chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate increased, Rheumatoid factor positive
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 64 year old male with hypertension, helicobacter pylori infection, mitral valve prolapse, paroxysmal atrial fibrillation, glomerulonephritis proliferative and osteopenia and a history of PPD skin test positive and cataract extraction and placement of IOL in OS on 18-FEB-2008 was vaccinated SC with ZOSTAVAX (Merck) (lot # 659323/1613U) in left upper arm. Concomitant therapy included lisinopril (manufacturer unknown) and aspirin 81 QD. Subsequently the patient experienced arthralgia, chest discomfort, headache, inflammation, joint stiffness, malaise, musculoskeletal pain, myalgia, neck pain, pain, paraesthesia, pleuritic pain, polymyalgia rheumatica and steroid therapy. The patient was feeling well and there was no pre-existing illness at the time of vaccination. He was vaccinated on 18-FEB-2008 and did satisfactorily until 25-FEB-2008 when he felt a deep aching pain in his left shoulder that cleared about three weeks later. On 06-MAR-2008 the patient noticed tingling in his left hand and forearm, which lasted until about 20-APR-2008. On 17-APR-2008 mild chest tightness started. On 26-APR-2008 the patient noticed worsening headache, malaise, aching in shoulders, neck, knees and elsewhere started. Elevated sedimentation rates and C-reactive protein suggested an inflammation. Headache cleared on its own 7 days later, but rheumatic symptoms required low-dose prednisone for suppression. Polymyalgia rheumatica was diagnosed. The patient felt better by 06-MAY-2008 while taking prednisone. Received rheumatology office note of 23-MAY-2008. Final diagnosis: polymyalgia rheumatica. Record revealed patient was pain free and feeling well at that time. The patient had previously had pleuritic chest pain, now resolved. The patient was continued on slow steroid taper. Reviewed (primary care physician) PCP medical records of 29-APR-2008 to 06-MAY-2008, records revealed patient experienced arthralgia/myalgia worst in morning with stiffness in multiple joints, generalized headache (HA). Received additional medical records from patient via email which consisted of labs and healthcare providers contact information. Treated with tapering steroids starting on 23-MAY-2008. The listing indicated that one or more of the events was considered to be immediately life-threatening. This originally reporting source was not provided. The VAERS ID # is 314325. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Acute disseminated encephalomyelitis, CSF protein normal, CSF test abnormal, CSF white blood cell count increased, Clonus
Clinical narrative: JULY 1 2009  Patient recieved MENACTRA lot #U2844AA and Addacel (Tdap) lot#C3248AA Exp 11/29/11.  Right after recieving the shot the patient became pale and diaporetic, he was laid down on the exam table and then passed out (vagel Reaction.  He was quickly brought conscious with smelling salts. He was given some water and remained in the exam room @ 15 minutes.  He appeared to be fine.                                                                                               Pt remained asymptomatic for about 1 week, then started to develope back pain, followed by abdominal pain.  From july 8 through july 15 he was seen by several medical providers including several er visits, pcp,chiropracter.  symptoms worsened until july 17 when he was admitted and diagnosed with accute demylenating encphalomylitis and treated.                                                                                                                                            This has been reported and Case #352153
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Hyperreflexia, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Red blood cells CSF positive
Clinical narrative: JULY 1 2009  Patient recieved MENACTRA lot #U2844AA and Addacel (Tdap) lot#C3248AA Exp 11/29/11.  Right after recieving the shot the patient became pale and diaporetic, he was laid down on the exam table and then passed out (vagel Reaction.  He was quickly brought conscious with smelling salts. He was given some water and remained in the exam room @ 15 minutes.  He appeared to be fine.                                                                                               Pt remained asymptomatic for about 1 week, then started to develope back pain, followed by abdominal pain.  From july 8 through july 15 he was seen by several medical providers including several er visits, pcp,chiropracter.  symptoms worsened until july 17 when he was admitted and diagnosed with accute demylenating encphalomylitis and treated.                                                                                                                                            This has been reported and Case #352153
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Sensory loss
Clinical narrative: JULY 1 2009  Patient recieved MENACTRA lot #U2844AA and Addacel (Tdap) lot#C3248AA Exp 11/29/11.  Right after recieving the shot the patient became pale and diaporetic, he was laid down on the exam table and then passed out (vagel Reaction.  He was quickly brought conscious with smelling salts. He was given some water and remained in the exam room @ 15 minutes.  He appeared to be fine.                                                                                               Pt remained asymptomatic for about 1 week, then started to develope back pain, followed by abdominal pain.  From july 8 through july 15 he was seen by several medical providers including several er visits, pcp,chiropracter.  symptoms worsened until july 17 when he was admitted and diagnosed with accute demylenating encphalomylitis and treated.                                                                                                                                            This has been reported and Case #352153
