chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Skin warm
Clinical narrative: Patient is complaining of numbess in his Right Arm following ANT, TYV, and TPP immunizations on 14 Jun 2007; 5 days following immunizations.  Pt recieved Typhoid vaccine in Right Deltoid with IM injection, Anthrax in left deltoid with Sub-Q injection and PPD on right forearm.  The numbess is localized from his R Shoulder to his R Elbow with associated weakness upon a neuro exam.  Skin Color is Pink, Skin is Warm and Moist with Cap Refill < 3 Sec.  Individual has decreased muscle strength at shoulder with Full strength at Elbow.  At this time, Individual is being considered for Referral to Neurology evaluation.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Blood creatine phosphokinase, Blood culture negative, C-reactive protein increased, Chest X-ray normal
Clinical narrative: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no medical history, was vaccinated IM in the left arm, on 16-MAR-2007, with the second dose of Gardasil (Lot #656051/0244U). On 27-MAR-2007 the patient experienced severe myalgias that progressed over 2 weeks until the patient was unable to sit up or walk. On 04-APR-2007, the patient developed a fever and within one hour of onset, became hypotensive and developed a flushing rash: she was admitted to the pediatric intensive care unit (PICU). The patient experienced the events of abasia, diarrhea, flushing , hypokinesia, hypotension, hypotension, inflammation, myalgia, nausea, pharyngolaryngeal pain, pyrexia and rash. Treatment included pressors (unspecified) and dopamine. As of 06-APR-2007, no source had been identified (the source of infection may have been an inflammed area on the back of the patient's earlobe at an earring hole site), and the patient was improving. The listing indicated that one or more of the events required a visit to the emergency room, resulted in hospitalization, was considered to be life threatening. No further information is available. The original reporting source was not identified. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards and was released. 04-Apr-2007 DA Streptococcus oralis culture negative, 04-Apr-2007 DA blood negative, 04-Apr-2007 DA chest X-ray normal, 04-APR-2007 DA diagnostic hematology blood test negative, 04-APR-2007 DA erythrocyte sedimentation rate 36 (units not provided), 04-Apr-2007 DA serum C-reaction protein test 8.3 (units not provided), 04-Apr-2007 DA serum antistreptolysin O antigen test negative, 04-Apr-2007 DA urine culture negative, 04-Apr-2007 DA white blood cell count elevated.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Culture urine negative, Diarrhoea, Flushing, Haematology test normal, Hypokinesia
Clinical narrative: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no medical history, was vaccinated IM in the left arm, on 16-MAR-2007, with the second dose of Gardasil (Lot #656051/0244U). On 27-MAR-2007 the patient experienced severe myalgias that progressed over 2 weeks until the patient was unable to sit up or walk. On 04-APR-2007, the patient developed a fever and within one hour of onset, became hypotensive and developed a flushing rash: she was admitted to the pediatric intensive care unit (PICU). The patient experienced the events of abasia, diarrhea, flushing , hypokinesia, hypotension, hypotension, inflammation, myalgia, nausea, pharyngolaryngeal pain, pyrexia and rash. Treatment included pressors (unspecified) and dopamine. As of 06-APR-2007, no source had been identified (the source of infection may have been an inflammed area on the back of the patient's earlobe at an earring hole site), and the patient was improving. The listing indicated that one or more of the events required a visit to the emergency room, resulted in hospitalization, was considered to be life threatening. No further information is available. The original reporting source was not identified. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards and was released. 04-Apr-2007 DA Streptococcus oralis culture negative, 04-Apr-2007 DA blood negative, 04-Apr-2007 DA chest X-ray normal, 04-APR-2007 DA diagnostic hematology blood test negative, 04-APR-2007 DA erythrocyte sedimentation rate 36 (units not provided), 04-Apr-2007 DA serum C-reaction protein test 8.3 (units not provided), 04-Apr-2007 DA serum antistreptolysin O antigen test negative, 04-Apr-2007 DA urine culture negative, 04-Apr-2007 DA white blood cell count elevated.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Infection, Inflammation, Myalgia, Nausea
