chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: F
Vaccine: HIBV, PNC, HIBV, MMRV, PNC
Symptoms: Somnolence
Clinical narrative: fever x 7 - 10 days starting 2 days after vaccination, behavior change (irritability alternating with somnolence) starting 14 days after vaccination.  Patient was admitted for evaluation and observation.  Symptoms resolved by the time of discharge (4 days later) and the child has had normal development since that time.  06/11/2007 MR received for 2 admissions (7/15-19/2006 and 7/23-24/2006). Child initially presented 7/15/07 with c/o mental status changes following a week long febrile viral syndrome.  Changes include uncontrollable screaming, restlessness,  behavior changes, excessive sleepiness with difficulty keeping awake.  Child was seen outpatient and had a head CT showing diffuse cerebral edema and was admitted with a dx of encephalitis vs ADEM.  PE: WNL. Txd with steroids, anti-virals, and antibiotics. Discharge DX: Possible Vaccine Associated Encephalomyelitis 2nd admission 7/23 child presented with low grade fever, vomiting and associated intermittant lethargy. Somnolence was similar to episodes from prior admission.  Discharge DX:  Emesis, Fever from unclear etiology, most likely viral-resolved.  S/P Acute disseminated encephalomyelitis, possibly vaccine related.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC, HIBV, MMRV, PNC
Symptoms: Abnormal behaviour, Computerised tomogram normal, Encephalitis, Irritability, Laboratory test
Clinical narrative: fever x 7 - 10 days starting 2 days after vaccination, behavior change (irritability alternating with somnolence) starting 14 days after vaccination.  Patient was admitted for evaluation and observation.  Symptoms resolved by the time of discharge (4 days later) and the child has had normal development since that time.  06/11/2007 MR received for 2 admissions (7/15-19/2006 and 7/23-24/2006). Child initially presented 7/15/07 with c/o mental status changes following a week long febrile viral syndrome.  Changes include uncontrollable screaming, restlessness,  behavior changes, excessive sleepiness with difficulty keeping awake.  Child was seen outpatient and had a head CT showing diffuse cerebral edema and was admitted with a dx of encephalitis vs ADEM.  PE: WNL. Txd with steroids, anti-virals, and antibiotics. Discharge DX: Possible Vaccine Associated Encephalomyelitis 2nd admission 7/23 child presented with low grade fever, vomiting and associated intermittant lethargy. Somnolence was similar to episodes from prior admission.  Discharge DX:  Emesis, Fever from unclear etiology, most likely viral-resolved.  S/P Acute disseminated encephalomyelitis, possibly vaccine related.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC, HIBV, MMRV, PNC
Symptoms: Nuclear magnetic resonance imaging brain normal, Pyrexia, Somnolence
Clinical narrative: fever x 7 - 10 days starting 2 days after vaccination, behavior change (irritability alternating with somnolence) starting 14 days after vaccination.  Patient was admitted for evaluation and observation.  Symptoms resolved by the time of discharge (4 days later) and the child has had normal development since that time.  06/11/2007 MR received for 2 admissions (7/15-19/2006 and 7/23-24/2006). Child initially presented 7/15/07 with c/o mental status changes following a week long febrile viral syndrome.  Changes include uncontrollable screaming, restlessness,  behavior changes, excessive sleepiness with difficulty keeping awake.  Child was seen outpatient and had a head CT showing diffuse cerebral edema and was admitted with a dx of encephalitis vs ADEM.  PE: WNL. Txd with steroids, anti-virals, and antibiotics. Discharge DX: Possible Vaccine Associated Encephalomyelitis 2nd admission 7/23 child presented with low grade fever, vomiting and associated intermittant lethargy. Somnolence was similar to episodes from prior admission.  Discharge DX:  Emesis, Fever from unclear etiology, most likely viral-resolved.  S/P Acute disseminated encephalomyelitis, possibly vaccine related.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: Information has been received from an physician concerning a 4 year old white female patient weighing 30 lbs 6 oz and height 38.5 inches, with a history of fever and abdominal pain at one year of age requiring hospitalization after prior vaccination with Hib conj vaccine (OMPC) (mfr. unknown) (WAES# 0704USA00518), who on 03-FEB-2005, was vaccinated in the left arm with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (lot# 648606/0558P). There were no concomitant medication. There was no illness at the time of vaccination. On 03-FEB-2005, the patient developed a fever after vaccination that continued for several weeks. The patient recovered 2 to 3 months after being vaccinated. Unspecified medical attention was sought. A lot check has been requested. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Accidental overdose, Incorrect dose administered, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his 13 month old white son with a history of gastrooesophageal reflux disease who was vaccinated with a first and second 0.5 ml dose of MMR II on 01-MAR-2006 (lot # 649245/0467R) (given in the left thigh) and 03-APR-2006 (lot # 649817/0728R) (given in the right thigh). Concomitant vaccination included a first and second dose of Varivax on 01-MAR-2006 (lot # 651177/0428R) (in the left thigh) and 03-APR-2006 (lot # 652455/1018R) (given in the left thigh), respectively. Other concomitant vaccination included a third and fourth dose PREVNAR given in the right thigh on 01-MAR-2006 (lot # B08633D) and 03-APR-2006 (lot # B08638F), respectively. There was no illness at the time of vaccination. On 03-APR-2006 it was reported that the patient "currently has a fever." Unspecified medication was sought. There was no product quality complaint involved. Additional information was received and indicated that the parents reported a fever which was not documented in the clinic. NO other adverse events were reported. Subsequently the patient recovered. It was reported that the patient's sibling had a seizure at six months of age following the third dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (unknown manufacturer). No further information is available.