chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Inguinal hernia, Surgery, Testicular disorder, Testicular swelling
Clinical narrative: Information has been received from a physician concerning a 9-week-old male who on 05-DEC-2006 was vaccinated PO with the first 2.0 ml dose of Rotateq vaccine (human-bovine) (lot#655082/0779F). Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine and a dose of Hib conj vaccine (manufacturer unknown). The physician reported that on 06-DEC-2006, the patient developed a inguinal hernia. Unspecified medical attention was sought and the patient was subsequently hospitalized and underwent surgery. After surgery, the patient was considered to be recovered as he was noted to be fine. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Inappropriate schedule of drug administration, Nausea, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described an 8-year-old male subject who was inadvertently vaccinated with FluLaval and experienced queasiness. On 25 October 2006 the subject received unspecified dose of FluLaval. FluLaval is recommended for immunizing individuals 18 years and older. Follow-up was received on 27 October 2006 from the reporting healthcare professional. The subject had no pre-existing medical conditions. Information regarding previous immunization with influenza virus vaccine was not provided. The subject received FluLaval at 2:00 pm on 25 October 2006. At approximately 5:30 pm on 25 October 2006, three and one-half hours following the administration of FluLaval, the subject experiences queasiness and fatigue. The subject vomited "the evening of" 25 October 2006. The subject was seen at a  physician's office. The events resolved on an unspecified date on or after 25 October 2006 and on or before 27 October 2006. The healthcare professional considered the events unlikely to be related to vaccination with FluLaval.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itchy legs in a 29-year-old female subject who was vaccinated with FluLaval for prophylaxis. The subject had no pre-existing medical conditions. There were no concurrent medications. The subject had received influenza virus vaccine previous years with no subsequent events. On 25 October 2006 at 7:00 am, the subject received unspecified dose of FluLaval in the left thigh. On 25 October 2006 at 7:00 pm, 12 hours after vaccination with FluLaval, the subject experienced itchy legs. The subject was seen at a physician's office. The subject was treated with mineral oil (Baby oil). At the time of initial reporting, 30 October 2006, the event was ongoing. The healthcare professional considered the event was unrelated to vaccination with FluLaval.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 32-year-old female subject who was vaccinated with FluLaval vaccine during an unspecified trimester of pregnancy. The subject's medical history included "a tattoo just above the injection site". On 06 November 2006 the subject received unspecified dose of FluLaval at an unspecified injection site. On or after 06 November 2006 and on or before 08 November 2006, less than one week after vaccination with FluLaval, the subject experienced injection site redness. The reporter noted that the subject has a tattoo just above the injection site. The healthcare professional reported that the subject was pregnant at the time of the FluLaval administration. The trimester of pregnancy, date of last menstrual period and estimated date of delivery were not reported. At the time of initial reporting, 08 November 2006, the injection site redness was ongoing. The healthcare professional considered the injection site redness to probably be related to vaccination with FluLaval.  Follow-up information was received from the reporter on 02 March 2007.  The subject's medical history included one previous pregnancy that resulted in spontaneous loss.  Concurrent medication included prenatal vitamins (Duet with DHA) one soft gel tablet daily beginning 29 March 2006.  There was no evidence of a defect from a prenatal test.  This was a normal conception.  On 29 November 2006, at 18 weeks and six days of gestation, the subject gave birth via normal vaginal delivery to a female who weighed seven pounds, three ounces, was 21 and a half inches in length, and had a head circumference of 12 and a half inches.  No birth defects were noted.  Follow up information was received on 05 March 2007 via a reporting nurse, who noted that the subject was 27 years old and was vaccinated during the third trimester of pregancy at an employer's health clinic.  The subject's last menstrual period prior to vaccination was 02 March 2006.  On 06 November 2006, the subject received 0.5 cc of FLULAVAL (intramuscular) in the left deltoid.  The subject had a tattoo "just below" the injection site.  Two days after vaccination with FLULAVAL, on 08 November 2006, the subject developed an area of redness at the injection site that was approximately "one and three-quarters inches wide by three-quarters inches".  The patient did not complain of itching or burning, and the injection site was checked by the nurse daily until the redness resolved completely on 15 November 2006.  In the nurse's opinion, the injection site redness was related to vaccination with FLULAVAL.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye discharge, Ocular hyperaemia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of dry tickly cough in a 49-year-old female subject who was vaccinated with FluLaval vaccine for prophylaxis. There was no concurrent medications. The subject had not previously received any flu shots. On 7 November 2006 the subject received 1st dose of FluLaval (unknown, left arm). On 7 November 2006, about three hours after vaccination with FluLaval, the subject developed a dry, tickly cough which had resolved by the next morning. About five hours after her vaccination, her eyes became red. When she woke up the next morning her eyes were "pastey and pussy", a discharge was coming out of her eyes. She was prescribed Tobradex by a optometrist. At the time of reporting the outcome of the red and "pastey and pussy" eyes was unspecified. Follow-up was received from the reporting healthcare professional on 04 December 2006. All the events resolved on 08 November 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye discharge, Ocular hyperaemia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of dry cough in a female subject of unspecified age who was vaccinated with FluLaval vaccine for prophylaxis. On 7 November 2006 the subject received an unspecified dose of FluLaval (unknown). On 7 November 2006, at an unspecified time after vaccination with FluLaval, the subject experienced dry cough and red, "pastey" eyes. At the time of follow-up reporting, 04 