Clinical narrative: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no medical history, was vaccinated IM in the left arm, on 16-MAR-2007, with the second dose of Gardasil (Lot #656051/0244U). On 27-MAR-2007 the patient experienced severe myalgias that progressed over 2 weeks until the patient was unable to sit up or walk. On 04-APR-2007, the patient developed a fever and within one hour of onset, became hypotensive and developed a flushing rash: she was admitted to the pediatric intensive care unit (PICU). The patient experienced the events of abasia, diarrhea, flushing , hypokinesia, hypotension, hypotension, inflammation, myalgia, nausea, pharyngolaryngeal pain, pyrexia and rash. Treatment included pressors (unspecified) and dopamine. As of 06-APR-2007, no source had been identified (the source of infection may have been an inflammed area on the back of the patient's earlobe at an earring hole site), and the patient was improving. The listing indicated that one or more of the events required a visit to the emergency room, resulted in hospitalization, was considered to be life threatening. No further information is available. The original reporting source was not identified. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards and was released. 04-Apr-2007 DA Streptococcus oralis culture negative, 04-Apr-2007 DA blood negative, 04-Apr-2007 DA chest X-ray normal, 04-APR-2007 DA diagnostic hematology blood test negative, 04-APR-2007 DA erythrocyte sedimentation rate 36 (units not provided), 04-Apr-2007 DA serum C-reaction protein test 8.3 (units not provided), 04-Apr-2007 DA serum antistreptolysin O antigen test negative, 04-Apr-2007 DA urine culture negative, 04-Apr-2007 DA white blood cell count elevated.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngolaryngeal pain, Pyrexia, Rash, Red blood cell count increased, Streptococcal identification test negative
Clinical narrative: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no medical history, was vaccinated IM in the left arm, on 16-MAR-2007, with the second dose of Gardasil (Lot #656051/0244U). On 27-MAR-2007 the patient experienced severe myalgias that progressed over 2 weeks until the patient was unable to sit up or walk. On 04-APR-2007, the patient developed a fever and within one hour of onset, became hypotensive and developed a flushing rash: she was admitted to the pediatric intensive care unit (PICU). The patient experienced the events of abasia, diarrhea, flushing , hypokinesia, hypotension, hypotension, inflammation, myalgia, nausea, pharyngolaryngeal pain, pyrexia and rash. Treatment included pressors (unspecified) and dopamine. As of 06-APR-2007, no source had been identified (the source of infection may have been an inflammed area on the back of the patient's earlobe at an earring hole site), and the patient was improving. The listing indicated that one or more of the events required a visit to the emergency room, resulted in hospitalization, was considered to be life threatening. No further information is available. The original reporting source was not identified. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards and was released. 04-Apr-2007 DA Streptococcus oralis culture negative, 04-Apr-2007 DA blood negative, 04-Apr-2007 DA chest X-ray normal, 04-APR-2007 DA diagnostic hematology blood test negative, 04-APR-2007 DA erythrocyte sedimentation rate 36 (units not provided), 04-Apr-2007 DA serum C-reaction protein test 8.3 (units not provided), 04-Apr-2007 DA serum antistreptolysin O antigen test negative, 04-Apr-2007 DA urine culture negative, 04-Apr-2007 DA white blood cell count elevated.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count, X-ray normal
Clinical narrative: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no medical history, was vaccinated IM in the left arm, on 16-MAR-2007, with the second dose of Gardasil (Lot #656051/0244U). On 27-MAR-2007 the patient experienced severe myalgias that progressed over 2 weeks until the patient was unable to sit up or walk. On 04-APR-2007, the patient developed a fever and within one hour of onset, became hypotensive and developed a flushing rash: she was admitted to the pediatric intensive care unit (PICU). The patient experienced the events of abasia, diarrhea, flushing , hypokinesia, hypotension, hypotension, inflammation, myalgia, nausea, pharyngolaryngeal pain, pyrexia and rash. Treatment included pressors (unspecified) and dopamine. As of 06-APR-2007, no source had been identified (the source of infection may have been an inflammed area on the back of the patient's earlobe at an earring hole site), and the patient was improving. The listing indicated that one or more of the events required a visit to the emergency room, resulted in hospitalization, was considered to be life threatening. No further information is available. The original reporting source was not identified. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards and was released. 04-Apr-2007 DA Streptococcus oralis culture negative, 04-Apr-2007 DA blood negative, 04-Apr-2007 DA chest X-ray normal, 04-APR-2007 DA diagnostic hematology blood test negative, 04-APR-2007 DA erythrocyte sedimentation rate 36 (units not provided), 04-Apr-2007 DA serum C-reaction protein test 8.3 (units not provided), 04-Apr-2007 DA serum antistreptolysin O antigen test negative, 04-Apr-2007 DA urine culture negative, 04-Apr-2007 DA white blood cell count elevated.