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Abdominal pain, Acute disseminated encephalomyelitis, Back pain, Hyperhidrosis, Loss of consciousness
Clinical narrative: JULY 1 2009  Patient recieved MENACTRA lot #U2844AA and Addacel (Tdap) lot#C3248AA Exp 11/29/11.  Right after recieving the shot the patient became pale and diaporetic, he was laid down on the exam table and then passed out (vagel Reaction.  He was quickly brought conscious with smelling salts. He was given some water and remained in the exam room @ 15 minutes.  He appeared to be fine.                                                                                               Pt remained asymptomatic for about 1 week, then started to develope back pain, followed by abdominal pain.  From july 8 through july 15 he was seen by several medical providers including several er visits, pcp,chiropracter.  symptoms worsened until july 17 when he was admitted and diagnosed with accute demylenating encphalomylitis and treated.                                                                                                                                            This has been reported and Case #352153
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: JULY 1 2009  Patient recieved MENACTRA lot #U2844AA and Addacel (Tdap) lot#C3248AA Exp 11/29/11.  Right after recieving the shot the patient became pale and diaporetic, he was laid down on the exam table and then passed out (vagel Reaction.  He was quickly brought conscious with smelling salts. He was given some water and remained in the exam room @ 15 minutes.  He appeared to be fine.                                                                                               Pt remained asymptomatic for about 1 week, then started to develope back pain, followed by abdominal pain.  From july 8 through july 15 he was seen by several medical providers including several er visits, pcp,chiropracter.  symptoms worsened until july 17 when he was admitted and diagnosed with accute demylenating encphalomylitis and treated.                                                                                                                                            This has been reported and Case #352153
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea decreased
Clinical narrative: Diagnosed with Type 1 Diabetes Mellitus 10 days after receiving 3rd dose of GARDASIL vaccine made by Merck.  8/25/09 PCP records rec'd. WCC with no concerns 6/3/08-healthy.  HPV#1 given. Returned 12/30/08 with c/o fatigue x several weeks, eating and drinking more than usual and rapid wt loss.  Urine (+) for ketones at home. Assessment:  Diabetes mellitus.  Labs:  Urinalysis (+) for protein 30, trace blood, large ketones (160). glucose 1000.  BS 358.   9/3/09 Hospital records received DOS 12/30/08 to 1/1/09. Assessment: Diabetes mellitus new onset, Diabetic ketoacidosis. Presented with recent weight loss, increased thirst, increased urination, increased hunger. Generalized weakness, fatigue, headache, fever. Episode of vomiting. Constipation. Decreased muscle bulk.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Carbon dioxide decreased, Type 1 diabetes mellitus
Clinical narrative: Diagnosed with Type 1 Diabetes Mellitus 10 days after receiving 3rd dose of GARDASIL vaccine made by Merck.  8/25/09 PCP records rec'd. WCC with no concerns 6/3/08-healthy.  HPV#1 given. Returned 12/30/08 with c/o fatigue x several weeks, eating and drinking more than usual and rapid wt loss.  Urine (+) for ketones at home. Assessment:  Diabetes mellitus.  Labs:  Urinalysis (+) for protein 30, trace blood, large ketones (160). glucose 1000.  BS 358.   9/3/09 Hospital records received DOS 12/30/08 to 1/1/09. Assessment: Diabetes mellitus new onset, Diabetic ketoacidosis. Presented with recent weight loss, increased thirst, increased urination, increased hunger. Generalized weakness, fatigue, headache, fever. Episode of vomiting. Constipation. Decreased muscle bulk.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Agitation, Cerebral atrophy, Computerised tomogram abnormal, Convulsion, Developmental delay
Clinical narrative: Hypoxic brain injury after a possible averted SIDS event. Five hours (approx.). Receiving second series of vaccines. 9/9/09 Hospital records received DOS 4/17/09 to 5/6/09. Assessment: Anoxic brain injury, Seizures in response to acute event. Acidosis, Cardiopulmonary arrest, Respiratory failure without hypercapnia. Parent found infant in crib, face down, blue, not breathing. Vomited after rescue breaths. EMS found baby unresponsive, apneic, and pulseless. Cardiac Arrest CPR. Upon arrival at previous facilty was intubated. Pupils fixed and dilated. After transfer was awake, fussy. Unable to fix or track with eyes. Increased tone all extremities. Tense abdomen with lack of bowel sounds. Anasarca. Phenobarb coma to suppress seizure activity. Hypotension. Pneumothorax. ARDS. Mechanical ventilation. TPN. Second pneumothorax. Stridor after extubation. Significant brain damage. Dysphagia, spasticity, clonus. NG dependent.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Dyskinesia, Dysphagia, Gastrointestinal tube insertion, Gastrooesophageal reflux disease, Hypertonia
