chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: DTP
Symptoms: Liver function test, Malnutrition, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Encephalopathy, severe malnutrition and hairloss, ADD, ADHD, vitamin deficiency, memory loss, concentration problems, burning in head, acute "electric" pain originating in head and coursing through to feet, decreased states of consciousness, tunnel vision, breathing/heart murmurs, chronic headaches, chronic fatigue, severe depression, suicidal thoughts, bi-polarity, arnold-chiari brain malformation type 1 etc.
Age: 22.0
Sex: F
Vaccine: DTP
Symptoms: Suicidal ideation, Thyroid function test, Tunnel vision
Clinical narrative: Encephalopathy, severe malnutrition and hairloss, ADD, ADHD, vitamin deficiency, memory loss, concentration problems, burning in head, acute "electric" pain originating in head and coursing through to feet, decreased states of consciousness, tunnel vision, breathing/heart murmurs, chronic headaches, chronic fatigue, severe depression, suicidal thoughts, bi-polarity, arnold-chiari brain malformation type 1 etc.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None- Vaccine administered @ inappropriate initiation.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Anxiety, Cholecystectomy, Dyspepsia
Clinical narrative: I had the last shot in early November 07, been sick sense. November 20 Fainted in store multiple times. Perfectly normal healthy happy teenager before.  Have severe pain in stoamche area, had galbladder removed, pain still occured. Have an all over sick feeling. Some days I cant get out of bed.  Had to quit going to highscool after the shot. Have serious stomache and digestive problems. Take medication for IBS which occured after the third Gardail shot. Been to Emergency room over 10 times in the last two years due to ilness and severe pain. 11/2/09:  Vaccine record received, VAERS updated. 11/3/09:  Outpatient Records received for dates of service 11/26/07 to 8/10/09. Dx:  Pelvic pain Assessment:  Long hx. of RUQ and RLQ abdominal pain.  Underwent cholecystectomy with resolution of RUQ pain, but continued to have persistent RLQ pain. Has alternating constipation and diarrhea as well and headaches, blurred vision, dizzy spells and occasional nausea.  Pt. had risk factors for PID so was treated with Rocephin and doxycycline with no relief of sx.  She underwent a diagnostic laparoscopy which was normal.  She is medicated with Lortab for when the pain is most severe.  Her sx. continue.  ICD 9 Codes:  724.2, 789.01, 789.03.  11/13/09 ER recs received for dates 11/20/07 to 6/20/09. DX: viral URI. Presenting SX: cough, nausea, wheezing, abdominal pain x2-3 days. Assessment: WNL.ER visit on 10/25/09 for c/o assault. DX: strain of wrist muscles, shoulder strain, contusion of chest. ER visit 6/2/08 c/o stomach pain, diarrhea. DX: UTI, acute abdominal pain. UA(+)WBC. ER visit on 12/29/07 c/o f/u abdominal pain LUQ pain, epigastric abdominal pain.DX: abdominal pain of undeterm etiology. ER visit 12/15/07 DX:postmononucleosis syndrome, dehydration, presyncope.  Chief c/o vomiting and side pain. Pt. c/o LUQ pain. Pt states have had many episodes off and on. Also c/o dizziness, lightheadedness. PMH: dx w/ mononucleosis weeks prior. US, bloodwork, UA, WNL. ER visit 11/20/07 DX: h/o syncopal episodes, dizziness and nausea resolved. Presented to ER with c/o dizziness, nausea, hives, rt. side flank pain, syncopal episodes, diarrhea. Assessment WNL. Diagnostics WNL.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Irritable bowel syndrome, Malaise, Mononucleosis syndrome, Syncope
Clinical narrative: I had the last shot in early November 07, been sick sense. November 20 Fainted in store multiple times. Perfectly normal healthy happy teenager before.  Have severe pain in stoamche area, had galbladder removed, pain still occured. Have an all over sick feeling. Some days I cant get out of bed.  Had to quit going to highscool after the shot. Have serious stomache and digestive problems. Take medication for IBS which occured after the third Gardail shot. Been to Emergency room over 10 times in the last two years due to ilness and severe pain. 11/2/09:  Vaccine record received, VAERS updated. 11/3/09:  Outpatient Records received for dates of service 11/26/07 to 8/10/09. Dx:  Pelvic pain Assessment:  Long hx. of RUQ and RLQ abdominal pain.  Underwent cholecystectomy with resolution of RUQ pain, but continued to have persistent RLQ pain. Has alternating constipation and diarrhea as well and headaches, blurred vision, dizzy spells and occasional nausea.  Pt. had risk factors for PID so was treated with Rocephin and doxycycline with no relief of sx.  She underwent a diagnostic laparoscopy which was normal.  