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 12 month old male with an allergy to amoxicillin who on 28-MAR-2007 was vaccinated intramuscularly in the left thigh with a 0.5 mL third dose of PedvaxHib (lot 653523/0063U). The patient was concomitantly vaccinated subcutaneously in the right thigh with a 0.5 mL first dose of MMR II (lot 654820/1027F) and intramuscularly in the left thigh with a fourth dose of Prevnar (lot B08684K). An unrelated pinpoint rash over trunk and diaper area was present prior to vaccination on 28-MAR-2007. On 28-MAR-2007, the patient experienced increased irritability, fever, redness around the injection site of MMR II, and redness below the site on the left thigh. The patient developed injection site swelling shortly after vaccination with PedvaxHib and went to the emergency room. The patient was not admitted to the hospital. The patient was examined in the office on 29-MAR-2007, and the reaction was described as a red, warm, swollen, painful knot the size of a quarter. The patient was treated with cephalexin 125mg/5mL 4cc three times a day for 7 days. On 30-MAR-2007, the patient's mother reported that the patient was recovering as of that date. On 05-APR-2007, the patient recovered that the patient was recovering as of that date. On 05-APR-2007, the patient recovered from erythema, injection site erythema, irritability, and fever. The patient's increased irritability, fever, redness around the injection site of  MMR II, and redness below injection site on left thigh were considered to be other important medical events by the physician. The office requested a lot check be performed on  lot 653523/0063U. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This is one of several reports from the same source. No additional information is expected.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site swelling, Injection site warmth, Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 month old male with an allergy to amoxicillin who on 28-MAR-2007 was vaccinated intramuscularly in the left thigh with a 0.5 mL third dose of PedvaxHib (lot 653523/0063U). The patient was concomitantly vaccinated subcutaneously in the right thigh with a 0.5 mL first dose of MMR II (lot 654820/1027F) and intramuscularly in the left thigh with a fourth dose of Prevnar (lot B08684K). An unrelated pinpoint rash over trunk and diaper area was present prior to vaccination on 28-MAR-2007. On 28-MAR-2007, the patient experienced increased irritability, fever, redness around the injection site of MMR II, and redness below the site on the left thigh. The patient developed injection site swelling shortly after vaccination with PedvaxHib and went to the emergency room. The patient was not admitted to the hospital. The patient was examined in the office on 29-MAR-2007, and the reaction was described as a red, warm, swollen, painful knot the size of a quarter. The patient was treated with cephalexin 125mg/5mL 4cc three times a day for 7 days. On 30-MAR-2007, the patient's mother reported that the patient was recovering as of that date. On 05-APR-2007, the patient recovered that the patient was recovering as of that date. On 05-APR-2007, the patient recovered from erythema, injection site erythema, irritability, and fever. The patient's increased irritability, fever, redness around the injection site of  MMR II, and redness below injection site on left thigh were considered to be other important medical events by the physician. The office requested a lot check be performed on  lot 653523/0063U. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This is one of several reports from the same source. No additional information is expected.
Age: 10.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Anxiety, Asperger's disorder, Depression
Clinical narrative: Information has been received from a mother concerning her 10 year old son with depression and anxiety, who on 19-NOV-1996 was vaccinated with a dose of PedvaxHib, (lot # 6B71096, 6A811666L71162, 7A9162"). Concomitant suspect therapy included Recombivax HB (lot # "05311, 053H, 31156D"), for the treatment of prophylaxis (dose not reported). Other concomitant therapy included poliovirus vaccine and Dtap. On 25-May-2006 the patient was diagnosed with Asperger's syndrome. Unspecified medical attention was sought. The patient's Asperger's syndrome persisted. Upon internal review, Asperger's syndrome was determined to be a serious as an other important medical event. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Diet refusal, Haematochezia, Insomnia, Irritability
Clinical narrative: Information has been received from a registered nurse concerning a 6-month-old male with no pertinent medical history and no drug reactions/allergies who on 01-JUN-2007 was vaccinated PO with a 2mL third dose of Rotateq (lot number not provided). There was no concomitant medication. On 04-JUN-2007 the patient experienced contant irritability. On 05-JUN-2007 the patient was cranky and did not eat or sleep. He was taken to the hospital suffering from diarrhea, vomiting, and possible blood in stool. It was not known if the child was admitted as an inpatient. There was no product quality complaint. Upon internal review, blood in stool was considered to be an other important medical event. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 6-month-old male with no pertinent medical history and no drug reactions/allergies who on 01-JUN-2007 was vaccinated PO with a 2mL third dose of Rotateq (lot number not provided). There was no concomitant medication. On 04-JUN-2007 the patient experienced contant irritability. On 05-JUN-2007 the patient was cranky and did not eat or sleep. He was taken to the hospital suffering from diarrhea, vomiting, and possible blood in stool. It was not known if the child was admitted as an inpatient. There was no product quality complaint. Upon internal review, blood in stool was considered to be an other important medical event. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Intussusception, Vomiting
