chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient started to notice hives on the back of her neck, between legs and on wrist about 5 hours after administration of the vaccine.  Patient has been taking diphenhydramine which is controlling symptoms and was notified to seek immediate medical attention if she had any trouble breathing.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Oedema, Tenderness
Clinical narrative: Minor local reaction at the left deltoid - mild erythema, tenderness and edema.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Blood test normal, Dehydration, Influenza serology negative, Unresponsive to stimuli, Vomiting
Clinical narrative: He vomited about 5 hrs. after being vaccinated and still continues. He became very unresponsive at times. He ended up getting dehydrated which caused us an E.R. visit.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain lower, Abdominal pain upper, Blood test normal, Endoscopy normal, Pyrexia
Clinical narrative: High fever of 106F, wheezing, upper right quadrant pain and lower right quadrant pain. It lasted for 8 months. Treatments were antibioctics.  5/26/09 Hospital records received ED and inpatient DOS 9/18/07 to 11/19/08. FINAL DIAGNOSIS: Focal acute colitis. Post vaccination presented with abdominal pain all quadrants, fever, headache, nausea, hepatosplenomegaly, polyuria, polydipsia. Additional visits for sore throat, congestion, runny nose and cough.   8/7/09 ICD-9 Codes: 789.00 abdominal pain unspecified, 789.01 Right upper quadrant abdominal pain, 793.6 Nonspecific radiologic abnormality of the abdomen or retroperitoneum, 309.24 Adjustment disorder with anxiety, V15.09 Other allergy other than to medicinal agents, 462 Acute pharyngitis, 465.9 Acute upper respiratory infection unspecified sites, 079.99 Viral infection unspecified in condition classified elsewhere, 571.8 Other non-alcoholic chronic liver disease.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Red blood cell count normal, Wheezing, X-ray with contrast upper gastrointestinal tract
Clinical narrative: High fever of 106F, wheezing, upper right quadrant pain and lower right quadrant pain. It lasted for 8 months. Treatments were antibioctics.  5/26/09 Hospital records received ED and inpatient DOS 9/18/07 to 11/19/08. FINAL DIAGNOSIS: Focal acute colitis. Post vaccination presented with abdominal pain all quadrants, fever, headache, nausea, hepatosplenomegaly, polyuria, polydipsia. Additional visits for sore throat, congestion, runny nose and cough.   8/7/09 ICD-9 Codes: 789.00 abdominal pain unspecified, 789.01 Right upper quadrant abdominal pain, 793.6 Nonspecific radiologic abnormality of the abdomen or retroperitoneum, 309.24 Adjustment disorder with anxiety, V15.09 Other allergy other than to medicinal agents, 462 Acute pharyngitis, 465.9 Acute upper respiratory infection unspecified sites, 079.99 Viral infection unspecified in condition classified elsewhere, 571.8 Other non-alcoholic chronic liver disease.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a consumer and described the occurrence of possible acute hepatitis in a female subject of unspecified age who was vaccinated with Hepatitis B vaccine recombinant (manufacturer unspecified), Hepatitis A inactivated and Hepatitis B  recombinant vaccine. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown) or an unspecified dose of Hepatitis a + b vaccine (unknown). Three weeks after vaccination with Hepatitis B vaccine or Hepatitis a + b vaccine, the subject's blood showed positive hepatitis b surface antigen. The consumer reported that the physician was not sure whether the subject is having acute hepatitis or if the blood test result is related to the vaccine three weeks prior. At the time of reporting the outcome of the event was unspecified.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Activities of daily living impaired, Dizziness, Dysstasia, Gait disturbance, Headache
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site soreness in a 29-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included high blood pressure.  Concurrent medications included PINDOLOL.  On 11 February 2009 and 11 March 2009 at 09:30 the subject received 1st dose and 2nd dose of ENGERIX B (10 mcg, unknown, right arm).  On 11 February 2009, less than one day after vaccination with ENGERIX B, the subject experienced injection site soreness in her right arm which started late that day and lasted a couple of days.  On 14 March 2009, at 6:30 am, the subject experienced vertigo and dizziness.  She developed headache in the afternoon.  The subject was seen in the emergency room, but was not admitted to the hospital.  For the first three days (dates unspecified) the subject could not get up and walk as a result of these events.  The subject reported that the events had improved, but they were  still ongoing.  The pharmacist considered the events were disabling.  On an unspecified date, the injection site soreness resolved.  At the time of reporting the events of vertigo, dizziness, headaches and inability to get up and walk were improved.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Vertigo
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site soreness in a 29-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included high blood pressure.  Concurrent medications included PINDOLOL.  On 11 February 2009 and 11 March 2009 at 09:30 the subject received 1st dose and 2nd dose of ENGERIX B (10 mcg, unknown, right arm).  On 11 February 2009, less than one day after vaccination with ENGERIX B, the subject experienced injection site soreness in her right arm which started late that day and lasted a couple of days.  On 14 March 2009, at 6:30 am, the subject experienced vertigo and dizziness.  She developed headache in the afternoon.  The subject was seen in the emergency room, but was not admitted to the hospital.  For the first three days (dates unspecified) the subject could not get up and walk as a result of these events.  The subject reported that the events had improved, but they were  still ongoing.  The pharmacist considered the events were disabling.  On an unspecified date, the injection site soreness resolved.  At the time of reporting the events of vertigo, dizziness, headaches and inability to get up and walk were improved.
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Headache, Hypoaesthesia, Hypothyroidism
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain, swelling and stiffness of the joints of his body, including his elbows and knees. He additionally experienced flu-like symptoms, possible nerve injury, possible autoimmune disease, activities of daily living impaired, numbness, headache and possible memory loss. At the time of reporting the outcome of the events was unspecified. The information in this case was received via a Statement of Injuries. Follow-up information was received on 26 March 2009 in the form of a claimant interview. The subject reported a medical history of varicocele, allergies, tonsillectomy and growth in leg. He received three doses of LYMERIX vaccine, 15 June 1999, July 1999 and June 2000. Events that the subject attributed to LYMERIX vaccine include joint pain (started in his knees and then began in his neck, back, shoulders and wrists) with onset may 2000, Peyronie's disease with onset 2002 or 2003, hypothyroidism with onset 2007 and enlarged prostate with onset 2008. All of these events were reportedly ongoing. Conditions that the subject developed post vaccination that he had not attributed to vaccine included high cholesterol, palpitations, torn bicep and bronchitis. Medications listed were as follows: Ibuprofen, Fexofenadine, Nasonex, Arthrotec, Nasacort, Epi-pen, Alfuzosin, Aspirin, Colestipol, Cyanocobalamin, Glucosamine, Levothyroxine and Lycopene.
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Influenza like illness, Joint stiffness, Joint swelling, Peyronie's disease, Prostatomegaly
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain, swelling and stiffness of the joints of his body, including his elbows and knees. He additionally experienced flu-like symptoms, possible nerve injury, possible autoimmune disease, activities of daily living impaired, numbness, headache and possible memory loss. At the time of reporting the outcome of the events was unspecified. The information in this case was received via a Statement of Injuries. Follow-up information was received on 26 March 2009 in the form of a claimant interview. The subject reported a medical history of varicocele, allergies, tonsillectomy and growth in leg. He received three doses of LYMERIX vaccine, 15 June 1999, July 1999 and June 2000. Events that the subject attributed to LYMERIX vaccine include joint pain (started in his knees and then began in his neck, back, shoulders and wrists) with onset may 2000, Peyronie's disease with onset 2002 or 2003, hypothyroidism with onset 2007 and enlarged prostate with onset 2008. All of these events were reportedly ongoing. Conditions that the subject developed post vaccination that he had not attributed to vaccine included high cholesterol, palpitations, torn bicep and bronchitis. Medications listed were as follows: Ibuprofen, Fexofenadine, Nasonex, Arthrotec, Nasacort, Epi-pen, Alfuzosin, Aspirin, Colestipol, Cyanocobalamin, Glucosamine, Levothyroxine and Lycopene.
Age: 28.0
Sex: M
Vaccine: FLUX, HEPA, TD, TYP
Symptoms: Artery dissection, Coordination abnormal, Discomfort, Dysstasia, Headache
Clinical narrative: While attending graduate school, this 40 year old member reported receipt of hepatitis A #1, influenza, and typhoid vaccinations on 11/7/1997. Medical records show tetanus-diphtheria given 8/5/1997 not 11/7/1997. He remembers experiencing flu-like symptoms that evening that worsened the next day to resolve within 24 hours. Day 2 post vaccination (11/9/1997) he began to experience a dull ache to neck near base of skull. This discomfort gradually increased over the next 1 1/2 weeks until he was unable to rotate head side-side due to pain but he could shake it "yes" without pain. He denied any other symptoms (headache, n/v, muscular weakness, speech or visual disturbance). He presented to medical where he was treated for muscle strain and placed on muscle relaxer and MOTRIN. He took one "muscle relaxer" and developed a severe headache. He didn't take any more and represented to medical where he was advised he was given a vasodilator instead of muscle relaxer. His medications were changed with resolution of all neck pain for 4 days. On Thanksgiving day he rapidly hyperextended his neck to "knock back a shot of whiskey" with family members at home when he suddenly "felt weird". He was reported to go pale, his coordination was off, and he had a headache. He was unable to stand due to muscle weakness and was assisted to the floor. He denied any paralysis, respiratory or visual complaints. He was taken to an emergency room, admitted and diagnosed with dissected cerebral artery. He remained in ICU for 1 week then in rehab for 3 weeks with full recovery except for mild residual pain/temperature deficit to his right side. He received his second hepatitis A vaccine 9/2 2005 with hepatitis B given 9/8/2005, 2/11/2006, 9/11/2006, and 3 influenza vaccinations (2005, 2006, 2007) with no adverse events. Symptoms: Gait abnormality, Weakness, Headaches, general, Inability to turn head (CN X1), Flu-like symptoms<96 hours, Pain.   4/14/09 Received medical records of 4/1/2009. FINAL DX: CVA/dissected cerebral artery Records reveal patient experienced flu-like symptoms after flu, hep A #1 & typhoid #2 vaccinations on 11/7/1997.  (Had received Td on 8/5/1997.)  Developed basilar HA 2 days s/p vax which increased over 10 days.  Seen in clinic & given muscle relaxer for muscle strain.  HA increased & meds changed w/complete resolution for 4 days.  Then on Thanksgiving day, after neck hyperextension became pale, uncoordinated, HA, unable to stand & assisted to floor.  Admitted to ICU x 1 wk w/dissected cerebral artery, then rehab x 3 wk w/full recovery except for mild residual pain/temperature deficit on right side.  Received subsequent vaccines w/o adverse events.
Age: 28.0
Sex: M
Vaccine: FLUX, HEPA, TD, TYP
Symptoms: Influenza like illness, Intensive care, Muscle strain, Muscular weakness, Neck pain
Clinical narrative: While attending graduate school, this 40 year old member reported receipt of hepatitis A #1, influenza, and typhoid vaccinations on 11/7/1997. Medical records show tetanus-diphtheria given 8/5/1997 not 11/7/1997. He remembers experiencing flu-like symptoms that evening that worsened the next day to resolve within 24 hours. Day 2 post vaccination (11/9/1997) he began to experience a dull ache to neck near base of skull. This discomfort gradually increased over the next 1 1/2 weeks until he was unable to rotate head side-side due to pain but he could shake it "yes" without pain. He denied any other symptoms (headache, n/v, muscular weakness, speech or visual disturbance). He presented to medical where he was treated for muscle strain and placed on muscle relaxer and MOTRIN. He took one "muscle relaxer" and developed a severe headache. He didn't take any more and represented to medical where he was advised he was given a vasodilator instead of muscle relaxer. His medications were changed with resolution of all neck pain for 4 days. On Thanksgiving day he rapidly hyperextended his neck to "knock back a shot of whiskey" with family members at home when he suddenly "felt weird". He was reported to go pale, his coordination was off, and he had a headache. He was unable to stand due to muscle weakness and was assisted to the floor. He denied any paralysis, respiratory or visual complaints. He was taken to an emergency room, admitted and diagnosed with dissected cerebral artery. He remained in ICU for 1 week then in rehab for 3 weeks with full recovery except for mild residual pain/temperature deficit to his right side. He received his second hepatitis A vaccine 9/2 2005 with hepatitis B given 9/8/2005, 2/11/2006, 9/11/2006, and 3 influenza vaccinations (2005, 2006, 2007) with no adverse events. Symptoms: Gait abnormality, Weakness, Headaches, general, Inability to turn head (CN X1), Flu-like symptoms<96 hours, Pain.   4/14/09 Received medical records of 4/1/2009. FINAL DX: CVA/dissected cerebral artery Records reveal patient experienced flu-like symptoms after flu, hep A #1 & typhoid #2 vaccinations on 11/7/1997.  (Had received Td on 8/5/1997.)  Developed basilar HA 2 days s/p vax which increased over 10 days.  Seen in clinic & given muscle relaxer for muscle strain.  HA increased & meds changed w/complete resolution for 4 days.  Then on Thanksgiving day, after neck hyperextension became pale, uncoordinated, HA, unable to stand & assisted to floor.  Admitted to ICU x 1 wk w/dissected cerebral artery, then rehab x 3 wk w/full recovery except for mild residual pain/temperature deficit on right side.  Received subsequent vaccines w/o adverse events.
Age: 28.0
Sex: M
Vaccine: FLUX, HEPA, TD, TYP
Symptoms: Pain, Pallor
Clinical narrative: While attending graduate school, this 40 year old member reported receipt of hepatitis A #1, influenza, and typhoid vaccinations on 11/7/1997. Medical records show tetanus-diphtheria given 8/5/1997 not 11/7/1997. He remembers experiencing flu-like symptoms that evening that worsened the next day to resolve within 24 hours. Day 2 post vaccination (11/9/1997) he began to experience a dull ache to neck near base of skull. This discomfort gradually increased over the next 1 1/2 weeks until he was unable to rotate head side-side due to pain but he could shake it "yes" without pain. He denied any other symptoms (headache, n/v, muscular weakness, speech or visual disturbance). He presented to medical where he was treated for muscle strain and placed on muscle relaxer and MOTRIN. He took one "muscle relaxer" and developed a severe headache. He didn't take any more and represented to medical where he was advised he was given a vasodilator instead of muscle relaxer. His medications were changed with resolution of all neck pain for 4 days. On Thanksgiving day he rapidly hyperextended his neck to "knock back a shot of whiskey" with family members at home when he suddenly "felt weird". He was reported to go pale, his coordination was off, and he had a headache. He was unable to stand due to muscle weakness and was assisted to the floor. He denied any paralysis, respiratory or visual complaints. He was taken to an emergency room, admitted and diagnosed with dissected cerebral artery. He remained in ICU for 1 week then in rehab for 3 weeks with full recovery except for mild residual pain/temperature deficit to his right side. He received his second hepatitis A vaccine 9/2 2005 with hepatitis B given 9/8/2005, 2/11/2006, 9/11/2006, and 3 influenza vaccinations (2005, 2006, 2007) with no adverse events. Symptoms: Gait abnormality, Weakness, Headaches, general, Inability to turn head (CN X1), Flu-like symptoms<96 hours, Pain.   4/14/09 Received medical records of 4/1/2009. FINAL DX: CVA/dissected cerebral artery Records reveal patient experienced flu-like symptoms after flu, hep A #1 & typhoid #2 vaccinations on 11/7/1997.  (Had received Td on 8/5/1997.)  Developed basilar HA 2 days s/p vax which increased over 10 days.  Seen in clinic & given muscle relaxer for muscle strain.  HA increased & meds changed w/complete resolution for 4 days.  Then on Thanksgiving day, after neck hyperextension became pale, uncoordinated, HA, unable to stand & assisted to floor.  Admitted to ICU x 1 wk w/dissected cerebral artery, then rehab x 3 wk w/full recovery except for mild residual pain/temperature deficit on right side.  Received subsequent vaccines w/o adverse events.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mass, Pain, Swelling
Clinical narrative: Per pt had orange size lump/ swelling/ redness - sore to touch first 24h - used ice - advised use allergy crm & ice for sx
Age: 44.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: Pt was given GARDASIL instead of ADACEL.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Swelling
Clinical narrative: About 2 1/2 inches red area with swelling, mild induration.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling red ball under skin @ injection site that is painful  DX: Cellulitis
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea 15 min after GARDASIL Dizziness 30 min after vaccine still c/o dizziness, now on 4/2 , got vaccine on 3/31/09
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Febrile seizure. Temp. 105. TYLENOL. 4/30/09 scheduled for f/u MRI.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying
Clinical narrative: 12 n Mother gave child TYLENOL 0.4ml but did not take temp.  1pm Mom woke child for feeding.  Mother stated he was upset, he could not decide if he wanted to cry or breath.  Mom called 911, child was not blue did not feel hot or clammy.  Child stopped crying - paramedic neighbor arrived first, child was then in a "ball" with bubbles from mouth, eyes open a little not rolled back, good color body / abdomen tight.  When rescue squad arrived child was normal, 15 on Glascow coma scale, skin normal, pupils PERLA.  No transport to hospital No ER or doctor visit.  Observed at home by parents.  4pm temp 100.4 Rx
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chest pain, Myalgia, Nausea
Clinical narrative: Soreness in joints, muscles - constant. Periodic nausea, periodic chest pain.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site urticaria
Clinical narrative: Lg area of bumps at injection site going down into underarm & side of back started date of injection & still present on 4-2-09
Age: 59.0
Sex: F
Vaccine: HEPA, TD, TYP
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site reaction
Clinical narrative: Redness/ itching at injection site right delt.  Pt states "feels like sunburn"
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Moderate redness and swelling of Rt triceps after DTAP. Moderately tender. This is a minor side effect
Age: 78.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Erythema right upper arm below injection site extending to medial arm.  Warm to touch.  Pt reported itching started several hours later.  Warmth noted following day
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Blister, Eye burns, Eye pruritus, Lacrimation increased, Tenderness
Clinical narrative: 3-27-09 1:00 PM - began experiencing rt. eye itching, burning, watery raw @ rt. corner of eye, later in day blister appeared corner of rt. eye went to Dr. on 3-28-09 Tx - Zpack & steroid cream. 3-30-09 whelp appeared on rt. cheek, itching nerves tender in cheek area (Rt.) 3-31-09 - whelp red, raised tender to bottom of rt. jaw 4-1-09 Dr. Tx Prednisone Acyclovir
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Urticaria
Clinical narrative: 3-27-09 1:00 PM - began experiencing rt. eye itching, burning, watery raw @ rt. corner of eye, later in day blister appeared corner of rt. eye went to Dr. on 3-28-09 Tx - Zpack & steroid cream. 3-30-09 whelp appeared on rt. cheek, itching nerves tender in cheek area (Rt.) 3-31-09 - whelp red, raised tender to bottom of rt. jaw 4-1-09 Dr. Tx Prednisone Acyclovir
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Blister, Eye irritation, Eye pruritus, Lacrimation increased, Swelling
Clinical narrative: 3-27-09 1:00 PM - began experiencing rt. eye itching, burning, watery raw @ rt. corner of eye, later in day blister appeared corner of rt. eye went to Dr. on 3-28-09 Tx - Zpack & steroid cream. 3-30-09 whelp appeared on rt. cheek, itching nerves tender in cheek area (Rt.) 3-31-09 - whelp red, raised tender to bottom of rt. jaw 4-1-09 Dr. Tx Prednisone Acyclovir
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Tenderness, Urticaria
Clinical narrative: 3-27-09 1:00 PM - began experiencing rt. eye itching, burning, watery raw @ rt. corner of eye, later in day blister appeared corner of rt. eye went to Dr. on 3-28-09 Tx - Zpack & steroid cream. 3-30-09 whelp appeared on rt. cheek, itching nerves tender in cheek area (Rt.) 3-31-09 - whelp red, raised tender to bottom of rt. jaw 4-1-09 Dr. Tx Prednisone Acyclovir
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Headache, Injection site pain, Insomnia, Malaise
Clinical narrative: Pain at injection site, malaise, nausea, photosensitivity, headache, diarrhea and trouble sleeping.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Photosensitivity reaction
Clinical narrative: Pain at injection site, malaise, nausea, photosensitivity, headache, diarrhea and trouble sleeping.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PPV, RV5
Symptoms: Apnoea, Intensive care, Laboratory test normal, Respiratory syncytial virus infection, Vomiting
Clinical narrative: Initial report received on 21 April 2008 from another manufacturer, report# WAES 0804USA01346. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "'Information has been received from a physician concerning a 2 month old male who was vaccinated PO with his first 2.0 ml dose of ROTATEQ on 12-MAR-2008. On 13-MAR-2008, the day after the vaccine was administered, the patient experienced vomiting. On 14-MAR-2008 the patient was diagnosed with RSV and was hospitalized for approximately 1 week. The outcome was unknown. There was no product quality complaint. Follow-up information from the physician's office concerning a 9 week old male with no pertinent medical history who was vaccinated PO with his first 2.0 ml dose of ROTATEQ (lot# 659680/0018X) on 12-MAR-2008. Suspect vaccination included a dose of hepatitis B virus vaccine rHBsAg (lot# 65556/0659U), a dose of PREVNAR, a dose of ACTHIB and a dose of DTaP. On 13-MAR-2008 the patient experienced vomiting. The patient was admitted to the hospital on 15-MAR-2008 for 7 days. The patient was started on antibiotics which were discontinued after a septic workup was negative. The patient was treated iwth caffeine for three days. The patient had three self-limiting periods of apnea. After several days in the ICU, the patient was transferred to the floor on 2 liters of oxygen. The patient was discharged from the hospital on 21-MAR-2008. On 10-APR-2008 the patient was seen in the physician's office with same symptoms. It was reported that the patient was not recovered. RSV and vomiting were also considered to be other important medical events by the physician. Additional information has been requested."
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal pain, Enema administration, Gastrointestinal oedema, Haematochezia, Intussusception
Clinical narrative: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 20-FEB-2008, a 4 year old male with no relevant medical history was vaccinated with his second dose of ROTATEQ (lot number 1394U) by mouth. The suspected vaccine included ACTHIB (unspecified carrier) (lot number UF238AA, vaccinated IM into the right legs), DAPTACEL (lot number C2933B, vaccinated IM into the left leg) and IPOL (unspecified) (lot number A0474, vaccinated IM into the left leg). On 31-MAR-2008, the patient experienced abdominal pain, enema administration, gastrointestinal edema, haematochezia, intussusception and vomiting. Hospital medical records were from 31-MAR-2008 to 01-APR-2008. Records reveal that the patient experienced vomiting, bloody stools one day and overnight apparent abdominal pain upon feeding. The patient was diagnosed by X-ray: abdominal US (+) for IS, was reduced. The repeat US for SI was negative, which revealed mild bowel edema. Subsequently, the symptom were improved and the patient was discharged to home. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. A lot check has been requested." "The original reporting source was not provided. The VAERS ID # is 309597." Additional information was obtained on 22 July 2008 via a search of the VAERS database. The patient was four months old at the time of the event, not four years old as previously reported. All vaccines were administered on 20 February 2008, and all were the first dose. The patient presented to the hospital with a one-day history of vomiting and bloody stools. An abdominal ultrasound revealed intussusception. He underwent administration of a barium enema, and the intussusception was reduced. He was admitted to the hospital for one day following reduction, and overnight had apparent abdominal pain upon feeding. A repeat ultrasound was negative for intussusception. The patient subsequently improved, and was discharged to home on 01 April 2008. The event was considered to be resolved.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 20-FEB-2008, a 4 year old male with no relevant medical history was vaccinated with his second dose of ROTATEQ (lot number 1394U) by mouth. The suspected vaccine included ACTHIB (unspecified carrier) (lot number UF238AA, vaccinated IM into the right legs), DAPTACEL (lot number C2933B, vaccinated IM into the left leg) and IPOL (unspecified) (lot number A0474, vaccinated IM into the left leg). On 31-MAR-2008, the patient experienced abdominal pain, enema administration, gastrointestinal edema, haematochezia, intussusception and vomiting. Hospital medical records were from 31-MAR-2008 to 01-APR-2008. Records reveal that the patient experienced vomiting, bloody stools one day and overnight apparent abdominal pain upon feeding. The patient was diagnosed by X-ray: abdominal US (+) for IS, was reduced. The repeat US for SI was negative, which revealed mild bowel edema. Subsequently, the symptom were improved and the patient was discharged to home. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. A lot check has been requested." "The original reporting source was not provided. The VAERS ID # is 309597." Additional information was obtained on 22 July 2008 via a search of the VAERS database. The patient was four months old at the time of the event, not four years old as previously reported. All vaccines were administered on 20 February 2008, and all were the first dose. The patient presented to the hospital with a one-day history of vomiting and bloody stools. An abdominal ultrasound revealed intussusception. He underwent administration of a barium enema, and the intussusception was reduced. He was admitted to the hospital for one day following reduction, and overnight had apparent abdominal pain upon feeding. A repeat ultrasound was negative for intussusception. The patient subsequently improved, and was discharged to home on 01 April 2008. The event was considered to be resolved.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Abscess, Appendicectomy, Caecectomy
Clinical narrative: Initial report received on 18 July 2008 from an other manufacturer (WAES0807USA02505), who received the information identified from a line listing obtained on request from the FDA (VAERS ID # 309851). The original reporting source was not provided. Verbatim from report: "On 04-JAN-2008, a 2 month old male with gastroesophageal reflux on ZANTAC was vaccinated with a first dose of ROTATEQ (lot number 657668/1390U) by mouth. Suspected therapy included PREVNAR (unspecified) (lot number B570143D, vaccinated IM into the left leg), ACTHIB (unspecified carrier) (lot number UF218AB, vaccinated IM into the right leg) and PEDIARIX (lot number AC21B1250B, vaccinated IM into the left leg). Concomitant therapy included ranitidine hydrochloride (lot number not reported). On 10-JAN-2008, 8 days after receiving the first dose of immunizations (including ROTATEQ), the patient developed bilious vomiting and blood in stool. The patient was sent to ED and was found to have ileocecal reduced. The appendectomy records reveal that the patient experienced significant abdominal distention. The second air contrast enema was unsuccessful. The patient was well progressed post operatively and was discharged to home for the outdoor research. The listing indicated that one or more of the events required hospitalization. No further information is available. The original reporting source was not provided. The VAERS ID # 309851". Additional information was obtained on 22 July 2008 via a search of the VAERS database of VAERS ID # 309851. The subject had received on 04 January 2008 a first intramuscular, right leg injection of ACTHIB (Lot number UF218AB, Sanofi Pasteur SA lot number A0365-2), a first intramuscular left leg injection of PEDIARIX (manufacturer GlaxoSmithKline, lot number AC21B1250B), a first intramuscular left leg injection of PREVNAR (manufacturer Wyeth, lot number B70143D), and a first oral dose of ROTATEQ (manufacturer Merck, lot number 1390U (657668/01390U). Six days post-vaccination, the patient developed bilious vomiting and blood in the stool. He presented to the emergency room and was found to have ileocecal intussusception with hypoactive bowel sounds and was admitted to the hospital (11 January 2008). Air contrast enema reducing was initially thought to be successful but the patient did not improve and subsequently developed significant abdominal distention. A repeat abdominal x-ray and ultrasound were completed and the patient subsequently had a repeat enema with air contrast that was also unsuccessful. The patient was then taken to the operating room for surgical reduction of the ileocecal intussusception and underwent an ileocecectomy with primary anastomosis and appendectomy. Pathology report revealed acute adn chronic inflammation, hemorrhage, abscess formation, transmural necrosis and acute serositis. The patient progressed well post-operatively and was subsequently recovered; however the recovery date was to provided.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Gastrointestinal sounds abnormal, Haematochezia, Haemorrhage, Inflammation
Clinical narrative: Initial report received on 18 July 2008 from an other manufacturer (WAES0807USA02505), who received the information identified from a line listing obtained on request from the FDA (VAERS ID # 309851). The original reporting source was not provided. Verbatim from report: "On 04-JAN-2008, a 2 month old male with gastroesophageal reflux on ZANTAC was vaccinated with a first dose of ROTATEQ (lot number 657668/1390U) by mouth. Suspected therapy included PREVNAR (unspecified) (lot number B570143D, vaccinated IM into the left leg), ACTHIB (unspecified carrier) (lot number UF218AB, vaccinated IM into the right leg) and PEDIARIX (lot number AC21B1250B, vaccinated IM into the left leg). Concomitant therapy included ranitidine hydrochloride (lot number not reported). On 10-JAN-2008, 8 days after receiving the first dose of immunizations (including ROTATEQ), the patient developed bilious vomiting and blood in stool. The patient was sent to ED and was found to have ileocecal reduced. The appendectomy records reveal that the patient experienced significant abdominal distention. The second air contrast enema was unsuccessful. The patient was well progressed post operatively and was discharged to home for the outdoor research. The listing indicated that one or more of the events required hospitalization. No further information is available. The original reporting source was not provided. The VAERS ID # 309851". Additional information was obtained on 22 July 2008 via a search of the VAERS database of VAERS ID # 309851. The subject had received on 04 January 2008 a first intramuscular, right leg injection of ACTHIB (Lot number UF218AB, Sanofi Pasteur SA lot number A0365-2), a first intramuscular left leg injection of PEDIARIX (manufacturer GlaxoSmithKline, lot number AC21B1250B), a first intramuscular left leg injection of PREVNAR (manufacturer Wyeth, lot number B70143D), and a first oral dose of ROTATEQ (manufacturer Merck, lot number 1390U (657668/01390U). Six days post-vaccination, the patient developed bilious vomiting and blood in the stool. He presented to the emergency room and was found to have ileocecal intussusception with hypoactive bowel sounds and was admitted to the hospital (11 January 2008). Air contrast enema reducing was initially thought to be successful but the patient did not improve and subsequently developed significant abdominal distention. A repeat abdominal x-ray and ultrasound were completed and the patient subsequently had a repeat enema with air contrast that was also unsuccessful. The patient was then taken to the operating room for surgical reduction of the ileocecal intussusception and underwent an ileocecectomy with primary anastomosis and appendectomy. Pathology report revealed acute adn chronic inflammation, hemorrhage, abscess formation, transmural necrosis and acute serositis. The patient progressed well post-operatively and was subsequently recovered; however the recovery date was to provided.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intestinal anastomosis, Intussusception, Necrosis, Pathology test, Serositis
Clinical narrative: Initial report received on 18 July 2008 from an other manufacturer (WAES0807USA02505), who received the information identified from a line listing obtained on request from the FDA (VAERS ID # 309851). The original reporting source was not provided. Verbatim from report: "On 04-JAN-2008, a 2 month old male with gastroesophageal reflux on ZANTAC was vaccinated with a first dose of ROTATEQ (lot number 657668/1390U) by mouth. Suspected therapy included PREVNAR (unspecified) (lot number B570143D, vaccinated IM into the left leg), ACTHIB (unspecified carrier) (lot number UF218AB, vaccinated IM into the right leg) and PEDIARIX (lot number AC21B1250B, vaccinated IM into the left leg). Concomitant therapy included ranitidine hydrochloride (lot number not reported). On 10-JAN-2008, 8 days after receiving the first dose of immunizations (including ROTATEQ), the patient developed bilious vomiting and blood in stool. The patient was sent to ED and was found to have ileocecal reduced. The appendectomy records reveal that the patient experienced significant abdominal distention. The second air contrast enema was unsuccessful. The patient was well progressed post operatively and was discharged to home for the outdoor research. The listing indicated that one or more of the events required hospitalization. No further information is available. The original reporting source was not provided. The VAERS ID # 309851". Additional information was obtained on 22 July 2008 via a search of the VAERS database of VAERS ID # 309851. The subject had received on 04 January 2008 a first intramuscular, right leg injection of ACTHIB (Lot number UF218AB, Sanofi Pasteur SA lot number A0365-2), a first intramuscular left leg injection of PEDIARIX (manufacturer GlaxoSmithKline, lot number AC21B1250B), a first intramuscular left leg injection of PREVNAR (manufacturer Wyeth, lot number B70143D), and a first oral dose of ROTATEQ (manufacturer Merck, lot number 1390U (657668/01390U). Six days post-vaccination, the patient developed bilious vomiting and blood in the stool. He presented to the emergency room and was found to have ileocecal intussusception with hypoactive bowel sounds and was admitted to the hospital (11 January 2008). Air contrast enema reducing was initially thought to be successful but the patient did not improve and subsequently developed significant abdominal distention. A repeat abdominal x-ray and ultrasound were completed and the patient subsequently had a repeat enema with air contrast that was also unsuccessful. The patient was then taken to the operating room for surgical reduction of the ileocecal intussusception and underwent an ileocecectomy with primary anastomosis and appendectomy. Pathology report revealed acute adn chronic inflammation, hemorrhage, abscess formation, transmural necrosis and acute serositis. The patient progressed well post-operatively and was subsequently recovered; however the recovery date was to provided.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen, Vomiting
Clinical narrative: Initial report received on 18 July 2008 from an other manufacturer (WAES0807USA02505), who received the information identified from a line listing obtained on request from the FDA (VAERS ID # 309851). The original reporting source was not provided. Verbatim from report: "On 04-JAN-2008, a 2 month old male with gastroesophageal reflux on ZANTAC was vaccinated with a first dose of ROTATEQ (lot number 657668/1390U) by mouth. Suspected therapy included PREVNAR (unspecified) (lot number B570143D, vaccinated IM into the left leg), ACTHIB (unspecified carrier) (lot number UF218AB, vaccinated IM into the right leg) and PEDIARIX (lot number AC21B1250B, vaccinated IM into the left leg). Concomitant therapy included ranitidine hydrochloride (lot number not reported). On 10-JAN-2008, 8 days after receiving the first dose of immunizations (including ROTATEQ), the patient developed bilious vomiting and blood in stool. The patient was sent to ED and was found to have ileocecal reduced. The appendectomy records reveal that the patient experienced significant abdominal distention. The second air contrast enema was unsuccessful. The patient was well progressed post operatively and was discharged to home for the outdoor research. The listing indicated that one or more of the events required hospitalization. No further information is available. The original reporting source was not provided. The VAERS ID # 309851". Additional information was obtained on 22 July 2008 via a search of the VAERS database of VAERS ID # 309851. The subject had received on 04 January 2008 a first intramuscular, right leg injection of ACTHIB (Lot number UF218AB, Sanofi Pasteur SA lot number A0365-2), a first intramuscular left leg injection of PEDIARIX (manufacturer GlaxoSmithKline, lot number AC21B1250B), a first intramuscular left leg injection of PREVNAR (manufacturer Wyeth, lot number B70143D), and a first oral dose of ROTATEQ (manufacturer Merck, lot number 1390U (657668/01390U). Six days post-vaccination, the patient developed bilious vomiting and blood in the stool. He presented to the emergency room and was found to have ileocecal intussusception with hypoactive bowel sounds and was admitted to the hospital (11 January 2008). Air contrast enema reducing was initially thought to be successful but the patient did not improve and subsequently developed significant abdominal distention. A repeat abdominal x-ray and ultrasound were completed and the patient subsequently had a repeat enema with air contrast that was also unsuccessful. The patient was then taken to the operating room for surgical reduction of the ileocecal intussusception and underwent an ileocecectomy with primary anastomosis and appendectomy. Pathology report revealed acute adn chronic inflammation, hemorrhage, abscess formation, transmural necrosis and acute serositis. The patient progressed well post-operatively and was subsequently recovered; however the recovery date was to provided.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Activated partial thromboplastin time normal, Petechiae, Platelet aggregation abnormal, Platelet count normal, Prothrombin time normal
Clinical narrative: Initial report received on 04 April 2008 from a health care professional. A four-month-old male patient, with no past medical history, had received a second dose injection of ACTHIB, lot number unknown; a second dose injection of PEDIARIX, manufacturer GSK (reported as Merck), lot number unknown; and a second dose injection of PREVNAR, manufacturer Wyeth (reported as Merck), lot number unknown; on an unknown date. There was no illness at the time of vaccination, and the patient was on no other medications. Approximately 11 days post-vaccination, the patient developed petechiae. Diagnostic testing revealed an unspecific platelet aggregation disorder. PT, PTT, and platelet count were within normal limits. At the time of this report, recovery status was unknown.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hypersomnia, Injection site erythema, Screaming
Clinical narrative: Initial information was received form a health care professional on 03 July 2008. This case represents one of a cluster of two patients. A two month old female patient received the following vaccinations on 02 July 2008: an intramuscular right leg injection of ACTHIB (lot number U370AA), an intramuscular left leg injection of DAPTACEL (lot number C295BBA), an intramuscular left leg injection of IPOL (lot number A0836), an intramuscular right leg injection of PREVNAR (lot number C63110), and per oral ROTATEQ (lot number 0218X). Additionally on 02 June 2008, she had received an intramuscular right leg injection second dose of RECOMBIVAX HB (lot number 1714U). Per the reporter the patient had an URI at the time of vaccination. On 02 July 2008, approximately four hours post vaccination, the patient had redness of entire right thigh where ACTHIB and PREVNAR were given. She had episodes of screaming then sleeping for four hours after the redness was noted. The redness lasted about an hour. The patient recovered from the events. 14 July 2008: A corrective version has been created to reflect the statement of a cluster case using the latest receipt date from the previous version.  Follow up information was received on 05 August 2008 from a health care professional. The patient recovered from screaming after four hours. She was treated with TYLENOL. The patient was not on any medication for her URI which she had at the time of vaccination. The physician reported a similar adverse event in another patient. this event has been captured in case number 2008-02192.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Initial report received on 08 August 2008 from a physician.  A healthy 2-year-old male patient, had received on 04 August 2008 a fourth intramuscular injection of TRIPEDIA, (lot number U2397CA combined with a second intramuscular injection of ACTHIB (lot number UF195AB (Sanofi Pasteur SA lot number A0217-2).  The site of administration was not provided for either vaccines.  Suddenly (time not specified) the patient experienced swelling and redness of the thigh up to the knee (site not specified).  Physician follow-up check revealed some increase in the redness with no pain.  No diagnostic tests or laboratory data were performed.  The recovery status of the patient was not provided.  The reporter for this case is the same as for case 2008-02545.
Age: 19.9
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Alopecia, Contusion, Diarrhoea, Dyspnoea, Ear infection
Clinical narrative: Cough and fever. Developed pneumonia after HPV # 2. Antibiotics given.
Age: 19.9
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Full blood count, Influenza like illness, Nasopharyngitis, Pyrexia, Sinusitis
Clinical narrative: Cough and fever. Developed pneumonia after HPV # 2. Antibiotics given.
Age: 19.9
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Vomiting
Clinical narrative: Cough and fever. Developed pneumonia after HPV # 2. Antibiotics given.
Age: 19.9
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Cough, Pneumonia, Pyrexia
Clinical narrative: Cough and fever. Developed pneumonia after HPV # 2. Antibiotics given.
Age: 19.9
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Alopecia, Chest X-ray, Contusion, Diarrhoea, Dyspnoea
Clinical narrative: Cough and fever. Developed pneumonia after HPV # 2. Antibiotics given.
Age: 19.9
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Ear infection, Influenza like illness, Nasopharyngitis, Pneumonia, Pyrexia
Clinical narrative: Cough and fever. Developed pneumonia after HPV # 2. Antibiotics given.
Age: 19.9
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Sinusitis, Vomiting
Clinical narrative: Cough and fever. Developed pneumonia after HPV # 2. Antibiotics given.