chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.41
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Body temperature increased, Erythema, Irritability, Localised oedema, Pyrexia
Clinical narrative: Fussy and slept after shots, slept. Felt very warm - T 104 under arm. Gave TYLENOL - brought it down about 101 - 102. Fever lasted 2-3 days-no other symptoms. Redness/swelling on leg(doesn't remember which one).
Age: 0.41
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Skin warm
Clinical narrative: Fussy and slept after shots, slept. Felt very warm - T 104 under arm. Gave TYLENOL - brought it down about 101 - 102. Fever lasted 2-3 days-no other symptoms. Redness/swelling on leg(doesn't remember which one).
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: Nausea, arm pain, site swollen and red.
Age: 77.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Small area of shingles, lower abdomen shingles cleaned up, residual nerve pain under treatment. The event was one year after vaccinations.
Age: 15.0
Sex: F
Vaccine: RAB
Symptoms: Blood test normal, Headache, Nausea, X-ray normal
Clinical narrative: Developed headache and nausea after vaccine. Unrelieved by TYLENOL or MOTRIN.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Myalgia, Rhabdomyolysis
Clinical narrative: Diffuse muscle aches, Rhabdomyolysis.
Age: 3.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: 4cm x 3cm reaction at immunization site. Also fever 103 orally noted.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered at inappropriate site, Medication error
Clinical narrative: A non-serious spontaneous report of eye exposure to FLUMIST was received from a registered nurse concerning a four-year-old male. The patient's medical history and concomitant medications were not reported. During the administration of the second half of FLUMIST, the patient turned his head and some of the FLUMIST got in his eye. Also, some of the FLUMIST leaked out of his nose. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponser causally assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune;s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. 10/14/2009 A non-serious spontaneous report of eye exposure to FLUMIST was received from a registered nurse concerning a four-year-old female. The patient's medical history and concomitant medications were not reported. On 27-Aug-2009, during the administration of the second half of the first dose of FLUMIST, the patient turned her head and some of the FLUMIST got in her eye. Also, some of the FLUMIST leaked out of her nose. On 14-Oct-2009, the reporter confirmed there was no adverse event associated with this medication error therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 14-Oct-2009 and incorporated into the narrative included: confirmation the patient did not experience any adverse events, the patient's date of birth, correction to patient's sex, and number of FLUMIST doses administered.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a consumer in the United States concerning a four year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Medical history and concomitant medications were not reported. On 17 Aug 2009 at 9:30 am, the patient received FluMist. At the time of reporting on 17 Aug 2009, the patient had a fever of 102.2. The outcome of the event was not reported.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Decreased appetite, Feeling abnormal, Insomnia, Irritability, Pyrexia
Clinical narrative: A non serious spontaneous report of spaces out; not sleeping well; cranky; whiney; fever and  decreased appetite has been received from a parent concerning a 26 month old female, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FluMist 17 Aug 2009. The parent reported that since receiving the vaccine the patient has been spaced out; not sleeping well; cranky/whiney, fever; and decreased appetite. The outcome for spaced out; not sleeping well; cranky/whiney; fever; and decreased appetite was not reported.
Age: 1.6
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: A non-serious spontaneous report of "inadvertent administration" and Fever has been received from a nurse concerning a 19-month-old male, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications have been reported for this patient. The patient inadvertently received FluMist on 18 Aug 2009. The nurse reported the event of fever that developed after the administration of FluMist. The cutcome of fever was not reported.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Economic problem, Mental disorder, Pain
Clinical narrative: Information has been received from a lawsuit concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently the patient suffered damages including but not limited to seizures, pain and suffering, mental anguish and economic losses. At the time of the report, the patient continued to experience the residual effects of taking the product. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: 23 y/o female received AVA #3 12/10/2008 & was found to be pregnant on 1/13/2009; no immediate reaction to vaccine reported, 1st LMP 12/1/2008; primigravida. Past history: depression treated with SERTRALINE. In Feb 2009 TVUS was normal. In Apr 2009 quad screen was negative. In Jun 2009 limited OB report indicated single living intrauterine gestation, in breech presentation; fetal facial profile appeared normal; fetal heart did not appear to exhibit normal four-chamber configuration, with suggested findings of large ASD or absence of the atrial septum, & possible small right ventricle; right ventricular outflow tract could not be identified; findings suggested possibility of hypoplastic right heart syndrome with possible pulmonary atresia. In Jul 2009 OB note indicated at 32 weeks gestation pt had elevated BP (145/94) with a TRACE urine protein -BPs had been elevated at 17-20 weeks pregnancy; pt was asymptomatic; base-line pre-eclampsia work up negative with baby active, moving well, abdomen nontender & measured appropriately. In Aug 2009 pt was dx with PIH & received close monitoring with frequent fetal NSTs; no BP meds prescribed. In Aug 2009 pt developed symptoms c/w GERD & was prescribed NEXIUM. On 9 Sep 2009 pt delivered infant girl by C-section. Per record, baby noted to have Down's Syndrome clinically & AV canal; baby was airlifted to Inpatient care at hospital; referrals planned for peds genetics, peds neurodevelopmental, & peds cardiology. Initial VAERS filed 27 Jan 2009 (338432-1). Pt symptoms/diagnosis: PIH Delivery outcome: Infant female with Down's Syndrome clinically & AV canal.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Blood pressure increased, Drug exposure during pregnancy, Pregnancy induced hypertension
Clinical narrative: 23 y/o female received AVA #3 12/10/2008 & was found to be pregnant on 1/13/2009; no immediate reaction to vaccine reported, 1st LMP 12/1/2008; primigravida. Past history: depression treated with SERTRALINE. In Feb 2009 TVUS was normal. In Apr 2009 quad screen was negative. In Jun 2009 limited OB report indicated single living intrauterine gestation, in breech presentation; fetal facial profile appeared normal; fetal heart did not appear to exhibit normal four-chamber configuration, with suggested findings of large ASD or absence of the atrial septum, & possible small right ventricle; right ventricular outflow tract could not be identified; findings suggested possibility of hypoplastic right heart syndrome with possible pulmonary atresia. In Jul 2009 OB note indicated at 32 weeks gestation pt had elevated BP (145/94) with a TRACE urine protein -BPs had been elevated at 17-20 weeks pregnancy; pt was asymptomatic; base-line pre-eclampsia work up negative with baby active, moving well, abdomen nontender & measured appropriately. In Aug 2009 pt was dx with PIH & received close monitoring with frequent fetal NSTs; no BP meds prescribed. In Aug 2009 pt developed symptoms c/w GERD & was prescribed NEXIUM. On 9 Sep 2009 pt delivered infant girl by C-section. Per record, baby noted to have Down's Syndrome clinically & AV canal; baby was airlifted to Inpatient care at hospital; referrals planned for peds genetics, peds neurodevelopmental, & peds cardiology. Initial VAERS filed 27 Jan 2009 (338432-1). Pt symptoms/diagnosis: PIH Delivery outcome: Infant female with Down's Syndrome clinically & AV canal.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Blood test, CSF protein increased, Computerised tomogram normal, Confusional state
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no medical history or drug allergies, who over a year ago was vaccinated with a 0.5 mL second dose of GARDASIL. Two months later the patient started experiencing "major seizures". With her first seizure she went to the emergency room and later she was diagnosed with Hashimoto's encephalitis. The nurse mentioned that the patient was hospitalized and intubated twice because the seizures would cause her to go into respiratory arrest. She was placed on steroids as well as other medications (manufacturers unspecified) and steroids caused her to gain weight. The patient had a series of spinal taps, electroencephalographies, and other unspecified laboratory tests done. Therapy with GARDASIL was discontinued. At the time of this report the patient had not recovered. Hashimoto's encephalitis, gain weight and respiratory arrest were considered to be immediately life-threatening. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Electroencephalogram, Endotracheal intubation, Grand mal convulsion, Headache
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no medical history or drug allergies, who over a year ago was vaccinated with a 0.5 mL second dose of GARDASIL. Two months later the patient started experiencing "major seizures". With her first seizure she went to the emergency room and later she was diagnosed with Hashimoto's encephalitis. The nurse mentioned that the patient was hospitalized and intubated twice because the seizures would cause her to go into respiratory arrest. She was placed on steroids as well as other medications (manufacturers unspecified) and steroids caused her to gain weight. The patient had a series of spinal taps, electroencephalographies, and other unspecified laboratory tests done. Therapy with GARDASIL was discontinued. At the time of this report the patient had not recovered. Hashimoto's encephalitis, gain weight and respiratory arrest were considered to be immediately life-threatening. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Lethargy, Lumbar puncture, Mood swings, Nausea
