chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Intussusception, Ultrasound scan abnormal
Clinical narrative: Our son has been having severe bowel cramping ever since the first dose of the rotavirus vaccine RotaTeq.  He has suffered from abdominal cramping, severe crying spells, problems passing bowel movements, decreased appetite, fussiness, and loss of sleep.  After having the second dose of the vaccine, his symptoms worsened until he finally developed intussuception.  The day he developed this adverse reaction he began the morning with his usual fussiness.  He hadn't slept well the night before and was having trouble being held and bending in the middle.  As I tried to give him his morning feeding, he persistantly refused to nurse and became more and more fussy.  He arched his back and his stomach became hard.  He began screaming out in pain and essentially foaming at the mouth. Following a severe screaming and crying spell, he went into shock.  His skin became cool and clammy and he went limp in my arms. We called the pediatrician and they told us to take a rectal temperature.  While taking a rectal tempature he passed a large bowel movement containing jelly-like blood clots.  We rushed him to the emeregency room where he began to wheeze and vomit up bile.  They took an X-ray of his abdomin, and followed up the X-ray with an ultrasound.  The ultrasound confirmed the bowel telescoping.  They did an air contrast enema to reduce the obstruction and then kept him in the hospital for the next two days for monitoring.  When we met with our pediatrician following the intussuception, he didn't mention that it could be related to the rotavirus vaccine.  He went ahead and administered the third dose of the vaccine about a month after our son's hospitalization.  Since the third dose of the vaccine, we have been back to the emergency room with the same symptoms, but the bowel twisting has resolved itself without further medical enemas.   3/23/07 Received ER medical records which reveal patient experienced nasal congestion, pulling at left ear & irritability for approx 3 days prior to being seen in ER on 3/18/07.  Exam revealed reddened left TM. PMH: s/p IS 3 wks ago. FINAL DX: left otitis media. 4/13/07 Received medical records from treating hospital which reveals patient experienced jaw clenching, diaphoresis, screaming, pallor, gen fussiness & bloody stools.  In ER had bilious vomiting.  Held overnight s/p IS reduction by enema.  Progressed well & d/c to home. FINAL DX: Intussusception, reduced by air contrast enema.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: R Deltoid red and swollen.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Dyspnoea, Visual disturbance
Clinical narrative: less than 4 hours aftoer vaccine developed shortness of breath whihch was still on going on the 22nd but much less.  Also lightheaded ness and vision out of focus with in foru hours after vaccie and lasting 36 hours  Gave Prednisone 40mg on 3/22 for SOB as patient also has hisotry of asthma, patient to foolowup if anny changes occur
Age: 0.13
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Breast feeding, Faeces discoloured, Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Patient developed green, mucousy, bloody stools the night after receiving her first dose of Rotateq.  She continued to have such stools for 3 days.  Throughout this course she did not have fever, diarrhea, vomiting, or severe abdominal pain.  She came into the office on the second day and the stool was tested and was heme positive.  As the patient was exclusively breastfeeding, we asked mom to eliminated milk, soy, and wheat from her diet for presumptive allergic colitis.  No other interventions were performed.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Disturbance in attention, Dizziness, Headache
Clinical narrative: Pt reported that approximately 24hrs after receiving the vaccinations she had a headache, dizziness.  Went home, took shower, slept through the night.  The next day she didn't remember much of the previous day.  Feels she continues to have trouble absorbing subjects at school.  Feels she is gradually getting better.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Injection site pain, Oedema peripheral
Clinical narrative: Pt.'s arm is red/swollen, hard, painful to touch where vaccine was administered.  Pt. now running a temperature.  The redness is spreading.  Dr. has yet to review the pt.  Unknown outcome at this time.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Blood calcium decreased, Blood calcium normal, Blood culture negative, CSF culture negative, CSF test normal
