chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Vomiting, White blood cell disorder
Clinical narrative: From initial information received on 02May06 from a literature report. It was reported that a four year old male pt who had missed his previous Dtap booster vaccination at 12-18 months of age had received his fourth dose of a 3 component acellular pertussis vaccine combined with diphtheria and tetanus toxoids (Dtap) into the right thigh, and a measles mumps rubella vaccine injection into the left thigh. Manf, routes and lot numbers were not reported for either vaccine. 12 hrs post immunization, he presented to the ER room with diffuse swelling and erythema of the right thigh. The erythema and swelling progressed to involve the entire right thigh with mild pain noted around the Dtap injection site. No other systemic reactions such as fever, nausea, vomiting, diarrhea, abdominal pain or dyspnea were noted. Physical examination in the ER revealed a well appearing child in no acute distress. The right anterior thigh was markedly erythematous, warm to touch and mildly painful with movement. An erythematous papule surrounded by an area of pallor marked the injection site of the Dtap vaccine. The remainder of the physical examination was normal. Lab studies showed a white blood cell count of 8700/mm3 a platelet count of 118,000/mm3 and a negative blood culture. Because of concern for infection, therapy with intravenous oxacillin was initiated. Over the course of several hours, area became increasingly pruritic and diphenhydramine was administered. A contrasted computed tomography scan of both thighs revealed extensive edema and soft tissue swelling of the right anterior thigh. The thickness of the soft tissues between the anterior surface of the thigh and the patella on the right was 1.10cm and that on the left was 0.43cm. The thickness of the muscles in the right thigh was 6.92cm, and that on the left was 6.64cm. No evidence of abscess or bone abnormalities was seen. A venous Doppler study of both lower extremities demonstrated no evidence of deep venous thrombosis. During the hospitalization, the child remained afebrile and playful, with normal appetite and normal leg mobility. The reaction resolved completely by the end of the second hospital day, and the child was discharged.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Seriousness criteria Other medically significant (OMIC). Initial report received from a health care professional on 5/2/2006. A four year old male patient with a medical history of reactive air way disease, had received a fourth dose of Daptacel, lot number C2431AA, in the right deltoid, a dose of Ipol, lot number Y0824-2, in the right deltoid, and a dose of measles, mumps and rubella vaccine MMR in the left deltoid on 4/24/2006. The routes of administration were not reported for any of the products. The Daptacel vaccine was administered with a 5/8 in 25 gauge needle. Three days later, on 4/27/2006, the patient developed right arm swelling, which was described by the reporter as involving a large area. In addition, the patient had itchiness at the injection site and pain in his arm. He was seen by a physician that same day and was diagnosed with possible cellulitis. No laboratory results or culture results were reported. The patient was treated with Admacef 250 mg. At the time of this report he had not recovered from the events. The reporter of this case is the same as for the non serious cases 200601015 and 200601017.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Aphasia, CSF culture negative, Convulsion, Electroencephalogram abnormal, Encephalopathy
Clinical narrative: On May 2, 2006 pt admitted to hospital with status epilepticus r/o encephalitis. Pt currently intubated continuing to have seizures. Etiology unk at this time. 5/16/06 Received medical records from PCP which reveal patient developed hard red blotch at DTaP site on 4/26/06.  No fever.  Next day developed 2 lumps on right side of neck.  Dx w/tonsillitis, cervical adenitis, pharyngitis & local reaction to DTaP.  Started augmentin.  Throat c/s gre mod Grp A strep & was to continue antibiotic.  Next contact was when admitted to PICA on 5/2/ with diagnosis of seizures.  8/21/06 Received medical records from hospital.  Patient remained hospitalized until 7/27/06 w/final diagnosis of status epilepticus & encephalopathy of unknown origin.  While hospitalized, experienced line infection w/enterovirus & c.diff colitis.  Received multiple antibiotics & antivirals. Exam by PCP revealed + strep throat & place on antibiotics.  Had fever for 4 days.  On evening of admit, very tired, sleepy & had pounding HA.  Mom had found him in bathroom covered with stool & mumbling incoherently. Then he began starring, drooling, had oral cyanosis & would not respond to verbal stimuli for approx 5 min before falling asleep.  Had continued seizures in ER (unresponsive,drooling, eyes rolled back, but no shaking.  Pupils were sluggish on admit & he had a rash.  Patient continued to have seizures & was intubated & placed into Pb coma.  Trached on 6/7/06 & G-tube placed.  PMH: negative Procedures: EEG, CT scan, MRI, LP Consults: Neuro, ID, GI (for G-tube placement), Ortho (for AFO splinting) & endocrine (due to abnormal low T3 level).  ID notes patient had MMR also prior to hospitalization & had local reaction.  Post auricle shoddy lymphadenopathy noted./ss. Pt aphasic S/P status epilepticus. Pt tracked on CPAP at night. All workup negative. Pt sent to rehabilitation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Fatigue, Hypoxia, Injection site induration, Injection site warmth, Laboratory test
