chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Fatigue, Idiopathic thrombocytopenic purpura, Platelet count decreased, Thrombocytopenia
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 female patient (age unspecified) with idiopathic thrombocytopenic purpura and thrombocytopenia was vaccinated on 09-MAR-2010 with the third dose of GARDASIL, (lot # 1378Y), (site route and dose not reported). Concomitant vaccine given on the same date included a dose of AFLURIA, (Lot #, site and route not reported). This medically confirmed spontaneous report (initial receipt 09-MAY-2012) concerned a female patient 17 or 18 years of age. On 01-APR-2008 the patient received her first dose of GARDASIL (batch number: #1978U) via injection at a dose of 0.5 ml. Fairly quickly after the first dose of GARDASIL (received on 01-APR-2008), the patient developed ITP (idiopathic thrombocytopenic purpura) and was referred to children's hematology. Her ITP was thrombocytopenia. The doctor at first said that she wasn't convinced it was from (GARDASIL), but hematologist said it may have been. They went through her past medical history and saw nothing out of the ordinary. On 28-SEP-2009 the patient received her second dose of GARDASIL at a different clinic. On 09-MAR-2010 the patient received of AFLURIA (batch and manufacturer unspecified). On the same day, the patient also received her third dose of GARDASIL (batch number: #1378Y). She finished the series (of GARDASIL injections) of AFLURIA was reported as a concomitant medication. It was unspecified if other vaccines were given with previous doses of GARDASIL. The patient's platelet levels were going up and down. Her platelet levels got as low as 20 (which was her lowest), it was unspecified when this count was taken. Her platelet count went up to 114 at some point, and the last checked count was at 85. The patient became very fatigue and was followed up by hematology, but she was never hospitalized. The symptoms were still continuing. The event improved after stopping GARDASIL therapy. Rechallenge with AFLURIA was not performed. At the time of the report, patient's outcome for all the events was reported as improved. This report was considered non-serious, no conditions by the agency. Upon internal review, it was determined that Idiopathic Thrombocytopenic Purpura was an other important medical event. The original reporting source was not provided. The VAERS ID # is 455875. No further information is available.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Condition aggravated, Fatigue, Idiopathic thrombocytopenic purpura, Platelet count decreased, Thrombocytopenia
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 female patient (age unspecified) with idiopathic thrombocytopenic purpura and thrombocytopenia was vaccinated on 09-MAR-2010 with the third dose of GARDASIL, (lot # 1378Y), (site route and dose not reported). Concomitant vaccine given on the same date included a dose of AFLURIA, (Lot #, site and route not reported). This medically confirmed spontaneous report (initial receipt 09-MAY-2012) concerned a female patient 17 or 18 years of age. On 01-APR-2008 the patient received her first dose of GARDASIL (batch number: #1978U) via injection at a dose of 0.5 ml. Fairly quickly after the first dose of GARDASIL (received on 01-APR-2008), the patient developed ITP (idiopathic thrombocytopenic purpura) and was referred to children's hematology. Her ITP was thrombocytopenia. The doctor at first said that she wasn't convinced it was from (GARDASIL), but hematologist said it may have been. They went through her past medical history and saw nothing out of the ordinary. On 28-SEP-2009 the patient received her second dose of GARDASIL at a different clinic. On 09-MAR-2010 the patient received of AFLURIA (batch and manufacturer unspecified). On the same day, the patient also received her third dose of GARDASIL (batch number: #1378Y). She finished the series (of GARDASIL injections) of AFLURIA was reported as a concomitant medication. It was unspecified if other vaccines were given with previous doses of GARDASIL. The patient's platelet levels were going up and down. Her platelet levels got as low as 20 (which was her lowest), it was unspecified when this count was taken. Her platelet count went up to 114 at some point, and the last checked count was at 85. The patient became very fatigue and was followed up by hematology, but she was never hospitalized. The symptoms were still continuing. The event improved after stopping GARDASIL therapy. Rechallenge with AFLURIA was not performed. At the time of the report, patient's outcome for all the events was reported as improved. This report was considered non-serious, no conditions by the agency. Upon internal review, it was determined that Idiopathic Thrombocytopenic Purpura was an other important medical event. The original reporting source was not provided. The VAERS ID # is 455875. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blood glucose increased, Loss of consciousness, Musculoskeletal stiffness, Tremor
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 14 year old male patient with type 1 diabetes and no previous illnesses was vaccinated on 02-MAY-2012 with the first dose of GARDASIL (lot # 1860AA), I.M, in the left arm (dose not reported). Other concomitant medications included insulin. On 02-MAY-2012, vaccine was given in the left arm, intramuscularly, then the patient became stiff, had mild shaking, then loss consciousness for approx 20 to 30 seconds, then became awake, alert (blood pressure was checked), oriented and was observed in the office for 30 minutes. At the time of the report, patient's outcome for all the events was reported as recovered. This report was considered non serious, no conditions by the agency. Upon internal review, loss consciousness was considered an other important medical event. The original reporting source was not provided. The VAERS ID # is 455911. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Tremor
