chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Decreased appetite, Irritability, Muscle spasms, Pyrexia, Screaming
Clinical narrative: This case was reported by a physician and described the occurrence of fussy in a 4-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines given on 2 July 2009. On 2 July 2009 at 16:00 the subject received 1st dose of ROTARIX (oral). On 2 July 2009, less than one day after vaccination with ROTARIX, the subject experienced fussy, clarified as screaming. She also had a fever of 99.6. The subject was treated with unknown medication. At the time of reporting the fever was resolved. The event of fussy was unresolved, and the outcome of screaming was unknown. The vaccination course with ROTARIX was discontinued. 10/07/2009 Follow up information received on 07 August 2009 indicated that in addition to already reported events, the subject developed extreme crampiness, vomiting and decreased appetite following administration of ROTARIX. Low grade temperature, extreme crampiness and vomiting were said to have started two  hours post vaccination with ROTARIX. Resolution of all events was documented as  06 July 2009. It was thought that the events were probably related to ROTARIX since this was the first time this vaccine was given. PEDIARIX, PREVNAR and HIB also given on 02 July 2009 were administered for the second time with no history of reaction following the first of each of these vaccines. TYLNEOL was given for treatment of events.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of fussy in a 4-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines given on 2 July 2009. On 2 July 2009 at 16:00 the subject received 1st dose of ROTARIX (oral). On 2 July 2009, less than one day after vaccination with ROTARIX, the subject experienced fussy, clarified as screaming. She also had a fever of 99.6. The subject was treated with unknown medication. At the time of reporting the fever was resolved. The event of fussy was unresolved, and the outcome of screaming was unknown. The vaccination course with ROTARIX was discontinued. 10/07/2009 Follow up information received on 07 August 2009 indicated that in addition to already reported events, the subject developed extreme crampiness, vomiting and decreased appetite following administration of ROTARIX. Low grade temperature, extreme crampiness and vomiting were said to have started two  hours post vaccination with ROTARIX. Resolution of all events was documented as  06 July 2009. It was thought that the events were probably related to ROTARIX since this was the first time this vaccine was given. PEDIARIX, PREVNAR and HIB also given on 02 July 2009 were administered for the second time with no history of reaction following the first of each of these vaccines. TYLNEOL was given for treatment of events.
Age: 0.2
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a physician and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline).  Concurrent medical conditions included gastro esophageal reflux.  Concurrent medications included ZANTAC.  On 26 June 2009 the subject received 1st dose of ROTARIX (oral).  On 27 May 2009, 1 day after vaccination with ROTARIX, the subject experienced diarrhea.  At the time of reporting the event was unresolved.
Age: 0.3
Sex: F
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a physician, via a GSK representative and described the occurrence of vomiting in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ROTARIX (1 ml, oral). Four days after vaccination with ROTARIX, the subject experienced vomiting. At the time of reporting the outcome of the event was unspecified. At the time of reporting the outcome of the event was unspecified. The vaccination series with ROTARIX was delayed.
Age: 0.2
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with live attenuated human ROTARIX, (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced diarrhea. At the time of reporting the outcome of the event was unspecified.  Please see case A0798921A for an additional case of diarrhea with ROTARIX reported by the consumer.
Age: 0.1
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline. A physician or other health care professional has not verified this report. Previous and/ or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) (non-GSK manufacturer given on an unspecified date; Hepatitis B vaccine recombinant; manufacturer unspecified given on an unspecified date; Pneumococcal vaccines (non-GSK) ; non-GSK manufacturer given on an unspecified date. On an unspecified date the subject received unspecified dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced diarrhea. At the time of reporting the outcome of the event was unspecified. Please see case A0798920A for additional case of diarrhea with ROTARIX reported by the consumer.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included PEDIARIX; GlaxoSmithKline given on 20 July 2009; HIB (non-gsk); Sanofi Pasteur MSD given on 20 July 2009, PREVNAR; Wyeth Labs given on 20 July 2009. There were no concurrent medications. On 20 July at 11:45 the subject received 2nd dose of ROTARIX (1 ml, oral). On 20 July 2009, 10 to 15 minutes after vaccination with ROTARIX, the subject experienced vomiting. At the time of reporting the outcome of the event was unspecified. Follow-up information recieved on 11 august 2009 indicated that the event of vomiting resolved. It was also reported that the subject had recived a first dose of ROTARIX on 20 May 2009 and experienced vomiting. Concurrent vaccines given were injected intramuscularly at 0.5ml dose each on 20 July 2009. For details involving the second dose of ROTARIX and vomiting refer to case AO79928BB.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Bronchospasm, Stridor