Clinical narrative: Hypoxic brain injury after a possible averted SIDS event. Five hours (approx.). Receiving second series of vaccines. 9/9/09 Hospital records received DOS 4/17/09 to 5/6/09. Assessment: Anoxic brain injury, Seizures in response to acute event. Acidosis, Cardiopulmonary arrest, Respiratory failure without hypercapnia. Parent found infant in crib, face down, blue, not breathing. Vomited after rescue breaths. EMS found baby unresponsive, apneic, and pulseless. Cardiac Arrest CPR. Upon arrival at previous facilty was intubated. Pupils fixed and dilated. After transfer was awake, fussy. Unable to fix or track with eyes. Increased tone all extremities. Tense abdomen with lack of bowel sounds. Anasarca. Phenobarb coma to suppress seizure activity. Hypotension. Pneumothorax. ARDS. Mechanical ventilation. TPN. Second pneumothorax. Stridor after extubation. Significant brain damage. Dysphagia, spasticity, clonus. NG dependent.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Hypotonia, Hypoxic encephalopathy, Nuclear magnetic resonance imaging brain abnormal, Posturing, Scan brain
Clinical narrative: Hypoxic brain injury after a possible averted SIDS event. Five hours (approx.). Receiving second series of vaccines. 9/9/09 Hospital records received DOS 4/17/09 to 5/6/09. Assessment: Anoxic brain injury, Seizures in response to acute event. Acidosis, Cardiopulmonary arrest, Respiratory failure without hypercapnia. Parent found infant in crib, face down, blue, not breathing. Vomited after rescue breaths. EMS found baby unresponsive, apneic, and pulseless. Cardiac Arrest CPR. Upon arrival at previous facilty was intubated. Pupils fixed and dilated. After transfer was awake, fussy. Unable to fix or track with eyes. Increased tone all extremities. Tense abdomen with lack of bowel sounds. Anasarca. Phenobarb coma to suppress seizure activity. Hypotension. Pneumothorax. ARDS. Mechanical ventilation. TPN. Second pneumothorax. Stridor after extubation. Significant brain damage. Dysphagia, spasticity, clonus. NG dependent.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Subdural hygroma
Clinical narrative: Hypoxic brain injury after a possible averted SIDS event. Five hours (approx.). Receiving second series of vaccines. 9/9/09 Hospital records received DOS 4/17/09 to 5/6/09. Assessment: Anoxic brain injury, Seizures in response to acute event. Acidosis, Cardiopulmonary arrest, Respiratory failure without hypercapnia. Parent found infant in crib, face down, blue, not breathing. Vomited after rescue breaths. EMS found baby unresponsive, apneic, and pulseless. Cardiac Arrest CPR. Upon arrival at previous facilty was intubated. Pupils fixed and dilated. After transfer was awake, fussy. Unable to fix or track with eyes. Increased tone all extremities. Tense abdomen with lack of bowel sounds. Anasarca. Phenobarb coma to suppress seizure activity. Hypotension. Pneumothorax. ARDS. Mechanical ventilation. TPN. Second pneumothorax. Stridor after extubation. Significant brain damage. Dysphagia, spasticity, clonus. NG dependent.
Age: 1.8
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Child received both vaccines in right thigh at the same time. Within 48 hrs. site became large, red, and warm. No signs of systemic reaction. Treated with oral BENADRYL. Redness disappeared within 24 hrs. Site remains firm and is about the size of a quarter. Child appears fine w/o discomfort.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Received Shingles Vaccine ZOSTAVAX 7/21/09. After 48hrs, had rash on chest and under breasts. Returned to doctor 8/4/09. No diagnosis. Given fungal cream. Went to dermatologist 8-11-09 and diagnosed with pityriasis rosea. Given Hydroxyzine, Loratadine, and cream.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in jaw
Clinical narrative: Outbreak of shingles Post Vaccine Rash, pain R jaw.  Saw MD Tx Famvir 500mg TID x 7 days.
Age: 2.0
Sex: M
Vaccine: FLUN3, HEPA, HIBV, PNC
Symptoms: Cough, Laryngoscopy, Respiratory distress
Clinical narrative: I saw him for well check up at 09:30. He had history of mild cough and normal exam. He had vaccines and went home. He took a nap and awoke with bark-like cough and respiratory distress.  8/31/09 Hospital medical records received for 8/19-8/20/2009.   FINAL DX: croup Records reveal patient experienced mild cough & rhinorrhea prior to office visit but had slept well.  No abnormal findings on office exam when received vaccines including initial dose of Flumist.  After nap at home, awoke w/stridor & respiratory distress.  ENT consult & laryngoscopy done which revealed an abnormally shaped epiglottis but no edema.  Had stridor & agitation upon awakening from anesthesia & admitted for observation.  Tx w/steroids & epi.  Responded well to tx & d/c to home. ICD-9 codes for DC 464.0, 786.1
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Computerised tomogram, Contusion, Head injury, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately following vaccine (about 4 mins) patient passed out - hit her head on a table then concrete floor. health Unit called emergency and she was taken to local hospital. Doctor stated no internal injuries but she still has bruising on body and a lump on her head.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: X-ray
Clinical narrative: Immediately following vaccine (about 4 mins) patient passed out - hit her head on a table then concrete floor. health Unit called emergency and she was taken to local hospital. Doctor stated no internal injuries but she still has bruising on body and a lump on her head.
