chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Anogenital warts, Papilloma viral infection
Clinical narrative: Started developing warts on inside of vagina which had never occured before. Three weeks later they were still there and getting uncomfortable so i went to the gynocologist and they diagnosed me with HPV type 6.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Papilloma viral infection
Clinical narrative: Started developing warts on inside of vagina which had never occured before. Three weeks later they were still there and getting uncomfortable so i went to the gynocologist and they diagnosed me with HPV type 6.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical polyp, Drug exposure during pregnancy, Evacuation of retained products of conception, Haemorrhage, Muscle spasms
Clinical narrative: Pt saw PCP on 2/4/09 for GYN/PAP and received #1 GARDASIL that day. Urine HCG on 2/4/09 was negative. Pt subsequently had (+) pg test 2/16/09. Pt had onset of vaginal bleeding 3/25/09 - presented to ER and was found to have a sub chorionic hemorrhage with viable fetus - pt- had episodes of vag. bldg 3/26/09, 3/28/09, 4/1/09, 4/8/09, 4/27/09 and was noted to have a "fleshy" cervical polyp on exam 5/11/09. Patient returned to our office for continued bleeding and cramping and was sent for dx. U/S at ER -> dx of 17 wk fetal demise with subsequent delivery of infant. On 5-11-09 developed retained placenta with hemorrhaging requiring D&C for manual removal of placenta.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Retained placenta or membranes, Ultrasound scan abnormal, Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: Pt saw PCP on 2/4/09 for GYN/PAP and received #1 GARDASIL that day. Urine HCG on 2/4/09 was negative. Pt subsequently had (+) pg test 2/16/09. Pt had onset of vaginal bleeding 3/25/09 - presented to ER and was found to have a sub chorionic hemorrhage with viable fetus - pt- had episodes of vag. bldg 3/26/09, 3/28/09, 4/1/09, 4/8/09, 4/27/09 and was noted to have a "fleshy" cervical polyp on exam 5/11/09. Patient returned to our office for continued bleeding and cramping and was sent for dx. U/S at ER -> dx of 17 wk fetal demise with subsequent delivery of infant. On 5-11-09 developed retained placenta with hemorrhaging requiring D&C for manual removal of placenta.
Age: 1.2
Sex: M
Vaccine: MMR
Symptoms: Blood product transfusion, Platelet count decreased
Clinical narrative: Ear infection 1 week prior to abnormal labs, cough x 1 week, nasal congestion x 1 week, croup 2 months prior to admission - 3/16 plts 12,000 received IVIG 10 gm x 1 dose. See labs below. 5/26/09-records received for DOS 3/16-3/17/09-presented with low platelet count of 19,000. In ED presented with petechial rash and bruising.  Stool little loose.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Autism spectrum disorder, Cerebral disorder, Clumsiness, Constipation, Diarrhoea
Clinical narrative: The following day, noted increased fever, increased rash to chest & arms (red pimples). 3-5 days later, decreased speech, clumsiness, huge dilated pupils, loss of eye contact, constipation, diarrhea, severe anxiety PDD insomnia, cerebral dysfunction, forgetfulness.  8/4/09 Medical records received DOS 6/23/08 to 6/23/09 Assessment: Autism Spectrum Disorder. Parental concerns for child include impulse control, attention, diet, following commands, social, poor language fluency. ASD behaviours. Biting at school. Yeast infection. Clostridia infection. Enterobacter cloacae infection.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Encephalopathy, Gastric disorder, Insomnia, Laboratory test abnormal, Memory impairment
Clinical narrative: The following day, noted increased fever, increased rash to chest & arms (red pimples). 3-5 days later, decreased speech, clumsiness, huge dilated pupils, loss of eye contact, constipation, diarrhea, severe anxiety PDD insomnia, cerebral dysfunction, forgetfulness.  8/4/09 Medical records received DOS 6/23/08 to 6/23/09 Assessment: Autism Spectrum Disorder. Parental concerns for child include impulse control, attention, diet, following commands, social, poor language fluency. ASD behaviours. Biting at school. Yeast infection. Clostridia infection. Enterobacter cloacae infection.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Metal poisoning, Mydriasis, Pyrexia, Rash, Social avoidant behaviour
Clinical narrative: The following day, noted increased fever, increased rash to chest & arms (red pimples). 3-5 days later, decreased speech, clumsiness, huge dilated pupils, loss of eye contact, constipation, diarrhea, severe anxiety PDD insomnia, cerebral dysfunction, forgetfulness.  8/4/09 Medical records received DOS 6/23/08 to 6/23/09 Assessment: Autism Spectrum Disorder. Parental concerns for child include impulse control, attention, diet, following commands, social, poor language fluency. ASD behaviours. Biting at school. Yeast infection. Clostridia infection. Enterobacter cloacae infection.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Speech disorder
Clinical narrative: The following day, noted increased fever, increased rash to chest & arms (red pimples). 3-5 days later, decreased speech, clumsiness, huge dilated pupils, loss of eye contact, constipation, diarrhea, severe anxiety PDD insomnia, cerebral dysfunction, forgetfulness.  8/4/09 Medical records received DOS 6/23/08 to 6/23/09 Assessment: Autism Spectrum Disorder. Parental concerns for child include impulse control, attention, diet, following commands, social, poor language fluency. ASD behaviours. Biting at school. Yeast infection. Clostridia infection. Enterobacter cloacae infection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes simplex serology, Hyperkeratosis, Pain, Rash erythematous
Clinical narrative: Examined by MD 5-12-09 in Dermatology - note enclosure.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Seborrhoea, Virus culture