Clinical narrative: Stridor and bronchospasm gave Racemic Epi 1/2 vial in 2cc NS via nebulizer. Pt responded well- No stridor after tx.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Asthenia, Body temperature increased, Dysphonia, Rash
Clinical narrative: Destiny had fevers of 102 for 3 days. a rash on both legs and stoamic. stoamic pain. weakness, hoarse.and a little wheezing.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Destiny had fevers of 102 for 3 days. a rash on both legs and stoamic. stoamic pain. weakness, hoarse.and a little wheezing.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Abdominal pain upper, Blood pressure normal, Body temperature, Erythema, Heart rate normal
Clinical narrative: Stomach hurt, body red and itchy, mouth itchy, throat felt constricted. Reacted within 15 minutes after injection. Treated in ER with epinephrine, Benadryl, Solu-medrol. By 1-yr-old experienced first allergic food reaction to milk and eggs. No reaction that we recall to 1st MMR vaccination but have since waived further MMR shots as well as flu and chicken pox vaccinations due to egg protein.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: No reaction on previous exposure to drug, Oral pruritus, Oxygen saturation normal, Palatal oedema, Pruritus
Clinical narrative: Stomach hurt, body red and itchy, mouth itchy, throat felt constricted. Reacted within 15 minutes after injection. Treated in ER with epinephrine, Benadryl, Solu-medrol. By 1-yr-old experienced first allergic food reaction to milk and eggs. No reaction that we recall to 1st MMR vaccination but have since waived further MMR shots as well as flu and chicken pox vaccinations due to egg protein.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Throat tightness
Clinical narrative: Stomach hurt, body red and itchy, mouth itchy, throat felt constricted. Reacted within 15 minutes after injection. Treated in ER with epinephrine, Benadryl, Solu-medrol. By 1-yr-old experienced first allergic food reaction to milk and eggs. No reaction that we recall to 1st MMR vaccination but have since waived further MMR shots as well as flu and chicken pox vaccinations due to egg protein.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC, RV5
Symptoms: Cold sweat, Feeding disorder of infancy or early childhood, Insomnia, Irritability, Pallor
Clinical narrative: Dramatic irritability several hours after administration, accompanied by pallor and clammy skin, poor feeding and sleeping.  This lasted for at least 48 hours.  She received treatment for possible GE reflux when seen on 8/6.
Age: 0.6
Sex: M
Vaccine: DTPPHIB, PNC, RV5
Symptoms: Blood test normal, Convulsion, Culture stool negative, Electroencephalogram normal, Hypotonia
Clinical narrative: he receved vaccination on a friday and had a high fever from friday until Monday morning. He was staring into space body limp no reaction.doctor concluded he had seizures caused from the vaccinations.  9/21/09 Hospital records received DOS 8/3/09 to 8/5/09. Assessment: Febrile seizure secondary to vaccination. Patient presented with fever, unresponsive episode, drooling, "breathing hard', hot, temp 104. Postictal or near end of seizure. Right arm flexed, listless, staring. Admitted for evaluation of fever and possible seizure.  ICD9: 780.31, E949.6
Age: 0.6
Sex: M
Vaccine: DTPPHIB, PNC, RV5
Symptoms: Lumbar puncture normal, Pyrexia, Staring
Clinical narrative: he receved vaccination on a friday and had a high fever from friday until Monday morning. He was staring into space body limp no reaction.doctor concluded he had seizures caused from the vaccinations.  9/21/09 Hospital records received DOS 8/3/09 to 8/5/09. Assessment: Febrile seizure secondary to vaccination. Patient presented with fever, unresponsive episode, drooling, "breathing hard', hot, temp 104. Postictal or near end of seizure. Right arm flexed, listless, staring. Admitted for evaluation of fever and possible seizure.  ICD9: 780.31, E949.6
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Anorexia, Blood heavy metal test, Blood test, Body temperature decreased, Cardiac failure congestive
Clinical narrative: Sweating, chills,  headache, head congestion, blurry vision, dizziness, chest pain, heart palpitations, congestive heart failure, tinnitus, postural tachycardia, loss of appetite, fatigue, fever (1 week) followed by low body temperature, weight loss, brain fog, jaw pain, TMJ, swollen lymph nodes, nausea, suppressed immune function.  8/11/09 Cardiology consult records received DOS 7/16/09 to 3/12/09. Assessment: History of chronic babesiosis and mild non-ischemic cardiomyopathy, left posterior fascicular block.  Patient reports that he had endocarditis that began after flu shot. Presents with vague left anterior chest pain with radiation into left arm. Dyspnea on exertion, palpitation, and near syncope. Fatigue. Weight loss, generalized lymphadenopathy, poor appetite. Eye pain. Dizziness and lightheadedness. Limited lifestyle. 9/29/09 Medical records received from ID physician for date range: 11/9/08 to 8/28/09. Patient presents with positive testing for Lyme Disease and babesia infection. C/O fatigue night sweats, blurred vision, poor sleeping, weight loss, easy brusing, pale in color, HA, head throbbing and pressure, right side jaw clenching, tinnitus, hair loss, SOB, chest pain, heart palpitations, N/V, constipation. DX: Neurologic Lyme Disease and babesia, elevated murcury level, heavy metal positive. TX with multiple IV medications.    10/30/09 Medical records received for DOS 11/06/06-11/30/06. Developed weakness and decreased vision/vision changes in R eye s/p vaccine.  Multiple PCP visits for fatigue and visual changes s/p vaccine.Viral syndrome.  Nausea, early satiety and weight loss. Maxillary sinusitis. Head CT otherwise normal. Vision 20/20. Neuro WNL.  H/O increased HGB. Decreasing. Developed diar on abx therapy for sinusitis. Probable c. diff. ED visit for weakness and visual changes. PE WNL. Labs WNL. Etiology unclear.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Chills, Computerised tomogram, DNA antibody, Dizziness
