chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Asthma, Chest discomfort, Medication error, Rash, Skin ulcer
Clinical narrative: Developed mild chest tightness with wheeze 6 to 8 hours after meningococcal vaccine on 7/13/2004. Albuterol inhaler was started the next day as symptoms increased. She slept well through the night. She was seen by me, her PCP, the next day, two days after the vacine. Exam & spirometry were both normal. She had a prior history of asthma at age 9 years of mild degree, followed by occasional exercise-induced asthma, but none in over one year from this incident.  On 7/21/2004, six days after the first office exam and eight days after the vaccine, she returned for evaluation of a rash. She had small urticarial lesions around her waist. No wheezing on auscultation. Last inhaler use was five hours before the exam. Intermittent welts had been present for two days. Rx'd with Benadryl oral. QVAR inhaler started.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Urticaria, Wheezing
Clinical narrative: Developed mild chest tightness with wheeze 6 to 8 hours after meningococcal vaccine on 7/13/2004. Albuterol inhaler was started the next day as symptoms increased. She slept well through the night. She was seen by me, her PCP, the next day, two days after the vacine. Exam & spirometry were both normal. She had a prior history of asthma at age 9 years of mild degree, followed by occasional exercise-induced asthma, but none in over one year from this incident.  On 7/21/2004, six days after the first office exam and eight days after the vaccine, she returned for evaluation of a rash. She had small urticarial lesions around her waist. No wheezing on auscultation. Last inhaler use was five hours before the exam. Intermittent welts had been present for two days. Rx'd with Benadryl oral. QVAR inhaler started.
Age: 33.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Febrile at 104 degrees; arthralgias; poor response to anti-inflammatories.
Age: 33.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site mass, Injection site pain
Clinical narrative: Febrile at 104 degrees; arthralgias; poor response to anti-inflammatories.
Age: 33.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Nausea, Photosensitivity reaction, Pyrexia, Retching, Rhinorrhoea
Clinical narrative: Febrile at 104 degrees; arthralgias; poor response to anti-inflammatories.
Age: 33.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Visual disturbance
Clinical narrative: Febrile at 104 degrees; arthralgias; poor response to anti-inflammatories.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Skin discolouration
Clinical narrative: 14 1/2 x 12cm area of erythema noted on Left upper ventral leg with 1 x 1.5cm black border around white center with injection site centrally.  Sx 36-48 after injection.  Cold compress and benedryl Q-6hrs.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Apnoea, Brain oedema, Convulsion, Eye irritation, Eye swelling
Clinical narrative: 7/4/04: Puffy eyes/itchy eyes, diagnosed with OM. Prescribed but did not take amoxicillin (because of possible allergy). 7/6/04: Clinic. Temp 102.7. B posterior lymphadenopathy; alert, well appearing. 7/7/04 Seizure at home. ED; repeat seizure, apneic episodes 3 times. Flumazanil, Dilantin and transferred. Never regained consciousness. LP positive, WBC. Died 7/9/04. Labs. Nurse follow up on 08/02/04 states: "Complete." Autopsy report received stated patient experienced Epstein Barr infection and cerebral edema.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Lymphadenopathy, Pyrexia, Viral infection
Clinical narrative: 7/4/04: Puffy eyes/itchy eyes, diagnosed with OM. Prescribed but did not take amoxicillin (because of possible allergy). 7/6/04: Clinic. Temp 102.7. B posterior lymphadenopathy; alert, well appearing. 7/7/04 Seizure at home. ED; repeat seizure, apneic episodes 3 times. Flumazanil, Dilantin and transferred. Never regained consciousness. LP positive, WBC. Died 7/9/04. Labs. Nurse follow up on 08/02/04 states: "Complete." Autopsy report received stated patient experienced Epstein Barr infection and cerebral edema.
Age: 22.0
Sex: F
Vaccine: HEPAB, IPV, MMR
Symptoms: Paraesthesia
Clinical narrative: Began complaining of tingling of lips, throat and then tongue 10 minutes after receiving vaccines. Benadryl 50mg IM given. Blood pressure 122/86, pulse 60, respiration 15. Rested and recovered. Left health department with employer after 1 hour.  Nurse follow up on 07/27/04 states: "numbness of lips, tingling of tongue."
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation, Anorexia, Choking, Crying, Cyanosis
Clinical narrative: Patient received vaccinations in morning at clinic. Went home and napped longer than usual. Upon awakening, patient soon appeared ill, started staring off into space, had frothy saliva, lips turned white, appeared as through he was choking/suffocating. Mom had difficulty arousing him, but after several minutes, patient cried. Brought to hospital via EMS. Seemed more lethargic than normal. Recovered without sequelae.  Nurse follow up on 07/30/04 states: "cyanosis; increased salvia; irritability; decreased appetite."
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Depressed level of consciousness, Lethargy, Saliva altered, Salivary hypersecretion, Somnolence
Clinical narrative: Patient received vaccinations in morning at clinic. Went home and napped longer than usual. Upon awakening, patient soon appeared ill, started staring off into space, had frothy saliva, lips turned white, appeared as through he was choking/suffocating. Mom had difficulty arousing him, but after several minutes, patient cried. Brought to hospital via EMS. Seemed more lethargic than normal. Recovered without sequelae.  Nurse follow up on 07/30/04 states: "cyanosis; increased salvia; irritability; decreased appetite."
