chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: CSF test, Herpes zoster, Meningitis
Clinical narrative: Information has been received from a paper and poster presented at the Conference on Vaccine Research. Four real-time polymerase chain reaction protocols were used to target four vaccine-associated single-base polymorphisms, allowing the identification of VZV-positive specimens and discrimination of vaccine from wild-type VZV strains. Cerebral spinal fluid samples were sent to the CDC for genotyping. Additional clinical information was requested for the 26 cases that were successfully genotyped. Patients ranged in age from 12-85 years (median 46.5): seven (27%) were years of age. Eight were immunocompromised (30%). Eleven (42%) had rash: 9 (35%) were described as zosteriform. Median CSF white blood cell count was 267 cells/mm3 (range: 6-1615), median CSF protein level was 96 mg/dl (mg:17-239) and median CSF glucose was 59 mg/dL (range: 24-79). Of the seven pediatric cases, 6/7 were immunocompetent, four had a history of at least one dose of varicella vaccine, two had a history of disease, and one was unimmunized. Genotype analysis identified: 20 foreign strains; four foreign strains, one of which was the vaccine strain; and two foreign strains. This report includes the fourth documented case of VZV vaccine strain associated with CNS disease, presenting 11 years post immunization [with] meningitis and herpes zoster rash. This strain was found in a previously healthy 12-year-old girl, who presented with meningitis symptoms. These results suggested that varicella-zoster virus continues to be associated with CNS disease, including reactivation of vaccine virus. Upon internal review, meningitis was considered to be an other important medical event. No further information available. No further information available.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Immediate post-injection reaction, Loss of consciousness, Pyrexia, Vomiting
Clinical narrative: Initial report was received 01 July 2009 from a health care professional.  A 14-year-old female patient with a history of vomiting following a prior vaccination, had received a first dose left deltoid intramuscular injection of MENACTRA, lot number U2922A on 30 June 2009, and immediately following vaccination, she momentarily passed out.  She also developed fever, chills and vomiting later that same day.  She had not received any other vaccines within four weeks of MENACTRA.  At the time of the report, she continued to have fever and nausea and her recovery status was reported as unknown.  The reporter for this case is the same as for case number 2009-02918.  Documents held by sender:  None.
Age: 63.0
Sex: F
Vaccine: MEN
Symptoms: Activities of daily living impaired, Amnesia, Chest X-ray normal, Dyspnoea, Fatigue
Clinical narrative: Initial report received on 02 July 2009 from a nurse. A 63-year-old female patient, who has a current medical history of lupus, had received an intramuscular right deltoid injection of MENOMUNE A/C/Y/W-135 (lot number UF501AA) ON 18 June 2009. Prior to vaccination, the patient had laboratory data that revealed a positive ANA test (date not reported). The patient had not received any other vaccinations within four weeks of 18 June 2009. Six days post-vaccination on 24 June 2009, the patient reported she required medical evaluation for symptoms of profound fatigue which caused symptoms of nausea, memory loss, mild headache and shortness of breath. As a result, the patient has experienced "loss of work." Treatments received were not reported. Subsequently, a chest X-ray was completed that was negative. A CBC (complete blood count) and chemistry panel were completed; however the results of these tests were not reported. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: MEN
Symptoms: Full blood count, Headache, Laboratory test, Nausea
Clinical narrative: Initial report received on 02 July 2009 from a nurse. A 63-year-old female patient, who has a current medical history of lupus, had received an intramuscular right deltoid injection of MENOMUNE A/C/Y/W-135 (lot number UF501AA) ON 18 June 2009. Prior to vaccination, the patient had laboratory data that revealed a positive ANA test (date not reported). The patient had not received any other vaccinations within four weeks of 18 June 2009. Six days post-vaccination on 24 June 2009, the patient reported she required medical evaluation for symptoms of profound fatigue which caused symptoms of nausea, memory loss, mild headache and shortness of breath. As a result, the patient has experienced "loss of work." Treatments received were not reported. Subsequently, a chest X-ray was completed that was negative. A CBC (complete blood count) and chemistry panel were completed; however the results of these tests were not reported. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Myalgia
Clinical narrative: It has been over 2 weeks since my last guardasil shot and my left arm is still sore at the injection site. Feels like a sore muscle.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Presyncope
Clinical narrative: Near syncope event.
Age: 50.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Epistaxis, Injection site discharge, Lymphadenopathy, Thrombosis
Clinical narrative: PINKISH DISCHARGE AT INJECTION SITE, SWOLLEN GLANDS, HEAVY NOSE BLEED, LARGE BLOOD CLOTS
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Cold sweat, Cyanosis, Dizziness, Pallor
Clinical narrative: After administration of vaccines. Client complained of lightheadedness. Nurse observed client to be pale, cold,clammy with buccal cyanosis client never lost consciousness.  Nurse assisted client onto exam table and applied cool compresses to head and neck area.  Client was given juice (apple) and tolerated well.  Vital signs assesed to be within normal limits.  Client recovered fully within 25 minutes.  Mother present and able to transport home.