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his 13 month old white son with a history of gastrooesophageal reflux disease who was vaccinated with a first and second 0.5 ml dose of MMR II on 01-MAR-2006 (lot # 649245/0467R) (given in the left thigh) and 03-APR-2006 (lot # 649817/0728R) (given in the right thigh). Concomitant vaccination included a first and second dose of Varivax on 01-MAR-2006 (lot # 651177/0428R) (in the left thigh) and 03-APR-2006 (lot # 652455/1018R) (given in the left thigh), respectively. Other concomitant vaccination included a third and fourth dose PREVNAR given in the right thigh on 01-MAR-2006 (lot # B08633D) and 03-APR-2006 (lot # B08638F), respectively. There was no illness at the time of vaccination. On 03-APR-2006 it was reported that the patient "currently has a fever." Unspecified medication was sought. There was no product quality complaint involved. Additional information was received and indicated that the parents reported a fever which was not documented in the clinic. NO other adverse events were reported. Subsequently the patient recovered. It was reported that the patient's sibling had a seizure at six months of age following the third dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (unknown manufacturer). No further information is available.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Acoustic stimulation tests, Deafness, Vertigo
Clinical narrative: 05/13/07 - Experienced sudden onset of complete hearing loss left ear, with vertigo and nausea. Had slight temperature. Contacted PMD and was prescribed Ibuprofen and Benadryl. 5/14/07 - Evaluated by ENT ---> diagnose with sudden hearing loss syndrome, prescribed Prednisone, blood work and MRI done.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Body temperature increased, Nausea, Nuclear magnetic resonance imaging normal, Sudden hearing loss
Clinical narrative: 05/13/07 - Experienced sudden onset of complete hearing loss left ear, with vertigo and nausea. Had slight temperature. Contacted PMD and was prescribed Ibuprofen and Benadryl. 5/14/07 - Evaluated by ENT ---> diagnose with sudden hearing loss syndrome, prescribed Prednisone, blood work and MRI done.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Vertigo, White blood cell count increased
Clinical narrative: 05/13/07 - Experienced sudden onset of complete hearing loss left ear, with vertigo and nausea. Had slight temperature. Contacted PMD and was prescribed Ibuprofen and Benadryl. 5/14/07 - Evaluated by ENT ---> diagnose with sudden hearing loss syndrome, prescribed Prednisone, blood work and MRI done.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Nausea, Nuclear magnetic resonance imaging normal, Pyrexia, Sudden hearing loss
Clinical narrative: 05/13/07 - Experienced sudden onset of complete hearing loss left ear, with vertigo and nausea. Had slight temperature. Contacted PMD and was prescribed Ibuprofen and Benadryl. 5/14/07 - Evaluated by ENT ---> diagnose with sudden hearing loss syndrome, prescribed Prednisone, blood work and MRI done.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Deafness
Clinical narrative: 05/13/07 - Experienced sudden onset of complete hearing loss left ear, with vertigo and nausea. Had slight temperature. Contacted PMD and was prescribed Ibuprofen and Benadryl. 5/14/07 - Evaluated by ENT ---> diagnose with sudden hearing loss syndrome, prescribed Prednisone, blood work and MRI done.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Deafness, Deafness unilateral, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: 05/13/07 - Experienced sudden onset of complete hearing loss left ear, with vertigo and nausea. Had slight temperature. Contacted PMD and was prescribed Ibuprofen and Benadryl. 5/14/07 - Evaluated by ENT ---> diagnose with sudden hearing loss syndrome, prescribed Prednisone, blood work and MRI done.
Age: 42.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Pyrexia, Sudden hearing loss, Vertigo
Clinical narrative: 05/13/07 - Experienced sudden onset of complete hearing loss left ear, with vertigo and nausea. Had slight temperature. Contacted PMD and was prescribed Ibuprofen and Benadryl. 5/14/07 - Evaluated by ENT ---> diagnose with sudden hearing loss syndrome, prescribed Prednisone, blood work and MRI done.
Sex: F
Vaccine: HEP, TD, DT, HEP, VARCEL
Symptoms: Erythema, Myalgia, Oedema peripheral, Skin warm
Clinical narrative: On 5/24 noticed burning and redness post. R upper arm - where varicella vaccine given
Sex: F
Vaccine: HEP, TD, DT, HEP, VARCEL
Symptoms: Erythema, Skin burning sensation
Clinical narrative: On 5/24 noticed burning and redness post. R upper arm - where varicella vaccine given
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Headache, Injection site cellulitis, Injection site erythema
Clinical narrative: Patient recieved Pneumovax on 5.31.07 in Dr.'s office.  Patient states 4 hours after injection he started with redness to site.  He called MD in AM was instructed to use ice and use Motrin.  He also started to get a HA, joint pain and low back pain.  He presents today to ED stable vital signs, cellulitiss to right upper arm where he states injection was given.