She is medicated with Lortab for when the pain is most severe.  Her sx. continue.  ICD 9 Codes:  724.2, 789.01, 789.03.  11/13/09 ER recs received for dates 11/20/07 to 6/20/09. DX: viral URI. Presenting SX: cough, nausea, wheezing, abdominal pain x2-3 days. Assessment: WNL.ER visit on 10/25/09 for c/o assault. DX: strain of wrist muscles, shoulder strain, contusion of chest. ER visit 6/2/08 c/o stomach pain, diarrhea. DX: UTI, acute abdominal pain. UA(+)WBC. ER visit on 12/29/07 c/o f/u abdominal pain LUQ pain, epigastric abdominal pain.DX: abdominal pain of undeterm etiology. ER visit 12/15/07 DX:postmononucleosis syndrome, dehydration, presyncope.  Chief c/o vomiting and side pain. Pt. c/o LUQ pain. Pt states have had many episodes off and on. Also c/o dizziness, lightheadedness. PMH: dx w/ mononucleosis weeks prior. US, bloodwork, UA, WNL. ER visit 11/20/07 DX: h/o syncopal episodes, dizziness and nausea resolved. Presented to ER with c/o dizziness, nausea, hives, rt. side flank pain, syncopal episodes, diarrhea. Assessment WNL. Diagnostics WNL.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Malaise, Retching, Vomiting
Clinical narrative: Not feeling well two hours after vaccine.  Threw up about 3 hours after.  Threw up after dinner.  Dry heaves and temp up to 103.7 during night.  temp down to 100 by mornig.  Normal temp by afternoon
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Right arm cellulitis following ADACEL - minor - tx: BIAXIN 500mg 1 POBID X 10d.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Death, Echocardiogram abnormal, Electrocardiogram abnormal, Mitral valve disease
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 75 year old female with sinusitis (sore throat and congestion), chronic atrial fibrillation and hyperlipidaemia (increased cholesterol), hypertension, heart valve disease, bilatrial enlargement, right ventricular enlargement and premature ventricular contraction and a history of mitral valve repair in 1991 was seen by cardiologist with "all good with valves" two months prior vaccination. The patient was vaccinated with a second dose of ZOSTAVAX (Merck) (lot# 658867/1413U) in the left arm (route not reported) on 19-FEB-2008. Other suspect vaccination included a second dose of PNEUMOVAX (lot# 659148/1382U) SQ on 19-FEB-2008. Concomitant therapy included COUMADIN, Lisinopril (manufacturer unknown), Digoxin "CRT" (therapy unspecified) and cholesterol. On 21-FEB-2008, 48 hours after receiving vaccinations, the patient died in her sleep, and the cause of death was mitral valve disease. No autopsy was done. The reporter did not think it was related to vaccination but it close time frame with vaccination. The originally reporting source was not provided. 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 for Biologics Evaluation and Research and was released. No further information is available. The VAERS ID# is 306283.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Death, Erythema, Herpes zoster, Inflammatory carcinoma of the breast
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 75 year old female with blood pressure and cholesterol and past medical history of hypertension, hypercholesterolaemia, leg cramps, acid reflux and seborrhoeic keratosis (removed in October 2005), on 25-APR-2007 was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 656609/0015U). On an unspecified date, the following events were reported: biopsy, herpes zoster, inflammatory carcinoma of the breast, keloid scar, metastasis, rash pruritic, rash vesicular, scab, tenderness. The patient had normal mammogram in March 2007. During physical on 25-APR-2007 the patient was given ZOSTAVAX (Merck). Days later the patient developed symptoms on chest. The patient was told it was shingles from the vaccine. The shingles did not improve and was biopsied. Diagnosed as Inflammatory Breast Cancer. Death certificate stated cause of death as metastatic inflammatory breast cancer. Reviewed primary care physician (PCP) medical records of 19-APR-2007 to 10-JUL-2007 which revealed patient experienced good health on 19-APR-2007 with a normal breast examination. The patient returned on 15-JUN-2007 with rash on right breast x 2-3 weeks. Vesicular rash in T8 dermatome was crusting over but had been pruritic and tender. The patient was diagnosed with shingles. The patient returned on 10-JUL-2007 because rash was not healing. Examination at that time revealed a keloid type rash over the anterior chest and right breast into the axilla. A biopsy was done and started on antibiotic for surrounding erythema. The patient did mammogram on 23-MAR-2007 indicated negative and Pap smear in 2006 indicated negative. This originally reporting source was not provided. The VAERS ID # is 312298. 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.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Keloid scar, Mammogram normal, Metastasis, Rash pruritic, Rash vesicular