Clinical narrative: Ten days after Proquad vaccination given, patient suffered a prolonged generalized seizure of 40-45 minutes in length that occurred 3-4 hours after development of fever to 101. Fever in ED while seizure was in progress was noted to be 103. He was given 3 doses of IV Ativan after which the seizure stopped. He was considered to have status epilepticus and started on phospenytoin. He also had URI symptoms with clear nasal discharge 2-3 days prior to this febrile episode. Subsequently was noted to have otitis media and cough. MRI of the brain was unremarkable. He is no longer on seizure medication and is back to normal.  04/12/2007 MR received for a 1 night hospitalization 03/8-9/2007 for report of new onset seizure activity and continued seizure activity during ER visit. Total seizure time 40-45 minutes. Temp in the ER was 103.6'F Rectal.   Txd with Ativan, Tylenol, and phosphenytoin with resolution of seizures.  Discharged home the next day. Discharge DX:  Status Epilepticus, presumed due to complex febrile seizure. 2' DX: Febrile illness, possibly a consequence of recent ProQuad Vaccination vs. acute viral URI.  Suspected viral URI.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Chest X-ray normal, Convulsion, Cough, Full blood count, Gram stain negative
Clinical narrative: Ten days after Proquad vaccination given, patient suffered a prolonged generalized seizure of 40-45 minutes in length that occurred 3-4 hours after development of fever to 101. Fever in ED while seizure was in progress was noted to be 103. He was given 3 doses of IV Ativan after which the seizure stopped. He was considered to have status epilepticus and started on phospenytoin. He also had URI symptoms with clear nasal discharge 2-3 days prior to this febrile episode. Subsequently was noted to have otitis media and cough. MRI of the brain was unremarkable. He is no longer on seizure medication and is back to normal.  04/12/2007 MR received for a 1 night hospitalization 03/8-9/2007 for report of new onset seizure activity and continued seizure activity during ER visit. Total seizure time 40-45 minutes. Temp in the ER was 103.6'F Rectal.   Txd with Ativan, Tylenol, and phosphenytoin with resolution of seizures.  Discharged home the next day. Discharge DX:  Status Epilepticus, presumed due to complex febrile seizure. 2' DX: Febrile illness, possibly a consequence of recent ProQuad Vaccination vs. acute viral URI.  Suspected viral URI.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Lymphocyte count, Metabolic function test normal, Neutrophil count, Nuclear magnetic resonance imaging brain normal, Otitis media
Clinical narrative: Ten days after Proquad vaccination given, patient suffered a prolonged generalized seizure of 40-45 minutes in length that occurred 3-4 hours after development of fever to 101. Fever in ED while seizure was in progress was noted to be 103. He was given 3 doses of IV Ativan after which the seizure stopped. He was considered to have status epilepticus and started on phospenytoin. He also had URI symptoms with clear nasal discharge 2-3 days prior to this febrile episode. Subsequently was noted to have otitis media and cough. MRI of the brain was unremarkable. He is no longer on seizure medication and is back to normal.  04/12/2007 MR received for a 1 night hospitalization 03/8-9/2007 for report of new onset seizure activity and continued seizure activity during ER visit. Total seizure time 40-45 minutes. Temp in the ER was 103.6'F Rectal.   Txd with Ativan, Tylenol, and phosphenytoin with resolution of seizures.  Discharged home the next day. Discharge DX:  Status Epilepticus, presumed due to complex febrile seizure. 2' DX: Febrile illness, possibly a consequence of recent ProQuad Vaccination vs. acute viral URI.  Suspected viral URI.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rhinorrhoea, Status epilepticus, Upper respiratory tract infection, Urine analysis normal
Clinical narrative: Ten days after Proquad vaccination given, patient suffered a prolonged generalized seizure of 40-45 minutes in length that occurred 3-4 hours after development of fever to 101. Fever in ED while seizure was in progress was noted to be 103. He was given 3 doses of IV Ativan after which the seizure stopped. He was considered to have status epilepticus and started on phospenytoin. He also had URI symptoms with clear nasal discharge 2-3 days prior to this febrile episode. Subsequently was noted to have otitis media and cough. MRI of the brain was unremarkable. He is no longer on seizure medication and is back to normal.  04/12/2007 MR received for a 1 night hospitalization 03/8-9/2007 for report of new onset seizure activity and continued seizure activity during ER visit. Total seizure time 40-45 minutes. Temp in the ER was 103.6'F Rectal.   Txd with Ativan, Tylenol, and phosphenytoin with resolution of seizures.  Discharged home the next day. Discharge DX:  Status Epilepticus, presumed due to complex febrile seizure. 2' DX: Febrile illness, possibly a consequence of recent ProQuad Vaccination vs. acute viral URI.  Suspected viral URI.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: White blood cell count