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Staring, Suffocation feeling
Clinical narrative: Patient received vaccinations in morning at clinic. Went home and napped longer than usual. Upon awakening, patient soon appeared ill, started staring off into space, had frothy saliva, lips turned white, appeared as through he was choking/suffocating. Mom had difficulty arousing him, but after several minutes, patient cried. Brought to hospital via EMS. Seemed more lethargic than normal. Recovered without sequelae.  Nurse follow up on 07/30/04 states: "cyanosis; increased salvia; irritability; decreased appetite."
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Woke up from nap approximately few hours after vaccine crying. Cried for 2 hours. Difficult to console. Brought back to office. Given Tylenol and heat packs and swaddled. Calmed and stayed cal within 30 minutes. Did vomit during crying. Next day, developed temp < 101 (was 100.2), vomiting, and diarrhea. Admitted to hospital after septic work up. Diarrhea persisted for 2 weeks.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Pruritus, Rash papular, Skin burning sensation
Clinical narrative: 23MAY2003 sought treatment for burning/ itching "blisters" in groin region: practitioner observed "papules" on right hand and groin region: over the ensuing months he received multiple types of treatment including "antifungals/ antihistamines/ antibiotics / total + for staph in October 2003) with symptomatic relief temporary and ultimately spreading term elbows, knees, axilla to trunk, buttocks, abdomen and scalp. Referred to dermatology 31MAR2004. Biopsies were done to rule out dermatitis herpetiforms. (I can fin no evidence viral cultures were obtained at any time of the lesions). See attached list meds given.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Discomfort, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: After his third anthrax vaccine, given in his left triceps area on 4/12/03, he reports waking up the next am with redness, increased warmth and swelling from his shoulder to his elbow, almost the whole circumference of his upper arm. He repots that his skin was stretched tight causing significant discomfort. He called his unit for instruction and was referred to his local VA Medical Center on 4/14/03. (No records of visit available.) Patient reports that he was instructed to elevate his arm, apply ice to the affected area, and to take Ibuprofen. After 2 days, the redness, warmth and swelling began decreasing and was completely resolved within the next week. PFC also reports experiencing a mild headache, generalized muscle aches and fatigue during the first few days following receipt of his third anthrax vaccine. He denies any persistent systemic symptoms. Symptom : edema at injection site 50-120 mm Start: 4/13/2003. Symptom: erythema start: 4/13/2003 Comment: surrounding vaccine site. Symptom: Pain start: 4/13/2003 Comment: at vaccine site
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Myalgia, Skin reaction
Clinical narrative: After his third anthrax vaccine, given in his left triceps area on 4/12/03, he reports waking up the next am with redness, increased warmth and swelling from his shoulder to his elbow, almost the whole circumference of his upper arm. He repots that his skin was stretched tight causing significant discomfort. He called his unit for instruction and was referred to his local VA Medical Center on 4/14/03. (No records of visit available.) Patient reports that he was instructed to elevate his arm, apply ice to the affected area, and to take Ibuprofen. After 2 days, the redness, warmth and swelling began decreasing and was completely resolved within the next week. PFC also reports experiencing a mild headache, generalized muscle aches and fatigue during the first few days following receipt of his third anthrax vaccine. He denies any persistent systemic symptoms. Symptom : edema at injection site 50-120 mm Start: 4/13/2003. Symptom: erythema start: 4/13/2003 Comment: surrounding vaccine site. Symptom: Pain start: 4/13/2003 Comment: at vaccine site
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: After his third anthrax vaccine, given in his left triceps area on 4/12/03, he reports waking up the next am with redness, increased warmth and swelling from his shoulder to his elbow, almost the whole circumference of his upper arm. He repots that his skin was stretched tight causing significant discomfort. He called his unit for instruction and was referred to his local VA Medical Center on 4/14/03. (No records of visit available.) Patient reports that he was instructed to elevate his arm, apply ice to the affected area, and to take Ibuprofen. After 2 days, the redness, warmth and swelling began decreasing and was completely resolved within the next week. PFC also reports experiencing a mild headache, generalized muscle aches and fatigue during the first few days following receipt of his third anthrax vaccine. He denies any persistent systemic symptoms. Symptom : edema at injection site 50-120 mm Start: 4/13/2003. Symptom: erythema start: 4/13/2003 Comment: surrounding vaccine site. Symptom: Pain start: 4/13/2003 Comment: at vaccine site
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Hypoaesthesia, Pain, Paraesthesia, Pruritus
Clinical narrative: Right arm, inner and triceps area swollen down to elbow with red rash, tingling and numbness down through hand and fingers. Frequent pain and itching.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Swelling
Clinical narrative: Right arm, inner and triceps area swollen down to elbow with red rash, tingling and numbness down through hand and fingers. Frequent pain and itching.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Injection site induration
Clinical narrative: 60cm area of induration and erythema and warmth
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dysphonia, Swelling face
Clinical narrative: Swollen lips and husky voice
Age: 5.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varivax given on 02/01/2000. Had chicken pox on 06/24/2004
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varivax given on 8/29/02. Chicken pox on 4/13/004.