Age: 1.0
Sex: F
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Blister, Rash, Skin lesion
Clinical narrative: Rash x1 week, develops water filled blister which then pops.  Several lesions on arms, trunk
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Condition aggravated, Syncope
Clinical narrative: Client fainted after receiving immuizations as follows: IPV, Tdap,MMR,Hep A, Hep B. The temperature outside was 103degrees, the client stated she had eaten a power bar about an hour before. She was advised to lie down in a cool room, drink fluids,and eat a sandwich and some fruit. If she fainted again to call 911. A companion was staying with her.
Age: 65.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Anxiety, Blood cholesterol increased, Diabetes mellitus, Hyperhidrosis, Hypertension
Clinical narrative: Aproximately 15 minutes after vaccine administration client c/o, tingling of her upper lip and a hive forming above her left eyebrow. Shortly there after she began to feel diaphoretic.Client took benedryl and laid down on a clinic bed for about 30-40 minutes, at which time she felt better and was taken home by a friend.
Age: 65.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Hypothyroidism, Paraesthesia oral, Urticaria
Clinical narrative: Aproximately 15 minutes after vaccine administration client c/o, tingling of her upper lip and a hive forming above her left eyebrow. Shortly there after she began to feel diaphoretic.Client took benedryl and laid down on a clinic bed for about 30-40 minutes, at which time she felt better and was taken home by a friend.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Bruxism, Computerised tomogram normal, Electroencephalogram normal, Eye disorder, Feeling cold
Clinical narrative: Within 12 hours of immuniation Child called to Mom and was found in a crawling position able to talk but unable to move.  His mother picked him up and he began having non-rhythmic myoclonic jerks of the arms and legs.  This continued for 40 minutes and resolved prior to arriving in the ER.  Dad held him for a while when this was occuring and he became glassy eyed but still communicated.  He also clenched his fists and ground his teeth.  He was cold to the touch when the episode began, at the Emergency Department he had a fever of 101. He had several myoclonic arm jerks the next 2 days, seemed uncordinated and less active on day 1 after immunization.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Myoclonus, Pyrexia
Clinical narrative: Within 12 hours of immuniation Child called to Mom and was found in a crawling position able to talk but unable to move.  His mother picked him up and he began having non-rhythmic myoclonic jerks of the arms and legs.  This continued for 40 minutes and resolved prior to arriving in the ER.  Dad held him for a while when this was occuring and he became glassy eyed but still communicated.  He also clenched his fists and ground his teeth.  He was cold to the touch when the episode began, at the Emergency Department he had a fever of 101. He had several myoclonic arm jerks the next 2 days, seemed uncordinated and less active on day 1 after immunization.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warmth at injection site.  Approximately 2-3 inches in diameter.  Hard knot at sight.  Used ice to injection site.  S/S X 2 days.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Full blood count, Haematocrit decreased, Haemoglobin normal, Injection site pain, Metabolic function test
Clinical narrative: Pt received Tdap 0.5ml Im in left deltoid on 6/30/09. She called that evening to complain of pain at injection site. Used ice and took ibuprofen with some relief. Examined 7/1/09, no redness or swelling at site, some tenderness on moving shoulder. Went to ER 7/3/09. Saw Dr. who consulted with orthopedist on call. She received steroids and pain meds. His note states "Lab OK, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa, synovial joint inflamed 2nd to high placement of DT" . On 7/8/09 pt reported she has been taking pain meds and using a sling which helps some, but hard to work. Has appoinment to see Dr on 7/13/09. Spoke with her 7-8-09 she reports still considerable pain but better than before ER visit.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Monocyte count increased, White blood cell count decreased
Clinical narrative: Pt received Tdap 0.5ml Im in left deltoid on 6/30/09. She called that evening to complain of pain at injection site. Used ice and took ibuprofen with some relief. Examined 7/1/09, no redness or swelling at site, some tenderness on moving shoulder. Went to ER 7/3/09. Saw Dr. who consulted with orthopedist on call. She received steroids and pain meds. His note states "Lab OK, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa, synovial joint inflamed 2nd to high placement of DT" . On 7/8/09 pt reported she has been taking pain meds and using a sling which helps some, but hard to work. Has appoinment to see Dr on 7/13/09. Spoke with her 7-8-09 she reports still considerable pain but better than before ER visit.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Arthritis, Bursitis, Full blood count, Granulocyte count decreased