Clinical narrative: Examined by MD 5-12-09 in Dermatology - note enclosure.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 10mm induration with redness R lateral thigh
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Gaze palsy, Hypotonia, Inflammation, Rash erythematous
Clinical narrative: Parents took child across street to groc store.  She was crying when suddenly went limp + eyes rolled back in her head.  She had mild inflammation of R upper lip + erythematous macules on face.  Dad roused her & she recovered.  Brought into clinic + all S/S resolved.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Rash macular
Clinical narrative: Parents took child across street to groc store.  She was crying when suddenly went limp + eyes rolled back in her head.  She had mild inflammation of R upper lip + erythematous macules on face.  Dad roused her & she recovered.  Brought into clinic + all S/S resolved.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: 15-20 seconds after injection became diophoretic, lightheaded, passed out for 15-20 seconds.  C/o swelling in throat and throat soreness, no SOB or pain.  No visible swelling in throat.  C/o ringing in ears.  Symptoms quickly resolved.  Xyzal 5mg given.  Pt states "fine" within 10 minutes, released to home.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Tinnitus
Clinical narrative: 15-20 seconds after injection became diophoretic, lightheaded, passed out for 15-20 seconds.  C/o swelling in throat and throat soreness, no SOB or pain.  No visible swelling in throat.  C/o ringing in ears.  Symptoms quickly resolved.  Xyzal 5mg given.  Pt states "fine" within 10 minutes, released to home.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever X 9 days vomiting X 2 days
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Local redness approximately 10mm.  Vesicles.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Pt reacted immediately to VAR + MMR with redness + swelling @ sites, generalized urticaria on legs, arms, + back + abdomen.  Given 0.2cc of Benadryl IM + monitored for 30 min. Significant reduction in urticaria.  Breathing normal throughout.  Given prescription for Benadryl 2.5-3 ml  & 4 hrs PRN.  Parent told to call 911 if breathing diff. + increase in symptoms.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site induration
Clinical narrative: 40mm X 30mm area of induration on L lateral thigh.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, HPV4, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: No adverse event of symptoms, wrong vaccine given. In clinic 1hr. Past injection with no problems.
Age: 9.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Oedema peripheral
Clinical narrative: Achy headache, fatigue, tremors, arm swelling, myalgias, weakness.
Age: 9.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pain, Tremor
Clinical narrative: Achy headache, fatigue, tremors, arm swelling, myalgias, weakness.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5, RV5
Symptoms: Culture stool positive, Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: Infant with "milk protein allergy" at 1 month of age, developed diarrhea about 3 weeks after getting only dose of ROTATEQ.  Found to have rotavirus diarrhea that has lasted at least 4 months.  Stool virus confirmed to be vaccine strain in lab.  Child proven later to have SCID due to RAG-1 homozygous deficiency.  7/10/09 Hospital records received DOS 11/10/08 to 2/24/09. Assessment: Severe Combined Immunodeficiency Disease, Persistent Rotavirus Gastroenteritis - strain consistent with vaccine, Pneumothorax resolved, Feeding intolerance. Patient presented with fever, vomiting, increased output of 'mucousy' stools. Floppy, low tone. Hyperpigmentation rash on neck and upper chest. Dehydration, poor feeds and weight loss. Continued diarrhea, tachycardia, tachypnea, abdominal distention. NG tube placed. TPN initiated. PCP pneumonia. Pneumothorax. Difficulty swallowing secretions. Enteral IVIG administered.  ICD-9 Codes: 136.3 Pneumocystic carinii infection  8/20/09 ICD-9 Codes: 279.2 Combined immune deficiency, 999.39 Infection following injection unspecified person, 008.61 Viral enteritis due to Rotavirus, 558.3 Allergic gastroenteritis and colitis, 783.3 Feeding difficulties, 512.8 Pneumothorax other, 5733 unspecified hepatitis, 511.9 Pleural effusion, 789.59 Abdominal tenderness in multiple sites, 423.9 other disease of pericardium unspecified, 263.9 Other protein-caloric malnutrition unspecified, 783.41 Failure to thrive, 783.21 Loss of weight, 781.3 Recurrent dislocation of joint, 996.1 Mechanical complication of other vascular device implant and graft, 276.51 Dehydration, 578.0 Hematemesis.  9/28/09 Hospital records, multiple admissions, consultations, and follow-up visits, received DOS 2/24/09 to 8/6/09. Assessment: SCID, chronic rotovirus infection Rotateq strain, chronic hepatitis, failure to thrive. Patient transferred from another facilty for haplo match BMT from parent donor. Patient presents with tachypnea, feeding intolerance, course breath sounds. Fever and cut Broviac line, mouth pain, emesis, upper airway congestion. Mucous in stools. Oral Ulcer. TPN. IVIG. Hepatosplenomegaly. Epiglottitis. Rhinorrhea. No evidence of BMT engraftment. Iron deficiency anemia. Rectal area - erythematous rash. 2nd BMT preformed. Bloody emesis, bright red blood per rectum, friable/oozing esophagus. PICU. Upper airway obstruction. Respiratory insufficiency. Tachycardic. Icteric. Hepatic veno-occlusive disease. Alopecia. Rotavirus enterocolitis. Massive upper GI bleeding. Gallbladder wall thickening, sludge. Malnutrition. Pre-renal failure. Gingival eruption cyst.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5, RV5
Symptoms: Blood test, Primary immunodeficiency syndrome
