chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Liver function test abnormal, Mononucleosis syndrome
Clinical narrative: Within one week of recieving Guardacil and meningitis vaccine on same day, had mono-like symptoms, with elevated LFTs.  10/24/2008 MR received from PCP.  OV 8/7/07 for c/o swollen glands in the neck with neck stiffness and soreness, fatigue.  PE (+) for redness and swelling in the tonsil area and prominant cervical nodes.  Assessment:  Swollen lymph nodes, very minimal pharyngitis. Liver clinic visit 10/17/07 with DX; autoimmune hepatitis. Abnormal Liver Enzymes/Transaminitis. Rapidly improved on steroids. Behavioral Health intake 11/2/07 with c/o anxiety and depression with crying spells, feeling nervous, difficulty sleeping. DX: Adjustment d/o with anxiety and depressed mood. OV 4/30/08 with sore throat and asthma. Tonsils enlarged. Recently increased EIA. Returned 8/10/08 with continued c/o swollen glands and sore throat. Assessment Severe pharyngitis. Returned 8/13/08 No improvement on abx. L tonsil more enlarged w/ erythema. Large anterior cervical lymph nodes. Assessment: One sided tonsillitis, mono-like infection.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Rash macular
Clinical narrative: ON 9-9-2008 PATIENT RECEIVED TDAP AND HPV, ON 09/10/2008 MOHTER BROUGHT CHILD IN FOR A DISCRETE MACULAR RASH ON TOP OF HANDS AND FEET.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope episode after receiving 4 injections
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Oedema peripheral
Clinical narrative: Patient was here last week for varicella vaccine on Thursday, 9/04/2008.  The next day, he had about a two inch area around the varicella injection site that was red and swollen.  Then on Saturday, it was red and swollen from the elbow to the shoulder.  No pain but warm and itchy.  No fever.  She gave him Benadryl, iced area, and that seemed to help. She almost called but had a friend who works at a hospital take a look at it.  Now, today the swelling is back to the two inch area with redness and itch.  Still no fever and no pain. Mom stated it's getting better but she just wanted to let someone know the type of reaction he had to the injection.  Advised if s/s increase or patient develops pain or fever to call for assessment.  Mother stated appreciation and agreement.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pruritus, Skin warm
Clinical narrative: Patient was here last week for varicella vaccine on Thursday, 9/04/2008.  The next day, he had about a two inch area around the varicella injection site that was red and swollen.  Then on Saturday, it was red and swollen from the elbow to the shoulder.  No pain but warm and itchy.  No fever.  She gave him Benadryl, iced area, and that seemed to help. She almost called but had a friend who works at a hospital take a look at it.  Now, today the swelling is back to the two inch area with redness and itch.  Still no fever and no pain. Mom stated it's getting better but she just wanted to let someone know the type of reaction he had to the injection.  Advised if s/s increase or patient develops pain or fever to call for assessment.  Mother stated appreciation and agreement.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Blood culture, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: I had severe and very painful swelling starting around the area where the shot was administered. Then the sweeling and pain traveled to my left underarm, elbow and forearm. The shot was administered on 9/9/2008 and within 24 hours it left me unable to bend my left arm completely. The IV  in my left arm was also affected and had to be moved a day later.A week later I still have pain and some swelling,especially around the area where the IV was. I was on antibiotics for a different problem the whole time this reaction took place.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: I had severe and very painful swelling starting around the area where the shot was administered. Then the sweeling and pain traveled to my left underarm, elbow and forearm. The shot was administered on 9/9/2008 and within 24 hours it left me unable to bend my left arm completely. The IV  in my left arm was also affected and had to be moved a day later.A week later I still have pain and some swelling,especially around the area where the IV was. I was on antibiotics for a different problem the whole time this reaction took place.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Feeling hot, Lip swelling, Rash generalised