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no medical history or drug allergies, who over a year ago was vaccinated with a 0.5 mL second dose of GARDASIL. Two months later the patient started experiencing "major seizures". With her first seizure she went to the emergency room and later she was diagnosed with Hashimoto's encephalitis. The nurse mentioned that the patient was hospitalized and intubated twice because the seizures would cause her to go into respiratory arrest. She was placed on steroids as well as other medications (manufacturers unspecified) and steroids caused her to gain weight. The patient had a series of spinal taps, electroencephalographies, and other unspecified laboratory tests done. Therapy with GARDASIL was discontinued. At the time of this report the patient had not recovered. Hashimoto's encephalitis, gain weight and respiratory arrest were considered to be immediately life-threatening. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Personality change, Retching, Skin papilloma, Tremor
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no medical history or drug allergies, who over a year ago was vaccinated with a 0.5 mL second dose of GARDASIL. Two months later the patient started experiencing "major seizures". With her first seizure she went to the emergency room and later she was diagnosed with Hashimoto's encephalitis. The nurse mentioned that the patient was hospitalized and intubated twice because the seizures would cause her to go into respiratory arrest. She was placed on steroids as well as other medications (manufacturers unspecified) and steroids caused her to gain weight. The patient had a series of spinal taps, electroencephalographies, and other unspecified laboratory tests done. Therapy with GARDASIL was discontinued. At the time of this report the patient had not recovered. Hashimoto's encephalitis, gain weight and respiratory arrest were considered to be immediately life-threatening. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no medical history or drug allergies, who over a year ago was vaccinated with a 0.5 mL second dose of GARDASIL. Two months later the patient started experiencing "major seizures". With her first seizure she went to the emergency room and later she was diagnosed with Hashimoto's encephalitis. The nurse mentioned that the patient was hospitalized and intubated twice because the seizures would cause her to go into respiratory arrest. She was placed on steroids as well as other medications (manufacturers unspecified) and steroids caused her to gain weight. The patient had a series of spinal taps, electroencephalographies, and other unspecified laboratory tests done. Therapy with GARDASIL was discontinued. At the time of this report the patient had not recovered. Hashimoto's encephalitis, gain weight and respiratory arrest were considered to be immediately life-threatening. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Autoimmune thyroiditis, Convulsion, Electroencephalogram, Encephalitis, Endotracheal intubation
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no medical history or drug allergies, who over a year ago was vaccinated with a 0.5 mL second dose of GARDASIL. Two months later the patient started experiencing "major seizures". With her first seizure she went to the emergency room and later she was diagnosed with Hashimoto's encephalitis. The nurse mentioned that the patient was hospitalized and intubated twice because the seizures would cause her to go into respiratory arrest. She was placed on steroids as well as other medications (manufacturers unspecified) and steroids caused her to gain weight. The patient had a series of spinal taps, electroencephalographies, and other unspecified laboratory tests done. Therapy with GARDASIL was discontinued. At the time of this report the patient had not recovered. Hashimoto's encephalitis, gain weight and respiratory arrest were considered to be immediately life-threatening. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Lumbar puncture, Respiratory arrest, Weight increased
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no medical history or drug allergies, who over a year ago was vaccinated with a 0.5 mL second dose of GARDASIL. Two months later the patient started experiencing "major seizures". With her first seizure she went to the emergency room and later she was diagnosed with Hashimoto's encephalitis. The nurse mentioned that the patient was hospitalized and intubated twice because the seizures would cause her to go into respiratory arrest. She was placed on steroids as well as other medications (manufacturers unspecified) and steroids caused her to gain weight. The patient had a series of spinal taps, electroencephalographies, and other unspecified laboratory tests done. Therapy with GARDASIL was discontinued. At the time of this report the patient had not recovered. Hashimoto's encephalitis, gain weight and respiratory arrest were considered to be immediately life-threatening. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, TTOX, HPV4, TTOX
Symptoms: Anaemia, Asthenia, Autoimmune disorder, Bundle branch block, Dysphagia
Clinical narrative: Sept 2008 - tongue swelling, hyper nasal speech.  Oct 2008 - tonsillectomy.  Dec 2008 - drooping lower lip / lack of gag reflex disarthric speech.  Dec 2008 - diagnosed - myasthenia gravis.
Age: 13.0
Sex: F
Vaccine: HPV4, TTOX, HPV4, TTOX
Symptoms: Lip disorder, Plasmapheresis, Speech disorder, Swollen tongue
Clinical narrative: Sept 2008 - tongue swelling, hyper nasal speech.  Oct 2008 - tonsillectomy.  Dec 2008 - drooping lower lip / lack of gag reflex disarthric speech.  Dec 2008 - diagnosed - myasthenia gravis.
Age: 13.0
Sex: F
Vaccine: HPV4, TTOX, HPV4, TTOX
Symptoms: Areflexia, Dysarthria, Myasthenia gravis, Speech disorder, Swollen tongue
Clinical narrative: Sept 2008 - tongue swelling, hyper nasal speech.  Oct 2008 - tonsillectomy.  Dec 2008 - drooping lower lip / lack of gag reflex disarthric speech.  Dec 2008 - diagnosed - myasthenia gravis.