Clinical narrative: Pt received two doses of Rotateq. Pt was sent to hospital on 5/28/07 for excessive vomiting. It was concluded that pt had intussusception.  6/22/07 Received PCP med recs which included hospital D/C summary & vax record which confirms RO lot & dose number as reported & includes other vax received same date.  VAERS database updated w/same. D/C Summary reveals patient admitted 5/28-5/29/07 for vomiting & abdominal pain.  Progressed we// & d/c to home. LABS: abdominal x-ray.  air contrast barium enema + for IS. FINAL DX: Intussusception.  07/27/07 Received hospital medical records which reveal patient experienced fever, vomiting, heme (+) stool & abdominal pain.  Admitted 5/28-5/29/07 for observation s/p reduction of intussusception by air contrast barium enema. FINAL DX: Intussusception.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Barium enema, Intussusception, Vomiting
Clinical narrative: Pt received two doses of Rotateq. Pt was sent to hospital on 5/28/07 for excessive vomiting. It was concluded that pt had intussusception.  6/22/07 Received PCP med recs which included hospital D/C summary & vax record which confirms RO lot & dose number as reported & includes other vax received same date.  VAERS database updated w/same. D/C Summary reveals patient admitted 5/28-5/29/07 for vomiting & abdominal pain.  Progressed we// & d/c to home. LABS: abdominal x-ray.  air contrast barium enema + for IS. FINAL DX: Intussusception.  07/27/07 Received hospital medical records which reveal patient experienced fever, vomiting, heme (+) stool & abdominal pain.  Admitted 5/28-5/29/07 for observation s/p reduction of intussusception by air contrast barium enema. FINAL DX: Intussusception.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Asthenia, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Ongoing symptoms Elevated heart rate-Difficulty Breathing joint pain-fever 102-103 deg Lethargic neck tightness-Weakness Rocephin IV in hospital-Doxycycline-Keflex after rtn home 6/27/07-records received for DOS 6/18/07-no DC summary dictated per facility. Assessment:Fever. Chest pain, specific etiology uncertain. C/O stabbing chest pain and states chest pain may be associated with fever. C/O weakness.  PE: No significant shortness of breath.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Heart rate increased, Lethargy, Muscle tightness, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Ongoing symptoms Elevated heart rate-Difficulty Breathing joint pain-fever 102-103 deg Lethargic neck tightness-Weakness Rocephin IV in hospital-Doxycycline-Keflex after rtn home 6/27/07-records received for DOS 6/18/07-no DC summary dictated per facility. Assessment:Fever. Chest pain, specific etiology uncertain. C/O stabbing chest pain and states chest pain may be associated with fever. C/O weakness.  PE: No significant shortness of breath.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: White blood cell count, X-ray
Clinical narrative: Ongoing symptoms Elevated heart rate-Difficulty Breathing joint pain-fever 102-103 deg Lethargic neck tightness-Weakness Rocephin IV in hospital-Doxycycline-Keflex after rtn home 6/27/07-records received for DOS 6/18/07-no DC summary dictated per facility. Assessment:Fever. Chest pain, specific etiology uncertain. C/O stabbing chest pain and states chest pain may be associated with fever. C/O weakness.  PE: No significant shortness of breath.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Joint swelling, Oedema peripheral, Pain, Tonsillitis
Clinical narrative: 6/19/07 onset of urticaria , Left index finger swelling; 6/20/07 generalized urticaria, joint swelling of wrists/index finger, pain of coccyx, pain bilateral forearms with redness slight tonsil/ 6/21/07 swelling severe of hands, wrists, knees, increased urticara.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: 6/19/07 onset of urticaria , Left index finger swelling; 6/20/07 generalized urticaria, joint swelling of wrists/index finger, pain of coccyx, pain bilateral forearms with redness slight tonsil/ 6/21/07 swelling severe of hands, wrists, knees, increased urticara.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Infection, Pyrexia, Swelling
Clinical narrative: Fever of 102 F at home patient given 1 dose Tylenol 0.4ml- Temp in office was 99 F and monitored in office with pulse and office and 4 hours  swell infection and at home and return to office for re-eval in 4 hours.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Large erythema warm to touch edematous area 14 cm x 3 cm just below and boarding injection site. Pt to take Benadryl PO PRN for itching and Medrol dose pack.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Lymphadenopathy, Parotid gland enlargement, Rash papular
Clinical narrative: Submanibular/parotid gland swelling, moderate onset 10 days after ProQuad, without fever or other known cause. Papular rash on chest, neck.