Age: 0.8
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Drug screen negative
Clinical narrative: The cause for pt's death has yet to be determined.  6/8/07 Rceived medical records & vax records from PCP which confirms vax as reported.  Patient had episode of whooping cough at 6 wks of age.  Dx w/URI 1/5/07, constipation 1/10/07.  Seen in ER 2/19/07 & dx w/fever, cough but was dx w/UTI & started septa.  Returned to PCP 2/20 w/fever 104.2, pale w/shiners & was advised to continue antibiotic & symptomatic tx.  Returned to PCP on 4/11/07 as well child but had not been gaining weight as expected despite parent report of good appetite.  Dx w/failure to thrive & advised lactobacillus qd.  Next seen on 4/17 & continued w/constipation, sallow color complexion, had only gained 2# in 4 mos at that time. 10/30/07 Reviewed Autopsy Report which reveals COD as undetermined.  Patient had clinical features of failure to thrive w/o source.  Possibility of asphyxia by overlaying during co-sleeping w/parent or rare functional disorder, metabolic or otherwise could not be ruled out.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cold compress therapy, Heat therapy, Nausea, Paraesthesia, Pruritus generalised
Clinical narrative: initial and follow up information has been received from a registered nurse, concerning a 19 year old female student with allergy to codeine, who was vaccinated with a first dose of (date not specified) Gardasil with no reported problems, and on 11-MAY-2007 at 10:30am was vaccinated with the second dose of Gardasil (Lot #657617/0384U). Concomitant therapy included ORTHO TRI-CYCLEN. On 12-MAY-2007 the patient started feeling nauseous; on 13-MAY-2007, she started feeling a tingly sensation in her shoulder, neck and scapula (reported by patient's phone call on 14-MAY-2007); she was instructed to alternate between hot and cold packs every 20 minutes and was prescribed MOTRIN 800mg, every 6-8 hours as treatment. On approximately 15-MAY-2007 ("later"), she experienced itching all over her body (reported by patient's phone call on 21-MAY-2007). The nurse reported that by 21-MAY-2007, the patient had completely recovered from all the symptoms. Follow up information indicated that the reporter considered one or more of the events to require medical intervention to prevent more serious symptoms, and were therefore considered to be other significant medical events. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Angiogram normal, Antinuclear antibody, Borrelia burgdorferi serology negative, Cardiolipin antibody, Diagnostic procedure
Clinical narrative: Information has been received from a physician and a 20 year old female consumer with Ceclor and sulfonamide allergy who on 19-APR-2007 was vaccinated with the first dose of Gardasil, IM. Concomitant medication was not reported. On approximately 26-APR-2007 ("within a week of receiving the vaccination), the patient reported that she had continued blurred vision "MS type symptoms" and had a 3 day hospital stay. A physician reported that on 29-APR-2007, the patient developed double vision which became progressively worse. The patient was diagnosed with sixth cranial nerve palsy. The patient had numerous diagnostic tests performed which included MRI's, an angiogram, lumbar puncture, visual tests and blood tests including a complete blood count, metabolic profile, antinuclear antibody (ANA) test, anticardiolipin antibody, sedimentation rate and blood test to rule out syphilis, Myasthenia Gravis, Sarcoidosis and Lyme disease. All of these test results were within normal limits. The patient was treated with steroids and was improving. Additional information has been requested.  06/06/07-records received from facility for DOS 5/1-5/2/07-DC DX: Left cranial nerve VI palsey on left. Mild hypertension. On 4/29/07 while watching TV noticed double vision on looking to left. Gradual onset. On 4/30/07 woke with double vision when looking in all directions. Double vision is with one image side by side to the other image. MRI brain showed right hemispheric lesion. Ophthamologist noted optic nerve lesion. Headache come on after having double vision. No eye pain no numbness or weakness.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Diplopia, Full blood count normal, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician and a 20 year old female consumer with Ceclor and sulfonamide allergy who on 19-APR-2007 was vaccinated with the first dose of Gardasil, IM. Concomitant medication was not reported. On approximately 26-APR-2007 ("within a week of receiving the vaccination), the patient reported that she had continued blurred vision "MS type symptoms" and had a 3 day hospital stay. A physician reported that on 29-APR-2007, the patient developed double vision which became progressively worse. The patient was diagnosed with sixth cranial nerve palsy. The patient had numerous diagnostic tests performed which included MRI's, an angiogram, lumbar puncture, visual tests and blood tests including a complete blood count, metabolic profile, antinuclear antibody (ANA) test, anticardiolipin antibody, sedimentation rate and blood test to rule out syphilis, Myasthenia Gravis, Sarcoidosis and Lyme disease. All of these test results were within normal limits. The patient was treated with steroids and was improving. Additional information has been requested.  06/06/07-records received from facility for DOS 5/1-5/2/07-DC DX: Left cranial nerve VI palsey on left. Mild hypertension. On 4/29/07 while watching TV noticed double vision on looking to left. Gradual onset. On 4/30/07 woke with double vision when looking in all directions. Double vision is with one image side by side to the other image. MRI brain showed right hemispheric lesion. Ophthamologist noted optic nerve lesion. Headache come on after having double vision. No eye pain no numbness or weakness.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syphilis test negative, VIth nerve paralysis, Vision blurred, Visual acuity tests normal