Age: 13.0
Sex: F
Vaccine: HPV4, TTOX, HPV4, TTOX
Symptoms: Tonsillectomy
Clinical narrative: Sept 2008 - tongue swelling, hyper nasal speech.  Oct 2008 - tonsillectomy.  Dec 2008 - drooping lower lip / lack of gag reflex disarthric speech.  Dec 2008 - diagnosed - myasthenia gravis.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Heart rate increased, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a diagnosis of anxiety on 10-JUN-2009, no drug allergies and no other medical history, who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (IM, lot # unspecified). Suspect therapy included MENACTRA. There was no other concomitant medication. Two hours after the vaccination, the patient developed numbness to her arms and hands, lightheadedness and increased heart rate. Several hours after the symptoms began the patient was taken to the emergency room (name of hospital was not specified) by squad. The patient was released home from the emergency room. A few days later the symptoms continued and the patient was hospitalized for 48 hours (diagnosis not specified). The patient had been in the physician's office for follow up appointments on 12-AUG-2009, 20-AUG-2009 and on 10-SEP-2009. Labs and diagnostic tests included PPD skin test on 11-AUG-2009. Tests were completed (types of tests and results were not specified). At the time of the report, the patient had recovered (date unknown). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Heart rate increased, Hypoaesthesia, Laboratory test, Tuberculin test
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a diagnosis of anxiety on 10-JUN-2009, no drug allergies and no other medical history, who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (IM, lot # unspecified). Suspect therapy included MENACTRA. There was no other concomitant medication. Two hours after the vaccination, the patient developed numbness to her arms and hands, lightheadedness and increased heart rate. Several hours after the symptoms began the patient was taken to the emergency room (name of hospital was not specified) by squad. The patient was released home from the emergency room. A few days later the symptoms continued and the patient was hospitalized for 48 hours (diagnosis not specified). The patient had been in the physician's office for follow up appointments on 12-AUG-2009, 20-AUG-2009 and on 10-SEP-2009. Labs and diagnostic tests included PPD skin test on 11-AUG-2009. Tests were completed (types of tests and results were not specified). At the time of the report, the patient had recovered (date unknown). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Amnesia, Anxiety, Condition aggravated, Dizziness, Heart rate increased
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a diagnosis of anxiety on 10-JUN-2009, no drug allergies and no other medical history, who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (IM, lot # unspecified). Suspect therapy included MENACTRA. There was no other concomitant medication. Two hours after the vaccination, the patient developed numbness to her arms and hands, lightheadedness and increased heart rate. Several hours after the symptoms began the patient was taken to the emergency room (name of hospital was not specified) by squad. The patient was released home from the emergency room. A few days later the symptoms continued and the patient was hospitalized for 48 hours (diagnosis not specified). The patient had been in the physician's office for follow up appointments on 12-AUG-2009, 20-AUG-2009 and on 10-SEP-2009. Labs and diagnostic tests included PPD skin test on 11-AUG-2009. Tests were completed (types of tests and results were not specified). At the time of the report, the patient had recovered (date unknown). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Hypoaesthesia, Incoherent, Insomnia, Lethargy, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a diagnosis of anxiety on 10-JUN-2009, no drug allergies and no other medical history, who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (IM, lot # unspecified). Suspect therapy included MENACTRA. There was no other concomitant medication. Two hours after the vaccination, the patient developed numbness to her arms and hands, lightheadedness and increased heart rate. Several hours after the symptoms began the patient was taken to the emergency room (name of hospital was not specified) by squad. The patient was released home from the emergency room. A few days later the symptoms continued and the patient was hospitalized for 48 hours (diagnosis not specified). The patient had been in the physician's office for follow up appointments on 12-AUG-2009, 20-AUG-2009 and on 10-SEP-2009. Labs and diagnostic tests included PPD skin test on 11-AUG-2009. Tests were completed (types of tests and results were not specified). At the time of the report, the patient had recovered (date unknown). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Tuberculin test negative
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a diagnosis of anxiety on 10-JUN-2009, no drug allergies and no other medical history, who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (IM, lot # unspecified). Suspect therapy included MENACTRA. There was no other concomitant medication. Two hours after the vaccination, the patient developed numbness to her arms and hands, lightheadedness and increased heart rate. Several hours after the symptoms began the patient was taken to the emergency room (name of hospital was not specified) by squad. The patient was released home from the emergency room. A few days later the symptoms continued and the patient was hospitalized for 48 hours (diagnosis not specified). The patient had been in the physician's office for follow up appointments on 12-AUG-2009, 20-AUG-2009 and on 10-SEP-2009. Labs and diagnostic tests included PPD skin test on 11-AUG-2009. Tests were completed (types of tests and results were not specified). At the time of the report, the patient had recovered (date unknown). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Injection site rash, Injection site warmth
Clinical narrative: Hot, raised at injection site, rash, fever of 100.4 degrees. Dizziness, trouble breathing, body aches. Diarrhea, vomiting.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Hot, raised at injection site, rash, fever of 100.4 degrees. Dizziness, trouble breathing, body aches. Diarrhea, vomiting.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Hepatic enzyme abnormal, Ultrasound scan
Clinical narrative: Liver enzymes were elevated. On the day of the vaccination (7/16/09), ALT was recorded at 17. On 08/26/09, ALT was recorded at 130. On 9/4/09, ALT was recorded at 158. On 9/11/09, ALT was recorded at 117. Ultrasound of the liver was performed on 9/16/09 with results pending.  8/5/09 PCP medical records service dates 716/09 to 9/11/09. Assessment: Gastritis Patient presented with abdominal pain, black stools, fever, nausea. Dizziness.