Clinical narrative: Ten days after Proquad vaccination given, patient suffered a prolonged generalized seizure of 40-45 minutes in length that occurred 3-4 hours after development of fever to 101. Fever in ED while seizure was in progress was noted to be 103. He was given 3 doses of IV Ativan after which the seizure stopped. He was considered to have status epilepticus and started on phospenytoin. He also had URI symptoms with clear nasal discharge 2-3 days prior to this febrile episode. Subsequently was noted to have otitis media and cough. MRI of the brain was unremarkable. He is no longer on seizure medication and is back to normal.  04/12/2007 MR received for a 1 night hospitalization 03/8-9/2007 for report of new onset seizure activity and continued seizure activity during ER visit. Total seizure time 40-45 minutes. Temp in the ER was 103.6'F Rectal.   Txd with Ativan, Tylenol, and phosphenytoin with resolution of seizures.  Discharged home the next day. Discharge DX:  Status Epilepticus, presumed due to complex febrile seizure. 2' DX: Febrile illness, possibly a consequence of recent ProQuad Vaccination vs. acute viral URI.  Suspected viral URI.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Blood test, CSF test, Connective tissue disorder, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Guillain-Barre Syndrome, neuromuscular/connective/soft tissue complaints c/o muscle weakness. Flu like sx prior to muscle weakness and numbness and tingling 6/20/07-records received from facility for DOS 3/10-3/27/07- DC DX: Guillain-Barre Syndrome. Chief complaint loss of sensation and motor function in extremities. Inability to ejaculate. Presented to hospital on 3/9/07- with 2-3 day complaint of numbness in hands and feet as well as difficulty ambulating. Prior to this he had several weeks of prodromal illness including nausea, headache and fever. On 2/12/07-Fever up to 104 degrees for 1 week. Complained of night sweats, headaches, emesis and nonproductive cough. 3/1/07-complaint of pain in shoulders and hips. Continued to complain of headaches. 3-4 days before admission began having tingling in hands and feet. followed by tingling in groin and perineal region. Decreased sensation while defecating and inability to tell when voiding was complete. PE: decreased distal reflexes in lower extremities. Very mild improvement since treatment with IVG. Requires long term rehabilitation.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Muscular weakness, Neuromyopathy, Paraesthesia, Soft tissue disorder
Clinical narrative: Guillain-Barre Syndrome, neuromuscular/connective/soft tissue complaints c/o muscle weakness. Flu like sx prior to muscle weakness and numbness and tingling 6/20/07-records received from facility for DOS 3/10-3/27/07- DC DX: Guillain-Barre Syndrome. Chief complaint loss of sensation and motor function in extremities. Inability to ejaculate. Presented to hospital on 3/9/07- with 2-3 day complaint of numbness in hands and feet as well as difficulty ambulating. Prior to this he had several weeks of prodromal illness including nausea, headache and fever. On 2/12/07-Fever up to 104 degrees for 1 week. Complained of night sweats, headaches, emesis and nonproductive cough. 3/1/07-complaint of pain in shoulders and hips. Continued to complain of headaches. 3-4 days before admission began having tingling in hands and feet. followed by tingling in groin and perineal region. Decreased sensation while defecating and inability to tell when voiding was complete. PE: decreased distal reflexes in lower extremities. Very mild improvement since treatment with IVG. Requires long term rehabilitation.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Abdominal pain upper, Erythema, Pain in extremity, Pyrexia
Clinical narrative: MOM CALLED TODAY (03/23/07 11:30AM).CLAIMS CHILD HAS FEVER STARTED FEVER OF 38DEGREES CELSIUS AS OF THIS MORNING.  SHE NOTICED TODAY THAT RIGHT ARM HAS PAIN, RED CIRCLE, TIGHT IN TEXTURE.  ALSO THAT SHE HAS A TUMMY ACHE. INFORMED MOM TO CALL DOCTOR FOR FURTHER EVALUATION.  SPOKE TO MOM FEW MINUTES LATER, INFORMED ME THAT DOCTOR TOLD HER FEVER NORMAL, AS FOR RED NOT SURE BUT TO MONITOR AND IF FEVER DOES NOT GO AWAY IN 24HRS TO BRING IN. MOTHER GAVE MOTRIN.
Age: 15.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Blood pressure normal, Fall, Injury, Pain in extremity, Pallor
Clinical narrative: 5 mins after shots turn white and bumped self on door and fell slowly to floor. BP and VS normal. Reportedly now with pain and paresthesia of L arm.
Age: 15.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Paraesthesia
Clinical narrative: 5 mins after shots turn white and bumped self on door and fell slowly to floor. BP and VS normal. Reportedly now with pain and paresthesia of L arm.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Fatigue, Headache, Injection site erythema, Injection site reaction
Clinical narrative: Large wheal at site about 6 cm with erythema, fatigue, HA, nausea, chest tightness and pain opposite arm.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Large wheal at site about 6 cm with erythema, fatigue, HA, nausea, chest tightness and pain opposite arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: 8 inch x 6 inch area of erythema to R thigh treated with Keflex 250/5 7.5 ml PO TID x 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Blister, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Swelling R arm, erythematous, warm, non tender. A small open blister. No induration , no LNE or d/c. No further treatment (given 30 mg PO Prednisolone in ER).