Age: 27.0
Sex: U
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Left shoulder pain, decrease ROM after injection of vaccine.  Pain on palpation of shoulder 3 days later.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: Pain- redness - firm - Golf ball size tender to touch- greater than 48 hours later.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test normal, Diagnostic procedure, Dizziness, Electrocardiogram normal
Clinical narrative: Right leg had no feeling/wd not support weight.  Dizzy/Light Headed.  Blacked out. 8/26/09  PCP note received.  Pt in for PE on 6/29/09  HPV vax given./pc 9/21/09 Spoke with parent.  Still reports some numbness as well as new symptom of twitching of the fingers.  Has not seen a physician since the ER./pc
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Sensory loss
Clinical narrative: Right leg had no feeling/wd not support weight.  Dizzy/Light Headed.  Blacked out. 8/26/09  PCP note received.  Pt in for PE on 6/29/09  HPV vax given./pc 9/21/09 Spoke with parent.  Still reports some numbness as well as new symptom of twitching of the fingers.  Has not seen a physician since the ER./pc
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 12 noon approx Received Pentacel vaccine.  By three hours later, the leg was red, swollen, very tender to touch.  Redness and swelling disappeared within 20 min however tenderness remained.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 7" length x 6" width. Redness, with heat at injection site. Rec' pt use ibuprofen for pain 6-8 hours. Up to 800mg, ice packets for comfort.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Fainting and dizzy 1 hour after shot given.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Culture stool negative, Faeces discoloured, Haematochezia, Laboratory test normal, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 56 day old breast fed male who on 08-JUN-2009 was vaccinated with the first dose of ROTATEQ (Lot # not provided) orally. On the same day the patient experienced fever and discolored stool. On 13-JUL-2009, he was administered the second dose (lot # not provided) orally. On 24-JUL-2009 the patient experienced blood in stool on two occasions including clumps and streaks. The third dose was not given. Concomitant medication included "additional required vaccines". A culture was done and no bacteria were found. Blood work also came back normal. After stopping therapy, adverse events improved. The patient sought unspecified medical attention. As of 06-AUG-2009 the patient was believed to be recovering. Upon internal review, blood in stool was considered to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Anorexia, Bacteraemia, Blood culture negative, Body temperature increased, Chills
Clinical narrative: Information has been received from an office manager concerning a male physician who on 11-AUG-2008 was vaccinated intramuscularly into the left upper arm with a 0.5mL dose of PNEUMOVAX (lot number 662785/1124X).  On 12-AUG-2009, the patient developed redness, swelling and pain at the injection site of the left arm.  The patient then experienced high fever of 104F, headache, anorexia and delirium. On 14-AUG-2009, the patient experienced elevated white blood cell count and decreased renal function and was admitted to hospital.  At the time of reporting, the patient had not recovered from redness, swelling and pain at injection site, high fever of 104F, headache, anorexia, delirium, elevated white blood cell count and decreased renal function persisted.  Follow up information was received from the physician.  It was reported that after receiving PNEUMOVAX, the patient had fever, chills, redness and swelling.  He was hospitalized for dehydration and assumed bacteremia and was treated with multiple antibiotics.  The patient had an echocardiogram which was negative and blood cultures that were negative.  The patient was ultimately given steroids and sent home on AMOXICILLIN (+) AUGMENTIN.  The patient's condition had improved.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Dehydration, Delirium, Echocardiogram normal, Headache, Injection site erythema
Clinical narrative: Information has been received from an office manager concerning a male physician who on 11-AUG-2008 was vaccinated intramuscularly into the left upper arm with a 0.5mL dose of PNEUMOVAX (lot number 662785/1124X).  On 12-AUG-2009, the patient developed redness, swelling and pain at the injection site of the left arm.  The patient then experienced high fever of 104F, headache, anorexia and delirium. On 14-AUG-2009, the patient experienced elevated white blood cell count and decreased renal function and was admitted to hospital.  At the time of reporting, the patient had not recovered from redness, swelling and pain at injection site, high fever of 104F, headache, anorexia, delirium, elevated white blood cell count and decreased renal function persisted.  Follow up information was received from the physician.  It was reported that after receiving PNEUMOVAX, the patient had fever, chills, redness and swelling.  He was hospitalized for dehydration and assumed bacteremia and was treated with multiple antibiotics.  The patient had an echocardiogram which was negative and blood cultures that were negative.  The patient was ultimately given steroids and sent home on AMOXICILLIN (+) AUGMENTIN.  The patient's condition had improved.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Renal impairment, White blood cell count increased