December 2006, the outcome of the events was unspecified. Follow-up was received from the reporting healthcare professional on 04 December 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary tract infection, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence in hives in a 48-year-old female subject who received Wellbutrin and vaccination with FluLaval vaccine for prophlaxis. Concurrent medications included unknown concurrent medications. Medical history was not provided. On an unspecified date in 2006 before 03 November 2006, the subject initiated therapy with Wellbutrin for an unspecified drug indication. On 03 November 2006 the subject received a dose of FluLaval. On 03 November 2006, the  subject had been receiving Wellbutrin for "weeks". About 4 hours following immunization with FluLaval and "weeks" after initiation of Wellbutrin, on 03 November 2006, the subject developed a rash/hives and went to the emergency room. The subject also experienced a urinary tract infection that developed on an unspecified date on or after 03 November 2006 and before 21 November 2006. The physician considered that the events were probably related to vaccination with FluLaval or therapy with Wellbutrin. At the time of initial reporting, 21 November 2006, the events were improved.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of maculopapular rash in a 61 year old male subject who was vaccinated with FluLaval for prophylaxis. The subject's medical history included "lung issues." The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included Effexor, Albuterol, Imitrex, Roxicodone, Ultram, Flonase, Claritin, Adodart and Nexium. On 16 November 2006 the subject received a dose of FluLaval in the left arm. The healthcare professional reported that on 16 November 2006, the subject also initiated therapy with "a new lung medication." The name of the lung medication was not reported. On 17 November 2006, 1 day after vaccination with FluLaval, the subject experienced maculopapular rash and urticaria. The rash was described as "diffuse in location." The subject was seen at a physician's office and was treated with Benadryl and Prednisone. At the time of initial reporting, 21 November 2006, the events were ongoing. The healthcare professional considered the events were possibly related to vaccination with FluLaval. Follow up received on 19 December 2006 indicated that the subject started on Asmanex on 10 November 2006 and she considered that the events could have been associated with this medication. The events resolved on 22 November 2006.
Age: 40.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site rash in a 40 year old male subject who was vaccinated with FluLaval for prophylaxis. On 17 November 2006 the subject received a dose of FluLaval in an unspecified arm. On 17 November 2006, the subject also received Havrix at an unspecified site of injection. The next day, on 18 November 2006, the healthcare professional noted that at the site of the FluLaval injection the subject experienced "a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site. " The events were completely resolved by 20 November 2006. In the reporter's opinion, the events were possibly related to treatment with FluLaval.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site rash in a 21 year old female subject who was vaccinated with FluLaval for prophylaxis. Medical history included non-smoker and non-drinker. On 13 November 2006 the subject received a dose of FluLaval in an unspecified arm. The healthcare professional noted that at the site of the FluLaval injection, on 13 November 2006, less than one day after vaccination with FluLaval, the subject experienced "a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site." The events resolved on 14 November 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.
Age: 40.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site rash, Skin discolouration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site rash in a 40 year old male subject who was vaccinated FluLaval for prophylaxis. Medical history included non smoker and non drinker. On 17 November 2006 the subject received a dose FluLaval in an unspecified arm. On 17 November 2006, the subject also received Havrix at an unspecified site of injection. The healthcare professional noted that at the site of the FluLaval injection, on 17 November 2006, less than one day after vaccination with FluLaval, the subject experienced " a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site." The events resolved on 20 November 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site mass, Injection site warmth, Pruritus
Clinical narrative: Erythema, injection site warmth, injection site mass, pruritus
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 46 year old female subject who was vaccinated with Flulaval for prophylaxis. On 27 December 2006 at 12:00 the subject received 1st dose of Flulaval (.5ml, subcutaneous) instead of a tuberculin skin test. She experienced injection site redness, wrong drug administered and wrong route of administration. The subjec had already received an influenza vaccination this year. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Flulaval.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Conjunctival hyperaemia, Cough, Decreased appetite, Erythema
Clinical narrative: 24 hours post vaccine (VZV) mom reported entire body was red. 48 hours post vaccine fever of 102 and cough. 72 hours post vaccine-itching red rash-progressed to blisters with poor appetite, restless sleep, lethargy, cough, congestion and yellow nasal drainage continue at 5 days post vaccine. Talked with mom 1/31/2007 rash improving, continues with cough, nasal drainage. Has MD appointment 2/1/07. rit cough.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Lethargy, Nasal mucosal discolouration, Poor quality sleep, Pyrexia, Rash pruritic
Clinical narrative: 24 hours post vaccine (VZV) mom reported entire body was red. 48 hours post vaccine fever of 102 and cough. 72 hours post vaccine-itching red rash-progressed to blisters with poor appetite, restless sleep, lethargy, cough, congestion and yellow nasal drainage continue at 5 days post vaccine. Talked with mom 1/31/2007 rash improving, continues with cough, nasal drainage. Has MD appointment 2/1/07. rit cough.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: 24 hours post vaccine (VZV) mom reported entire body was red. 48 hours post vaccine fever of 102 and cough. 72 hours post vaccine-itching red rash-progressed to blisters with poor appetite, restless sleep, lethargy, cough, congestion and yellow nasal drainage continue at 5 days post vaccine. Talked with mom 1/31/2007 rash improving, continues with cough, nasal drainage. Has MD appointment 2/1/07. rit cough.
