chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Disturbance in attention, Headache, Insomnia, Laboratory test, Nausea
Clinical narrative: This non serious case was received on 20 February 2009 from a health care professional.  A 13 year old female patient who inadvertently received a second dose of MENACTRA on 26 December 2008 instead of receiving GARDASIL vaccine.  The lot number, route and site of administration was not reported.  The patient's first dose of MENACTRA was four months prior.  The lot number, route and site of administration was not reported.  On approximately 10 February 2009 the patient developed daily headaches, nausea, inability to focus at school, and poor sleep.  The patient returned to the office 18 February 2009 and continued to complain of daily headaches.  Lab work was completed and the patient was referred to a neurologist for evaluation.  No further details were provided.  The patient was not recovered at the time of the report.  List of Documents held by Sender: none.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: This non serious case was received on 20 February 2009 from a health care professional.  A 13 year old female patient who inadvertently received a second dose of MENACTRA on 26 December 2008 instead of receiving GARDASIL vaccine.  The lot number, route and site of administration was not reported.  The patient's first dose of MENACTRA was four months prior.  The lot number, route and site of administration was not reported.  On approximately 10 February 2009 the patient developed daily headaches, nausea, inability to focus at school, and poor sleep.  The patient returned to the office 18 February 2009 and continued to complain of daily headaches.  Lab work was completed and the patient was referred to a neurologist for evaluation.  No further details were provided.  The patient was not recovered at the time of the report.  List of Documents held by Sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Tremor
Clinical narrative: Initial report received on 11 February 2009 from a healthcare professional.  A 17-year-old female patient, with an allergy to penicillin, received a first left deltoid intramuscular injection of MENACTRA (lot number U2660BA) on 10 February 2009 at 11:00.  The patient had no medical conditions, no concomitant drugs or illness at the time of vaccination.  Six hours after vaccination, at 17:00, the patient returned to the physician's office and was observed to have bilateral leg tremors.  The patient was sent home and was to be reassessed by the physician the following day.  No other information was reported.  The patient's recovery status was reported as unknown. Follow-up information received 16 March 2009 from a healthcare provider who reviewed the case and had no new relevant medically significant information to provide at the time of the report.   Follow-up information received 03 April 2009 from a health care provider who reviewed the case and had no new relevant medically significant information to provide at the time of the report. Documents held by sender: None.
Age: 0.8
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HIBV, PNC
Symptoms: Cough, Erythema, Injection site erythema, Injection site swelling, Nasopharyngitis
Clinical narrative: Initial and follow-up information has been received from a physician and a nurse concerning a 10 month old male who had a history of being born premature 35 weeks, and had hyperbilirubinemia 1 week of age.  The child had a history of a fever and redness at the injection site with prior vaccination (unspecified).  His siblings (2) also experienced a fever and redness at the injection site with prior vaccination (unspecified).  On an unspecified date, the patient was vaccinated with the first dose of PEDVAXHIB.  At the time of being vaccinated with the second dose, the child had no illness.  On 27-NOV-2007, the child was vaccinated with a second dose of PEDVAXHIB (lot # 656519/0259U) IM in the left vastus laterlis (LVL) at 11 AM.  Concomitant therapy given also on 27-NOV-2007 included PEDIARIX (lot # AC21B125BB) IM in the right vastus lateralis (RVL); PREVNAR (lot # B70143C) IM in the right vastus lateralis (RVL); and DTAP.  On 27-NOV-2007, in the PM, the patient experienced a fever up to 102.5 degrees.  On 28-NOV-2007, the second day, the fever was 100 and on 29-NOV-2007, the 3rd day post injection was afebrile.  The patient also experienced redness of both legs, swelling at the injection site, and swelling of one of his legs which took about 2 weeks to resolve.  It was reported that the patient also received DTAP on the same day in one leg and PEDVAXHIB in the other.  The mother of the patient did not remember which leg was injected with what vaccine.  No treatment was given.  Medical attention was not sought.  No diagnostic tests were performed.  Follow-up information was received from a nurse.  On 21-DEC-2007 at 3 PM, the mother called the clinic and reported that her child has a bad viral cold since receiving the vaccine and has not gotten better.  The mother had received a letter about PEDVAXHIB vaccine bad lot.  The child now had a cold, and is congested.  Coughing is bad at night time.  No fever.  The child is teething so the child has been given TYLENOL and MOTRIN.  The mother was told to bring the child to the clinic on 21-DEC-2007.  The outcome of the viral cold, cough, and congestion was not reported.  No additional information is expected.