Clinical narrative: On May 2, 2006 pt admitted to hospital with status epilepticus r/o encephalitis. Pt currently intubated continuing to have seizures. Etiology unk at this time. 5/16/06 Received medical records from PCP which reveal patient developed hard red blotch at DTaP site on 4/26/06.  No fever.  Next day developed 2 lumps on right side of neck.  Dx w/tonsillitis, cervical adenitis, pharyngitis & local reaction to DTaP.  Started augmentin.  Throat c/s gre mod Grp A strep & was to continue antibiotic.  Next contact was when admitted to PICA on 5/2/ with diagnosis of seizures.  8/21/06 Received medical records from hospital.  Patient remained hospitalized until 7/27/06 w/final diagnosis of status epilepticus & encephalopathy of unknown origin.  While hospitalized, experienced line infection w/enterovirus & c.diff colitis.  Received multiple antibiotics & antivirals. Exam by PCP revealed + strep throat & place on antibiotics.  Had fever for 4 days.  On evening of admit, very tired, sleepy & had pounding HA.  Mom had found him in bathroom covered with stool & mumbling incoherently. Then he began starring, drooling, had oral cyanosis & would not respond to verbal stimuli for approx 5 min before falling asleep.  Had continued seizures in ER (unresponsive,drooling, eyes rolled back, but no shaking.  Pupils were sluggish on admit & he had a rash.  Patient continued to have seizures & was intubated & placed into Pb coma.  Trached on 6/7/06 & G-tube placed.  PMH: negative Procedures: EEG, CT scan, MRI, LP Consults: Neuro, ID, GI (for G-tube placement), Ortho (for AFO splinting) & endocrine (due to abnormal low T3 level).  ID notes patient had MMR also prior to hospitalization & had local reaction.  Post auricle shoddy lymphadenopathy noted./ss. Pt aphasic S/P status epilepticus. Pt tracked on CPAP at night. All workup negative. Pt sent to rehabilitation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Lymphadenopathy, Nuclear magnetic resonance imaging brain normal, Pharyngitis, Pyrexia, Staring
Clinical narrative: On May 2, 2006 pt admitted to hospital with status epilepticus r/o encephalitis. Pt currently intubated continuing to have seizures. Etiology unk at this time. 5/16/06 Received medical records from PCP which reveal patient developed hard red blotch at DTaP site on 4/26/06.  No fever.  Next day developed 2 lumps on right side of neck.  Dx w/tonsillitis, cervical adenitis, pharyngitis & local reaction to DTaP.  Started augmentin.  Throat c/s gre mod Grp A strep & was to continue antibiotic.  Next contact was when admitted to PICA on 5/2/ with diagnosis of seizures.  8/21/06 Received medical records from hospital.  Patient remained hospitalized until 7/27/06 w/final diagnosis of status epilepticus & encephalopathy of unknown origin.  While hospitalized, experienced line infection w/enterovirus & c.diff colitis.  Received multiple antibiotics & antivirals. Exam by PCP revealed + strep throat & place on antibiotics.  Had fever for 4 days.  On evening of admit, very tired, sleepy & had pounding HA.  Mom had found him in bathroom covered with stool & mumbling incoherently. Then he began starring, drooling, had oral cyanosis & would not respond to verbal stimuli for approx 5 min before falling asleep.  Had continued seizures in ER (unresponsive,drooling, eyes rolled back, but no shaking.  Pupils were sluggish on admit & he had a rash.  Patient continued to have seizures & was intubated & placed into Pb coma.  Trached on 6/7/06 & G-tube placed.  PMH: negative Procedures: EEG, CT scan, MRI, LP Consults: Neuro, ID, GI (for G-tube placement), Ortho (for AFO splinting) & endocrine (due to abnormal low T3 level).  ID notes patient had MMR also prior to hospitalization & had local reaction.  Post auricle shoddy lymphadenopathy noted./ss. Pt aphasic S/P status epilepticus. Pt tracked on CPAP at night. All workup negative. Pt sent to rehabilitation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Status epilepticus, Tonsillitis