Clinical narrative: Pt received Tdap 0.5ml Im in left deltoid on 6/30/09. She called that evening to complain of pain at injection site. Used ice and took ibuprofen with some relief. Examined 7/1/09, no redness or swelling at site, some tenderness on moving shoulder. Went to ER 7/3/09. Saw Dr. who consulted with orthopedist on call. She received steroids and pain meds. His note states "Lab OK, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa, synovial joint inflamed 2nd to high placement of DT" . On 7/8/09 pt reported she has been taking pain meds and using a sling which helps some, but hard to work. Has appoinment to see Dr on 7/13/09. Spoke with her 7-8-09 she reports still considerable pain but better than before ER visit.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Haematocrit decreased, Haemoglobin normal, Injection site pain, Metabolic function test, Monocyte count increased
Clinical narrative: Pt received Tdap 0.5ml Im in left deltoid on 6/30/09. She called that evening to complain of pain at injection site. Used ice and took ibuprofen with some relief. Examined 7/1/09, no redness or swelling at site, some tenderness on moving shoulder. Went to ER 7/3/09. Saw Dr. who consulted with orthopedist on call. She received steroids and pain meds. His note states "Lab OK, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa, synovial joint inflamed 2nd to high placement of DT" . On 7/8/09 pt reported she has been taking pain meds and using a sling which helps some, but hard to work. Has appoinment to see Dr on 7/13/09. Spoke with her 7-8-09 she reports still considerable pain but better than before ER visit.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: White blood cell count decreased
Clinical narrative: Pt received Tdap 0.5ml Im in left deltoid on 6/30/09. She called that evening to complain of pain at injection site. Used ice and took ibuprofen with some relief. Examined 7/1/09, no redness or swelling at site, some tenderness on moving shoulder. Went to ER 7/3/09. Saw Dr. who consulted with orthopedist on call. She received steroids and pain meds. His note states "Lab OK, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa, synovial joint inflamed 2nd to high placement of DT" . On 7/8/09 pt reported she has been taking pain meds and using a sling which helps some, but hard to work. Has appoinment to see Dr on 7/13/09. Spoke with her 7-8-09 she reports still considerable pain but better than before ER visit.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Spinal X-ray normal
Clinical narrative: Pt received HPV vaccine on 14 Apr 09. Pt went to urgent care clinic on 24 Apr 09 complaining that her right hand had been numb for the past 6 days. Pt received Gardasil in left arm. When pt came in for 2nd series pt states her hand is still numb and believes it may be related to the Gardasil vaccine.
Age: 73.0
Sex: M
Vaccine: PPV, TD, VARZOS
Symptoms: Blister, Eye swelling
Clinical narrative: Received a call from son-in-law of patient stating that patient has two small fluid filled spots on patient forehead and that his eyes are puffy.  He stated that the reactions came up yesterday and that they had been appling cool towels to the patients eyes and covering the spots with bandaids.  He said that one eye was more puffy than the other.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pruritus, Shock, Swelling face
Clinical narrative: Shingles vaccine given at 1:35PM. At 1:45PM itching, facial swelling, difficult breathing, signs of shock began. Taken to emergency room at 1:50PM. After being given I.V. antidotes to relieve the swelling and symptoms, she recovered and was released at 4:00PM.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine given in Right deltoid.  Next day hot to touch, redness, and swelling measuring 40 X 19 cm
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Immediate post-injection reaction, Laboratory test
Clinical narrative: Pt report onset of pain in joints on injection side arm immediatly after injection, this progressed to joint pains in wrists bilaterally x 6 weeks since injection.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash maculo-papular, Skin warm
Clinical narrative: Measures 10cm x 10cm Flat with raised middle, reddened and warm to touch. Advised pt to apply cool compress and massage every 20 minutes
Age: 1.5
Sex: M
Vaccine: DTAP, DTAPIPVHIB, IPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Duplicate doses of DTap and IPV were given on 12/8/08 to this patient due to confusion re contents of new combination vaccine being used at Clinic (Pentacel).  The combo vaccine was given, and single doses of DTaP and IPV were also given.
Age: 14.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram, Endoscopy
Clinical narrative: Extreme fatigue (sleeping 20-22 hours per day).  In Jan. she started to throw up, on 1/19 she had a migraine symptom that was painful and affected her vision for 3 days, vomiting continued for 5 weeks, then fainting started and lasted for a week, extreme fatigue and underlying headache during all this time.  In end of April, headache stopped, but fatigue continued.  In Jan. patient had a CT scan, EKG and blood work, along with an ophthalmologist appt. In Feb. she got the 2nd dose of Gardasil (we didn't know what was wrong with her).  She had an upper GI in Feb.  In March she had an endoscope, ultra sound of all her organs, MRI, EEG and more blood work.  We are currently seeing a naturpath Dr. trying to "detox" her.  9/22/09 School medical records received DOS 12/14/08 to 2/17/09. Several visits. Patient tired, could not function, slept all day and night, thowing up several times a day. Dizzy, sweaty, feels she will pass out. Vision blurry, poor depth perception. Migraine headache.  9/22/09 PCP medical records received DOS 12/02/08 to 6/19/09. Assessment: Complex Migraines.  Patient presents with unexplained vision abnormality. Eye exam normal. Dizzy spells, headaches, vomiting, GERD, weight loss, syncope. Neurology consult - Complex Migraines - otherwise WNL.