Clinical narrative: Mother reported rash beginning on face and swelling of lips approximately 7 hours after immunizations were administered.  Rash spread to entire body and extremities. Mother states child felt hot to touch, but did not check his temperature.  He did not have any difficulty breathing, continued to play, eat, and drink as usual.  Mother brought the child to clinic 9/15/08 to be checked.  Appears well, fading rash noted.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Abnormal behaviour, Alanine aminotransferase normal, Albumin globulin ratio decreased, Analgesic drug level therapeutic, Aphasia
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Arthropod bite, Aspartate aminotransferase decreased, Balance disorder, Basophil percentage decreased, Bilirubin conjugated normal
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood bilirubin unconjugated normal, Blood calcium normal
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood osmolarity decreased, Blood potassium normal
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Blood sodium normal, CSF culture negative, CSF glucose normal, CSF lymphocyte count normal, CSF neutrophil count increased
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: CSF protein normal, CSF test abnormal, CSF white blood cell count increased, Carbon dioxide normal, Cerebellar ataxia
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Chest X-ray normal, Chills, Computerised tomogram normal, Coxsackie virus serology test, Disturbance in attention
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Drug screen negative, Eosinophil percentage increased, Full blood count normal, Gait disturbance, Globulin
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Haematocrit normal, Haemoglobin normal, Herpes simplex serology, Lethargy, Lymphocyte percentage
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Monocyte percentage increased, Neurological examination abnormal, Neutrophil percentage decreased, Platelet count normal, Posture abnormal
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Red blood cells CSF positive, Serology test, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Urine analysis normal, White blood cell count normal
Clinical narrative: THIS 2 YR 2 MO OLD CAUCASIAN MALE WAS FOUND UNRESPONSIVE ANS ASSUMING BIZZARE POSTURES WITH TREMULOUSNESS SINCE THE MORNING OF 09/12/2008. HE WAS ADMINISTERED CATCH UP VACCINES ON 09/09/2008 WHICH ARE DTaP/Hib/MMR1/VARICELLA1/PCV. NO HISTORY OF FEVER/VOMITING/DIARRHEA/SEIZURES/RASH. BUT GRAND MOM, WHO IS A NURSE, REPORTED THE CHILD HAVING CHILLS SINCE THE MORNING OF 09/12/2008. KID HAD MULTIPLE MOSQUITO BITES ALL OVER HIS BODY. ACCORDING TO CONSULTANT NEUROLOGIST: THE PATIENT BEGAN DISPLAYING BEHAVIORAL CHANGES ON FRIDAY, 09-12-2008 WITH LOSS OF LANGUGAE ABILITIES AND LETHARGY OR INATTENTIVENESS. HE SEEMED TO ENGAGE IN SOME" STARING" BEHAVIOR. NO FEVER OR CONVULSIVE SEIZURE ACTIVITY NOTED. 0N 09-14-2008, NEUROLOGIC STATUS HAS IMPROVED. THE PATIENT SEEMS TO BE RETURNING TO HIS HEALTHY BASELINE. HE STILL APPEARS SLIGHLTY "UNSTEADY AND SHAKY", AS CORROBORATED BY HIS MOTHER. HE IS NOW TALKING SOME, EATING, PLAYING AND ENGAGING WITH HIS ENVIRONMENT. HE HAS NO CLOUDING OF SENSORIUM. HE REMAINS SEIZURE FREE DESPITE BEING ON ANY ANTI CONVULSANT. EEG IS PLANNED TODAY 09/15/2008. THIS MORNING HE IS QUITE ACTIVE BUT STILL A LITTLE SWAYING IS PRESENT IN HIS GAIT PROBABLY DUE TO CERBELLAR ATAXIA.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Cellulitis, Culture negative, Erythema
Clinical narrative: Seen by dermatologist 06/23/2008. "fulminating blistors clustered on spine/buttocks. area of fanlike redness above. Dx as herpatic lesions? cellulitis in the gluteal cleft. Tx.with Valtrex 1 gm tid,7d. then red blotchy patches appeared all over chest and trunk c/o pain all over. poss rxn. to valtrex, erythema multiformi. Day of interview client still c/o back pain,numbness back of Rt. Leg,L leg,  inside of upper Rt. shoulder.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema multiforme, Herpes virus infection, Hypoaesthesia, Pain, Rash macular
Clinical narrative: Seen by dermatologist 06/23/2008. "fulminating blistors clustered on spine/buttocks. area of fanlike redness above. Dx as herpatic lesions? cellulitis in the gluteal cleft. Tx.with Valtrex 1 gm tid,7d. then red blotchy patches appeared all over chest and trunk c/o pain all over. poss rxn. to valtrex, erythema multiformi. Day of interview client still c/o back pain,numbness back of Rt. Leg,L leg,  inside of upper Rt. shoulder.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Virus culture negative
Clinical narrative: Seen by dermatologist 06/23/2008. "fulminating blistors clustered on spine/buttocks. area of fanlike redness above. Dx as herpatic lesions? cellulitis in the gluteal cleft. Tx.with Valtrex 1 gm tid,7d. then red blotchy patches appeared all over chest and trunk c/o pain all over. poss rxn. to valtrex, erythema multiformi. Day of interview client still c/o back pain,numbness back of Rt. Leg,L leg,  inside of upper Rt. shoulder.