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 75 year old female with blood pressure and cholesterol and past medical history of hypertension, hypercholesterolaemia, leg cramps, acid reflux and seborrhoeic keratosis (removed in October 2005), on 25-APR-2007 was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 656609/0015U). On an unspecified date, the following events were reported: biopsy, herpes zoster, inflammatory carcinoma of the breast, keloid scar, metastasis, rash pruritic, rash vesicular, scab, tenderness. The patient had normal mammogram in March 2007. During physical on 25-APR-2007 the patient was given ZOSTAVAX (Merck). Days later the patient developed symptoms on chest. The patient was told it was shingles from the vaccine. The shingles did not improve and was biopsied. Diagnosed as Inflammatory Breast Cancer. Death certificate stated cause of death as metastatic inflammatory breast cancer. Reviewed primary care physician (PCP) medical records of 19-APR-2007 to 10-JUL-2007 which revealed patient experienced good health on 19-APR-2007 with a normal breast examination. The patient returned on 15-JUN-2007 with rash on right breast x 2-3 weeks. Vesicular rash in T8 dermatome was crusting over but had been pruritic and tender. The patient was diagnosed with shingles. The patient returned on 10-JUL-2007 because rash was not healing. Examination at that time revealed a keloid type rash over the anterior chest and right breast into the axilla. A biopsy was done and started on antibiotic for surrounding erythema. The patient did mammogram on 23-MAR-2007 indicated negative and Pap smear in 2006 indicated negative. This originally reporting source was not provided. The VAERS ID # is 312298. 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.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Smear cervix normal, Tenderness
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 75 year old female with blood pressure and cholesterol and past medical history of hypertension, hypercholesterolaemia, leg cramps, acid reflux and seborrhoeic keratosis (removed in October 2005), on 25-APR-2007 was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 656609/0015U). On an unspecified date, the following events were reported: biopsy, herpes zoster, inflammatory carcinoma of the breast, keloid scar, metastasis, rash pruritic, rash vesicular, scab, tenderness. The patient had normal mammogram in March 2007. During physical on 25-APR-2007 the patient was given ZOSTAVAX (Merck). Days later the patient developed symptoms on chest. The patient was told it was shingles from the vaccine. The shingles did not improve and was biopsied. Diagnosed as Inflammatory Breast Cancer. Death certificate stated cause of death as metastatic inflammatory breast cancer. Reviewed primary care physician (PCP) medical records of 19-APR-2007 to 10-JUL-2007 which revealed patient experienced good health on 19-APR-2007 with a normal breast examination. The patient returned on 15-JUN-2007 with rash on right breast x 2-3 weeks. Vesicular rash in T8 dermatome was crusting over but had been pruritic and tender. The patient was diagnosed with shingles. The patient returned on 10-JUL-2007 because rash was not healing. Examination at that time revealed a keloid type rash over the anterior chest and right breast into the axilla. A biopsy was done and started on antibiotic for surrounding erythema. The patient did mammogram on 23-MAR-2007 indicated negative and Pap smear in 2006 indicated negative. This originally reporting source was not provided. The VAERS ID # is 312298. 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.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Acute sinusitis, Arthralgia, Balance disorder, Blindness unilateral, Computerised tomogram
Clinical narrative: 4/14/08 Received 3rd GARDASIL vaccine. 4-18-08 experienced ice pick type pain in back of head - lost vision in right eye - right side of face and arm completely numb. Dr sent us to hospital for Cat Scan and MRI. Sphrenoid sinusitis was diagnosed - prescribed Z-pack/Nuproloan. Pt improved a little but cont. to complain of achy joints - lower back, hips, knees, ankles and also experienced twitching - on the right side of face and arm. Pain felt like it was coming from inside the bone. Took pt to hospital. Dr admitted her with suspicion of M.S. She could not balancing on walk without assistance at this point. We still are trying to find out how to help her. She is able to walk and participate in activities but told better the pain on a daily bases. Has several migraine a week. Please hep us find out what is wrong. She is only 15 years old. 1/26/2010 Follow up: Consistent pain in lower back, hips, knees and weekly migraines. Describes pain as someone trying to bend the bone at times. Extremely fatigued. Sleeps alot.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Headache, Hypoaesthesia, Hypoaesthesia facial, Migraine
