chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.44
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash generalised, Screaming, Viral infection
Clinical narrative: Patient received the MMR vaccination, along with the chickenpox on January 31, 2008.  She awoke in the middle of the night screaming. To date, (Feb. 15, 08) she has had diarrhea.  She had small dots on her trunk for three days (Feb 1-3) then the "rash" became clustered and raised and spread over her entire body. She still has the rash as well.  She has had a low-grade fever which comes and goes the entire time.  We have been to the pediatrician office and to Hospital and they keep saying that she has a virus and dismissing her.  04/14/2008 MR received for DOS 2/17-21/2008 w/o specific D/C DX but admitted with DX: Diarrhea and Dehydration, as well as ER visit 2/14/2008 with DX: Macular Skin Rash, Viral Illness. Child presented 2/14/08 with 2 wk hx of rash which began 1 days/p MMR&V vax and diarrhea, vomiting, fever and decreased po intake.  PE (+) for mild generalized, mottled rash on trunk, legs, arms and back.  Erythematous patches noted on face.  Pt presented again 2/17/08 with above concerns as well as irritability, aggressive behavior and abdominal distention.  PE (+) for facial eczema and malar rash, as well as maculopapular erythematous rash on back and 2-3 ecchymotic lesions on the lower extremities. Neurology consult r/o seizures and encephalitis.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Fever, disseminated vesicles and erythematous crusted papules.
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: Eye swelling, Headache, Musculoskeletal stiffness, Nausea, Nervousness
Clinical narrative: 8-10 hours after vaccine - swollen left eye, headache, stiff neck, shaky, nausea, soreness left thigh.  Most symptoms relieved with Benadryl p.o.  No reaction after 1st 2 doses of vaccine (8/10/07 & 9/4/07).
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: 8-10 hours after vaccine - swollen left eye, headache, stiff neck, shaky, nausea, soreness left thigh.  Most symptoms relieved with Benadryl p.o.  No reaction after 1st 2 doses of vaccine (8/10/07 & 9/4/07).
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: N/A at this time.  Office will follow up with immunizations.
Age: 5.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient was administered Zostavax instead of Varivax.  *This would have been the patient's second dose of Varicella vaccine*.  Her first dose was on 7-14-03.
Age: 1.3
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: N/A at this time.  Office will follow up with immunizations.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Flu vaccine given 0.5ml 2/8/08.  Woke up 2/9/08 with swollen face.  No other swelling.  Illness, swelling lasted until 2:30 pm 2/9/08.  Resolved with Benadryl.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient was vaccinated with Tdap on 1/28/08.  Patient states on 2/2/08 at approximately 2:00 AM, she experienced pain, her "arm was throbbing".  Through workers compensation physician, patient was instructed to take Vicodin 1-2 for pain relief during the night and Advil 600mg during the day.  She was given exercises to stretch the muscle and ice was recommended at night for 20 minutes.  Follow up on 2/21/08.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient experienced mild outbreak of zoster-like lesions to Left breast 3 weeks after receiving vaccine.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Confusional state, Death, Demyelination, Disorientation
Clinical narrative: On 11/21 the husband noticed that patient was having confusion and forgetting little things.  The husband notified the PCP who advised him to take the patient to the hospital. Prior to this the patient was treated on 10/24/07 for pneumonia with 7 days of Avelox. On 11/5 the patient came to the clinic complaining of myalgias. This was ruled to be a viral process. On 11/16 the patient recieved the influenza vaccine in the clinic.  The morning of 11/21 the patient woke up with a headache and progressively became disoriented with muscle weakness and by 4pm that day could not talk.  Once at the hospital the patient was given steroids, antibiotics, and antifungals.  The patient improved for two days and then got progressively worse each day after that.  The patient became completely unresponsive, pupils fixed and dilated by 11/28. Patient expired on 11/28.  Diagnosis was unclear. Patient with definite demylinating process and encephalopathy, so vaccine reaction was in the differential. However some of the symptoms did start prior to receiving the vaccine.  8/26/08 Death certificate states COD as acute disseminated encephalomyelitis.    2/19/08 Reviewed hospital medical records of 11/21-11/28/2007. FINAL DX: acute disseminated encephalomyelitis; hyperlipidemia; pre-diabetes; & HTN. Records reveal patient experienced confusion, disorientation & loss of speech x 1 day   Admitted 11/21-11/28/2007 when she expired.  Exam revealed inability to speak but was able to mime; cranial nerve exam WNL, general muscle weakness w/reflexes intact.  Tx w/antibiotics, steroids, antivirals & prophylactic antiseizure meds.  Received IVIG x 2.  By hospital day #4, conditioned worsened & was unresponsive w/left side weakness.  C/S neg & antibiotics/antivirals were d/c.  Continued to deteriorate & on vent.  Family decision to withdraw tx as condition contined to worsen & pt expired.   5/2/08 Reviewed pcp medical records which included vax record that confirms as reported.  Office note of 11/16/07 was for flu shot only, no pcp note.  10/24 vs for URI s/s x approx 1 week.  Runny nose, facial tenderness, lightheadedness, cough, LBP, poor appetite.  Apouse had been ill w/viral syndrome.  CXR that day revealed patchy RUL infiltrate; CBC WNL.  10/29 visit reveals patient seen in f/u for pneumonia, dermatitis & pain in left shoulder.  She had less cough & improved appetite but was still tired.  CXR that day revealed near resolution of pneumonia.  Records also included some hospital medical records. Neurosurgery & neurology consults done.  Patient w/fever on admission.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Memory impairment, Muscular weakness, Myalgia, Mydriasis