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 14 year old male patient with type 1 diabetes and no previous illnesses was vaccinated on 02-MAY-2012 with the first dose of GARDASIL (lot # 1860AA), I.M, in the left arm (dose not reported). Other concomitant medications included insulin. On 02-MAY-2012, vaccine was given in the left arm, intramuscularly, then the patient became stiff, had mild shaking, then loss consciousness for approx 20 to 30 seconds, then became awake, alert (blood pressure was checked), oriented and was observed in the office for 30 minutes. At the time of the report, patient's outcome for all the events was reported as recovered. This report was considered non serious, no conditions by the agency. Upon internal review, loss consciousness was considered an other important medical event. The original reporting source was not provided. The VAERS ID # is 455911. No further information is available.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL, HEPA, HPV4, TDAP, VARCEL
Symptoms: Convulsion, Hyperhidrosis, Hypotonia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old male patient who on 22-MAY-2012, was vaccinated IM in the right arm with the first dose of GARDASIL (lot# 669313/0692AA, exp 13-AUG-2013). Secondary suspect vaccines given on the same day included the second dose of VARIVAX (Merck) (lot# 670992/0822AA, exp 02-JUN-2013) given IM in the right arm, the second dose of BOOSTRIX (lot# AC52B072EA) given IM in the right arm and the first dose of HAVRIX (lot# AHAVB533CA) given IM in the left arm. It was reported that on 22-MAY-2012, after administration of the fourth vaccine, the patient became limp and lost consciousness. The patient immediately began having an upper body seizure, lasting 5-7 seconds, the patient became alert for approximately 5 seconds, then had another seizure lasting 5-7 seconds. The patient was then alert, but pale and diaphoretic. The patient was transported to the hospital via ambulance. The patient's outcome for convulsion, hyperhidrosis, hypotonia, immediate post-injection reaction, loss of consciousness and pallor were unknown. This report was considered non serious with not conditions by the agency. Upon internal review convulsion and loss of consciousness were considered to be another important medical event. The original reporting source was not provided. The VAERS ID# is 456024-1. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL, HEPA, HPV4, TDAP, VARCEL
Symptoms: Pallor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old male patient who on 22-MAY-2012, was vaccinated IM in the right arm with the first dose of GARDASIL (lot# 669313/0692AA, exp 13-AUG-2013). Secondary suspect vaccines given on the same day included the second dose of VARIVAX (Merck) (lot# 670992/0822AA, exp 02-JUN-2013) given IM in the right arm, the second dose of BOOSTRIX (lot# AC52B072EA) given IM in the right arm and the first dose of HAVRIX (lot# AHAVB533CA) given IM in the left arm. It was reported that on 22-MAY-2012, after administration of the fourth vaccine, the patient became limp and lost consciousness. The patient immediately began having an upper body seizure, lasting 5-7 seconds, the patient became alert for approximately 5 seconds, then had another seizure lasting 5-7 seconds. The patient was then alert, but pale and diaphoretic. The patient was transported to the hospital via ambulance. The patient's outcome for convulsion, hyperhidrosis, hypotonia, immediate post-injection reaction, loss of consciousness and pallor were unknown. This report was considered non serious with not conditions by the agency. Upon internal review convulsion and loss of consciousness were considered to be another important medical event. The original reporting source was not provided. The VAERS ID# is 456024-1. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Erythema, Injection site swelling, Pyrexia
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 14 years old male patient. The patient was vaccinated intramuscularly in the right arm with lot # (672232/1495AA) dose 1 of GARDASIL (dose number not reported) on 15-MAY-2012. Other suspect therapies included dose 2 of VARIVAX (lot # 1878AA) subcutaneously in the right arm (dose not reported) on 15-MAY-2012 and dose 1 of VAQTA (lot # 671897/1288AA) intramuscularly in the left arm on 15-MAY-2012. No concomitant medications were reported. On 15-MAY-2012 the patient was red had fever and swollen where the shot was given on the right deltoid and posterior right upper arm. No treatment information was reported. The patient sought medical attention. The outcome of the events was unknown. The relatedness for the reported events was not provided for GARDASIL, VAQTA and VARIVAX. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 453741. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Pain