Clinical narrative: On May 2, 2006 pt admitted to hospital with status epilepticus r/o encephalitis. Pt currently intubated continuing to have seizures. Etiology unk at this time. 5/16/06 Received medical records from PCP which reveal patient developed hard red blotch at DTaP site on 4/26/06.  No fever.  Next day developed 2 lumps on right side of neck.  Dx w/tonsillitis, cervical adenitis, pharyngitis & local reaction to DTaP.  Started augmentin.  Throat c/s gre mod Grp A strep & was to continue antibiotic.  Next contact was when admitted to PICA on 5/2/ with diagnosis of seizures.  8/21/06 Received medical records from hospital.  Patient remained hospitalized until 7/27/06 w/final diagnosis of status epilepticus & encephalopathy of unknown origin.  While hospitalized, experienced line infection w/enterovirus & c.diff colitis.  Received multiple antibiotics & antivirals. Exam by PCP revealed + strep throat & place on antibiotics.  Had fever for 4 days.  On evening of admit, very tired, sleepy & had pounding HA.  Mom had found him in bathroom covered with stool & mumbling incoherently. Then he began starring, drooling, had oral cyanosis & would not respond to verbal stimuli for approx 5 min before falling asleep.  Had continued seizures in ER (unresponsive,drooling, eyes rolled back, but no shaking.  Pupils were sluggish on admit & he had a rash.  Patient continued to have seizures & was intubated & placed into Pb coma.  Trached on 6/7/06 & G-tube placed.  PMH: negative Procedures: EEG, CT scan, MRI, LP Consults: Neuro, ID, GI (for G-tube placement), Ortho (for AFO splinting) & endocrine (due to abnormal low T3 level).  ID notes patient had MMR also prior to hospitalization & had local reaction.  Post auricle shoddy lymphadenopathy noted./ss. Pt aphasic S/P status epilepticus. Pt tracked on CPAP at night. All workup negative. Pt sent to rehabilitation.
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthritis, Atrioventricular block, Bacterial infection, Bradycardia, Cardiac disorder
Clinical narrative: Developed fever 101-103 within 12 hours of Fluzone. Seen 3 days later. Diagnosed viral pharyngitis. Seen again on day 7/10/12/05, with erythema and swelling of M-P joints 2-5 in both hands. DX'd with acute arthritis, possibly lymes W/- serology. Had strep throat x 2 on 3/30/06. and on 4/11/06 TX'd amoxil and Duricef respectively, but on 4/11/06 was noted to have HR 52. EKG complete heart block, admitted to hospital cardiac pacemaker placed. Note EKG at birth was normal sinus rhythm. Discharge summary states bradycardia, fever, heart block. msv
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Heart rate irregular, Joint swelling, Pharyngitis, Pharyngolaryngeal pain
Clinical narrative: Developed fever 101-103 within 12 hours of Fluzone. Seen 3 days later. Diagnosed viral pharyngitis. Seen again on day 7/10/12/05, with erythema and swelling of M-P joints 2-5 in both hands. DX'd with acute arthritis, possibly lymes W/- serology. Had strep throat x 2 on 3/30/06. and on 4/11/06 TX'd amoxil and Duricef respectively, but on 4/11/06 was noted to have HR 52. EKG complete heart block, admitted to hospital cardiac pacemaker placed. Note EKG at birth was normal sinus rhythm. Discharge summary states bradycardia, fever, heart block. msv
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Viral infection
Clinical narrative: Developed fever 101-103 within 12 hours of Fluzone. Seen 3 days later. Diagnosed viral pharyngitis. Seen again on day 7/10/12/05, with erythema and swelling of M-P joints 2-5 in both hands. DX'd with acute arthritis, possibly lymes W/- serology. Had strep throat x 2 on 3/30/06. and on 4/11/06 TX'd amoxil and Duricef respectively, but on 4/11/06 was noted to have HR 52. EKG complete heart block, admitted to hospital cardiac pacemaker placed. Note EKG at birth was normal sinus rhythm. Discharge summary states bradycardia, fever, heart block. msv
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthritis, Atrioventricular block, Bacterial infection, Bradycardia, Erythema
Clinical narrative: Developed fever 101-103 within 12 hours of Fluzone. Seen 3 days later. Diagnosed viral pharyngitis. Seen again on day 7/10/12/05, with erythema and swelling of M-P joints 2-5 in both hands. DX'd with acute arthritis, possibly lymes W/- serology. Had strep throat x 2 on 3/30/06. and on 4/11/06 TX'd amoxil and Duricef respectively, but on 4/11/06 was noted to have HR 52. EKG complete heart block, admitted to hospital cardiac pacemaker placed. Note EKG at birth was normal sinus rhythm. Discharge summary states bradycardia, fever, heart block. msv
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Joint swelling, Pharyngitis, Pharyngolaryngeal pain, Pyrexia, Viral infection
Clinical narrative: Developed fever 101-103 within 12 hours of Fluzone. Seen 3 days later. Diagnosed viral pharyngitis. Seen again on day 7/10/12/05, with erythema and swelling of M-P joints 2-5 in both hands. DX'd with acute arthritis, possibly lymes W/- serology. Had strep throat x 2 on 3/30/06. and on 4/11/06 TX'd amoxil and Duricef respectively, but on 4/11/06 was noted to have HR 52. EKG complete heart block, admitted to hospital cardiac pacemaker placed. Note EKG at birth was normal sinus rhythm. Discharge summary states bradycardia, fever, heart block. msv
Age: 23.0
Sex: M
Vaccine: HEP, HEPA, SMALL
Symptoms: Headache, Injection site reaction, Malaise
Clinical narrative: 24 y/o male, presents with multiple erythemic papules 3cm in diameter across trunk. Pt had H/A and malaise. Site was robust with enlarged lesion.