Clinical narrative: Sweating, chills,  headache, head congestion, blurry vision, dizziness, chest pain, heart palpitations, congestive heart failure, tinnitus, postural tachycardia, loss of appetite, fatigue, fever (1 week) followed by low body temperature, weight loss, brain fog, jaw pain, TMJ, swollen lymph nodes, nausea, suppressed immune function.  8/11/09 Cardiology consult records received DOS 7/16/09 to 3/12/09. Assessment: History of chronic babesiosis and mild non-ischemic cardiomyopathy, left posterior fascicular block.  Patient reports that he had endocarditis that began after flu shot. Presents with vague left anterior chest pain with radiation into left arm. Dyspnea on exertion, palpitation, and near syncope. Fatigue. Weight loss, generalized lymphadenopathy, poor appetite. Eye pain. Dizziness and lightheadedness. Limited lifestyle. 9/29/09 Medical records received from ID physician for date range: 11/9/08 to 8/28/09. Patient presents with positive testing for Lyme Disease and babesia infection. C/O fatigue night sweats, blurred vision, poor sleeping, weight loss, easy brusing, pale in color, HA, head throbbing and pressure, right side jaw clenching, tinnitus, hair loss, SOB, chest pain, heart palpitations, N/V, constipation. DX: Neurologic Lyme Disease and babesia, elevated murcury level, heavy metal positive. TX with multiple IV medications.    10/30/09 Medical records received for DOS 11/06/06-11/30/06. Developed weakness and decreased vision/vision changes in R eye s/p vaccine.  Multiple PCP visits for fatigue and visual changes s/p vaccine.Viral syndrome.  Nausea, early satiety and weight loss. Maxillary sinusitis. Head CT otherwise normal. Vision 20/20. Neuro WNL.  H/O increased HGB. Decreasing. Developed diar on abx therapy for sinusitis. Probable c. diff. ED visit for weakness and visual changes. PE WNL. Labs WNL. Etiology unclear.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Echocardiogram, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Sweating, chills,  headache, head congestion, blurry vision, dizziness, chest pain, heart palpitations, congestive heart failure, tinnitus, postural tachycardia, loss of appetite, fatigue, fever (1 week) followed by low body temperature, weight loss, brain fog, jaw pain, TMJ, swollen lymph nodes, nausea, suppressed immune function.  8/11/09 Cardiology consult records received DOS 7/16/09 to 3/12/09. Assessment: History of chronic babesiosis and mild non-ischemic cardiomyopathy, left posterior fascicular block.  Patient reports that he had endocarditis that began after flu shot. Presents with vague left anterior chest pain with radiation into left arm. Dyspnea on exertion, palpitation, and near syncope. Fatigue. Weight loss, generalized lymphadenopathy, poor appetite. Eye pain. Dizziness and lightheadedness. Limited lifestyle. 9/29/09 Medical records received from ID physician for date range: 11/9/08 to 8/28/09. Patient presents with positive testing for Lyme Disease and babesia infection. C/O fatigue night sweats, blurred vision, poor sleeping, weight loss, easy brusing, pale in color, HA, head throbbing and pressure, right side jaw clenching, tinnitus, hair loss, SOB, chest pain, heart palpitations, N/V, constipation. DX: Neurologic Lyme Disease and babesia, elevated murcury level, heavy metal positive. TX with multiple IV medications.    10/30/09 Medical records received for DOS 11/06/06-11/30/06. Developed weakness and decreased vision/vision changes in R eye s/p vaccine.  Multiple PCP visits for fatigue and visual changes s/p vaccine.Viral syndrome.  Nausea, early satiety and weight loss. Maxillary sinusitis. Head CT otherwise normal. Vision 20/20. Neuro WNL.  H/O increased HGB. Decreasing. Developed diar on abx therapy for sinusitis. Probable c. diff. ED visit for weakness and visual changes. PE WNL. Labs WNL. Etiology unclear.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Immune system disorder, Laboratory test, Lymphadenopathy, Metabolic function test, Nausea