Clinical narrative: Infant with "milk protein allergy" at 1 month of age, developed diarrhea about 3 weeks after getting only dose of ROTATEQ.  Found to have rotavirus diarrhea that has lasted at least 4 months.  Stool virus confirmed to be vaccine strain in lab.  Child proven later to have SCID due to RAG-1 homozygous deficiency.  7/10/09 Hospital records received DOS 11/10/08 to 2/24/09. Assessment: Severe Combined Immunodeficiency Disease, Persistent Rotavirus Gastroenteritis - strain consistent with vaccine, Pneumothorax resolved, Feeding intolerance. Patient presented with fever, vomiting, increased output of 'mucousy' stools. Floppy, low tone. Hyperpigmentation rash on neck and upper chest. Dehydration, poor feeds and weight loss. Continued diarrhea, tachycardia, tachypnea, abdominal distention. NG tube placed. TPN initiated. PCP pneumonia. Pneumothorax. Difficulty swallowing secretions. Enteral IVIG administered.  ICD-9 Codes: 136.3 Pneumocystic carinii infection  8/20/09 ICD-9 Codes: 279.2 Combined immune deficiency, 999.39 Infection following injection unspecified person, 008.61 Viral enteritis due to Rotavirus, 558.3 Allergic gastroenteritis and colitis, 783.3 Feeding difficulties, 512.8 Pneumothorax other, 5733 unspecified hepatitis, 511.9 Pleural effusion, 789.59 Abdominal tenderness in multiple sites, 423.9 other disease of pericardium unspecified, 263.9 Other protein-caloric malnutrition unspecified, 783.41 Failure to thrive, 783.21 Loss of weight, 781.3 Recurrent dislocation of joint, 996.1 Mechanical complication of other vascular device implant and graft, 276.51 Dehydration, 578.0 Hematemesis.  9/28/09 Hospital records, multiple admissions, consultations, and follow-up visits, received DOS 2/24/09 to 8/6/09. Assessment: SCID, chronic rotovirus infection Rotateq strain, chronic hepatitis, failure to thrive. Patient transferred from another facilty for haplo match BMT from parent donor. Patient presents with tachypnea, feeding intolerance, course breath sounds. Fever and cut Broviac line, mouth pain, emesis, upper airway congestion. Mucous in stools. Oral Ulcer. TPN. IVIG. Hepatosplenomegaly. Epiglottitis. Rhinorrhea. No evidence of BMT engraftment. Iron deficiency anemia. Rectal area - erythematous rash. 2nd BMT preformed. Bloody emesis, bright red blood per rectum, friable/oozing esophagus. PICU. Upper airway obstruction. Respiratory insufficiency. Tachycardic. Icteric. Hepatic veno-occlusive disease. Alopecia. Rotavirus enterocolitis. Massive upper GI bleeding. Gallbladder wall thickening, sludge. Malnutrition. Pre-renal failure. Gingival eruption cyst.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5, RV5
Symptoms: Bone marrow transplant, Combined immunodeficiency, Dehydration, Diarrhoea, Pneumocystis jiroveci infection
Clinical narrative: Infant with "milk protein allergy" at 1 month of age, developed diarrhea about 3 weeks after getting only dose of ROTATEQ.  Found to have rotavirus diarrhea that has lasted at least 4 months.  Stool virus confirmed to be vaccine strain in lab.  Child proven later to have SCID due to RAG-1 homozygous deficiency.  7/10/09 Hospital records received DOS 11/10/08 to 2/24/09. Assessment: Severe Combined Immunodeficiency Disease, Persistent Rotavirus Gastroenteritis - strain consistent with vaccine, Pneumothorax resolved, Feeding intolerance. Patient presented with fever, vomiting, increased output of 'mucousy' stools. Floppy, low tone. Hyperpigmentation rash on neck and upper chest. Dehydration, poor feeds and weight loss. Continued diarrhea, tachycardia, tachypnea, abdominal distention. NG tube placed. TPN initiated. PCP pneumonia. Pneumothorax. Difficulty swallowing secretions. Enteral IVIG administered.  ICD-9 Codes: 136.3 Pneumocystic carinii infection  8/20/09 ICD-9 Codes: 279.2 Combined immune deficiency, 999.39 Infection following injection unspecified person, 008.61 Viral enteritis due to Rotavirus, 558.3 Allergic gastroenteritis and colitis, 783.3 Feeding difficulties, 512.8 Pneumothorax other, 5733 unspecified hepatitis, 511.9 Pleural effusion, 789.59 Abdominal tenderness in multiple sites, 423.9 other disease of pericardium unspecified, 263.9 Other protein-caloric malnutrition unspecified, 783.41 Failure to thrive, 783.21 Loss of weight, 781.3 Recurrent dislocation of joint, 996.1 Mechanical complication of other vascular device implant and graft, 276.51 Dehydration, 578.0 Hematemesis.  9/28/09 Hospital records, multiple admissions, consultations, and follow-up visits, received DOS 2/24/09 to 8/6/09. Assessment: SCID, chronic rotovirus infection Rotateq strain, chronic hepatitis, failure to thrive. Patient transferred from another facilty for haplo match BMT from parent donor. Patient presents with tachypnea, feeding intolerance, course breath sounds. Fever and cut Broviac line, mouth pain, emesis, upper airway congestion. Mucous in stools. Oral Ulcer. TPN. IVIG. Hepatosplenomegaly. Epiglottitis. Rhinorrhea. No evidence of BMT engraftment. Iron deficiency anemia. Rectal area - erythematous rash. 2nd BMT preformed. Bloody emesis, bright red blood per rectum, friable/oozing esophagus. PICU. Upper airway obstruction. Respiratory insufficiency. Tachycardic. Icteric. Hepatic veno-occlusive disease. Alopecia. Rotavirus enterocolitis. Massive upper GI bleeding. Gallbladder wall thickening, sludge. Malnutrition. Pre-renal failure. Gingival eruption cyst.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5, RV5
Symptoms: Rotavirus infection, Sputum culture positive, Stool analysis abnormal