Age: 4.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria - given BENADRYL in clinic.
Age: 59.0
Sex: F
Vaccine: FLU3
Clinical narrative: (See attached). 10/12/09 Hospital records, DC summary, received service dates 11/26/08 to 12/03/08. Assessment: Guillain-Barre Syndrome. Patient noted achiness in her back and down into her legs one week ago. Pain increased and developed in palms and fingertips, generalized tingling sensation in toes and finger tips. Patient presents with burning sensation in lateral thighs and aching feeling in calves. Fingertips and feet are numb. Urinary frequency. Little sleep at night. Muscle weakness extremities, deceased temperature and pain sensation. Wide-based, ataxic gait. Needs assistance with ambulation. IVIG.  ICD-9 Codes: 357.0 Ac Infect Polyneuritis, 781.3 Lack of Coordination, 782.0 Skin Sensation Disturbance, 788.41 Urinary Frequency, 781.2 Abnormality of Gait.   10/14/09 Neurology consult records received, service dates 11/25/08 to 8/25/09. Assessment: Guillain Barre Syndrome. Patient presented with a 1 week history of weakness, pain, and achiness in back and legs. Pain in palms and fingertips, tingling and parasthesias.  Tingling progressed to the toes.  She also developed imbalance and weakness with several falls.  Reflexes are absent throughout.  Upon follow up from hospitalization:  remains unsteady, using a cane.  Unable to drive.  Feet feel like bricks.  Needs assistance with ADL's (showering).  Pain can be incapacitating. Knee pain since fall 6 weeks ago.  Absent reflexes in LE's, diminished reflexes in biceps.   Gait is shaky. 8/25/09-Compared with the initial study on 11/26/09 the degree of demyelination and axonal loss is worse, likely a reflection of continued injury to the nerves during the acute phase of her illness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5cm by 4cm on Right arm induration and redness.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Scab
Clinical narrative: Information has been received from a physician concerning a 70 year old male patient with hypertension, gout, paroxysmal atrial fibrillation and no known drug allergies who on 03-AUG-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (subcutaneous injection, lot# 662856/1559X). Concomitant therapy included LOTREL and allopurinol. On 06-SEP-2009 the patient experienced shingles on the left side of face around the eye. The patient was seen by an ophthalmologist and the shingles did not extend into the eye. The patient was travelling when the symptoms began. Upon his arrival he was seen in an emergency room and was hospitalised. He was given acyclovir. The patient had been seen by his responsible physician and photographs confirmed diagnosis of shingles. The physician mentioned the patient was improving; the vesicles were gone and scabs remained along in the maxillary along the trigeminal nerve. No lab diagnostic study was performed. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose increased, Blood test, Body temperature increased, Hallucination, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 57 year old female patient with diverticulitis, depression and colostomy and no known drug allergies/drug reactions who in 1998 was vaccinated with the first dose of PNEUMOVAX (Lot # 660718/0551X). The patient received the second dose of PNEUMOVAX about 2-3 years ago, (approximately in 2006), and the third dose was given on 10-SEP-2009. There were no other vaccinations at the same time. It was reported that since the recent vaccination the patient had developed a fever as high as 101 F, a swollen injection site of about 4 cm, body aches, elevated blood glucose, tremors in her chest and arms and hallucinations. The patient sought medical attention in the office. It was reported that the patient was treated with TYLENOL, intravenous fluids and insulin. On an unspecified date a blood work was performed (results not provided). It was reported that the patient had not recovered at the time of the  report. The reporting physician considered that fever as high as 101 F, a swollen injection site of about 4 cm, body aches, elevated blood glucose, tremors in her chest and arms and hallucinations required intervention to prevent serious criteria. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Information has been received from a physician concerning a 57 year old female patient with diverticulitis, depression and colostomy and no known drug allergies/drug reactions who in 1998 was vaccinated with the first dose of PNEUMOVAX (Lot # 660718/0551X). The patient received the second dose of PNEUMOVAX about 2-3 years ago, (approximately in 2006), and the third dose was given on 10-SEP-2009. There were no other vaccinations at the same time. It was reported that since the recent vaccination the patient had developed a fever as high as 101 F, a swollen injection site of about 4 cm, body aches, elevated blood glucose, tremors in her chest and arms and hallucinations. The patient sought medical attention in the office. It was reported that the patient was treated with TYLENOL, intravenous fluids and insulin. On an unspecified date a blood work was performed (results not provided). It was reported that the patient had not recovered at the time of the  report. The reporting physician considered that fever as high as 101 F, a swollen injection site of about 4 cm, body aches, elevated blood glucose, tremors in her chest and arms and hallucinations required intervention to prevent serious criteria. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Hypertension, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a certified medical assistant concerning a 29 year old female who on 25-SEP-2008 was vaccinated with a first dose of GARDASIL. The patient developed high blood pressure. The patient had always had normal blood pressure. Her blood pressure on 02-OCT-2008 was 148/88 and on 06-JAN-2009 it was 158/98. The patient sought unspecified medical attention. The patient's outcome is unknown. Follow up information received on 14-SEP-2009 from a physician indicated that the patient was a 28 year old female with no medical history, allergies or illness at the time of vaccination; it was also reported that the patient did not experience any adverse events following prior vaccinations. On 25-SEP-2008 at 10:15 was vaccinated with the first dose of GARDASIL (lot # 661764/0650X), intramuscularly. The patient received a second dose of GARDASIL (lot # 661764/0650X), intramuscularly on 20-NOV-2008 at 10:00. In October 2008, after the 2 doses of GARDASIL the patient developed high blood pressure. The patient was treated with hypertensive medication. The patient had an electrocardiogram done. At the time of this report the patient had not recovered. High blood pressure was considered to be an other important medical event. No further information is available.   9/30/09 Received PCP medical records of 6/30/09-  Records reveal patient was new patient to practice on 6/30 for essential hypertension management & had palpitations, microscopic hematuria, migraines, iron def anemia & acne.  Work up had been done be another MD.  Exam revealed xanthelasma.  BCPs had been d/c for 1 wk.  Advised against restarting & was also advised to d/c all meds due to probable drug induced HTN.  RTC 8/6/09 w/fever, cold s/s, enlarged & tender cervical lymph nodes.  Dx w/chronic tonsillitis & adnoiditis, dehydration.  Tx w/oral antibiotics.  Did not improve & RTC 8/13/09 w/wheezing & SOB.  Dx w/acute bronchitis.  Tx w/steroids, nebs, continued antibiotics & cough syrup.  RTC 9/10 w/continued HTN, restarted on anti-HTN meds & low dose ASA.  No further records available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour
Clinical narrative: Information has been received from a office manager, for GARDASIL, a Pregnancy Registry Product, concerning a 23 year old female who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL (0.5ml, IM). On 31-OCT-2008 the patient received the second dose of GARDASIL (0.5ml, IM, lot# 659653/1448U). Concomitant therapy included omeprazole and DIFLUCAN. Subsequently the patient got pregnant on an unspecified date. In April 2009, the baby girl was born prematurely and was on an incubator. The patient had a 2 month postpartum visit on 30-JUN-2009. A physician had a note in a chart saying the third dose of GARDASIL would hold off since the patient was breastfeeding. At the reporting time the outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Acoustic stimulation tests, Autism, Disturbance in social behaviour, Irritability
Clinical narrative: Information has been received from a consumer concerning the 14 year old daughter with no pertinent medical history and no drug allergies, who was vaccinated with MMR II when she was younger. There was no concomitant medication. She received other unspecified shots later on. The patient was delayed in everything after the vaccination of MMR II. She showed all types of autism when she was younger. The mother mentioned that at her daughter's 2 month shots (unspecified), the patient ran a fever and was irritable. Few other shots (unspecified) later on, the patient stopped smiling and made no eye contact. The patient was a happy and smiley baby and then would not smile. The mother felt as her daughter received more shots, she changed more and more. By the age of 3, the patient was only saying 30 words. The mother stated "My daughter is doing better but her personality is different. Everyone in my family is outgoing and my daughter is outgoing but not in the same way. My daughter takes everything literally so you have to watch you don't use the wrong words, for example if you told her to put the watermelon in the freezer, she would put it in the freezer,even though this is incorrect." Labs and diagnostic tests included hearing test and "a lot of different tests". The patient visited office for medical attention. At the time of the report, the patient's status was unknown. Upon internal review, autism was considered to be an other important medical event. No further information is available.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test, Pyrexia