Clinical narrative: Information has been received from a physician and a 20 year old female consumer with Ceclor and sulfonamide allergy who on 19-APR-2007 was vaccinated with the first dose of Gardasil, IM. Concomitant medication was not reported. On approximately 26-APR-2007 ("within a week of receiving the vaccination), the patient reported that she had continued blurred vision "MS type symptoms" and had a 3 day hospital stay. A physician reported that on 29-APR-2007, the patient developed double vision which became progressively worse. The patient was diagnosed with sixth cranial nerve palsy. The patient had numerous diagnostic tests performed which included MRI's, an angiogram, lumbar puncture, visual tests and blood tests including a complete blood count, metabolic profile, antinuclear antibody (ANA) test, anticardiolipin antibody, sedimentation rate and blood test to rule out syphilis, Myasthenia Gravis, Sarcoidosis and Lyme disease. All of these test results were within normal limits. The patient was treated with steroids and was improving. Additional information has been requested.  06/06/07-records received from facility for DOS 5/1-5/2/07-DC DX: Left cranial nerve VI palsey on left. Mild hypertension. On 4/29/07 while watching TV noticed double vision on looking to left. Gradual onset. On 4/30/07 woke with double vision when looking in all directions. Double vision is with one image side by side to the other image. MRI brain showed right hemispheric lesion. Ophthamologist noted optic nerve lesion. Headache come on after having double vision. No eye pain no numbness or weakness.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician for the pregnancy registry for Gardasil concerning a female who was vaccinated with an unknown number of 0.5 mL doses of Gardasil. "A few weeks ago," the patient developed a miscarriage in the first trimester. The patient's outcome was unknown. Upon internal review, the patient's spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Coagulopathy
Clinical narrative: Information has been received from a physician's assistant concerning a female who was vaccinated with her first dose of Gardasil. Subsequently the patient experienced "coagulation" (not further specified). The patient needed to return to see the physician's assistant on several occasions for unknown treatment or follow-up. Subsequently, the patient recovered from "coagulation". "Coagulation" was determined to be an other important medical event by the reporting physician's assistant. Additional information is not expected.
Age: 91.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a nurse concerning a 91 year old male with anaemia, prostatic nodule, hypertension and lactose intolerance who on 07-MAY-2007 was vaccinated intramuscularly in the left deltoid with Pneumovax 23 (Lot#654977/0888F). Concomitant therapy included finasteride, aspirin and lisinopril. Subsequently, the patient experienced that from his left elbow down to his left hand became grossly swollen. It was reported that the area "was very hot, very erythematous, and very red". The nurse reported that the reaction was described as a "boggy elbow" (mushy) and was the texture of the skin of an orange. It was also reported that it was difficult for the patient to raise his arm. The patient was treated with prednisone (dose not provided) immediately and then prednisone, 20mg daily for two days. The patient was also treated with Benadryl, dose not specified. The nurse reported that the reaction resolved in 3 to 5 days. The nurse considered the events to be disabling and a serious other medical event. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 72 year old female with asthma, osteoporosis and hypothyroidism and a history of kidney stone and migraine who on 12-FEB-2007 was vaccinated intramuscularly in the left deltoid with Pneumovax 23 (Lot#654977/08888F). Concomitant therapy included SYNTHROID, LIPITOR, aspirin, alendronate sodium, CITRACAL, PIORINAL, cholecalciferol, NOVO-GABAPENTIN and BENADRYL. On 13-FEB-2007 the patient experienced that her upper left arm became extremely red and bright in color, swollen, painful and hot. The nurse reported that the texture of the reaction was smooth. She also reported that the patient had limited use of her left arm because of the reaction. The patient was treated with BENADRYL (dose not specified) and prednisone (dose not specified). Subsequently, it was reported that the reaction had resolved and the patient had recovered within one week. The events were considered to be disabling by the reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 72 year old female with asthma, osteoporosis and hypothyroidism and a history of kidney stone and migraine who on 12-FEB-2007 was vaccinated intramuscularly in the left deltoid with Pneumovax 23 (Lot#654977/08888F). Concomitant therapy included SYNTHROID, LIPITOR, aspirin, alendronate sodium, CITRACAL, PIORINAL, cholecalciferol, NOVO-GABAPENTIN and BENADRYL. On 13-FEB-2007 the patient experienced that her upper left arm became extremely red and bright in color, swollen, painful and hot. The nurse reported that the texture of the reaction was smooth. She also reported that the patient had limited use of her left arm because of the reaction. The patient was treated with BENADRYL (dose not specified) and prednisone (dose not specified). Subsequently, it was reported that the reaction had resolved and the patient had recovered within one week. The events were considered to be disabling by the reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, Pharyngeal oedema