Clinical narrative: Infant with "milk protein allergy" at 1 month of age, developed diarrhea about 3 weeks after getting only dose of ROTATEQ.  Found to have rotavirus diarrhea that has lasted at least 4 months.  Stool virus confirmed to be vaccine strain in lab.  Child proven later to have SCID due to RAG-1 homozygous deficiency.  7/10/09 Hospital records received DOS 11/10/08 to 2/24/09. Assessment: Severe Combined Immunodeficiency Disease, Persistent Rotavirus Gastroenteritis - strain consistent with vaccine, Pneumothorax resolved, Feeding intolerance. Patient presented with fever, vomiting, increased output of 'mucousy' stools. Floppy, low tone. Hyperpigmentation rash on neck and upper chest. Dehydration, poor feeds and weight loss. Continued diarrhea, tachycardia, tachypnea, abdominal distention. NG tube placed. TPN initiated. PCP pneumonia. Pneumothorax. Difficulty swallowing secretions. Enteral IVIG administered.  ICD-9 Codes: 136.3 Pneumocystic carinii infection  8/20/09 ICD-9 Codes: 279.2 Combined immune deficiency, 999.39 Infection following injection unspecified person, 008.61 Viral enteritis due to Rotavirus, 558.3 Allergic gastroenteritis and colitis, 783.3 Feeding difficulties, 512.8 Pneumothorax other, 5733 unspecified hepatitis, 511.9 Pleural effusion, 789.59 Abdominal tenderness in multiple sites, 423.9 other disease of pericardium unspecified, 263.9 Other protein-caloric malnutrition unspecified, 783.41 Failure to thrive, 783.21 Loss of weight, 781.3 Recurrent dislocation of joint, 996.1 Mechanical complication of other vascular device implant and graft, 276.51 Dehydration, 578.0 Hematemesis.  9/28/09 Hospital records, multiple admissions, consultations, and follow-up visits, received DOS 2/24/09 to 8/6/09. Assessment: SCID, chronic rotovirus infection Rotateq strain, chronic hepatitis, failure to thrive. Patient transferred from another facilty for haplo match BMT from parent donor. Patient presents with tachypnea, feeding intolerance, course breath sounds. Fever and cut Broviac line, mouth pain, emesis, upper airway congestion. Mucous in stools. Oral Ulcer. TPN. IVIG. Hepatosplenomegaly. Epiglottitis. Rhinorrhea. No evidence of BMT engraftment. Iron deficiency anemia. Rectal area - erythematous rash. 2nd BMT preformed. Bloody emesis, bright red blood per rectum, friable/oozing esophagus. PICU. Upper airway obstruction. Respiratory insufficiency. Tachycardic. Icteric. Hepatic veno-occlusive disease. Alopecia. Rotavirus enterocolitis. Massive upper GI bleeding. Gallbladder wall thickening, sludge. Malnutrition. Pre-renal failure. Gingival eruption cyst.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: Deep, aching pain in Rt arm, very tender to the touch, very red and very hot. Dr put her on antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV, DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included IPOL (Sanofi) given on 24 April 2009. On 24 April 2009 at 09:00 the subject received 5th dose of INFANRIX (0.5 ml, unknown route, left arm). On 24 April 2009, 5 hours after vaccination with INFANRIX, the subject developed injection site pain; he awoke from a nap and "complained of pain in his arm". The subject's mother had reported that he "felt warm" and his temperature around 03:00 on 25 April 2009 revealed a fever of 100.1 degrees Fahrenheit. During the early morning on 25 April 2009, the subject developed swelling of the arm of injection; his arm was described as "huge and was hard as a rock from the elbow to his shoulder". The subject also developed injection site redness and injection site hot to touch; his arm was described as "dark red and hot to the touch". The subject's mother spoke with a physician on the telephone. The subject was treated with MOTRIN and BENADRYL. The subject began to "act and feel better" around 18:00 on 26 April 2009. His arm still sore to the touch. The subject returned to school on 27 April 2009. Although his arm remained "slightly swollen and red". At the time of reporting the events were improved. Follow up received from healthcare professional on 11 May 2009: The subject had not experienced adverse events following previous vaccinations. The subject had received 3 previous doses of IPOL without reaction. Route of administration of INFANRIX was intramuscular. The diagnosis was reported as localized reaction to immunization. The events had end date of 29 April 2009. The healthcare professional considered the events were clinically significant (or requiring intervention), due to the subject being "in pain with an extremity 2-3 times the size it should be". The healthcare professional considered the events were not associated with the subject's medical history or a concurrent illness, and that it was doubtful they were associated with erroneous administration or suspected transmission of an infectious agent via a medicinal product. The healthcare professional considered the events were possibly related to vaccination with INFANRIX. The healthcare professional has reported this case to the Regulatory Agency (reference number 345080).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV, DTAP, IPV
Symptoms: Body temperature increased, Feeling hot, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included IPOL (Sanofi) given on 24 April 2009. On 24 April 2009 at 09:00 the subject received 5th dose of INFANRIX (0.5 ml, unknown route, left arm). On 24 April 2009, 5 hours after vaccination with INFANRIX, the subject developed injection site pain; he awoke from a nap and "complained of pain in his arm". The subject's mother had reported that he "felt warm" and his temperature around 03:00 on 25 April 2009 revealed a fever of 100.1 degrees Fahrenheit. During the early morning on 25 April 2009, the subject developed swelling of the arm of injection; his arm was described as "huge and was hard as a rock from the elbow to his shoulder". The subject also developed injection site redness and injection site hot to touch; his arm was described as "dark red and hot to the touch". The subject's mother spoke with a physician on the telephone. The subject was treated with MOTRIN and BENADRYL. The subject began to "act and feel better" around 18:00 on 26 April 2009. His arm