Clinical narrative: Information has been received from a consumer concerning the 14 year old daughter with no pertinent medical history and no drug allergies, who was vaccinated with MMR II when she was younger. There was no concomitant medication. She received other unspecified shots later on. The patient was delayed in everything after the vaccination of MMR II. She showed all types of autism when she was younger. The mother mentioned that at her daughter's 2 month shots (unspecified), the patient ran a fever and was irritable. Few other shots (unspecified) later on, the patient stopped smiling and made no eye contact. The patient was a happy and smiley baby and then would not smile. The mother felt as her daughter received more shots, she changed more and more. By the age of 3, the patient was only saying 30 words. The mother stated "My daughter is doing better but her personality is different. Everyone in my family is outgoing and my daughter is outgoing but not in the same way. My daughter takes everything literally so you have to watch you don't use the wrong words, for example if you told her to put the watermelon in the freezer, she would put it in the freezer,even though this is incorrect." Labs and diagnostic tests included hearing test and "a lot of different tests". The patient visited office for medical attention. At the time of the report, the patient's status was unknown. Upon internal review, autism was considered to be an other important medical event. No further information is available.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Auricular swelling, Blood test, Erythema, External ear pain, Skin necrosis
Clinical narrative: Within 24 hrs. after shots, patient's outer ears swelled and turned red with severe pain. Within 48hrs, both outer ears (sparing the lobes) turned black. She'd had massive blood clots in both ears. She was hospitalized for 13 days receiving treatment / dealing with add % compilations.  10/15/09:  Medical Records and Discharge Summary received for Dates of Service 8/6/09-8/19/09.  Discharge Diagnoses:  Antiphospholipid antibody syndrome, Juvenile rheumatoid arthritis, Multiple thrombotic events, Iatrogenic right neck hematoma with extension into the superior mediastinum following attempt at right internal jugular venous catheterization, Adrenal hematoma. Presenting sx:  Pt. admitted for microvascular necrosis of the ears probably secondary to lupus anticoagulant syndrome two days after meningococcal and Tdap vaccines. She was started on unfractionated heparin IV infusion, while coumadin was continued.  She suffered a right Para tracheal hematoma extending into the superior mediastinum after an attempt at internal jugular venous catheterization.  Coumadin was discontinued on 8/18 in favor of low molecular weight heparin and Lovenox.   IVIg was ordered.  Nitroglycerine paste was used on the ears for vasodilation.   A 1/6 systolic murmur is noted throughout the precordium.   Lymphopenia and anemia noted.  The patient was discharged on Lovenox, Amicar, Imuran and prednisone to be tapered as an outpatient.  Follow up consults with Hematology and Rheumatology.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Thrombosis
Clinical narrative: Within 24 hrs. after shots, patient's outer ears swelled and turned red with severe pain. Within 48hrs, both outer ears (sparing the lobes) turned black. She'd had massive blood clots in both ears. She was hospitalized for 13 days receiving treatment / dealing with add % compilations.  10/15/09:  Medical Records and Discharge Summary received for Dates of Service 8/6/09-8/19/09.  Discharge Diagnoses:  Antiphospholipid antibody syndrome, Juvenile rheumatoid arthritis, Multiple thrombotic events, Iatrogenic right neck hematoma with extension into the superior mediastinum following attempt at right internal jugular venous catheterization, Adrenal hematoma. Presenting sx:  Pt. admitted for microvascular necrosis of the ears probably secondary to lupus anticoagulant syndrome two days after meningococcal and Tdap vaccines. She was started on unfractionated heparin IV infusion, while coumadin was continued.  She suffered a right Para tracheal hematoma extending into the superior mediastinum after an attempt at internal jugular venous catheterization.  Coumadin was discontinued on 8/18 in favor of low molecular weight heparin and Lovenox.   IVIg was ordered.  Nitroglycerine paste was used on the ears for vasodilation.   A 1/6 systolic murmur is noted throughout the precordium.   Lymphopenia and anemia noted.  The patient was discharged on Lovenox, Amicar, Imuran and prednisone to be tapered as an outpatient.  Follow up consults with Hematology and Rheumatology.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Induration, Oedema
Clinical narrative: Edema > 10cm of arm with induration and erythema. ( Encompassed >2/3 of upper arm ).
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Hyperhidrosis, Induration, Oedema peripheral, Pain
Clinical narrative: Received Tdap 8/7/09. About 12 hours later noted erythema swelling & aching. Next day stated arm above elbow to shoulder was swollen, indurated, warm & erythematous x 5 days. Felt Feverish, (+) perspiration (+) aches x 5 day. states she was treated with AUGMENTIN & BACTRIM. No official record of treatment. Advised her PMD not to take Tdap again.