Clinical narrative: Sweating, chills,  headache, head congestion, blurry vision, dizziness, chest pain, heart palpitations, congestive heart failure, tinnitus, postural tachycardia, loss of appetite, fatigue, fever (1 week) followed by low body temperature, weight loss, brain fog, jaw pain, TMJ, swollen lymph nodes, nausea, suppressed immune function.  8/11/09 Cardiology consult records received DOS 7/16/09 to 3/12/09. Assessment: History of chronic babesiosis and mild non-ischemic cardiomyopathy, left posterior fascicular block.  Patient reports that he had endocarditis that began after flu shot. Presents with vague left anterior chest pain with radiation into left arm. Dyspnea on exertion, palpitation, and near syncope. Fatigue. Weight loss, generalized lymphadenopathy, poor appetite. Eye pain. Dizziness and lightheadedness. Limited lifestyle. 9/29/09 Medical records received from ID physician for date range: 11/9/08 to 8/28/09. Patient presents with positive testing for Lyme Disease and babesia infection. C/O fatigue night sweats, blurred vision, poor sleeping, weight loss, easy brusing, pale in color, HA, head throbbing and pressure, right side jaw clenching, tinnitus, hair loss, SOB, chest pain, heart palpitations, N/V, constipation. DX: Neurologic Lyme Disease and babesia, elevated murcury level, heavy metal positive. TX with multiple IV medications.    10/30/09 Medical records received for DOS 11/06/06-11/30/06. Developed weakness and decreased vision/vision changes in R eye s/p vaccine.  Multiple PCP visits for fatigue and visual changes s/p vaccine.Viral syndrome.  Nausea, early satiety and weight loss. Maxillary sinusitis. Head CT otherwise normal. Vision 20/20. Neuro WNL.  H/O increased HGB. Decreasing. Developed diar on abx therapy for sinusitis. Probable c. diff. ED visit for weakness and visual changes. PE WNL. Labs WNL. Etiology unclear.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain in jaw, Palpitations, Postural orthostatic tachycardia syndrome, Pyrexia
Clinical narrative: Sweating, chills,  headache, head congestion, blurry vision, dizziness, chest pain, heart palpitations, congestive heart failure, tinnitus, postural tachycardia, loss of appetite, fatigue, fever (1 week) followed by low body temperature, weight loss, brain fog, jaw pain, TMJ, swollen lymph nodes, nausea, suppressed immune function.  8/11/09 Cardiology consult records received DOS 7/16/09 to 3/12/09. Assessment: History of chronic babesiosis and mild non-ischemic cardiomyopathy, left posterior fascicular block.  Patient reports that he had endocarditis that began after flu shot. Presents with vague left anterior chest pain with radiation into left arm. Dyspnea on exertion, palpitation, and near syncope. Fatigue. Weight loss, generalized lymphadenopathy, poor appetite. Eye pain. Dizziness and lightheadedness. Limited lifestyle. 9/29/09 Medical records received from ID physician for date range: 11/9/08 to 8/28/09. Patient presents with positive testing for Lyme Disease and babesia infection. C/O fatigue night sweats, blurred vision, poor sleeping, weight loss, easy brusing, pale in color, HA, head throbbing and pressure, right side jaw clenching, tinnitus, hair loss, SOB, chest pain, heart palpitations, N/V, constipation. DX: Neurologic Lyme Disease and babesia, elevated murcury level, heavy metal positive. TX with multiple IV medications.    10/30/09 Medical records received for DOS 11/06/06-11/30/06. Developed weakness and decreased vision/vision changes in R eye s/p vaccine.  Multiple PCP visits for fatigue and visual changes s/p vaccine.Viral syndrome.  Nausea, early satiety and weight loss. Maxillary sinusitis. Head CT otherwise normal. Vision 20/20. Neuro WNL.  H/O increased HGB. Decreasing. Developed diar on abx therapy for sinusitis. Probable c. diff. ED visit for weakness and visual changes. PE WNL. Labs WNL. Etiology unclear.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Sinus congestion, Temporomandibular joint syndrome, Tinnitus, Vision blurred, Weight decreased
Clinical narrative: Sweating, chills,  headache, head congestion, blurry vision, dizziness, chest pain, heart palpitations, congestive heart failure, tinnitus, postural tachycardia, loss of appetite, fatigue, fever (1 week) followed by low body temperature, weight loss, brain fog, jaw pain, TMJ, swollen lymph nodes, nausea, suppressed immune function.  8/11/09 Cardiology consult records received DOS 7/16/09 to 3/12/09. Assessment: History of chronic babesiosis and mild non-ischemic cardiomyopathy, left posterior fascicular block.  Patient reports that he had endocarditis that began after flu shot. Presents with vague left anterior chest pain with radiation into left arm. Dyspnea on exertion, palpitation, and near syncope. Fatigue. Weight loss, generalized lymphadenopathy, poor appetite. Eye pain. Dizziness and lightheadedness. Limited lifestyle. 9/29/09 Medical records received from ID physician for date range: 11/9/08 to 8/28/09. Patient presents with positive testing for Lyme Disease and babesia infection. C/O fatigue night sweats, blurred vision, poor sleeping, weight loss, easy brusing, pale in color, HA, head throbbing and pressure, right side jaw clenching, tinnitus, hair loss, SOB, chest pain, heart palpitations, N/V, constipation. DX: Neurologic Lyme Disease and babesia, elevated murcury level, heavy metal positive. TX with multiple IV medications.    10/30/09 Medical records received for DOS 11/06/06-11/30/06. Developed weakness and decreased vision/vision changes in R eye s/p vaccine.  Multiple PCP visits for fatigue and visual changes s/p vaccine.Viral syndrome.  Nausea, early satiety and weight loss. Maxillary sinusitis. Head CT otherwise normal. Vision 20/20. Neuro WNL.  H/O increased HGB. Decreasing. Developed diar on abx therapy for sinusitis. Probable c. diff. ED visit for weakness and visual changes. PE WNL. Labs WNL. Etiology unclear.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Arthralgia, Gait disturbance, Joint range of motion decreased
Clinical narrative: Limping, favoring right leg. Limitation at flexion and rotation of right hip due to pain.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Tingling and numbness in both hands and feet for over 12 hours. Soreness at the injection site continues.