Age: 0.8
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Respiratory tract congestion, Viral infection
Clinical narrative: Initial and follow-up information has been received from a physician and a nurse concerning a 10 month old male who had a history of being born premature 35 weeks, and had hyperbilirubinemia 1 week of age.  The child had a history of a fever and redness at the injection site with prior vaccination (unspecified).  His siblings (2) also experienced a fever and redness at the injection site with prior vaccination (unspecified).  On an unspecified date, the patient was vaccinated with the first dose of PEDVAXHIB.  At the time of being vaccinated with the second dose, the child had no illness.  On 27-NOV-2007, the child was vaccinated with a second dose of PEDVAXHIB (lot # 656519/0259U) IM in the left vastus laterlis (LVL) at 11 AM.  Concomitant therapy given also on 27-NOV-2007 included PEDIARIX (lot # AC21B125BB) IM in the right vastus lateralis (RVL); PREVNAR (lot # B70143C) IM in the right vastus lateralis (RVL); and DTAP.  On 27-NOV-2007, in the PM, the patient experienced a fever up to 102.5 degrees.  On 28-NOV-2007, the second day, the fever was 100 and on 29-NOV-2007, the 3rd day post injection was afebrile.  The patient also experienced redness of both legs, swelling at the injection site, and swelling of one of his legs which took about 2 weeks to resolve.  It was reported that the patient also received DTAP on the same day in one leg and PEDVAXHIB in the other.  The mother of the patient did not remember which leg was injected with what vaccine.  No treatment was given.  Medical attention was not sought.  No diagnostic tests were performed.  Follow-up information was received from a nurse.  On 21-DEC-2007 at 3 PM, the mother called the clinic and reported that her child has a bad viral cold since receiving the vaccine and has not gotten better.  The mother had received a letter about PEDVAXHIB vaccine bad lot.  The child now had a cold, and is congested.  Coughing is bad at night time.  No fever.  The child is teething so the child has been given TYLENOL and MOTRIN.  The mother was told to bring the child to the clinic on 21-DEC-2007.  The outcome of the viral cold, cough, and congestion was not reported.  No additional information is expected.
Age: 1.2
Sex: F
Vaccine: FLU3, HIBV, PNC
Symptoms: Abasia, Crying, Injection site swelling, Limb injury, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 14 month old niece, with no medical history and no allergies, who on 10-DEC-2007 was vaccinated with a dose of PREVNAR (manufacturer unknown).  Concomitant suspect vaccination included PEDVAXHIB.  Other concomitant vaccine included a dose of FLUZONE (unspecified).  Two vaccines were administered in the right thigh region, and the third was administered on her left thigh.  It was reported that, on 10-DEC-2007, "When the nurse administered the vaccine, the needle went through her leg and out the other side".  The area swelled up twice the normal size.  The patient was unable to walk for two days.  The patient also experienced a fever and was crying all evening and night.  At the time of the report the patient was recovering.  It was noted that the patient was checked at a clinic.  There were no laboratory of diagnostic tests performed.  No product quality complaint was involved.  No other information was provided.  Follow-up information was reported by a nurse who stated that the patient received PEDVAXHIB and "the needle went through the other side".  Additional follow-up information was received from a physician and a Medical Assistant who clarified that the patient never received PREVNAR (manufacturer unknown) or PEDVAXHIB.  It was reported that on 10-DEC-2007, the patient received the following vaccinations:  PEDVAXHIB, Lot # 657392/1164U, right thigh, concomitant suspect therapy, PREVNAR (manufacturer Wyeth), Lot # 854015C, left thigh and FLUZONE, (manufacturer Sanofi). Lot # U2512AA, right thigh.  The physician stated that the vaccine that was injected by incorrect technique on 10-DEC-2007 was PREVNAR.  The physician stated that the patient had recovered.  Additional information is not expected.
Age: 1.2
Sex: F
Vaccine: FLU3, HIBV, PNC
Symptoms: Wrong technique in drug usage process
Clinical narrative: Information has been received from a consumer concerning her 14 month old niece, with no medical history and no allergies, who on 10-DEC-2007 was vaccinated with a dose of PREVNAR (manufacturer unknown).  Concomitant suspect vaccination included PEDVAXHIB.  Other concomitant vaccine included a dose of FLUZONE (unspecified).  Two vaccines were administered in the right thigh region, and the third was administered on her left thigh.  It was reported that, on 10-DEC-2007, "When the nurse administered the vaccine, the needle went through her leg and out the other side".  The area swelled up twice the normal size.  The patient was unable to walk for two days.  The patient also experienced a fever and was crying all evening and night.  At the time of the report the patient was recovering.  It was noted that the patient was checked at a clinic.  There were no laboratory of diagnostic tests performed.  No product quality complaint was involved.  No other information was provided.  Follow-up information was reported by a nurse who stated that the patient received PEDVAXHIB and "the needle went through the other side".  Additional follow-up information was received from a physician and a Medical Assistant who clarified that the patient never received PREVNAR (manufacturer unknown) or PEDVAXHIB.  It was reported that on 10-DEC-2007, the patient received the following vaccinations:  PEDVAXHIB, Lot # 657392/1164U, right thigh, concomitant suspect therapy, PREVNAR (manufacturer Wyeth), Lot # 854015C, left thigh and FLUZONE, (manufacturer Sanofi). Lot # U2512AA, right thigh.  The physician stated that the vaccine that was injected by incorrect technique on 10-DEC-2007 was PREVNAR.  The physician stated that the patient had recovered.  Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: HIBV
Symptoms: Blood test, Chest X-ray, Laboratory test, Pyrexia, Urine analysis
Clinical narrative: Information has been received from a consumer concerning her 13 month old son with no medical history and an allergy to amoxicillin who on 10-NOV-2007, was vaccinated with a dose of HIB. On 12-NOV-2007, the patient experienced a fever. He has a second fever a week after that and a third fever on 21-DEC-2007. Each time he was taken to local emergency room and was given TYLENOL and MOTIN. At his last visit, tests were done to identify the cause of the fever and to no avail. Laboratory diagnostic studies performed included unspecified blood work, a chest x-ray and a urine test. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M normal, Joint effusion, Muscular weakness, Red blood cell count increased
Clinical narrative: Information has been received from a Nurse Practitioner, (N.P.), concerning a 2 year old male patient who on 10-DEC-2007 was vaccinated IM i "left arm" with a dose of PEDVAXHIB , 656519/0259U.  Two days post vaccination the patient was taken to the emergency room with left leg weakness, swelling, and left knee joint effusion.  CBC blood work tests were performed, white blood count was elevated, sedimentation rate elevated.  Also, blood work tests for Parvovirus B19, Streptococcus, and Lyme disease performed.  Result for Lyme disease was IGM negative, and IGG positive.  The child was not hospitalized.  He was scheduled for follow up with an orthopedic specialist the next day and treated with AMOXICILLIN and NAPROXEN.  The reporter stated the child's adverse event resolved by itself.  Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Swelling, White blood cell count increased
Clinical narrative: Information has been received from a Nurse Practitioner, (N.P.), concerning a 2 year old male patient who on 10-DEC-2007 was vaccinated IM i "left arm" with a dose of PEDVAXHIB , 656519/0259U.  Two days post vaccination the patient was taken to the emergency room with left leg weakness, swelling, and left knee joint effusion.  CBC blood work tests were performed, white blood count was elevated, sedimentation rate elevated.  Also, blood work tests for Parvovirus B19, Streptococcus, and Lyme disease performed.  Result for Lyme disease was IGM negative, and IGG positive.  The child was not hospitalized.  He was scheduled for follow up with an orthopedic specialist the next day and treated with AMOXICILLIN and NAPROXEN.  The reporter stated the child's adverse event resolved by itself.  Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Antibody test negative, Incorrect dose administered
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 3 year old female with chronic ear infections and nasal congestion, and with no drug allergies, who, on an unspecified date, was vaccinated with the first two doses of PEDVAXHIB and then was vaccinated with two doses of ACTHIB.  Subsequently, the patient experienced low Haemophilus influenzae type b titer.  The patient's Haemophilus influenzae type b titer result was 0.96, and the lab's reference range was reported to be 1.00 and greater.  The patient was seen at the office.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: HIBV
Symptoms: Pharyngitis streptococcal
Clinical narrative: Initial and follow-up information has been received from a physical therapist concerning a 5 year old female, who on 26-OCT-2007 was vaccinated with a first dose of PEDVAXHIB.  Subsequently, since the vaccination the patient has experienced strep throat.  It was reported that the patient had failed two courses of antibiotics.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Follow-up information indicated that it was later determined that the strep throat was unrelated to the vaccination.  Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 15 month old male with no illness at the time of being vaccinated and no pre-existing illness who on 03-DEC-2007, at approximately 11 AM, was vaccinated with a first dose of PEDVAXHIB (lot # 656522/0437U)  IM in the left thigh.  On 03-DEC-2007, within 24 hours of being vaccinated, the patient developed watery stools that lasted for 2 weeks.  Medical attention was sought.  The patient did not have a fever or vomiting.  No one else was with illness.  No diagnostic tests were performed.  The diarrhea lasted 2 and 1/2 weeks that prompted a repeat visit.  On an unspecified date, the patient recovered.  The physician reported that the lot number was one of the recalled lots.  No additional information is expected.
Age: 1.5
Sex: F
Vaccine: HIBV, PNC
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician and a medical assistant concerning an 18 month old female patient with a peanut allergy, who on 03-JAN-2008 was vaccinated intramuscularly into the left thigh with the second dose of PEDVAXHIB (Lot # 656518/0258U).  Concomitant therapy included intramuscular vaccination into the right thigh with the second dose of PREVNAR (Lot # B04190).  On 09-JAN-2008 at 12:14 pm, the patient experienced a pea size, (1 centimeter) rash on the face, leg, hands and groin area.  It was reported that the patient was also given a new food, yogurt with strawberries.  The reporter indicated a questionable allergy to strawberries.  The patient was diagnosed with urticaria.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning his approximately 15 month old daughter who on 12-DEC-2007 was vaccinated with a dose of PEDVAXHIB.  Concomitant vaccinations on 12-DEC-2007 included VARIVAX (Oka/Merck) (MSD) and M-M-R II (Wistar RA 27/3) (MSD).  Illness at time of vaccination included a cold and ear infection.  Other concomitant therapy included AUGMENTIN.  In December 2007, "several days later," the patient developed a "huge, red, swollen area on her leg in the precise area where was given her vaccine."  The patient's doctor was called immediately and was told to bring the patient in.  On 24-DEC-207, the patient was diagnosed with an infection in the leg area where her vaccine had been administered.  The patient was immediately treated with CEPHALEXIN.  At the time of the report, the patient still had significant area of leg infected which was extremely painful to touch but "appears to be recovering."  It was reported that the patient's physician said that she may be left with a permanent knot on her thigh.  It was reported that the physician stated that had the patient not been on an antibiotic for an ear infection, the infection could have potentially been "devastational" and that the antibiotics somewhat controlled the infection and controlled it to this isolated area.  No further information is available.
Age: 0.6
Sex: F
Vaccine: HIBV
Symptoms: Injection site induration
Clinical narrative: Information has been received from a physician concerning a 7 month old female with no pertinent medical history and no drug reactions or allergies, who on 24-JAN-2008 was vaccinated intramuscularly with PEDVAXHIB, (Lot # 657386/0820U).  There was no concomitant medication.  The patient experienced a local induration at the site of injection.  The area was not red, not warm and not inflamed.  It was confirmed by the physician PEDVAXHIB was accidentally given after the recall.  The physician already filed a report with VAERS.  No further information was available.  This is case 2 of 2.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 12 month old son who on 28-NOV-2006 was vaccinated with the third dose of PEDVAXHIB (Lot #657176/0499U).  On 08-OCT-2007 the patient experienced vomiting and diarrhea.  Subsequently, the patient recovered from vomiting and diarrhea.  Follow up information was received from the physician reporting that no adverse reactions as per their records.  Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HIBV
Symptoms: Convulsion, Kawasaki's disease
Clinical narrative: Information has been received regarding a case in litigation from a lawyer via paralegal articles concerning a 6 year old female child with enterovirus infection who in approximately January 2001, was vaccinated with PEDVAXHIB (OMPC) (manufacturer unknown) (lot # not reported).  Concomitant suspect therapy included DTaP (manufacturer unknown).  Subsequently the patient experienced seizure and Kawasaki disease.  The outcome was unknown.  Upon internal review seizure was determined to be an other important medical event.  No further information is available.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Decreased appetite, Ear infection, Injection site rash, Pyrexia, Sinusitis
Clinical narrative: Information has been received from a mother concerning her 12 month old son with an unremarkable medical history and no allergies, who was vaccinated with a first and second dose of PEDVAXHIB.  There was no concomitant medication.  On 14-FEB-2008, shortly after receiving the second dose of PEDVAXHIB, the patient developed a rash at the injection site.  Subsequently, the patient also experienced sinusitis, fever, ear infection and loss of appetite.  The patient sought unspecified medical attention.  The reporter states that the rash has improved, but all other events have not been reversed.  No diagnostic studies were performed.  No product quality complaint was involved.  Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: HIBV, PNC
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Information has been received from a occupational therapist concerning her 5 year old daughter with pertinent medical history and drug reaction/allergies reported as none who in 2003 was vaccinated with a dose of PEDVAXHIB and concomitantly with PREVNAR.  In 2003 later that day, the patient experienced a high fever and breathing irregularities that lasted one week.  Unspecified medical attention was sought.  Subsequently on an unspecified date, the patient recovered from high fever and breathing irregularities.  No product quality complaint was involved.  Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Nervous system disorder, Tremor
Clinical narrative: Information has been received for a case in litigation from information obtained from a published literature article concerning a 4 month old female who on 24-JUN-2002 was vaccinated with a dose of PEDVAXHIB and concomitantly with DTAP and poliovirus vaccine.  Within 24 hours, the patient began to exhibit unusual shaking movements, which proved to be symptoms of a neurological disorder.  The reporter felt that neurological disorder was related to therapy with PEDVAXHIB.  The outcome of the event was not reported.  No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Cough, Influenza, Monocyte count increased, Nasal congestion
Clinical narrative: Information has been received from a physician via medical records concerning a 16 week old female with no known drug allergies, a gastrointestinal reflux disease, and a history of congenital genital malformation female, colic, left nasolacrimal duct stenosis, mild gynecomastia, mild jaundice and sudden screaming (all events reported in WAES # 0704USA06160) who on 11-JAN-2008 was vaccinated with a first dose of PEDVAXHIB (lot # 656518/0258U) in the left thigh.  Concomitant therapy also given on 11-JAN-2008 included a first dose of ROTATEQ (lot # 657292/0551U);  a first dose of PEDIARIX (lot # AC21B129AA) in the right thigh; and a first dose of PREVNAR (lot # B54016SD) in the left thigh.  Other concomitant therapy included ZANTAC and TYLENOL.  On 05-MAR-2008, the patient was seen in the physician's office for a fever of 102.9 degrees for 24 hours, occasional cough, nasal congestion, and green nasal discharge.  Her temperature in the office was 99.9 degrees rectally.  Lungs were clear to auscultation.  Diagnosis was influenza.  The patient was prescribed TAMIFLU 60/5  1/2 teaspoon bid for 5 days. On an unspecified date, the patient recovered.  Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Nasal mucosal discolouration, Pyrexia, White blood cell count normal
Clinical narrative: Information has been received from a physician via medical records concerning a 16 week old female with no known drug allergies, a gastrointestinal reflux disease, and a history of congenital genital malformation female, colic, left nasolacrimal duct stenosis, mild gynecomastia, mild jaundice and sudden screaming (all events reported in WAES # 0704USA06160) who on 11-JAN-2008 was vaccinated with a first dose of PEDVAXHIB (lot # 656518/0258U) in the left thigh.  Concomitant therapy also given on 11-JAN-2008 included a first dose of ROTATEQ (lot # 657292/0551U);  a first dose of PEDIARIX (lot # AC21B129AA) in the right thigh; and a first dose of PREVNAR (lot # B54016SD) in the left thigh.  Other concomitant therapy included ZANTAC and TYLENOL.  On 05-MAR-2008, the patient was seen in the physician's office for a fever of 102.9 degrees for 24 hours, occasional cough, nasal congestion, and green nasal discharge.  Her temperature in the office was 99.9 degrees rectally.  Lungs were clear to auscultation.  Diagnosis was influenza.  The patient was prescribed TAMIFLU 60/5  1/2 teaspoon bid for 5 days. On an unspecified date, the patient recovered.  Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, UNK
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 1 year old daughter with a murmur and no drug reactions/allergies who on 15-NOV-2007 was vaccinated with a third dose of PEDVAXHIB (lot# 655546/0075U) injected in her leg.  Concomitant therapy on 15-NOV-2007 included PEDIARIX and (therapy unspecified) "PCV vaccine" (manufacturer unspecified).  On 15-NOV-2007 the patient experienced swelling of both legs twice the normal sized and a fever after receiving the third dose of PEDVAXHIB.  No further information was given.  Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cough, Diarrhoea, Infantile spitting up, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
Clinical narrative: Information has been received from pediatric medical records and a pediatrician concerning a 19 week old male patient with a history of respiratory syncytial virus infection (Hospitalized at 2 weeks of age), failure to gain weight and stuffy nose who on 08-FEB-2008, was vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIX, PREVNAR and ROTATEQ.  At this visit the patient's mother states that her son is still a little congested and occasionally snorts from a previous questionable ear infection.  On 11-APR-2008, the patient was again vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIX, PREVNAR and ROTATEQ.  On 21-APR-2008, the patient experienced a cough, clear runny nose and some congestion.  He also had a little bit of wheezing.  No fever was noted (97.8).  He also had some diarrhea that has continue on and off with a little bit of spitting up but no true vomiting.  Laboratory diagnostic studies performed on 22-APR-2008 was a swab to test for RSV which was reported as positive.  The patient was alert and did not appear to be ill.  He was well hydrated with a moist oral mucosa.  He was smiling and quite active.  His lungs were clear, no rales, rhonchi or wheeze.  The physician wrote a prescription for a nebulizer machine and ALBUTEROL.  The order was to fill only if necessary and follow up if the baby was not improving or was worse.  On 02-JUN-2008, the patient was vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIS, PREVNAR and ROTATEQ.  At this visit the mother was concerned about the patient's cough which he has had for the last four days beginning on 29-MAY-2008.  He has also had some slight wheezing associated with this.  No fever was noted but he has had some rhinorrhea.  The plan was to monitor the patient and his development and follow up when he is nine months of age.  The mother was in agreement with this plan.  On 05-JUN-2008, a follow up renal ultrasound appointment was made for 06-JUN-2008.  On 09-JUN-2008, a prescription for AMOX, 400/5, 3/4 tsp twice a day for 10 days for cough and "mallery eyes" was written for the patient.  Subsequently, the patient recovered from RSV and diarrhea.  The patient's cough, slight wheezing, rhinorrhea and "mallery eyes" persisted.  Additional information has been requested.  All medical records will be available upon request.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory tract congestion, Rhinorrhoea, Ultrasound scan, Wheezing
Clinical narrative: Information has been received from pediatric medical records and a pediatrician concerning a 19 week old male patient with a history of respiratory syncytial virus infection (Hospitalized at 2 weeks of age), failure to gain weight and stuffy nose who on 08-FEB-2008, was vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIX, PREVNAR and ROTATEQ.  At this visit the patient's mother states that her son is still a little congested and occasionally snorts from a previous questionable ear infection.  On 11-APR-2008, the patient was again vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIX, PREVNAR and ROTATEQ.  On 21-APR-2008, the patient experienced a cough, clear runny nose and some congestion.  He also had a little bit of wheezing.  No fever was noted (97.8).  He also had some diarrhea that has continue on and off with a little bit of spitting up but no true vomiting.  Laboratory diagnostic studies performed on 22-APR-2008 was a swab to test for RSV which was reported as positive.  The patient was alert and did not appear to be ill.  He was well hydrated with a moist oral mucosa.  He was smiling and quite active.  His lungs were clear, no rales, rhonchi or wheeze.  The physician wrote a prescription for a nebulizer machine and ALBUTEROL.  The order was to fill only if necessary and follow up if the baby was not improving or was worse.  On 02-JUN-2008, the patient was vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIS, PREVNAR and ROTATEQ.  At this visit the mother was concerned about the patient's cough which he has had for the last four days beginning on 29-MAY-2008.  He has also had some slight wheezing associated with this.  No fever was noted but he has had some rhinorrhea.  The plan was to monitor the patient and his development and follow up when he is nine months of age.  The mother was in agreement with this plan.  On 05-JUN-2008, a follow up renal ultrasound appointment was made for 06-JUN-2008.  On 09-JUN-2008, a prescription for AMOX, 400/5, 3/4 tsp twice a day for 10 days for cough and "mallery eyes" was written for the patient.  Subsequently, the patient recovered from RSV and diarrhea.  The patient's cough, slight wheezing, rhinorrhea and "mallery eyes" persisted.  Additional information has been requested.  All medical records will be available upon request.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Constipation, Eczema, Positional plagiocephaly
Clinical narrative: Information has been received from a physician in the form of pediatric medical records which were received and reviewed concerning an approximately 3 month old normal female infant with a history of upper respiratory tract infection and constipation and with thrush and positional plagiocephaly (WAES # 0708USA01526), who on 09-MAY-2008 was vaccinated with PEDVAXHIB and PEDIARIX and PREVNAR.  On 09-MAY-2008 the infant was noted to have age appropriate growth and development weighted: 12 pounds, Height:  24 inches, and (FOC):  41.4.  Physical exam revealed positional plagiocephaly (infant was encouraged to look towards left) and constipation.  Reinforced safe sleep practices, supervised (tummy time) were recommended.  Also 1 ounce of prune juice added to 1 or 2 bottles of formula per day was recommended.  In June 2008, the approximately 3 month old infant with age appropriate growth and development weighted 15 pounds and 1 ounce.  Height:  25, 5 inches and FOC: 43.0  Physical exams were normal.  Ocassional constipation was noted.  Reinforced safe sleep practices supervised were  recommended (tummy time).  On 19-JUN-2008, mild eczema-like rash was noted on left cheek treated with EUCERIN.  On 15-JUL-2008 the approximately 4 months and a half old infant was vaccinated with PEDIARIX, PEDVAXHIB, PREVNAR.  Weight 16 pounds.  Height:  26.25 inches and FOC: 44.4  Physical and development exams were normal.  No further information is available.
Age: 0.3
Sex: F
Vaccine: HIBV
Symptoms: Candidiasis, Dermatitis diaper, Rash erythematous, Rash papular
Clinical narrative: Information has been received from a physician in the form of medical record concerning a white female patient who on 18-MAR-2008 was vaccinated with the first dose of PEDVAXHIB, on 15-MAY-2008 was vaccinated with the second dose of PEDVAXHIB and on 22-JUL-2008 was vaccinated with the third dose of PEDVAXHIB.  Secondary suspect therapy included HEPATITIS B VIRUS vaccine rHBsAg (yeast) (manufacturer unknown).  Concomitant therapy included POLIOVAX and PNEUMOCOCCAL vaccine (unspecified).  On 25-JUN-2008 the patient experienced mild thrush.  The physician advised to hold on treatment for a few days and see if it resolved on its own since it was a very mild case.  Also use some water after bottle to rinse and if she failed to improve or she worsened start the NYSTATIN ORAL suspension after feeding 1 ml 4 times a day, paint on and use until clear.  Subsequently, the patient experienced very mild papular rash over the entire perineum both labia down through the buttock and cheeks.  No pustules, no vesicles.  Diaper rash may indeed of fungal nature in that it was redder.  The patient's mom had been using NYSTATIN and it seems to be fading.  However, the patient was teething and acidic urine might be responsible for symptoms as well.  The patient would use very thin layer of cream sparingly once a day and might continue with the rest of the NYSTATIN.  On an unspecified date, the patient's skin there was fairly symmetrical clusters of 2-3 mm mildly erythematous, popular lesions on posterior aspect of both thighs just inferior to the diaper line.  Several of the lesions appeared umbilicated although not all of them did.  Rash, bilateral posterior thighs was most similar to molluscum but that it could be another form of viral rash.  This type of rash could linger for several weeks.  At the time of reporting, the outcome was unknown.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a female patient with allergic reaction to antibiotics cefaclor who was vaccinated with a dose of HIB (date not reported). The nurse reported that the patient had an allergic reaction to HIB. This incident occurred years ago (date, year not specified). The patient recovered. No other information was available. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a 16 week old female with a history of nasal congestion and constipation who on 22-JUL-2008 was vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIX and PREVNAR.  On 11-SEP-2008 the baby was seen for an upper respiratory infection (URI).  Eating and drinking well  with good urine output.  Mother described clear nasal drainage without respiratory difficulty and no fever.  Symptoms were better with TYLENOL.  Fluids, vapor, nasal saline and over the counter acetaminophen was recommended and follow up in 3 days if not significantly better, or sooner if worse.  On 01-OCT-2008 the baby was seen for a 4-5 month well child visit with no concerns from parents and was doing well.  No further information is available.
Age: 0.4
Sex: M
Vaccine: HIBV, PNC
Symptoms: Decreased appetite, Diarrhoea, Gastroenteritis, Insomnia, Nasal congestion
Clinical narrative: Information has been received from a physician concerning a 23 week old male with a history jaundice and group b betahaemolytic streptococcal positive who on 10-MAY-2008 was vaccinated with HIB (manufacturer unknown) (Lot # not provided). Concomitant therapy included PREVNAR. On 4-AUG-2008 the patient was seen in the office with a history of 5 days of diarrhea (10 or more loose stools/ day), decreased sleep and appetite and nasal congestion. The baby formula was switched to lactose free formula and it was recommended that PEDIALYTE be continued. Diaper cream was recommended to be applied three times a day, as needed. On an unspecified date the baby recovered from gastroenteritis. On 26-SEP-2008 the patient was seen in the doctor's office and diagnosed with otitis media and placed on therapy with AMOXIL. Subsequently, the patient recovered from otitis media on an unspecified date. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: HIBV, PNC
Symptoms: Otitis media
Clinical narrative: Information has been received from a physician concerning a 23 week old male with a history jaundice and group b betahaemolytic streptococcal positive who on 10-MAY-2008 was vaccinated with HIB (manufacturer unknown) (Lot # not provided). Concomitant therapy included PREVNAR. On 4-AUG-2008 the patient was seen in the office with a history of 5 days of diarrhea (10 or more loose stools/ day), decreased sleep and appetite and nasal congestion. The baby formula was switched to lactose free formula and it was recommended that PEDIALYTE be continued. Diaper cream was recommended to be applied three times a day, as needed. On an unspecified date the baby recovered from gastroenteritis. On 26-SEP-2008 the patient was seen in the doctor's office and diagnosed with otitis media and placed on therapy with AMOXIL. Subsequently, the patient recovered from otitis media on an unspecified date. Additional information has been requested.
Sex: M
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: This adult male (unknown age) took the first dose of VIVOTIF (Batch no. : unknown) on unknown date.  Within one day he experienced severe nausea why he was unable to go to work.  The patient didn't continue with the oral typhoid immunization.  Unknown recovery status.  Follow-up information was requested on 07.Apr.2008 and 05.May.2008 by PV Crucell, Berna Products tried to reach the patient by phone.  No further information was received.
Age: 9.0
Sex: U
Vaccine: TYP
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Initial report was received on 22. Jul.2008 from a physician.  This 9-year old patient took first dose of VIVOTIF (Batch no.: unknown) on 21.JUL.2008.  The patient developed pruritic, papular erythematous rash on extensor surface of arms and on back.  According to the mother the symptoms were to come and go.  Otherwise the child had no systemic complaints, no fever, no chills, no shortness of breath and no cold or flu.  The patient was healthy when he took VIVOTIF.  This case was forwarded by Crucell / Berna Products.  Follow-up information was requested on 23.Jul.2008, 22.Aug.2008, 19.Sep.2008.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Encapsulation reaction, Injection site erythema, Injection site inflammation, Pain
Clinical narrative: This case was reported by a physician (also the father of the subject) and described the occurrence of encapsulation reaction in a 2-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline) as well as DTAP (unspecified manufacturer). Concurrent vaccination included IPV (manufacturer unspecified) given on 02 March 2009. There were no concurrent medications. On an unspecified date when the subject was 2 years old, he received 1st dose of DTAP. Approximately 2 to 3 days following administration of DTAP, the injection site was red, inflamed and encapsulated. The subject was taken to the emergency room and the encapsulation was filled with puss and had to be surgically removed. This required stitches and the subject developed a scar. The redness, inflammation and encapsulation were reportedly improved. The same thing happened to the subject following his 2nd dose of DTAP when he was 4 years old (dates not provided). Within 2 to 3 days of administration of the 2nd DTAP dose, the subject developed injection site redness, inflammation and encapsulation. These events were described as improved. On 02 March 2009 at 13:00 the subject at the age of 5 received 3rd dose of INFANRIX. The next day, on 03 March 2009, the subject developed a rash that at the time of reporting continued to worsen, spreading down the leg. It was reported that the subject was unable to bear weight on that leg. The rash was described as red, irritated and very painful. Additionally, he was running a fever which was treated with TYLENOL. The subject's pediatrician reported that the subject had cellulitis. He was started on antibiotics. The outcome of cellulitis, unable to bear weight on leg and fever were unknown at the time of reporting. The physician considered the events were probably related to vaccination with INFANRIX and DTAP.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Rash, Scar, Surgery, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician (also the father of the subject) and described the occurrence of encapsulation reaction in a 2-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline) as well as DTAP (unspecified manufacturer). Concurrent vaccination included IPV (manufacturer unspecified) given on 02 March 2009. There were no concurrent medications. On an unspecified date when the subject was 2 years old, he received 1st dose of DTAP. Approximately 2 to 3 days following administration of DTAP, the injection site was red, inflamed and encapsulated. The subject was taken to the emergency room and the encapsulation was filled with puss and had to be surgically removed. This required stitches and the subject developed a scar. The redness, inflammation and encapsulation were reportedly improved. The same thing happened to the subject following his 2nd dose of DTAP when he was 4 years old (dates not provided). Within 2 to 3 days of administration of the 2nd DTAP dose, the subject developed injection site redness, inflammation and encapsulation. These events were described as improved. On 02 March 2009 at 13:00 the subject at the age of 5 received 3rd dose of INFANRIX. The next day, on 03 March 2009, the subject developed a rash that at the time of reporting continued to worsen, spreading down the leg. It was reported that the subject was unable to bear weight on that leg. The rash was described as red, irritated and very painful. Additionally, he was running a fever which was treated with TYLENOL. The subject's pediatrician reported that the subject had cellulitis. He was started on antibiotics. The outcome of cellulitis, unable to bear weight on leg and fever were unknown at the time of reporting. The physician considered the events were probably related to vaccination with INFANRIX and DTAP.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Weight bearing difficulty
Clinical narrative: This case was reported by a physician (also the father of the subject) and described the occurrence of encapsulation reaction in a 2-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline) as well as DTAP (unspecified manufacturer). Concurrent vaccination included IPV (manufacturer unspecified) given on 02 March 2009. There were no concurrent medications. On an unspecified date when the subject was 2 years old, he received 1st dose of DTAP. Approximately 2 to 3 days following administration of DTAP, the injection site was red, inflamed and encapsulated. The subject was taken to the emergency room and the encapsulation was filled with puss and had to be surgically removed. This required stitches and the subject developed a scar. The redness, inflammation and encapsulation were reportedly improved. The same thing happened to the subject following his 2nd dose of DTAP when he was 4 years old (dates not provided). Within 2 to 3 days of administration of the 2nd DTAP dose, the subject developed injection site redness, inflammation and encapsulation. These events were described as improved. On 02 March 2009 at 13:00 the subject at the age of 5 received 3rd dose of INFANRIX. The next day, on 03 March 2009, the subject developed a rash that at the time of reporting continued to worsen, spreading down the leg. It was reported that the subject was unable to bear weight on that leg. The rash was described as red, irritated and very painful. Additionally, he was running a fever which was treated with TYLENOL. The subject's pediatrician reported that the subject had cellulitis. He was started on antibiotics. The outcome of cellulitis, unable to bear weight on leg and fever were unknown at the time of reporting. The physician considered the events were probably related to vaccination with INFANRIX and DTAP.
Age: 1.72
Sex: F
Vaccine: DTAP, MMRV, UNK
Symptoms: Injection site erythema, Injection site rash, Malaise, Rash erythematous, Rash generalised
Clinical narrative: Patient was given vaccines on 2/25/09, developed a red cluster of bumps on right leg where vaccine was given on 3/6/09, and by 3/8/09 a full body rash of red spots had developed. As of 3/13/09, the rash is still all over her body and face, and she's not feeling well. (No fever however) I've spoken with 3 different nurses and nobody knows how long it will take to go away. The clinic has the names of vaccines and where they were given, (right and left legs) lot numbers, etc. in her chart.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Autoimmune disorder, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: First symptoms was my left arm where flu shot was given, began to be very sore days later. Continued throughout the whole arm and my hand, wrist and fingers. Then my neck started to be stiff and sore. Then my right arm was stiff and sore. This eventually grew to my legs, knees, and angles.  Primary Doctor gave me physical and suggested I see a Rheumatologist. In January after this Dr. took extensive blood work. It was determined I had Auto Immune Disease which will eventually become Rheumatoid Arthritis. Was healthy before October 9th, 2008.  Ankles and left hand still swollen and knee joints are painful.  4/6/09 Received Rheum medical records of 12/17/08-3/29/2009. FINAL DX: undifferentiated connective tissue disease, likely seronegative inflammatory polyarthritis, fibromyalgia syndrome Records reveal patient experienced neck, leg & arm pain since 11/2008.  Neuro consult done 12/17/08 dx w/C5-6 DDD.  Referred to PT & MRI.  Referred to Rheum for fibromyalgia 12/08 & tx w/meds.  Rheum 2nd opinion 1/22/09 for polyarthritis unimproved w/meds revealed active synovitis.  Tx w/steroids & recommended plaquenil although pt declined.    6/9/09 Medical records recieved DOS 12/21/07 to 2/26/09. FINAL DIAGNOSIS: Inflammatory polyarthritis. Post vaccination patient presented with left arm and shoulder pain, neck pain. Hand, thumb, wrist pain, weakness. Knee pain. Sent for rheumatology consult.