Sex: U
Vaccine: RV5
Symptoms: Lethargy, Vomiting
Clinical narrative: Info has been received from a physician concerning a pediatric pt who on 3/15/06 was vaccinated with a dose of rotavirus 01 02 03 F1 reassortant vaccine live (Human-bovine). The physician reported that on 3/15/06, the pt developed vomiting and lethargy. Unspecified medical attention was sought. Subsequently, the pt's vomiting and lethargy resolved. Additional info has been requested.
Sex: F
Vaccine: RV5
Symptoms: Eye pain
Clinical narrative: Info has been received from an RN concerning another female nurse who had a pt spit rotavirus G1 02 03 04 P1 reassortant vaccine live (human-bovine) into her eye. The RN reported that the nurse had some burning in her eye. Unspecified medical attention was sought and it was noted that the nurse did not wash her eye. At the time of this report, the outcome was unknown. Additional info has been requested.
Age: 1.67
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse (RN) concerning an 8-month-old infant who on 12-APR-2006, was vaccinated PO with the 1st dose of ROTATEQ. Unspecified medical attention was sought, but no adverse events were reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Info has been received from a  physician concerning a few children who in 2006, were vaccinated po with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) at 4 months of age. Unspecified medical attention was sought. No further info is available.
Age: 0.85
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 10-month-old infant who on 12-APR-2006, was vaccinated PO with the 1st dose of ROTATEQ. Unspecified medical attention was sought, but no adverse events were reported. Additional info has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Child developed fever, sore throat and varicella.
Age: 1.25
Sex: F
Vaccine: HIBV, OPV
Symptoms: Dermatitis bullous
Clinical narrative: Multiple papules, vesicles
Age: 1.05
Sex: M
Vaccine: MER, VARCEL
Symptoms: Rash papular
Clinical narrative: >50 lesions. Multiple papulovesicular lesions.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Pruritus
Clinical narrative: Pt brought to clinic 5/5/06 for PPD read. Dad mentioned red area, circled by mom 5/4/06, that was 2 1/2" x 3" area. Checked now 4" x 6" red. Pt afebrile. Pt c/o "itchy" at red area. Pt seen by pediatrician. Benadryl recommended with ibuprofen. (DX: Inflammatory reaction not infectious).
Age: 1.12
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Quarter-sized red, swollen and tender R thigh the night of vaccine administration. The next day, temperature up to 104. At ER, treated with antipyretics. The 2nd day, temperature still up to 103.5 + vomiting x 2. Examined on 3rd day, redness gone, irritable, clingy.
Age: 1.12
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Vomiting
Clinical narrative: Quarter-sized red, swollen and tender R thigh the night of vaccine administration. The next day, temperature up to 104. At ER, treated with antipyretics. The 2nd day, temperature still up to 103.5 + vomiting x 2. Examined on 3rd day, redness gone, irritable, clingy.
Age: 1.01
Sex: F
Vaccine: DTAP, HEP, HIBV, MMR, PNC
Symptoms: Dermatitis bullous
Clinical narrative: 5 year old female, presented with chicken pox lesions. Less the 50 total lesions today.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on legs and under arms.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site red, sore, tight, numb and hot.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Injection site red and swollen. Pt very fussy.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Injection site red, swollen and itchy.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Injection site very swollen, red and hot. Itchy too. Injection site is documented to be Pediarix.