Clinical narrative: Information has been received from an office manager concerning a male physician who on 11-AUG-2008 was vaccinated intramuscularly into the left upper arm with a 0.5mL dose of PNEUMOVAX (lot number 662785/1124X).  On 12-AUG-2009, the patient developed redness, swelling and pain at the injection site of the left arm.  The patient then experienced high fever of 104F, headache, anorexia and delirium. On 14-AUG-2009, the patient experienced elevated white blood cell count and decreased renal function and was admitted to hospital.  At the time of reporting, the patient had not recovered from redness, swelling and pain at injection site, high fever of 104F, headache, anorexia, delirium, elevated white blood cell count and decreased renal function persisted.  Follow up information was received from the physician.  It was reported that after receiving PNEUMOVAX, the patient had fever, chills, redness and swelling.  He was hospitalized for dehydration and assumed bacteremia and was treated with multiple antibiotics.  The patient had an echocardiogram which was negative and blood cultures that were negative.  The patient was ultimately given steroids and sent home on AMOXICILLIN (+) AUGMENTIN.  The patient's condition had improved.  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Ear infection, Gastrointestinal disorder
Clinical narrative: Information has been received from a consumer concerning a "3.5 year old" male patient with no pertinent medical history and no drug allergies, who was vaccinated with an unspecified vaccine at two months of age and started having health issues since. The patient started having constant ear infections and serious gastrointestinal issues. "At two months of age" he received "one dose" of MMR II, and "after getting the vaccine", "it seemed like he was slipping even more". It was reported that the patient "has autism". The patient sought unspecified medical attention. At the time of the report, the patient's status was not recovered. No further information is available.
Age: 13.0
Sex: F
Vaccine: DTAP, HEPA, HPV4
Symptoms: Convulsion, Gaze palsy, Loss of consciousness, Syncope, Tremor
Clinical narrative: Information has been received from a physician and an other medical professional concerning a 13 year old female with no pertinent medical history and no known drug allergies who was vaccinated with the first 0.5ml dose of GARDASIL (Lot#660553/0070X) on 18-JUN-2009 in the right arm. Other vaccines given that day included: HAVRIX (unspecified) (GSK) (Lot#AHAYB296BA) and ADACEL (Sanofi Pasteur) (Lot#C2826AA). There were no other concomitant drugs. On 18-JUN-2009, after receiving the first dose of GARDASIL, the patient's eyes rolled back in her head and she fainted while in the office. While she was unconscious the patient experienced "seizure-like head shaking". The other medical professional said there was nothing definitive in the chart to confirm or negate a seizure, as the physician was in another room when the event occurred, chart showed "seizure-like head shaking". The patient had sought medical attention, in the office. There were no diagnostic tests performed. The patient was not sent to emergency room. There was no treatment required. The event was not disabling. At the time of report the patient's status was recovered. Upon internal review, "seizure-like head shaking" was determined to be an other medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Headache, Injection site erythema, Injection site swelling, Syncope
Clinical narrative: Information has been received from a medical assistant concerning her 15 year old sister with no known drug reactions/allergies and no known pertinent medical history who on 30-AUG-2008 received the first dose of GARDASIL (Lot # 655849/0263U) into the right arm. On 08-AUG-2009 was vaccinated with the second dose of GARDASIL (Lot # 662300/0100Y). Concomitant vaccine included Tetanus toxoid and MENACTRA (Lot # U2662A). The medical assistant reported that after second vaccine the patient experienced injection site swelling and redness. On 11-AUG-2009, in the afternoon, the patient fainted on the sports field (according to the medical assistant the event was not environmentally connected); the syncope was followed by a 30 second convulsion which was witnessed by the coach; when the patient came out of it, she had a pounding headache which lasted a week; patient refused any treatment at the time. The patient saw a neurologist on 13-AUG-2009. On 17-AUG-2009, an MRI of head, MRI of neck and EEG were performed (results not expected until 25-AUG-2009). At the time of reporting the patient was recovering. The patient sought medical attention. Upon internal review seizure was considered to be other important medical event. Additional information has been requested.  8/27/09 Neuro consult received dated 8/13/09 with assessment: Cervicalgia-worsening, Convulsions-new, Headache, worsening. Pt presented after episode of generalized tonic-clonic seizure.  Pt also reports daily H/As x 1 year-recently worse, neck and back pain and stiffness.  PE (+) for trigger points and mildly decreased ROM of the neck.  Sent for testing. PT for neck.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a respiratory therapist concerning a herself who on an unspecified date was vaccinated with a dose of GARDASIL (Lot not reported) while pregnant (date of last menstrual period was not reported). She delivered a boy on 04-MAY-2009, the boy born with "3 holes in his heart". It was unknown if the patient and her baby sought medical attention. At the time of reporting the baby's outcome was unknown. Upon internal review, "3 holes in heart" was considered to be a congenital anomaly. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Fatigue, Lethargy, Pain in extremity, Palpitations
Clinical narrative: arm pain - severe fatigue, lethargy, chills, heart racing.