Age: 1.01
Sex: M
Vaccine: VARZOS, HIBV, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Medication error-infant was inadvertently given an adult dose of Zostavax instead of age appropriate dose of ProQuad.
Age: 1.01
Sex: M
Vaccine: VARZOS, HIBV, VARZOS
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Medication error-infant was inadvertently given an adult dose of Zostavax instead of age appropriate dose of ProQuad.
Age: 66.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Administered Tetanus 0.5ml IM Left deltoid on 11/16. Awoke with redness and swelling at injection site 6 days later on 11/21/06. Seen on 11/21. Treated with Keflex 500 mg four times daily for 10 days. Symptoms lasted for 6 weeks.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: itching, swelling and hivelike rash with bumps on face the 1st day.  next day, rash over face, neck, chest, upper arms.  worse with exposure to cold air.  resolved after warming about 15-20 min 1st day. 2nd day resolved with benadryl 25mg x 1.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Employee c/o Redness,swelling and pain at injection site. It has been 4 days since injection of Tdap. Advised her to take 25 mg Benydrl PO for swelling and Tylenol for discomfort. Instructed her to come to Employee Health to see the MD if symptoms presist.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Employee c/o flu like symptoms. Achy all over, fever lasted 2-3 days past injection. Sent off work to go home.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Vomiting
Clinical narrative: Patient's mother called and said her daughter felt nauseous and vomitted 20 minutes after the injection was given.  While at daycare patient vomitted again at 12:00pm.  No other sign or symptoms reported.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Fatigue, Irritability, Pyrexia
Clinical narrative: High fever to 102.4 rectally on 1-31-07 (one week after immunization).  Also irritability and fatigue
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Pain in extremity, Skin laceration
Clinical narrative: L Deltoid has a firm knot at the injection site.  Area is reddened.  She complains of arm pain.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Similar reaction on previous exposure to drug
Clinical narrative: 10 x 6 cm area of erythema on left deltoid area developed, one day after patient received an Influenza A vaccine. Erythema is around and distal to injection site. No fever. No tenderness. No treatment required - observation. Of note last year patient also had similar reaction to the influenza vaccine but was thought to be cellulitis and was treated with antibiotics. (Mom states it was reported).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Abnormal behaviour, Aggression, Arthralgia, Crying, Disturbance in attention
Clinical narrative: ON JAN. 25 HAD IMMUNIZATIONS, THEN NOTICED DRASTIC CHANGE, SLUGGISH, JOINTS OF LEGS HURT. 1/27/07 LOW GRADE FEVER. 1/29/07 THEN VIOLENT OUTBURSTS UNABLE TO CALM, 1/30/07 THREW FOOD, NOT NORMAL BEHAVOR AT TABLE, THEN HIT FATHER WITH OBJECT CAUSED LACERATIION, 1/31/07 HITTING TEACHER, CRYING UNCONTROLLABLY, PINCHED CHILD, PINNED BOY DOWN ON GROUND. FOCUS AND LISTENING SKILLS POOR, NOT FOLLOWING INSTRUCTIONS.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pain in extremity, Personality change, Pyrexia, Sluggishness
Clinical narrative: ON JAN. 25 HAD IMMUNIZATIONS, THEN NOTICED DRASTIC CHANGE, SLUGGISH, JOINTS OF LEGS HURT. 1/27/07 LOW GRADE FEVER. 1/29/07 THEN VIOLENT OUTBURSTS UNABLE TO CALM, 1/30/07 THREW FOOD, NOT NORMAL BEHAVOR AT TABLE, THEN HIT FATHER WITH OBJECT CAUSED LACERATIION, 1/31/07 HITTING TEACHER, CRYING UNCONTROLLABLY, PINCHED CHILD, PINNED BOY DOWN ON GROUND. FOCUS AND LISTENING SKILLS POOR, NOT FOLLOWING INSTRUCTIONS.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Angiogram normal, Arteriogram carotid normal, Aspiration tracheal, Blood product transfusion, Blood test normal
Clinical narrative: Fever 7 days post vaccination.  Seizure disorder and encephalitis of unknown etiology (dr suspects possible viral though tests negative) diagnosed 9 days post vaccination. Patient is now severely weak on her entire left side and is unable to verbally communicate and has difficulty swallowing...all secondary to encephalitis. Was treated at Hospital in PICU for a week and then two weeks in regular hospitalization. Was treated with acyclovir q 8 hrs for 21 days, is now on kepra for seizures.  will require months of PT/ST/OT to try to get her back to "normal". Can provide more info if needed just call.  03/07/2007 MR received from pediatrician showing a well-child check on 12/26/2006. No c/o.  PE WNL. Meeting developmental milestones with the exception of walking alone. Proquad and Hep A vax given.  03/05/2007 MR received from hospital.  