chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ventricular tachycardia, Virus serology test
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 17 year old female was vaccinated with the second dose of GARDASIL (Lot # 659962/1740U) intramuscularly on 24-JUL-2008. The patient presented on 03-AUG-2008 with an approximately 4-day history of nonspecific nausea and abdominal discomfort. This was initially thought to be dyspepsia. The patient was treated with Pepto-Bismol. There may had been some initial improvement; however, the patient continued to have persisting abdominal discomfort. Upon admission, patient had increased symptoms of shortness of breath with dizziness and left upper extremity and left lower extremity numbness. The patient also had crushing substernal left-sided chest discomfort. The patient presented to the emergency department, at which point cardiac enzymes ordered were significantly elevated. Patient was given Zofran for her nausea. Patient was also given aspirin 81 mg x3. D-dimer was checked (2). Patient was started on dopamine drip. Due to the patient's deteriorating status, the patient was taken emergently by Cardiologist for a right and left heart catheterization. Based on report, left heart catheterization showed no evidence of coronary disease. Ejection fraction was measured at 23%. Based on the verbal report from the doctor, there was no tamponade physiology on right heart catheterization. Patient has no previous surgical or significant medical history. She had recently received the GARDASIL from her primary care physician. Patient denies history of asthma, cardiac disease. Secondary to her ejection fraction, an intraaortic balloon pump was placed and the patient was returned to critical care unit. However, over the next 6-8 hours, her function continued to deteriorate, she went into V tach which led her to further decompensate. She was resuscitated for more than 1-1/2 hours to maintain her blood pressure above 90. Cardiothoracic surgery was consulted to place her on bypass and place her on an assistive device. However, due to her current status, it was elected not to do so. CPR continued until the priest was available, and care was withdrawn. Patient was pronounced dead on 04-AUG-2008. A Coxsackie virus antibody panel was negative. Streptolysin antibody 200 (pos); Adenovirus, Echovirus, Influenza A, Influenza B (32-past or recent inf), ANA tests were performed with negative results. The autopsy found: fulminant lymphocytic myocarditis, myocardial hypoperfusion. A standard lot check investigation was performed. All in-process quality checks for the lot number in question 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 research center and was released. The original reporting source was not provided. The Vaers # is: 325063. No further  information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Carditis, Death, Dyspnoea, Hypoaesthesia
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 17 year old female was vaccinated with the second dose of GARDASIL (Lot # 659962/1740U) intramuscularly on 24-JUL-2008. The patient presented on 03-AUG-2008 with an approximately 4-day history of nonspecific nausea and abdominal discomfort. This was initially thought to be dyspepsia. The patient was treated with Pepto-Bismol. There may had been some initial improvement; however, the patient continued to have persisting abdominal discomfort. Upon admission, patient had increased symptoms of shortness of breath with dizziness and left upper extremity and left lower extremity numbness. The patient also had crushing substernal left-sided chest discomfort. The patient presented to the emergency department, at which point cardiac enzymes ordered were significantly elevated. Patient was given Zofran for her nausea. Patient was also given aspirin 81 mg x3. D-dimer was checked (2). Patient was started on dopamine drip. Due to the patient's deteriorating status, the patient was taken emergently by Cardiologist for a right and left heart catheterization. Based on report, left heart catheterization showed no evidence of coronary disease. Ejection fraction was measured at 23%. Based on the verbal report from the doctor, there was no tamponade physiology on right heart catheterization. Patient has no previous surgical or significant medical history. She had recently received the GARDASIL from her primary care physician. Patient denies history of asthma, cardiac disease. Secondary to her ejection fraction, an intraaortic balloon pump was placed and the patient was returned to critical care unit. However, over the next 6-8 hours, her function continued to deteriorate, she went into V tach which led her to further decompensate. She was resuscitated for more than 1-1/2 hours to maintain her blood pressure above 90. Cardiothoracic surgery was consulted to place her on bypass and place her on an assistive device. However, due to her current status, it was elected not to do so. CPR continued until the priest was available, and care was withdrawn. Patient was pronounced dead on 04-AUG-2008. A Coxsackie virus antibody panel was negative. Streptolysin antibody 200 (pos); Adenovirus, Echovirus, Influenza A, Influenza B (32-past or recent inf), ANA tests were performed with negative results. The autopsy found: fulminant lymphocytic myocarditis, myocardial hypoperfusion. A standard lot check investigation was performed. All in-process quality checks for the lot number in question 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 research center and was released. The original reporting source was not provided. The Vaers # is: 325063. No further  information is available.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Vaccinated during pregnancy.  Pregnancy resulted in Voluntary Interruption of Pregnancy at ~ 11+2 weeks