Age: 5.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varivax on 10/18/2000. Had chicken pox on 5/11/04.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parent noticed swollen and red arm at the site of Infanrix, 2.5x4.5.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Rash, Tinnitus
Clinical narrative: Patient reported 7/6/04 she had rash on legs, ringing in ears and dull headache since 6/20/04. Pt related symptoms staring after Pneumovax given.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pyrexia, Swelling
Clinical narrative: Patient experienced chills, fever and swelling in arm within 24 hours of vaccination. Resolved by 6/7/04. No treatment. Patient reported above on 6/7/04.
Age: 0.75
Sex: F
Vaccine: HEP, PNC
Symptoms: Injection site rash, Rash papular
Clinical narrative: Rash at site of injection occurred 3 days after immunization. Rash consisted of 1-2mm papular skin spread from site of immunization down leg next day to outer leg by knee. No itchiness.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Mom called on 6/14/04 and stated child broke out with chicken pox.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash vesicular
Clinical narrative: Mom called 7/15/04 states child's broke out with fluid filled blisters 2 days ago, on face, head, hairline, arms, afeb
Age: 2.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varicella zoster in right arm. clinical diagnosis. No clinical history of natural varicella. Pt received varicella vaccine one year ago.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site induration
Clinical narrative: 15x15cm red indurated area right thigh
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Pruritus, Rash
Clinical narrative: Temporary rash, itching
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness from middle of chin up to above ear. Some tingling. No problem with first two shots. This was his third Hep B. Left side.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Injection site induration, Injection site inflammation
Clinical narrative: 2 cm induration right Uq with mild inflammation
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: RD redness and high temp, swollen area 17cm in circumference.
Age: 33.0
Sex: M
Vaccine: HEP, HEPA, RAB
Symptoms: Dizziness, Nausea
Clinical narrative: Pt noted onset of dizziness 5/28/04, 1 day after receiving Hep A #2, Hep B #1, rabies PCEV #1, Which gradually abated over the following 1-3 weeks. Rabies PCEV #2 was given 6/3/04 without exacerbation of Sx. 6/29/04 received hep B #2 and rabies #3, felt worse afterwards with complaints of nausea, lightheadedness.
Age: 32.0
Sex: F
Vaccine: MEN, RAB
Symptoms: Asthenia, Chills, Dry throat, Fatigue, Lymphadenopathy
Clinical narrative: 5/29 Had chills, dry throat, felt feverish-but had no thermometer to check temp. Noticed a mild, raised rash over neck and trunk. Not itchy, not very red, resolved within 24 hrs. 5/30 Feverish off and on, felt tired and weak, existing lymph node on right side under ear still hard. 6/30/04 has completed all vaccine series no further reaction.
Age: 32.0
Sex: F
Vaccine: MEN, RAB
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: 5/29 Had chills, dry throat, felt feverish-but had no thermometer to check temp. Noticed a mild, raised rash over neck and trunk. Not itchy, not very red, resolved within 24 hrs. 5/30 Feverish off and on, felt tired and weak, existing lymph node on right side under ear still hard. 6/30/04 has completed all vaccine series no further reaction.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bacterial infection, Disorientation, Drug ineffective, Hearing impaired, Herpes simplex
Clinical narrative: I have a very interesting patient, date of birth 3/28/1950, who received her first Pneumovax-23 vaccination on 10/18/94 and then had another vaccination on 2/20/04. She is an allergic woman with hives and swelling documented with Augmentin, Bactrim DS, Cephalexin, Cipro, Levaquin, Biaxin, Lorabid, Doxycycline, and Famvir. She had a hysterectomy and BSO in 1999. She is allergic to some foods including pine nuts and sulfites. In addition to seeing an allergist, she takes Zyrtec 10mg a day, Lipitor 10mg a day, and carries an Epi Pen injector. She is using Flonase nasal spray frequently. Despite being followed by an ENT specialist, she has had recurrent sinusitis. On 4/14/04, she was admitted to the hospital with disorientation. She was found to have pneumococcal bacteremia and pneumococcal meningitis with obstructive hydrocephalus. She was admitted to the ICU having received an injection of Cefoxitin in the emergency room. She was treated with IV Penicillin, Vancomycin and Solumedrol. She developed an allergic reaction requiring readmission to the ICU and desensitization to Penicillin starting with very low dosage and then gradually increasing. She had developed significant hearing loss especially in the left ear which occurred about the time of a severe outbreak of herpes simplex on the left side of her face. She had involvement of cranial nerves VI, VII, VIII, XII. She required readmission to the hospital on 5/22/04 when she again appeared disoriented but her cultures were negative. She responded to hydration, antihistamines, glucocorticoids, and Famvir. A skin biopsy documented herpes simplex and eliminated varicella zoster. The reference lab for the hospital using AML found that her Pneumococcal organism was serotype group 19. In the Pneumovax-23 package insert we see that our vaccine included 19F and 19A as two of the 23 capsular antigens. Although this patient did survive she had a well documented and severe illness despite receiving the pneumococcal vaccination ten years before her illness and then again two months before her illness. I am not sure what to do with this information but for those of you who have a special interest in this field, I would want you to be aware of this case. Although the patient has multiple allergies, I am not aware of her having cellular or humoral immunodeficiency. She has had HIV testing which is negative and she has had normal globulin levels. Are there additional studies that we should do on this patient in the future that might be helpful to her or might be helpful to your understanding of how these vaccinations and her infections have worked. Please let me know if you have any advice.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hydrocephalus, Hypersensitivity, Meningitis
