognitive Dysfunction - decreased concentration increased effort to retain and understand when he reads, hard to focus. Now it is also with any exertion like mowing the lawn. Worse when working out. Still trying to run. Increased time to recover. Also after eating associated visual disturbance with the above.  2. Sleep Disturbance - sleeps 8 hours/night  - wakes up - 2x night, has night sweats 2-3x week, does not awaken refreshed. 3. Myalgias - generalized muscles pain effecting thighs, forearms, calf, neck, back. Low level irritating 2-3 constant, works through it.  4. Fatigue - constantly tired, naps during day if able, feels need to sleep early in the evening. 5. Chronic Rhinitis - constant post nasal drip irritating constant flow that sometimes causes. Also sometimes has to sit down in the shower hoarseness. Causes cough if exercising, which leaves him with cough the next day.  6. Paresthesias - mild tingling in fingers and toes that started in last couple months. 7. Tension Headache, mild- manifests in pressure in frontal region, is with problem #! and made worse after exercise and eating. Follow-up Information 09-OCT-2007: Progressive chronic rhinitis, fatigue, myalgias, cognitive dysfunction, scintillating scotomas. Follow-up Information 09-OCT-2007: Diagnosed with Chronic Fatigue Syndrome after extensive workup at a hospital and clinic.
Age: 43.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Disturbance in attention, Dysphonia, Electromyogram abnormal, Fatigue, Hyperhidrosis
Clinical narrative: 1. Cognitive Dysfunction - decreased concentration increased effort to retain and understand when he reads, hard to focus. Now it is also with any exertion like mowing the lawn. Worse when working out. Still trying to run. Increased time to recover. Also after eating associated visual disturbance with the above.  2. Sleep Disturbance - sleeps 8 hours/night  - wakes up - 2x night, has night sweats 2-3x week, does not awaken refreshed. 3. Myalgias - generalized muscles pain effecting thighs, forearms, calf, neck, back. Low level irritating 2-3 constant, works through it.  4. Fatigue - constantly tired, naps during day if able, feels need to sleep early in the evening. 5. Chronic Rhinitis - constant post nasal drip irritating constant flow that sometimes causes. Also sometimes has to sit down in the shower hoarseness. Causes cough if exercising, which leaves him with cough the next day.  6. Paresthesias - mild tingling in fingers and toes that started in last couple months. 7. Tension Headache, mild- manifests in pressure in frontal region, is with problem #! and made worse after exercise and eating. Follow-up Information 09-OCT-2007: Progressive chronic rhinitis, fatigue, myalgias, cognitive dysfunction, scintillating scotomas. Follow-up Information 09-OCT-2007: Diagnosed with Chronic Fatigue Syndrome after extensive workup at a hospital and clinic.