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Chest pain, Hypertension, Pain
Clinical narrative: High blood pressure, pain lower back, vision problem; urinary frequency; skin rashed; pain joint and back, pain leg, pain chest; sinusitis.
Sex: M
Vaccine: ANTH
Symptoms: Pollakiuria, Rash, Sinusitis, Visual disturbance
Clinical narrative: High blood pressure, pain lower back, vision problem; urinary frequency; skin rashed; pain joint and back, pain leg, pain chest; sinusitis.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Epistaxis, Pyrexia
Clinical narrative: Pt developed fever and nose bleeding after vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Redness, swelling, itching, warmth, pain in right thigh. Worsening, seen in HD 5/10/06 in morning. Presented to ER in evening.
Age: 5.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema, Tenderness
Clinical narrative: 5/3/06 mom calling to report swelling upper right arm from elbow to well into shoulder double the size. Skin hot to touch redness from shoulder to past elbow, tender to touch left arm shot site lump with redness.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Injection site haemorrhage, Injection site reaction
Clinical narrative: MMR admin without difficulty, no c/o by patient. Stated she forgot about shot and bandaid after showering 4/25/06am she removed the bandaid and noted a 6cm circular bruise on her left upper posterior arm. Upon removing the bandaid the adhesive left an imprint on the arm where placed. Pt reported this to campus health nurse 4/27/06 after being referred by her instructor. On 4/27/06 an oblong 4cm x 6cm area of ecchymotic skin was noted in the area the MMR was administered. No erythema or streaking, no warmth to touch. Pt has full range of motion of left arm and can do all daily activities. No other side effects noted. Evaluation of bruise on 4/28/06 measures 3 1/2 x 5cm. Evaluation 5/1/06 bruise measures 3x4cm. No other c/o. On 5/2/06 bruises on left arm measures 2 1/2 cm x 4cm. Follow up telephone call on 5/12/06 pt states bruise is resolved. No others complaints.
Age: 1.06
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Chicken Pox disease.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Face oedema
Clinical narrative: About 4 hours after immunization given child's, cheeks and lips became swollen (PO for Atarax 25mg QID) Child on Atarax 25mg for severe Eczema routinely. No resp distress noted. Child's lips remained swollen for several days.
Age: 1.03
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Measles like rash with temp developed 1 week after receiving immunization.
Age: 0.35
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Breath holding, Cough, Crying, Cyanosis
Clinical narrative: When receiving 4 injection, pt cried more strongly then developed perioral cyanosis with pale skin and cool extremities. Pt also developed coughing and grunting. I returned to exam room, Pt noted to be pale but breathing comfortably lungs clear, ALD Soft nontender. RA pulse OX 97%, with pulse 103, Pt became sleepy and erythema macular noted lower extremities. Mom quite concerned. Pt taken to ER for eval following discussion between mom and me. Accompanied with incident. After giving report to ER Dr. I joined her in the ER.  In triage pt noted to be less pale VVS. We elected to allow pt to leave with mom to closely observe, Unsure if pt had breath holding episode as a results of injection. +/- aspirates deltoid SZ. Observe for now.
Age: 0.35
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Grunting, Pallor, Peripheral coldness, Rash macular
Clinical narrative: When receiving 4 injection, pt cried more strongly then developed perioral cyanosis with pale skin and cool extremities. Pt also developed coughing and grunting. I returned to exam room, Pt noted to be pale but breathing comfortably lungs clear, ALD Soft nontender. RA pulse OX 97%, with pulse 103, Pt became sleepy and erythema macular noted lower extremities. Mom quite concerned. Pt taken to ER for eval following discussion between mom and me. Accompanied with incident. After giving report to ER Dr. I joined her in the ER.  In triage pt noted to be less pale VVS. We elected to allow pt to leave with mom to closely observe, Unsure if pt had breath holding episode as a results of injection. +/- aspirates deltoid SZ. Observe for now.
Age: 0.35
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Somnolence
Clinical narrative: When receiving 4 injection, pt cried more strongly then developed perioral cyanosis with pale skin and cool extremities. Pt also developed coughing and grunting. I returned to exam room, Pt noted to be pale but breathing comfortably lungs clear, ALD Soft nontender. RA pulse OX 97%, with pulse 103, Pt became sleepy and erythema macular noted lower extremities. Mom quite concerned. Pt taken to ER for eval following discussion between mom and me. Accompanied with incident. After giving report to ER Dr. I joined her in the ER.  In triage pt noted to be less pale VVS. We elected to allow pt to leave with mom to closely observe, Unsure if pt had breath holding episode as a results of injection. +/- aspirates deltoid SZ. Observe for now.