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cough, Dehydration, Enema administration, Haematochezia, Hypophagia
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 62 day old female who on 06-OCT-2008 was vaccinated with the first dose of ROTATEQ (lot no. 660934/0414X) by mouth. Concomitant therapy included the first dose of PEDIARIX (lot no. AC263192BA) IM, into the left leg, the first dose of PREVNAR (lot no. C40033) IM into the left leg and the first dose of ACTHIB (lot no UF491AB) IM into the right leg. Medical records of 11-OCT-2008 and 12-OCT-2008 revealed that the patient experienced vomiting, irritability, decreased oral intake, bloody stool with some clots. The patient was note to have some dehydration, nasal congestion, cough and sneezing. The patient was admitted overnight for observation and discharged to home next morning. The final diagnostic was Ileocolic Intussusception. An abdominal ultrasound was performed that was positive for Intussusception and was reduced with a barium enema. The listing indicated that the events were immediately life-threatening. A standard lot check investigation was performed for lot no. 660934/0414X. All in-process quality checks for the lot number in question 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 research center and was released. The original reporting source was not provided. The VAERS ID # is 334622. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Irritability, Nasal congestion, Sneezing, Thrombosis
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 62 day old female who on 06-OCT-2008 was vaccinated with the first dose of ROTATEQ (lot no. 660934/0414X) by mouth. Concomitant therapy included the first dose of PEDIARIX (lot no. AC263192BA) IM, into the left leg, the first dose of PREVNAR (lot no. C40033) IM into the left leg and the first dose of ACTHIB (lot no UF491AB) IM into the right leg. Medical records of 11-OCT-2008 and 12-OCT-2008 revealed that the patient experienced vomiting, irritability, decreased oral intake, bloody stool with some clots. The patient was note to have some dehydration, nasal congestion, cough and sneezing. The patient was admitted overnight for observation and discharged to home next morning. The final diagnostic was Ileocolic Intussusception. An abdominal ultrasound was performed that was positive for Intussusception and was reduced with a barium enema. The listing indicated that the events were immediately life-threatening. A standard lot check investigation was performed for lot no. 660934/0414X. All in-process quality checks for the lot number in question 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 research center and was released. The original reporting source was not provided. The VAERS ID # is 334622. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting
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 62 day old female who on 06-OCT-2008 was vaccinated with the first dose of ROTATEQ (lot no. 660934/0414X) by mouth. Concomitant therapy included the first dose of PEDIARIX (lot no. AC263192BA) IM, into the left leg, the first dose of PREVNAR (lot no. C40033) IM into the left leg and the first dose of ACTHIB (lot no UF491AB) IM into the right leg. Medical records of 11-OCT-2008 and 12-OCT-2008 revealed that the patient experienced vomiting, irritability, decreased oral intake, bloody stool with some clots. The patient was note to have some dehydration, nasal congestion, cough and sneezing. The patient was admitted overnight for observation and discharged to home next morning. The final diagnostic was Ileocolic Intussusception. An abdominal ultrasound was performed that was positive for Intussusception and was reduced with a barium enema. The listing indicated that the events were immediately life-threatening. A standard lot check investigation was performed for lot no. 660934/0414X. All in-process quality checks for the lot number in question 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 research center and was released. The original reporting source was not provided. The VAERS ID # is 334622. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Enema administration, Intussusception, Occult blood positive, Pyrexia
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 4 month old male patient who on 05-DEC-2008 was vaccinated with the second dose of ROTATEQ (lot no. 661687/0968X) given by mouth. Concomitant therapy included the second dose of PREVNAR (lot no. C25997) IM into the right leg and DAPTACEL (lot no. C3183AA) IM into the left leg. On 10-DEC-2008 the patient experienced vomiting and diarrhea hemorrhagic for one day and had fever. The patient was seen by the doctor who evaluated and then contacted surgery at medical center. The patient was transported by ambulance. The patient underwent surgery for intussusception. At the doctor's office was performed a Guaiac Fecal-Occult Blood Test which were positive. An ultrasound was performed that showed the abdomen dilated fluid filled bowel loops with small amount of free liquid. Intussusception was identified by a fluoroscopy and the air contrast enema revealed ileocolic intussusception. The listing indicated that the events were considered to be immediately life-threatening. A standard lot check investigation was performed for lot no. 661687/0968X. All in-process quality checks for the lot number in question 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 research center and was released. The original reporting source was not provided. The VAERS ID # is 335045. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, PNC, RV5
Symptoms: Surgery, Ultrasound abdomen abnormal, Vomiting, X-ray
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 4 month old male patient who on 05-DEC-2008 was vaccinated with the second dose of ROTATEQ (lot no. 661687/0968X) given by mouth. Concomitant therapy included the second dose of PREVNAR (lot no. C25997) IM into the right leg and DAPTACEL (lot no. C3183AA) IM into the left leg. On 10-DEC-2008 the patient experienced vomiting and diarrhea hemorrhagic for one day and had fever. The patient was seen by the doctor who evaluated and then contacted surgery at medical center. The patient was transported by ambulance. The patient underwent surgery for intussusception. At the doctor's office was performed a Guaiac Fecal-Occult Blood Test which were positive. An ultrasound was performed that showed the abdomen dilated fluid filled bowel loops with small amount of free liquid. Intussusception was identified by a fluoroscopy and the air contrast enema revealed ileocolic intussusception. The listing indicated that the events were considered to be immediately life-threatening. A standard lot check investigation was performed for lot no. 661687/0968X. All in-process quality checks for the lot number in question 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 research center and was released. The original reporting source was not provided. The VAERS ID # is 335045. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy lymph gland, Chemotherapy, Computerised tomogram abnormal, Lymphadenopathy, Non-Hodgkin's lymphoma
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 23 year old female patient was vaccinated with the second dose of GARDASIL (Lot # 0947X), intramuscularly in the left arm on 15-JUL-2008. On 15-SEP-2008, the patient was vaccinated with the third dose of GARDASIL. There was no concomitant therapy. The patient was diagnosed with Non-Hodgkins on 20-NOV-2008. She had lymphadenopathy in the neck and anterior mediastinum. She is currently undergoing chemotherapy. A lymph node biopsy was performed with primary mediastinal large b-cell lymphoma. A Pet scan, and Ct scans also done localizing the disease to neck and chest. Chemotherapy, lymphadenopathy and Non-Hodgkins lymphoma were considered to be life-threatening by the reporter. The original reporting source was not provided. The vaers ID# is: 335340. A standard lot check investigation was performed. All in-process quality checks for the lot number in question 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 Center and was released. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Positron emission tomogram abnormal, Primary mediastinal large B-cell lymphoma
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 23 year old female patient was vaccinated with the second dose of GARDASIL (Lot # 0947X), intramuscularly in the left arm on 15-JUL-2008. On 15-SEP-2008, the patient was vaccinated with the third dose of GARDASIL. There was no concomitant therapy. The patient was diagnosed with Non-Hodgkins on 20-NOV-2008. She had lymphadenopathy in the neck and anterior mediastinum. She is currently undergoing chemotherapy. A lymph node biopsy was performed with primary mediastinal large b-cell lymphoma. A Pet scan, and Ct scans also done localizing the disease to neck and chest. Chemotherapy, lymphadenopathy and Non-Hodgkins lymphoma were considered to be life-threatening by the reporter. The original reporting source was not provided. The vaers ID# is: 335340. A standard lot check investigation was performed. All in-process quality checks for the lot number in question 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 Center and was released. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: B-cell lymphoma, Chemotherapy, Laboratory test normal, Lymphadenopathy, Mediastinal mass
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 23 year old female patient was vaccinated with the second dose of GARDASIL (Lot # 0947X), intramuscularly in the left arm on 15-JUL-2008. On 15-SEP-2008, the patient was vaccinated with the third dose of GARDASIL. There was no concomitant therapy. The patient was diagnosed with Non-Hodgkins on 20-NOV-2008. She had lymphadenopathy in the neck and anterior mediastinum. She is currently undergoing chemotherapy. A lymph node biopsy was performed with primary mediastinal large b-cell lymphoma. A Pet scan, and Ct scans also done localizing the disease to neck and chest. Chemotherapy, lymphadenopathy and Non-Hodgkins lymphoma were considered to be life-threatening by the reporter. The original reporting source was not provided. The vaers ID# is: 335340. A standard lot check investigation was performed. All in-process quality checks for the lot number in question 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 Center and was released. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neck mass, Non-Hodgkin's lymphoma
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 23 year old female patient was vaccinated with the second dose of GARDASIL (Lot # 0947X), intramuscularly in the left arm on 15-JUL-2008. On 15-SEP-2008, the patient was vaccinated with the third dose of GARDASIL. There was no concomitant therapy. The patient was diagnosed with Non-Hodgkins on 20-NOV-2008. She had lymphadenopathy in the neck and anterior mediastinum. She is currently undergoing chemotherapy. A lymph node biopsy was performed with primary mediastinal large b-cell lymphoma. A Pet scan, and Ct scans also done localizing the disease to neck and chest. Chemotherapy, lymphadenopathy and Non-Hodgkins lymphoma were considered to be life-threatening by the reporter. The original reporting source was not provided. The vaers ID# is: 335340. A standard lot check investigation was performed. All in-process quality checks for the lot number in question 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 Center and was released. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Ileus, Intestinal resection, Intussusception, Nausea
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 60 day old male who on 07-AUG-2008 was vaccinated with the first dose of ROTATEQ (lot no. 660596/0211X) oral administration. Concomitant therapy included the first dose of PREVNAR (lot no. C86145) IM into the right leg, INFANRIX (lot no. AC21B156EA) IM into the left leg, ACTHIB (lot no. UF450AB) IM into the right leg and AXID. On 13-SEP-2008 the patient had an acute onset of intestinal ileus after a procedure of 3 to 4 days of nausea and diarrhea that becoming frank rectal bleeding. The patient was diagnosed with Intussusception requiring a 6 inch resection at caecum and small bowel. The listing indicated that the events required hospitalization and were considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed for lot no. 660596/0211X. All in-process quality checks for the lot number in question 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 Center and was released. The original reporting source was not provided. The VAERS ID # is 336228.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Rectal haemorrhage
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 60 day old male who on 07-AUG-2008 was vaccinated with the first dose of ROTATEQ (lot no. 660596/0211X) oral administration. Concomitant therapy included the first dose of PREVNAR (lot no. C86145) IM into the right leg, INFANRIX (lot no. AC21B156EA) IM into the left leg, ACTHIB (lot no. UF450AB) IM into the right leg and AXID. On 13-SEP-2008 the patient had an acute onset of intestinal ileus after a procedure of 3 to 4 days of nausea and diarrhea that becoming frank rectal bleeding. The patient was diagnosed with Intussusception requiring a 6 inch resection at caecum and small bowel. The listing indicated that the events required hospitalization and were considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed for lot no. 660596/0211X. All in-process quality checks for the lot number in question 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 Center and was released. The original reporting source was not provided. The VAERS ID # is 336228.
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported pain and swelling at injection site.  Exam revealed erythema (approx 3 cm in diameter) warm to touch and tender to palpation.  No fever.  Dx = cellulitis; Rx = Keflex 500 mg QID x 10 days.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Electroencephalogram
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female who approximately 6 months ago was intramuscularly vaccinated with the third dose of GARDASIL, shortly after which the patient experienced seizures.  The patient's mother is still taking the patient to the doctor a lot.  Electroencephalography (EEG) was performed but the result was unspecified.  At the time of reporting, the patient's outcome was unknown.  The nurse practitioner did not administer any of the vaccinations.  Upon internal review, seizures was considered to be an other important medical event.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram abnormal, Headache, Loss of consciousness, Neurological examination abnormal
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 17 year old female with no family history of seizures or drug allergies who received all three doses of GARDASIL and then experienced seizures. All 3 doses were administered at a different facility and the patient just started coming to the nurse's office in December 2008 so the dates or lot number of the GARDASIL administered were not available. The patient was vaccinated with the third dose of vaccine in mid-January 2008. The seizures began in April 2008. In December 2008 the seizures became consistent and occurred daily. Starting 09-FEB-2009 the patient experienced blackouts. A neurologist determined the patient was having monoclonic seizures and prescribed KEPPRA and DILANTIN. The KEPPRA would be discontinued and replaced with LAMICTAL. Neurological tests indicated abnormal electroencephalogram. The nurse also mentioned that the patient has been experiencing headaches but had no further information about them. At the time of reporting the patient was getting worse. The patient was hospitalized and was seen by a neurologist. Additional information has been requested.  2/24/09 Received hospital medical records of 12/10-12/11/2008. FINAL DX: myoclonic seizures Records reveal patient experienced HA, photophobia x 2 days then had involuntary jerking/shaking/twitching episode while in class 12/9.  Neuro consult done.  Tx w/meds.  3/5/09 Received Neuro medical records of 1/15/09 FINAL DX: seizure disorder, generalized, myoclonic Records reveal meds were adjusted.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Asthma, Developmental delay, Familial risk factor
Clinical narrative: Information has been received from a consumer concerning her son, a 5 year old male who allergic to amoxicillin who was vaccinated with one dose of MMR II, oral. Subsequently the patient experienced developmental delays and asthma and was hospitalized "overnight". The patient did not perform lab diagnostics study. At time of the report the patient's developmental delays and asthma were not recovered. The patient's brother also had an adverse event after vaccination with MMR II (WAES # 0902USA01776). No further information is available.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Computerised tomogram abnormal, Fasciitis, Muscle swelling
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old male patient with penicillin allergy and SULFONAMIDE allergy, who on 22-JAN-2009 was vaccinated with the second dose of PNEUMOVAX 23 (Lot # 662785/1124X), 0.5ml intramuscularly. Concomitant therapy included ALPRAZOLAM, FLOMAX, FLUOXETINE, OMEPRAZOLE and TRAMADOL HCl. The registered nurse reported that on 22-JAN-2009, the patient experienced fasciitis after receiving a dose of the vaccine. At the time of the report, the patient had not recovered. The patient sought medical attention at the emergency room. Follow-up information from a certified medical assistant revealed that the patient was a 71 year old male patient, weighing 120 pounds and 65 inches in height, with penicillin allergy and sulfonamide allergy, who was vaccinated in the left deltoid with the second dose of PNEUMOVAX 23, (Lot #662785/1124X), intramuscularly. There were no illnesses at the time of vaccination. The certified medical assistant reported that in the afternoon of 22-JAN-2009, the patient developed severe cellulitis and myofascial swelling (by CT scan) in arm where shot administered. The patient was hospitalized for 3 days and received intravenous antibiotics to which he responded. At the time of the report, the patient had recovered. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Convulsion, Dizziness, Headache, Loss of consciousness
Clinical narrative: Information has been received from a kindergarten teacher concerning her husband's relative's churchmember's daughter's friend at school, a girl who in August 2008 was vaccinated with the third dose of GARDASIL. The patient developed similar symptoms as her friend (WAES #0902USA01121) noted below, most of which started in September 2008. Headache, seizures, quit eating, passed out, lost weight, gastric disorder, blood pressure dropping extremely low, dizziness, tremors, and digestive disorder. It was also noted that this patient's digestive tract issues were worse. At the time of the report, the patient had been out of school about the same amount of time as her friend, approximately 8 or 9 weeks. The reporter considered both girls' symptoms to be due to the vaccine. Attempts are being made to verify the existence of an identifiable patient and reporter. Upon internal review, seizures is considered to be an other important medical event.  3/23/09 MR received from Vax provider. Seen 1/14/2008 for eval of menorrhagia.  PE WNL. Started on OCs to regulate menstrual cycle. HPV#1 given.  TC from parent 1/23/09 reporting worsening of abdominal pain since HPV vaccine #3 in 8/2008. Parent reports severe nausea and vomiting, anorexia, weakness and syncope. Pt has been unable to attend school. Seen by GI with DX:  Non-infectious gastroenteritis and colitis.  Unspecified vaccines causing adverse effects in therapeutic use. Forms completed for home school. 7/6/09 Per parent, pt has not seen a neurologist-only a phone consult. No records available
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tremor, Weight decreased
Clinical narrative: Information has been received from a kindergarten teacher concerning her husband's relative's churchmember's daughter's friend at school, a girl who in August 2008 was vaccinated with the third dose of GARDASIL. The patient developed similar symptoms as her friend (WAES #0902USA01121) noted below, most of which started in September 2008. Headache, seizures, quit eating, passed out, lost weight, gastric disorder, blood pressure dropping extremely low, dizziness, tremors, and digestive disorder. It was also noted that this patient's digestive tract issues were worse. At the time of the report, the patient had been out of school about the same amount of time as her friend, approximately 8 or 9 weeks. The reporter considered both girls' symptoms to be due to the vaccine. Attempts are being made to verify the existence of an identifiable patient and reporter. Upon internal review, seizures is considered to be an other important medical event.  3/23/09 MR received from Vax provider. Seen 1/14/2008 for eval of menorrhagia.  PE WNL. Started on OCs to regulate menstrual cycle. HPV#1 given.  TC from parent 1/23/09 reporting worsening of abdominal pain since HPV vaccine #3 in 8/2008. Parent reports severe nausea and vomiting, anorexia, weakness and syncope. Pt has been unable to attend school. Seen by GI with DX:  Non-infectious gastroenteritis and colitis.  Unspecified vaccines causing adverse effects in therapeutic use. Forms completed for home school. 7/6/09 Per parent, pt has not seen a neurologist-only a phone consult. No records available
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Loss of consciousness, Migraine, Pain
Clinical narrative: Information has been received from a kindergarten teacher concerning her husband's relative's churchmember's daughter's friend at school, a girl who in August 2008 was vaccinated with the third dose of GARDASIL. The patient developed similar symptoms as her friend (WAES #0902USA01121) noted below, most of which started in September 2008. Headache, seizures, quit eating, passed out, lost weight, gastric disorder, blood pressure dropping extremely low, dizziness, tremors, and digestive disorder. It was also noted that this patient's digestive tract issues were worse. At the time of the report, the patient had been out of school about the same amount of time as her friend, approximately 8 or 9 weeks. The reporter considered both girls' symptoms to be due to the vaccine. Attempts are being made to verify the existence of an identifiable patient and reporter. Upon internal review, seizures is considered to be an other important medical event.  3/23/09 MR received from Vax provider. Seen 1/14/2008 for eval of menorrhagia.  PE WNL. Started on OCs to regulate menstrual cycle. HPV#1 given.  TC from parent 1/23/09 reporting worsening of abdominal pain since HPV vaccine #3 in 8/2008. Parent reports severe nausea and vomiting, anorexia, weakness and syncope. Pt has been unable to attend school. Seen by GI with DX:  Non-infectious gastroenteritis and colitis.  Unspecified vaccines causing adverse effects in therapeutic use. Forms completed for home school. 7/6/09 Per parent, pt has not seen a neurologist-only a phone consult. No records available
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Caesarean section, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received through the Merck pregnancy registry from a physician concerning a 17 year old female who on 16-NOV-2007 was vaccinated with the first dose of GARDASIL. Subsequently, the patient learned that she is pregnant. The pregnancy was confirmed by a pregnancy test. Concomitant therapy included injection with the first dose of VARIVAX on 16-NOV-2007. Other concomitant therapy included HAVRIX and MENACTRA. No adverse side effects were reported as a result of this exposure. The patient sought unspecified medical attention. Follow up information was received from the nurse via phone call. It was reported the baby was "fine", healthy and normal. The reporters now see the baby was well. The baby was born by C-section (Caesarean-section) with no complications but the reporter did not know the indication for the C-section. The baby weighed 7 lbs 9 oz and was 18 and a half inches long. Upon internal review, "the baby was born by C-section" was determined to be an other important medical event. No further information was available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdomen scan normal, Convulsion, Dizziness, Fatigue, Muscular weakness
Clinical narrative: Information has been received from a Registered Nurse concerning her daughter (a 15 year old female) who in August 2008 was vaccinated with the third dose of GARDASIL (lot number was not available). The patient experienced leg weakness, dizziness, fatigue and syncope after receiving her third dose of vaccine. At the time of reporting the patient was not recovered. Follow-up AE Information was received from the Registered Nurse by phone concerning her daughter with no pertinent medical history and drug allergies who was vaccinated with her third dose of GARDASIL in April 2008 (not August 2008 as previously reported). Date of birth of the patient is 19-JUN-1993. Patient is not pregnant. Lot #s of GARDASIL are unspecified. Her symptoms began in October 2008. In addition to leg weakness, dizziness, fatigue and syncope the patient has also been experiencing seizure-like activity. No other vaccinations was administered with GARDASIL. Patient is on AVIANE birth control. The patient has seen a neurologist and has had an EEG, EMG of lower extremities and MRI of brain, MRI of abdomen and lab work. All tests have all come back negative. Dose 1 was administered on an unspecified date and dose 2 was administered on 09-SEP-2007. The patient's symptoms are getting worse. The syncope and seizure-like activity are occurring more often. No hospitalization, not life-threatening, not a significant disability. No treatment and no medication have been prescribed at this point. Upon internal review, seizure-like activity was determined to be an other important medical event. The patient sought medical attention. Additional information has been requested.  2/24/09 Received PCP medical records of 11/7/08, Records reveal patient experienced abdominal pain, dizziness, numbness & urinary incontinence x 1.  Refered to Neuro.  3/4/09 Received Neuro medical records of 11/18/2008-2/12/2009. FINAL DX: right peripheral vestibular dysfunction, vestibular neuronitis & restless leg syndrome Records reveal patient experienced episodes of disequilibrium & dizziness daily since 10/1/08; right leg numbness w/falls x 2 since 10/7/08; now w/numbness of right leg; urinary incontinence x 1; abdominal pain; fatigue; nausea; feelings of detachment or depersonalization x 8 mo.  Tx w/meds w/some improvement.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning her daughter (a 15 year old female) who in August 2008 was vaccinated with the third dose of GARDASIL (lot number was not available). The patient experienced leg weakness, dizziness, fatigue and syncope after receiving her third dose of vaccine. At the time of reporting the patient was not recovered. Follow-up AE Information was received from the Registered Nurse by phone concerning her daughter with no pertinent medical history and drug allergies who was vaccinated with her third dose of GARDASIL in April 2008 (not August 2008 as previously reported). Date of birth of the patient is 19-JUN-1993. Patient is not pregnant. Lot #s of GARDASIL are unspecified. Her symptoms began in October 2008. In addition to leg weakness, dizziness, fatigue and syncope the patient has also been experiencing seizure-like activity. No other vaccinations was administered with GARDASIL. Patient is on AVIANE birth control. The patient has seen a neurologist and has had an EEG, EMG of lower extremities and MRI of brain, MRI of abdomen and lab work. All tests have all come back negative. Dose 1 was administered on an unspecified date and dose 2 was administered on 09-SEP-2007. The patient's symptoms are getting worse. The syncope and seizure-like activity are occurring more often. No hospitalization, not life-threatening, not a significant disability. No treatment and no medication have been prescribed at this point. Upon internal review, seizure-like activity was determined to be an other important medical event. The patient sought medical attention. Additional information has been requested.  2/24/09 Received PCP medical records of 11/7/08, Records reveal patient experienced abdominal pain, dizziness, numbness & urinary incontinence x 1.  Refered to Neuro.  3/4/09 Received Neuro medical records of 11/18/2008-2/12/2009. FINAL DX: right peripheral vestibular dysfunction, vestibular neuronitis & restless leg syndrome Records reveal patient experienced episodes of disequilibrium & dizziness daily since 10/1/08; right leg numbness w/falls x 2 since 10/7/08; now w/numbness of right leg; urinary incontinence x 1; abdominal pain; fatigue; nausea; feelings of detachment or depersonalization x 8 mo.  Tx w/meds w/some improvement.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a female with penicillin and sulfa allergy and a history of knee surgery and tube placed in her ear as a child who in March 2008, was vaccinated with a first dose of GARDASIL 0.5 mL and in May 2008 was vaccinated with a second dose of GARDASIL. The reporter was unaware if patient received her third dose. Concomitant therapy included "birth control". On unknown date, the patient experienced seizures. It was unknown after what dose seizures occurred. The patient sought unspecified medical attention. At the time of reporting, the outcome was unknown. Upon internal review, seizures was determined to be an other important medical event. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood chloride normal, Blood creatinine increased, Blood potassium normal
Clinical narrative: Patient received the three doses of ROTATEQ - #1 dose on 06/18/08, #2 dose on 08/22/08, # 3 dose on 10/24/08. Diagnosed on 01/27/09 with rotavirus antigen.  2/20/09 MR received for DOS 1/26-27/2009 with DX: Acute Gastroenteritis. Pt presented with multiple episodes of projectile vomiting and fatigue.  PE (+) for pallor, dry mucous membranes, hypoactive BS. Vomiting continued in ER. Tx with Zofran and IVF  which helped.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: Patient received the three doses of ROTATEQ - #1 dose on 06/18/08, #2 dose on 08/22/08, # 3 dose on 10/24/08. Diagnosed on 01/27/09 with rotavirus antigen.  2/20/09 MR received for DOS 1/26-27/2009 with DX: Acute Gastroenteritis. Pt presented with multiple episodes of projectile vomiting and fatigue.  PE (+) for pallor, dry mucous membranes, hypoactive BS. Vomiting continued in ER. Tx with Zofran and IVF  which helped.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Lymphocyte percentage increased, Monocyte percentage increased, Neutrophil percentage decreased, Platelet count normal, Rotavirus infection
Clinical narrative: Patient received the three doses of ROTATEQ - #1 dose on 06/18/08, #2 dose on 08/22/08, # 3 dose on 10/24/08. Diagnosed on 01/27/09 with rotavirus antigen.  2/20/09 MR received for DOS 1/26-27/2009 with DX: Acute Gastroenteritis. Pt presented with multiple episodes of projectile vomiting and fatigue.  PE (+) for pallor, dry mucous membranes, hypoactive BS. Vomiting continued in ER. Tx with Zofran and IVF  which helped.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: White blood cell count increased
Clinical narrative: Patient received the three doses of ROTATEQ - #1 dose on 06/18/08, #2 dose on 08/22/08, # 3 dose on 10/24/08. Diagnosed on 01/27/09 with rotavirus antigen.  2/20/09 MR received for DOS 1/26-27/2009 with DX: Acute Gastroenteritis. Pt presented with multiple episodes of projectile vomiting and fatigue.  PE (+) for pallor, dry mucous membranes, hypoactive BS. Vomiting continued in ER. Tx with Zofran and IVF  which helped.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Blood creatinine normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Body temperature
Clinical narrative: Patient received the three doses of ROTATEQ - #1 dose on 06/18/08, #2 dose on 08/22/08, # 3 dose on 10/24/08. Diagnosed on 01/27/09 with rotavirus antigen.  2/20/09 MR received for DOS 1/26-27/2009 with DX: Acute Gastroenteritis. Pt presented with multiple episodes of projectile vomiting and fatigue.  PE (+) for pallor, dry mucous membranes, hypoactive BS. Vomiting continued in ER. Tx with Zofran and IVF  which helped.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Dehydration, Enterovirus serology test positive, Fatigue, Gastroenteritis norovirus, Gastrointestinal sounds abnormal
Clinical narrative: Patient received the three doses of ROTATEQ - #1 dose on 06/18/08, #2 dose on 08/22/08, # 3 dose on 10/24/08. Diagnosed on 01/27/09 with rotavirus antigen.  2/20/09 MR received for DOS 1/26-27/2009 with DX: Acute Gastroenteritis. Pt presented with multiple episodes of projectile vomiting and fatigue.  PE (+) for pallor, dry mucous membranes, hypoactive BS. Vomiting continued in ER. Tx with Zofran and IVF  which helped.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Haematocrit normal, Haemoglobin normal, Mucosal dryness, Pallor, Rotavirus infection
Clinical narrative: Patient received the three doses of ROTATEQ - #1 dose on 06/18/08, #2 dose on 08/22/08, # 3 dose on 10/24/08. Diagnosed on 01/27/09 with rotavirus antigen.  2/20/09 MR received for DOS 1/26-27/2009 with DX: Acute Gastroenteritis. Pt presented with multiple episodes of projectile vomiting and fatigue.  PE (+) for pallor, dry mucous membranes, hypoactive BS. Vomiting continued in ER. Tx with Zofran and IVF  which helped.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Rotavirus test positive, Vomiting projectile, White blood cell count increased
Clinical narrative: Patient received the three doses of ROTATEQ - #1 dose on 06/18/08, #2 dose on 08/22/08, # 3 dose on 10/24/08. Diagnosed on 01/27/09 with rotavirus antigen.  2/20/09 MR received for DOS 1/26-27/2009 with DX: Acute Gastroenteritis. Pt presented with multiple episodes of projectile vomiting and fatigue.  PE (+) for pallor, dry mucous membranes, hypoactive BS. Vomiting continued in ER. Tx with Zofran and IVF  which helped.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Vomiting
Clinical narrative: Headache, emesis. 2 ED visits.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: (L) arm/hand "pinging" when I tap thumb & pinkie + ring finger together ; (L) forearm feels irritated & achy when resting it on any sfc, Face of shoulder felt achy warm to touch, tender at shot site, soft mass under surface. Back of (L) shoulder felt very sore, achy when touching a sfc (chairback, bed) Jaw  & whole body ached for 1st 24-36 hrs.  Tx: lymphatic massage on (L) arm/shoulder x 6. Hot/cold compresses 3x/evening x 4 more days. Homeopathic detoxing supplements. Spread out over last month. Recovery is slow.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Sensory disturbance, Skin warm
Clinical narrative: (L) arm/hand "pinging" when I tap thumb & pinkie + ring finger together ; (L) forearm feels irritated & achy when resting it on any sfc, Face of shoulder felt achy warm to touch, tender at shot site, soft mass under surface. Back of (L) shoulder felt very sore, achy when touching a sfc (chairback, bed) Jaw  & whole body ached for 1st 24-36 hrs.  Tx: lymphatic massage on (L) arm/shoulder x 6. Hot/cold compresses 3x/evening x 4 more days. Homeopathic detoxing supplements. Spread out over last month. Recovery is slow.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: GARDASIL injection given in left deltoid at 4:15 pm, client stated she was dizzy and felt hot at that time. Client lost consciousness at 4:16 pm, was assisted to lie down. Client able to answer questions at 4:20 pm, BP 72/50, pulse 72. BP 88/50 at 4:35pm.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Rt Arm- 6.5X 8cm erythematous, indurated area
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Convulsion
Clinical narrative: Patient was seen at the Emergency Room because she was having seizures
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Irritability, Oedema peripheral
Clinical narrative: morning after had HEP A shot had bilat hand swelling and palms looked red, had been fussy during night. swelling was gone by end of day, feet were nl, no swelling noted by mother at site of shot.
Age: 79.0
Sex: U
Vaccine: HEP
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: pT. STATES GENERALIZED RASH AND ITCHING OF SKIN SINCE DAY AFTER hEP b VACCINE WAS ADMINISTERED.  pT. HAD RECEIVED tWINRIX ONE MONTH PRIOR WITH NO SIDE EFFECT.