chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Convulsion, Disorientation, Headache, Hypoaesthesia
Clinical narrative: My daughter received her second GARDASIL vaccine and had 2 30-45 second seizure 15 minutes after the injection in the doctors office on the floor. She became pale, disoriented, her pupils were dilated and she kept saying she doesn't feel good thereafter the whole night long. She experienced a glaze for hour after, slow movement numbness to both legs and a headache and has twitching in her left arm still at the present time. I took her to the ER on my own judgement because the pediatrician said there was no need this was normal following this vaccine and she had bloodwork drawn and now has to have an EEG today. Something has to be said to this company.  5/5/09 Received medical records DOS 1/2/09 to 4/23/09. Includes imminzation records.  FINAL DX: Seizures Two 'quick seizures' post vaccination. Also several episodes of eyes rolling, and twitching.   6/2/09 Received ER medical records for 4/21/2009. FINAL DX: seizure Records reveal patient experienced back to back seizures each lasting approx 15-20 secs w/no postictal period.  Pt had dizziness s/p vaccination & then had seizure.  No further seizure activity, no meds while in ER & d/c to home w/PCP f/u.  Follow-up - Patient recovered. Patient's address updated.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypokinesia, Malaise, Muscle twitching, Mydriasis, Neurological examination
Clinical narrative: My daughter received her second GARDASIL vaccine and had 2 30-45 second seizure 15 minutes after the injection in the doctors office on the floor. She became pale, disoriented, her pupils were dilated and she kept saying she doesn't feel good thereafter the whole night long. She experienced a glaze for hour after, slow movement numbness to both legs and a headache and has twitching in her left arm still at the present time. I took her to the ER on my own judgement because the pediatrician said there was no need this was normal following this vaccine and she had bloodwork drawn and now has to have an EEG today. Something has to be said to this company.  5/5/09 Received medical records DOS 1/2/09 to 4/23/09. Includes imminzation records.  FINAL DX: Seizures Two 'quick seizures' post vaccination. Also several episodes of eyes rolling, and twitching.   6/2/09 Received ER medical records for 4/21/2009. FINAL DX: seizure Records reveal patient experienced back to back seizures each lasting approx 15-20 secs w/no postictal period.  Pt had dizziness s/p vaccination & then had seizure.  No further seizure activity, no meds while in ER & d/c to home w/PCP f/u.  Follow-up - Patient recovered. Patient's address updated.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pallor
Clinical narrative: My daughter received her second GARDASIL vaccine and had 2 30-45 second seizure 15 minutes after the injection in the doctors office on the floor. She became pale, disoriented, her pupils were dilated and she kept saying she doesn't feel good thereafter the whole night long. She experienced a glaze for hour after, slow movement numbness to both legs and a headache and has twitching in her left arm still at the present time. I took her to the ER on my own judgement because the pediatrician said there was no need this was normal following this vaccine and she had bloodwork drawn and now has to have an EEG today. Something has to be said to this company.  5/5/09 Received medical records DOS 1/2/09 to 4/23/09. Includes imminzation records.  FINAL DX: Seizures Two 'quick seizures' post vaccination. Also several episodes of eyes rolling, and twitching.   6/2/09 Received ER medical records for 4/21/2009. FINAL DX: seizure Records reveal patient experienced back to back seizures each lasting approx 15-20 secs w/no postictal period.  Pt had dizziness s/p vaccination & then had seizure.  No further seizure activity, no meds while in ER & d/c to home w/PCP f/u.  Follow-up - Patient recovered. Patient's address updated.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Convulsion, Gaze palsy, No reaction on previous exposure to drug, Pallor
Clinical narrative: My daughter received her second GARDASIL vaccine and had 2 30-45 second seizure 15 minutes after the injection in the doctors office on the floor. She became pale, disoriented, her pupils were dilated and she kept saying she doesn't feel good thereafter the whole night long. She experienced a glaze for hour after, slow movement numbness to both legs and a headache and has twitching in her left arm still at the present time. I took her to the ER on my own judgement because the pediatrician said there was no need this was normal following this vaccine and she had bloodwork drawn and now has to have an EEG today. Something has to be said to this company.  5/5/09 Received medical records DOS 1/2/09 to 4/23/09. Includes imminzation records.  FINAL DX: Seizures Two 'quick seizures' post vaccination. Also several episodes of eyes rolling, and twitching.   6/2/09 Received ER medical records for 4/21/2009. FINAL DX: seizure Records reveal patient experienced back to back seizures each lasting approx 15-20 secs w/no postictal period.  Pt had dizziness s/p vaccination & then had seizure.  No further seizure activity, no meds while in ER & d/c to home w/PCP f/u.  Follow-up - Patient recovered. Patient's address updated.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tremor