Clinical narrative: 4/14/08 Received 3rd GARDASIL vaccine. 4-18-08 experienced ice pick type pain in back of head - lost vision in right eye - right side of face and arm completely numb. Dr sent us to hospital for Cat Scan and MRI. Sphrenoid sinusitis was diagnosed - prescribed Z-pack/Nuproloan. Pt improved a little but cont. to complain of achy joints - lower back, hips, knees, ankles and also experienced twitching - on the right side of face and arm. Pain felt like it was coming from inside the bone. Took pt to hospital. Dr admitted her with suspicion of M.S. She could not balancing on walk without assistance at this point. We still are trying to find out how to help her. She is able to walk and participate in activities but told better the pain on a daily bases. Has several migraine a week. Please hep us find out what is wrong. She is only 15 years old. 1/26/2010 Follow up: Consistent pain in lower back, hips, knees and weekly migraines. Describes pain as someone trying to bend the bone at times. Extremely fatigued. Sleeps alot.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging
Clinical narrative: 4/14/08 Received 3rd GARDASIL vaccine. 4-18-08 experienced ice pick type pain in back of head - lost vision in right eye - right side of face and arm completely numb. Dr sent us to hospital for Cat Scan and MRI. Sphrenoid sinusitis was diagnosed - prescribed Z-pack/Nuproloan. Pt improved a little but cont. to complain of achy joints - lower back, hips, knees, ankles and also experienced twitching - on the right side of face and arm. Pain felt like it was coming from inside the bone. Took pt to hospital. Dr admitted her with suspicion of M.S. She could not balancing on walk without assistance at this point. We still are trying to find out how to help her. She is able to walk and participate in activities but told better the pain on a daily bases. Has several migraine a week. Please hep us find out what is wrong. She is only 15 years old. 1/26/2010 Follow up: Consistent pain in lower back, hips, knees and weekly migraines. Describes pain as someone trying to bend the bone at times. Extremely fatigued. Sleeps alot.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cancer in remission, Chemotherapy, Chest X-ray, Computerised tomogram, Fatigue
Clinical narrative: Information has been received from a consumer concerning a her 19 year old daughter with pertinent medical history reported as none and drug reactions or allergies reported as none who in January or February 2007, was vaccinated with a first dose of GARDASIL (lot # not reported). In April 2007 she received second dose of GARDASIL (lot # not reported). In August 2007 she received third dose of GARDASIL (lot # not reported). In November 2007 after vaccination with GARDASIL the patient developed non-Hodgkin's lymphoma. The first symptoms were itching all over her body, swollen lymph nodes and fatigue. She had 3A nodular sclerosing lymphoma. She had undergone 6 cycles of chemotherapy in 2008. At the time on the report on 07-AUG-2009 she was currently in remission. Upon internal review non-Hodgkin's lymphoma was determined to be an other important medical event. Follow up information has been received via telephone call from a nurse who refused to give any information concerning the patient without written authorization from the patient. Also the nurse stated that the patient received GARDASIL vaccinations at another physician's office. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.  02/01/2010 Follow-up: Currently in remission. Requires regular CT, PET and chest x-rays for the next for years. She has recently had sever migraines and this pain.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Migraine, Non-Hodgkin's lymphoma, Pain, Positron emission tomogram