Sex: U
Vaccine: MNQ
Symptoms: Hypersensitivity, Leukopenia, Liver function test abnormal, Rash
Clinical narrative: Rash leukopenia and elevated LFT's (Give (5) days post vaccine while on Bactrim, felt to be allergic RXN to Bactrim rather than vaccine rxn.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area of Induration approx 4 cm in diameter with redness of same diameter to one injection site of L LE one site of R Le. This was noticed by mother about 24 after vaccinations.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Dizziness, Fall, Hyperhidrosis, Syncope, Syncope vasovagal
Clinical narrative: Pt received 5 vaccines was sitting in waiting room after injections, with her family. Approximately 5 minutes later mom yelled for help. Patient was lying on floor face down. She had been feeling dizzy and fainted. BP 106/60, P 76 diaphoretic. Recovered after approx 5 minutes.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Blood culture negative, CSF culture negative, Computerised tomogram normal, Convulsion, Gaze palsy
Clinical narrative: SEE ER Summary 6-1-07 (SEE D/C Summary from ICU Low grade fever 1 1/2 days. 2-3 episodes of generalized seizure, witnessed by doctor in office 6-1-07. Parents reported tonic-clonic movement and eyes rolling back. Sent to ER by doctor on 6-1-07.  6/22/07 Hospital D/C summary accompanied VAERS report & reveals patient experienced seizure activity x 1 day.  Admitted 6/1-6/3/07.  Had fever x 2 days s/p vax then on 6/1 noted to have 3 episodes of eyes rolling back, neck stiffening & legs extending & flexing each lasting approx 10 secs.  Taken to PCP office & sent to ER for w/u.  Started on antibiotics & admitted to PICU.  Neuro consult done.  D/C to home w/neuro & PCP f/u. FINAL DX: seizures, likely secondary to DTaP; mild hyponatremia, resolved w/IVF hydration; metabolic acidosis, likely secondary to seizures.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia, Tonic clonic movements
Clinical narrative: SEE ER Summary 6-1-07 (SEE D/C Summary from ICU Low grade fever 1 1/2 days. 2-3 episodes of generalized seizure, witnessed by doctor in office 6-1-07. Parents reported tonic-clonic movement and eyes rolling back. Sent to ER by doctor on 6-1-07.  6/22/07 Hospital D/C summary accompanied VAERS report & reveals patient experienced seizure activity x 1 day.  Admitted 6/1-6/3/07.  Had fever x 2 days s/p vax then on 6/1 noted to have 3 episodes of eyes rolling back, neck stiffening & legs extending & flexing each lasting approx 10 secs.  Taken to PCP office & sent to ER for w/u.  Started on antibiotics & admitted to PICU.  Neuro consult done.  D/C to home w/neuro & PCP f/u. FINAL DX: seizures, likely secondary to DTaP; mild hyponatremia, resolved w/IVF hydration; metabolic acidosis, likely secondary to seizures.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Head injury, Loss of consciousness, Syncope
Clinical narrative: Syncope head injury with loss of consciousness , questionable SZ, vomiting.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Syncope head injury with loss of consciousness , questionable SZ, vomiting.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Balance disorder, Computerised tomogram normal, Convulsion, Dizziness, Eye rolling
Clinical narrative: Syncope head injury with loss of consciousness , questionable SZ, vomiting.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Visual disturbance
Clinical narrative: Syncope head injury with loss of consciousness , questionable SZ, vomiting.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 5x4 inch area of erythema, edema, warmth left deltoid, < 24 hours after injection with Dtap, no fever, TX Benadryl
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: 5/3/07 pt experienced uriticaria and hives over chest, back, arms, and legs the day after receiving vaccines (within 24 hrs) - seen in local ER and treated successfully with epinephrine, prednisone and Benadryl.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Wild Varicella
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Very large swelling in injection area
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Lip swelling
Clinical narrative: 10am pt received Hep A 2. By 3pm he described swelling of bottom lip. No other signs or symptoms reported. By 6/21/07 10am pt says swelling going down and "appeared to be getting better".
Age: 22.0
Sex: F
Vaccine: JEV
Symptoms: Encephalitis Japanese B, Injection site pruritus, Pharyngeal oedema, Throat tightness
Clinical narrative: Client experienced itching at site of injection, tightness and swelling of throat 30 mins after 2nd injection of Japanese encephalitis client declined to stay in clinic. 30 min post injection. Had to call for  help in freeway. Was sent to clinic was tx with ephinphine and prednisone then sent home.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Received Varivax - 6-14-07 - Began with "Chicken Pox" Varicella lesions 6-20-07
Age: 2.0
Sex: M
Vaccine: DTP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Pt mother called stating the arm where shots were given L is red, swollen, looks like blisters, shots were given 6/18/07
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives lasting 7 days following vaccine
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister, Pruritus, Rash, Varicella
Clinical narrative: Received Varivax Wednesday morning. Started getting some bumps with itching that evening. Covered with blistering spots from head to toe by Friday morning. Went to Dermatologist and diagnosed with chicken pox. Was given Atarax and Zovirax.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Dizziness, Headache, Migraine, Musculoskeletal pain
Clinical narrative: Headache, fever, pain on my shoulders and knees, dizziness during the day. Feeling symptoms of Migraine.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Headache, fever, pain on my shoulders and knees, dizziness during the day. Feeling symptoms of Migraine.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Breath holding, Confusional state, Crying, Eye rolling, Grand mal convulsion
Clinical narrative: Varicella Vaccine and TB skin test administered at well child visit. Child cried, hyperventilated, apparently held breath. Became unresponsive, eyes rolled back, brief (<30sec) generalized tonic-clonic seizure. Appears briefly confused, tightened tired post- ictally. Fully recovering before leaving office.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Hyperventilation, Postictal state, Unresponsive to stimuli
Clinical narrative: Varicella Vaccine and TB skin test administered at well child visit. Child cried, hyperventilated, apparently held breath. Became unresponsive, eyes rolled back, brief (<30sec) generalized tonic-clonic seizure. Appears briefly confused, tightened tired post- ictally. Fully recovering before leaving office.