Clinical narrative: My daughter received her second GARDASIL vaccine and had 2 30-45 second seizure 15 minutes after the injection in the doctors office on the floor. She became pale, disoriented, her pupils were dilated and she kept saying she doesn't feel good thereafter the whole night long. She experienced a glaze for hour after, slow movement numbness to both legs and a headache and has twitching in her left arm still at the present time. I took her to the ER on my own judgement because the pediatrician said there was no need this was normal following this vaccine and she had bloodwork drawn and now has to have an EEG today. Something has to be said to this company.  5/5/09 Received medical records DOS 1/2/09 to 4/23/09. Includes imminzation records.  FINAL DX: Seizures Two 'quick seizures' post vaccination. Also several episodes of eyes rolling, and twitching.   6/2/09 Received ER medical records for 4/21/2009. FINAL DX: seizure Records reveal patient experienced back to back seizures each lasting approx 15-20 secs w/no postictal period.  Pt had dizziness s/p vaccination & then had seizure.  No further seizure activity, no meds while in ER & d/c to home w/PCP f/u.  Follow-up - Patient recovered. Patient's address updated.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 4/23/09 - reviewed PROTCOL questions with patient, denied steroid use  4/24/09 - patient came to pharmacy and showed pharmacist shingles-like rash.  MD notified & gave pt VALTREX and appt scheduled 4/27/09 Called pt 4/25/09 & she's feeling better on medicine.  MD said she had steroid epidural recently
Age: 40.0
Sex: F
Vaccine: HEPAB, MNQ, TDAP, YF
Symptoms: Influenza like illness, Migraine, Myalgia, Nausea
Clinical narrative: -migraine headache, - flu-like symptoms, -nausea; -muscle pain
Age: 1.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Body temperature increased, Injection site erythema, Injection site warmth
Clinical narrative: After receiving IM DTaP and IM PREVNAR on 4/20/09 to (R) thigh, pt. developed red, warm area and temp described as "hot" per mom day after shots. Seen in office 4/22/09 and was given BENADRYL liquid 12.5mg/5cc 3ml QD
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 4-20-09 pt was given a DTaP immunization
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized swelling, redness, and warmth to immunization site (right posterior upper arm).
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Erythema, Induration, Injected limb mobility decreased, Injection site pruritus
Clinical narrative: Body aches, shortness of breath, very painful with in 5 hours after injection, Pt states arm very painful unable to lift on 4/22 + 4/23 area near injection site began itching on the evening of 4/23. Pt has current redness. Warm to touch, and 5/10 pain in entire arm L > 10 CM 12 CM redness and induration.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Skin warm
Clinical narrative: Body aches, shortness of breath, very painful with in 5 hours after injection, Pt states arm very painful unable to lift on 4/22 + 4/23 area near injection site began itching on the evening of 4/23. Pt has current redness. Warm to touch, and 5/10 pain in entire arm L > 10 CM 12 CM redness and induration.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Urticaria
Clinical narrative: The day of the she c/o itching at the site - red area appeared 3 days later 15mm x 20 mm now. Started small welting after - no fever, no swelling in arms. FNP doesn't think related to shot.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Depressed level of consciousness, Incontinence, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Known Cerebral Palsy, 1 seizure periodically 12/08, sees Neurologist, EEG 12/08 abnormal, on KEPPRA, this episode = day after immunization mom called - found child slow to respond; incontinent, slow to talk. Neurologist notified increased KEPPRA 4.5 Bid. Sore, red arm, fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Speech disorder
Clinical narrative: Known Cerebral Palsy, 1 seizure periodically 12/08, sees Neurologist, EEG 12/08 abnormal, on KEPPRA, this episode = day after immunization mom called - found child slow to respond; incontinent, slow to talk. Neurologist notified increased KEPPRA 4.5 Bid. Sore, red arm, fever.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R shoulder to elbow swollen twice the size & with erythema.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Skin lesion, Varicella, Varicella post vaccine
Clinical narrative: Child received 2 chicken pox vaccines, chicken pox rash on 4/17/09
Age: 0.2
Sex: F
Vaccine: HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Developed hives within 10 minutes of HIB / PREVNAR administration.  BENEDRYL given in office.  Monitored X 20-30 min
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia oral, Vision blurred
Clinical narrative: About 2:30PM Hep A #1 given LA. After injection, stated she was dizzy and tip of tongue numb. Color pink. 2:35PM HR 34 R 20 BP 110/60 talking without difficulties. BS clear no wheezing lying on exam table. Reports blurry vision. 3:00PM tongue numbness resolving. Reports difficulty breathing inside hard to get air in and out. BS clear color pink HR 84 R 20 ambulance called - mom aware - will come to school. Ambulance arrives about 3:15 PM.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Headache, Pain, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: - Patient developed headaches, little fever, and body aches. Also pain on thighs, shins, neck back, wrists. She took Ibuprofen with some relief. No swelling noted but joints were painful, per mom. Labs showed elevated ESR rest was normal.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Chest discomfort, Oxygen saturation, Throat irritation, Vomiting
Clinical narrative: Received vaccines - approx 30 mins later father returned to clinic stating child c/o "scratchy throat" - no SOB - vomited x3 - c/o chest tightness EPI. 3 ml given - no wheezing - pulse ox 97%, RA - EMS to ED - child later discharged from ER.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site swelling, X-ray normal
Clinical narrative: As related by parent, Pt.'s R arm and shoulder at injection site became very swollen, child taken to ER. Parents thought needle was in arm. Arm X rayed. No needle in it. Child was placed on KEFLEX TID. " For something about cells" stated the father.