HPI:  Child presented to local ER in status epilepticus.  Father had found her in her crib unresponsive, with head and eyes turned to the right.  She was covered in various bodily fluids.   She was quickly transferred to the hospital PICU with admission DX of Complex febrile seizure with left hemiparesis.   Treated with Acyclovir, Rocephin, Fosphenytoin, Ativan, Keppra and IVIG. Seizure activity gradually decreased although a left hemiparesis and facial palsy remained. Feeding modifications made due to aspiration risk.  Discharged after 21 day stay. Discharge DX:  Focal encephalitis, possibly herpes simplex virus encephalitis. Per information received from the annual follow up recipient has not recovered. Still has significant left side hemiparesis & significant congative delay-operating at 9-12 month level though now 25 months old. Case pending with VICP. Parents not recovered either.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Cerebral ataxia, Cognitive disorder, Communication disorder, Computerised tomogram normal, Convulsion
Clinical narrative: Fever 7 days post vaccination.  Seizure disorder and encephalitis of unknown etiology (dr suspects possible viral though tests negative) diagnosed 9 days post vaccination. Patient is now severely weak on her entire left side and is unable to verbally communicate and has difficulty swallowing...all secondary to encephalitis. Was treated at Hospital in PICU for a week and then two weeks in regular hospitalization. Was treated with acyclovir q 8 hrs for 21 days, is now on kepra for seizures.  will require months of PT/ST/OT to try to get her back to "normal". Can provide more info if needed just call.  03/07/2007 MR received from pediatrician showing a well-child check on 12/26/2006. No c/o.  PE WNL. Meeting developmental milestones with the exception of walking alone. Proquad and Hep A vax given.  03/05/2007 MR received from hospital.  HPI:  Child presented to local ER in status epilepticus.  Father had found her in her crib unresponsive, with head and eyes turned to the right.  She was covered in various bodily fluids.   She was quickly transferred to the hospital PICU with admission DX of Complex febrile seizure with left hemiparesis.   Treated with Acyclovir, Rocephin, Fosphenytoin, Ativan, Keppra and IVIG. Seizure activity gradually decreased although a left hemiparesis and facial palsy remained. Feeding modifications made due to aspiration risk.  Discharged after 21 day stay. Discharge DX:  Focal encephalitis, possibly herpes simplex virus encephalitis. Per information received from the annual follow up recipient has not recovered. Still has significant left side hemiparesis & significant congative delay-operating at 9-12 month level though now 25 months old. Case pending with VICP. Parents not recovered either.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Dysphagia, Echocardiogram abnormal, Encephalitis, Epilepsy, Eye movement disorder
Clinical narrative: Fever 7 days post vaccination.  Seizure disorder and encephalitis of unknown etiology (dr suspects possible viral though tests negative) diagnosed 9 days post vaccination. Patient is now severely weak on her entire left side and is unable to verbally communicate and has difficulty swallowing...all secondary to encephalitis. Was treated at Hospital in PICU for a week and then two weeks in regular hospitalization. Was treated with acyclovir q 8 hrs for 21 days, is now on kepra for seizures.  will require months of PT/ST/OT to try to get her back to "normal". Can provide more info if needed just call.  03/07/2007 MR received from pediatrician showing a well-child check on 12/26/2006. No c/o.  PE WNL. Meeting developmental milestones with the exception of walking alone. Proquad and Hep A vax given.  03/05/2007 MR received from hospital.  HPI:  Child presented to local ER in status epilepticus.  Father had found her in her crib unresponsive, with head and eyes turned to the right.  She was covered in various bodily fluids.   She was quickly transferred to the hospital PICU with admission DX of Complex febrile seizure with left hemiparesis.   Treated with Acyclovir, Rocephin, Fosphenytoin, Ativan, Keppra and IVIG. Seizure activity gradually decreased although a left hemiparesis and facial palsy remained. Feeding modifications made due to aspiration risk.  Discharged after 21 day stay. Discharge DX:  Focal encephalitis, possibly herpes simplex virus encephalitis. Per information received from the annual follow up recipient has not recovered. Still has significant left side hemiparesis & significant congative delay-operating at 9-12 month level though now 25 months old. Case pending with VICP. Parents not recovered either.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Gait disturbance, Hemiparesis, Hyporeflexia, Intensive care, Lumbar puncture normal
Clinical narrative: Fever 7 days post vaccination.  Seizure disorder and encephalitis of unknown etiology (dr suspects possible viral though tests negative) diagnosed 9 days post vaccination. Patient is now severely weak on her entire left side and is unable to verbally communicate and has difficulty swallowing...all secondary to encephalitis. Was treated at Hospital in PICU for a week and then two weeks in regular hospitalization. Was treated with acyclovir q 8 hrs for 21 days, is now on kepra for seizures.  will require months of PT/ST/OT to try to get her back to "normal". Can provide more info if needed just call.  03/07/2007 MR received from pediatrician showing a well-child check on 12/26/2006. No c/o.  PE WNL. Meeting developmental milestones with the exception of walking alone. Proquad and Hep A vax given.  03/05/2007 MR received from hospital.  HPI:  Child presented to local ER in status epilepticus.  Father had found her in her crib unresponsive, with head and eyes turned to the right.  She was covered in various bodily fluids.   She was quickly transferred to the hospital PICU with admission DX of Complex febrile seizure with left hemiparesis.   Treated with Acyclovir, Rocephin, Fosphenytoin, Ativan, Keppra and IVIG. Seizure activity gradually decreased although a left hemiparesis and facial palsy remained. Feeding modifications made due to aspiration risk.  Discharged after 21 day stay. Discharge DX:  Focal encephalitis, possibly herpes simplex virus encephalitis. Per information received from the annual follow up recipient has not recovered. Still has significant left side hemiparesis & significant congative delay-operating at 9-12 month level though now 25 months old. Case pending with VICP. Parents not recovered either.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Pyrexia, Tricuspid valve incompetence
Clinical narrative: Fever 7 days post vaccination.  Seizure disorder and encephalitis of unknown etiology (dr suspects possible viral though tests negative) diagnosed 9 days post vaccination. Patient is now severely weak on her entire left side and is unable to verbally communicate and has difficulty swallowing...all secondary to encephalitis. Was treated at Hospital in PICU for a week and then two weeks in regular hospitalization. Was treated with acyclovir q 8 hrs for 21 days, is now on kepra for seizures.  will require months of PT/ST/OT to try to get her back to "normal". Can provide more info if needed just call.  03/07/2007 MR received from pediatrician showing a well-child check on 12/26/2006. No c/o.  PE WNL. Meeting developmental milestones with the exception of walking alone. Proquad and Hep A vax given.  03/05/2007 MR received from hospital.  HPI:  Child presented to local ER in status epilepticus.  Father had found her in her crib unresponsive, with head and eyes turned to the right.  She was covered in various bodily fluids.   She was quickly transferred to the hospital PICU with admission DX of Complex febrile seizure with left hemiparesis.   Treated with Acyclovir, Rocephin, Fosphenytoin, Ativan, Keppra and IVIG. Seizure activity gradually decreased although a left hemiparesis and facial palsy remained. Feeding modifications made due to aspiration risk.  Discharged after 21 day stay. Discharge DX:  Focal encephalitis, possibly herpes simplex virus encephalitis. Per information received from the annual follow up recipient has not recovered. Still has significant left side hemiparesis & significant congative delay-operating at 9-12 month level though now 25 months old. Case pending with VICP. Parents not recovered either.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Computerised tomogram normal, Developmental delay, Encephalitis, Eye rolling, Hypoventilation
Clinical narrative: Fever 7 days post vaccination.  Seizure disorder and encephalitis of unknown etiology (dr suspects possible viral though tests negative) diagnosed 9 days post vaccination. Patient is now severely weak on her entire left side and is unable to verbally communicate and has difficulty swallowing...all secondary to encephalitis. Was treated at Hospital in PICU for a week and then two weeks in regular hospitalization. Was treated with acyclovir q 8 hrs for 21 days, is now on kepra for seizures.  will require months of PT/ST/OT to try to get her back to "normal". Can provide more info if needed just call.  03/07/2007 MR received from pediatrician showing a well-child check on 12/26/2006. No c/o.  PE WNL. Meeting developmental milestones with the exception of walking alone. Proquad and Hep A vax given.  03/05/2007 MR received from hospital.  HPI:  Child presented to local ER in status epilepticus.  Father had found her in her crib unresponsive, with head and eyes turned to the right.  She was covered in various bodily fluids.   