Sex: M
Vaccine: ANTH
Symptoms: Dry skin, Headache, Myalgia, Pruritus generalised, Rash
Clinical narrative: Body itching, Muscle pain, rash, head ache, dry skin
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Chest pain, Paraesthesia, Paraesthesia oral
Clinical narrative: 6-15-07 pt came to urgent care and reported having side effect from TD injection given at ER hospital. 6/13/07 to report tingling to forehead, lips aching in chest.
Age: 1.2
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema, Skin warm
Clinical narrative: Reddened area - spread around to inside thigh by next day. Red and hot to touch. 5 inch x 5 inch
Age: 1.3
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen at injection site. About 4-5 cm in diameter 2 days later.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Rash 2 unlikely due to Dtap
Age: 0.1
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Aphthous stomatitis, Fatigue, Inappropriate schedule of drug administration
Clinical narrative: Fatigue and "canker sores: in mouth noted between 2nd and 3rd dose of Twinrix which was given on accelerated schedule.
Age: 0.1
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Fatigue, Mouth ulceration, Viral infection
Clinical narrative: Fatigue and "canker sores: in mouth noted between 2nd and 3rd dose of Twinrix which was given on accelerated schedule.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R arm SQ area - Red, swollen size of lemon, L arm IM area -  Red, swollen size of "50 cent piece". Benadryl and warm compresses
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Blister, Dry skin, Skin disorder, Skin exfoliation, Skin lesion
Clinical narrative: Referred for evaluation of recurrent lesions on fingers and feet following receipt of anthrax vaccines. First appearance of skin changes was after his initial 3 anthrax vaccines over a period of 5 weeks. To the best of his recollection, the lesions appeared within 1-2 weeks after his 3rd anthrax vaccine. They usually start as a few spots 'like a blister' on his fingertips and later on his toes. At their worst, in addition to his fingertips and toes, his feet and palms were affected too. There was no relationship to which arm he received the vaccines in - the lesions appeared bilaterally. The skin would later become dry (so dry it would sometimes crack) and flake and then it would peel. He described this pattern as 'cyclical; and usually lasts about 3-4 months. The cycle seemed to stop between anthrax vaccinations and the within 1 week of receiving his next anthrax vaccine, the spots would re-appear. Between 2000 and 2003 9period when no anthrax vaccine were received), the service member dose not recall having problems with skin changes. He had seen a dermatologist when the lesions were cyclical. He was treated with numerous topical, but nothing seemed to help. He has never been patch tested. He is not able to identify any other possible triggers (chemicals, cleaners, etc) Service member denies noted a temporal association to other vaccines. He denies any unusual or prolonged local reactions or other systemic symptoms following any of his 9 anthrax vaccines.
Age: 54.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia
Clinical narrative: arthralgias shoulder, wrist after IM injection deltoid
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Abdominal pain upper, Arthralgia, Overweight
Clinical narrative: Joint pain, stomache ache, overweight, articulation pain
Age: 28.0
Sex: F
Vaccine: ANTH, HEP, TYP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: ON 29 MAR 07 I WAS GIVEN THE ANTHRAX SHOT, AND THE NEXT DAY I HAD A REACTION.  THE AREA WHERE THE SHOT WAS GIVEN HAD SWELLING AND REDNESS.  IT WAS THERE FOR OVER 2WKS WITH THE LUMP IN THE AREA.  I VISITED THE CLINIC THE NEXT DAY AND PROVIDED A PHOTO OF THE AFFECTED AREA.