Age: 4.8
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Skin warm
Clinical narrative: Large red warm area without induration occurred 4/19 (2 days after vaccines given).
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Lip blister, Lip swelling
Clinical narrative: Administered ROTATEQ orally before other vaccines - within 1 min of giving oral vaccine, infant mucous membranes of upper and lower lips began to swell - em. blister-like bumps appeared across membranes of upper and lower lips - no difficulty breathing.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling abnormal, Headache, Hyperpallaesthesia, Multiple sclerosis
Clinical narrative: Patient is here for evaluation of dizziness and symptoms that she thinks may be related temporally to the injection of a TDAP that was given on 4/14/09.  Immediately that evening, patient did note headache.  Normally she doesn't get headaches, but this seemed to be over the entire head.  She did use some ibuprofen and went to bed.  She did notice that she had a faint headache the following day, but it seemed to have subsided.  She noted today, however, that when she moved her eyes to the right she felt that she had some tingling in her lower legs.  She has not been seeing double at all, but she had a hard time focusing with the right eye.  That seems to have resolved completely without any symptoms at this point.  She notes that she has had a history of multiple sclerosis and that has been stable for many years.  She did have interferon in the past with her neurologist, but has not had any weakness in the lower extremities or urinary symptoms or visual symptoms that she initially started out with when she was first diagnosed with the multiple sclerosis many years ago.  She is not on any type of treatment for that.  In addition, she notes that she feels somewhat dizzy, head in the cloud sensation, but not spinney sensation and not the sensation of fainting.  When she is lying in bed and getting up, she doesn't feel particularly dizzy; however, if she is sitting and then moves her head in certain positions and then turns her eyes, she will get those associated vibratory sensations in the lower extremities.  It seems to be getting better, however, but is here for documentation.  Patient also is here to reevaluate her blood work results.  These are discussed with her.  Her cholesterol profile is much better on the omega-3.  She just started also LOVASA, and looking up the adverse reactions to this, there are no neurological side effects.  In fact, looking up the side effects of the TDAP, there is no direct causal relationship with the type of symptoms this patient is having although mention of a neuritis and demyelinization has been made without definitive causal relationships.  Alert and oriented.  Fundoscopic difficult to see, but the part that is seen shows the disks to be flat.  AV ratio is 1:2 bilaterally. PERRLA.  EOM intact.  There is no hyphema.  There is no diplopia.  Visual fields arm normal by confrontation.  Pharynx is clear.  TMs normal.  Neck-Full range of motion.  Neurological - Cranial nerves II-XII grossly normal and DTRs are 3/4 equally bilaterally upper and lower extremities.  Otherwise, neurologically, her gait is normal.  She is not dizzy, and she has a negative hill-pike maneuver.  Symptoms may be Side effects of a TDAP Inoculation in a patient with Underlying but Stable Multiple Sclerosis.  Since these are getting better, will watch them for now, but if things get worse and she has localizing symptoms, then will refer her to her neurologist, for further evaluation and / or workup or treatment.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: Patient is here for evaluation of dizziness and symptoms that she thinks may be related temporally to the injection of a TDAP that was given on 4/14/09.  Immediately that evening, patient did note headache.  Normally she doesn't get headaches, but this seemed to be over the entire head.  She did use some ibuprofen and went to bed.  She did notice that she had a faint headache the following day, but it seemed to have subsided.  She noted today, however, that when she moved her eyes to the right she felt that she had some tingling in her lower legs.  She has not been seeing double at all, but she had a hard time focusing with the right eye.  That seems to have resolved completely without any symptoms at this point.  She notes that she has had a history of multiple sclerosis and that has been stable for many years.  She did have interferon in the past with her neurologist, but has not had any weakness in the lower extremities or urinary symptoms or visual symptoms that she initially started out with when she was first diagnosed with the multiple sclerosis many years ago.  She is not on any type of treatment for that.  In addition, she notes that she feels somewhat dizzy, head in the cloud sensation, but not spinney sensation and not the sensation of fainting.  When she is lying in bed and getting up, she doesn't feel particularly dizzy; however, if she is sitting and then moves her head in certain positions and then turns her eyes, she will get those associated vibratory sensations in the lower extremities.  It seems to be getting better, however, but is here for documentation.  Patient also is here to reevaluate her blood work results.  These are discussed with her.  Her cholesterol profile is much better on the omega-3.  She just started also LOVASA, and looking up the adverse reactions to this, there are no neurological side effects.  In fact, looking up the side effects of the TDAP, there is no direct causal relationship with the type of symptoms this patient is having although mention of a neuritis and demyelinization has been made without definitive causal relationships.  Alert and oriented.  Fundoscopic difficult to see, but the part that is seen shows the disks to be flat.  