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female, with an unspecified medical history, who was vaccinated with a dose of ProQuad. It was reported that the patient "developed swelling in her throat shortly after being vaccinated". The patient was treated with Benadryl and recovered. Unspecified medical attention was sought. No product quality complaint was involved. The patient's adverse event was considered to be other important medical event. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a certified medical assistant concerning a 6 month old male, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of Rotateq (Lot# 654422/0607F and 656187/1237F) on 16-JAN-2007 and 19-MAR-2007, respectively. Concomitant therapy included Tylenol as needed. On 28-APR-2007 the patient was taken to the emergency room and was transported to another facility that was equipped to handle children. The patient was hospitalized and underwent surgery to correct intussusception. It was reported that a nurse mentioned that the child was seen on 21-MAY-2007 for a well check up and was still recovering at that time. It was noted that the patient was due for a third dose of Rotateq, but the physician decided not to complete the series. No product quality complaint was involved. No other information was provided. The patient's intussusception was considered to be an other important medical event by the reporter. Additional information has been requested. A lot check has been requested.  6/14/07 Received medical records via fax from CDC which reveal patient experienced abdominal pain w/bilious emesis x 1 day.  Seen at outlying ER where UGI films were neg & stool was + for occult blood.  Admitted 4/20-5/2/07.  Taken to OR for operative reduction of ileocolic IS & appendectomy.  Progressed well & d/c to home. FINAL DX: Intussusception. 6/14/07 Received medical records of ER visit via fax from CDC which reveals patient experienced congestion, bilious vomiting, fever & crampy intermittent abdominal pain w/difficulty sleeping.  Transferred to higher level of care.
Age: 42.0
Sex: M
Vaccine: HEPAB, IPV
Symptoms: Hepatic enzyme increased, Hepatitis
Clinical narrative: This case was received from a health professional on 24 May 2007. A 4-year-old patient received an injection of YF-Vax (lot number not reported) and subsequently developed elevated liver enzymes and "may have developed hepatitis". No additional information was provided. 6/21/07-records received for DOS 5/20-5/25/07-DC DX:Viral syndrome likely mononucleosis reactivation. Patient was in China from 3/30-4/12/07 and developed diarrhea and has not really felt well since. Admitted with fever, nausea and recurrent diarrhea. He had mono as a teenager with hepatitis.
Age: 9.0
Sex: M
Vaccine: TYP
Symptoms: Fatigue, Hallucination, Headache, Pyrexia
Clinical narrative: This case was received from a health professional on 25 May 2007. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A nine-year-old male patient received an intramuscular right deltoid injection of Typhim Vi on 16 May 2007 and six to eight hours later experienced hallucinations, in addition to fever (102 degrees), headache, and fatigue. He was seen at an urgent care facility and was treated with "routine antipyretics". He had no known pre-existing conditions, and was not ill at the time of vaccination. The events were considered to be recovered.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Employee presents to EHS complaining of swelling, redness, itching at injection site. States she had some discomfort within 24-48 hours and by Friday, 6/1/07, she had pronounced swelling and more discomfort at injection site. Began itching yesterday. States she also had swelling in her left underarm. Pain extends to elbow. Marked edema, 60 mm x 70 mm erythema, increased skin temperature and fine raised maculopapular rash noted left deltoid area.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash maculo-papular, Swelling
Clinical narrative: Employee presents to EHS complaining of swelling, redness, itching at injection site. States she had some discomfort within 24-48 hours and by Friday, 6/1/07, she had pronounced swelling and more discomfort at injection site. Began itching yesterday. States she also had swelling in her left underarm. Pain extends to elbow. Marked edema, 60 mm x 70 mm erythema, increased skin temperature and fine raised maculopapular rash noted left deltoid area.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Axillary mass, Cellulitis, Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: Employee presents to EHS complaining of swelling, redness, itching at injection site. States she had some discomfort within 24-48 hours and by Friday, 6/1/07, she had pronounced swelling and more discomfort at injection site. Began itching yesterday. States she also had swelling in her left underarm. Pain extends to elbow. Marked edema, 60 mm x 70 mm erythema, increased skin temperature and fine raised maculopapular rash noted left deltoid area.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Oedema
Clinical narrative: Employee presents to EHS complaining of swelling, redness, itching at injection site. States she had some discomfort within 24-48 hours and by Friday, 6/1/07, she had pronounced swelling and more discomfort at injection site. Began itching yesterday. States she also had swelling in her left underarm. Pain extends to elbow. Marked edema, 60 mm x 70 mm erythema, increased skin temperature and fine raised maculopapular rash noted left deltoid area.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMRV, PPV, HEP, HEPA, MMRV, PNC
Symptoms: Rash
Clinical narrative: Skin rash started on left thigh, we noticed the rash at about 12:00PM.  Initial skin rash was two ovals, one 1.5" and other 2" in diameter.  2 hours later, skin rash had joined, grown and spread to arms.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMRV, PPV, HEP, HEPA, MMRV, PNC
Symptoms: Pruritus, Radioallergosorbent test, Swelling, Urticaria
Clinical narrative: Skin rash started on left thigh, we noticed the rash at about 12:00PM.  Initial skin rash was two ovals, one 1.5" and other 2" in diameter.  2 hours later, skin rash had joined, grown and spread to arms.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: One day after vaccine administration, site was swollen, red and warm.  Got worse on second day.  Administered diphenhydramine 25mg IV.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RIGHT UPPER ARM WITH MILD SWELLING, NONTENDER AND SLIGHT ERYTHEMA; LEFT ARM WITH QUARTER SIZE ERYTHEMATOUS AREA- NONTENDER
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Dizziness, headache and vomiting. Onset <24 hours after administration of Adacel (Tdap)
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Rash
Clinical narrative: Vaccine was administered in accordance with standard procedures, subcutaneously in the Left arm over the triceps muscle on May 15, 2007. On May 20, the patient developed a painful, red, blistering rash involving the Left T-7/8 dermatome. He contacted me on ~May 24 and was treated with Famcyclovir 500mg three times daily for one week. Given the timing, the patient is convinced that the vaccine caused his Zoster-like illness.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth, Rash generalised
Clinical narrative: Left deltoid swelling, bruising, warm at site, rash over all of body. Small bumps began day after Td given 5/21/07. Patient seen by Dr, PMD seen 5/22/07. Given antibiotics requested Td due to cut to right lower leg.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Palpitations
Clinical narrative: Visited County on 3/21/07 and was given Rx for Ty21a (Live oral typhoid vaccine). Client took Rx to local pharmacy to have it filled. Client did not have Rx filled until 5-2-07. Approximately on 5-9-07, she began experiencing "heart racing" which she reported increasingly severe over the next few days. She sought treatment at her internist's office. She was to wear a holter monitor and several medications.
Age: 0.13
Sex: F
Vaccine: HEP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Urticaria/ Benadryl 2ml. Q6 hrs.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Flatulence
Clinical narrative: Mother reports pt developed significant flatus and subsequent diarrhea (>8 times daily) beginning three days after being vaccinated (5/14/07).  Diarrhea has been watery and explosive and at times there has been blood and mucous streaking. This has continued for 2 weeks.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Blood test, Diarrhoea, Erythema nodosum, Similar reaction on previous exposure to drug
Clinical narrative: After first injection diahrrea occurred for 3 weeks.  After second injection vomiting/diahhrea occurred.  After third injection what appears to be erythema nodosum has occurred.  Been to primary doctor twice.  No explanations.  Been to dermatologist, back to original obgyn and have been referred to a rheumatologist.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: After first injection diahrrea occurred for 3 weeks.  After second injection vomiting/diahhrea occurred.  After third injection what appears to be erythema nodosum has occurred.  Been to primary doctor twice.  No explanations.  Been to dermatologist, back to original obgyn and have been referred to a rheumatologist.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Cellulitis
Clinical narrative: childs parents brought in sister who had had a vzv injection on 5/22/07 also.  the sister had a cellulitis on the arm of the injection.  parents reported that this patient had the same type of reaction.  the parents were advised to bring this patient in for evaluation of reaction.  the parents never brought this patient in so the exact reaction is unknown and as far as the office knows no treatment was undertaken.  contact with patient and family x2 were attempted, messages left with no response
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Cheilitis, Lip blister, Oral herpes
Clinical narrative: Mom stated red lips 24 hours post injection.  Mom stated fever blisters around lips 48 hours post injection. Mom called md today; Doctor, who stated not to give second vaccine.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Blood culture, Cellulitis, Erythema, Full blood count, Induration
Clinical narrative: patient came into clinic on 5/24/07 to have reaction evaluated.cellulitis of left arm was diaagnosed, erythema,warmth, diffuse induration, no fever, about 15-20 cm.  patient hospitalized 5/24-27/07 given iv ancef and vancomycin, blood cultures and nasal swab cultures done both negative, cbc and differential-wnl, patient discharged  home on bactrim and keflex 06/12/07-records received for DOS 5/24-5/27/07-DC DX:Left upper arm cellulitis, resolving. Obesity, rule out metabolic syndrome. HX of present illness:erythema, warmth and induration diffusely over lateral left upper arm. Temperature on admission 37.3 and remained afebrile for duration of hospital stay. WBC 6.6 with normal differential. Question of metabolic syndrome versus prediabetes. Given this cellulitis reaction and the patient's obesity there was a question of an immunocompromised host.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Skin warm
Clinical narrative: patient came into clinic on 5/24/07 to have reaction evaluated.cellulitis of left arm was diaagnosed, erythema,warmth, diffuse induration, no fever, about 15-20 cm.  patient hospitalized 5/24-27/07 given iv ancef and vancomycin, blood cultures and nasal swab cultures done both negative, cbc and differential-wnl, patient discharged  home on bactrim and keflex 06/12/07-records received for DOS 5/24-5/27/07-DC DX:Left upper arm cellulitis, resolving. Obesity, rule out metabolic syndrome. HX of present illness:erythema, warmth and induration diffusely over lateral left upper arm. Temperature on admission 37.3 and remained afebrile for duration of hospital stay. WBC 6.6 with normal differential. Question of metabolic syndrome versus prediabetes. Given this cellulitis reaction and the patient's obesity there was a question of an immunocompromised host.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Pt appears to have acquired shingles after the vaccine over the right leg L4/5 dermatomes. Mild pain, no pruritis, lesions are vesicular.
Age: 1.83
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large 12 cm diameter area of redness/induration surrounding injection site on L thigh
Age: 75.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Back pain, Chest pain, Diarrhoea, Musculoskeletal pain
Clinical narrative: Chest pain, abdominal pain, nausea, diarrhea, pain in bilateral shoulder girdles and upper thoracic back within a few hours after vaccine administered. Most of these symptoms were gone in less than 24 hours except for the pain in both shoulders and upper thoracic back has persisted and both shoulders especially the right shoulder persists. The areas are also tender to the touch. Injection ghivenb in the left deltoid area.
Age: 75.0
Sex: M
Vaccine: HEPA
Symptoms: Nausea
Clinical narrative: Chest pain, abdominal pain, nausea, diarrhea, pain in bilateral shoulder girdles and upper thoracic back within a few hours after vaccine administered. Most of these symptoms were gone in less than 24 hours except for the pain in both shoulders and upper thoracic back has persisted and both shoulders especially the right shoulder persists. The areas are also tender to the touch. Injection ghivenb in the left deltoid area.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Full blood count, Laboratory test, Urticaria, Wheezing
Clinical narrative: Hives x 2 days Wheezing decreased Epinephrine IM Benadryl IM Prednisone PO Zantac PO.  06/19/2007 MR received for ER admit for c/o development of a urticaric/erythematic rash over the past 72 hours with low grade temp of 99-100.  Seen prior to ER visit and txd with epi and Solumedrol, however rash progressed and child developed orbital swelling and lip swelling.    Initial PE showed mild erythema of the posterior pharynx, swollen lips and eyelids, no respiratory sx. Increased drooling.  Swelling resolved with Benadryl and Prelone. Impression:  Urticaric like rash with hx of angioedema, currently resolved.  Candidal rash.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Neurological symptom
Clinical narrative: Rec'd message from mother-pt admitted to hospital with neuro changes 5/16/07-12:51pm.  6/5/07 Received records from PCP which reveal patient on day of vax for well chld vs.  No problems noted.  Vax records received which confirm lot # & dose as reported. 6/22/07 Received hospital med recs which reveal patient experienced acute mental status changes, sudden onset left frontal HA, fatigue, sleepiness, urinary incontinence, difficult to arouse, loss of speech, unable to follow commands, right sided weakness, emesis.  Taken to ER where CT of head was WNL & labs were all WNL.  Started on IV antibiotics & antivirals in ER & transferred to higher level of care.  Admitted 5/15-6/7/07.  Was minimally responsive on arrival to hospital w/right side weakness, pupils minimally reactive, no speech, hyperreflexia of LEs.  Progressed to inpatient rehab service & continued to improve.  Developed RLL foot drop.  D/C to home on continued daily ASA & continued outpatient rehab services FINAL DX: right sided hemiplegia; stroke; impaired functional mobility; aphasia.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: 1st Rotavirus given after 12 wks of age. No adverse reaction from vaccine.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Chills, Hyperaesthesia, Pyrexia
Clinical narrative: Onset of fever, chills, backache and extreme sensitivity to touch of skin, the morning after vaccine administered.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Hyperaesthesia, Myalgia, Pyrexia
Clinical narrative: Fever, chills, myalgias, and sensitivity to touch of skin, beginning th evening of immunization.
Sex: M
Vaccine: ANTH, HEP, TDAP, TYP
Symptoms: Erythema, Induration
Clinical narrative: Soldier received his second anthrax injection day after he had a hard lump under his skin with erythema. Instructed him to see the doctor here.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: VZV vaccine #1 given 5-16-07. Developed varicella disease on 5-27-07.
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: (L) arm swollen, red sore
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: 5 min after injections given, mom approached RN asking about the child having a reaction to one of the shots. On RAT, less than 1/2 inch from ProQuad injection site there was a hiv approx 1.5 x 2cm with an area of warmth and redness approx 3.5 x 4 cm. Benadryl 12.5mg given p.o and approx 15-20 min after med dosing hive gone but redness remained.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Body temperature increased, Lymphadenopathy, Nausea, Vomiting
Clinical narrative: Nausea, Vomiting, Abdominal Pains, Swollen Lymph Glands. T>103 Onset 6hrs after vaccine
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Cold compress therapy, Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: fever to 100.4 and vomiting. (L) upper arm red, swollen, warm to touch area circled with pen-father will watch, cool compress. Will recheck tomorrow if needed
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: High Fever 104 and vomiting Resolved after 2 days with symptomatic tx
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Ear pain, Fatigue, Neck pain, Pain in jaw, Pharyngolaryngeal pain
Clinical narrative: 05-17-07 Sore throat and ear pain. 05-18-07 Progressed to jaw and neck pain. 5-18-07 was seen by her family physician. Treated with "a shot" and antibiotics (unknown what the shot was.) 05-19-07 fever and fatigue.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 05-17-07 Sore throat and ear pain. 05-18-07 Progressed to jaw and neck pain. 5-18-07 was seen by her family physician. Treated with "a shot" and antibiotics (unknown what the shot was.) 05-19-07 fever and fatigue.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Injection site reaction, Nausea, Pallor
Clinical narrative: Injection given and pt became weak, color drained from face and felt nauseated and faint. Pt did not faint- no LOC
Age: 7.0
Sex: M
Vaccine: HEP, IPV, MMRV, TD
Clinical narrative: Warm, Red, Induration->upper (L) arm 5 1/2" x 4". Denies Pain- (1) Ice packs (2) Ibuprofen 3 tsp Children every 6 hours by mouth. Return if sx increase.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Since injection (L) deltoid, pt experiencing shoulder/elbow pain. Treatment:now given Medrol dosepack
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Ear pain, Gaze palsy, Loss of consciousness, Postictal state, Posture abnormal
Clinical narrative: Within 101 min of immunizations, was staring and had ear pain, then eyes rolled back and pt "passed out" mom noted neck pulled to side and pt postured-lasted approx 1 min and postical state. Appeared well after incident (+) For Hx vagal syncope (Dad)
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Staring
Clinical narrative: Within 101 min of immunizations, was staring and had ear pain, then eyes rolled back and pt "passed out" mom noted neck pulled to side and pt postured-lasted approx 1 min and postical state. Appeared well after incident (+) For Hx vagal syncope (Dad)
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: 1 1/2" raised hard knot, very red, itching. "Looked like golfball under the skin" stated by Dad. This was (L) leg, anterior lateral thigh at the Proquad site. On Fri, May 25, babysitter reported to Dad it was worse, (softball size) put ice on till dr could see it. By that time was back to golf ball size. Dr told them to keep ice on it. Dad also applied 1% hydrocortisone. By 5-29 had decreased to small marble size with burising and tender but improving. Subsequently, on an unspecified date, the patient recovered. It was unspecified if a product quality complaint was involved.  02/19/2010 In follow up information, it was reported that on 31-JUL-2007, the patient's mother stated that the patient was fine-no lasting effects. Outcome  was reported as: 31-JUL-2007- Full recovery. Not further information is available.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Contusion, Erythema, Induration, Pruritus, Tenderness
Clinical narrative: 1 1/2" raised hard knot, very red, itching. "Looked like golfball under the skin" stated by Dad. This was (L) leg, anterior lateral thigh at the Proquad site. On Fri, May 25, babysitter reported to Dad it was worse, (softball size) put ice on till dr could see it. By that time was back to golf ball size. Dr told them to keep ice on it. Dad also applied 1% hydrocortisone. By 5-29 had decreased to small marble size with burising and tender but improving. Subsequently, on an unspecified date, the patient recovered. It was unspecified if a product quality complaint was involved.  02/19/2010 In follow up information, it was reported that on 31-JUL-2007, the patient's mother stated that the patient was fine-no lasting effects. Outcome  was reported as: 31-JUL-2007- Full recovery. Not further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Dysphonia, Oxygen saturation, Pharyngeal oedema, Swollen tongue, Throat tightness
Clinical narrative: Child received immunizations at regular check up. Went to ER same day c/o something being in throat, voice change, throat & tongue swollen. Got IV fluids, Benadryl 7.5 mg, Solu medrol 30 mg IV. Epinephrine 1:1,000 0.15 ml SQ, Benadryl 7.5 IV. Sent home with Orapred 15 mg/5 ml 10 ml QD x 5 days.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Cold compress therapy, Erythema, Injection site erythema
Clinical narrative: Localized redness of MMRV injection site 6-8 cm, red splotches on face cold compresses applied to L arm, red splotches resolved obs X L arm redness faded.
Age: 59.0
Sex: U
Vaccine: TDAP
Symptoms: Diarrhoea
Clinical narrative: On May 8, 07, I was injected with the vaccine. On May 9, 07, I had diarrhea the whole day. On May 10th, 07, I had soft stools. No treatment was given.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Axillary pain, Back pain, Body temperature increased, Headache
Clinical narrative: Received Menactra vaccine 5/16/07 PM. Arm became sore 6-8 hrs later. Woke 5/17/07 with temp 99.7, soreness in underarm. 5/18/07 soreness/swelling underarm worse. Developed body aches, back and hip pain. Slight headache. To HC provider 5/18/07 PM 5/21/07 recovered.