Age: 1.08
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMRV, PPV
Symptoms: Cold compress therapy, Injection site mass
Clinical narrative: Patients mother called clinic and states her son received vaccination last week in clinic and still has a lump in his right arm.  Patients mother was notified during phone call of the "After the Shots" information including, use of tylenol or motrin prn, cool wet washcloth for comfort, and to notify his healthcare provider or go to urgent care if symptoms do not improve.  Also instructed to call healthcare provider or go to urgent care if the child has temperature greater than 101.9, child pale or limp, crying more than 3 hours, strange high pitched cry, childs body shaking, twitching or jerking or any decrease in activity or responsiveness.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Cold compress therapy, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Redness and swelling at injection siteon right arm, low grade fever, emesis X1 beginning 06/20/2007 AM.  Treating with Tylenol and cold pack to site.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Respiratory rate increased
Clinical narrative: Pt had shots on yesterday and now comes in today to the office c/o rapid breathing and high temp of 104 degrees tympanic  Dr Dx Pt with Reaction to Shot Possible the Pediarix
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash at injection site - red rash - no blisters
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Full blood count, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Immunized on 6/18/07 then 6/20/07 noticed arm redness and swelling. Then 6/20/07 mnoticed underarm swelling and mass. Left anterior axillary lymphnode 2 cm largest diameter
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L arm redness and swelling 3inches x 2 inches
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling R arm sub Q. Area swollen x 8 inches around.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody, Full blood count, Hypoaesthesia, Rash, Red blood cell sedimentation rate normal
Clinical narrative: Predominantly left side facial rash began around left eyelid ~1 week after vaccination. Associated with swelling and numbness. Lesser but similar findings present on right side of face. Rash responded to 2 courses of Valtrex. Rash resolved completely within 6 weeks without apparent sequelae.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Predominantly left side facial rash began around left eyelid ~1 week after vaccination. Associated with swelling and numbness. Lesser but similar findings present on right side of face. Rash responded to 2 courses of Valtrex. Rash resolved completely within 6 weeks without apparent sequelae.
Age: 14.0
Sex: F
Vaccine: DTIPV, FLUX, HPV4, MNQ
Symptoms: Blood glucose increased, C-reactive protein normal, Carbon dioxide normal, Dehydration, Hypersensitivity
Clinical narrative: Initial information received on 13 June 2007 from another manufacturer, report# WAES0705USA05099. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received from a line listing obtained on request by the company from the FDA under the Freedom of Information Act concerning a 14 year old female with rhinitis allergic environmental allergy and eczema and a history of immunization reaction who on 25-OCT-2006 was vaccinated with Gardasil, IM thigh (lot 653978/0955F). Concomitant suspect immunizations included DTaP (unspecified) (IM thigh); Menactra (IM thigh), influenza virus vaccine (unspecified) (IM same thigh as Gardasil). The same day patient received allergenic extract (both arms). Additional concomitant medication included Nasocort and Zyrtec. The following day, on 26-OCT-2006 the patient was hospitalized with dehydration, hypersensitivity, muscle spasms and pyrexia (103F). Exam revealed injection site visible on extremities, no rash, erythema or exudate noted around the site. No other rashes. She was discharged the following day with diagnosis of allergic reaction. She also experienced pain and symptomatic problems 3 weeks prior following allergy injection. No further information is available."
Age: 14.0
Sex: F
Vaccine: DTIPV, FLUX, HPV4, MNQ
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: Initial information received on 13 June 2007 from another manufacturer, report# WAES0705USA05099. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received from a line listing obtained on request by the company from the FDA under the Freedom of Information Act concerning a 14 year old female with rhinitis allergic environmental allergy and eczema and a history of immunization reaction who on 25-OCT-2006 was vaccinated with Gardasil, IM thigh (lot 653978/0955F). Concomitant suspect immunizations included DTaP (unspecified) (IM thigh); Menactra (IM thigh), influenza virus vaccine (unspecified) (IM same thigh as Gardasil). The same day patient received allergenic extract (both arms). Additional concomitant medication included Nasocort and Zyrtec. The following day, on 26-OCT-2006 the patient was hospitalized with dehydration, hypersensitivity, muscle spasms and pyrexia (103F). Exam revealed injection site visible on extremities, no rash, erythema or exudate noted around the site. No other rashes. She was discharged the following day with diagnosis of allergic reaction. She also experienced pain and symptomatic problems 3 weeks prior following allergy injection. No further information is available."
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Back pain, Discomfort, Dizziness, Headache, Nystagmus
Clinical narrative: This case was received from another manufacturer (reference number WAES0705USA05077) on 07 June 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from an agency concerning an 18 year old female with a history of very minimal upper respiratory infection symptoms who on 06-MAR-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (Lot # 654535/0960F). Concomitant therapy included Menactra (Lot # U2115AA) in the right arm. On 07-MAR-2007 at 1:30 the patient experienced backache, headache, dizziness and generalized discomfort in the clinic and the patient was referred to her family practice. At her family practice, the patient developed stridor and nystagmus and was transferred to the facility (reported at 4:30) and was admitted to the ICU. Based on records received from the facility, the patient had fever and altered neurological status. She had a temperature of 101.2 and fell at the clinic. The patient presented to the emergency room with nystagmus with mainly her gaze toward the right. The patient was not speaking and was hyperventilating. It was reported that the patient had a fever a few days ago and had been sick with viral syndrome. Physical exam showed pupils equally round and reactive to light but she had nystagmus frequently every few seconds and 'mainly seemed with a right". The patient required an interpreter but she had no spontaneous speech and carpal pedal spasm. A lumbar puncture was performed in the hospital with the following with the following results: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56 and protein of 19. Other laboratory tests included: WBC of 16.3, neutrophil of 90%, Influenza A and B negative and an EEG which was mildly abnormal due to excessive presence of beta activity which could be drug related. The patient was discharged on 09-MAR-2007 and diagnosed with diseases/disorders of the nervous system, convulsions, tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago and fever. At the time of this report, the outcome was unknown. The original reporting source was not indicated. No further information is available."
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Stridor
Clinical narrative: This case was received from another manufacturer (reference number WAES0705USA05077) on 07 June 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from an agency concerning an 18 year old female with a history of very minimal upper respiratory infection symptoms who on 06-MAR-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (Lot # 654535/0960F). Concomitant therapy included Menactra (Lot # U2115AA) in the right arm. On 07-MAR-2007 at 1:30 the patient experienced backache, headache, dizziness and generalized discomfort in the clinic and the patient was referred to her family practice. At her family practice, the patient developed stridor and nystagmus and was transferred to the facility (reported at 4:30) and was admitted to the ICU. Based on records received from the facility, the patient had fever and altered neurological status. She had a temperature of 101.2 and fell at the clinic. The patient presented to the emergency room with nystagmus with mainly her gaze toward the right. The patient was not speaking and was hyperventilating. It was reported that the patient had a fever a few days ago and had been sick with viral syndrome. Physical exam showed pupils equally round and reactive to light but she had nystagmus frequently every few seconds and 'mainly seemed with a right". The patient required an interpreter but she had no spontaneous speech and carpal pedal spasm. A lumbar puncture was performed in the hospital with the following with the following results: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56 and protein of 19. Other laboratory tests included: WBC of 16.3, neutrophil of 90%, Influenza A and B negative and an EEG which was mildly abnormal due to excessive presence of beta activity which could be drug related. The patient was discharged on 09-MAR-2007 and diagnosed with diseases/disorders of the nervous system, convulsions, tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago and fever. At the time of this report, the outcome was unknown. The original reporting source was not indicated. No further information is available."
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Back pain, Bronchitis, CSF glucose normal, CSF protein normal, Convulsion
Clinical narrative: This case was received from another manufacturer (reference number WAES0705USA05077) on 07 June 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from an agency concerning an 18 year old female with a history of very minimal upper respiratory infection symptoms who on 06-MAR-2007 was vaccinated intramuscularly into the left arm with a first dose of Gardasil (Lot # 654535/0960F). Concomitant therapy included Menactra (Lot # U2115AA) in the right arm. On 07-MAR-2007 at 1:30 the patient experienced backache, headache, dizziness and generalized discomfort in the clinic and the patient was referred to her family practice. At her family practice, the patient developed stridor and nystagmus and was transferred to the facility (reported at 4:30) and was admitted to the ICU. Based on records received from the facility, the patient had fever and altered neurological status. She had a temperature of 101.2 and fell at the clinic. The patient presented to the emergency room with nystagmus with mainly her gaze toward the right. The patient was not speaking and was hyperventilating. It was reported that the patient had a fever a few days ago and had been sick with viral syndrome. Physical exam showed pupils equally round and reactive to light but she had nystagmus frequently every few seconds and 'mainly seemed with a right". The patient required an interpreter but she had no spontaneous speech and carpal pedal spasm. A lumbar puncture was performed in the hospital with the following with the following results: clear fluid, 1 WBC, 0 RBC, Glucose WNL at 56 and protein of 19. Other laboratory tests included: WBC of 16.3, neutrophil of 90%, Influenza A and B negative and an EEG which was mildly abnormal due to excessive presence of beta activity which could be drug related. The patient was discharged on 09-MAR-2007 and diagnosed with diseases/disorders of the nervous system, convulsions, tetany, bronchitis, nystagmus, altered mental status, hyperventilation, headache, lumbago and fever. At the time of this report, the outcome was unknown. The original reporting source was not indicated. No further information is available."