Age: 25.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Full blood count normal, Injection site erythema, Musculoskeletal pain, Pyrexia, White blood cell count increased
Clinical narrative: Pt seen in office 3-9-07 with c/o L arm shoulder pain and fever. Symptoms started after vaccination L deltoid 3-7-07. Pt c/o fever at home of 103 deg. 8x8cm demarcated area of erythema L upper deltoid. Started on Keflex.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Diarrhea, Nausea, headache
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: 2x3 cm red area with itching right arm, tenderness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site rash, Meningitis
Clinical narrative: Patients mom called RN 11/15/2006 med given. On 11-14-06 to tell the office that he has a red spot at the site of the MMR injection . Mom was told to bring patient in to be seen on 2 different occasions and did not do it.
Age: 22.0
Sex: M
Vaccine: FLUN3, HEPAB, IPV, MEN, MMR, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received from the agency reported, who originally received the report from a health care professional. A 22-year-old male patient, who had no illnesses or pre-existing conditions, had received a dose of ADACEL, lot number C25272AA; a dose of IPOL, lot number Y10302; a dose of MENOMUNE A/C/Y/W-135, lot number UE514AA; a dose of FLUMIST, manufacturer reported, lot number 500428P; a dose of MMR II, manufacturer reported, lot number 0730R; and a dose of TWINRIX, manufacturer reported, lot number AHAVB068BB, on 30 October 2006. Thirty-four days post-immunization, the patient developed Guillain Barre Syndrome and was hospitalized for three days. The patient was treated with Penicillin V-K. At the time of this report, it was unknown if the patient had recovered.
Age: 41.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Malaise, Pain, Tachycardia, Tenderness
Clinical narrative: Initial report received on 20 November 2006 from a health care professional. A 41-year-old male patient, who has a past history of tachycardia, had received a first dose. Twenty-four hours post-immunization, the patient experienced general malaise with left arm and side tenderness. He also had one episode of tachycardia (length of episode not reported) that resolved without incident. The patient did not seek medical attention. The events of general malaise, left arm and side tenderness resolved 24 hours after onset. At the time of this report, the patient had recovered. Follow-up information received on 24 November 2006. The patient was a 41-year-old male. No other medical information was provided. Follow-up information received on 22 January 2007 from a health care professional. The patient had no past medical history and was no medications. The patient had experienced left deltoid and left side of chest tenderness. The reported tachycardia episode was brief as per the patient, and there were no other symptoms associated with the tachycardia episode. All symptoms initiated approximately 24 hours following vaccination. No medical attention was sought, and the patient had recovered. The reporter in this case is the same as in case 2006-03201 and 2006-03273.
Age: 41.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Malaise, Musculoskeletal chest pain, Tachycardia, Tenderness
Clinical narrative: Initial report received on 20 November 2006 from a health care professional. A 41-year-old male patient, who has a past history of tachycardia, had received a first dose. Twenty-four hours post-immunization, the patient experienced general malaise with left arm and side tenderness. He also had one episode of tachycardia (length of episode not reported) that resolved without incident. The patient did not seek medical attention. The events of general malaise, left arm and side tenderness resolved 24 hours after onset. At the time of this report, the patient had recovered. Follow-up information received on 24 November 2006. The patient was a 41-year-old male. No other medical information was provided. Follow-up information received on 22 January 2007 from a health care professional. The patient had no past medical history and was no medications. The patient had experienced left deltoid and left side of chest tenderness. The reported tachycardia episode was brief as per the patient, and there were no other symptoms associated with the tachycardia episode. All symptoms initiated approximately 24 hours following vaccination. No medical attention was sought, and the patient had recovered. The reporter in this case is the same as in case 2006-03201 and 2006-03273.
Age: 48.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Malaise, Pain, Palpitations
Clinical narrative: Initial report received on 28 November 2006 from a health care professional. A 48-year-old female patient, had received a first dose, left arm, IM injection of ADACEL, lot number C2557AA, and a right arm, IM injection of Influenza vaccine, manufacturer reported, lot number AFLUR216AA, on 14 November 2006 at 14:30 pm. The patient stated that she begun to have intermittent bouts of palpitations that evening after receiving the vaccinations. The symptom resolved with 24 hours. She did not seek medical attention or advise. The patient reported that she was taking Advil for general malaise and aching during that period. At the time of this report, the patient had recovered. Follow-up information received on 22 January 2007 from a health care professional. Per the reporter related to the influenza product administered, the "flu vaccine is as stated in report" (as previously documented). The patient had no significant past medial history. No treatment was sought for the symptoms. The general body aches were treated with Advil only. The patient had received yearly influenza vaccinations in the past. The reporter in this case is the same as in cases 2006-03200 and 2006-03201.