Age: 14.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Fatigue, Hypersomnia, Nuclear magnetic resonance imaging, Ophthalmological examination, Pain
Clinical narrative: Extreme fatigue (sleeping 20-22 hours per day).  In Jan. she started to throw up, on 1/19 she had a migraine symptom that was painful and affected her vision for 3 days, vomiting continued for 5 weeks, then fainting started and lasted for a week, extreme fatigue and underlying headache during all this time.  In end of April, headache stopped, but fatigue continued.  In Jan. patient had a CT scan, EKG and blood work, along with an ophthalmologist appt. In Feb. she got the 2nd dose of Gardasil (we didn't know what was wrong with her).  She had an upper GI in Feb.  In March she had an endoscope, ultra sound of all her organs, MRI, EEG and more blood work.  We are currently seeing a naturpath Dr. trying to "detox" her.  9/22/09 School medical records received DOS 12/14/08 to 2/17/09. Several visits. Patient tired, could not function, slept all day and night, thowing up several times a day. Dizzy, sweaty, feels she will pass out. Vision blurry, poor depth perception. Migraine headache.  9/22/09 PCP medical records received DOS 12/02/08 to 6/19/09. Assessment: Complex Migraines.  Patient presents with unexplained vision abnormality. Eye exam normal. Dizzy spells, headaches, vomiting, GERD, weight loss, syncope. Neurology consult - Complex Migraines - otherwise WNL.
Age: 14.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Syncope, Ultrasound scan, Visual impairment, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Extreme fatigue (sleeping 20-22 hours per day).  In Jan. she started to throw up, on 1/19 she had a migraine symptom that was painful and affected her vision for 3 days, vomiting continued for 5 weeks, then fainting started and lasted for a week, extreme fatigue and underlying headache during all this time.  In end of April, headache stopped, but fatigue continued.  In Jan. patient had a CT scan, EKG and blood work, along with an ophthalmologist appt. In Feb. she got the 2nd dose of Gardasil (we didn't know what was wrong with her).  She had an upper GI in Feb.  In March she had an endoscope, ultra sound of all her organs, MRI, EEG and more blood work.  We are currently seeing a naturpath Dr. trying to "detox" her.  9/22/09 School medical records received DOS 12/14/08 to 2/17/09. Several visits. Patient tired, could not function, slept all day and night, thowing up several times a day. Dizzy, sweaty, feels she will pass out. Vision blurry, poor depth perception. Migraine headache.  9/22/09 PCP medical records received DOS 12/02/08 to 6/19/09. Assessment: Complex Migraines.  Patient presents with unexplained vision abnormality. Eye exam normal. Dizzy spells, headaches, vomiting, GERD, weight loss, syncope. Neurology consult - Complex Migraines - otherwise WNL.
Age: 14.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Activities of daily living impaired, Fatigue, Hypersomnia, Immediate post-injection reaction, No reaction on previous exposure to drug
Clinical narrative: Extreme fatigue (sleeping 20-22 hours per day).  In Jan. she started to throw up, on 1/19 she had a migraine symptom that was painful and affected her vision for 3 days, vomiting continued for 5 weeks, then fainting started and lasted for a week, extreme fatigue and underlying headache during all this time.  In end of April, headache stopped, but fatigue continued.  In Jan. patient had a CT scan, EKG and blood work, along with an ophthalmologist appt. In Feb. she got the 2nd dose of Gardasil (we didn't know what was wrong with her).  She had an upper GI in Feb.  In March she had an endoscope, ultra sound of all her organs, MRI, EEG and more blood work.  We are currently seeing a naturpath Dr. trying to "detox" her.  9/22/09 School medical records received DOS 12/14/08 to 2/17/09. Several visits. Patient tired, could not function, slept all day and night, thowing up several times a day. Dizzy, sweaty, feels she will pass out. Vision blurry, poor depth perception. Migraine headache.  9/22/09 PCP medical records received DOS 12/02/08 to 6/19/09. Assessment: Complex Migraines.  Patient presents with unexplained vision abnormality. Eye exam normal. Dizzy spells, headaches, vomiting, GERD, weight loss, syncope. Neurology consult - Complex Migraines - otherwise WNL.