AV ratio is 1:2 bilaterally. PERRLA.  EOM intact.  There is no hyphema.  There is no diplopia.  Visual fields arm normal by confrontation.  Pharynx is clear.  TMs normal.  Neck-Full range of motion.  Neurological - Cranial nerves II-XII grossly normal and DTRs are 3/4 equally bilaterally upper and lower extremities.  Otherwise, neurologically, her gait is normal.  She is not dizzy, and she has a negative hill-pike maneuver.  Symptoms may be Side effects of a TDAP Inoculation in a patient with Underlying but Stable Multiple Sclerosis.  Since these are getting better, will watch them for now, but if things get worse and she has localizing symptoms, then will refer her to her neurologist, for further evaluation and / or workup or treatment.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Upper right arm within about 4" from injection site bright red, swollen, hard and hot to touch on 3/19/09. 3/20/09 signs and symptoms persist with larger area involved to about 6" from site. 3/20/09 treated with oral Prednisone 16 mg BID x 2 days. (on 3/19/09 - mother applied hydrocortisone cream). S/s subside 3/31/2009.
Age: 3.8
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Chest pain, Urticaria, Wheezing
Clinical narrative: Patient was brought back to office 25-30 minutes after injection given complaining that his chest hurt. Patient exhibiting welts, wheezing, welt around MMR site. Patient was given albuterol nebulizer treatment and oral BENDRYL. Was given IM SOLUMEDROL: all symptoms resolved at time of discharge.
Age: 3.8
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Rash macular, Respiratory distress
Clinical narrative: Patient was brought back to office 25-30 minutes after injection given complaining that his chest hurt. Patient exhibiting welts, wheezing, welt around MMR site. Patient was given albuterol nebulizer treatment and oral BENDRYL. Was given IM SOLUMEDROL: all symptoms resolved at time of discharge.
Age: 3.8
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Wheezing
Clinical narrative: Patient was brought back to office 25-30 minutes after injection given complaining that his chest hurt. Patient exhibiting welts, wheezing, welt around MMR site. Patient was given albuterol nebulizer treatment and oral BENDRYL. Was given IM SOLUMEDROL: all symptoms resolved at time of discharge.
Age: 1.0
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash at injection site 2" x 1" redness w/ 2" raised areas w/i. No vesicle. No streaky redness.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. c/o pain in Rt. deltoid about 2-3 hours after receiving pneumonia vaccination. Pt could not move her arm or fingers and went to the ER. Pt given a sling and PERCOCET and told to apply ice. These tx's did not help. Pt. saw PA on Mar-29 and was given SOLUMEDROL 60mg IM. Pt. given NSAIDS as well. Pt. also referred to physical therapy.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Immunology test abnormal, Pneumonia pneumococcal
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced pneumococcal pneumonia. The patient received the fourth dose on 03-Aug-2004. The nurse reported that the patient experienced pneumococcal pneumonia after receiving the completed immunization series of PREVNAR. The child experienced pneumonia 2 to 3 times and was referred to the hospital for evaluation. The evaluating physician suggested that the child have a blood test for immune response and a PREVNAR booster. At the time of the report, it is unknown if the patient recovered. See related case(s): US-WYE-H03100208 (overdose without AE, non-expedited). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site induration
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced induration on thigh after receiving multiple immunizations at site. The patient received the first dose on an unspecified date. The patient experienced induration on thigh after receiving multiple immunizations at site. The induration was so severe that it requested plastic surgery to repair. Outcome was unknown. See related case (s): US-WYE-H03552408 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Antibody test abnormal, Labyrinthitis, Pneumonia, Sinusitis, Vaccination failure
Clinical narrative: This case was considered medically important. Follow-up information provided recovery status. Information regarding PREVNAR was received form a consumer and confirmed by a healthcare professional regarding a 3-year-old female patient who had received 4 doses of PREVNAR (completing her primary series on 15-Nov-2004). The patient's titers determined that the vaccines had failed. The patient additionally experienced pneumonia, inner ear infections and sinusitis. On 15-Nov-2004, the patient received a fourth dose of PREVNAR, which completed her primary series. At the age of about 3 years (approximately 2006), the patient became chronically ill with pneumonia, inner ear infections and sinusitis occurring about every 6 weeks. In Feb-2008, the patient's titers determined that the vaccines had failed (vaccination failure). On 06-Mar-2008, the physician opted to give a fifth dose of PREVNAR. On 08-Mar-2008, the physician noted she gave the patient a "HIB" and "DTAP" booster and "pneumo-23". On 24-Apr-2008 titers were drawn (see laboratory results). The physician stated the patient showed an "excellent response". As of 20-Jan-2009, the patient had recovered. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Pneumonia, Surgery
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a consumer regarding her granddaughter who suffered from pneumonia after getting vaccines. The patient received a dose on an unspecified date. On an unspecified date in 2008, the patient's grandmother reported that her granddaughter suffered from pneumonia after getting vaccines, resulting in surgery on 06-May-2008. The patient's outcome was unknown. No additional information was available at the time of this report.