Age: 48.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Malaise, Myalgia, Palpitations
Clinical narrative: Initial report received on 28 November 2006 from a health care professional. A 48-year-old female patient, had received a first dose, left arm, IM injection of ADACEL, lot number C2557AA, and a right arm, IM injection of Influenza vaccine, manufacturer reported, lot number AFLUR216AA, on 14 November 2006 at 14:30 pm. The patient stated that she begun to have intermittent bouts of palpitations that evening after receiving the vaccinations. The symptom resolved with 24 hours. She did not seek medical attention or advise. The patient reported that she was taking Advil for general malaise and aching during that period. At the time of this report, the patient had recovered. Follow-up information received on 22 January 2007 from a health care professional. Per the reporter related to the influenza product administered, the "flu vaccine is as stated in report" (as previously documented). The patient had no significant past medial history. No treatment was sought for the symptoms. The general body aches were treated with Advil only. The patient had received yearly influenza vaccinations in the past. The reporter in this case is the same as in cases 2006-03200 and 2006-03201.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Pain of skin, Paraesthesia
Clinical narrative: Client said had sharp painful sensations starting at both hips and ran down entire length of leg three days after receiving vaccine. States has had this problem since receiving vaccine until this week in March 23,2007.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Client said had sharp painful sensations starting at both hips and ran down entire length of leg three days after receiving vaccine. States has had this problem since receiving vaccine until this week in March 23,2007.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood creatine phosphokinase normal, Injection site discomfort, Swelling
Clinical narrative: Initial report received on 08 February 2007 from a health care professional. The reporter stated that this case had been reported. A 43 year old female patient received on 16 January 2007 Adacel (lot number C2609AA), IM into the left deltoid. On the same day, she experienced swelling and pain. The patient saw a physician, 6 days post-vaccination, on 22 January 2007, for decreased range of motion. Treatment included heat and Motrin. The patient was seen again in the office, 17 days post-vaccination on 02 February 2007 with diffuse swelling in the left shoulder and scapular area. Prednisone was prescribed. It was unknown if the patient had recovered. The patient was allergic to sulfides. Last TD (vaccine) was given in 2000. No other concomitant vaccines were given within 4 weeks prior to 16 January 2007.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Joint range of motion decreased, Pain, Swelling
Clinical narrative: Initial report received on 08 February 2007 from a health care professional. The reporter stated that this case had been reported. A 43 year old female patient received on 16 January 2007 Adacel (lot number C2609AA), IM into the left deltoid. On the same day, she experienced swelling and pain. The patient saw a physician, 6 days post-vaccination, on 22 January 2007, for decreased range of motion. Treatment included heat and Motrin. The patient was seen again in the office, 17 days post-vaccination on 02 February 2007 with diffuse swelling in the left shoulder and scapular area. Prednisone was prescribed. It was unknown if the patient had recovered. The patient was allergic to sulfides. Last TD (vaccine) was given in 2000. No other concomitant vaccines were given within 4 weeks prior to 16 January 2007.