She was quickly transferred to the hospital PICU with admission DX of Complex febrile seizure with left hemiparesis.   Treated with Acyclovir, Rocephin, Fosphenytoin, Ativan, Keppra and IVIG. Seizure activity gradually decreased although a left hemiparesis and facial palsy remained. Feeding modifications made due to aspiration risk.  Discharged after 21 day stay. Discharge DX:  Focal encephalitis, possibly herpes simplex virus encephalitis. Per information received from the annual follow up recipient has not recovered. Still has significant left side hemiparesis & significant congative delay-operating at 9-12 month level though now 25 months old. Case pending with VICP. Parents not recovered either.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Inflammation, Lumbar puncture normal, Muscle rigidity, Nervous system disorder, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Fever 7 days post vaccination.  Seizure disorder and encephalitis of unknown etiology (dr suspects possible viral though tests negative) diagnosed 9 days post vaccination. Patient is now severely weak on her entire left side and is unable to verbally communicate and has difficulty swallowing...all secondary to encephalitis. Was treated at Hospital in PICU for a week and then two weeks in regular hospitalization. Was treated with acyclovir q 8 hrs for 21 days, is now on kepra for seizures.  will require months of PT/ST/OT to try to get her back to "normal". Can provide more info if needed just call.  03/07/2007 MR received from pediatrician showing a well-child check on 12/26/2006. No c/o.  PE WNL. Meeting developmental milestones with the exception of walking alone. Proquad and Hep A vax given.  03/05/2007 MR received from hospital.  HPI:  Child presented to local ER in status epilepticus.  Father had found her in her crib unresponsive, with head and eyes turned to the right.  She was covered in various bodily fluids.   She was quickly transferred to the hospital PICU with admission DX of Complex febrile seizure with left hemiparesis.   Treated with Acyclovir, Rocephin, Fosphenytoin, Ativan, Keppra and IVIG. Seizure activity gradually decreased although a left hemiparesis and facial palsy remained. Feeding modifications made due to aspiration risk.  Discharged after 21 day stay. Discharge DX:  Focal encephalitis, possibly herpes simplex virus encephalitis. Per information received from the annual follow up recipient has not recovered. Still has significant left side hemiparesis & significant congative delay-operating at 9-12 month level though now 25 months old. Case pending with VICP. Parents not recovered either.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Unresponsive to stimuli, X-ray abnormal
Clinical narrative: Fever 7 days post vaccination.  Seizure disorder and encephalitis of unknown etiology (dr suspects possible viral though tests negative) diagnosed 9 days post vaccination. Patient is now severely weak on her entire left side and is unable to verbally communicate and has difficulty swallowing...all secondary to encephalitis. Was treated at Hospital in PICU for a week and then two weeks in regular hospitalization. Was treated with acyclovir q 8 hrs for 21 days, is now on kepra for seizures.  will require months of PT/ST/OT to try to get her back to "normal". Can provide more info if needed just call.  03/07/2007 MR received from pediatrician showing a well-child check on 12/26/2006. No c/o.  PE WNL. Meeting developmental milestones with the exception of walking alone. Proquad and Hep A vax given.  03/05/2007 MR received from hospital.  HPI:  Child presented to local ER in status epilepticus.  Father had found her in her crib unresponsive, with head and eyes turned to the right.  She was covered in various bodily fluids.   She was quickly transferred to the hospital PICU with admission DX of Complex febrile seizure with left hemiparesis.   Treated with Acyclovir, Rocephin, Fosphenytoin, Ativan, Keppra and IVIG. Seizure activity gradually decreased although a left hemiparesis and facial palsy remained. Feeding modifications made due to aspiration risk.  Discharged after 21 day stay. Discharge DX:  Focal encephalitis, possibly herpes simplex virus encephalitis. Per information received from the annual follow up recipient has not recovered. Still has significant left side hemiparesis & significant congative delay-operating at 9-12 month level though now 25 months old. Case pending with VICP. Parents not recovered either.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Encephalitis