Clinical narrative: On 11/21 the husband noticed that patient was having confusion and forgetting little things.  The husband notified the PCP who advised him to take the patient to the hospital. Prior to this the patient was treated on 10/24/07 for pneumonia with 7 days of Avelox. On 11/5 the patient came to the clinic complaining of myalgias. This was ruled to be a viral process. On 11/16 the patient recieved the influenza vaccine in the clinic.  The morning of 11/21 the patient woke up with a headache and progressively became disoriented with muscle weakness and by 4pm that day could not talk.  Once at the hospital the patient was given steroids, antibiotics, and antifungals.  The patient improved for two days and then got progressively worse each day after that.  The patient became completely unresponsive, pupils fixed and dilated by 11/28. Patient expired on 11/28.  Diagnosis was unclear. Patient with definite demylinating process and encephalopathy, so vaccine reaction was in the differential. However some of the symptoms did start prior to receiving the vaccine.  8/26/08 Death certificate states COD as acute disseminated encephalomyelitis.    2/19/08 Reviewed hospital medical records of 11/21-11/28/2007. FINAL DX: acute disseminated encephalomyelitis; hyperlipidemia; pre-diabetes; & HTN. Records reveal patient experienced confusion, disorientation & loss of speech x 1 day   Admitted 11/21-11/28/2007 when she expired.  Exam revealed inability to speak but was able to mime; cranial nerve exam WNL, general muscle weakness w/reflexes intact.  Tx w/antibiotics, steroids, antivirals & prophylactic antiseizure meds.  Received IVIG x 2.  By hospital day #4, conditioned worsened & was unresponsive w/left side weakness.  C/S neg & antibiotics/antivirals were d/c.  Continued to deteriorate & on vent.  Family decision to withdraw tx as condition contined to worsen & pt expired.   5/2/08 Reviewed pcp medical records which included vax record that confirms as reported.  Office note of 11/16/07 was for flu shot only, no pcp note.  10/24 vs for URI s/s x approx 1 week.  Runny nose, facial tenderness, lightheadedness, cough, LBP, poor appetite.  Apouse had been ill w/viral syndrome.  CXR that day revealed patchy RUL infiltrate; CBC WNL.  10/29 visit reveals patient seen in f/u for pneumonia, dermatitis & pain in left shoulder.  She had less cough & improved appetite but was still tired.  CXR that day revealed near resolution of pneumonia.  Records also included some hospital medical records. Neurosurgery & neurology consults done.  Patient w/fever on admission.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pupil fixed, Unresponsive to stimuli
Clinical narrative: On 11/21 the husband noticed that patient was having confusion and forgetting little things.  The husband notified the PCP who advised him to take the patient to the hospital. Prior to this the patient was treated on 10/24/07 for pneumonia with 7 days of Avelox. On 11/5 the patient came to the clinic complaining of myalgias. This was ruled to be a viral process. On 11/16 the patient recieved the influenza vaccine in the clinic.  The morning of 11/21 the patient woke up with a headache and progressively became disoriented with muscle weakness and by 4pm that day could not talk.  Once at the hospital the patient was given steroids, antibiotics, and antifungals.  The patient improved for two days and then got progressively worse each day after that.  The patient became completely unresponsive, pupils fixed and dilated by 11/28. Patient expired on 11/28.  Diagnosis was unclear. Patient with definite demylinating process and encephalopathy, so vaccine reaction was in the differential. However some of the symptoms did start prior to receiving the vaccine.  8/26/08 Death certificate states COD as acute disseminated encephalomyelitis.    2/19/08 Reviewed hospital medical records of 11/21-11/28/2007. FINAL DX: acute disseminated encephalomyelitis; hyperlipidemia; pre-diabetes; & HTN. Records reveal patient experienced confusion, disorientation & loss of speech x 1 day   Admitted 11/21-11/28/2007 when she expired.  Exam revealed inability to speak but was able to mime; cranial nerve exam WNL, general muscle weakness w/reflexes intact.  Tx w/antibiotics, steroids, antivirals & prophylactic antiseizure meds.  Received IVIG x 2.  By hospital day #4, conditioned worsened & was unresponsive w/left side weakness.  C/S neg & antibiotics/antivirals were d/c.  Continued to deteriorate & on vent.  Family decision to withdraw tx as condition contined to worsen & pt expired.   5/2/08 Reviewed pcp medical records which included vax record that confirms as reported.  Office note of 11/16/07 was for flu shot only, no pcp note.  10/24 vs for URI s/s x approx 1 week.  Runny nose, facial tenderness, lightheadedness, cough, LBP, poor appetite.  Apouse had been ill w/viral syndrome.  CXR that day revealed patchy RUL infiltrate; CBC WNL.  10/29 visit reveals patient seen in f/u for pneumonia, dermatitis & pain in left shoulder.  She had less cough & improved appetite but was still tired.  CXR that day revealed near resolution of pneumonia.  Records also included some hospital medical records. Neurosurgery & neurology consults done.  Patient w/fever on admission.