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This report refers to a 18 years old female patient with soreness and fatigue at the time of vaccination. The patient was vaccinated in the left arm with dose 4 of GARDASIL (dose, route and lot # not reported) on 01-MAY-2009. No other co-suspects and no concomitant medications were reported. On an unknown date the patient continued to experience fatigue and soreness. No treatment information was reported. The outcome of soreness and fatigue was unknown. The relatedness for fatigue and soreness was unknown for GARDASIL. This report was considered no conditions and non serious by the agency. The original reporting source was not provided. The VAERS ID# is 456172. No further information is available.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This report refers to a 11 years old female patient with no known allergies and no previous illness who on 19-AUG-2011 was vaccinated in the left arm with (lot # 668819/0477AA) dose 2 of GARDASIL (dose and route not reported). Secondary suspect vaccine included dose 2 of VARIVAX (Lot # 671474/1381AA) subcutaneously in the right arm (dose not reported). Concomitant vaccines included: dose 2 of HAVRIX (lot # AHAVB522BA) in the right arm. On 18-MAY-2012 the patient experienced redness and swelling the size of a baseball. No treatment information was reported. The outcome of redness and swelling the size of a baseball was unknown. The relatedness for swelling the size of a baseball was not provided for GARDASIL and VARIVAX. This report was considered no conditions and non serious by the agency. The original reporting source was not provided. The VAERS ID# is 456177-1. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Constipation, Decreased appetite, Diarrhoea, Diplopia, Dizziness
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 21 years old female patient was vaccinated on left arm with the first dose GARDASIL on 14-AUG-2009. No other co-suspects were reported. No concomitant medications were reported. On 14-AUG-2009 the patient experienced Activities of daily living impaired, Alopecia, Constipation, Decreased appetite, Diarrhoea, Diplopia, Dizziness, Dyskinesia, Fatigue, Feeling abnormal, Gait disturbance, Headache, Heart rate increased, Injection site pain, Insomnia, Malaise, Muscle spasms, Muscle tightness, Nausea, Paraesthesia, Pyrexia, Thirst, Tremor, Vertigo, Vomiting, Weight decreased. The patient experience nerve jerks and insomnia for first six months and muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. The patient severally visited to emergency room (E.R.) for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, have rest, low cholesterol, low sodium, low sugar diet with lots of rest. On 01-JUN-2012 emergency room (ER) records received for DOS 9/23-28/2009 with differential diagnosis (Dx): severe GARDASIL reaction with neuro component as has been described infrequently vital signs (vs) new mental status (MS) vital signs (vs) doubt Guillain Barre Syndrome (GBS) as no further progression since last evaluation (eval), normal (nl) reflexes vs doubt stroke by physical exam (PE) and symptoms (sx). Patient complained of (c/o) feeling unwell since 09-AUG-2009 status post (s/p) vaccination. Immediately after vaccination patient complained of (c/o) vertiginous/dizzy feelings followed by fevers (resolved), fatigue, "groggy in the head", variable tingling in fingers/toes, muscle cramps & tremor, weight loss, constipation/diarrhea, hair loss, headaches, difficulty walking, double vision. Patient unable to participate in usual activities. Physical exam (PE): tremor lt hand > rt at rest. Patient returned for follow up (f/u). Labs, neuro exam unremarkable. The patient did Magnetic Resonance Imaging (MRI) and blood tests. On 01-JUN-2012 lab/diagnostic records received for DOS (23-SEP-2009 to 28-SEP-2009). MRI brain: multiple tiny foci of increased signal intensity in both hemispheres. Chest X Ray (CXR) within normal limits (WNL). The results of HIV, Antinuclear antibody (ANA), RF, monospot, pregnancy test were negative (-). Urinalysis (UA): white blood cell (WBC) 6-20 (High), RBC >50 (High), leukocyte esterase (+). Blood: white blood cell (WBC) 10.7 K/mcL (High), Plt 460 K/mcL (High), Mean platelet volume (MPV) 6.4 fL (Low), neutros 52.4% (Low), lymphs 40.8% (High), blood urea nitrogen (BUN) 7 mg/dL (Low), protein 9.1 g/dL (High). The patient required an emergency room visit and the reporter considered the events were serious. The adverse events were considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID# is 456264.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Barium enema, Gastrointestinal surgery, Haematochezia, Hypophagia, Intussusception
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. On 02-APR-2012, a 0.5 year old male with no known relevant medical history or pre-existing illness was vaccinated orally with a third dose of ROTATEQ (Lot# 671724/1543AA). Suspect therapy on the same day included a third dose of RECOMBIVAX HB given intramuscularly. Concomitant therapy on the same day given intramuscularly included a first dose of FLUZONE (Lot# UT4159AA), a third dose of PENTACEL (Lot# C3970AA) and a third dose of PREVNAR 13 (Lot# F80382). The patient experienced vomited on 10-MAY-2012, bloody stools on 10-MAY-12, left otitis media on 14-MAY-2012, bloody stools, poor oral intake on 16-MAY-2012. Open reduction of intussusception after failed barium enema. The following information was obtained through follow-up and/or provided by the government on 4-JUN-2012. Hospital records date of service from 16-MAY-2012 to 22-MAY-2012. Diagnosis: intussusception; other acute post-op pain. Concurrent condition included vomiting, bloody stool, irritable; on antibiotic for bilateral