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Pain
Clinical narrative: Right arm injection site with large X erythematous reaction. Slight tenderness, positive blanching of body skin color. Flu-like sxs with body aches, fever, chills.
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pallor, Pyrexia
Clinical narrative: Right arm injection site with large X erythematous reaction. Slight tenderness, positive blanching of body skin color. Flu-like sxs with body aches, fever, chills.
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Localized reaction to left thigh.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site discomfort, Injection site reaction, Injection site swelling
Clinical narrative: Vaccines given on 8/11/09 (Tdap, MCV4 & Varicella). Mother called on 8/12/09 to report swelling, increased (abnormal) discomfort to back of left arm. Took this pt -her son- to ER, the MD called it an adverse reaction as vaccine given in "triceps". Varicella only vaccine given to posterior (R) arm-SQ.
Age: 33.0
Sex: M
Vaccine: TD, YF
Symptoms: Foreign travel, Pruritus, Rash
Clinical narrative: Patient states he developed a rash to lower legs on 8/8/2009, intermittent itching.  Pt went to foreign country from July 29 through August 8, 2009.  Has taken Benadryl PRN for itching.  Rash still present on 8/11/09.  Referred by health unit to PMD.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Blood glucose increased, Electrocardiogram normal, Hyperhidrosis, Hypotension, Malaise
Clinical narrative: 9:35AM pt. returns with c/o malaise, pallor, diaphoretic, hypotensive with no Sxs of SOB or resp. distress. V/S: B/P 96/.  10:45 EKG performed; read by Dr. (=) normal. Glucose: 120, adult 70-100, children 60-109 (=) normal range.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Pallor
Clinical narrative: 9:35AM pt. returns with c/o malaise, pallor, diaphoretic, hypotensive with no Sxs of SOB or resp. distress. V/S: B/P 96/.  10:45 EKG performed; read by Dr. (=) normal. Glucose: 120, adult 70-100, children 60-109 (=) normal range.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse reaction noted to extra dose of ROTARIX given one month after 2nd.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Client going into nursing school, received varicella vaccine 8-4-09. On 8.15 and 16 took home pregnancy test which confirmed pregnancy. She had stopped her birth control pills 2 weeks prior vaccination due to menstrual period for entire month of July 2009. Will see Gyn/ob F.u.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Febrile illness t max 103. Severe myalgias. Redness at site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area of induration & erythema at site of DTaP/IPV on (L) deltoid.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swollen where immunization was given.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Induration, Oedema peripheral
Clinical narrative: Local reaction: red, swollen, hard to touch. Went to Dr. Dx with early cellulitis - put on antibiotics 8/19/09.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Father states child began favoring leg yesterday. Today, child's leg has 3 1/2 x 2 1/4" area of redness, swelling and warmth. MOTRIN given.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood pressure decreased, Fall, Heart rate decreased, Syncope
Clinical narrative: Patient had syncopal episode & fell to ground in office after immunizations with VARIVAX. BP decreased pulse decreased not cyanotic or pale had had no breakfast in AM. Patient known Hx seizure disorder. In past has had syncopal episode to blood draw.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Rt upper arm 2in x 2in reddened hard area warm to touch. Denies pain c/o.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Nausea, Oedema peripheral, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm swollen in a 11-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  Concurrent vaccination included VARIVAX (Merck) given in the left arm on 18 August 2009.  There were no concurrent medications.  On 18 August 2009 at 08:00 the subject received 1st dose of BOOSTRIX at 0.5 ml in the right arm.  On approximately 19 August 2009, 1 day after vaccination with BOOSTRIX, the subject experienced arm swelling (to the size of a baseball), hot arm, arm redness and nausea.  The healthcare professional considered the events were disabling.  The subject was treated with ice.  At the time of reporting the events unresolved.  The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC, RV1, RV1
Symptoms: Abdominal mass, Barium enema, Incorrect dose administered, Intussusception, Lethargy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX (GlaxoSmithKline) given on 25 March 2009 and ROTATEQ (manufacturer unspecified) given on 15 May 2009. Concurrent vaccination included PENTACEL (manufacturer unspecified), ACTHIB (manufacturer unspecified), ENGERIX B (GlaxoSmithKline) and PREVNAR (Wyeth Labs) all given on 17 July 2009. There were no concurrent medications. On 17 July 2009 at 11:09 the subject received 2nd dose of ROTARIX (oral). This was actually the 3rd dose of rotavirus vaccine as ROTATEQ was given to the subject inbetween doses of ROTARIX. An extra dose was administered. It was noted that the lot number for the ROTARIX diluent given with dose 2 was A41DA860A with an expiration date of 25 September 2011. On 18 August 2009, in the evening, 1 month after vaccination with ROTARIX, the subject experienced intussusception with pain, fever, abdominal mass and lethargy. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was seen by his physician and administered a barium enema as treatment which seemed to straighten everything out. At the time of reporting, the subject was at home resting and was reportedly improved. The subject's physician did not think the events were caused by ROTARIX.  9/23/09  PCP records received dated 8/18/09-9/17/09 with DX:  Intussusception. Pt presented 8/18/09 with vomiting, watery stool and excessive drooling. T'=99.2'F.  Abd mass palpated in LLQ. Sent for outpt US which was (+) for IS. Barium Enema done with reduction of the IS.  Observed in pcp office and d/c home doing well.  Returned 9/13 09 after episode of vomiting. Abd exam WNL.  (+) R OM.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC, RV1, RV1
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX (GlaxoSmithKline) given on 25 March 2009 and ROTATEQ (manufacturer unspecified) given on 15 May 2009. Concurrent vaccination included PENTACEL (manufacturer unspecified), ACTHIB (manufacturer unspecified), ENGERIX B (GlaxoSmithKline) and PREVNAR (Wyeth Labs) all given on 17 July 2009. There were no concurrent medications. On 17 July 2009 at 11:09 the subject received 2nd dose of ROTARIX (oral). This was actually the 3rd dose of rotavirus vaccine as ROTATEQ was given to the subject inbetween doses of ROTARIX. An extra dose was administered. It was noted that the lot number for the ROTARIX diluent given with dose 2 was A41DA860A with an expiration date of 25 September 2011. On 18 August 2009, in the evening, 1 month after vaccination with ROTARIX, the subject experienced intussusception with pain, fever, abdominal mass and lethargy. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was seen by his physician and administered a barium enema as treatment which seemed to straighten everything out. At the time of reporting, the subject was at home resting and was reportedly improved. The subject's physician did not think the events were caused by ROTARIX.  9/23/09  PCP records received dated 8/18/09-9/17/09 with DX:  Intussusception. Pt presented 8/18/09 with vomiting, watery stool and excessive drooling. T'=99.2'F.  Abd mass palpated in LLQ. Sent for outpt US which was (+) for IS. Barium Enema done with reduction of the IS.  Observed in pcp office and d/c home doing well.  Returned 9/13 09 after episode of vomiting. Abd exam WNL.  (+) R OM.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC, RV1, RV1
Symptoms: Abdominal pain, Barium enema, Full blood count, Intussusception, Lethargy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX (GlaxoSmithKline) given on 25 March 2009 and ROTATEQ (manufacturer unspecified) given on 15 May 2009. Concurrent vaccination included PENTACEL (manufacturer unspecified), ACTHIB (manufacturer unspecified), ENGERIX B (GlaxoSmithKline) and PREVNAR (Wyeth Labs) all given on 17 July 2009. There were no concurrent medications. On 17 July 2009 at 11:09 the subject received 2nd dose of ROTARIX (oral). This was actually the 3rd dose of rotavirus vaccine as ROTATEQ was given to the subject inbetween doses of ROTARIX. An extra dose was administered. It was noted that the lot number for the ROTARIX diluent given with dose 2 was A41DA860A with an expiration date of 25 September 2011. On 18 August 2009, in the evening, 1 month after vaccination with ROTARIX, the subject experienced intussusception with pain, fever, abdominal mass and lethargy. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was seen by his physician and administered a barium enema as treatment which seemed to straighten everything out. At the time of reporting, the subject was at home resting and was reportedly improved. The subject's physician did not think the events were caused by ROTARIX.  9/23/09  PCP records received dated 8/18/09-9/17/09 with DX:  Intussusception. Pt presented 8/18/09 with vomiting, watery stool and excessive drooling. T'=99.2'F.  Abd mass palpated in LLQ. Sent for outpt US which was (+) for IS. Barium Enema done with reduction of the IS.  Observed in pcp office and d/c home doing well.  Returned 9/13 09 after episode of vomiting. Abd exam WNL.  (+) R OM.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC, RV1, RV1
Symptoms: Metabolic function test, Pyrexia, Ultrasound abdomen
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX (GlaxoSmithKline) given on 25 March 2009 and ROTATEQ (manufacturer unspecified) given on 15 May 2009. Concurrent vaccination included PENTACEL (manufacturer unspecified), ACTHIB (manufacturer unspecified), ENGERIX B (GlaxoSmithKline) and PREVNAR (Wyeth Labs) all given on 17 July 2009. There were no concurrent medications. On 17 July 2009 at 11:09 the subject received 2nd dose of ROTARIX (oral). This was actually the 3rd dose of rotavirus vaccine as ROTATEQ was given to the subject inbetween doses of ROTARIX. An extra dose was administered. It was noted that the lot number for the ROTARIX diluent given with dose 2 was A41DA860A with an expiration date of 25 September 2011. On 18 August 2009, in the evening, 1 month after vaccination with ROTARIX, the subject experienced intussusception with pain, fever, abdominal mass and lethargy. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was seen by his physician and administered a barium enema as treatment which seemed to straighten everything out. At the time of reporting, the subject was at home resting and was reportedly improved. The subject's physician did not think the events were caused by ROTARIX.  9/23/09  PCP records received dated 8/18/09-9/17/09 with DX:  Intussusception. Pt presented 8/18/09 with vomiting, watery stool and excessive drooling. T'=99.2'F.  Abd mass palpated in LLQ. Sent for outpt US which was (+) for IS. Barium Enema done with reduction of the IS.  Observed in pcp office and d/c home doing well.  Returned 9/13 09 after episode of vomiting. Abd exam WNL.  (+) R OM.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: initial small erythema for 2 days, resolved.  subsequent cellulitic erythema at site and proximal/distal began 5 days post vaccination.  given antibiotics to address possible bacterial cellulitis.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Back pain, Chills, Headache, Influenza serology negative, Malaise
Clinical narrative: Received vaccinations around 12:30 p.m. and started feeling ill around 8:30 p.m. Fever of 103, stiff neck and neck pain, back pain, headache and body aches with chills. Fever lasted for 24 hours off and on. Went to the doctor, and I was told to take to the ER if symptoms get worse or any new symptoms occur. Still complaining of headache and neck stiffness, 3 days later.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pyrexia
Clinical narrative: Received vaccinations around 12:30 p.m. and started feeling ill around 8:30 p.m. Fever of 103, stiff neck and neck pain, back pain, headache and body aches with chills. Fever lasted for 24 hours off and on. Went to the doctor, and I was told to take to the ER if symptoms get worse or any new symptoms occur. Still complaining of headache and neck stiffness, 3 days later.
Age: 12.0
Sex: M
Vaccine: MMR, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Extensive Left Deltoid swelling, erythema, warmth.  Onset day after immunizations (Tdap, MMR in left arm).  Treated with ice, anti-inflammitories, antihistamines.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt given outside of FDA approved age limits.  Pt is 9 and youngest limit is 11.  No reported adverse reaction or illness reported by patient or family.  Pt required tetanus due to dirty wound and more than 5 years since last tetanus dose.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Fatigue, Nausea, Pyrexia, Rash, Rash generalised
Clinical narrative: Vaccine administered 08/20/2009. Client had nausea and vomiting on 08/21/2009.  Client had rash to L arm accompanied by fever of 101.5 and fatigue on 08/22/2009.  Client had rash on the rest of the body with fever on 08/23/2009.  Client recovered 08/24/2009 when event called into health department.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Vomiting
Clinical narrative: Vaccine administered 08/20/2009. Client had nausea and vomiting on 08/21/2009.  Client had rash to L arm accompanied by fever of 101.5 and fatigue on 08/22/2009.  Client had rash on the rest of the body with fever on 08/23/2009.  Client recovered 08/24/2009 when event called into health department.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Cold sweat, Eye rolling, Fatigue, Pallor, Pyrexia
Clinical narrative: After patient received the immunizations (Kinrix, MMR, Varicella, Hep A) he left the building with his mom and sister. After they got in the car, his sister said his eyes rolled back and he was shaking for approx. 20 seconds. Mom brought him immediately back to the office. He was noted to be alert but extremely pale and clammy. His vital signs were normal but he was given oxygen via mask until he became less pale and he was given some apple juice to drink. The patient was alert and could converse easily. He did not appear to be post ictal. He kept saying "I feel fine." He was observed in the office for approximately 15 minutes and his vital signs remained normal (pulse:90 B/P:90/60)and his color returned. He was then released with his mom. Two days after the event mom states that he had remained asymptomatic other than low grade fever and slightly more tired the rest of the day.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Tremor
Clinical narrative: After patient received the immunizations (Kinrix, MMR, Varicella, Hep A) he left the building with his mom and sister. After they got in the car, his sister said his eyes rolled back and he was shaking for approx. 20 seconds. Mom brought him immediately back to the office. He was noted to be alert but extremely pale and clammy. His vital signs were normal but he was given oxygen via mask until he became less pale and he was given some apple juice to drink. The patient was alert and could converse easily. He did not appear to be post ictal. He kept saying "I feel fine." He was observed in the office for approximately 15 minutes and his vital signs remained normal (pulse:90 B/P:90/60)and his color returned. He was then released with his mom. Two days after the event mom states that he had remained asymptomatic other than low grade fever and slightly more tired the rest of the day.