Age: 72.0
Sex: M
Vaccine: PPV, TD
Symptoms: Asthenia, Paraesthesia
Clinical narrative: PER PATIENT'S FAMILY, PATIENT C/O TINGLING ON LOWER EXTREMITIES AND BEING VERY WEAK.  FAMILY CALLED DOCTOR OFFICE TO REPORT REACTIONS ON JULY 31, 2009
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: fever, seizure x2
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Abdominal pain, Autism, Cognitive disorder, Developmental delay, Insomnia
Clinical narrative: After first vaccination (Hepatitis B) - Colic, sleeplessness, irritability. Same following next several vaccinations, followed by cognitive skill delays, speech delays, social delays and restrictive interests. Increased delays following last vaccinations given on 10/11/2006. Finally diagnosed with Autism at 23 months old. Course of treatment was ABA, OT and Speech therapy, along with GFCF diet and other biomedical treatments.  8/21/09 Psych/Autism consultation records received DOS 9/12/07. Assessment: Pervasive Developmental Disorder, Not Otherwise Specified. Parents are concerned about language delay. Does not respond to name or understand what is said to her. Impaired peer relationships, social and emotional reciprocity. Spins in circles. Temper tantrums. She presents with 3 cafe' au lait birthmarks.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Irritability, Social avoidant behaviour, Speech disorder developmental
Clinical narrative: After first vaccination (Hepatitis B) - Colic, sleeplessness, irritability. Same following next several vaccinations, followed by cognitive skill delays, speech delays, social delays and restrictive interests. Increased delays following last vaccinations given on 10/11/2006. Finally diagnosed with Autism at 23 months old. Course of treatment was ABA, OT and Speech therapy, along with GFCF diet and other biomedical treatments.  8/21/09 Psych/Autism consultation records received DOS 9/12/07. Assessment: Pervasive Developmental Disorder, Not Otherwise Specified. Parents are concerned about language delay. Does not respond to name or understand what is said to her. Impaired peer relationships, social and emotional reciprocity. Spins in circles. Temper tantrums. She presents with 3 cafe' au lait birthmarks.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: On August 6, 2009 my son recieved the Pneumococcal Vaccine.  Four hours later he  devolped a fever which lasted for 2 days and ranged from 101 to 102.  In the injection area, the following day it became reddish in color, warm to the touch thus causing his entire left thight to swel.  For two days my son was walking with a limp.  In addition his behavoir became very sluggish and irratable.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Sluggishness
Clinical narrative: On August 6, 2009 my son recieved the Pneumococcal Vaccine.  Four hours later he  devolped a fever which lasted for 2 days and ranged from 101 to 102.  In the injection area, the following day it became reddish in color, warm to the touch thus causing his entire left thight to swel.  For two days my son was walking with a limp.  In addition his behavoir became very sluggish and irratable.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 63 year old female patient who on 01-MAY-2007 was vaccinated with the first dose of ZOSTAVAX (Merck) (lot# 656394/016U) subcutaneously in the left arm. The patient came down with shingles and was treated with gabapentin and Acyclovir. On 21-JAN-2009, the physician's office received a note from PCP DOS dated 14-JAN-2009 with a diagnosis of shingles outbreak. The patient noted the rash with general malaise and arthralgias. Scattered vesicles on right chest wall in mid-thoracic dermatome distribute were observed. The patient received treatment with Acyclovir and NEURONTIN. The listing indicated that one or more of the events was considered to be immediately life-threatening. This was originally reported by a physician. The VAERS ID# is 337346. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blister, Herpes zoster, Malaise, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 63 year old female patient who on 01-MAY-2007 was vaccinated with the first dose of ZOSTAVAX (Merck) (lot# 656394/016U) subcutaneously in the left arm. The patient came down with shingles and was treated with gabapentin and Acyclovir. On 21-JAN-2009, the physician's office received a note from PCP DOS dated 14-JAN-2009 with a diagnosis of shingles outbreak. The patient noted the rash with general malaise and arthralgias. Scattered vesicles on right chest wall in mid-thoracic dermatome distribute were observed. The patient received treatment with Acyclovir and NEURONTIN. The listing indicated that one or more of the events was considered to be immediately life-threatening. This was originally reported by a physician. The VAERS ID# is 337346. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 67.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal discomfort, Cold sweat, Dizziness, Heart rate normal, Nasopharyngitis
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of strange feeling in a 67-year-old female subject who was vaccinated with HAVRIX ADULT (GlaxoSmithKline) for travel. The subject's medical history included Bell's palsy. Concurrent medical conditions included very high blood pressure, non-Hodgkin's lymphoma previously treated with chemotherapy, and very overweight. Previous vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (manufacturer unspecified) and bacillus calmette-guerin vaccine (manufacturer unspecified) given 3 weeks ago. The subject had not experienced adverse events following previous vaccinations. Concurrent medications included Blood pressure medication. On 31 July 2009 at 12:15 the subject received 1st dose of HAVRIX ADULT (details unknown). On 31 July 2009, 90 seconds after vaccination with HAVRIX ADULT, the subject experienced strange feeling and dizziness; the healthcare professional reported the subject had a vasovagal attack. Her blood pressure dropped to 80/60. The subject was cold, sweaty and clammy. She had a weak pulse. She was administered epinephrine 0.5 mg and her legs were elevated. The subject also experienced abdominal pain, nausea and increased dizziness. She received another 0.5 mg epinephrine and BENADRYL 25 mg. She was taken via ambulance to the Emergency Room. Thirty minutes after vaccination with HAVRIX, the subject was in the Emergency Room experiencing respiratory distress. She received prednison in the Emergency Room. She was in the Emergency Room for 4 hours and then sent home. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine, BENADRYL and Prednison. At the time of reporting the events were resolved. The Emergency Room physician did not think the subject's reaction was due to vaccination with HAVRIX. The reporting healthcare professional did not provide a causality statement.