otitis media. After unsuccessful reduction by enema, the patient was taken to open reduction for laparoscopic reduction, same failed; open incision done and intussusception reduced. Hospital course included Pediatric Intensive Care Unit admission. Discharge in good condition to follow-up surgery. Primary care physician records on 07-MAY-2012: diagnosis: viral infection. Concurrent condition: fever; nasal congestion; diarrhea; vomiting; lethargy. Return to clinic on 12-MAY-2012. Diagnosis: bloody diarrhea; LOM. Concurrent condition: blood in stool; irritability. Physical examination: L TM full et opaque. Rxed medically. Return to clinic on 24-MAY-2012. Diagnosis: intussusception. Concurrent condition: follow up hospital discharge. Physical exam: head lag. Referred to neurologist. Lab diagnostic studies performed included 04-JUN-2012 CRP 17.3 mg/dL (H), albumin 1.9 g/dL (L), Ca 7.7 mg/dL (L), lipase 55 u/L (L). WBC 18.2 K/mm3 (H), neuts 14% (L), lymphs 77% (H). US abd: findings c/w ileocolic intussusception perhaps with a lymph node as lead point. KUB: solid soft tissue mass c/w intussusception in R side of abd; one short segment of bowel is markedly displaced by intussusception. Ba enema: unsuccessful hydrostatic reduction of intussusception. 6/5/12. Labs/diagnostics. ALT 47 u/L (H). Hgb 8.6 g/dL (L), hct 26% (L), plt 482 K/mm3 (H). The patient's status was not reported. The original reporting source was not provided. The VAERS ID # is 456383. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Otitis media, Ultrasound abdomen, Vomiting
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. On 02-APR-2012, a 0.5 year old male with no known relevant medical history or pre-existing illness was vaccinated orally with a third dose of ROTATEQ (Lot# 671724/1543AA). Suspect therapy on the same day included a third dose of RECOMBIVAX HB given intramuscularly. Concomitant therapy on the same day given intramuscularly included a first dose of FLUZONE (Lot# UT4159AA), a third dose of PENTACEL (Lot# C3970AA) and a third dose of PREVNAR 13 (Lot# F80382). The patient experienced vomited on 10-MAY-2012, bloody stools on 10-MAY-12, left otitis media on 14-MAY-2012, bloody stools, poor oral intake on 16-MAY-2012. Open reduction of intussusception after failed barium enema. The following information was obtained through follow-up and/or provided by the government on 4-JUN-2012. Hospital records date of service from 16-MAY-2012 to 22-MAY-2012. Diagnosis: intussusception; other acute post-op pain. Concurrent condition included vomiting, bloody stool, irritable; on antibiotic for bilateral otitis media. After unsuccessful reduction by enema, the patient was taken to open reduction for laparoscopic reduction, same failed; open incision done and intussusception reduced. Hospital course included Pediatric Intensive Care Unit admission. Discharge in good condition to follow-up surgery. Primary care physician records on 07-MAY-2012: diagnosis: viral infection. Concurrent condition: fever; nasal congestion; diarrhea; vomiting; lethargy. Return to clinic on 12-MAY-2012. Diagnosis: bloody diarrhea; LOM. Concurrent condition: blood in stool; irritability. Physical examination: L TM full et opaque. Rxed medically. Return to clinic on 24-MAY-2012. Diagnosis: intussusception. Concurrent condition: follow up hospital discharge. Physical exam: head lag. Referred to neurologist. Lab diagnostic studies performed included 04-JUN-2012 CRP 17.3 mg/dL (H), albumin 1.9 g/dL (L), Ca 7.7 mg/dL (L), lipase 55 u/L (L). WBC 18.2 K/mm3 (H), neuts 14% (L), lymphs 77% (H). US abd: findings c/w ileocolic intussusception perhaps with a lymph node as lead point. KUB: solid soft tissue mass c/w intussusception in R side of abd; one short segment of bowel is markedly displaced by intussusception. Ba enema: unsuccessful hydrostatic reduction of intussusception. 6/5/12. Labs/diagnostics. ALT 47 u/L (H). Hgb 8.6 g/dL (L), hct 26% (L), plt 482 K/mm3 (H). The patient's status was not reported. The original reporting source was not provided. The VAERS ID # is 456383. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Alanine aminotransferase increased, Alanine aminotransferase normal, Barium enema, Blood albumin decreased, Blood calcium increased
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. On 02-APR-2012, a 0.5 year old male with no known relevant medical history or pre-existing illness was vaccinated orally with a third dose of ROTATEQ (Lot# 671724/1543AA). Suspect therapy on the same day included a third dose of RECOMBIVAX HB given intramuscularly. Concomitant therapy on the same day given intramuscularly included a first dose of FLUZONE (Lot# UT4159AA), a third dose of PENTACEL (Lot# C3970AA) and a third dose of PREVNAR 13 (Lot# F80382). The patient experienced vomited on 10-MAY-2012, bloody stools on 10-MAY-12, left otitis media on 14-MAY-2012, bloody stools, poor oral intake on 16-MAY-2012. Open reduction of intussusception after failed barium enema. The following information was obtained through follow-up and/or provided by the government on 4-JUN-2012. Hospital records date of service from 16-MAY-2012 to 22-MAY-2012. Diagnosis: intussusception; other acute post-op pain. Concurrent condition included vomiting, bloody stool, irritable; on antibiotic for bilateral otitis media. After unsuccessful reduction by enema, the patient was taken to open reduction for laparoscopic reduction, same failed; open incision done and intussusception reduced. Hospital course included Pediatric Intensive Care Unit