still sore to the touch. The subject returned to school on 27 April 2009. Although his arm remained "slightly swollen and red". At the time of reporting the events were improved. Follow up received from healthcare professional on 11 May 2009: The subject had not experienced adverse events following previous vaccinations. The subject had received 3 previous doses of IPOL without reaction. Route of administration of INFANRIX was intramuscular. The diagnosis was reported as localized reaction to immunization. The events had end date of 29 April 2009. The healthcare professional considered the events were clinically significant (or requiring intervention), due to the subject being "in pain with an extremity 2-3 times the size it should be". The healthcare professional considered the events were not associated with the subject's medical history or a concurrent illness, and that it was doubtful they were associated with erroneous administration or suspected transmission of an infectious agent via a medicinal product. The healthcare professional considered the events were possibly related to vaccination with INFANRIX. The healthcare professional has reported this case to the Regulatory Agency (reference number 345080).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV, DTAP, IPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included IPOL (Sanofi) given on 24 April 2009. On 24 April 2009 at 09:00 the subject received 5th dose of INFANRIX (0.5 ml, unknown route, left arm). On 24 April 2009, 5 hours after vaccination with INFANRIX, the subject developed injection site pain; he awoke from a nap and "complained of pain in his arm". The subject's mother had reported that he "felt warm" and his temperature around 03:00 on 25 April 2009 revealed a fever of 100.1 degrees Fahrenheit. During the early morning on 25 April 2009, the subject developed swelling of the arm of injection; his arm was described as "huge and was hard as a rock from the elbow to his shoulder". The subject also developed injection site redness and injection site hot to touch; his arm was described as "dark red and hot to the touch". The subject's mother spoke with a physician on the telephone. The subject was treated with MOTRIN and BENADRYL. The subject began to "act and feel better" around 18:00 on 26 April 2009. His arm still sore to the touch. The subject returned to school on 27 April 2009. Although his arm remained "slightly swollen and red". At the time of reporting the events were improved. Follow up received from healthcare professional on 11 May 2009: The subject had not experienced adverse events following previous vaccinations. The subject had received 3 previous doses of IPOL without reaction. Route of administration of INFANRIX was intramuscular. The diagnosis was reported as localized reaction to immunization. The events had end date of 29 April 2009. The healthcare professional considered the events were clinically significant (or requiring intervention), due to the subject being "in pain with an extremity 2-3 times the size it should be". The healthcare professional considered the events were not associated with the subject's medical history or a concurrent illness, and that it was doubtful they were associated with erroneous administration or suspected transmission of an infectious agent via a medicinal product. The healthcare professional considered the events were possibly related to vaccination with INFANRIX. The healthcare professional has reported this case to the Regulatory Agency (reference number 345080).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV, DTAP, IPV
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included IPOL (Sanofi) given on 24 April 2009. On 24 April 2009 at 09:00 the subject received 5th dose of INFANRIX (0.5 ml, unknown route, left arm). On 24 April 2009, 5 hours after vaccination with INFANRIX, the subject developed injection site pain; he awoke from a nap and "complained of pain in his arm". The subject's mother had reported that he "felt warm" and his temperature around 03:00 on 25 April 2009 revealed a fever of 100.1 degrees Fahrenheit. During the early morning on 25 April 2009, the subject developed swelling of the arm of injection; his arm was described as "huge and was hard as a rock from the elbow to his shoulder". The subject also developed injection site redness and injection site hot to touch; his arm was described as "dark red and hot to the touch". The subject's mother spoke with a physician on the telephone. The subject was treated with MOTRIN and BENADRYL. The subject began to "act and feel better" around 18:00 on 26 April 2009. His arm still sore to the touch. The subject returned to school on 27 April 2009. Although his arm remained "slightly swollen and red". At the time of reporting the events were improved. Follow up received from healthcare professional on 11 May 2009: The subject had not experienced adverse events following previous vaccinations. The subject had received 3 previous doses of IPOL without reaction. Route of administration of INFANRIX was intramuscular. The diagnosis was reported as localized reaction to immunization. The events had end date of 29 April 2009. The healthcare professional considered the events were clinically significant (or requiring intervention), due to the subject being "in pain with an extremity 2-3 times the size it should be". The healthcare professional considered the events were not associated with the subject's medical history or a concurrent illness, and that it was doubtful they were associated with erroneous administration or suspected transmission of an infectious agent via a medicinal product. The healthcare professional considered the events were possibly related to vaccination with INFANRIX. The healthcare professional has reported this case to the Regulatory Agency (reference number 345080).