Clinical narrative: Information has been received from a consumer concerning a her 19 year old daughter with pertinent medical history reported as none and drug reactions or allergies reported as none who in January or February 2007, was vaccinated with a first dose of GARDASIL (lot # not reported). In April 2007 she received second dose of GARDASIL (lot # not reported). In August 2007 she received third dose of GARDASIL (lot # not reported). In November 2007 after vaccination with GARDASIL the patient developed non-Hodgkin's lymphoma. The first symptoms were itching all over her body, swollen lymph nodes and fatigue. She had 3A nodular sclerosing lymphoma. She had undergone 6 cycles of chemotherapy in 2008. At the time on the report on 07-AUG-2009 she was currently in remission. Upon internal review non-Hodgkin's lymphoma was determined to be an other important medical event. Follow up information has been received via telephone call from a nurse who refused to give any information concerning the patient without written authorization from the patient. Also the nurse stated that the patient received GARDASIL vaccinations at another physician's office. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.  02/01/2010 Follow-up: Currently in remission. Requires regular CT, PET and chest x-rays for the next for years. She has recently had sever migraines and this pain.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a consumer concerning a her 19 year old daughter with pertinent medical history reported as none and drug reactions or allergies reported as none who in January or February 2007, was vaccinated with a first dose of GARDASIL (lot # not reported). In April 2007 she received second dose of GARDASIL (lot # not reported). In August 2007 she received third dose of GARDASIL (lot # not reported). In November 2007 after vaccination with GARDASIL the patient developed non-Hodgkin's lymphoma. The first symptoms were itching all over her body, swollen lymph nodes and fatigue. She had 3A nodular sclerosing lymphoma. She had undergone 6 cycles of chemotherapy in 2008. At the time on the report on 07-AUG-2009 she was currently in remission. Upon internal review non-Hodgkin's lymphoma was determined to be an other important medical event. Follow up information has been received via telephone call from a nurse who refused to give any information concerning the patient without written authorization from the patient. Also the nurse stated that the patient received GARDASIL vaccinations at another physician's office. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.  02/01/2010 Follow-up: Currently in remission. Requires regular CT, PET and chest x-rays for the next for years. She has recently had sever migraines and this pain.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAP, HEP, IPV, PNC, RV5
Symptoms: Intussusception, Surgery
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 2 month old male on 18-JUN-2009 was vaccinated by mouth with a first dose of ROTATEQ (lot # 663843/0069Y). Concomitant therapy included a second dose of ENGERIX-B (lot # AHBV608AA) which was administered intramuscularly, a first dose of QUADRACEL (lot # C3305AA) which was administered intramuscularly and a first dose of PREVNAR (lot # D34347) which was administered intramuscularly. On 21-JUN-2009 experienced intussusception. On 22-JUN-2009 the patient experienced surgery for intussusception. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 350567. 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.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Hemiparesis, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia
Clinical narrative: I received my second dose of the gardasil (HPV) vaccine on 6/9/09. Six days later I woke up and my left arm was numb. The loss of sensation persisted, and three days after that the entire left side of my body (face, neck, chest, torso, arm, leg, hand) lost sensation. I began to have a shock sensation when I put my head down to my chest. I saw a neurologist who sent me to the emergency room for x-rays. It turned out that my cervical spine was inflamed. It is now two months later, and I am finally starting to get sensation back on the left side of my body. I was 100% healthy before going in for this vaccine.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vascular imaging
Clinical narrative: I received my second dose of the gardasil (HPV) vaccine on 6/9/09. Six days later I woke up and my left arm was numb. The loss of sensation persisted, and three days after that the entire left side of my body (face, neck, chest, torso, arm, leg, hand) lost sensation. I began to have a shock sensation when I put my head down to my chest. I saw a neurologist who sent me to the emergency room for x-rays. It turned out that my cervical spine was inflamed. It is now two months later, and I am finally starting to get sensation back on the left side of my body. I was 100% healthy before going in for this vaccine.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Borrelia burgdorferi serology, Hypoaesthesia, Inflammation, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: I received my second dose of the gardasil (HPV) vaccine on 6/9/09. Six days later I woke up and my left arm was numb. The loss of sensation persisted, and three days after that the entire left side of my body (face, neck, chest, torso, arm, leg, hand) lost sensation. I began to have a shock sensation when I put my head down to my chest. I saw a neurologist who sent me to the emergency room for x-rays. It turned out that my cervical spine was inflamed. It is now two months later, and I am finally starting to get sensation back on the left side of my body. I was 100% healthy before going in for this vaccine.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Sensory loss