Age: 67.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Respiratory rate increased
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of strange feeling in a 67-year-old female subject who was vaccinated with HAVRIX ADULT (GlaxoSmithKline) for travel. The subject's medical history included Bell's palsy. Concurrent medical conditions included very high blood pressure, non-Hodgkin's lymphoma previously treated with chemotherapy, and very overweight. Previous vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (manufacturer unspecified) and bacillus calmette-guerin vaccine (manufacturer unspecified) given 3 weeks ago. The subject had not experienced adverse events following previous vaccinations. Concurrent medications included Blood pressure medication. On 31 July 2009 at 12:15 the subject received 1st dose of HAVRIX ADULT (details unknown). On 31 July 2009, 90 seconds after vaccination with HAVRIX ADULT, the subject experienced strange feeling and dizziness; the healthcare professional reported the subject had a vasovagal attack. Her blood pressure dropped to 80/60. The subject was cold, sweaty and clammy. She had a weak pulse. She was administered epinephrine 0.5 mg and her legs were elevated. The subject also experienced abdominal pain, nausea and increased dizziness. She received another 0.5 mg epinephrine and BENADRYL 25 mg. She was taken via ambulance to the Emergency Room. Thirty minutes after vaccination with HAVRIX, the subject was in the Emergency Room experiencing respiratory distress. She received prednison in the Emergency Room. She was in the Emergency Room for 4 hours and then sent home. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine, BENADRYL and Prednison. At the time of reporting the events were resolved. The Emergency Room physician did not think the subject's reaction was due to vaccination with HAVRIX. The reporting healthcare professional did not provide a causality statement.
Age: 67.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain, Blood pressure decreased, Cold sweat, Dizziness, Feeling abnormal
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of strange feeling in a 67-year-old female subject who was vaccinated with HAVRIX ADULT (GlaxoSmithKline) for travel. The subject's medical history included Bell's palsy. Concurrent medical conditions included very high blood pressure, non-Hodgkin's lymphoma previously treated with chemotherapy, and very overweight. Previous vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (manufacturer unspecified) and bacillus calmette-guerin vaccine (manufacturer unspecified) given 3 weeks ago. The subject had not experienced adverse events following previous vaccinations. Concurrent medications included Blood pressure medication. On 31 July 2009 at 12:15 the subject received 1st dose of HAVRIX ADULT (details unknown). On 31 July 2009, 90 seconds after vaccination with HAVRIX ADULT, the subject experienced strange feeling and dizziness; the healthcare professional reported the subject had a vasovagal attack. Her blood pressure dropped to 80/60. The subject was cold, sweaty and clammy. She had a weak pulse. She was administered epinephrine 0.5 mg and her legs were elevated. The subject also experienced abdominal pain, nausea and increased dizziness. She received another 0.5 mg epinephrine and BENADRYL 25 mg. She was taken via ambulance to the Emergency Room. Thirty minutes after vaccination with HAVRIX, the subject was in the Emergency Room experiencing respiratory distress. She received prednison in the Emergency Room. She was in the Emergency Room for 4 hours and then sent home. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine, BENADRYL and Prednison. At the time of reporting the events were resolved. The Emergency Room physician did not think the subject's reaction was due to vaccination with HAVRIX. The reporting healthcare professional did not provide a causality statement.