admission. Discharge in good condition to follow-up surgery. Primary care physician records on 07-MAY-2012: diagnosis: viral infection. Concurrent condition: fever; nasal congestion; diarrhea; vomiting; lethargy. Return to clinic on 12-MAY-2012. Diagnosis: bloody diarrhea; LOM. Concurrent condition: blood in stool; irritability. Physical examination: L TM full et opaque. Rxed medically. Return to clinic on 24-MAY-2012. Diagnosis: intussusception. Concurrent condition: follow up hospital discharge. Physical exam: head lag. Referred to neurologist. Lab diagnostic studies performed included 04-JUN-2012 CRP 17.3 mg/dL (H), albumin 1.9 g/dL (L), Ca 7.7 mg/dL (L), lipase 55 u/L (L). WBC 18.2 K/mm3 (H), neuts 14% (L), lymphs 77% (H). US abd: findings c/w ileocolic intussusception perhaps with a lymph node as lead point. KUB: solid soft tissue mass c/w intussusception in R side of abd; one short segment of bowel is markedly displaced by intussusception. Ba enema: unsuccessful hydrostatic reduction of intussusception. 6/5/12. Labs/diagnostics. ALT 47 u/L (H). Hgb 8.6 g/dL (L), hct 26% (L), plt 482 K/mm3 (H). The patient's status was not reported. The original reporting source was not provided. The VAERS ID # is 456383. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: C-reactive protein increased, Diarrhoea, Diarrhoea haemorrhagic, Haematochezia, Haematocrit decreased
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. On 02-APR-2012, a 0.5 year old male with no known relevant medical history or pre-existing illness was vaccinated orally with a third dose of ROTATEQ (Lot# 671724/1543AA). Suspect therapy on the same day included a third dose of RECOMBIVAX HB given intramuscularly. Concomitant therapy on the same day given intramuscularly included a first dose of FLUZONE (Lot# UT4159AA), a third dose of PENTACEL (Lot# C3970AA) and a third dose of PREVNAR 13 (Lot# F80382). The patient experienced vomited on 10-MAY-2012, bloody stools on 10-MAY-12, left otitis media on 14-MAY-2012, bloody stools, poor oral intake on 16-MAY-2012. Open reduction of intussusception after failed barium enema. The following information was obtained through follow-up and/or provided by the government on 4-JUN-2012. Hospital records date of service from 16-MAY-2012 to 22-MAY-2012. Diagnosis: intussusception; other acute post-op pain. Concurrent condition included vomiting, bloody stool, irritable; on antibiotic for bilateral otitis media. After unsuccessful reduction by enema, the patient was taken to open reduction for laparoscopic reduction, same failed; open incision done and intussusception reduced. Hospital course included Pediatric Intensive Care Unit admission. Discharge in good condition to follow-up surgery. Primary care physician records on 07-MAY-2012: diagnosis: viral infection. Concurrent condition: fever; nasal congestion; diarrhea; vomiting; lethargy. Return to clinic on 12-MAY-2012. Diagnosis: bloody diarrhea; LOM. Concurrent condition: blood in stool; irritability. Physical examination: L TM full et opaque. Rxed medically. Return to clinic on 24-MAY-2012. Diagnosis: intussusception. Concurrent condition: follow up hospital discharge. Physical exam: head lag. Referred to neurologist. Lab diagnostic studies performed included 04-JUN-2012 CRP 17.3 mg/dL (H), albumin 1.9 g/dL (L), Ca 7.7 mg/dL (L), lipase 55 u/L (L). WBC 18.2 K/mm3 (H), neuts 14% (L), lymphs 77% (H). US abd: findings c/w ileocolic intussusception perhaps with a lymph node as lead point. KUB: solid soft tissue mass c/w intussusception in R side of abd; one short segment of bowel is markedly displaced by intussusception. Ba enema: unsuccessful hydrostatic reduction of intussusception. 6/5/12. Labs/diagnostics. ALT 47 u/L (H). Hgb 8.6 g/dL (L), hct 26% (L), plt 482 K/mm3 (H). The patient's status was not reported. The original reporting source was not provided. The VAERS ID # is 456383. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Haemoglobin decreased, Head lag, Hypophagia, Intensive care, Intestinal operation
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. On 02-APR-2012, a 0.5 year old male with no known relevant medical history or pre-existing illness was vaccinated orally with a third dose of ROTATEQ (Lot# 671724/1543AA). Suspect therapy on the same day included a third dose of RECOMBIVAX HB given intramuscularly. Concomitant therapy on the same day given intramuscularly included a first dose of FLUZONE (Lot# UT4159AA), a third dose of PENTACEL (Lot# C3970AA) and a third dose of PREVNAR 13 (Lot# F80382). The patient experienced vomited on 10-MAY-2012, bloody stools on 10-MAY-12, left otitis media on 14-MAY-2012, bloody stools, poor oral intake on 16-MAY-2012. Open reduction of intussusception after failed barium enema. The following information was obtained through follow-up and/or provided by the government on 4-JUN-2012. Hospital records date of service from 16-MAY-2012 to 22-MAY-2012. Diagnosis: intussusception; other acute post-op pain. Concurrent condition included vomiting, bloody stool, irritable; on antibiotic for bilateral otitis media. After unsuccessful reduction by enema, the patient was taken to open reduction for laparoscopic reduction, same failed; open incision done and intussusception reduced. Hospital course included Pediatric Intensive Care Unit admission. Discharge in good condition to follow-up surgery. Primary care physician records on 07-MAY-2012: diagnosis: viral infection. Concurrent condition: fever; nasal congestion; diarrhea; vomiting; lethargy. Return to clinic on 12-MAY-2012. Diagnosis: bloody diarrhea; LOM. Concurrent condition: blood in stool; irritability. Physical examination: L TM full et opaque. Rxed medically. Return to clinic on 24-MAY-2012. Diagnosis: intussusception. Concurrent condition: follow up hospital discharge. Physical exam: head lag. Referred to neurologist. Lab diagnostic studies performed included 04-JUN-2012 CRP 17.3 mg/dL (H), albumin 1.9 g/dL (L), Ca 7.7 mg/dL (L), lipase 55 u/L (L). WBC 18.2 K/mm3 (H), neuts 14% (L), lymphs 77% (H). US abd: findings c/w ileocolic intussusception perhaps with a lymph node as lead point. KUB: solid soft tissue mass c/w intussusception in R side of abd; one short segment of bowel is markedly displaced by intussusception. Ba enema: unsuccessful hydrostatic reduction of intussusception. 