Age: 0.52
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Intussusception, Rash, Vomiting
Clinical narrative: Information received on 15 March 2007 from another manufacturer, report WAES0701 USA05034, VAERS# 271991. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "This is in follow-up to report(S) previously submitted on 2/8/2007, 2/21/2007. Information has been received from a certified medical assistant concerning a 7-month0old male with no medical history or allergies who on 10-Aug-2006, 12-Oct-2006 and on the morning of 14-Dec-2006 was vaccinated PO with the first, second and third doses, respectively, of Rotateq (lot #s 654248/0577F and 655484/1032F administration dated not specified). Concomitant vaccination administered on the morning of 14-Dec-2006 included the third IM dose in the left thigh of Pediarix (Lot # AC21B070AA), the second IM dose in the left thigh of PedvaxHib (lot #653596/0281F), the third IM dose in the right thigh of Prevnar (lot #B08675C) and in IM dose in the right thigh of Fluzone (Lot U2243AA). The CMA reported that on 26-Jan-2007, at 0915, the patient presented with a rash and vomiting. The patient was diagnosed with an ileocolic intussusception that could not be reduced by barium enema. The patient was subsequently hospitalized and surgical correction was pending. No laboratory/diagnostic test were performed. The patient was hospitalize for four days and subsequently recovered. The CMA also considered the patients rash and ileocolic intussusception to be life-threatening and other important medical event. The record of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements and were released. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: Information received on 15 March 2007 from another manufacturer, report WAES0701 USA05034, VAERS# 271991. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "This is in follow-up to report(S) previously submitted on 2/8/2007, 2/21/2007. Information has been received from a certified medical assistant concerning a 7-month0old male with no medical history or allergies who on 10-Aug-2006, 12-Oct-2006 and on the morning of 14-Dec-2006 was vaccinated PO with the first, second and third doses, respectively, of Rotateq (lot #s 654248/0577F and 655484/1032F administration dated not specified). Concomitant vaccination administered on the morning of 14-Dec-2006 included the third IM dose in the left thigh of Pediarix (Lot # AC21B070AA), the second IM dose in the left thigh of PedvaxHib (lot #653596/0281F), the third IM dose in the right thigh of Prevnar (lot #B08675C) and in IM dose in the right thigh of Fluzone (Lot U2243AA). The CMA reported that on 26-Jan-2007, at 0915, the patient presented with a rash and vomiting. The patient was diagnosed with an ileocolic intussusception that could not be reduced by barium enema. The patient was subsequently hospitalized and surgical correction was pending. No laboratory/diagnostic test were performed. The patient was hospitalize for four days and subsequently recovered. The CMA also considered the patients rash and ileocolic intussusception to be life-threatening and other important medical event. The record of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements and were released. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Intussusception, Rash, Surgery, Vomiting
Clinical narrative: Information received on 15 March 2007 from another manufacturer, report WAES0701 USA05034, VAERS# 271991. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "This is in follow-up to report(S) previously submitted on 2/8/2007, 2/21/2007. Information has been received from a certified medical assistant concerning a 7-month0old male with no medical history or allergies who on 10-Aug-2006, 12-Oct-2006 and on the morning of 14-Dec-2006 was vaccinated PO with the first, second and third doses, respectively, of Rotateq (lot #s 654248/0577F and 655484/1032F administration dated not specified). Concomitant vaccination administered on the morning of 14-Dec-2006 included the third IM dose in the left thigh of Pediarix (Lot # AC21B070AA), the second IM dose in the left thigh of PedvaxHib (lot #653596/0281F), the third IM dose in the right thigh of Prevnar (lot #B08675C) and in IM dose in the right thigh of Fluzone (Lot U2243AA). The CMA reported that on 26-Jan-2007, at 0915, the patient presented with a rash and vomiting. The patient was diagnosed with an ileocolic intussusception that could not be reduced by barium enema. The patient was subsequently hospitalized and surgical correction was pending. No laboratory/diagnostic test were performed. The patient was hospitalize for four days and subsequently recovered. The CMA also considered the patients rash and ileocolic intussusception to be life-threatening and other important medical event. The record of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met the requirements and were released. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a health care professional 05 February 2007. A 44 year old female patient developed induration/depression of 20-22mm in the left upper arm after she received an IM injection of ADACEL (lot number C2457AA) in the left deltoid on 20 November 2006. The day after, her arm was sore - within one week she had redness, swelling, was warm and raised area - no drainage. It was reported the patient recovered. On 17 October 2006, she received an influenza vaccine - FLUARIX (lot number AFLUA213BA) IM in the left deltoid.