Clinical narrative: I have a very interesting patient, date of birth 3/28/1950, who received her first Pneumovax-23 vaccination on 10/18/94 and then had another vaccination on 2/20/04. She is an allergic woman with hives and swelling documented with Augmentin, Bactrim DS, Cephalexin, Cipro, Levaquin, Biaxin, Lorabid, Doxycycline, and Famvir. She had a hysterectomy and BSO in 1999. She is allergic to some foods including pine nuts and sulfites. In addition to seeing an allergist, she takes Zyrtec 10mg a day, Lipitor 10mg a day, and carries an Epi Pen injector. She is using Flonase nasal spray frequently. Despite being followed by an ENT specialist, she has had recurrent sinusitis. On 4/14/04, she was admitted to the hospital with disorientation. She was found to have pneumococcal bacteremia and pneumococcal meningitis with obstructive hydrocephalus. She was admitted to the ICU having received an injection of Cefoxitin in the emergency room. She was treated with IV Penicillin, Vancomycin and Solumedrol. She developed an allergic reaction requiring readmission to the ICU and desensitization to Penicillin starting with very low dosage and then gradually increasing. She had developed significant hearing loss especially in the left ear which occurred about the time of a severe outbreak of herpes simplex on the left side of her face. She had involvement of cranial nerves VI, VII, VIII, XII. She required readmission to the hospital on 5/22/04 when she again appeared disoriented but her cultures were negative. She responded to hydration, antihistamines, glucocorticoids, and Famvir. A skin biopsy documented herpes simplex and eliminated varicella zoster. The reference lab for the hospital using AML found that her Pneumococcal organism was serotype group 19. In the Pneumovax-23 package insert we see that our vaccine included 19F and 19A as two of the 23 capsular antigens. Although this patient did survive she had a well documented and severe illness despite receiving the pneumococcal vaccination ten years before her illness and then again two months before her illness. I am not sure what to do with this information but for those of you who have a special interest in this field, I would want you to be aware of this case. Although the patient has multiple allergies, I am not aware of her having cellular or humoral immunodeficiency. She has had HIV testing which is negative and she has had normal globulin levels. Are there additional studies that we should do on this patient in the future that might be helpful to her or might be helpful to your understanding of how these vaccinations and her infections have worked. Please let me know if you have any advice.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bacterial infection, Blister, Disorientation, Drug ineffective, Herpes simplex
Clinical narrative: I have a very interesting patient, date of birth 3/28/1950, who received her first Pneumovax-23 vaccination on 10/18/94 and then had another vaccination on 2/20/04. She is an allergic woman with hives and swelling documented with Augmentin, Bactrim DS, Cephalexin, Cipro, Levaquin, Biaxin, Lorabid, Doxycycline, and Famvir. She had a hysterectomy and BSO in 1999. She is allergic to some foods including pine nuts and sulfites. In addition to seeing an allergist, she takes Zyrtec 10mg a day, Lipitor 10mg a day, and carries an Epi Pen injector. She is using Flonase nasal spray frequently. Despite being followed by an ENT specialist, she has had recurrent sinusitis. On 4/14/04, she was admitted to the hospital with disorientation. She was found to have pneumococcal bacteremia and pneumococcal meningitis with obstructive hydrocephalus. She was admitted to the ICU having received an injection of Cefoxitin in the emergency room. She was treated with IV Penicillin, Vancomycin and Solumedrol. She developed an allergic reaction requiring readmission to the ICU and desensitization to Penicillin starting with very low dosage and then gradually increasing. She had developed significant hearing loss especially in the left ear which occurred about the time of a severe outbreak of herpes simplex on the left side of her face. She had involvement of cranial nerves VI, VII, VIII, XII. She required readmission to the hospital on 5/22/04 when she again appeared disoriented but her cultures were negative. She responded to hydration, antihistamines, glucocorticoids, and Famvir. A skin biopsy documented herpes simplex and eliminated varicella zoster. The reference lab for the hospital using AML found that her Pneumococcal organism was serotype group 19. In the Pneumovax-23 package insert we see that our vaccine included 19F and 19A as two of the 23 capsular antigens. Although this patient did survive she had a well documented and severe illness despite receiving the pneumococcal vaccination ten years before her illness and then again two months before her illness. I am not sure what to do with this information but for those of you who have a special interest in this field, I would want you to be aware of this case. Although the patient has multiple allergies, I am not aware of her having cellular or humoral immunodeficiency. She has had HIV testing which is negative and she has had normal globulin levels. Are there additional studies that we should do on this patient in the future that might be helpful to her or might be helpful to your understanding of how these vaccinations and her infections have worked. Please let me know if you have any advice.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hydrocephalus, Hypersensitivity, Hypoacusis, Laboratory test abnormal, Meningitis