6/5/12. Labs/diagnostics. ALT 47 u/L (H). Hgb 8.6 g/dL (L), hct 26% (L), plt 482 K/mm3 (H). The patient's status was not reported. The original reporting source was not provided. The VAERS ID # is 456383. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Intussusception, Irritability, Laparoscopic surgery, Lethargy, Lipase normal
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. On 02-APR-2012, a 0.5 year old male with no known relevant medical history or pre-existing illness was vaccinated orally with a third dose of ROTATEQ (Lot# 671724/1543AA). Suspect therapy on the same day included a third dose of RECOMBIVAX HB given intramuscularly. Concomitant therapy on the same day given intramuscularly included a first dose of FLUZONE (Lot# UT4159AA), a third dose of PENTACEL (Lot# C3970AA) and a third dose of PREVNAR 13 (Lot# F80382). The patient experienced vomited on 10-MAY-2012, bloody stools on 10-MAY-12, left otitis media on 14-MAY-2012, bloody stools, poor oral intake on 16-MAY-2012. Open reduction of intussusception after failed barium enema. The following information was obtained through follow-up and/or provided by the government on 4-JUN-2012. Hospital records date of service from 16-MAY-2012 to 22-MAY-2012. Diagnosis: intussusception; other acute post-op pain. Concurrent condition included vomiting, bloody stool, irritable; on antibiotic for bilateral otitis media. After unsuccessful reduction by enema, the patient was taken to open reduction for laparoscopic reduction, same failed; open incision done and intussusception reduced. Hospital course included Pediatric Intensive Care Unit admission. Discharge in good condition to follow-up surgery. Primary care physician records on 07-MAY-2012: diagnosis: viral infection. Concurrent condition: fever; nasal congestion; diarrhea; vomiting; lethargy. Return to clinic on 12-MAY-2012. Diagnosis: bloody diarrhea; LOM. Concurrent condition: blood in stool; irritability. Physical examination: L TM full et opaque. Rxed medically. Return to clinic on 24-MAY-2012. Diagnosis: intussusception. Concurrent condition: follow up hospital discharge. Physical exam: head lag. Referred to neurologist. Lab diagnostic studies performed included 04-JUN-2012 CRP 17.3 mg/dL (H), albumin 1.9 g/dL (L), Ca 7.7 mg/dL (L), lipase 55 u/L (L). WBC 18.2 K/mm3 (H), neuts 14% (L), lymphs 77% (H). US abd: findings c/w ileocolic intussusception perhaps with a lymph node as lead point. KUB: solid soft tissue mass c/w intussusception in R side of abd; one short segment of bowel is markedly displaced by intussusception. Ba enema: unsuccessful hydrostatic reduction of intussusception. 6/5/12. Labs/diagnostics. ALT 47 u/L (H). Hgb 8.6 g/dL (L), hct 26% (L), plt 482 K/mm3 (H). The patient's status was not reported. The original reporting source was not provided. The VAERS ID # is 456383. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Lymphocyte percentage increased, Nasal congestion, Neutrophil percentage decreased, Otitis media, Platelet count increased
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. On 02-APR-2012, a 0.5 year old male with no known relevant medical history or pre-existing illness was vaccinated orally with a third dose of ROTATEQ (Lot# 671724/1543AA). Suspect therapy on the same day included a third dose of RECOMBIVAX HB given intramuscularly. Concomitant therapy on the same day given intramuscularly included a first dose of FLUZONE (Lot# UT4159AA), a third dose of PENTACEL (Lot# C3970AA) and a third dose of PREVNAR 13 (Lot# F80382). The patient experienced vomited on 10-MAY-2012, bloody stools on 10-MAY-12, left otitis media on 14-MAY-2012, bloody stools, poor oral intake on 16-MAY-2012. Open reduction of intussusception after failed barium enema. The following information was obtained through follow-up and/or provided by the government on 4-JUN-2012. Hospital records date of service from 16-MAY-2012 to 22-MAY-2012. Diagnosis: intussusception; other acute post-op pain. Concurrent condition included vomiting, bloody stool, irritable; on antibiotic for bilateral otitis media. After unsuccessful reduction by enema, the patient was taken to open reduction for laparoscopic reduction, same failed; open incision done and intussusception reduced. Hospital course included Pediatric Intensive Care Unit admission. Discharge in good condition to follow-up surgery. Primary care physician records on 07-MAY-2012: diagnosis: viral infection. Concurrent condition: fever; nasal congestion; diarrhea; vomiting; lethargy. Return to clinic on 12-MAY-2012. Diagnosis: bloody diarrhea; LOM. Concurrent condition: blood in stool; irritability. Physical examination: L TM full et opaque. Rxed medically. Return to clinic on 24-MAY-2012. Diagnosis: intussusception. Concurrent condition: follow up hospital discharge. Physical exam: head lag. Referred to neurologist. Lab diagnostic studies performed included 04-JUN-2012 CRP 17.3 mg/dL (H), albumin 1.9 g/dL (L), Ca 7.7 mg/dL (L), lipase 55 u/L (L). WBC 18.2 K/mm3 (H), neuts 14% (L), lymphs 77% (H). US abd: findings c/w ileocolic intussusception perhaps with a lymph node as lead point. KUB: solid soft tissue mass c/w intussusception in R side of abd; one short segment of bowel is markedly displaced by intussusception. Ba enema: unsuccessful hydrostatic reduction of intussusception. 