Age: 14.0
Sex: F
Vaccine: HPV4, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Extreme fatigue (sleeping 20-22 hours per day).  In Jan. she started to throw up, on 1/19 she had a migraine symptom that was painful and affected her vision for 3 days, vomiting continued for 5 weeks, then fainting started and lasted for a week, extreme fatigue and underlying headache during all this time.  In end of April, headache stopped, but fatigue continued.  In Jan. patient had a CT scan, EKG and blood work, along with an ophthalmologist appt. In Feb. she got the 2nd dose of Gardasil (we didn't know what was wrong with her).  She had an upper GI in Feb.  In March she had an endoscope, ultra sound of all her organs, MRI, EEG and more blood work.  We are currently seeing a naturpath Dr. trying to "detox" her.  9/22/09 School medical records received DOS 12/14/08 to 2/17/09. Several visits. Patient tired, could not function, slept all day and night, thowing up several times a day. Dizzy, sweaty, feels she will pass out. Vision blurry, poor depth perception. Migraine headache.  9/22/09 PCP medical records received DOS 12/02/08 to 6/19/09. Assessment: Complex Migraines.  Patient presents with unexplained vision abnormality. Eye exam normal. Dizzy spells, headaches, vomiting, GERD, weight loss, syncope. Neurology consult - Complex Migraines - otherwise WNL.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Abdominal pain, Aphonia, Asthenia, Chest discomfort, Cough
Clinical narrative: Coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs.  7/10/09 Received ER medical records of 5/10/2007. FINAL DX: laryngitis Records reveal patient had chest congestion, dry cough, abnormal taste x 1 week.  Seen by PCP & dx w/allergies.  OTC allergy med not helpful.  Tx w/oral antibiotics & cough syrup.  D/C to home w/PCP f/u. 11/23/09  Merdical recs received for date 5/7/07. OV for c/o sore throat. DX: postnasal drip. OV 5/14/07 c/o sore throat f/u ER visit. DX: postnasal drip.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Crying, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs.  7/10/09 Received ER medical records of 5/10/2007. FINAL DX: laryngitis Records reveal patient had chest congestion, dry cough, abnormal taste x 1 week.  Seen by PCP & dx w/allergies.  OTC allergy med not helpful.  Tx w/oral antibiotics & cough syrup.  D/C to home w/PCP f/u. 11/23/09  Merdical recs received for date 5/7/07. OV for c/o sore throat. DX: postnasal drip. OV 5/14/07 c/o sore throat f/u ER visit. DX: postnasal drip.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Injection site pain, Injection site swelling, Malaise, Restless legs syndrome
Clinical narrative: Coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs.  7/10/09 Received ER medical records of 5/10/2007. FINAL DX: laryngitis Records reveal patient had chest congestion, dry cough, abnormal taste x 1 week.  Seen by PCP & dx w/allergies.  OTC allergy med not helpful.  Tx w/oral antibiotics & cough syrup.  D/C to home w/PCP f/u. 11/23/09  Merdical recs received for date 5/7/07. OV for c/o sore throat. DX: postnasal drip. OV 5/14/07 c/o sore throat f/u ER visit. DX: postnasal drip.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Abdominal pain, Aphonia, Asthenia, Chest X-ray normal, Chest discomfort
Clinical narrative: Coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs.  7/10/09 Received ER medical records of 5/10/2007. FINAL DX: laryngitis Records reveal patient had chest congestion, dry cough, abnormal taste x 1 week.  Seen by PCP & dx w/allergies.  OTC allergy med not helpful.  Tx w/oral antibiotics & cough syrup.  D/C to home w/PCP f/u. 11/23/09  Merdical recs received for date 5/7/07. OV for c/o sore throat. DX: postnasal drip. OV 5/14/07 c/o sore throat f/u ER visit. DX: postnasal drip.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Cough, Crying, Dizziness, Dysgeusia, Dyspnoea
Clinical narrative: Coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs.  7/10/09 Received ER medical records of 5/10/2007. FINAL DX: laryngitis Records reveal patient had chest congestion, dry cough, abnormal taste x 1 week.  Seen by PCP & dx w/allergies.  OTC allergy med not helpful.  Tx w/oral antibiotics & cough syrup.  D/C to home w/PCP f/u. 11/23/09  Merdical recs received for date 5/7/07. OV for c/o sore throat. DX: postnasal drip. OV 5/14/07 c/o sore throat f/u ER visit. DX: postnasal drip.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Fatigue, Headache, Hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs.  7/10/09 Received ER medical records of 5/10/2007. FINAL DX: laryngitis Records reveal patient had chest congestion, dry cough, abnormal taste x 1 week.  Seen by PCP & dx w/allergies.  OTC allergy med not helpful.  Tx w/oral antibiotics & cough syrup.  D/C to home w/PCP f/u. 11/23/09  Merdical recs received for date 5/7/07. OV for c/o sore throat. DX: postnasal drip. OV 5/14/07 c/o sore throat f/u ER visit. DX: postnasal drip.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Laryngitis, Malaise, Respiratory tract congestion, Restless legs syndrome
Clinical narrative: Coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs.  7/10/09 Received ER medical records of 5/10/2007. FINAL DX: laryngitis Records reveal patient had chest congestion, dry cough, abnormal taste x 1 week.  Seen by PCP & dx w/allergies.  OTC allergy med not helpful.  Tx w/oral antibiotics & cough syrup.  D/C to home w/PCP f/u. 11/23/09  Merdical recs received for date 5/7/07. OV for c/o sore throat. DX: postnasal drip. OV 5/14/07 c/o sore throat f/u ER visit. DX: postnasal drip.