Age: 1.6
Sex: M
Vaccine: PNC
Symptoms: Drug ineffective, Meningitis
Clinical narrative: Information regarding PREVENAR was received from a healthcare professional regarding a 19-month-old male patient who experienced drug ineffective and meningitis. At 19 months of age, the patient received the fourth dose on an unspecified date. The patient received all four doses of PREVNAR therapy. On an unspecified date, the patient was admitted to the hospital and diagnosed with meningitis. Patient has since recovered. It was noted that titer levels were not done. No further information was provided.
Age: 1.4
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Asthma, Dyspnoea, Ear infection, Febrile convulsion, Laboratory test abnormal
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from consumer regarding a 15-month-old male patient who experienced asthma, bacterial pneumonia, ear infection, vomiting and febrile seizure. The patient received the third dose on 09-Apr-2008. Within 48 hours of being administered the PREVNAR vaccine, the patient experienced a fever, shortness of breath with wheezing, vomiting, and a febrile seizure after being administered the third dose of the PREVNAR in April-2008. He was also diagnosed with an ear infection, bacterial pneumonia and asthma in 2008. The patient was not hospitalized. The patient was treated with oral and injectable antibiotics. No additional information was available at the time of this report. No additional information was available at the time of this report.
Age: 1.4
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Pneumonia bacterial, Pyrexia, Vomiting, Wheezing
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from consumer regarding a 15-month-old male patient who experienced asthma, bacterial pneumonia, ear infection, vomiting and febrile seizure. The patient received the third dose on 09-Apr-2008. Within 48 hours of being administered the PREVNAR vaccine, the patient experienced a fever, shortness of breath with wheezing, vomiting, and a febrile seizure after being administered the third dose of the PREVNAR in April-2008. He was also diagnosed with an ear infection, bacterial pneumonia and asthma in 2008. The patient was not hospitalized. The patient was treated with oral and injectable antibiotics. No additional information was available at the time of this report. No additional information was available at the time of this report.
Age: 1.3
Sex: M
Vaccine: PNC
Symptoms: Adenoidectomy, Antimicrobial susceptibility test, Blood culture negative, Bronchoscopy abnormal, Chest X-ray abnormal
Clinical narrative: Follow-up received provided additional patient details, medical history, event details, and test results. Information regarding PREVNAR was received from a healthcare professional regarding a 15-month-old male patient who experienced pneumococcal infection of lungs, ears, nose, and adenoids and recurrent pneumococcal infection. At 15 months of age, the patient received the fourth dose on 14-Aug-2008. In Oct-2008 the patient experienced pneumococcal infection of lungs, ears, nose, and adenoids and a recurrent pneumococcal infection in 2008. In early Oct-2008 the patient presented with a three week history of fever, wheezing, snotty nose, and ear infection unresponsive to antibiotics. The patient was brought to the hospital on 12-Oct-2008 since he continued with symptoms of fever, and wheezing and became blue around the nose and mouth with oxygen levels in the 80's. On 13-Oct-2008 the hospital performed rigid and flexible bronchoscopy, suctioned mucous plugs and cultured the patient's lung secretions (see test result below). Post-procedure treatment consisted of PULMICORT nebulizer treatments, ORAPRED and IV VANCOMYCIN for 18 days via a PICC line with a return to normal health, symptom free. Forty-eight hours after the PICC line was removed, the same symptoms returned. He had bilateral otitis media and was treated with IM CEFTRIAXONE. On 13-Nov-2008 the patient had adenoids removed and ear tubes inserted. The lungs were suctioned again and sputum was sent for examination. Post-operative treatment consisted of oral AUGMENTIN and CIPRO drops to ears. On 17-Nov-2008 a follow-up appointment with the pediatric pulmonary physician was performed (see results below). The patient is recovered from the events. No additional information was available at the time of this report.