Age: 53.0
Sex: U
Vaccine: PPV
Symptoms: Bronchopneumonia
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with bronchopneumonia.  Vaccination took place on 10/10/07 and hospital admission was 11/21/07. According to physician, relationship to study treatment is 'Unlikely'. We would be happy to forward the Study's SAE Report Form upon request.  2/19/08 Reviewed SAE report which states pt admitted to hospital 11/21-11/26/2007 w/increased SOB & productive cough.  Tx w/antibiotics & steroids. FINAL DX: bronchopneumonia.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: The nurse misread my childs medical records and administered an unnessesary dose of MMR, polio, and DTaP boosters.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Swelling, warmth, redness where shot was given.  Persisting 5 days (so far). Slight itching ocurred also.  No treatment.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Less than 2 hours after injection, patient developed urticaria on righ thigh.  Waxed and waned.  Next morning had urticaria on right thigh, left thigh, and lower extremities.  Seen in clinic.  No signs of systemic reaction.  No recent URI, no other symoptoms at this time.
Age: 2.0
Sex: M
Vaccine: MU
Symptoms: Mumps, Mumps antibody test positive
Clinical narrative: Patient came down with the Mumps after receiving the Mumps vaccine.  I will not allow my kids to get the MMR as I believe there is a strong link to autism.  After daycare called we took him to the ER.  He was seen by several doctors and we were sent home to await results.  When we got home the county health department called and told us that we were under quarantine for 10 days.  When the test results finally came back they were positive for Mumps.  As some results of contracting the Mumps are not known until adulthood (such as sterility) we will have to wait to see if my son will be able to have children.  I consider the fact that since we will not know if he was permanently harmed by the Mumps I will consider him to be permanently disabled until it's proven otherwise.  03/17/2008 MR received from PCP including vax record, ER record and labs. Child received Mumpsvax on 4/27/2006 per parenta request for single vaccine.  Seen in ER 5/18/2006 for facial swelling with DX: L Parotiditis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: 2/14/08 102 degree fever @ 900pm/gave Tylenol. 2/15/08 100 degree fever @ 400am/gave Tylenol.  2/15/08 100.1 degree fever @ 925am/gave Tylenol.
Age: 35.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash papular, Scar, Vaccine positive rechallenge
Clinical narrative: Presented with injection site swelling and redness, and papule on chin after receiving 2nd Varicella vaccine.  She reports papular rash after 1st Varicella vaccine but did not report it. She had several papules that left scars after 1st vaccine.  No fever or generalized complaints currently.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain
Clinical narrative: Soreness at site of injection, erythema.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Intusussception, Surgery required 02-01-08, associated with administration of ROTATEQ 01-29-08. 03/03/2008 MR received from PCP including vax record and hospital surgical report and F/U. DOS 2/1-2/2008 with DX: Intussusception. Child had first OV WCC on 1/29/08 with normal exam except eczema. Seen again 2/1/08 with c/o crying and decreased appetite.  Had bloody, mucusy stool in office. Transferred to hospital for eval and tx.  Air contrast enema (+) for Intussusception but unable to fully reduce.  Pt had an Exploratory Laparotomy, confirmation of intussusception, reduction and appendectomy. D/C next day. F/U OV with PCP doing well except for facial eczema. Surgical F/U 2/25/08 doing well.
Age: 1.34
Sex: F
Vaccine: HIBV, MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Patient provided ProQuad and Varivax on same visit 8/7/07.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: Vaccination administered at 1000 hr on 11/8/07.  Patient developed fever at 2000 hr and went to Emergency Room.  Fever in ER notes at 100.3 and man complained of abdominal pain that he has had off and on for one week. He states tests done to check for appendicitis, nothing found and discharged and he was feeling better.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Rash papular, Thrombocytopenia
Clinical narrative: MOTHER STATES THAT RASH APPEARED APPROX. 2 HRS. AFTER HE RECEIVED VACCINES. RASH APPEARS ASYMMTRICAL, PINK IN COLOR, AND RAISED. RASH COVERS NECK, TORSO, ARMS, LEGS, FEET AND HANDS. DENIES ANY RESP. OR SWALLOWNIG DIFFICULTY.