Age: 18.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Skin lesion
Clinical narrative: Satiellate lesion on left shoulder next to primary.
Age: 65.0
Sex: M
Vaccine: HEP, HEPA, IPV, TD, TYP
Symptoms: Injection site mass
Clinical narrative: Pt called and c/o bump on right shoulder area where vaccine was given.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: 9-13-08 noon Pts left arm red, swollen, itchy/warm on and off.  Saw Family Physician 9-15-2008, Physician said its a local reaction and a good thing and to do nothing (per patient.)
Age: 16.0
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Pt given HPV and Hep A vaccines. After vaccines given, pt wanted a pregnancy test and she was pregnant.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: l DELTOID 4 INCH RED SWOLLEN AREA. ITCHY AREA.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Woke up with leg pain the next morning with swelling of his thigh, inability to bend leg, and fever.  09/18/2008 MR received for DOS 9/12-13/2008 with DX:  Left Leg Cellulitis.  Pt awoke the day after vax with c/o leg pain and being unable to bend knee. Leg swelling noted and low grade fever.  On PE L thigh edema, non-pitting and warmth noted. No erythema.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Myalgia, Ultrasound scan, Wrong drug administered
Clinical narrative: Patient c/o residual pain in deltoid muscle where vaccine was administered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Vaccination complication
Clinical narrative: DaPT AND MMR INTO right ARM ON 9/11/2008 - red & hot R upper arm noted that night - worse the next AM, involving shoulder to elbow and more than 1/2 of circumference of upper arm  - taken to ER where parent told this was cellulitis and vaccine reaction - treated w/ clindamicin with improvement by next day. Still remained active - no meds given for pain. Today, area of redness approx 2 x 3 inch, minimal pain.
Age: 13.0
Sex: M
Vaccine: MEN
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: vaccine given 9/10/08. Both legs became sore and stiffon 9/11/08. I contacted nurse today her statement was symptoms not un-natural, give tylenol, could last several days.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Mother described localized site reaction 6 inches diameter, swollen, hot, red, painful. Worse yesterday than today. Visited physician who explained localized site reaction and drew a line around induration with marker to watch for changes (according to mother). Observation only, no treatment, report back if worsens.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Back pain, Blood product transfusion, Chest X-ray, Dizziness
Clinical narrative: 9/10/08 dizziness, back pain - seen ER - home.  9/11/08 weakness, shortness of breath - ER - PICU oxygen, Bipap, IVIG, IV antibiotics, IV fluids, labs, CXR.  10/09/2008 MR received for  ER 9/9/08 and DOS 9/12-15/2008 with DX: Acute respiratory failure 2' to chest wall and neuromuscular weakness due to Guillain Barre Syndrome.  Chronic suppurative otitis media.  Chronic mastoiditis.  Central perforation of L tympanic membrane. Initially presented to ER 9/9/08 with c/o 24' hx of dizziness, back pain, H/A, vomiting, diarrhea and syncopal episode with head injury. Also ear pain and cough-previously dx otitis media with perforated ear drum. Tx with IVF and D/c. Returned 9/12/08 with c/o lethargy, 2nd syncopal episode, generalized weakness, SOB, inability to stand and head, neck and back pain. PE (+) for pallor, L ear drainage, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased WOB, and decreased strength-3/5 upper, 2/5 lower extremities. Admitted in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Tx with IVIG with good response. Neuro will consider EMG/NCS if sx recur. ENT consult with Assessment: Chronic supporative OM, chronic mastoiditis, OM, central perforation of L TM.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dyspnoea, Intensive care, Laboratory test, Oxygen supplementation