Age: 44.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain in extremity
Clinical narrative: Initial report received from a health care professional 05 February 2007. A 44 year old female patient developed induration/depression of 20-22mm in the left upper arm after she received an IM injection of ADACEL (lot number C2457AA) in the left deltoid on 20 November 2006. The day after, her arm was sore - within one week she had redness, swelling, was warm and raised area - no drainage. It was reported the patient recovered. On 17 October 2006, she received an influenza vaccine - FLUARIX (lot number AFLUA213BA) IM in the left deltoid.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laboratory test, Surgery, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from the agency reported through another agency reported concerning a male with no medical history or allergies who on 06-DEC-2006 at 15:00 was vaccinated with the first oral dose of Rotateq (Lot # 655405/1113F). Concomitant vaccination administered that day included an IM first dose in right leg of PEDIARIX (Lot # AC21B074BA), an IM first dose in left leg ACTHIB (Lot # UF023AA) and an IM first dose in left leg PREVNAR (Lot 3 B0862D). There was no illness at the time of vaccination. On 17-JAN-2007, the patient developed vomiting and was hospitalized for intussusception requiring surgical intervention. The patient's hospitalization lasted two days. The patient underwent laboratory tests and X-ray with contrast of upper GI tract (results not provided). Subsequently, the patient recovered from intussusception and vomiting on an unspecified date. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laboratory test, Surgery, Vomiting, X-ray gastrointestinal tract
Clinical narrative: Information has been received from the agency reported through another agency reported concerning a male with no medical history or allergies who on 06-DEC-2006 at 15:00 was vaccinated with the first oral dose of Rotateq (Lot # 655405/1113F). Concomitant vaccination administered that day included an IM first dose in right leg of PEDIARIX (Lot # AC21B074BA), an IM first dose in left leg ACTHIB (Lot # UF023AA) and an IM first dose in left leg PREVNAR (Lot 3 B0862D). There was no illness at the time of vaccination. On 17-JAN-2007, the patient developed vomiting and was hospitalized for intussusception requiring surgical intervention. The patient's hospitalization lasted two days. The patient underwent laboratory tests and X-ray with contrast of upper GI tract (results not provided). Subsequently, the patient recovered from intussusception and vomiting on an unspecified date. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Constipation, Haematochezia, Surgery, Vomiting
Clinical narrative: Information has been received from the agency reported through the agency reported concerning a 5 month old male no medical history or allergies who on 01-NOV-2006 was vaccinated with the first oral Rotateq (Lot # 654422/0607F). On 04-JAN-2007, the patient was vaccinated with the second dose of oral Rotateq (Lot # not provided). Concomitant vaccinations included first dose of INFANRIX (Lot# ac14b040ca) IM in the left leg, the first dose of ENGERIX-B (Lot # UE861AA) IM in the left leg, the first dose of PREVNAR (Lot # B0864C) IM in the right leg and the first dose of IPOL (Lot # Y0991-2) IM in the left leg. There was no illness at the time of vaccination. On 14-FEB-2007, the patient had surgery for intussusception. He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days,a nd questionable blood in the diaper four days ago. He required two days of hospitalization for the reported events. The patient recovered from the abdominal distention, absence of gas/bowel movement, and questionable blood in diaper on an unspecified date. He was still in the hospital at the time of the report. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Constipation, Haematochezia, Infrequent bowel movements, Intussusception
Clinical narrative: Information has been received from the agency reported through the agency reported concerning a 5 month old male no medical history or allergies who on 01-NOV-2006 was vaccinated with the first oral Rotateq (Lot # 654422/0607F). On 04-JAN-2007, the patient was vaccinated with the second dose of oral Rotateq (Lot # not provided). Concomitant vaccinations included first dose of INFANRIX (Lot# ac14b040ca) IM in the left leg, the first dose of ENGERIX-B (Lot # UE861AA) IM in the left leg, the first dose of PREVNAR (Lot # B0864C) IM in the right leg and the first dose of IPOL (Lot # Y0991-2) IM in the left leg. There was no illness at the time of vaccination. On 14-FEB-2007, the patient had surgery for intussusception. He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days,a nd questionable blood in the diaper four days ago. He required two days of hospitalization for the reported events. The patient recovered from the abdominal distention, absence of gas/bowel movement, and questionable blood in diaper on an unspecified date. He was still in the hospital at the time of the report. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Surgery, Vomiting
Clinical narrative: Information has been received from the agency reported through the agency reported concerning a 5 month old male no medical history or allergies who on 01-NOV-2006 was vaccinated with the first oral Rotateq (Lot # 654422/0607F). On 04-JAN-2007, the patient was vaccinated with the second dose of oral Rotateq (Lot # not provided). Concomitant vaccinations included first dose of INFANRIX (Lot# ac14b040ca) IM in the left leg, the first dose of ENGERIX-B (Lot # UE861AA) IM in the left leg, the first dose of PREVNAR (Lot # B0864C) IM in the right leg and the first dose of IPOL (Lot # Y0991-2) IM in the left leg. There was no illness at the time of vaccination. On 14-FEB-2007, the patient had surgery for intussusception. He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days,a nd questionable blood in the diaper four days ago. He required two days of hospitalization for the reported events. The patient recovered from the abdominal distention, absence of gas/bowel movement, and questionable blood in diaper on an unspecified date. He was still in the hospital at the time of the report. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Bowel sounds abnormal, Constipation, Haematochezia, Infrequent bowel movements