Age: 6.0
Sex: U
Vaccine: DTAP
Symptoms: Induration, Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Severe swelling, induration, pain and fever locally.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Gaze palsy, Muscle rigidity, Pallor
Clinical narrative: Approx. less than a minute after vaccines, he complained of lightheadedness followed by unresponsiveness, pallor and rolling of eyes, lasting for about 10-15 seconds. Responded gradually after light tapping of face. 2 more episodes happened similar to 1st  one; however 3rd one was accompanied by rigidity of arms and legs. As he started to respond he becomes clammy and cool. A 4th episode occurred in room while EMT in attendance.  7/10/09 Medical Records received DOS 7/7/09. Assessment: Syncope - vasovagal  Records reveal that one minute after vaccine and Mantoux administration patient c/o being 'light-headed'. Unresponsive for several seconds, eyes rolled back, "gurgling sound" in throat. Patient responded to light slapping on face. Attempted to sit, drank water, became lightheaded and unresponsive, eyes rolled back, with stiffening of upper and lower extremities, jaw clenching. Responded after 20 seconds, skin cold and clammy. 3 episodes in 15-20 minutes. Transported by response team to hospital. Hydrated and discharged in good condition.  7/14/09 ER records received DOS 7/7/09. Impression: Vasovagal Episode; Syncope Patient has experienced lightheadedness, tingling. Multiple episodes of syncope, unresponsive, with violent shaking and upward rolling of the eyes. Spasm of arms, leg cramps. Weakness. Bradycardia. Skin cold and clammy.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Approx. less than a minute after vaccines, he complained of lightheadedness followed by unresponsiveness, pallor and rolling of eyes, lasting for about 10-15 seconds. Responded gradually after light tapping of face. 2 more episodes happened similar to 1st  one; however 3rd one was accompanied by rigidity of arms and legs. As he started to respond he becomes clammy and cool. A 4th episode occurred in room while EMT in attendance.  7/10/09 Medical Records received DOS 7/7/09. Assessment: Syncope - vasovagal  Records reveal that one minute after vaccine and Mantoux administration patient c/o being 'light-headed'. Unresponsive for several seconds, eyes rolled back, "gurgling sound" in throat. Patient responded to light slapping on face. Attempted to sit, drank water, became lightheaded and unresponsive, eyes rolled back, with stiffening of upper and lower extremities, jaw clenching. Responded after 20 seconds, skin cold and clammy. 3 episodes in 15-20 minutes. Transported by response team to hospital. Hydrated and discharged in good condition.  7/14/09 ER records received DOS 7/7/09. Impression: Vasovagal Episode; Syncope Patient has experienced lightheadedness, tingling. Multiple episodes of syncope, unresponsive, with violent shaking and upward rolling of the eyes. Spasm of arms, leg cramps. Weakness. Bradycardia. Skin cold and clammy.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness around injection site "hardness" warmth to touch. Injections given on Wednesday. Father did not notice symptoms until Friday morning. Father brought child to doctor, child was treated with antibiotics for infection. Follow up call from Dr.'s office says client says doing better after treatment.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling cold, Monoparesis, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: 1. Shot administered on Wed. 2. Thursday - dizzy - low fever by evening, very cold. 3. Friday am fever - dizzy - feeling faint. Friday by 12:00 very cold - lost use of right leg, use of leg did not fully recover until Sunday, still feel lightheaded.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right thigh (injection site) with 4 in x 7 in red, indurated, warm to touch, antibiotic (po. given to tx cellulitis.
Age: 10.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: ZOSTAVAX was administered on 6/9/09.  Pt got a fever on 6/10 and then a shingles rash on 6/21.  She was diagnosed with shingles on 6/24/09.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Induration and erythema.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Nausea, Vomiting
Clinical narrative: Back pain, nausea and vomiting - patient was sent to ER.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient received GARDASIL and DTaP in left arm. Patient had allergic reaction to GARDASIL, come in on 7-29-09 to report. small red rash and soreness at injection site.
Age: 1.2
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Pt developed Varicella infection; < 50 lesions all over body, oral lesions, with fever; but crop of 10-15 vesicles grouped around vaccine site in thigh.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, TYP
Symptoms: Oedema peripheral
Clinical narrative: 5cm by 4cm swollen right upper arm and 2 by 2 cm lower right arm lateral aspect.
Age: 49.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain upper, Diarrhoea, Injection site erythema, Nausea, Pyrexia
Clinical narrative: Received yellow fever vaccine on 7/1/09 no complications. 7/4/09 c/o: nausea, vomiting, severe stomach ache, diarrhea, low grade fever and flat rash to torso, no itching. Lasted about 2 1/2 hours, redness at injection site.
Age: 49.0
Sex: F
Vaccine: YF
Symptoms: Rash, Vomiting
Clinical narrative: Received yellow fever vaccine on 7/1/09 no complications. 7/4/09 c/o: nausea, vomiting, severe stomach ache, diarrhea, low grade fever and flat rash to torso, no itching. Lasted about 2 1/2 hours, redness at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling R arm deltoid.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and pruritus.  Marked induration/erythema entire left upper arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: Herpetic vesical 2" X 1" surrounded by hot, red area 6" X 8" (injection site left arm) itching, painful.  Symptoms began 24 hours after receiving vaccine.  Treated with VALTREX 1g BID X 5 day.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Child received vaccination 7-7-09; child awoke 7-8-09 with redness and pain on right thigh area of vaccine administration, mom took child to MD office for assessment and antibiotic. Child received: AUGMENTIN 7 ml BID for 10 days; 7/9/09 back to MD due to right deltoid site red and swollen.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria
Clinical narrative: Pt. received MMR and VARIVAX subcutaneous to right upper leg. Within 5 minutes developed large red hive to area of injection. Pt was given oral BENADRYL; no wheezing.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large area of erythema at deltoid area, no fever, non-tender, no cellulitis.
Age: 1.3
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Injection site abscess sterile, Injection site erythema, Injection site nodule
Clinical narrative: L thigh sterile abscess with 5 X 3 cm redness and 2 cm non tender subcutaneous knot.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt noticed erythema ~2 1/2 inches oval with warmth about 24 hrs after imm. 48 hrs-72 hrs later the redness increased to 17 x 13 cm oval on (R) upper arm area with central oval 4 x 4 cm nodule, tender pink, slightly raised , warm.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Body temperature increased, Chest X-ray normal, Chills, Computerised tomogram normal
Clinical narrative: 7-2-09 - Leg, knee pain. 7-3-09 - Numbness, low grade temp, chills - saw MD - labs done - tested neg for strep/flu - sore throat. 7-4-09 - No strength - edema of neck - trouble walking - blurry vision. 7-5-09 - Seen in ER - IV fluids, BENADRYL, EKG, CAT scan, thyroid level done, CXR.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Electrocardiogram normal, Full blood count normal, Gait disturbance, Hypoaesthesia, Influenza serology negative
Clinical narrative: 7-2-09 - Leg, knee pain. 7-3-09 - Numbness, low grade temp, chills - saw MD - labs done - tested neg for strep/flu - sore throat. 7-4-09 - No strength - edema of neck - trouble walking - blurry vision. 7-5-09 - Seen in ER - IV fluids, BENADRYL, EKG, CAT scan, thyroid level done, CXR.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Localised oedema, Metabolic function test normal, Oropharyngeal pain, Pain in extremity, Protein urine
Clinical narrative: 7-2-09 - Leg, knee pain. 7-3-09 - Numbness, low grade temp, chills - saw MD - labs done - tested neg for strep/flu - sore throat. 7-4-09 - No strength - edema of neck - trouble walking - blurry vision. 7-5-09 - Seen in ER - IV fluids, BENADRYL, EKG, CAT scan, thyroid level done, CXR.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Red blood cell sedimentation rate normal, Streptococcal identification test negative, Thyroid function test normal, Urine analysis normal, Vision blurred
Clinical narrative: 7-2-09 - Leg, knee pain. 7-3-09 - Numbness, low grade temp, chills - saw MD - labs done - tested neg for strep/flu - sore throat. 7-4-09 - No strength - edema of neck - trouble walking - blurry vision. 7-5-09 - Seen in ER - IV fluids, BENADRYL, EKG, CAT scan, thyroid level done, CXR.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Received 15 mos vaccines. Developed swelling and erythema, first noticed by mom the following day at 11:00AM. Approx 5x9 cm swelling and erythema on exam.
Age: 1.5
Sex: F
Vaccine: HEPA, IPV
Symptoms: Gait disturbance, Injection site swelling
Clinical narrative: Pt with sl swelling at site of injection (thighs) with refusal to walk 2 days later day. Pt seen & was able to bear weight but refused to walk next morning otherwise Nl PE.
Age: 19.0
Sex: M
Vaccine: HEPA, JEV, RAB
Symptoms: Palpitations
Clinical narrative: Palpitations.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: (L) arm - red, swollen, tender to touch in small area.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, White blood cell count normal
Clinical narrative: L upper arm swelling, temp and pain. On day 2 after immunization given.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Approximately 12 hours after administration of hepatitis A vaccine, pt developed hives over entire body. No other known cause for hives.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Back pain, Body temperature increased, Bone pain, Headache, Nausea
Clinical narrative: Initial report received on 02 June 2009 from a health care professional. A 16 year old female patient with allergies to Augmentin and Ampicillin received ADACEL (lot number C3246B) in the right deltoid and MENACTRA (lot number U2844AA) in the left deltoid on 28 May 2009. On 29 May 2009 the patient developed a temperature of 101, neck pain, headache, nausea, and a rash on head and arms. When the patient was asked to put her chin to her chest the patient complained of severe neck and spinal pain. The patient reported that the evening after the vaccine was administered she was bumped on her back and felt severe back pain. The recovery status was unknown. List of Documents held by Sender: none.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Neck pain, Rash
Clinical narrative: Initial report received on 02 June 2009 from a health care professional. A 16 year old female patient with allergies to Augmentin and Ampicillin received ADACEL (lot number C3246B) in the right deltoid and MENACTRA (lot number U2844AA) in the left deltoid on 28 May 2009. On 29 May 2009 the patient developed a temperature of 101, neck pain, headache, nausea, and a rash on head and arms. When the patient was asked to put her chin to her chest the patient complained of severe neck and spinal pain. The patient reported that the evening after the vaccine was administered she was bumped on her back and felt severe back pain. The recovery status was unknown. List of Documents held by Sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, IPV, PNC
Symptoms: Autism, Convulsion, Cough, Developmental delay, Immune system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of afebrile seizure in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PREVNAR. A physician or other health care professional has not verified this report. Concurrent vaccination included hepatitis B recombinant (manufacturer unspecified) and inactivated poliomyelitis virus vaccine (manufacturer unspecified) both given on 26 August 2005. On 26 August 2005 at 10:00 the subject received 3rd dose of PEDIARIX (unknown). Also on 26 August 2005 the subject received 2nd dose of PREVNAR (unknown). Within 24 hours to three days, the subject developed fever and afebrile seizures. The subject was seen at the physician's office, however, it was unknown if she was hospitalized. On 07 September 2005, medical records reportedly indicated that the subject had a fever for one and a half weeks and was diagnosed with otitis media. In the following months, the subject experienced runny nose, cough, congestion, sinus infection and a urinary tract infection. An MRI performed in approximately January 2006 showed isotropia, clarified by the reporter as crossing eyes and developmental concerns. The subject reportedly has experienced permanent effects fur to the events experienced including immune problems, microcephaly, clarified by the reporter as small head, and she had been diagnosed with Autism. Immune problems were reported as unresolved. The outcome of the other events was not known. This case was assessed as medically serious by GSK. The reporter remarked that the suspect medications were PEDIARIX and PREVNAR or the combination together. He also reported that the subject received the Aventis vaccine for the previous series of PEDIARIX. 60 day Follow-up Information 15-AUG-2006: Microcephly!! Nurological disorders - verbal disturbances - motor & coordination disturbances. No walking - left hand & arm weakness - Heavy metals. We demand compensation! We have statements from other people & doctors - movies - and all medical records - she was fine when she was born !!!!! Her head stopped growing at about 8-9 months when major problems began. Murderers - taking the lives of healthy childrens and flushing it away
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, IPV, PNC
Symptoms: Microcephaly, Nuclear magnetic resonance imaging abnormal, Otitis media, Pyrexia, Respiratory tract congestion
Clinical narrative: This case was reported by a lawyer and described the occurrence of afebrile seizure in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PREVNAR. A physician or other health care professional has not verified this report. Concurrent vaccination included hepatitis B recombinant (manufacturer unspecified) and inactivated poliomyelitis virus vaccine (manufacturer unspecified) both given on 26 August 2005. On 26 August 2005 at 10:00 the subject received 3rd dose of PEDIARIX (unknown). Also on 26 August 2005 the subject received 2nd dose of PREVNAR (unknown). Within 24 hours to three days, the subject developed fever and afebrile seizures. The subject was seen at the physician's office, however, it was unknown if she was hospitalized. On 07 September 2005, medical records reportedly indicated that the subject had a fever for one and a half weeks and was diagnosed with otitis media. In the following months, the subject experienced runny nose, cough, congestion, sinus infection and a urinary tract infection. An MRI performed in approximately January 2006 showed isotropia, clarified by the reporter as crossing eyes and developmental concerns. The subject reportedly has experienced permanent effects fur to the events experienced including immune problems, microcephaly, clarified by the reporter as small head, and she had been diagnosed with Autism. Immune problems were reported as unresolved. The outcome of the other events was not known. This case was assessed as medically serious by GSK. The reporter remarked that the suspect medications were PEDIARIX and PREVNAR or the combination together. He also reported that the subject received the Aventis vaccine for the previous series of PEDIARIX. 60 day Follow-up Information 15-AUG-2006: Microcephly!! Nurological disorders - verbal disturbances - motor & coordination disturbances. No walking - left hand & arm weakness - Heavy metals. We demand compensation! We have statements from other people & doctors - movies - and all medical records - she was fine when she was born !!!!! Her head stopped growing at about 8-9 months when major problems began. Murderers - taking the lives of healthy childrens and flushing it away