Age: 1.3
Sex: M
Vaccine: PNC
Symptoms: Culture positive, Cyanosis, Ear infection, Ear tube insertion, Gram stain positive
Clinical narrative: Follow-up received provided additional patient details, medical history, event details, and test results. Information regarding PREVNAR was received from a healthcare professional regarding a 15-month-old male patient who experienced pneumococcal infection of lungs, ears, nose, and adenoids and recurrent pneumococcal infection. At 15 months of age, the patient received the fourth dose on 14-Aug-2008. In Oct-2008 the patient experienced pneumococcal infection of lungs, ears, nose, and adenoids and a recurrent pneumococcal infection in 2008. In early Oct-2008 the patient presented with a three week history of fever, wheezing, snotty nose, and ear infection unresponsive to antibiotics. The patient was brought to the hospital on 12-Oct-2008 since he continued with symptoms of fever, and wheezing and became blue around the nose and mouth with oxygen levels in the 80's. On 13-Oct-2008 the hospital performed rigid and flexible bronchoscopy, suctioned mucous plugs and cultured the patient's lung secretions (see test result below). Post-procedure treatment consisted of PULMICORT nebulizer treatments, ORAPRED and IV VANCOMYCIN for 18 days via a PICC line with a return to normal health, symptom free. Forty-eight hours after the PICC line was removed, the same symptoms returned. He had bilateral otitis media and was treated with IM CEFTRIAXONE. On 13-Nov-2008 the patient had adenoids removed and ear tubes inserted. The lungs were suctioned again and sputum was sent for examination. Post-operative treatment consisted of oral AUGMENTIN and CIPRO drops to ears. On 17-Nov-2008 a follow-up appointment with the pediatric pulmonary physician was performed (see results below). The patient is recovered from the events. No additional information was available at the time of this report.
Age: 1.3
Sex: M
Vaccine: PNC
Symptoms: Otitis media, Oxygen saturation decreased, Pneumococcal infection, Pyrexia, Rhinorrhoea
Clinical narrative: Follow-up received provided additional patient details, medical history, event details, and test results. Information regarding PREVNAR was received from a healthcare professional regarding a 15-month-old male patient who experienced pneumococcal infection of lungs, ears, nose, and adenoids and recurrent pneumococcal infection. At 15 months of age, the patient received the fourth dose on 14-Aug-2008. In Oct-2008 the patient experienced pneumococcal infection of lungs, ears, nose, and adenoids and a recurrent pneumococcal infection in 2008. In early Oct-2008 the patient presented with a three week history of fever, wheezing, snotty nose, and ear infection unresponsive to antibiotics. The patient was brought to the hospital on 12-Oct-2008 since he continued with symptoms of fever, and wheezing and became blue around the nose and mouth with oxygen levels in the 80's. On 13-Oct-2008 the hospital performed rigid and flexible bronchoscopy, suctioned mucous plugs and cultured the patient's lung secretions (see test result below). Post-procedure treatment consisted of PULMICORT nebulizer treatments, ORAPRED and IV VANCOMYCIN for 18 days via a PICC line with a return to normal health, symptom free. Forty-eight hours after the PICC line was removed, the same symptoms returned. He had bilateral otitis media and was treated with IM CEFTRIAXONE. On 13-Nov-2008 the patient had adenoids removed and ear tubes inserted. The lungs were suctioned again and sputum was sent for examination. Post-operative treatment consisted of oral AUGMENTIN and CIPRO drops to ears. On 17-Nov-2008 a follow-up appointment with the pediatric pulmonary physician was performed (see results below). The patient is recovered from the events. No additional information was available at the time of this report.
Age: 1.3
Sex: M
Vaccine: PNC
Symptoms: Sweat test normal, Wheezing
Clinical narrative: Follow-up received provided additional patient details, medical history, event details, and test results. Information regarding PREVNAR was received from a healthcare professional regarding a 15-month-old male patient who experienced pneumococcal infection of lungs, ears, nose, and adenoids and recurrent pneumococcal infection. At 15 months of age, the patient received the fourth dose on 14-Aug-2008. In Oct-2008 the patient experienced pneumococcal infection of lungs, ears, nose, and adenoids and a recurrent pneumococcal infection in 2008. In early Oct-2008 the patient presented with a three week history of fever, wheezing, snotty nose, and ear infection unresponsive to antibiotics. The patient was brought to the hospital on 12-Oct-2008 since he continued with symptoms of fever, and wheezing and became blue around the nose and mouth with oxygen levels in the 80's. On 13-Oct-2008 the hospital performed rigid and flexible bronchoscopy, suctioned mucous plugs and cultured the patient's lung secretions (see test result below). Post-procedure treatment consisted of PULMICORT nebulizer treatments, ORAPRED and IV VANCOMYCIN for 18 days via a PICC line with a return to normal health, symptom free. Forty-eight hours after the PICC line was removed, the same symptoms returned. He had bilateral otitis media and was treated with IM CEFTRIAXONE. On 13-Nov-2008 the patient had adenoids removed and ear tubes inserted. The lungs were suctioned again and sputum was sent for examination. Post-operative treatment consisted of oral AUGMENTIN and CIPRO drops to ears. On 17-Nov-2008 a follow-up appointment with the pediatric pulmonary physician was performed (see results below). The patient is recovered from the events. No additional information was available at the time of this report.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Convulsion, Cyanosis, Staring, Unresponsive to stimuli
Clinical narrative: Information regarding PREVNAR was received form a consumer regarding a 5-month-old male patient who experienced multiple seizures. The patient received the first dose on 16-Dec-2008. The patient also received the first dose of TRIPEDIA (Connaught Medical Research Laboratories) on 16-Dec-2008. On 18-Dec-2008, 48 hours post-vaccination, the patient experienced multiple seizures characterized by cyanosis and unresponsiveness. The child was hospitalized where he experienced several more episodes of "staring and not responding to anything". Treatment included phenobarbital and evaluation from neurologist who commented, "This type of thing has been seen with pertussis". Further continuation with the vaccine schedule has not been determined. The outcome of the event was unknown. No additional information was available at the time of this report.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Blood culture positive, Drug ineffective, Pneumococcal bacteraemia
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old male patient who experienced drug ineffective and invasive pneumococcal bacteremia. The patient received the third dose on an unspecified date. On an unspecified date in or around Oct-2008, the patient experienced invasive pneumococcal bacteremia and hospitalized. Treatment included antibiotics (unspecified). The patient recovered on an unspecified date. No additional information was available at the time of this report.
Age: 0.5
Sex: F
Vaccine: HIBV, PNC
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old female patient who experienced a linear, raised, red, bumpy, "cellulitis like" reaction at the injection site on her leg which developed into a hard lump and pain.  The patient experienced a linear, raised, red bumpy "cellulitis like" reaction at the injection site on her leg which developed into a hard lump. The redness lasted 3 to 4 weeks and the lump lasted for 2 months. The pain was treated with TYLENOL and MOTRIN and completely resolved. No additional information was available at the time of this report.
Age: 0.3
Sex: M
Vaccine: FLUX, PNC, TDAP
Symptoms: Culture wound negative, Injection site abscess
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old male patient who experienced injection site abscess. The patient received a second dose on 24-Sep-2007.  The patient also received a dose of Haemophilus Influenzae B (manufacturer unknown) and a dose of BOOSTRIX (GlaxoSmithKline) on 24-Sep-2007. The patient received a second dose of PREVNAR on 24-Sep-2007. On 05-Nov-2007, while at the doctors for a cold, the patient was diagnosed with an injection site abscess in his right thigh. Treatment was not reported. The patient recovered, "but left permanent 5cm at site". See related case (s): US-WYE-H03233908 (adverse event, non-expedited). No additional information was available at the time of this report
Age: 0.5
Sex: M
Vaccine: PNC, TDAP
Symptoms: Bacterial culture negative, Injection site abscess, Purulent discharge, Surgery, Vaccine positive rechallenge
Clinical narrative: Follow-up information provided patient demographics, recovery status, concomitant vaccine, and dose details including lot numbers.  Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced injection site abscess in both injection sites.  The patient received the third dose on 26-Nov-2007.  The patient also received a dose of BOOSTRIX (GlaxoSmithKline) on 26-Nov-2007.  Medical History:  The patient has a past history of injection site abscess (after the previous dose of PREVNAR that diagnosed on 04-Nov-2007) (See related case US-WYE-H03187808).  The patient experienced injection site abscess on 17-Dec-2007 following his third dose of PREVNAR and a dose of BOOSTERIX.  The top of the abscess was surgically removed in the office and a large amount of pus was removed.  The  drainage was cultured but no organism was found.  The patient recovered.  No additional information was available at the time of this report.
Age: 0.3
Sex: M
Vaccine: HIBV, PNC
Symptoms: Petechiae
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old male patient who developed petechia 11 days after receiving his second dose of PREVNAR. The patient received the second dose on 15-Feb-2007. The patient developed petechia 11 days after receiving his second dose of PREVNAR on 26-Feb-2008. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Incorrect storage of drug
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who was administered the vaccine that was stored with a temperature of 33 degrees for one hour.  The patient received a dose on an unspecified date.  The patient was administered the PREVNAR vaccine that was stored at a temperature of 33 degrees for one hour.  No additional information was available at the time of this report.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Accidental overdose, Incorrect dose administered
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old female patient who inadvertently was given a repeat immunization of PREVNAR, ROTATEQ (Merck & Co Inc), ACT-HiB (Aventis) and PEDIARIX (GlaxoSmithKline) on 16-Jun-2008. On 09-Jun-2008, the patient received a dose of PREVNAR and other childhood vaccines. On 16-Jun-2008, the child inadvertently was given a repeat immunization because the patient's immunizations from 09-Jun-2008 were not recorded. No adverse event was reported. No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Screaming
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced redness at the injection site and screaming for 2 hours. The patient received a dose on an unspecified date. Additional suspect medication included ACT-HIB. The patient experienced redness at the injection site and screaming for 2 hours. The event resolved.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Screaming
Clinical narrative: Follow up information was received that provided patient information and lot number.  Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old female patient who experienced screaming hysterically, redness, swelling and warmth expanded form her groin to her foot. The patient received the third dose on 28-Jul-2009. The patient also received a dose of Haemophilus Influenzae B (manufacturer unknown) and a dose of Diphtheria and Tetanus Toxoids and Pertussis (manufacturer unknown) on 28-Jul-2008. On 28-Jul-2008, the patient began screaming hysterically 3-5 minutes after receiving the PREVNAR. The area around the site became red, warm and swollen about 4 inches in size. Within 20 minutes the redness, swelling and warmth expanded from her groin to  her foot. The outcome of the events is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Antibody test abnormal
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced low antibody titers. The patient received a dose on an unspecified date. The patient experienced low antibody titers. The patient's outcome is unknown. No additional information was available at the time of this report.