Age: 29.0
Sex: M
Vaccine: MEN
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hypoaesthesia, Skin burning sensation
Clinical narrative: Numbness and burning down ulnar portion of arm into hypothenar area for one week. And down back of both legs for 3 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Left deltoid and Left outer aspect of upper arm swollen, red, hot to touch, denies pain, DR notified and see client. Advise to apply ice or cold compress and take Motrin.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site inflammation, Injection site warmth
Clinical narrative: Inflamed, red, warm to touch upper arm, deltoid are with 50/50 mm red area. Temp 98.1.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site inflammation
Clinical narrative: Inflamed upper arm deltoid 40 x 40 mm, red, temp 98.4, child c/o no pain.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Swollen right arm red, hot all the way to the elbow 1xN to DTaP.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, pain, warmth at injection site 6 inches long 4 inches wide.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: 2 days after vaccine DTaP given, woke up with red, swollen, left arm. Size of a baseball, redness did start to go away on second day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: Left arm knotted and hot to touch. DTaP.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: Received DTaP to left thigh during 4 yo PE on 5/10/06. Started having a vaccine reaction that night which became enlarged reddened and hard on the left thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis left thigh vs reaction to immunization.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Left deltoid red and swollen (mild redness to deltoid) TX Augmentin 400mg BID x 10 Days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Agitation, Crying, Injection site hypersensitivity, Injection site mass, Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site redness in a 5 year old male subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix) for prophylaxis. The subject had no pre existing medical conditions. There were no concurrent medications. ON 5/4/2006 at 4:00 pm, the subject received 5th dose of Infanrix in the left arm (lot AC14B018AA). On 5/4/2005, the subject also received the 4th dose of inactivated poliomyelitis virus vaccine (Ipol, lot Y0241) at an unspecified site of administration. On 5/4/2006, the same day as the vaccination with Infanrix, the subject experienced crying, fever, and injection site redness, hardening and heat at the site of the Infanrix administration. The subject was treated with Ibuprofen Advil and compresses. The physician considered the events to be disabling. The events resolved on an unspecified date on or after 5/4/2006 and on or before 5/11/2006.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of injection site redness in a 5 year old male subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix) for prophylaxis. The subject had no pre existing medical conditions. There were no concurrent medications. ON 5/4/2006 at 4:00 pm, the subject received 5th dose of Infanrix in the left arm (lot AC14B018AA). On 5/4/2005, the subject also received the 4th dose of inactivated poliomyelitis virus vaccine (Ipol, lot Y0241) at an unspecified site of administration. On 5/4/2006, the same day as the vaccination with Infanrix, the subject experienced crying, fever, and injection site redness, hardening and heat at the site of the Infanrix administration. The subject was treated with Ibuprofen Advil and compresses. The physician considered the events to be disabling. The events resolved on an unspecified date on or after 5/4/2006 and on or before 5/11/2006.
Sex: F
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Cognitive disorder, Dizziness, Dysgraphia
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced arthralgia, fatigue, rashes, dizziness, memory loss, vision problems, headaches, sleeping problems, joint stiffness, difficulty reading and writing, rheumatologic, neurologic, and or cognitive impairment of autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of the reporting the outcome of the events was unspecified.
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Headache, Immune system disorder, Joint stiffness, Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced arthralgia, fatigue, rashes, dizziness, memory loss, vision problems, headaches, sleeping problems, joint stiffness, difficulty reading and writing, rheumatologic, neurologic, and or cognitive impairment of autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of the reporting the outcome of the events was unspecified.