Clinical narrative: Fever 7 days post vaccination.  Seizure disorder and encephalitis of unknown etiology (dr suspects possible viral though tests negative) diagnosed 9 days post vaccination. Patient is now severely weak on her entire left side and is unable to verbally communicate and has difficulty swallowing...all secondary to encephalitis. Was treated at Hospital in PICU for a week and then two weeks in regular hospitalization. Was treated with acyclovir q 8 hrs for 21 days, is now on kepra for seizures.  will require months of PT/ST/OT to try to get her back to "normal". Can provide more info if needed just call.  03/07/2007 MR received from pediatrician showing a well-child check on 12/26/2006. No c/o.  PE WNL. Meeting developmental milestones with the exception of walking alone. Proquad and Hep A vax given.  03/05/2007 MR received from hospital.  HPI:  Child presented to local ER in status epilepticus.  Father had found her in her crib unresponsive, with head and eyes turned to the right.  She was covered in various bodily fluids.   She was quickly transferred to the hospital PICU with admission DX of Complex febrile seizure with left hemiparesis.   Treated with Acyclovir, Rocephin, Fosphenytoin, Ativan, Keppra and IVIG. Seizure activity gradually decreased although a left hemiparesis and facial palsy remained. Feeding modifications made due to aspiration risk.  Discharged after 21 day stay. Discharge DX:  Focal encephalitis, possibly herpes simplex virus encephalitis. Per information received from the annual follow up recipient has not recovered. Still has significant left side hemiparesis & significant congative delay-operating at 9-12 month level though now 25 months old. Case pending with VICP. Parents not recovered either.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: PATIENT HAD A PNEUMOVAX INJECTION IN RIGHT ARM.  PATIENT CALLED THE MORNING AFTER INJECTION AND STATED: THERE IS A LARGE PONE IN THE AREA OF THE INJECTION.  ARM IS SWOLLEN AND WARM TOO TOUCH. SWELLING AS NOT REACHED THE ELBOW.  ARM IS NOT RED.  HAD FEVER AND CHILLS AND WAS UNABLE TO SLEEP THE NIGHT AFTER INJECTION DUE TO THE PAIN. PATIENT WAS CALLED BACK BY THE NURSE LATER THAT DAY AND STATED THAT HIS ARM WAS BETTER, NO FURTHER SWELLING, NO HEAT NOTED.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: PATIENT HAD A PNEUMOVAX INJECTION IN RIGHT ARM.  PATIENT CALLED THE MORNING AFTER INJECTION AND STATED: THERE IS A LARGE PONE IN THE AREA OF THE INJECTION.  ARM IS SWOLLEN AND WARM TOO TOUCH. SWELLING AS NOT REACHED THE ELBOW.  ARM IS NOT RED.  HAD FEVER AND CHILLS AND WAS UNABLE TO SLEEP THE NIGHT AFTER INJECTION DUE TO THE PAIN. PATIENT WAS CALLED BACK BY THE NURSE LATER THAT DAY AND STATED THAT HIS ARM WAS BETTER, NO FURTHER SWELLING, NO HEAT NOTED.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Breast mass, Breast pain, Breast swelling, Lymphadenopathy
Clinical narrative: Patient complained of swelling to right breast and right axilla three days after receiving the varicella vaccine.  Patient states she also developed lumps to her right breast with an aching sensation.  Patient states she also had some swelling to left breast with lumps.
Age: 1.8
Sex: F
Vaccine: UNK
Symptoms: Ear infection, Febrile convulsion, Pyrexia
Clinical narrative: Thursday Jan 25 had a pneumococcal vaccine around 6pm. By 1pm next day had developed a high fever (102.6). By 2:15pm started to have a febrile seizure. Lasted about a couple of minutes. Was rushed to ER by ambulance. Checked out at hospital to find the beginnings of an ear infection. The beginnings of the ear infection and the immunization together may have caused a high fever then caused the febrile seizure. Was discharged from ER 8:30pm Friday night. Not admitted to hospital.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Vomiting
Clinical narrative: Vomiting one time. Denies fever and rash.
Age: 10.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope at time of vaccine administration. Patient was placed in a supine position with head lower than up. He regained consciousness spontaneously without complication.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site vesicles
Clinical narrative: Reaction to vaccine 6 days after receiving Zostavax. 3" ring around sight, center white, few small blisters at top and bottom of circle.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Skin reaction
Clinical narrative: Reaction to vaccine 6 days after receiving Zostavax. 3" ring around sight, center white, few small blisters at top and bottom of circle.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Hypotonia, Unresponsive to stimuli
Clinical narrative: Within 10 minutes of administration of the Pediarix the patient became limp and unresponsive, although breathing on his own and maintaining his skin color. The event lasted for about 5-6 minutes.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: HBIG administered PO, notified MD immediately, VS taken within 20 minutes within normal limits. Repeat VS in 30 min within normal limits. Poison control called because MD not immediately available no action required per their recommendation, vaccine not considered effective.