Age: 67.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Feeling cold, Hyperhidrosis, Nausea, Presyncope, Pulse pressure decreased
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of strange feeling in a 67-year-old female subject who was vaccinated with HAVRIX ADULT (GlaxoSmithKline) for travel. The subject's medical history included Bell's palsy. Concurrent medical conditions included very high blood pressure, non-Hodgkin's lymphoma previously treated with chemotherapy, and very overweight. Previous vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (manufacturer unspecified) and bacillus calmette-guerin vaccine (manufacturer unspecified) given 3 weeks ago. The subject had not experienced adverse events following previous vaccinations. Concurrent medications included Blood pressure medication. On 31 July 2009 at 12:15 the subject received 1st dose of HAVRIX ADULT (details unknown). On 31 July 2009, 90 seconds after vaccination with HAVRIX ADULT, the subject experienced strange feeling and dizziness; the healthcare professional reported the subject had a vasovagal attack. Her blood pressure dropped to 80/60. The subject was cold, sweaty and clammy. She had a weak pulse. She was administered epinephrine 0.5 mg and her legs were elevated. The subject also experienced abdominal pain, nausea and increased dizziness. She received another 0.5 mg epinephrine and BENADRYL 25 mg. She was taken via ambulance to the Emergency Room. Thirty minutes after vaccination with HAVRIX, the subject was in the Emergency Room experiencing respiratory distress. She received prednison in the Emergency Room. She was in the Emergency Room for 4 hours and then sent home. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine, BENADRYL and Prednison. At the time of reporting the events were resolved. The Emergency Room physician did not think the subject's reaction was due to vaccination with HAVRIX. The reporting healthcare professional did not provide a causality statement.
Age: 67.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Respiratory distress
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of strange feeling in a 67-year-old female subject who was vaccinated with HAVRIX ADULT (GlaxoSmithKline) for travel. The subject's medical history included Bell's palsy. Concurrent medical conditions included very high blood pressure, non-Hodgkin's lymphoma previously treated with chemotherapy, and very overweight. Previous vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (manufacturer unspecified) and bacillus calmette-guerin vaccine (manufacturer unspecified) given 3 weeks ago. The subject had not experienced adverse events following previous vaccinations. Concurrent medications included Blood pressure medication. On 31 July 2009 at 12:15 the subject received 1st dose of HAVRIX ADULT (details unknown). On 31 July 2009, 90 seconds after vaccination with HAVRIX ADULT, the subject experienced strange feeling and dizziness; the healthcare professional reported the subject had a vasovagal attack. Her blood pressure dropped to 80/60. The subject was cold, sweaty and clammy. She had a weak pulse. She was administered epinephrine 0.5 mg and her legs were elevated. The subject also experienced abdominal pain, nausea and increased dizziness. She received another 0.5 mg epinephrine and BENADRYL 25 mg. She was taken via ambulance to the Emergency Room. Thirty minutes after vaccination with HAVRIX, the subject was in the Emergency Room experiencing respiratory distress. She received prednison in the Emergency Room. She was in the Emergency Room for 4 hours and then sent home. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Epinephrine, BENADRYL and Prednison. At the time of reporting the events were resolved. The Emergency Room physician did not think the subject's reaction was due to vaccination with HAVRIX. The reporting healthcare professional did not provide a causality statement.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Eye swelling, Oral pruritus, Paraesthesia oral, Pharyngeal oedema, Swelling face
Clinical narrative: Client received 1st GARDASIL and 2nd VARIVAX vaccines afternoon of 8/5/09, experienced swelling of face, eyes, throat, itchy and tingling in mouth - difficulty speaking, taken to ER 12am 8/6/09
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Pallor
Clinical narrative: Pt was nervous prior to receiving vaccinations and after 5th immunization pt stated "I feel weak". Color from lips went pale. Gave pt orange juice. Pt's mother said daughter had not eaten since breakfast. Applied cold compress to neck. Took vital signs. Vital signs within normal range. MD notified. MD assessed pt. MD released pt to parent. Advised pt. to eat prior to vaccinations per MD.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Convulsion, Fear, Hypoventilation, Nervousness, Oedema peripheral
Clinical narrative: she has developed hives all over her body. Her legs and hands are swallon. The hives are slowly spreading to her face. Temperature since 08/08/08 has been between 103.2`F and 102.2`F from 7:30 pm to now 08/10/09 12AM. She has been given cold showers to bring fever down and given 1.875 ml Motrin alternated every 6 hrs to Tylonol infant drop of 1.6 ml. Fever and mild seizure still available. Very shallow breathing. Child is excessively fearful and jumpy to any movements or sounds.  8/11/09 Medical records received DOS 8/5/09 to 8/10/09. Assessment: Viral exanthem unspecified, gingivostomatitis.  Fever for 3 days, not eating well, fussy, taking fluids in small amounts. Blisters in mouth, erythematous maculopapular rash on forearms/feet and abdomen, clear nasal discharge, no wet diaper. Mucous membranes dry. Referred to ER for possible IV fluids. Pt did not go to ER.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: she has developed hives all over her body. Her legs and hands are swallon. The hives are slowly spreading to her face. Temperature since 08/08/08 has been between 103.2`F and 102.2`F from 7:30 pm to now 08/10/09 12AM. She has been given cold showers to bring fever down and given 1.875 ml Motrin alternated every 6 hrs to Tylonol infant drop of 1.6 ml. Fever and mild seizure still available. Very shallow breathing. Child is excessively fearful and jumpy to any movements or sounds.  8/11/09 Medical records received DOS 8/5/09 to 8/10/09. Assessment: Viral exanthem unspecified, gingivostomatitis.  Fever for 3 days, not eating well, fussy, taking fluids in small amounts. Blisters in mouth, erythematous maculopapular rash on forearms/feet and abdomen, clear nasal discharge, no wet diaper. Mucous membranes dry. Referred to ER for possible IV fluids. Pt did not go to ER.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 19 female patient who on 12-JUN-2009 was vaccinated with the second 0.5ml dose of GARDASIL (lot number, route and site not reported). Subsequently, the patient experienced seizure after getting second dose of GARDASIL. The patient had sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. The patient did not have any adverse event from the first dose of GARDASIL. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Drug exposure during pregnancy, Hyperventilation, Intensive care, Mental disorder, Mydriasis
Clinical narrative: Information have been received from the register nurse and a hospital central service technician, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient who on 23-JUN-2009 was vaccinated with a first dose of GARDASIL (lot#661846/1312X, route and site not reported) and a dose of MENACTRA (Sanofi Pasteur, lot#U2872AA). The patient was pregnant, the menstrual period was in May 2009, and the estimated delivery date was 05-Feb-2010. The hospital central service technician who was the patient's grandmother reported that the patient did not want to pregnant and was experiencing multiple relationship problems. "Something happened to her after she became pregnant. She did not sound like herself". On 22-JUL-2009, the patient contacted her grandmother and reported she was hyperventilating. The patient's father took her to the hospital on 23-JUL-2009 and she was admitted. On 24-JUL-2009, the patient was placed in the ICU. On 25-JUL-2009, she was transferred to the crisis unit. The grandmother visited the patient on 01-AUG-2009. The patient's eyes were dilated and she only communicated with a few words instead of complete sentences or by shaking her head. The nurse said that the patient was in a type of shock and was experiencing a chemical imbalance. At the time of reporting, the patient did not recover and was still hospitalized. Additional information has been requested.  8/24/09 Hospital records received DOS 7/23/09 to 8/10/09. Assessment: Major depressive disorder, anxiety disorder, pregnancy. Patient presents with psychomotor slowing. Stares for extended periods of time without answering. Thought blocking. Not responding to internal stimuli. Eating poorly, nausea and vomiting. Affect blunted. Dehydrated. Auditory hallucinations and suicidal ideation. Haldol - acathesia.  ICD-9 Codes 648.43 Mental disorder complicating pregnancy antepartum condition or complication, 296.24 Major depression single episode severe with psychotic behavior, 300.0 Anxiety states, 646.63 Genitourinary tract infection in pregnancy antepartum condition or complication, 590.0 Chronic pyelonephritis, 643.13 Hyperemesis gravidarum with metabolic disturbance antepartum condition or complication, 276.51 Dehydration, 276.8 Hypokalemia, 780.52 Insomnia unspecified.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Shock, Social avoidant behaviour, Social problem, Speech disorder
Clinical narrative: Information have been received from the register nurse and a hospital central service technician, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient who on 23-JUN-2009 was vaccinated with a first dose of GARDASIL (lot#661846/1312X, route and site not reported) and a dose of MENACTRA (Sanofi Pasteur, lot#U2872AA). The patient was pregnant, the menstrual period was in May 2009, and the estimated delivery date was 05-Feb-2010. The hospital central service technician who was the patient's grandmother reported that the patient did not want to pregnant and was experiencing multiple relationship problems. "Something happened to her after she became pregnant. She did not sound like herself". On 22-JUL-2009, the patient contacted her grandmother and reported she was hyperventilating. The patient's father took her to the hospital on 23-JUL-2009 and she was admitted. On 24-JUL-2009, the patient was placed in the ICU. On 25-JUL-2009, she was transferred to the crisis unit. The grandmother visited the patient on 01-AUG-2009. The patient's eyes were dilated and she only communicated with a few words instead of complete sentences or by shaking her head. The nurse said that the patient was in a type of shock and was experiencing a chemical imbalance. At the time of reporting, the patient did not recover and was still hospitalized. Additional information has been requested.  8/24/09 Hospital records received DOS 7/23/09 to 8/10/09. Assessment: Major depressive disorder, anxiety disorder, pregnancy. Patient presents with psychomotor slowing. Stares for extended periods of time without answering. Thought blocking. Not responding to internal stimuli. Eating poorly, nausea and vomiting. Affect blunted. Dehydrated. Auditory hallucinations and suicidal ideation. Haldol - acathesia.  ICD-9 Codes 648.43 Mental disorder complicating pregnancy antepartum condition or complication, 296.24 Major depression single episode severe with psychotic behavior, 300.0 Anxiety states, 646.63 Genitourinary tract infection in pregnancy antepartum condition or complication, 590.0 Chronic pyelonephritis, 643.13 Hyperemesis gravidarum with metabolic disturbance antepartum condition or complication, 276.51 Dehydration, 276.8 Hypokalemia, 780.52 Insomnia unspecified.