6/5/12. Labs/diagnostics. ALT 47 u/L (H). Hgb 8.6 g/dL (L), hct 26% (L), plt 482 K/mm3 (H). The patient's status was not reported. The original reporting source was not provided. The VAERS ID # is 456383. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Posture abnormal, Procedural pain, Pyrexia, Small intestinal intussusception reduction, Soft tissue disorder
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. On 02-APR-2012, a 0.5 year old male with no known relevant medical history or pre-existing illness was vaccinated orally with a third dose of ROTATEQ (Lot# 671724/1543AA). Suspect therapy on the same day included a third dose of RECOMBIVAX HB given intramuscularly. Concomitant therapy on the same day given intramuscularly included a first dose of FLUZONE (Lot# UT4159AA), a third dose of PENTACEL (Lot# C3970AA) and a third dose of PREVNAR 13 (Lot# F80382). The patient experienced vomited on 10-MAY-2012, bloody stools on 10-MAY-12, left otitis media on 14-MAY-2012, bloody stools, poor oral intake on 16-MAY-2012. Open reduction of intussusception after failed barium enema. The following information was obtained through follow-up and/or provided by the government on 4-JUN-2012. Hospital records date of service from 16-MAY-2012 to 22-MAY-2012. Diagnosis: intussusception; other acute post-op pain. Concurrent condition included vomiting, bloody stool, irritable; on antibiotic for bilateral otitis media. After unsuccessful reduction by enema, the patient was taken to open reduction for laparoscopic reduction, same failed; open incision done and intussusception reduced. Hospital course included Pediatric Intensive Care Unit admission. Discharge in good condition to follow-up surgery. Primary care physician records on 07-MAY-2012: diagnosis: viral infection. Concurrent condition: fever; nasal congestion; diarrhea; vomiting; lethargy. Return to clinic on 12-MAY-2012. Diagnosis: bloody diarrhea; LOM. Concurrent condition: blood in stool; irritability. Physical examination: L TM full et opaque. Rxed medically. Return to clinic on 24-MAY-2012. Diagnosis: intussusception. Concurrent condition: follow up hospital discharge. Physical exam: head lag. Referred to neurologist. Lab diagnostic studies performed included 04-JUN-2012 CRP 17.3 mg/dL (H), albumin 1.9 g/dL (L), Ca 7.7 mg/dL (L), lipase 55 u/L (L). WBC 18.2 K/mm3 (H), neuts 14% (L), lymphs 77% (H). US abd: findings c/w ileocolic intussusception perhaps with a lymph node as lead point. KUB: solid soft tissue mass c/w intussusception in R side of abd; one short segment of bowel is markedly displaced by intussusception. Ba enema: unsuccessful hydrostatic reduction of intussusception. 6/5/12. Labs/diagnostics. ALT 47 u/L (H). Hgb 8.6 g/dL (L), hct 26% (L), plt 482 K/mm3 (H). The patient's status was not reported. The original reporting source was not provided. The VAERS ID # is 456383. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Urinary system x-ray abnormal, Urine analysis abnormal, Viral infection, Vomiting
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. On 02-APR-2012, a 0.5 year old male with no known relevant medical history or pre-existing illness was vaccinated orally with a third dose of ROTATEQ (Lot# 671724/1543AA). Suspect therapy on the same day included a third dose of RECOMBIVAX HB given intramuscularly. Concomitant therapy on the same day given intramuscularly included a first dose of FLUZONE (Lot# UT4159AA), a third dose of PENTACEL (Lot# C3970AA) and a third dose of PREVNAR 13 (Lot# F80382). The patient experienced vomited on 10-MAY-2012, bloody stools on 10-MAY-12, left otitis media on 14-MAY-2012, bloody stools, poor oral intake on 16-MAY-2012. Open reduction of intussusception after failed barium enema. The following information was obtained through follow-up and/or provided by the government on 4-JUN-2012. Hospital records date of service from 16-MAY-2012 to 22-MAY-2012. Diagnosis: intussusception; other acute post-op pain. Concurrent condition included vomiting, bloody stool, irritable; on antibiotic for bilateral otitis media. After unsuccessful reduction by enema, the patient was taken to open reduction for laparoscopic reduction, same failed; open incision done and intussusception reduced. Hospital course included Pediatric Intensive Care Unit admission. Discharge in good condition to follow-up surgery. Primary care physician records on 07-MAY-2012: diagnosis: viral infection. Concurrent condition: fever; nasal congestion; diarrhea; vomiting; lethargy. Return to clinic on 12-MAY-2012. Diagnosis: bloody diarrhea; LOM. Concurrent condition: blood in stool; irritability. Physical examination: L TM full et opaque. Rxed medically. Return to clinic on 24-MAY-2012. Diagnosis: intussusception. Concurrent condition: follow up hospital discharge. Physical exam: head lag. Referred to neurologist. Lab diagnostic studies performed included 04-JUN-2012 CRP 17.3 mg/dL (H), albumin 1.9 g/dL (L), Ca 7.7 mg/dL (L), lipase 55 u/L (L). WBC 18.2 K/mm3 (H), neuts 14% (L), lymphs 77% (H). US abd: findings c/w ileocolic intussusception perhaps with a lymph node as lead point. KUB: solid soft tissue mass c/w intussusception in R side of abd; one short segment of bowel is markedly displaced by intussusception. Ba enema: unsuccessful hydrostatic reduction of intussusception. 6/5/12. Labs/diagnostics. ALT 47 u/L (H). Hgb 8.6 g/dL (L), hct 26% (L), plt 482 K/mm3 (H). The patient's status was not reported. The original reporting source was not provided. The VAERS ID # is 456383. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: White blood cell count increased