Clinical narrative: Information has been received from the agency reported through the agency reported concerning a 5 month old male no medical history or allergies who on 01-NOV-2006 was vaccinated with the first oral Rotateq (Lot # 654422/0607F). On 04-JAN-2007, the patient was vaccinated with the second dose of oral Rotateq (Lot # not provided). Concomitant vaccinations included first dose of INFANRIX (Lot# ac14b040ca) IM in the left leg, the first dose of ENGERIX-B (Lot # UE861AA) IM in the left leg, the first dose of PREVNAR (Lot # B0864C) IM in the right leg and the first dose of IPOL (Lot # Y0991-2) IM in the left leg. There was no illness at the time of vaccination. On 14-FEB-2007, the patient had surgery for intussusception. He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days,a nd questionable blood in the diaper four days ago. He required two days of hospitalization for the reported events. The patient recovered from the abdominal distention, absence of gas/bowel movement, and questionable blood in diaper on an unspecified date. He was still in the hospital at the time of the report. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Surgery, Vomiting
Clinical narrative: Information has been received from the agency reported through the agency reported concerning a 5 month old male no medical history or allergies who on 01-NOV-2006 was vaccinated with the first oral Rotateq (Lot # 654422/0607F). On 04-JAN-2007, the patient was vaccinated with the second dose of oral Rotateq (Lot # not provided). Concomitant vaccinations included first dose of INFANRIX (Lot# ac14b040ca) IM in the left leg, the first dose of ENGERIX-B (Lot # UE861AA) IM in the left leg, the first dose of PREVNAR (Lot # B0864C) IM in the right leg and the first dose of IPOL (Lot # Y0991-2) IM in the left leg. There was no illness at the time of vaccination. On 14-FEB-2007, the patient had surgery for intussusception. He presented with symptoms of vomiting, abdominal distention, absence of gas/bowel movement for 4 days,a nd questionable blood in the diaper four days ago. He required two days of hospitalization for the reported events. The patient recovered from the abdominal distention, absence of gas/bowel movement, and questionable blood in diaper on an unspecified date. He was still in the hospital at the time of the report. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Barium enema, Intensive care, Intestinal perforation, Intubation, Intussusception
Clinical narrative: Initial report received on 12 March 2007 from an other manufacturer, report number WAES0702USA02967. This manufacturer had received the original report from the agency reported. Verbatim from report: "Information has been received from the agency reported concerning a male with gastrooesophageal reflux who on 03-Jan-2007, at 12:30 p.m. was vaccinated with a third oral dose Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of PEDIARIX (Lot# AC21B079BA) and a third intramuscular dose in the left leg of ACTHIB (Lot# ue992aa). Concomitant therapy included PREVACID. The patient had an upper respiratory infection at the time of vaccination. On 03-FEB-2007 the patient developed gastrointestinal symptoms. The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check has been requested. Additional information has been requested." The patient had an abdominal ultrasound on 07 February 2007 that demonstrated intussusception.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Laparotomy, Sepsis, Small intestinal anastomosis, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Initial report received on 12 March 2007 from an other manufacturer, report number WAES0702USA02967. This manufacturer had received the original report from the agency reported. Verbatim from report: "Information has been received from the agency reported concerning a male with gastrooesophageal reflux who on 03-Jan-2007, at 12:30 p.m. was vaccinated with a third oral dose Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of PEDIARIX (Lot# AC21B079BA) and a third intramuscular dose in the left leg of ACTHIB (Lot# ue992aa). Concomitant therapy included PREVACID. The patient had an upper respiratory infection at the time of vaccination. On 03-FEB-2007 the patient developed gastrointestinal symptoms. The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check has been requested. Additional information has been requested." The patient had an abdominal ultrasound on 07 February 2007 that demonstrated intussusception.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Barium enema, Gastrointestinal disorder, Intestinal perforation, Intubation, Intussusception
Clinical narrative: Initial report received on 12 March 2007 from an other manufacturer, report number WAES0702USA02967. This manufacturer had received the original report from the agency reported. Verbatim from report: "Information has been received from the agency reported concerning a male with gastrooesophageal reflux who on 03-Jan-2007, at 12:30 p.m. was vaccinated with a third oral dose Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of PEDIARIX (Lot# AC21B079BA) and a third intramuscular dose in the left leg of ACTHIB (Lot# ue992aa). Concomitant therapy included PREVACID. The patient had an upper respiratory infection at the time of vaccination. On 03-FEB-2007 the patient developed gastrointestinal symptoms. The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check has been requested. Additional information has been requested." The patient had an abdominal ultrasound on 07 February 2007 that demonstrated intussusception.