Age: 23.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test normal, Computerised tomogram normal, Muscle rigidity, Ophthalmoplegia, Pain in extremity
Clinical narrative: On 4-27-09 8:45/AM received Hep A #2, was fine walked out to pay - had to wait few min for clerk to arrive. I was with pt. She was behind me, heard a sound and looked, she was going down to floor was stiff, arms flexed, jaws clenched, jerking notedly, unresponsive x around 30 seconds. Then she could look at me, after another 30 seconds was able to respond and ask for her mother and mother and father were called. Arrived. Pt doing well V.S. stable - instructed family to see doctor - then pt began vomiting, AAA ambulance called - arrived soon and pt. taken to ER. Before shot on questionnaire states had history of seizure acitivity. When asked about it stated had some jerking at birth for couple days - but denies any seizure since then and says has recover been on any seizure meds. When mother came said child was born with cord around neck and child have trembling for several days. States never had EEG. A sister later told employee here that ER doctor said was not a seizure - was a tonic episode. I spoke with mother who said pt is scheduled to see neurologist 5-20-09. She also said pt said after Hep A #1 on 8-14-08 that she was dizzy but she didn't think anything about that because she often gets dizzy she thinks related to her migraines (not often but "sometimes").
Age: 23.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: On 4-27-09 8:45/AM received Hep A #2, was fine walked out to pay - had to wait few min for clerk to arrive. I was with pt. She was behind me, heard a sound and looked, she was going down to floor was stiff, arms flexed, jaws clenched, jerking notedly, unresponsive x around 30 seconds. Then she could look at me, after another 30 seconds was able to respond and ask for her mother and mother and father were called. Arrived. Pt doing well V.S. stable - instructed family to see doctor - then pt began vomiting, AAA ambulance called - arrived soon and pt. taken to ER. Before shot on questionnaire states had history of seizure acitivity. When asked about it stated had some jerking at birth for couple days - but denies any seizure since then and says has recover been on any seizure meds. When mother came said child was born with cord around neck and child have trembling for several days. States never had EEG. A sister later told employee here that ER doctor said was not a seizure - was a tonic episode. I spoke with mother who said pt is scheduled to see neurologist 5-20-09. She also said pt said after Hep A #1 on 8-14-08 that she was dizzy but she didn't think anything about that because she often gets dizzy she thinks related to her migraines (not often but "sometimes").
Age: 23.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Dyskinesia, Electroencephalogram, Musculoskeletal stiffness, Unresponsive to stimuli, Vomiting
Clinical narrative: On 4-27-09 8:45/AM received Hep A #2, was fine walked out to pay - had to wait few min for clerk to arrive. I was with pt. She was behind me, heard a sound and looked, she was going down to floor was stiff, arms flexed, jaws clenched, jerking notedly, unresponsive x around 30 seconds. Then she could look at me, after another 30 seconds was able to respond and ask for her mother and mother and father were called. Arrived. Pt doing well V.S. stable - instructed family to see doctor - then pt began vomiting, AAA ambulance called - arrived soon and pt. taken to ER. Before shot on questionnaire states had history of seizure acitivity. When asked about it stated had some jerking at birth for couple days - but denies any seizure since then and says has recover been on any seizure meds. When mother came said child was born with cord around neck and child have trembling for several days. States never had EEG. A sister later told employee here that ER doctor said was not a seizure - was a tonic episode. I spoke with mother who said pt is scheduled to see neurologist 5-20-09. She also said pt said after Hep A #1 on 8-14-08 that she was dizzy but she didn't think anything about that because she often gets dizzy she thinks related to her migraines (not often but "sometimes").
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Activities of daily living impaired, Apnoea, Back pain, Confusional state, Crying
Clinical narrative: First complaint was neck arm stiffness of left side, which continued, confustion (goofy like she was drunk), conti complaints of neck arm, then exhaustion just wanted to sleep out of no where, then extreme headache migraine past 10 in pain, crying holding head, light/sound sensitivity... then could not breathe, starting paniacing can't breathe , cant breathe my chest ..911 called, became hot sweaty, dizzy, neauseous, somewhat incoherent, emt had to ask questions 3 or 4 times to get answer, brought to hospital, had apnea issues 3X ( had nurse give her oxygen) while waiting for Dr. She was hydrated and given raglan after symptoms subsided sent home after midnight. Stayed home the next day, headaches, light/noise sensitivity continued, attempted to go to work 5/12 at 5pm had to be brought home 2.5 hours later, attempted school 5/13 headache, fatigued, exhaustion, back ache, leg pain helped 2 nurses office by 2 friends, called at 10:30am picked up at 11:17 bourght to car in wheel chair... 5/13 brought to dr's office for continued symptoms. Tried to say it could be other things. My child hardly gets sick, was fine not even a sniffle before vaccinations were administered. She is on bed rest with continued symptoms until 5/15.  5/14/09 ED records received DOS 5/11/09. FINAL DIAGNOSIS: Adverse reaction to Menactra vaccine Complained of neck pain and headache, then chills, tingling in arm, dizziness, symptoms exacerbated by light and noise. Confusion.  LABS and DIAGNOSTICS: CBC - WNL, CHEM - WNL, CT Head - WNL.  5/15/09 medical records received (also contains copy of ED records for 5/11/09) DOS 5/11/09 to 5/13/09. FINAL DIAGNOSIS: Possible Menactra reaction Fever, chills, headache, sore throat with erythema, decreased appetite, and fatigue persist post ED visit on 5/11/09.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling drunk, Feeling hot
Clinical narrative: First complaint was neck arm stiffness of left side, which continued, confustion (goofy like she was drunk), conti complaints of neck arm, then exhaustion just wanted to sleep out of no where, then extreme headache migraine past 10 in pain, crying holding head, light/sound sensitivity... then could not breathe, starting paniacing can't breathe , cant breathe my chest ..911 called, became hot sweaty, dizzy, neauseous, somewhat incoherent, emt had to ask questions 3 or 4 times to get answer, brought to hospital, had apnea issues 3X ( had nurse give her oxygen) while waiting for Dr. She was hydrated and given raglan after symptoms subsided sent home after midnight. Stayed home the next day, headaches, light/noise sensitivity continued, attempted to go to work 5/12 at 5pm had to be brought home 2.5 hours later, attempted school 5/13 headache, fatigued, exhaustion, back ache, leg pain helped 2 nurses office by 2 friends, called at 10:30am picked up at 11:17 bourght to car in wheel chair... 5/13 brought to dr's office for continued symptoms. Tried to say it could be other things. My child hardly gets sick, was fine not even a sniffle before vaccinations were administered. She is on bed rest with continued symptoms until 5/15.  5/14/09 ED records received DOS 5/11/09. FINAL DIAGNOSIS: Adverse reaction to Menactra vaccine Complained of neck pain and headache, then chills, tingling in arm, dizziness, symptoms exacerbated by light and noise. Confusion.  LABS and DIAGNOSTICS: CBC - WNL, CHEM - WNL, CT Head - WNL.  5/15/09 medical records received (also contains copy of ED records for 5/11/09) DOS 5/11/09 to 5/13/09. FINAL DIAGNOSIS: Possible Menactra reaction Fever, chills, headache, sore throat with erythema, decreased appetite, and fatigue persist post ED visit on 5/11/09.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Headache, Hyperacusis, Hyperhidrosis, Incoherent, Migraine
Clinical narrative: First complaint was neck arm stiffness of left side, which continued, confustion (goofy like she was drunk), conti complaints of neck arm, then exhaustion just wanted to sleep out of no where, then extreme headache migraine past 10 in pain, crying holding head, light/sound sensitivity... then could not breathe, starting paniacing can't breathe , cant breathe my chest ..911 called, became hot sweaty, dizzy, neauseous, somewhat incoherent, emt had to ask questions 3 or 4 times to get answer, brought to hospital, had apnea issues 3X ( had nurse give her oxygen) while waiting for Dr. She was hydrated and given raglan after symptoms subsided sent home after midnight. Stayed home the next day, headaches, light/noise sensitivity continued, attempted to go to work 5/12 at 5pm had to be brought home 2.5 hours later, attempted school 5/13 headache, fatigued, exhaustion, back ache, leg pain helped 2 nurses office by 2 friends, called at 10:30am picked up at 11:17 bourght to car in wheel chair... 5/13 brought to dr's office for continued symptoms. Tried to say it could be other things. My child hardly gets sick, was fine not even a sniffle before vaccinations were administered. She is on bed rest with continued symptoms until 5/15.  5/14/09 ED records received DOS 5/11/09. FINAL DIAGNOSIS: Adverse reaction to Menactra vaccine Complained of neck pain and headache, then chills, tingling in arm, dizziness, symptoms exacerbated by light and noise. Confusion.  LABS and DIAGNOSTICS: CBC - WNL, CHEM - WNL, CT Head - WNL.  5/15/09 medical records received (also contains copy of ED records for 5/11/09) DOS 5/11/09 to 5/13/09. FINAL DIAGNOSIS: Possible Menactra reaction Fever, chills, headache, sore throat with erythema, decreased appetite, and fatigue persist post ED visit on 5/11/09.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pain in extremity, Panic reaction
Clinical narrative: First complaint was neck arm stiffness of left side, which continued, confustion (goofy like she was drunk), conti complaints of neck arm, then exhaustion just wanted to sleep out of no where, then extreme headache migraine past 10 in pain, crying holding head, light/sound sensitivity... then could not breathe, starting paniacing can't breathe , cant breathe my chest ..911 called, became hot sweaty, dizzy, neauseous, somewhat incoherent, emt had to ask questions 3 or 4 times to get answer, brought to hospital, had apnea issues 3X ( had nurse give her oxygen) while waiting for Dr. She was hydrated and given raglan after symptoms subsided sent home after midnight. Stayed home the next day, headaches, light/noise sensitivity continued, attempted to go to work 5/12 at 5pm had to be brought home 2.5 hours later, attempted school 5/13 headache, fatigued, exhaustion, back ache, leg pain helped 2 nurses office by 2 friends, called at 10:30am picked up at 11:17 bourght to car in wheel chair... 5/13 brought to dr's office for continued symptoms. Tried to say it could be other things. My child hardly gets sick, was fine not even a sniffle before vaccinations were administered. She is on bed rest with continued symptoms until 5/15.  5/14/09 ED records received DOS 5/11/09. FINAL DIAGNOSIS: Adverse reaction to Menactra vaccine Complained of neck pain and headache, then chills, tingling in arm, dizziness, symptoms exacerbated by light and noise. Confusion.  LABS and DIAGNOSTICS: CBC - WNL, CHEM - WNL, CT Head - WNL.  5/15/09 medical records received (also contains copy of ED records for 5/11/09) DOS 5/11/09 to 5/13/09. FINAL DIAGNOSIS: Possible Menactra reaction Fever, chills, headache, sore throat with erythema, decreased appetite, and fatigue persist post ED visit on 5/11/09.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Phonophobia, Photophobia, Somnolence