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. On 02-APR-2012, a 0.5 year old male with no known relevant medical history or pre-existing illness was vaccinated orally with a third dose of ROTATEQ (Lot# 671724/1543AA). Suspect therapy on the same day included a third dose of RECOMBIVAX HB given intramuscularly. Concomitant therapy on the same day given intramuscularly included a first dose of FLUZONE (Lot# UT4159AA), a third dose of PENTACEL (Lot# C3970AA) and a third dose of PREVNAR 13 (Lot# F80382). The patient experienced vomited on 10-MAY-2012, bloody stools on 10-MAY-12, left otitis media on 14-MAY-2012, bloody stools, poor oral intake on 16-MAY-2012. Open reduction of intussusception after failed barium enema. The following information was obtained through follow-up and/or provided by the government on 4-JUN-2012. Hospital records date of service from 16-MAY-2012 to 22-MAY-2012. Diagnosis: intussusception; other acute post-op pain. Concurrent condition included vomiting, bloody stool, irritable; on antibiotic for bilateral otitis media. After unsuccessful reduction by enema, the patient was taken to open reduction for laparoscopic reduction, same failed; open incision done and intussusception reduced. Hospital course included Pediatric Intensive Care Unit admission. Discharge in good condition to follow-up surgery. Primary care physician records on 07-MAY-2012: diagnosis: viral infection. Concurrent condition: fever; nasal congestion; diarrhea; vomiting; lethargy. Return to clinic on 12-MAY-2012. Diagnosis: bloody diarrhea; LOM. Concurrent condition: blood in stool; irritability. Physical examination: L TM full et opaque. Rxed medically. Return to clinic on 24-MAY-2012. Diagnosis: intussusception. Concurrent condition: follow up hospital discharge. Physical exam: head lag. Referred to neurologist. Lab diagnostic studies performed included 04-JUN-2012 CRP 17.3 mg/dL (H), albumin 1.9 g/dL (L), Ca 7.7 mg/dL (L), lipase 55 u/L (L). WBC 18.2 K/mm3 (H), neuts 14% (L), lymphs 77% (H). US abd: findings c/w ileocolic intussusception perhaps with a lymph node as lead point. KUB: solid soft tissue mass c/w intussusception in R side of abd; one short segment of bowel is markedly displaced by intussusception. Ba enema: unsuccessful hydrostatic reduction of intussusception. 6/5/12. Labs/diagnostics. ALT 47 u/L (H). Hgb 8.6 g/dL (L), hct 26% (L), plt 482 K/mm3 (H). The patient's status was not reported. The original reporting source was not provided. The VAERS ID # is 456383. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Fall, Loss of consciousness, Syncope
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 17 years old female patient with no prex illness and had previous syncope after blood drawing was vaccinated with dose 2 GARDASIL (Lot# U3712AA) by intramuscular route on 21-MAY-2012. On 21-MAY-2012, the patient was asked to sit for 20 minutes. Before 20 minutes, the patient was fainted and fell off her chair. The patient regained consciousness after few seconds. The patient had a syncope test. There were no conditions. Upon internal review, loss of consciousness was determined to be an other important medical event. The original reporting source was not provided. The VAERS ID # is 456441. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Fall, Laboratory test, Loss of consciousness, Syncope
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 17 years old female patient with no prex illness and had previous syncope after blood drawing was vaccinated with dose 2 GARDASIL (Lot# U3712AA) by intramuscular route on 21-MAY-2012. On 21-MAY-2012, the patient was asked to sit for 20 minutes. Before 20 minutes, the patient was fainted and fell off her chair. The patient regained consciousness after few seconds. The patient had a syncope test. There were no conditions. Upon internal review, loss of consciousness was determined to be an other important medical event. The original reporting source was not provided. The VAERS ID # is 456441. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Syncope
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. This spontaneous report as received from a regulatory authority refers to a 13 years old female patient with allergies to pollen, allergies to animal dander and NKDA. The patient was vaccinated IM with dose 1 GARDASIL (lot # 671994/1537AA) on right arm on 30-MAY-2012. No other co-suspects were reported. Concomitant medications included MENACTRA (lot # U3778AA, IM, dose 1, on left arm), HAVRIX (lot # AHAVB550AA, IM, dose 1, on left arm) and fexofenadine hydrochloride. On 30-MAY-2012 the patient experienced syncopal episode approximately 2 minutes after last immunisation administration, episode lasting only a few seconds, vital signs stable-BP 120/80 and pulse 84, skin warm and dry. 1 day after onset of therapy. No treatment information was reported. At the time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided.