chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Streptococcal identification test negative, Urinary tract infection, Urine bilirubin increased, Urine ketone body present
Clinical narrative: After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urine leukocyte esterase positive, Urine protein, quantitative, Vaccine positive rechallenge, Vaginal haemorrhage
Clinical narrative: After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness,  acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now.  8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipation, bloody stools, stomach cramps. Anal fissure. Runny nose, itchy skin. Allergy symptoms.  Irritable bowel syndrome symptoms. Dysuria, flank pain, pyelonephritis. Lightheaded with dizziness. Serous otitis. Abdominal pain. LEEP procedure.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Nausea, Pain, Vomiting
Clinical narrative: The patient received a 1st Hep-B vaccine on 8/1/2009 10am without any difficulty at the time however, the patient reported N/V, abnormal pain with body aches sore @ 10pm 8/1/09 > sent to ER 8/2/09 10:30 am
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacteria urine, Blood calcium decreased, Cardiac failure congestive, Chest X-ray abnormal, Condition aggravated
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 61 year old female with bipolar disorder, neuropathic pain syndrome, degenerative joint disease, hypertension, diabetes mellitus, chronic pain, cholesterol high, S/P melanoma, hypothyroidism, neurogenic bladder, irritable bowel syndrome, basal cell carcinoma, and histories of streptococcal bacteraemia, anaemia, cholelithiasis, cardiac failure congestive in 1999 status post cardiac catheterization, pulmonary embolism in 1999, hernia repair, bilateral knee replacements, hysterectomy and umbilical hernia repair was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (lot# 658395/0966U) on 31-OCT-2007. Concomitant therapy included methadone hydrochloride, NEURONTIN, LAMICTAL, TOPAMAX, TRAZADINE, LIPITOR, TRAMADOL HYDROCHLORIDE, ROBAXIN, IBUPROFEN, ALLEGRA and GERBAN (unspecified). On 21-NOV-2007 the patient experienced congestive heart failure and fluid retention (20 lb weight gain 6 weeks after vaccination). On 10-JAN-2008 medical records received from primary care physician, including several follow up visits to pain specialist and hospital discharge summary for 27-AUG-2007 for Intractable recurrent tension headaches (prior to vaccination). The patient was seen by the physician on 31-OCT-2007 for ZOSTAVAX (Merck) due to family member with shingles. her weight was 143. The patient visited the physician's office on 19-DEC-2007 and complained of swelling and weight gain. Her weight was then 164. She felt fine. The patient was seen again on 21-DEC-2007 with weight of 169.5. Her weight decrease with LASIX down to 151 on 04-JAN-2008. Per 60 day follow up: Continued fluid retention of new onset requiring salt restriction LASIX 80 BID. Echocardiogram did not indicated cardiomyopathy. Endocrine consult was pending. Laboratory tests were performed. Chest x-ray indicated pulmonary congestion; complete blood cell count, erythrocyte sedimentation rate, renal function study and hepatic function tests were within normal limit. Labs and diagnostics results indicated CMP with low Calcium 8.3, protein 5.5 and globulin 1.8. Urinalysis test cloudy with 1+ leukocyte esterase, 6-10 epi, few bacteria and few Ca oxylate crystals. A standard lot check investigation was performed. All in-process quality checks for lot number 658395/0966U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The listing indicated that one or more of the events was considered immediately life-threatening. A priority lot check has been initiated. The original reporting source was not provided. The VAERS ID# is 301273. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Crystal urine present, Echocardiogram normal, Fluid retention, Full blood count normal, Globulins decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 61 year old female with bipolar disorder, neuropathic pain syndrome, degenerative joint disease, hypertension, diabetes mellitus, chronic pain, cholesterol high, S/P melanoma, hypothyroidism, neurogenic bladder, irritable bowel syndrome, basal cell carcinoma, and histories of streptococcal bacteraemia, anaemia, cholelithiasis, cardiac failure congestive in 1999 status post cardiac catheterization, pulmonary embolism in 1999, hernia repair, bilateral knee replacements, hysterectomy and umbilical hernia repair was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (lot# 658395/0966U) on 31-OCT-2007. Concomitant therapy included methadone hydrochloride, NEURONTIN, LAMICTAL, TOPAMAX, TRAZADINE, LIPITOR, TRAMADOL HYDROCHLORIDE, ROBAXIN, IBUPROFEN, ALLEGRA and GERBAN (unspecified). On 21-NOV-2007 the patient experienced congestive heart failure and fluid retention (20 lb weight gain 6 weeks after vaccination). On 10-JAN-2008 medical records received from primary care physician, including several follow up visits to pain specialist and hospital discharge summary for 27-AUG-2007 for Intractable recurrent tension headaches (prior to vaccination). The patient was seen by the physician on 31-OCT-2007 for ZOSTAVAX (Merck) due to family member with shingles. her weight was 143. The patient visited the physician's office on 19-DEC-2007 and complained of swelling and weight gain. Her weight was then 164. She felt fine. The patient was seen again on 21-DEC-2007 with weight of 169.5. Her weight decrease with LASIX down to 151 on 04-JAN-2008. Per 60 day follow up: Continued fluid retention of new onset requiring salt restriction LASIX 80 BID. Echocardiogram did not indicated cardiomyopathy. Endocrine consult was pending. Laboratory tests were performed. Chest x-ray indicated pulmonary congestion; complete blood cell count, erythrocyte sedimentation rate, renal function study and hepatic function tests were within normal limit. Labs and diagnostics results indicated CMP with low Calcium 8.3, protein 5.5 and globulin 1.8. Urinalysis test cloudy with 1+ leukocyte esterase, 6-10 epi, few bacteria and few Ca oxylate crystals. A standard lot check investigation was performed. All in-process quality checks for lot number 658395/0966U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The listing indicated that one or more of the events was considered immediately life-threatening. A priority lot check has been initiated. The original reporting source was not provided. The VAERS ID# is 301273. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Liver function test normal, Protein total normal, Pulmonary congestion, Red blood cell scan, Renal function test normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 61 year old female with bipolar disorder, neuropathic pain syndrome, degenerative joint disease, hypertension, diabetes mellitus, chronic pain, cholesterol high, S/P melanoma, hypothyroidism, neurogenic bladder, irritable bowel syndrome, basal cell carcinoma, and histories of streptococcal bacteraemia, anaemia, cholelithiasis, cardiac failure congestive in 1999 status post cardiac catheterization, pulmonary embolism in 1999, hernia repair, bilateral knee replacements, hysterectomy and umbilical hernia repair was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (lot# 658395/0966U) on 31-OCT-2007. Concomitant therapy included methadone hydrochloride, NEURONTIN, LAMICTAL, TOPAMAX, TRAZADINE, LIPITOR, TRAMADOL HYDROCHLORIDE, ROBAXIN, IBUPROFEN, ALLEGRA and GERBAN (unspecified). On 21-NOV-2007 the patient experienced congestive heart failure and fluid retention (20 lb weight gain 6 weeks after vaccination). On 10-JAN-2008 medical records received from primary care physician, including several follow up visits to pain specialist and hospital discharge summary for 27-AUG-2007 for Intractable recurrent tension headaches (prior to vaccination). The patient was seen by the physician on 31-OCT-2007 for ZOSTAVAX (Merck) due to family member with shingles. her weight was 143. The patient visited the physician's office on 19-DEC-2007 and complained of swelling and weight gain. Her weight was then 164. She felt fine. The patient was seen again on 21-DEC-2007 with weight of 169.5. Her weight decrease with LASIX down to 151 on 04-JAN-2008. Per 60 day follow up: Continued fluid retention of new onset requiring salt restriction LASIX 80 BID. Echocardiogram did not indicated cardiomyopathy. Endocrine consult was pending. Laboratory tests were performed. Chest x-ray indicated pulmonary congestion; complete blood cell count, erythrocyte sedimentation rate, renal function study and hepatic function tests were within normal limit. Labs and diagnostics results indicated CMP with low Calcium 8.3, protein 5.5 and globulin 1.8. Urinalysis test cloudy with 1+ leukocyte esterase, 6-10 epi, few bacteria and few Ca oxylate crystals. A standard lot check investigation was performed. All in-process quality checks for lot number 658395/0966U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The listing indicated that one or more of the events was considered immediately life-threatening. A priority lot check has been initiated. The original reporting source was not provided. The VAERS ID# is 301273. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urinary sediment present, Urine analysis abnormal, Urine leukocyte esterase positive, Weight fluctuation
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 61 year old female with bipolar disorder, neuropathic pain syndrome, degenerative joint disease, hypertension, diabetes mellitus, chronic pain, cholesterol high, S/P melanoma, hypothyroidism, neurogenic bladder, irritable bowel syndrome, basal cell carcinoma, and histories of streptococcal bacteraemia, anaemia, cholelithiasis, cardiac failure congestive in 1999 status post cardiac catheterization, pulmonary embolism in 1999, hernia repair, bilateral knee replacements, hysterectomy and umbilical hernia repair was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (lot# 658395/0966U) on 31-OCT-2007. Concomitant therapy included methadone hydrochloride, NEURONTIN, LAMICTAL, TOPAMAX, TRAZADINE, LIPITOR, TRAMADOL HYDROCHLORIDE, ROBAXIN, IBUPROFEN, ALLEGRA and GERBAN (unspecified). On 21-NOV-2007 the patient experienced congestive heart failure and fluid retention (20 lb weight gain 6 weeks after vaccination). On 10-JAN-2008 medical records received from primary care physician, including several follow up visits to pain specialist and hospital discharge summary for 27-AUG-2007 for Intractable recurrent tension headaches (prior to vaccination). The patient was seen by the physician on 31-OCT-2007 for ZOSTAVAX (Merck) due to family member with shingles. her weight was 143. The patient visited the physician's office on 19-DEC-2007 and complained of swelling and weight gain. Her weight was then 164. She felt fine. The patient was seen again on 21-DEC-2007 with weight of 169.5. Her weight decrease with LASIX down to 151 on 04-JAN-2008. Per 60 day follow up: Continued fluid retention of new onset requiring salt restriction LASIX 80 BID. Echocardiogram did not indicated cardiomyopathy. Endocrine consult was pending. Laboratory tests were performed. Chest x-ray indicated pulmonary congestion; complete blood cell count, erythrocyte sedimentation rate, renal function study and hepatic function tests were within normal limit. Labs and diagnostics results indicated CMP with low Calcium 8.3, protein 5.5 and globulin 1.8. Urinalysis test cloudy with 1+ leukocyte esterase, 6-10 epi, few bacteria and few Ca oxylate crystals. A standard lot check investigation was performed. All in-process quality checks for lot number 658395/0966U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The listing indicated that one or more of the events was considered immediately life-threatening. A priority lot check has been initiated. The original reporting source was not provided. The VAERS ID# is 301273. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight increased, White blood cells urine positive
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 61 year old female with bipolar disorder, neuropathic pain syndrome, degenerative joint disease, hypertension, diabetes mellitus, chronic pain, cholesterol high, S/P melanoma, hypothyroidism, neurogenic bladder, irritable bowel syndrome, basal cell carcinoma, and histories of streptococcal bacteraemia, anaemia, cholelithiasis, cardiac failure congestive in 1999 status post cardiac catheterization, pulmonary embolism in 1999, hernia repair, bilateral knee replacements, hysterectomy and umbilical hernia repair was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (lot# 658395/0966U) on 31-OCT-2007. Concomitant therapy included methadone hydrochloride, NEURONTIN, LAMICTAL, TOPAMAX, TRAZADINE, LIPITOR, TRAMADOL HYDROCHLORIDE, ROBAXIN, IBUPROFEN, ALLEGRA and GERBAN (unspecified). On 21-NOV-2007 the patient experienced congestive heart failure and fluid retention (20 lb weight gain 6 weeks after vaccination). On 10-JAN-2008 medical records received from primary care physician, including several follow up visits to pain specialist and hospital discharge summary for 27-AUG-2007 for Intractable recurrent tension headaches (prior to vaccination). The patient was seen by the physician on 31-OCT-2007 for ZOSTAVAX (Merck) due to family member with shingles. her weight was 143. The patient visited the physician's office on 19-DEC-2007 and complained of swelling and weight gain. Her weight was then 164. She felt fine. The patient was seen again on 21-DEC-2007 with weight of 169.5. Her weight decrease with LASIX down to 151 on 04-JAN-2008. Per 60 day follow up: Continued fluid retention of new onset requiring salt restriction LASIX 80 BID. Echocardiogram did not indicated cardiomyopathy. Endocrine consult was pending. Laboratory tests were performed. Chest x-ray indicated pulmonary congestion; complete blood cell count, erythrocyte sedimentation rate, renal function study and hepatic function tests were within normal limit. Labs and diagnostics results indicated CMP with low Calcium 8.3, protein 5.5 and globulin 1.8. Urinalysis test cloudy with 1+ leukocyte esterase, 6-10 epi, few bacteria and few Ca oxylate crystals. A standard lot check investigation was performed. All in-process quality checks for lot number 658395/0966U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The listing indicated that one or more of the events was considered immediately life-threatening. A priority lot check has been initiated. The original reporting source was not provided. The VAERS ID# is 301273. No further information is available.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4, FLUX, HPVX
Symptoms: Fall, Head injury, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Fainted after about 2 or 3 min the vaccines were administrated. She was sitting at the Dr's high examination bed. Fall down, hit her head and mouth, broke one tooth and another front tooth died. CT scan was performed to check for head injuries (negative). Immune system was affected after the adverse event. From tooth injury she has been treated either by Dentist and Oral Surgeon specialist every week after the incident. She was hospitalized in June 14th for 2 days with a severe tooth infection high temperature 103/104 face swollen from broken tooth. Another CT scan was performed to detect bacteria in dangerous body places (negative) intravenous Morphine and another strong pain medication was administrated for the Hospitalization and follow after with pills. She was release from Hospital June 16th and is currently under treatment, she will required a tooth implant after bone (tooth was subtracted) recovers from severe bacteria damage.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4, FLUX, HPVX
Symptoms: Computerised tomogram normal, Fall, Head injury, Laceration, Syncope
Clinical narrative: Fainted after about 2 or 3 min the vaccines were administrated. She was sitting at the Dr's high examination bed. Fall down, hit her head and mouth, broke one tooth and another front tooth died. CT scan was performed to check for head injuries (negative). Immune system was affected after the adverse event. From tooth injury she has been treated either by Dentist and Oral Surgeon specialist every week after the incident. She was hospitalized in June 14th for 2 days with a severe tooth infection high temperature 103/104 face swollen from broken tooth. Another CT scan was performed to detect bacteria in dangerous body places (negative) intravenous Morphine and another strong pain medication was administrated for the Hospitalization and follow after with pills. She was release from Hospital June 16th and is currently under treatment, she will required a tooth implant after bone (tooth was subtracted) recovers from severe bacteria damage.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4, FLUX, HPVX
Symptoms: Tooth injury
Clinical narrative: Fainted after about 2 or 3 min the vaccines were administrated. She was sitting at the Dr's high examination bed. Fall down, hit her head and mouth, broke one tooth and another front tooth died. CT scan was performed to check for head injuries (negative). Immune system was affected after the adverse event. From tooth injury she has been treated either by Dentist and Oral Surgeon specialist every week after the incident. She was hospitalized in June 14th for 2 days with a severe tooth infection high temperature 103/104 face swollen from broken tooth. Another CT scan was performed to detect bacteria in dangerous body places (negative) intravenous Morphine and another strong pain medication was administrated for the Hospitalization and follow after with pills. She was release from Hospital June 16th and is currently under treatment, she will required a tooth implant after bone (tooth was subtracted) recovers from severe bacteria damage.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4, FLUX, HPVX
Symptoms: Body temperature increased, Computerised tomogram normal, Fall, Head injury, Immune system disorder
Clinical narrative: Fainted after about 2 or 3 min the vaccines were administrated. She was sitting at the Dr's high examination bed. Fall down, hit her head and mouth, broke one tooth and another front tooth died. CT scan was performed to check for head injuries (negative). Immune system was affected after the adverse event. From tooth injury she has been treated either by Dentist and Oral Surgeon specialist every week after the incident. She was hospitalized in June 14th for 2 days with a severe tooth infection high temperature 103/104 face swollen from broken tooth. Another CT scan was performed to detect bacteria in dangerous body places (negative) intravenous Morphine and another strong pain medication was administrated for the Hospitalization and follow after with pills. She was release from Hospital June 16th and is currently under treatment, she will required a tooth implant after bone (tooth was subtracted) recovers from severe bacteria damage.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4, FLUX, HPVX
Symptoms: Mouth injury, Swelling face, Syncope, Tooth fracture, Tooth infection
Clinical narrative: Fainted after about 2 or 3 min the vaccines were administrated. She was sitting at the Dr's high examination bed. Fall down, hit her head and mouth, broke one tooth and another front tooth died. CT scan was performed to check for head injuries (negative). Immune system was affected after the adverse event. From tooth injury she has been treated either by Dentist and Oral Surgeon specialist every week after the incident. She was hospitalized in June 14th for 2 days with a severe tooth infection high temperature 103/104 face swollen from broken tooth. Another CT scan was performed to detect bacteria in dangerous body places (negative) intravenous Morphine and another strong pain medication was administrated for the Hospitalization and follow after with pills. She was release from Hospital June 16th and is currently under treatment, she will required a tooth implant after bone (tooth was subtracted) recovers from severe bacteria damage.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV1
Symptoms: Pyrexia
Clinical narrative: Began same day with high fevers 105.1. Went to ER. Ran mild fevers for 2 days then had 2 seizures went back to ER. Seizures were 30 min. apart lasting 10-15 min. each. Using TYLENOL and MOTRIN. Observation 24 hours in hospital.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV1
Symptoms: Convulsion, Full blood count, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Began same day with high fevers 105.1. Went to ER. Ran mild fevers for 2 days then had 2 seizures went back to ER. Seizures were 30 min. apart lasting 10-15 min. each. Using TYLENOL and MOTRIN. Observation 24 hours in hospital.
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Full blood count, Unevaluable event
Clinical narrative: None stated
Age: 1.3
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Abnormal behaviour, Aggression, Asterixis, Disturbance in social behaviour, Gait disturbance
Clinical narrative: Decreased-low eye contact, unresponsive to name being called, head-banging, stims like arm flapping, lining up objects, inappropriate play with toys, toe-walking, extreme tantrums, looking at objects through corner of eyes.  Diagnosed at Hospital with Autism in January 2008 and we began biomedical treatment January 2008.  8/10/09 Psychological assessment report received DOS 1/8/08 to 1/31/08. Assessment: Autism Spectrum Disorder. Patient presents with delayed speech/language skills, lack of social reciprocity, temper tantrums, repetitive behaviours. Daily functioning is lower than expected for age. Hand flapping and other stereotyped and rigid behaviors. Physical and neurological examination - WNL. Extensive developmental, language, and behavioral evaluation and testing. Mullen scales of early learning. Develpmental Profile II.
Age: 1.3
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Head banging, Laboratory test, Stool analysis, Unresponsive to stimuli, Urine analysis
Clinical narrative: Decreased-low eye contact, unresponsive to name being called, head-banging, stims like arm flapping, lining up objects, inappropriate play with toys, toe-walking, extreme tantrums, looking at objects through corner of eyes.  Diagnosed at Hospital with Autism in January 2008 and we began biomedical treatment January 2008.  8/10/09 Psychological assessment report received DOS 1/8/08 to 1/31/08. Assessment: Autism Spectrum Disorder. Patient presents with delayed speech/language skills, lack of social reciprocity, temper tantrums, repetitive behaviours. Daily functioning is lower than expected for age. Hand flapping and other stereotyped and rigid behaviors. Physical and neurological examination - WNL. Extensive developmental, language, and behavioral evaluation and testing. Mullen scales of early learning. Develpmental Profile II.
Age: 44.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time prolonged, Blood iron, Full blood count, Intensive care
Clinical narrative: Went to emergency room, transferred 60 miles to ICU in a bigger hospital. 3 days in ICU, 7 units of blood given in transfusion. Total 4 days in hospital.  8/12/09 Hospital records recieved DOS 11/23/08 to 11/26/08. Assessment: Severe iron deficiency anemia likely dietary in nature, protein and iron-poor diet, urinary tract infection. Patient transferred from another facility with c/o abdominal pain, fever, vomiting, multiple muscle pains, and malaise. Shortness of breath, fatigue, and excessive menstrual bleeding. Mild tenderness in the epigastrium. Skin dry, increased pigmentation on back. Transfusion 4X units packed red blood cells. 10/5/09 ICD9 codes received for dates of service 11/23/08 to 11/26/08 280.9, 599.0, 041.4, 269.9, 285.9
Age: 44.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Metabolic function test, Occult blood, Prothrombin time, Transfusion, Urine analysis
Clinical narrative: Went to emergency room, transferred 60 miles to ICU in a bigger hospital. 3 days in ICU, 7 units of blood given in transfusion. Total 4 days in hospital.  8/12/09 Hospital records recieved DOS 11/23/08 to 11/26/08. Assessment: Severe iron deficiency anemia likely dietary in nature, protein and iron-poor diet, urinary tract infection. Patient transferred from another facility with c/o abdominal pain, fever, vomiting, multiple muscle pains, and malaise. Shortness of breath, fatigue, and excessive menstrual bleeding. Mild tenderness in the epigastrium. Skin dry, increased pigmentation on back. Transfusion 4X units packed red blood cells. 10/5/09 ICD9 codes received for dates of service 11/23/08 to 11/26/08 280.9, 599.0, 041.4, 269.9, 285.9
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Differential white blood cell count normal, Full blood count normal, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: R arm - swelling on 7/24/09 - site of 2 immunizations and a bug bite, swelling increased became hard and hot to touch called PMD on 7/26. Went to ER -> immunization reaction or from bug bite? -> swelling increased - no pain, fever, IV antibiotics started - adm.  8/17/09 Hospital records received DOS 7/26/09 to 7/28/09. Assessment: Cellulitis of Arm. Patient reports postvaccination pain treated with Tylenol. Patient presents with swelling of right arm, erythema, warmth, induration, itchy but now w/o pain. Mosquito bite on affected arm.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Intussusception, diarrhea, vomiting, dehydration. 8/17/09 Hospital records received DOS 7/30/09 - 7/31/09. Assessment: Ileocolic intussusception. Patient presents with vomiting, irritable, pale, intermittent crying, drawing up legs, diarrhea then no stool, No PO intake, "choking on vomit". Trouble breathing. Currant jelly red stool. Dehydration.   9/23/09 ICD-9 Codes received: 560.0 Intussusception, 276.51 Dehydration.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: Pt. passed out, 1 day laid back on table shook and sat up direct. Pt. was laid back. Dr notified Dr. visited with pt and pt mom was given soda and rested until no symptoms.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Electrocardiogram normal, Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: Approximately 5 minutes after being vaccinated the patient started feeling lightheaded and nauseated, she then had a syncopal episode. When she regained consciousness vitals were taken which were normal, EKG was done showing a PVC but otherwise normal.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Ventricular extrasystoles
Clinical narrative: Approximately 5 minutes after being vaccinated the patient started feeling lightheaded and nauseated, she then had a syncopal episode. When she regained consciousness vitals were taken which were normal, EKG was done showing a PVC but otherwise normal.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Injection site rash, Irritability, Rash
Clinical narrative: Rash noted this morning by mother - first noted on left thigh spreading to trunk, forearms and head getting more spots as day goes on. Child fussy, with high temp. Per M.D. BENADRYL 2.5 mg/5 ml-3ml given. PRELONE 15 mg/5 ml-2 ml's given po.
Age: 17.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Eye rolling, Fall, Hyperhidrosis, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Client sitting in chair while vaccines administered within 2-3 minutes, while still sitting, client rolled his eyes back, stiffened arms and fell back in chair. Unresponsive to name for 10-15 seconds. Skin pale and diaphoretic. Continued to sit in chair, placed head down, cold pack to back of neck, drank juice. Returned to normal within few minutes.
Age: 17.0
Sex: M
Vaccine: MMR, MNQ, VARCEL
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Client sitting in chair while vaccines administered within 2-3 minutes, while still sitting, client rolled his eyes back, stiffened arms and fell back in chair. Unresponsive to name for 10-15 seconds. Skin pale and diaphoretic. Continued to sit in chair, placed head down, cold pack to back of neck, drank juice. Returned to normal within few minutes.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Pt reported fever to 101-102. Pt reported arm swollen at site of injection.
Age: 0.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: Patient had no adverse event. Patient received VARIVAX 7-15-09 and that evening developed temp 99-100 and  fine bumpy rash and she continues to have symptoms - Patient's mother, 22 weeks pregnant, broke out with rash 7-21-09 confirmed by doctor as chickenpox on 7-22-09, and she was treated with ZOVIRAX.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Developed left arm swelling, redness, itching below injection site around (L) bicep - Given BENADRYL 25 mg  tablet every 6 hrs prn and HC 1% cream tid 7/24/09.
Age: 0.35
Sex: U
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Injection site eczema, Injection site rash
Clinical narrative: Eczematoid rash both legs @ immunization sites.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash, itching and red patch of skin bilateral thighs at injection site and swelling.  Right thigh: Red area 13 X 12 cm. left thigh 10 X 8.5 cm red area.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 101 degrees --> 12 hr. after vaccine administration. Emesis multiple times at night (2-8 hr later).
Age: 15.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder, Streptococcal identification test positive
Clinical narrative: Information has been received from a Registered Nurse (R.N) and a Physician for the pregnancy registry for GARDASIL concerning a 17 year old female patient who was a heavy smoker, with anemia during her pregnancy which was treated with oral iron supplements who in March 2008 (also reported as almost 2 years ago) was vaccinated with the first dose of GARDASIL (Lot # not reported). Concomitant therapy included prenatal vitamins (unspecified) and FLUVIRIN. It was reported that the patient became pregnant. The patient's last menstrual period (LMP) was 10-SEP-2008 and her estimated date of delivery (EDD) by LMP was 17-JUN-2009, however was corrected to 08-JUN-2009 by early ultrasound. On 01-JUN-2009 (at 39 weeks gestation) the patient delivered a female neonate weighing 2690 gm/5lb and 15 ounces by C-section for non-reassuring fetal heart rate. The patient tested positive for group B strep and was treated with intravenous ((IV) antibiotics (name not provided) during labor. The baby's apgar scores were 7 at one minute, 8 at five minute and 9 at ten minute. It was reported that two days after birth, prior to discharge home, the baby was transferred to a Neonatal Intensive Care Unit (NICU) for a seizure like episode (not further specified). The physician did not have any record of the baby's exact or final diagnosis. He did note that the baby was not hospitalized for a long period of time and did not believe she was on any medication. The patient's last menstrual period was on 10-SEP-2008 and her estimated delivery date was on 08-JUN-2009 which was corrected by early ultrasound. Upon internal review, C-section for non reassuring fetal heart rate was considered to be an other important medical event.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Apgar score normal, Caesarean section, Drug exposure during pregnancy, Foetal disorder, Streptococcal identification test positive
Clinical narrative: Information has been received from a Registered Nurse (R.N) and a Physician for the pregnancy registry for GARDASIL concerning a 17 year old female patient who was a heavy smoker, with anemia during her pregnancy which was treated with oral iron supplements who in March 2008 (also reported as almost 2 years ago) was vaccinated with the first dose of GARDASIL (Lot # not reported). Concomitant therapy included prenatal vitamins (unspecified) and FLUVIRIN. It was reported that the patient became pregnant. The patient's last menstrual period (LMP) was 10-SEP-2008 and her estimated date of delivery (EDD) by LMP was 17-JUN-2009, however was corrected to 08-JUN-2009 by early ultrasound. On 01-JUN-2009 (at 39 weeks gestation) the patient delivered a female neonate weighing 2690 gm/5lb and 15 ounces by C-section for non-reassuring fetal heart rate. The patient tested positive for group B strep and was treated with intravenous ((IV) antibiotics (name not provided) during labor. The baby's apgar scores were 7 at one minute, 8 at five minute and 9 at ten minute. It was reported that two days after birth, prior to discharge home, the baby was transferred to a Neonatal Intensive Care Unit (NICU) for a seizure like episode (not further specified). The physician did not have any record of the baby's exact or final diagnosis. He did note that the baby was not hospitalized for a long period of time and did not believe she was on any medication. The patient's last menstrual period was on 10-SEP-2008 and her estimated delivery date was on 08-JUN-2009 which was corrected by early ultrasound. Upon internal review, C-section for non reassuring fetal heart rate was considered to be an other important medical event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Grand mal convulsion, Loss of consciousness, Pallor, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient with a history of acne and no known drug allergies who on 27-JUL-2009 was vaccinated with a dose of GARDASIL (Lot: 661954/1496X). The patient did not receive any concomitant vaccines when the GARDASIL was administered to the patient. Concomitant therapy included tetracycline. There were no concomitant vaccines. On 27-JUL-2009, within five minutes of receiving GARDASIL, the patient became light headed, fainted and passed out while sitting in the waiting room with her mother. Her left arm had seizures movement and her right arm had slight seizure movement, the patient had a tonic-clonic seizure which lasted for 2 to 3 seconds. The patient abruptly awoke. The patient had not eaten prior to the physician's visit and prior to the GARDASIL vaccination. The nurse stated that the patient was given something to eat and drink after the incident had occurred. The patient was white and shaky for a while. On the same day, 27-JUL-2009, the patient recovered. The Registered nurse did not consider the patient's experience to be disabling or life-threatening. The registered nurse stated that she spoke with the patient's mother via a telephone call on 27-JUL-2009 and 28-JUL-2009. The patient's mother stated that the patient "was doing fine". Upon internal review tonic-clonic seizure was considered as other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient with a history of acne and no known drug allergies who on 27-JUL-2009 was vaccinated with a dose of GARDASIL (Lot: 661954/1496X). The patient did not receive any concomitant vaccines when the GARDASIL was administered to the patient. Concomitant therapy included tetracycline. There were no concomitant vaccines. On 27-JUL-2009, within five minutes of receiving GARDASIL, the patient became light headed, fainted and passed out while sitting in the waiting room with her mother. Her left arm had seizures movement and her right arm had slight seizure movement, the patient had a tonic-clonic seizure which lasted for 2 to 3 seconds. The patient abruptly awoke. The patient had not eaten prior to the physician's visit and prior to the GARDASIL vaccination. The nurse stated that the patient was given something to eat and drink after the incident had occurred. The patient was white and shaky for a while. On the same day, 27-JUL-2009, the patient recovered. The Registered nurse did not consider the patient's experience to be disabling or life-threatening. The registered nurse stated that she spoke with the patient's mother via a telephone call on 27-JUL-2009 and 28-JUL-2009. The patient's mother stated that the patient "was doing fine". Upon internal review tonic-clonic seizure was considered as other important medical event. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: Information has been received from a physician concerning an 82 year old male patient (180 pounds and 67 inches), who on 14-JUL-2009 was vaccinated with 0.65 ml of a dose of ZOSTAVAX (Merck) intramuscularly. On an unspecified date in July 2009 the patient experienced local severe swelling. Local severe swelling was considered as other important medical event by the physician. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Convulsion
Clinical narrative: possible seizure
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Flank pain, Headache, Hypoaesthesia, Lymph node pain
Clinical narrative: Patient had the menactra vaccine on 7-29-09.Her arm was very sore,on 8-1-09 at approx 6 pm she complained of sore lymph nodes in her neck radiating into the collerbone area, in another 30 minutes she was having shooting pains in her neck and head, these seemed to subside somewhat, within another 20 minutes her whole side where she had received the vaccine was very painful including her ribs with all over stiffness her breathing was labored due to the pain and numbness in her arm and legs.We took her to emergency room they looked at her and determined it was a reaction to the vaccine.We were instructed to give her ibuprofen, her pain subsided and she still has soreness in the arm and shoulder.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient had the menactra vaccine on 7-29-09.Her arm was very sore,on 8-1-09 at approx 6 pm she complained of sore lymph nodes in her neck radiating into the collerbone area, in another 30 minutes she was having shooting pains in her neck and head, these seemed to subside somewhat, within another 20 minutes her whole side where she had received the vaccine was very painful including her ribs with all over stiffness her breathing was labored due to the pain and numbness in her arm and legs.We took her to emergency room they looked at her and determined it was a reaction to the vaccine.We were instructed to give her ibuprofen, her pain subsided and she still has soreness in the arm and shoulder.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Vaccination complication
Clinical narrative: Patient had the menactra vaccine on 7-29-09.Her arm was very sore,on 8-1-09 at approx 6 pm she complained of sore lymph nodes in her neck radiating into the collerbone area, in another 30 minutes she was having shooting pains in her neck and head, these seemed to subside somewhat, within another 20 minutes her whole side where she had received the vaccine was very painful including her ribs with all over stiffness her breathing was labored due to the pain and numbness in her arm and legs.We took her to emergency room they looked at her and determined it was a reaction to the vaccine.We were instructed to give her ibuprofen, her pain subsided and she still has soreness in the arm and shoulder.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hyperaesthesia, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Approximately 24 hours after pneumonia vaccine, my husband's arm swelled significantly, became very red from the shoulder to the elbow, and there was pain upon touching it.  He also began running a fever of 102 degrees.  We brought him in to the emergengy room for treatment that night.  He was treated with Prednisone, Benadryl, and Pepcid.  The physician also gave him a prescription for cephalexin, which he began taking the next day.  As of right now, 84 hours post-injection, the swelling has subsided, the redness has migrated to his forearm, and the pain is reduced.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2- 2 1/2 inch sized red/hot painful swollen area at site  varicella vaccine starting on 8/1/09.  Ice was applied intermitently and by 8/3/09 area was no longer painful, redness/warmth were greatly decreased.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Varivax vaccine administered to Right arm 7/16/2009. Parent noted red swollen area on right arm 07/26/2009. To clinic 7/29/2009 - area red and warm to touch and the size of silver dollar. ARNP in to see pt and advised OTC ibuprofen for discomfort; Benadryl cream to site PRN itch; and warm moist heat to area. RTC in 2-3 days if not better.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: rash on face
Age: 1.17
Sex: F
Vaccine: MER, VARCEL
Symptoms: Agitation, Crying, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: My daughter got her MMR and Varicella vaccination on 7/17/09 and started with symptoms on 7/26/09 where she developed a rash with raised bumps without blisters around the injection site. She followed with a fever on or around 7/28/09 and was very agitated and unable to be consoled. She also developed some bumps on other parts of the body. She was seen by her doctor on 7/29/09 and the rash was deemed a reaction to the varicella vaccination and to treat it like a virus and let it run its course and any further problems to return her to the office for more follow up.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fever, Chills, Neausa