Clinical narrative: First complaint was neck arm stiffness of left side, which continued, confustion (goofy like she was drunk), conti complaints of neck arm, then exhaustion just wanted to sleep out of no where, then extreme headache migraine past 10 in pain, crying holding head, light/sound sensitivity... then could not breathe, starting paniacing can't breathe , cant breathe my chest ..911 called, became hot sweaty, dizzy, neauseous, somewhat incoherent, emt had to ask questions 3 or 4 times to get answer, brought to hospital, had apnea issues 3X ( had nurse give her oxygen) while waiting for Dr. She was hydrated and given raglan after symptoms subsided sent home after midnight. Stayed home the next day, headaches, light/noise sensitivity continued, attempted to go to work 5/12 at 5pm had to be brought home 2.5 hours later, attempted school 5/13 headache, fatigued, exhaustion, back ache, leg pain helped 2 nurses office by 2 friends, called at 10:30am picked up at 11:17 bourght to car in wheel chair... 5/13 brought to dr's office for continued symptoms. Tried to say it could be other things. My child hardly gets sick, was fine not even a sniffle before vaccinations were administered. She is on bed rest with continued symptoms until 5/15.  5/14/09 ED records received DOS 5/11/09. FINAL DIAGNOSIS: Adverse reaction to Menactra vaccine Complained of neck pain and headache, then chills, tingling in arm, dizziness, symptoms exacerbated by light and noise. Confusion.  LABS and DIAGNOSTICS: CBC - WNL, CHEM - WNL, CT Head - WNL.  5/15/09 medical records received (also contains copy of ED records for 5/11/09) DOS 5/11/09 to 5/13/09. FINAL DIAGNOSIS: Possible Menactra reaction Fever, chills, headache, sore throat with erythema, decreased appetite, and fatigue persist post ED visit on 5/11/09.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Abasia, Back pain, Fatigue, Gait disturbance, Headache
Clinical narrative: First complaint was neck arm stiffness of left side, which continued, confustion (goofy like she was drunk), conti complaints of neck arm, then exhaustion just wanted to sleep out of no where, then extreme headache migraine past 10 in pain, crying holding head, light/sound sensitivity... then could not breathe, starting paniacing can't breathe , cant breathe my chest ..911 called, became hot sweaty, dizzy, neauseous, somewhat incoherent, emt had to ask questions 3 or 4 times to get answer, brought to hospital, had apnea issues 3X ( had nurse give her oxygen) while waiting for Dr. She was hydrated and given raglan after symptoms subsided sent home after midnight. Stayed home the next day, headaches, light/noise sensitivity continued, attempted to go to work 5/12 at 5pm had to be brought home 2.5 hours later, attempted school 5/13 headache, fatigued, exhaustion, back ache, leg pain helped 2 nurses office by 2 friends, called at 10:30am picked up at 11:17 bourght to car in wheel chair... 5/13 brought to dr's office for continued symptoms. Tried to say it could be other things. My child hardly gets sick, was fine not even a sniffle before vaccinations were administered. She is on bed rest with continued symptoms until 5/15.  5/14/09 ED records received DOS 5/11/09. FINAL DIAGNOSIS: Adverse reaction to Menactra vaccine Complained of neck pain and headache, then chills, tingling in arm, dizziness, symptoms exacerbated by light and noise. Confusion.  LABS and DIAGNOSTICS: CBC - WNL, CHEM - WNL, CT Head - WNL.  5/15/09 medical records received (also contains copy of ED records for 5/11/09) DOS 5/11/09 to 5/13/09. FINAL DIAGNOSIS: Possible Menactra reaction Fever, chills, headache, sore throat with erythema, decreased appetite, and fatigue persist post ED visit on 5/11/09.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Muscular weakness, Paraesthesia, Syncope, Wheelchair user
Clinical narrative: First complaint was neck arm stiffness of left side, which continued, confustion (goofy like she was drunk), conti complaints of neck arm, then exhaustion just wanted to sleep out of no where, then extreme headache migraine past 10 in pain, crying holding head, light/sound sensitivity... then could not breathe, starting paniacing can't breathe , cant breathe my chest ..911 called, became hot sweaty, dizzy, neauseous, somewhat incoherent, emt had to ask questions 3 or 4 times to get answer, brought to hospital, had apnea issues 3X ( had nurse give her oxygen) while waiting for Dr. She was hydrated and given raglan after symptoms subsided sent home after midnight. Stayed home the next day, headaches, light/noise sensitivity continued, attempted to go to work 5/12 at 5pm had to be brought home 2.5 hours later, attempted school 5/13 headache, fatigued, exhaustion, back ache, leg pain helped 2 nurses office by 2 friends, called at 10:30am picked up at 11:17 bourght to car in wheel chair... 5/13 brought to dr's office for continued symptoms. Tried to say it could be other things. My child hardly gets sick, was fine not even a sniffle before vaccinations were administered. She is on bed rest with continued symptoms until 5/15.  5/14/09 ED records received DOS 5/11/09. FINAL DIAGNOSIS: Adverse reaction to Menactra vaccine Complained of neck pain and headache, then chills, tingling in arm, dizziness, symptoms exacerbated by light and noise. Confusion.  LABS and DIAGNOSTICS: CBC - WNL, CHEM - WNL, CT Head - WNL.  5/15/09 medical records received (also contains copy of ED records for 5/11/09) DOS 5/11/09 to 5/13/09. FINAL DIAGNOSIS: Possible Menactra reaction Fever, chills, headache, sore throat with erythema, decreased appetite, and fatigue persist post ED visit on 5/11/09.