Sex: U
Vaccine: DTAP
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: Infanrix (DTaP) vaccine for children was administered to adults by occupational health for tetanus prophylaxis in patients of risk. Prefilled syringes were used that are not clearly labeled "for children use only" and so was administered instead of the adult booster Adacel (Tdap) which also has the same ingredients at a much smaller dose. Mix-ups between the children vaccines for tetanus/diphtheria/pertussis should be on high alert now that the CDC has recommended vaccines including pertussis protection should be administered to adults as well (although not the pediatric formulations since they are at much higher doses that adults don't tolerate as well). When mix-ups such as this occur, patients should be monitored for injection site reactions and should not be re-vaccinated. The shot should count as a TD booster and will not require another for 10 years.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown.  No product quality  complaint was involved.  Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HEP, MEA
Symptoms: Erythema, Fatigue, Flushing, Pain, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female patient, with no allergies, who on 19 Jun 2006 at 16:00 was vaccinated SC in the left arm with a first 0.5 ml dose of Attenuvax (Lot# 652338/0260F). Concomitant vaccination included a fourth dose of Recombivax HB (lot#652711/1213R) given IM in the right deltoid. There was no illness at the time of vaccination. On 30 Jun 2006 the patient developed fatigue. On 01 Jul 2006 the patient then developed aches to her whole body and she was flushed. On 03 Jul 2006 the patient developed a rash on the side of her face which was also reported to be an itchy, faint red rash to her scalp and chest. It was reported that on 05 Jul 2006 the rash was lighter and was no longer itchy, subsequently the patient recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought.  No product quality complaint was involved. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: HEP, MEA
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female patient, with no allergies, who on 19 Jun 2006 at 16:00 was vaccinated SC in the left arm with a first 0.5 ml dose of Attenuvax (Lot# 652338/0260F). Concomitant vaccination included a fourth dose of Recombivax HB (lot#652711/1213R) given IM in the right deltoid. There was no illness at the time of vaccination. On 30 Jun 2006 the patient developed fatigue. On 01 Jul 2006 the patient then developed aches to her whole body and she was flushed. On 03 Jul 2006 the patient developed a rash on the side of her face which was also reported to be an itchy, faint red rash to her scalp and chest. It was reported that on 05 Jul 2006 the rash was lighter and was no longer itchy, subsequently the patient recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought.  No product quality complaint was involved. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Dizziness, Feeling drunk, Gait disturbance, Stress
Clinical narrative: 2-1-07 Patient states she felt lightheaded the day after her injection. States she felt this was related to stress of school. 2nd day after injection felt "drunk". Terrible walking health center sent her to hospital by ambulance. Admit times 2 days. Diagnosis vertigo, CT Brain WNL was changed with prescription. Medicine - never filled per patient. Too busy with school at finals. No sign of reaction on right deltoid.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vertigo
Clinical narrative: 2-1-07 Patient states she felt lightheaded the day after her injection. States she felt this was related to stress of school. 2nd day after injection felt "drunk". Terrible walking health center sent her to hospital by ambulance. Admit times 2 days. Diagnosis vertigo, CT Brain WNL was changed with prescription. Medicine - never filled per patient. Too busy with school at finals. No sign of reaction on right deltoid.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Dizziness, Feeling drunk, Gait disturbance, Malaise
Clinical narrative: 2-1-07 Patient states she felt lightheaded the day after her injection. States she felt this was related to stress of school. 2nd day after injection felt "drunk". Terrible walking health center sent her to hospital by ambulance. Admit times 2 days. Diagnosis vertigo, CT Brain WNL was changed with prescription. Medicine - never filled per patient. Too busy with school at finals. No sign of reaction on right deltoid.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Haematocrit normal, Haemoglobin normal, Pyrexia, White blood cell count normal
Clinical narrative: Chills, temp 103F-onset 24 hours post vaccine administration. Prescribed Advil with good response.
Age: 0.72
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Erythema, Pruritus
Clinical narrative: 2 day after IM injection deepen with erythema of Left deltoid. 6 day after immunization in our clinic with 15x10cm erythematous/itchy/non tender patch on Left deltoid. Treated with Benadryl and ice (Dtap) site.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Irritability, Pruritus, Urticaria
Clinical narrative: Patient received Dtap and IPV left deltoid and MMRV and flu Right deltoid. About 5 minutes after administering patient developed aheal on at front shoulder, deltoid, arm and itchy. No respiratory distress. Chest normal in exam. Patient fussy called about 3 hours later patient seen. Patient seen clinic 11/30/06 and hives resolved and no symptoms.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Patient received 1st dose of Gardasil vaccine and the next day her arm got red and swollen and she experienced nausea and dizziness. 4 days later she reports arm continued to swell and be painful, but denies fever or chills. Patient was advised to take dihenhydramine and use ice on the area.
Sex: F
Vaccine: FLU3
Symptoms: Blister, Drug hypersensitivity, Herpes simplex, Injection site erythema, Injection site induration
Clinical narrative: Right deltoid-almond size red, swollen, hard, painful lump when approved. 10/18/06 AM when woke up -then area became blistered. Then came down with fever blisters, nose, lips, stuffy head, nose, head congestion. Primary care physician told her never to get flu shot again.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Nasal congestion
Clinical narrative: Right deltoid-almond size red, swollen, hard, painful lump when approved. 10/18/06 AM when woke up -then area became blistered. Then came down with fever blisters, nose, lips, stuffy head, nose, head congestion. Primary care physician told her never to get flu shot again.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain upper, Headache, Malaise, Pruritus, Rash generalised
Clinical narrative: Very severe skin rash covering the entire body. Itchy skin, some sneezing scratchy throat. Headache, stomach ache overall feeling of being unwell. After 4 days rash not gone. Treatment: Benadryl every 5 hours, Aveeno baths.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Sneezing, Throat irritation
Clinical narrative: Very severe skin rash covering the entire body. Itchy skin, some sneezing scratchy throat. Headache, stomach ache overall feeling of being unwell. After 4 days rash not gone. Treatment: Benadryl every 5 hours, Aveeno baths.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Stomach discomfort
Clinical narrative: Symptoms began at approximately 7pm and lasted 4-5 hours. Complained of chills, achy, headache and upset stomache. Felt okay next morning.