Age: 18.0
Sex: F
Vaccine: HPV4, MMR, TDAP
Symptoms: Chills, Pyrexia, Skin warm
Clinical narrative: 102 degree fever, chills, skin felt like it was "on fire", lasted 2-3 days.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Barium enema, Colectomy, Intestinal anastomosis, Intussusception, Surgery
Clinical narrative: Rotatec given at 2month visit at PMD  4/1/08 Reviewed hospital medical records of 2/14-2/19/2008. FINAL DX: gangrenous ileocolic, colocolic compound intussusception; laparotomy; right hemicolectomy w/ileocolic anastomosis. Records reveal patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output & rectal bleeding x 1 day.  Seen at outlying ER where US of abdomen confirmed IS.  Transferred to higher level of care.  Hydrostatic reduction was unsuccessful & taken to OR.  Surgical findings included compound ileocolic, colocolic IS involving entire large bowel to level of sigmoid colon.  Unable to manually reduce & terminal ileum & ascending colon were resected.  Patient admitted to PICU post operatively.  Progressed well & d/c to home w/surgery clinic f/u.  5/23/08 Reviewed ER medical records of 2/14/2008.   FINAL DX: Intussusception Records reveal patient experienced rectal bleeding, vomiting, lethargy & abdominal mass.  Transferred to higher level of care.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Colectomy, Intussusception, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Rotatec given at 2month visit at PMD  4/1/08 Reviewed hospital medical records of 2/14-2/19/2008. FINAL DX: gangrenous ileocolic, colocolic compound intussusception; laparotomy; right hemicolectomy w/ileocolic anastomosis. Records reveal patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output & rectal bleeding x 1 day.  Seen at outlying ER where US of abdomen confirmed IS.  Transferred to higher level of care.  Hydrostatic reduction was unsuccessful & taken to OR.  Surgical findings included compound ileocolic, colocolic IS involving entire large bowel to level of sigmoid colon.  Unable to manually reduce & terminal ileum & ascending colon were resected.  Patient admitted to PICU post operatively.  Progressed well & d/c to home w/surgery clinic f/u.  5/23/08 Reviewed ER medical records of 2/14/2008.   FINAL DX: Intussusception Records reveal patient experienced rectal bleeding, vomiting, lethargy & abdominal mass.  Transferred to higher level of care.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Gastrointestinal oedema, Intussusception, Rectal haemorrhage, Surgery, Ultrasound scan abnormal
Clinical narrative: Rotatec given at 2month visit at PMD  4/1/08 Reviewed hospital medical records of 2/14-2/19/2008. FINAL DX: gangrenous ileocolic, colocolic compound intussusception; laparotomy; right hemicolectomy w/ileocolic anastomosis. Records reveal patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output & rectal bleeding x 1 day.  Seen at outlying ER where US of abdomen confirmed IS.  Transferred to higher level of care.  Hydrostatic reduction was unsuccessful & taken to OR.  Surgical findings included compound ileocolic, colocolic IS involving entire large bowel to level of sigmoid colon.  Unable to manually reduce & terminal ileum & ascending colon were resected.  Patient admitted to PICU post operatively.  Progressed well & d/c to home w/surgery clinic f/u.  5/23/08 Reviewed ER medical records of 2/14/2008.   FINAL DX: Intussusception Records reveal patient experienced rectal bleeding, vomiting, lethargy & abdominal mass.  Transferred to higher level of care.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Abdominal pain, Barium enema abnormal, Blood culture
Clinical narrative: Rotatec given at 2month visit at PMD  4/1/08 Reviewed hospital medical records of 2/14-2/19/2008. FINAL DX: gangrenous ileocolic, colocolic compound intussusception; laparotomy; right hemicolectomy w/ileocolic anastomosis. Records reveal patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output & rectal bleeding x 1 day.  Seen at outlying ER where US of abdomen confirmed IS.  Transferred to higher level of care.  Hydrostatic reduction was unsuccessful & taken to OR.  Surgical findings included compound ileocolic, colocolic IS involving entire large bowel to level of sigmoid colon.  Unable to manually reduce & terminal ileum & ascending colon were resected.  Patient admitted to PICU post operatively.  Progressed well & d/c to home w/surgery clinic f/u.  5/23/08 Reviewed ER medical records of 2/14/2008.   FINAL DX: Intussusception Records reveal patient experienced rectal bleeding, vomiting, lethargy & abdominal mass.  Transferred to higher level of care.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood test normal, Colectomy, Crying, Diet refusal, Enema administration