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Rash erythematous, Skin warm
Clinical narrative: Received Tdap 8/7/09. About 12 hours later noted erythema swelling & aching. Next day stated arm above elbow to shoulder was swollen, indurated, warm & erythematous x 5 days. Felt Feverish, (+) perspiration (+) aches x 5 day. states she was treated with AUGMENTIN & BACTRIM. No official record of treatment. Advised her PMD not to take Tdap again.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bronchitis, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Shot area red, swollen, painful 4x4 area 101 degree-Temp. Extreme chills, aches, pain, headache, nausea, shot on 8/28 am - sick, 8/29, 8/30,8/31,9/1 am-pm. Went  into bronchitis sinus infection. Sick 9/1-9/2.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia, Sinusitis
Clinical narrative: Shot area red, swollen, painful 4x4 area 101 degree-Temp. Extreme chills, aches, pain, headache, nausea, shot on 8/28 am - sick, 8/29, 8/30,8/31,9/1 am-pm. Went  into bronchitis sinus infection. Sick 9/1-9/2.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Motion sickness
Clinical narrative: Headache, "sea sick" feeling when changing positions, moving head. Home measures. Call office if not feeling better in next 24 hours.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Feeling abnormal, Paraesthesia, Throat tightness
Clinical narrative: Patient came back in 1 hour after shot was administered claiming her throat was closing up tingling around shoulder and groin. "Just not feeling right" Patient later said she fell as well. 1 EPIPEN was administered which improved patient status. EMS came and patient refused therapy.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Gaze palsy, Loss of consciousness, Screaming, Vomiting
Clinical narrative: Normal for 2 hours then Started vomiting, lost consciousness, screaming, difficulty breathing. Eyes rolled to back of head but did seem to respond to voice, probably not seizure. Lasted a few minutes, then screamed, then slept 2 hours, then normal. No rash or physical findings.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia oral
Clinical narrative: Patient complained of ligh-headness and numbness if lips. No difficulty breathing, no treatment given. patient left pharmacy after 2 hours.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After administering the vaccine, pt complained of feeling lightheaded and passed out.  Pt responded immediately to smelling salts, was alert and oriented X 3, vital signs stable.  Pt reported she "forgot" to mention she has felt light headed after injections and her mother and sister have fainted just after injections.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Incorrect route of drug administration, Myalgia
Clinical narrative: Patient received Subq vaccine by IM Route. Had sore muscle.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vomiting
Clinical narrative: Employee complains of feeling dizzy & vomited. Donor laid in office and received no medications.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: Employee complains of headache and dizziness. Donor laid in office and received no medications.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: 09/23/09 Employee complains of feeling dizzy and faint. Donor laid in office x 30min. No medications given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash papular, Skin lesion, Varicella post vaccine
Clinical narrative: Papulovesicular lesions to skin increasing x 2 da.  Pt. diagnosed with varicella.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dyspnoea, Headache
Clinical narrative: Pt c/o headache x 2 days and CP with breathing x 2days. Patient referred to cardiology.  9/29/09 Cardiology consultation records received DOS 9/14/09 to 9/16/09. Includes orthopedic imaging studies from 2/5/09 and 6/16/09. Assessment: Aortic Regurgitation. Patient presents with chest pain.
Age: 44.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Patient received smallpox vaccine on 3 Sept 2009. She did not return for her take check 1 week later. She return on 14 Sept 09 due to hives and red rash on inner lower arms. Provider gave BENADRYL, patient returned again on 16 Sept with HIVES/red rash completely covering entire body including bottom of feet.  12/02/09 Vax records received. No changes to VAERS.  12/28/09 Medical records of 12/8/09 received.  Unable to contact patient.  Derm phone consult done & dx w/immune mediated exanthem.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Urticaria
Clinical narrative: Patient had received flu vaccine at 11am and around 12:00pm started to feel SOB and noticed what she thought was an insect bite. The next evening 9/22/09 was completely red and had hives and difficulty breathing was seen and treated at ER and released. She was given IM Benadryl - Steroids injection and Rx for - Medrol dose pk. Benadryl and Pepcid.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dry eye, Fatigue, Headache, Irritability, Ocular hyperaemia
Clinical narrative: Starting at about 4 hours after the shot had a headache.  At 6 hours after mild fever began and severe body ache and eyes very dry and red.  At around 7 hours began to have sore throat which was not listed under symptom.  Tingling in nose as if I have to sneeze but am unable.  Very tired and irritable.  Today is the next day and I feel all these symptoms at once.  It is nearly as bad as actually having the flu.  Not recovered yet but I suspect I will. Don't know who manufactured it but I had to enter something or I couldn't complete the form.