Clinical narrative: 9/10/08 dizziness, back pain - seen ER - home.  9/11/08 weakness, shortness of breath - ER - PICU oxygen, Bipap, IVIG, IV antibiotics, IV fluids, labs, CXR.  10/09/2008 MR received for  ER 9/9/08 and DOS 9/12-15/2008 with DX: Acute respiratory failure 2' to chest wall and neuromuscular weakness due to Guillain Barre Syndrome.  Chronic suppurative otitis media.  Chronic mastoiditis.  Central perforation of L tympanic membrane. Initially presented to ER 9/9/08 with c/o 24' hx of dizziness, back pain, H/A, vomiting, diarrhea and syncopal episode with head injury. Also ear pain and cough-previously dx otitis media with perforated ear drum. Tx with IVF and D/c. Returned 9/12/08 with c/o lethargy, 2nd syncopal episode, generalized weakness, SOB, inability to stand and head, neck and back pain. PE (+) for pallor, L ear drainage, shallow respirations, diminished breath sounds, faint expiratory wheezes, tachypnea, increased WOB, and decreased strength-3/5 upper, 2/5 lower extremities. Admitted in acute respiratory failure with anxiety, respiratory distress, tachypnea and early respiratory alkalosis. Tx with IVIG with good response. Neuro will consider EMG/NCS if sx recur. ENT consult with Assessment: Chronic supporative OM, chronic mastoiditis, OM, central perforation of L TM.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. reports symptoms started 9/8/08 at approx 6 pm (HA), 9/9/08-HA cont., weakness, fever (did not take), but felt like fever, redness at site and swollen area 9/10/08- decreased HA, no weakness, no reddness at site, warm to touch and mildly swollen.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Pt. reports symptoms started 9/8/08 at approx 6 pm (HA), 9/9/08-HA cont., weakness, fever (did not take), but felt like fever, redness at site and swollen area 9/10/08- decreased HA, no weakness, no reddness at site, warm to touch and mildly swollen.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event, Wrong drug administered
Clinical narrative: None- No adverse events. Pt is age 66 and ADACEL. Tdap is limited to ages 11-64 y.o. Given in error.
Sex: U
Vaccine: DTAP, MMR, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Varicella vaccination was given IM instead of subcutaneous (in the (L) thigh). No reaction observed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Mass, Pain in extremity, Skin discolouration, Skin warm, Tenderness
Clinical narrative: (L) armpit pain/lump. 3-4 -> 1-2 cm warm, tender mass with a slight bluish appearance just below (L) axilla.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 8 week old male infant who on 11-JUL-2008 was vaccinated with a first dose of ROTATEQ and immediately vomited the dose and milk. Medical attention was sought in the office. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the reporting physician indicated that the 9 week old (previously reported as 8 weeks old) male with a history of immunization (hepatitis B virus vaccine unspecified) at birth) who on 11-JUL-2008 at 17:00 was vaccinated with his first dose of ROTATEQ. Concomitant vaccination administered on that same day at 15:00 included the first IM dose of DAPTACEL (lot# C2952BA) in the right thigh, the first IM dose of ACTHIB (lot# UF342AB) in the right thigh, the first SC dose of IPOL (lot# A0491) in the left thigh and the first IM dose of PREVNAR (lot# C65045) in the right thigh. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 13 week old patient who on 01-MAY-2008 was vaccinated with the first dose of ROTATEQ (lot# not reported). Subsequently the patient experienced no adverse symptoms. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated 2mL, orally with ROTATEQ. Subsequently the patient experienced diarrhea that lasted for 6 weeks after receiving the second dose of the vaccination. Subsequently, the patient recovered from diarrhea. The patient sought unspecified medical attention via an office visit. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 60 day old female infant with no known allergies or pertinent medical history who on 20-JUN-2008 was vaccinated orally in the AM with a first dose of ROTATEQ (lot # 660379/0144X). There was no illness at the time of vaccination or any adverse events following prior vaccination. Subsequently, on the same day of vaccination (in the evening) the patient had 4-6 watery stools daily for 4-6 days. There were no lab studies performed. At the time of the report, the patient recovered on approximately 25-JUN-2008. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Arthralgia, Autoimmune disorder, Rash, Scar, Swelling
Clinical narrative: Patient received 1st HPV shot on 12/12/07. On 2/22/08 presented with symmetrical palpable nodular rash over face, neck and arm.  Labs done and ANA was done shortly thereafter.  Patient was diagnosed with mixed connective tissue disease.  On Prednisone.
Age: 16.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Antinuclear antibody positive, Mixed connective tissue disease, Nodule, Protein urine present, Rash
Clinical narrative: Patient received 1st HPV shot on 12/12/07. On 2/22/08 presented with symmetrical palpable nodular rash over face, neck and arm.  Labs done and ANA was done shortly thereafter.  Patient was diagnosed with mixed connective tissue disease.  On Prednisone.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Intensive care, Motor neurone disease, Muscle contractions involuntary
Clinical narrative: April 2008, started experiencing symptoms of muscle weakness in arms and neck, they progressed to interfering with muscle weakness in throat and breathing. Patient died on August 21, 2008.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Muscular weakness, Respiratory failure
Clinical narrative: April 2008, started experiencing symptoms of muscle weakness in arms and neck, they progressed to interfering with muscle weakness in throat and breathing. Patient died on August 21, 2008.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Death, Dyspnoea, Muscular weakness
Clinical narrative: April 2008, started experiencing symptoms of muscle weakness in arms and neck, they progressed to interfering with muscle weakness in throat and breathing. Patient died on August 21, 2008.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient who on an unspecified date was vaccinated with GARDASIL. Concomitant therapy included tetanus toxoid (manufacturer unknown). The medical assistant reported that the patient was diagnosed with Guillain-Barre Syndrome after receiving a dose of GARDASIL vaccine. After receiving GARDASIL vaccine, the patient suffered a concussion in a soccer game. She was taken to an emergency room and released. However she was taken to the emergency room again because she complained of headaches along, tingling in her hands and feet. She also felt weakness on her legs. She was then released from the emergency room. Then on 26-AUG-2008, she was admitted to the hospital because she complained of shortness of breath, headaches and numbness of her extremities. She could not walk without assistance. After she was admitted to the hospital, she was diagnosed with Guillain-Barre Syndrome. On 12-SEP-2008, follow-up information was received from a medical assistant who provided the primary physician's name and telephone number. The patient's Guillain-Barre Syndrome was considered to be disabling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Concussion, Dyspnoea, Gait disturbance, Guillain-Barre syndrome, Headache
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient who on an unspecified date was vaccinated with GARDASIL. Concomitant therapy included tetanus toxoid (manufacturer unknown). The medical assistant reported that the patient was diagnosed with Guillain-Barre Syndrome after receiving a dose of GARDASIL vaccine. After receiving GARDASIL vaccine, the patient suffered a concussion in a soccer game. She was taken to an emergency room and released. However she was taken to the emergency room again because she complained of headaches along, tingling in her hands and feet. She also felt weakness on her legs. She was then released from the emergency room. Then on 26-AUG-2008, she was admitted to the hospital because she complained of shortness of breath, headaches and numbness of her extremities. She could not walk without assistance. After she was admitted to the hospital, she was diagnosed with Guillain-Barre Syndrome. On 12-SEP-2008, follow-up information was received from a medical assistant who provided the primary physician's name and telephone number. The patient's Guillain-Barre Syndrome was considered to be disabling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient who on an unspecified date was vaccinated with GARDASIL. Concomitant therapy included tetanus toxoid (manufacturer unknown). The medical assistant reported that the patient was diagnosed with Guillain-Barre Syndrome after receiving a dose of GARDASIL vaccine. After receiving GARDASIL vaccine, the patient suffered a concussion in a soccer game. She was taken to an emergency room and released. However she was taken to the emergency room again because she complained of headaches along, tingling in her hands and feet. She also felt weakness on her legs. She was then released from the emergency room. Then on 26-AUG-2008, she was admitted to the hospital because she complained of shortness of breath, headaches and numbness of her extremities. She could not walk without assistance. After she was admitted to the hospital, she was diagnosed with Guillain-Barre Syndrome. On 12-SEP-2008, follow-up information was received from a medical assistant who provided the primary physician's name and telephone number. The patient's Guillain-Barre Syndrome was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fall, Syncope
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date, was vaccinated with the first dose of GARDASIL.  The nurse reported that the patient was getting HPV vaccine, and fainted and fell into a full blown seizure.  The patient was monitored at the office, recovered, and was sent home.  Upon internal review, fell into a full blown seizure was determined to be an other important medical event.  No further information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Groin pain, Herpes zoster, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a physician and a 77 year old female patient with allergy to codeine and a history of heart attack in December 2007, who on 02-JUL-2008 was vaccinated with a dose of ZOSTAVAX. The physician reported that the patient was vaccinated with the shingles vaccine by another physician. There was no concomitant medication. The patient reported that on 09-JUL-2008, she developed groin pain. On 11-JUL-2008, she developed a "big rash in her groin and down the side of her leg". The physician reported that on 12-JUL-2008, the patient was seen in the office with a rash in the inguinal area x 24Hrs; rash in gluteus at perineal area - red base with clear vesicles, the diagnosed was shingles. The patient was prescribed VALTREX and ZOVIRAX. The physician reported that on 14-JUL-2008, the patient was feeling better. The physician considered shingles to be an other important medical event because it required medical intervention. No further information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician and a 77 year old female patient with allergy to codeine and a history of heart attack in December 2007, who on 02-JUL-2008 was vaccinated with a dose of ZOSTAVAX. The physician reported that the patient was vaccinated with the shingles vaccine by another physician. There was no concomitant medication. The patient reported that on 09-JUL-2008, she developed groin pain. On 11-JUL-2008, she developed a "big rash in her groin and down the side of her leg". The physician reported that on 12-JUL-2008, the patient was seen in the office with a rash in the inguinal area x 24Hrs; rash in gluteus at perineal area - red base with clear vesicles, the diagnosed was shingles. The patient was prescribed VALTREX and ZOVIRAX. The physician reported that on 14-JUL-2008, the patient was feeling better. The physician considered shingles to be an other important medical event because it required medical intervention. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Abdominal pain, Dyspnoea
Clinical narrative: Information has been received from a physician concerning a 20 year old female with endometriosis who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL.  Concomitant suspect therapy included LUPRON DEPOT administered on 26-AUG-2008 (indication not reported).  Other concomitant therapy included meningococcal vaccine (unspecified).  On approximately 27-AUG-2008, "about 12 days after initial dose of GARDASIL vaccine" the patient experienced abdominal pain and shortness of breath.  On 02-SEP-2008 "last night" the patient visited hospital emergency room (ER) and was administered medication for abdominal pain.  Lab studies were performed with no results reported.  The patient was discharged from the emergency room.  The ER physician felt that the patient's visit was "probably related to patient's condition of endometriosis and LUPRON DEPOT vaccine."  The reporting physician was not the physician of record when the patient received the initial dose of HPV vaccine, as the patient was relocated due to hurricane.  At the time of this report, the patient's abdominal pain and shortness of breath persisted.  It was reported that the patient planned to received the next scheduled HPV vaccine and was scheduled to see the physician on 03-SEP-2008.  The patient's abdominal pain was considered to be an other important medical event since the event required pain medication in the ER.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Injection site pain
Clinical narrative: Initial and follow-up information has been received from a physician concerning a female patient who on 08-OCT-2007, was vaccinated with her first dose of GARDASIL (Lot # 657622/0388U). On 07-DEC-2007, was vaccinated with her second dose of GARDASIL (Lot # 659435/1265U). On 23-JUN-2008, was vaccinated with her third dose of GARDASIL (Lot # 660393/0067X). After receiving the vaccine "the patient experienced numbness at injection site. The physician stated that she may have thrombocytopenia, she required platelets." The patient sought unspecified medical attention. In follow-up, the nurse reported that the patient had a concurrent condition of Idiopathic thrombocytopenic purpura (ITP). The nurse stated that the patient's mother inquired if the GARDASIL vaccinations had anything to do with the problems her daughter was experiencing with ITP. The nurse stated that the patient made a general statement that the injection was painful and the patient did not complain of injection numbness. Upon internal review, thrombocytopenia was determined to be an Other Important Medical Event. No further information is available. This is follow-up to report(s) on 09/09/2008: Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL. After receiving the vaccine "the patient experienced numbness at injection site. The physician stated that she may have thrombocytopenia, she required platelets." The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Anti-HBc IgM antibody positive, Hepatic function abnormal, Hepatitis B core antigen positive
Clinical narrative: Information has been received from a physician concerning a male infant who on 12-AUG-2008 was vaccinated with a dose of RECOMBIVAX HB.  The reporting physician reported that the patient tested positive for Hepatitis B core antigen ("Hepatitis B Core IgM") after receiving the vaccine at another hospital.  The infant's mother tested negative for Hepatitis B and the reason why the infant received the RECOMBIVAX HB at birth was unknown.  At the time of this report the infant was hospitalized in the neonatal intensive care unit.  The patient developed unspecified hepatic dysfunction symptoms and a test for Hepatitis B core antigen was positive.  No other symptoms or treatment reported.  The patient had not recovered.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever 104.7 with febrile seizures.  9/25/2008 MR received for DOS 9/5-7/2008 with D/C DX:  Febrile Illness likely 2' to Pediarix immunization.  Questionable seizure. 30 wk premie.  Mild dehydration. Pt presented to ER with fever of 104'F, loose stools, spitting up and questionable seizure. Sepsis w/u (-). Given IVF and abx until cx were  (-). D/C home.
Sex: M
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Patient developed grade 2 diarrhea one day after 3rd vaccination.  Possibly related to Gardasil and unexpected.  Patient has recent history of diarrhea unrelated to vaccine.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV, VARCEL
Symptoms: Back pain, Cough, Gait disturbance, Neck pain, Pain in extremity
Clinical narrative: Pain in left leg, complaints when walking, unexplained: Fevers, symptoms associated with cough (unknown skin irritants), back and neck aches!  No treatments issued at clinic, no records made or recorded!2/2/09-records received-3/14/03-received 2 month series of shots at 4 months during well baby visit with C/O dry skin. Routine visits parent has concerns related to multiple infections. History or viral and bacterial infections.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV, VARCEL
Symptoms: Pyrexia, Skin irritation
Clinical narrative: Pain in left leg, complaints when walking, unexplained: Fevers, symptoms associated with cough (unknown skin irritants), back and neck aches!  No treatments issued at clinic, no records made or recorded!2/2/09-records received-3/14/03-received 2 month series of shots at 4 months during well baby visit with C/O dry skin. Routine visits parent has concerns related to multiple infections. History or viral and bacterial infections.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV, VARCEL
Symptoms: Condition aggravated, Cough, Dyspnoea, Furuncle, Gait disturbance
Clinical narrative: Pain in left leg, complaints when walking, unexplained: Fevers, symptoms associated with cough (unknown skin irritants), back and neck aches!  No treatments issued at clinic, no records made or recorded!2/2/09-records received-3/14/03-received 2 month series of shots at 4 months during well baby visit with C/O dry skin. Routine visits parent has concerns related to multiple infections. History or viral and bacterial infections.