Clinical narrative: Rotatec given at 2month visit at PMD  4/1/08 Reviewed hospital medical records of 2/14-2/19/2008. FINAL DX: gangrenous ileocolic, colocolic compound intussusception; laparotomy; right hemicolectomy w/ileocolic anastomosis. Records reveal patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output & rectal bleeding x 1 day.  Seen at outlying ER where US of abdomen confirmed IS.  Transferred to higher level of care.  Hydrostatic reduction was unsuccessful & taken to OR.  Surgical findings included compound ileocolic, colocolic IS involving entire large bowel to level of sigmoid colon.  Unable to manually reduce & terminal ileum & ascending colon were resected.  Patient admitted to PICU post operatively.  Progressed well & d/c to home w/surgery clinic f/u.  5/23/08 Reviewed ER medical records of 2/14/2008.   FINAL DX: Intussusception Records reveal patient experienced rectal bleeding, vomiting, lethargy & abdominal mass.  Transferred to higher level of care.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Full blood count normal, Intestinal anastomosis, Intestinal gangrene, Intestinal resection, Intussusception
Clinical narrative: Rotatec given at 2month visit at PMD  4/1/08 Reviewed hospital medical records of 2/14-2/19/2008. FINAL DX: gangrenous ileocolic, colocolic compound intussusception; laparotomy; right hemicolectomy w/ileocolic anastomosis. Records reveal patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output & rectal bleeding x 1 day.  Seen at outlying ER where US of abdomen confirmed IS.  Transferred to higher level of care.  Hydrostatic reduction was unsuccessful & taken to OR.  Surgical findings included compound ileocolic, colocolic IS involving entire large bowel to level of sigmoid colon.  Unable to manually reduce & terminal ileum & ascending colon were resected.  Patient admitted to PICU post operatively.  Progressed well & d/c to home w/surgery clinic f/u.  5/23/08 Reviewed ER medical records of 2/14/2008.   FINAL DX: Intussusception Records reveal patient experienced rectal bleeding, vomiting, lethargy & abdominal mass.  Transferred to higher level of care.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Laparotomy, Large intestinal obstruction reduction, Lethargy, Rectal haemorrhage, Surgery
Clinical narrative: Rotatec given at 2month visit at PMD  4/1/08 Reviewed hospital medical records of 2/14-2/19/2008. FINAL DX: gangrenous ileocolic, colocolic compound intussusception; laparotomy; right hemicolectomy w/ileocolic anastomosis. Records reveal patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output & rectal bleeding x 1 day.  Seen at outlying ER where US of abdomen confirmed IS.  Transferred to higher level of care.  Hydrostatic reduction was unsuccessful & taken to OR.  Surgical findings included compound ileocolic, colocolic IS involving entire large bowel to level of sigmoid colon.  Unable to manually reduce & terminal ileum & ascending colon were resected.  Patient admitted to PICU post operatively.  Progressed well & d/c to home w/surgery clinic f/u.  5/23/08 Reviewed ER medical records of 2/14/2008.   FINAL DX: Intussusception Records reveal patient experienced rectal bleeding, vomiting, lethargy & abdominal mass.  Transferred to higher level of care.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Urine output decreased, Vomiting, X-ray abnormal
Clinical narrative: Rotatec given at 2month visit at PMD  4/1/08 Reviewed hospital medical records of 2/14-2/19/2008. FINAL DX: gangrenous ileocolic, colocolic compound intussusception; laparotomy; right hemicolectomy w/ileocolic anastomosis. Records reveal patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output & rectal bleeding x 1 day.  Seen at outlying ER where US of abdomen confirmed IS.  Transferred to higher level of care.  Hydrostatic reduction was unsuccessful & taken to OR.  Surgical findings included compound ileocolic, colocolic IS involving entire large bowel to level of sigmoid colon.  Unable to manually reduce & terminal ileum & ascending colon were resected.  Patient admitted to PICU post operatively.  Progressed well & d/c to home w/surgery clinic f/u.  5/23/08 Reviewed ER medical records of 2/14/2008.   FINAL DX: Intussusception Records reveal patient experienced rectal bleeding, vomiting, lethargy & abdominal mass.  Transferred to higher level of care.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Blister, Erythema, Oedema peripheral
Clinical narrative: Mother called to report that L arm was red and swollen with blisters.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 days after Varivax and Gardasil vaccine, had redness and swelling to Varivax site.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, VARCEL
Symptoms: Body temperature increased, Induration, Rash erythematous, Skin discolouration
Clinical narrative: Temp 100.9 for 4 hours on 2/14/08, 12cm heterogeneous pink, slightly indurated area on left leg.  3cm erythematous area on right leg.  Temp 98.0 oral on 2/15/08 in office.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site dryness, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema at injection site for 1 week, then dry scaling (approximately 15cm).
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh with 17 1/2cm x 18 1/2cm swelling and erythema surrounding injection site, warm and indurated.  No fluxuence noted.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm at site became swollen with induration, red, hot and itchy.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Patient has Urticari Form Rash over the lower extremities and lower abdominal area.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Swelling face, Wheezing
Clinical narrative: Following immunizations, patient vomited.  On way home started with swollen, red face, eye lids, hands and feet and wheezing.  Stopped at urgent care at 14:10.  Benadryl 25mg PO and Epinephrine 1:1000 administered 14:15.  Swelling was resolved 14:25, wheezing resolved 14:30, vital signs stable at 14:50.  Sent home with Benadryl 25mg every 6 hours for 24 hours.  Follow up if symptoms return.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 4th of 5 scheduled Rabies Immunizations given 02/12/08 at 1611. Approx 2000 on 02/13/08 donor noticed area of injection slightly firm, red, warm. No other complaints reported. Denies any pain or other complaints. Came to plasma center on 02/14/08 to donate plasma and reported symptoms. 2 "diameter area of red warm, slightly firm.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm at site became swollen with induration, red, hot and itchy.  Symptoms resolved in 2 days.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Chest X-ray abnormal, Cough, Dehydration, Diarrhoea, Dyspnoea
Clinical narrative: A serious post-marketed study report of severe dehydration with anion gap metabolic acidosis and pneumonia was received from a physician concerning a four-year-old male subject.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The subject has a past medical history significant for congenital glaucoma, cataracts of both eyes, and adrenal insufficiency at nine months of age to exogenous steroid administration for management of glaucoma.  Past medical history is significant for four prior hospitalizations for similar symptoms described below.  Exposure history is significant that the subject attends daycare with exposure to other ill children.  Also subject's mother and 18-month-old brother both had a recent upper respiratory tract illness.  There was no information on concomitant medications.  The subject received FluMist on 29-Nov-2007.  On 10-Dec-2007, the subject developed cough, congestion, and runny nose with occasional emesis and shortness of breath.  On 22-Dec-2007, the subject had increased non-bilious and non-bloody emesis, diarrhea, and fever.  The subject was seen at the urgent care clinic on 24-Dec-2007 and was diagnosed with right middle lobe pneumonia and started on Azithromycin.  Because of continued symptoms with fever and decreased oral intake and urine output, the subject was reevaluated in the emergency room on 25-Dec-2007.  Physical exam was notable for dry mucous membranes and capillary refill of two-three seconds.  His breath sounds were clear without rales, wheeze or decreased breath sounds.  Chest X-ray was consistent with right middle lobe atelectasis versus pneumonia.  His white blood cell count was 13.8 with 76 percent neutrophils.  The subject had a significant anion gap (metabolic acidosis), and negative rapid tests for RSV, influenza, and rotavirus.  The subject received normal saline bolus, a dose of Rocephin, and was admitted for intravenous hydration and observation.  The subject had an unremarkable hospital course, was able to tolerate food without emesis or diarrhea, and was discharged the following day, 26-Dec-2007.  The subject was discharged on Azithromycin and topical drugs for his glaucoma.  The discharge diagnoses were severe dehydration with anion gap metabolic acidosis, and pneumonia.  No further details of the outcome for the events were provided by the reporter.  Rechallenge is not applicable to this adverse event.  The reporting physician assessed the events as not related to FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Exposure to communicable disease, Influenza serology negative, Metabolic acidosis, Mucosal dryness, Neutrophil percentage increased
Clinical narrative: A serious post-marketed study report of severe dehydration with anion gap metabolic acidosis and pneumonia was received from a physician concerning a four-year-old male subject.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The subject has a past medical history significant for congenital glaucoma, cataracts of both eyes, and adrenal insufficiency at nine months of age to exogenous steroid administration for management of glaucoma.  Past medical history is significant for four prior hospitalizations for similar symptoms described below.  Exposure history is significant that the subject attends daycare with exposure to other ill children.  Also subject's mother and 18-month-old brother both had a recent upper respiratory tract illness.  There was no information on concomitant medications.  The subject received FluMist on 29-Nov-2007.  On 10-Dec-2007, the subject developed cough, congestion, and runny nose with occasional emesis and shortness of breath.  On 22-Dec-2007, the subject had increased non-bilious and non-bloody emesis, diarrhea, and fever.  The subject was seen at the urgent care clinic on 24-Dec-2007 and was diagnosed with right middle lobe pneumonia and started on Azithromycin.  Because of continued symptoms with fever and decreased oral intake and urine output, the subject was reevaluated in the emergency room on 25-Dec-2007.  Physical exam was notable for dry mucous membranes and capillary refill of two-three seconds.  His breath sounds were clear without rales, wheeze or decreased breath sounds.  Chest X-ray was consistent with right middle lobe atelectasis versus pneumonia.  His white blood cell count was 13.8 with 76 percent neutrophils.  