Age: 0.5
Sex: F
Vaccine: PNC
Symptoms: Antibody test abnormal, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, HLA marker study positive
Clinical narrative: New information was received in dose details and source details. Information regarding PREVNAR was received from a mother and a physician regarding a 4-year-old female patient who experienced antibody test abnormal. At 6-months-of age, the patient received the third dose on 31-Dec-2003. The patient experienced antibody test abnormal on 08-Apr-2008. The mother stated that her daughter failed to mount antibodies after receiving 3 doses of PREVNAR. The outcome is not resolved. No additional information was available at the time of this report.
Age: 0.2
Sex: U
Vaccine: PNC
Symptoms: Incorrect storage of drug
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old patient who experienced administered improperly stored vaccine at 47 degrees for about 1 hour. The patient received a dose on 14-Aug-2008. The patient was administered improperly stored vaccine at 47 degrees for about 1 hour (medication error) 0n 14-Aug-2008. No additional information was available at the time of this report.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Dermatitis contact, Rash generalised
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old male patient who experienced rash from head to toe diagnosed as contact dermatitis. The patient received the second dose on 05-Sep-2008. The patient also received the second dose of DAPTACEL (Aventis-Pasteur), the second dose of Polio-Vaccine (Not Specified), the second dose of Hib (manufacturer unknown) and the second dose of ROTATEQ (Merck & Co Inc) on 05-Sep-2008. The patient experienced rash from head to toe on 10-Sep-2008. On 15-Sep-2008, the patient was seen by the physician who diagnosed as contact dermatitis. Treatment included ORAPRED. The patient is recovering. Se related case(s): US-WYE-H06036008 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Abdominal pain, Body temperature increased, Decreased appetite, Pyrexia
Clinical narrative: Additional Information provided test results and a possible cause for the reported events. Information regarding PREVNAR was received from a healthcare professional regarding a 4-year-old female patient who experienced poor appetite, fever spiking to 104 degrees F., abdominal pain and possible community acquired infection. At 4 years of age, the patient received the third dose on 22-Sep-2008. The patient experienced poor appetite in Sep-2008 and fever spiking to 104 degrees F. and abdominal pain on 22-Sep-2008. The reporting healthcare professional stated that community acquired infection could be a possible explanation for the reported symptoms of poor appetite, pyrexia and abdominal pain. Outcome was reported as not recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Incorrect storage of drug
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who received PREVNAR that had been frozen on an unspecified date. On an unspecified date, the patient received a dose of PREVNAR that had been frozen (medication error). No adverse events were reported. No additional information was available at the time of the report.
Sex: M
Vaccine: PNC
Symptoms: Speech disorder developmental
Clinical narrative: Information regarding PREVENAR was received from a company representative regarding a male patient who experienced decrease in babbling. The patient received the second dose on an unspecified date. After receiving the second dose of PREVENAR therapy it was reported that the child "stopped babbling as much". It was noted that the physician decided not to give the next dose. The child is now eight years old. No further information was provided.
Age: 0.4
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Pyrexia, White blood cells urine positive
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a 4-month-old female patient who experienced administered the 2nd dose 1 month after the first dose, increased urine white blood cells and fever. The patient received the second dose on 25-Nov-2008. The patient also received a dose of DTaP (manufacturer unknown) and a dose of POLIO-vaccine (Not Specified) on 25-Nov-2008. The patient was administered the 2nd dose of PREVNAR 1 month after the first dose (inappropriate schedule of drug administration) on 25-Nov-2008. The patient has been experiencing a fever of 102.5 deg. F for the past two weeks (Dec-2008) Test results revealed increased urine white blood cells. Treatment included unspecified antibiotic. Outcome was reported as not recovered for the fever. The outcome for the increased urine white blood cells was unknown. No additional information was available at the time of this report.