Sex: F
Vaccine: LYME
Symptoms: Rash, Rheumatoid factor, Sleep disorder, Visual disturbance
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced arthralgia, fatigue, rashes, dizziness, memory loss, vision problems, headaches, sleeping problems, joint stiffness, difficulty reading and writing, rheumatologic, neurologic, and or cognitive impairment of autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of the reporting the outcome of the events was unspecified.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Cognitive disorder, Disturbance in attention, Eye disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. On an unspecified date after vaccination with Lymerix, the subject experienced arthralgias, myalgias, difficulty concentrating, headaches, Bells palsy, jaw locking, fatigue, joint stiffness, decreased stamina, gastrointestinal problems, tinnitus, weakness, numbness and tingling in face, hands and feet, sleep difficulty, eye problems, weakness, muscle spasms, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Facial palsy, Fatigue, Gastrointestinal disorder, Headache, Hypoaesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. On an unspecified date after vaccination with Lymerix, the subject experienced arthralgias, myalgias, difficulty concentrating, headaches, Bells palsy, jaw locking, fatigue, joint stiffness, decreased stamina, gastrointestinal problems, tinnitus, weakness, numbness and tingling in face, hands and feet, sleep difficulty, eye problems, weakness, muscle spasms, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Immune system disorder, Insomnia, Joint stiffness, Muscle spasms, Myalgia
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. On an unspecified date after vaccination with Lymerix, the subject experienced arthralgias, myalgias, difficulty concentrating, headaches, Bells palsy, jaw locking, fatigue, joint stiffness, decreased stamina, gastrointestinal problems, tinnitus, weakness, numbness and tingling in face, hands and feet, sleep difficulty, eye problems, weakness, muscle spasms, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Nervous system disorder, Paraesthesia, Rheumatoid factor, Tinnitus
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. On an unspecified date after vaccination with Lymerix, the subject experienced arthralgias, myalgias, difficulty concentrating, headaches, Bells palsy, jaw locking, fatigue, joint stiffness, decreased stamina, gastrointestinal problems, tinnitus, weakness, numbness and tingling in face, hands and feet, sleep difficulty, eye problems, weakness, muscle spasms, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a physician and described the occurrence of injection site redness in a 4 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. Medical history included allergies to penicillin and cefaclor (Ceclor). There were no concurrent medications. On 5/3/2006 at 4:00pm, the subject received 5th dose of Infanrix in the left arm (lot AC14B018AA). On 5/3/2006, the subject also received the 4th dose of inactivated poliomyelitis virus vaccine (Ipol, lot Y0241) at an unspecified site of administration. On 5/5/2006,  2 days after vaccination with Infanrix, the subject experienced injection site redness, hardening injection site and heat at injection site at the site of the Infanrix administration. The subject was treated with ibuprofen (Advil) and compresses. The physician considered the events to be disabling. The outcome of the events was not reported.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a physician and described the occurrence of injection site redness in a 4 year old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. The subject had no pre existing medical conditions. There were no concurrent medications. On 3/22/2006, the subject received 5th dose of Infanrix in the left arm (lot AC14B018AA). On 3/22/2006, the subject also received the 4th dose of inactivated poliomyelitis virus vaccine (Ipol, lot Y0241) at an unspecified site of administration. On 3/22/2006, the same day as the vaccination with Infanrix, the subject experienced injection site redness, hardening injection site and heat at injection site at the site of the Infanrix administration. The subject was treated with Ibuprofen Advil and compresses. The physician considered who events to be disabling. The events resolved on an unspecified date on or after 3/22/2005 and on or before 5/11/2006.
Age: 1.52
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PPV, VARCEL
Symptoms: Convulsion, Meningitis
Clinical narrative: Seizures day 5 after shots. 23 page medical record received on 5/26/06 fromHospital. History and Physical, ED report documents arrival to ED on 5/14/2006 (5 days after DTAP, HIB, pneumococal conjugate, 3rd IPP, MMR and varicella vaccine), with generalized tonic clonic seizure observed. Subsequent seizure observed in ED. Treatment included Valium 6mg IV and phenytoin 195 mg IV. Physical exam documented sleepy, fussy irritable well nourished thirsty pale 18 month old. Temp 97.8, pupils equaly, reactive to light and accommodation. External ocular movements intact, red reflex present. Clear tympanic membranes, lungs clear, heart rate regular, neurologic without any focal deficit.  Mother stated that child is behind on immunizations. Admitted for overnight observation (from 5/14/06 at 14:31 to 05/15/06 at022:45) . Impression:First time seizures, possible reaction to vaccines with afebrile seizure or septic meningitis versus encephalitis. Discharge instructions included follow-up appointment with neurologist.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Hypoxia, Syncope vasovagal
Clinical narrative: Went to ER with possible seizure. Felt to be an Vasovagal syncopal episode with possible seizure ave to hypoxia.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Headache, Loss of consciousness, Night sweats, Pain