The subject had a significant anion gap (metabolic acidosis), and negative rapid tests for RSV, influenza, and rotavirus.  The subject received normal saline bolus, a dose of Rocephin, and was admitted for intravenous hydration and observation.  The subject had an unremarkable hospital course, was able to tolerate food without emesis or diarrhea, and was discharged the following day, 26-Dec-2007.  The subject was discharged on Azithromycin and topical drugs for his glaucoma.  The discharge diagnoses were severe dehydration with anion gap metabolic acidosis, and pneumonia.  No further details of the outcome for the events were provided by the reporter.  Rechallenge is not applicable to this adverse event.  The reporting physician assessed the events as not related to FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Oral intake reduced, Pneumonia, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: A serious post-marketed study report of severe dehydration with anion gap metabolic acidosis and pneumonia was received from a physician concerning a four-year-old male subject.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The subject has a past medical history significant for congenital glaucoma, cataracts of both eyes, and adrenal insufficiency at nine months of age to exogenous steroid administration for management of glaucoma.  Past medical history is significant for four prior hospitalizations for similar symptoms described below.  Exposure history is significant that the subject attends daycare with exposure to other ill children.  Also subject's mother and 18-month-old brother both had a recent upper respiratory tract illness.  There was no information on concomitant medications.  The subject received FluMist on 29-Nov-2007.  On 10-Dec-2007, the subject developed cough, congestion, and runny nose with occasional emesis and shortness of breath.  On 22-Dec-2007, the subject had increased non-bilious and non-bloody emesis, diarrhea, and fever.  The subject was seen at the urgent care clinic on 24-Dec-2007 and was diagnosed with right middle lobe pneumonia and started on Azithromycin.  Because of continued symptoms with fever and decreased oral intake and urine output, the subject was reevaluated in the emergency room on 25-Dec-2007.  Physical exam was notable for dry mucous membranes and capillary refill of two-three seconds.  His breath sounds were clear without rales, wheeze or decreased breath sounds.  Chest X-ray was consistent with right middle lobe atelectasis versus pneumonia.  His white blood cell count was 13.8 with 76 percent neutrophils.  The subject had a significant anion gap (metabolic acidosis), and negative rapid tests for RSV, influenza, and rotavirus.  The subject received normal saline bolus, a dose of Rocephin, and was admitted for intravenous hydration and observation.  The subject had an unremarkable hospital course, was able to tolerate food without emesis or diarrhea, and was discharged the following day, 26-Dec-2007.  The subject was discharged on Azithromycin and topical drugs for his glaucoma.  The discharge diagnoses were severe dehydration with anion gap metabolic acidosis, and pneumonia.  No further details of the outcome for the events were provided by the reporter.  Rechallenge is not applicable to this adverse event.  The reporting physician assessed the events as not related to FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Rotavirus test negative, Urine output decreased, Virus serology test, Vomiting, White blood cell count increased
Clinical narrative: A serious post-marketed study report of severe dehydration with anion gap metabolic acidosis and pneumonia was received from a physician concerning a four-year-old male subject.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The subject has a past medical history significant for congenital glaucoma, cataracts of both eyes, and adrenal insufficiency at nine months of age to exogenous steroid administration for management of glaucoma.  Past medical history is significant for four prior hospitalizations for similar symptoms described below.  Exposure history is significant that the subject attends daycare with exposure to other ill children.  Also subject's mother and 18-month-old brother both had a recent upper respiratory tract illness.  There was no information on concomitant medications.  The subject received FluMist on 29-Nov-2007.  On 10-Dec-2007, the subject developed cough, congestion, and runny nose with occasional emesis and shortness of breath.  On 22-Dec-2007, the subject had increased non-bilious and non-bloody emesis, diarrhea, and fever.  The subject was seen at the urgent care clinic on 24-Dec-2007 and was diagnosed with right middle lobe pneumonia and started on Azithromycin.  Because of continued symptoms with fever and decreased oral intake and urine output, the subject was reevaluated in the emergency room on 25-Dec-2007.  Physical exam was notable for dry mucous membranes and capillary refill of two-three seconds.  His breath sounds were clear without rales, wheeze or decreased breath sounds.  Chest X-ray was consistent with right middle lobe atelectasis versus pneumonia.  His white blood cell count was 13.8 with 76 percent neutrophils.  The subject had a significant anion gap (metabolic acidosis), and negative rapid tests for RSV, influenza, and rotavirus.  The subject received normal saline bolus, a dose of Rocephin, and was admitted for intravenous hydration and observation.  The subject had an unremarkable hospital course, was able to tolerate food without emesis or diarrhea, and was discharged the following day, 26-Dec-2007.  The subject was discharged on Azithromycin and topical drugs for his glaucoma.  The discharge diagnoses were severe dehydration with anion gap metabolic acidosis, and pneumonia.  No further details of the outcome for the events were provided by the reporter.  Rechallenge is not applicable to this adverse event.  The reporting physician assessed the events as not related to FluMist.