Clinical narrative: I have a very interesting patient, date of birth 3/28/1950, who received her first Pneumovax-23 vaccination on 10/18/94 and then had another vaccination on 2/20/04. She is an allergic woman with hives and swelling documented with Augmentin, Bactrim DS, Cephalexin, Cipro, Levaquin, Biaxin, Lorabid, Doxycycline, and Famvir. She had a hysterectomy and BSO in 1999. She is allergic to some foods including pine nuts and sulfites. In addition to seeing an allergist, she takes Zyrtec 10mg a day, Lipitor 10mg a day, and carries an Epi Pen injector. She is using Flonase nasal spray frequently. Despite being followed by an ENT specialist, she has had recurrent sinusitis. On 4/14/04, she was admitted to the hospital with disorientation. She was found to have pneumococcal bacteremia and pneumococcal meningitis with obstructive hydrocephalus. She was admitted to the ICU having received an injection of Cefoxitin in the emergency room. She was treated with IV Penicillin, Vancomycin and Solumedrol. She developed an allergic reaction requiring readmission to the ICU and desensitization to Penicillin starting with very low dosage and then gradually increasing. She had developed significant hearing loss especially in the left ear which occurred about the time of a severe outbreak of herpes simplex on the left side of her face. She had involvement of cranial nerves VI, VII, VIII, XII. She required readmission to the hospital on 5/22/04 when she again appeared disoriented but her cultures were negative. She responded to hydration, antihistamines, glucocorticoids, and Famvir. A skin biopsy documented herpes simplex and eliminated varicella zoster. The reference lab for the hospital using AML found that her Pneumococcal organism was serotype group 19. In the Pneumovax-23 package insert we see that our vaccine included 19F and 19A as two of the 23 capsular antigens. Although this patient did survive she had a well documented and severe illness despite receiving the pneumococcal vaccination ten years before her illness and then again two months before her illness. I am not sure what to do with this information but for those of you who have a special interest in this field, I would want you to be aware of this case. Although the patient has multiple allergies, I am not aware of her having cellular or humoral immunodeficiency. She has had HIV testing which is negative and she has had normal globulin levels. Are there additional studies that we should do on this patient in the future that might be helpful to her or might be helpful to your understanding of how these vaccinations and her infections have worked. Please let me know if you have any advice.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site oedema
Clinical narrative: 4 yo with area of redness and swelling right leg which started in area of vaccine placed 7/14/04. Area is 20cmx12cm
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Erythema, Injection site mass
Clinical narrative: Induration, erythema 2 cm diameter initially, at time of eval much smaller.
Age: 5.0
Sex: M
Vaccine: DTP, HIBV, IPV, UNK
Symptoms: Feeling hot, Oedema, Pyrexia, Vomiting
Clinical narrative: Vaccinate 7/12/04 Monday at 11:00. At 6PM vomited, again 8:00, fever at 100. 7/13-14/04 vomited, no fever, Left arm swollen and warm to touch. No problem retaining food or liquids.
Age: 1.33
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Oedema
Clinical narrative: Large swelling, redness on left thigh has been scratching the area.
Age: 1.0
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash around injection site as well as on other areas of torso and limbs
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Crying, Screaming
Clinical narrative: During 4 month visit parents described infant as screaming and crying for a long time hours after the second set of shots. Was very inconsolable.
Age: 32.0
Sex: F
Vaccine: MEA
Symptoms: Hyperkinesia, Pain
Clinical narrative: Excruciating pain in left leg, with left knee pain so severe that it is very difficult to walk.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Rash
Clinical narrative: Pneumovax admin 7/13/04 on 7/15/04 developed s/s 2 days after injection. Following with rash, redness, soreness axilla. Dx: probable cellulitis. Tx: Keflex 250mg 1 cap every 6 hours x 5 days
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site oedema, Pain
Clinical narrative: Pneumovax admin 7/8/04 on 7/9/04 developed s/s 1 day after injection following redness right arm injection site with pain and swelling. Dx: Cellulitis Tx: Cleocin 300mg, 1 cap q 8 hours x 7 days.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Cough, Urticaria, Vomiting
Clinical narrative: Immunization given at 16:45. That evening pt was fed Enfamil formula and breast milk and a pinch of scrambled eggs. She developed a congested cough had emesis and developed a generalized urticarial eruption app 2 has after feeding (and 4-5 hrs) after immunizations. Taken to ER given Benadryl and Pediapred.
Sex: U
Vaccine: TD
Symptoms: Erythema, Medication error, Oedema
Clinical narrative: Td Toxoid was erroneously injected IM instead of PPD. Erythema, edema, permanent scar.
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Pyrexia, Urinary tract infection
Clinical narrative: Seizure event, approx 20 min. Pt had 1 seizure episode prior to Fluvirin and was taken to the ER and found  to have a UTI and fever. After Fluvirin was given approx 20 min later mother reported child had 1 seizure and was taken to hospital and again found to have a UTI and fever that started developing. Currently this child is being worked up for seizure disorder unrelated to Fluvirin event.
Sex: U
Vaccine: HEP, UNK
Symptoms: Unevaluable event
Clinical narrative: Confusion between vaccinations (H-BIG and Baby-BIG), similar names causing confusion.
Sex: U
Vaccine: RAB
Symptoms: Medication error
Clinical narrative: The packaging on BayRab 2ml and 10ml vials look identical. We recently had a near miss in dispensing what we thought were 5 x 2ml vials but were actually 4 x 2ml and 1 x 10ml vial. They needed 10ml which would have been 5 x 2ml vials or 1 x 10ml. What happened was 4 x 2ml and 1 x 10ml was sent and the nurse started pulling up from all vials before realizing one was a different amount. Unfortunately the nurses drew up the excess and discarded it. It was a very expensive waste and this eliminated the only stock we had in our pharmacy had there been a second exposure we would not have been able to respond in a timely fashion.  The pt that the BayRab was ordered for did received the correct dose.  Package labeling was certainly the root cause of this error. Secondary causes included: not reading the labels closely, storage of the two different size vials in the same bin in the same drawer of the refrigerator (there was a divider in the bin to separate the two vial sizes but this obviously  was not enough of a distinction), not drawing up the dose and labeling it in the pharmacy. We completed education of all pharmacy staff at a staff meeting (show and tell), we separated the different vial sizes into two separate bins with different colored labels on the outside of each bin to visualized that there is a difference, we will now ask for a pt weight and draw up doses and label and send them to the ER when we received an order for this drug as opposed to just sending the vials. Please take a look at this and ask Bayer to do a better job distinguishing these two different size vials.
Sex: U
Vaccine: HEP, HIBV
Symptoms: Medication error
Clinical narrative: I would like to report an error that occurred in our facility in our NICU. We had an order that read HBIG 0.5 ml IM x 1. The pharmacist entered HIB or Hib titer (H Influenza), The baby received the incorrect vaccine with no adverse outcome. There was no harm to the pt, and the correct vaccine was given. However, it was written as the same abbreviation. I am sure the error was due to abbreviation confusion. The nurse taking over care of the baby discovered the error. She found it in the trash at the babies bedside. I have educated the NICU staff and physician about using this abbreviation. I know it is not on the list of unacceptable abbreviations, but would like to get this information out to others as a learning tool. I believe that abbreviations should be avoided in most instances.
Sex: F
Vaccine: TYP
Symptoms: Nausea, Rash
Clinical narrative: Pt took dose of oral typhoid vaccine and the next d developed a rash and nausea. She also had HIB. Sx lasted a little over 1 week. Didn't take doses 2-4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Autism, Crying, Screaming
Clinical narrative: Inconsolable crying per mom after 1st immunization (Never given DPT again-Continued other vaccinees DT) Pt diagnosed with autism. Now per mom (have moved out of state) Parents request report to VAERS.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure 24 hours after MMR, DTaP
Age: 1.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Mother brought child into ER on 7/15/04 at 20:80, complained of child's left leg being swollen with quarter size redness and warmth. Physician checked temperature right 100 degrees, gave Recephin 500 mg IM given. Mother brought child back on 7/16/04 to immunization clinic, where child's leg was redder and more swollen 8cmx6cm. Notified put child on antibiotic for 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Coma, Eye movement disorder, Syncope, Tremor
Clinical narrative: At Approximately 10:31 am after receiving 3 shots, DTaP, IPV, MMR child fell backwards in Mom's arms.  Shaking, eyes rolled back in head, lasted 2-3 seconds.  Child breathing, nonresponsive 3-5 minutes.  Very pale, shaking stopped but remained nonresponsive 3-5 minutes, breathing without difficulty.  Vital signs P88, 84/60 weak but awake. Walked unsteadily.  EMTs came, Mom was going to transport and said she would take to doctor.  Left alert and oriented.  Rec'd  call from Mother - she left message @ 11:51.  Went home with child - tired and eating at this time.  Rec'd another message @ 4:26 pm, Mom did take child to doctor, was told pt fainted due to holding breath.  Doing fine now."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: Left deltoid area red, swollen, hard to touch.
Age: 36.0
Sex: M
Vaccine: MMR
Symptoms: Glossodynia, Oral pain
Clinical narrative: cheek and mouth and tongue (lateral) soreness. Acidic foods bothersome. 7/16 crescendo to 7/20/04 worst day. Self resolved to normal by 7/21. 5d duration.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MER
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm to touch, swollen are left outer arm
Age: 4.0
Sex: M
Vaccine: DTAP, MM, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Left arm - red, hot to the touch, swelling from the shoulder to elbow around entire arm.
Age: 44.0
Sex: F
Vaccine: MMR, TD
Symptoms: Arthralgia, Cough, Headache, Hyperaesthesia, Lymphadenopathy
Clinical narrative: Vaccine (MMR) given on 7/9/04.  Developed aching and headache on 7/16/04.  Worse on 7/17/04--fever to 100.6-100.8, achy joints, headache, skin sensitive to clothing.  7/18 to 7/20--torso and back continue achy.  Taking Ibuprofen 600-800mg 2-3 times/day.  Seen in EOHD clinic 7/20/04--skin snsitivity (torso and back), aching (trunk), headache, non-productive cough.  Exam 7/20/04--no lymphadenopathy, temp 97.8, ears clear (cerumen occuluding right TM), nose & throat clear, breath sounds clear, AP 88.
Age: 44.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pain, Pyrexia
Clinical narrative: Vaccine (MMR) given on 7/9/04.  Developed aching and headache on 7/16/04.  Worse on 7/17/04--fever to 100.6-100.8, achy joints, headache, skin sensitive to clothing.  7/18 to 7/20--torso and back continue achy.  Taking Ibuprofen 600-800mg 2-3 times/day.  Seen in EOHD clinic 7/20/04--skin snsitivity (torso and back), aching (trunk), headache, non-productive cough.  Exam 7/20/04--no lymphadenopathy, temp 97.8, ears clear (cerumen occuluding right TM), nose & throat clear, breath sounds clear, AP 88.
Age: 17.0
Sex: F
Vaccine: HEP, MEN, TD, VARCEL
Symptoms: Abscess, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: 7/6/04 - Varicella given. On 7/13 bump noted by pt.  On 7/17, area of swelling about 15 mm noted and cont'd to increase in size. On 7/19, pt seen by Public Health Nurse, induration 70 mm, red, warm, tender. Ref. to private MD who dx'd sterile abscess, tx'd with heat packs, NSAIDS,& Benadryl. 7/23 - per Mom, area nearly resolved.
Age: 17.0
Sex: F
Vaccine: HEP, MEN, TD, VARCEL
Symptoms: Tenderness
Clinical narrative: 7/6/04 - Varicella given. On 7/13 bump noted by pt.  On 7/17, area of swelling about 15 mm noted and cont'd to increase in size. On 7/19, pt seen by Public Health Nurse, induration 70 mm, red, warm, tender. Ref. to private MD who dx'd sterile abscess, tx'd with heat packs, NSAIDS,& Benadryl. 7/23 - per Mom, area nearly resolved.
Age: 20.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Chills, Discomfort, Influenza like illness, Lymphadenitis
Clinical narrative: A few hours after pre exposure rabies vaccine, (second dose of series)complained of minor lymphatic pain, under arm injection was given in. 8 hours later had chills, felt like had the flu. Then fell asleep. 48 hours still has lymphatic discomfort.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Injection site abscess, Injection site erythema, Injection site swelling
Clinical narrative: While injecting IM Prevnar, felt small amount of solution under finger about an inch away from injection site like the solution leaked out of the muscle.  The next day the mom called and stated that the leg was swollen and red about an inch from the injection site.  No pain or fever.  Mom instructed to use cold compresses the first day and alternate cold and warm compresses the second day and also to check in with her doctor.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Bronchiolitis, Cyanosis, Peripheral vascular disorder, Pyrexia, Shock
Clinical narrative: Pt. had a 2 day history of fever and upper respiratory systems and presented to the emergency department with signs of shock (cyanosis, decreased perfusion).  Responded to fluid resuscitation and was started on Cefotaxime and admitted to the Ped. ICU for a sepsis work up.  Currently afebrile and doing well.  Nurse follow up on 08/30/04 states: "Complete."
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Upper respiratory tract infection, White blood cell count increased
Clinical narrative: Pt. had a 2 day history of fever and upper respiratory systems and presented to the emergency department with signs of shock (cyanosis, decreased perfusion).  Responded to fluid resuscitation and was started on Cefotaxime and admitted to the Ped. ICU for a sepsis work up.  Currently afebrile and doing well.  Nurse follow up on 08/30/04 states: "Complete."
Age: 6.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site warmth, Pruritus, Urticaria
Clinical narrative: Itchy, hives in 6 inch area around the injection. hot to touch. 2 days after shot, returned to doctor and was given benadryl and a cream to help. the next day it started to clear up. then the next day from that it stablized and was not yet gone, so parents continued to give benadryl and cream. still itching and red. it is sat so monday if not gone we'll take her back to the doctor. She has no difficulty breathing and does NOT appear to show any signs of needing immediate medical attention, from what we know of the serious reactions.
Age: 6.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Erythema, Pyrexia
Clinical narrative: Itchy, hives in 6 inch area around the injection. hot to touch. 2 days after shot, returned to doctor and was given benadryl and a cream to help. the next day it started to clear up. then the next day from that it stablized and was not yet gone, so parents continued to give benadryl and cream. still itching and red. it is sat so monday if not gone we'll take her back to the doctor. She has no difficulty breathing and does NOT appear to show any signs of needing immediate medical attention, from what we know of the serious reactions.
Age: 0.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Headache, Pain, Similar reaction on previous exposure to drug
Clinical narrative: A day after receiving my second anthrax vaccination, I began to have daily headaches and sharp piercing pains in my head, running down to my face and neck.  I also began to feel slightly light-headed.  I have an odd spacy feeling at times also.  The headaches have continued for every day since the vaccination.  After receiving my first anthrax vaccination I began having sharp pains in my head, but no sustained headaches.  Since receiving my second anthrax vaccination, the intensity of the sharp pains has increased and the headaches are a daily occurrence.  I received my first anthrax vaccination on May 19.  The lot number was FAV083.
Age: 42.0
Sex: F
Vaccine: HEP, TYP
Symptoms: Chest discomfort, Diarrhoea, Fatigue, Feeling hot, Injection site pain
Clinical narrative: Pain in the arm radiating to the fingers, right chest wall tightness, vision went "yellow" with fatigue for about an hour.  After the vision returned to normal, experienced fatigue with sedation and nausea and loose stools the next day.  She reported feeling hot, but did not have a thermometer.  She was evaluated by me the day after the event with some mild residual fatigue, loose stools, and soreness at the injection site with inability to lift arm over shoulder height.  Symptoms improved from the day of the injection.  BP 110/80, P 60 R 14, lungs clear, mouth moist, no local induration or erythema at site of injection. Pt instructed to return for follow up next drill weekend - end of August, and to see primary care provider sooner if worsens, or fails to improve in 1-2 weeks.
Age: 42.0
Sex: F
Vaccine: HEP, TYP
Symptoms: Joint range of motion decreased, Nausea, Pain, Visual disturbance
Clinical narrative: Pain in the arm radiating to the fingers, right chest wall tightness, vision went "yellow" with fatigue for about an hour.  After the vision returned to normal, experienced fatigue with sedation and nausea and loose stools the next day.  She reported feeling hot, but did not have a thermometer.  She was evaluated by me the day after the event with some mild residual fatigue, loose stools, and soreness at the injection site with inability to lift arm over shoulder height.  Symptoms improved from the day of the injection.  BP 110/80, P 60 R 14, lungs clear, mouth moist, no local induration or erythema at site of injection. Pt instructed to return for follow up next drill weekend - end of August, and to see primary care provider sooner if worsens, or fails to improve in 1-2 weeks.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a 60 day old male with no medical history and no allergies who on 6/28/04 at 10:00 was vaccinated IM in the left lower thigh with a first dose of hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 647237/1154N). On 6/28/04 at 10:00 the patient was also vaccinated IM in the left thigh with a first dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (lot # C1696AA), a first dose given SC in the right lower thigh of poliovirus vaccine inactivated (lot # X0711), and a first dose given IM in the right thigh of pneumococcal 4 6B 9V 14 18C 19F 23 F conjugate vaccine. It was reported that the patient received the vaccination at a two month check up examination which was reported as within normal limits. On 6/29/04 the patient died while asleep at the babysitters. On 6/30/04 the office was notified of the patient's death. From additional information received on 26Jul04 from another manufacturer, their case reference number was provided, WAES0407USA01244. From internal review completed on 27JUL2004 it was determined that the case in the cluster where the localized reacton does not occur at the Daptacel or IPOL injection site (case #2004-02306) is no longer considered part of the cluster. Additional information was received from another manufacturer (reference number WAES0407USA01244) on 05AUG2004. The lot number for COMVAX was reported as 647327/1154N previously reported as 1154N. No other new information was provided at this time.  The reporter of this case is the same reporter of cases 2004-02304 through 2004-02313.  From additional information received on 23Aug04 from the pediatrician's office, it was reported, reviewed, no additional information. From additional information received on 25Aug04 from the reporter's office it was reported that they are attempting to obtain all the necessary infomration and the responsible physician has been contacted for a copy of the death certificate as well as the results of the two month check up and prenatal history. It was reported that the pt had no siblings, he was the first and only child. From the second follow up phone call with the reporter on 30Aug04 it was verified that the responsible physician does not have the death certificate or autopsy report. The pt was born in Covington county and the birth records are not available. Per the responsible physician, during the two month check up the infant was fine developmentally. The type of crib the pt was sleeping in is not known. The reporter stated that if any further informatin associated with this case becomes available she would notify us.  From additional information received from a RN on 07Sep04, it was reported, we have no further information on this child to report. No further information is anticipated, this case is considered closed.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aggression, Encephalitis, Headache, Parotitis
Clinical narrative: Information has been received from a physician concerning a 4 year old patient who on 6/14/04 was vaccinated with MMR (lot # 646122/0610N). On 7/9/04 the patient presented to the reporting physician's office with parotiditis and possibly some encephalitis and headache. The physician based the suspicion of encephalitis on the fact that the child was not acting normal and was uncharacteristically combative. The reporting physician did not plan any treatment at that time. No product quality complaint involved. Upon internal review, the report of possibly some encephalitis due to the patient's not acting normal and uncharacteristically combative were considered to be an other important medical event (OMIC).  No product quality complaint involved. Follow up information reported that the pt on 03Jul04 developed a cough and congestoin. On 07Jul04 the pt complained of mouth hurting. On 08Jul04 the pt was described as combative and had unusual behaviors. On 09Jul04 the pt developed left parotid swelling. Subsequently, the pt recovered by 14Jul04. There were no relevant diagnostic tests or laboratory data. This report no longer meets the criteria for submission because the adverse events aggression and abnormal behavior are not serious.  No further information is expected.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Bladder stenosis, Chest pain, Constipation
Clinical narrative: Possible transverse myelitis, i.e. sudden onset of weakness, decreased sensation, numbness of upper and lower extremities, up to sternum with urinary retention. Sudden onset 10/12/03. States got influenza vaccination 10/08/2003.  Nurse follow up on 07/27/04 states: "chest pain; nausea; vomiting; constipation; back pain; balance impaired. Per annual report-Pt has hyper reflexion, mild spasticity, gait disturbance and urinary incontinence. Pt work up at hospital with neurologist and neurosurgeon.  Neurologist thinks it secondary to cervical myelopathy secondary cervical stenomi-pt underwent surgery care.