Clinical narrative: Patient awoke on 5/11/06 and 5/12/06 with the feeling he had a fever, his sheets were wet and he was achy with a slight headache.  He reports he passed out at 1930 on 5/12/06, and was out for about one minute and witness described that the patient was shaking and convulsing in a seizure like manner.  EMT services were called.  By the time the EMT's arrived the patient reports he was stable and recovered and declined tranport. Patient states his VS were WNL.  Since that event the patient reports he feels fine - no further issues.  He is following up with his primary care physician when he returns from vacation in two weeks.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Tremor
Clinical narrative: Patient awoke on 5/11/06 and 5/12/06 with the feeling he had a fever, his sheets were wet and he was achy with a slight headache.  He reports he passed out at 1930 on 5/12/06, and was out for about one minute and witness described that the patient was shaking and convulsing in a seizure like manner.  EMT services were called.  By the time the EMT's arrived the patient reports he was stable and recovered and declined tranport. Patient states his VS were WNL.  Since that event the patient reports he feels fine - no further issues.  He is following up with his primary care physician when he returns from vacation in two weeks.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Fatigue, Muscular weakness
Clinical narrative: Fever x 3 days starting the night after vaccines with increasing fatigue and proximal muscle weakness leading to rheumatology referral and hospital admission x 2wks with pending inpatient rehabilitation. Per 60 day follow up: Patient was diagnosed with a myopathy, likely unrelated to vaccines as symptoms preceded vaccination.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever x 3 days starting the night after vaccines with increasing fatigue and proximal muscle weakness leading to rheumatology referral and hospital admission x 2wks with pending inpatient rehabilitation. Per 60 day follow up: Patient was diagnosed with a myopathy, likely unrelated to vaccines as symptoms preceded vaccination.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Condition aggravated, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: Fever x 3 days starting the night after vaccines with increasing fatigue and proximal muscle weakness leading to rheumatology referral and hospital admission x 2wks with pending inpatient rehabilitation. Per 60 day follow up: Patient was diagnosed with a myopathy, likely unrelated to vaccines as symptoms preceded vaccination.
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: Abdominal pain upper, Blood pressure decreased, Nausea, Vertigo
Clinical narrative: Vertigo, Nausea, Stomach pain.
Age: 1.02
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Red, itchy rash on trunk identified as chicken pox by MD.
Age: 1.15
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: 1/6/06: Mom calls into office states daughter developed a rash 3 days after MMR given 12/15/05.  Mom reports that they saw Dr. for rash 10 days ago.  She was put on a "steroid cream" Mom reports.  Stated that the rash was spreading & Mom wonders what to do - advised to see MD for further follow-up. (Did not see child or evaluate rash.  Only Mom's telephone call to report).
Age: 52.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus
Clinical narrative: Had generalized itching start the day after his first oral typhoid pill. It progressivly became worse after each pill he took. Still has the itching, at it's worst today, four days after completing his last pill. No hives, SOB, etc.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Nausea, Pruritus, Vomiting
Clinical narrative: Patient received 2 dose of rabies vaccine as initial series prior to travel to endemic area.  She began to get full body pruritis shortly after leaving clinic.  3 hours after receiving vaccine, she felt abdominal cramping, nausea and vomited x 1.  Her abdominal cramping steadily decreased over next 24 hours.
Age: 1.53
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: pt. developed a nickel sized swelling on the right thigh the day after administration of DTAP and HIB. The redness also increased on the same day. Pt. also developed fever, vomiting and diarrhea but was active.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L Deltoid swelling into Bicep area w/ redness and tenderness.
Age: 40.0
Sex: F
Vaccine: MMR, TTOX
Symptoms: Contusion, Headache, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: RIGHT ARM SWOLLEN 3cm X 4cm wide. Red feverish spot. Bruise in the arm. At site of injection, you can feel a knot in the muscle. Patient had fever of 101, nausea, and headache for three days after shots received. Took Motrin for pain for 3 days after.
Age: 40.0
Sex: F
Vaccine: MMR, TTOX
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: RIGHT ARM SWOLLEN 3cm X 4cm wide. Red feverish spot. Bruise in the arm. At site of injection, you can feel a knot in the muscle. Patient had fever of 101, nausea, and headache for three days after shots received. Took Motrin for pain for 3 days after.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Cellulitis, Erythema, Injection site induration, Rash vesicular
Clinical narrative: Vesicular rash, induration, erythema, cellulitis 1 1/2 weeks after Varivax and Prevnar given.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left upper arm with marked erythema and increase calor of 4-5cm, indurated. Reaction allergic to drug Adacell, I am unsure if this is cellulitis but suspect it is just a strong immune response to the vaccine.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Flushing, Injection site oedema
Clinical narrative: Patient experienced right arm swelling, soreness, and redness that extended to the elbow and approximately 1 inch above the injection site. The area was hot to touch.  Temp - 99.5 She had a minor rash on both arms and complained of tiredness, headache, aching joints, and chills. She also had swollen lymph nodes under the right arm that extended down into the right breast.