Age: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FluMist administered was received from a nurse concerning a four-year-old unreported gender.  This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical or drug history was reported.  The patient received FluMist on 02-Jan-2008.  The product had an expiration date of 27-Dec-2007.  Follow-up twelve days after the FluMist dosing, the child had not experienced any adverse event.  A follow-up call to the reporter on 22-Apr-2008 confirmed that the patient did not experience any adverse events. The event was resolved. The reporter did not provide a causality assessment.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received on 22-APR-2008 and incorporated in above narrative: reporter confirmed patient had no adverse event.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired dose administered has been received from a nurse concerning a child of unknown age. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 11-Jan-2008. The FluMist that was administered on 11-Jan-2008, had expired the day prior to administration on 10-Jan-2008. No adverse events were reported at the time of the report. No adverse events were reported when the office was contacted on 08-Feb-2008. The Office Manager stated that the expired FluMist was given because the nurse did not check the expiration date prior to administration. The event is considered resolved. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to MEDI-0006413, the other case submitted by the same reporter.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious event of expired product administered was received from a nurse concerning a four-year-old male coincident with FluMist therapy.  This case is submitted in accordance with MedImmune post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical or drug history was provided.  FluMist was administered on 10-Jan-2008.  The FluMist expired ten days earlier on 31-Dec-2007.  Follow-up twelve days later revealed that the patient experienced no ill effects post exposure to the expired FluMist.  No additional dosing is indicated.  The reporter did not provide a causality assessment.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A nonserious report of expire dose of vaccine administered has been received from a nurse concerning a four year-old female patient.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history no concomitant medications were provided.  The patient received FluMist on 24-Jan-2008.  The FluMist had expired on 10-Jan-2008.  At the time of the report, no adverse events were reported from this error.  Rechallenge is not applicable.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired dose administered has been received from a nurse concerning a child of unknown age and gender. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 11-Jan-2008. The dose of vaccine that the patient received on 11-Jan-2008 had an expiration date of 10-Jan-2008. No events were reported at the time of the report. Upon follow-up, the Office Manager reported that no adverse events had developed as of 08-Feb-2008. The event resolved. The patient did not experience any rechallenge while receiving the suspect product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received 08-Feb-2008 and incorporated into the narrative no adverse events had been reported. This case is limited to MEDI-0006394, the other case from the same reporter.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Pallor, Pruritus, Rash macular
Clinical narrative: 2 DAYS AFTER ADMINISTRATION OF ANTHRAX. PT HAD AN ONSET OF A RASH. PT WENT TO MEDICAL CENTER. RASH WAS FINE MACULAR W/ POSITIVE BLANCHING TO TORSO, NECK, AND FACE. POSITIVE PRURITIC. PT WAS TREATED W/ PREDNISONE 40 MG DAILY X 4 DAYS, ZANTAC 150  BID X 10-14 DAYS, GIVEN BENADRYL 25 PRN, SIQ X 24HRS
Age: 0.53
Sex: M
Vaccine: HBHEPB
Symptoms: Diet refusal, Emotional distress, Pyrexia, Screaming
Clinical narrative: Approximately 5 hours after Comvax vaccine adimistered, patient began screaming, inconsolable, for 3.5 hours.  He had moments of fever throughout, although it fluctuated between normal and elevated, the highest temp being 99 degrees.  He refused to nurse throughout and his voice became hoarse.  Tylenol was given about 2 hours into screaming; no other treatment given.  After 3.5 hours, patient was willing to nurse and subsequently fell asleep.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Dysuria, Micturition urgency, Pyrexia
Clinical narrative: Chills, Fever and extreme pain in urination with very little coming out for 4 or 5 days. Much higher Urinary Urgency this week than last week afer taking Zostavax Vaccine at Medical Center - Shingles Vaccine. Stop taking aspirin for the heart after 2nd day. Started Tylenol.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site streaking, Oedema peripheral, Pain in extremity, Rash erythematous
Clinical narrative: After second pneumonia shot, arm quickly became almost too sore to use.  By next day, arm swollen and had a red rash, looked like cellulitis, streaking down from injection site.  Was treated at urgent care for cellulitis and started on antibiotics.  Symptoms almost disappeared after two more days.  Antibiotics were discontinued after urgent care staff concluded it was not cellulitis.