Clinical narrative: I received my second dose of the gardasil (HPV) vaccine on 6/9/09. Six days later I woke up and my left arm was numb. The loss of sensation persisted, and three days after that the entire left side of my body (face, neck, chest, torso, arm, leg, hand) lost sensation. I began to have a shock sensation when I put my head down to my chest. I saw a neurologist who sent me to the emergency room for x-rays. It turned out that my cervical spine was inflamed. It is now two months later, and I am finally starting to get sensation back on the left side of my body. I was 100% healthy before going in for this vaccine.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure normal, Heart rate normal, Nausea, Pallor, Shock
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who was vaccinated with the "first dose" of GARDASIL (injection, lot# not reported) in the "last week" (approximately 27-JUL-2009). Concomitant therapy included MENACTRA. The nurse stated that the patient received her first dose of GARDASIL and "2 minutes later the patient felt nauseated and she turned white, her lips were white". The nurse added that the patient looked like she maybe going into shock at that time. The nurse took blood pressure and checked her heart rate which were fine and they had the patient lie down for 5 to 10 minutes and then she started to feel better. The patient fully recovered after 20 to 30 minutes. The patient was given water and grapes. Upon internal review, shock was determined to be an other important medical events. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Impaired gastric emptying, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with no pertinent medical history and no known drug allergies who in "August/September 2006", was vaccinated with the first 0.5ml dose of GARDASIL (injection, lot# not reported). There was no concomitant medication. The consumer reported that in "mid January 2007", her daughter experienced diarrhea, vomiting and she was unable to keep food in her stomach after getting second dose of GARDASIL in November/December 2006. The patient was hospitalized end of February 2007 and was diagnosed with gastroparesis by physician at the hospital. The patient was discharged on 07-MAR-2007. She received the third dose of GARDASIL in April/May 2007. Lot# was not provided. The patient was recovered but she would get periodic gastroparesis it depended on what she ate. On unspecified day, a stomach emptying scan test and numerous other tests were performed, and the results were unknown. Follow up information has been received via telephone call from a physician indicating that the patient received the first dose of GARDASIL on 20-OCT-2006 (Lot number unavailable to the physician). The patient received the second dose of GARDASIL on 20-DEC-2006 (Lot number unavailable to the physician) and the third dose of GARDASIL on 01-MAY-2007 (Lot number unavailable to the physician). The physician stated that the lot number records for the GARDASIL vaccinations were accidentally discarded. The physician stated that she had changed her Physician Practice and had not seen the patient in over one year. The physician confirmed that the patient was hospitalized sometime at the end of February 2007 and was discharged from the hospital on 07-MAR-2007. The physician confirmed that the patient was diagnosed with Gastroparesis. The health care professional contacted during telephone follow-up could not supply the following information: lot number (if applicable). Additional information has been requested.   9/1/09  MR received for DOS 2/28-/06/2007 with D/C DX:  Gastroparesis.  Pt presented with c/o RUQ pain, diarrhea, vomiting, palpitations,sweating and H/A x 1 month.  Hypertensive with diarrhea and increased HR with abd pain. Worse after eating. PE (+) for abd tenderness, tearful. Referred to outpt GI. 11/12/09 Vaccination records received, same docs as prev. entry 10/19/09, no Lot number provided.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Aspiration, Atrial septal defect, Cerumen impaction, Echocardiogram abnormal, Feeding disorder
Clinical narrative: Information has been received from a physician via medical records concerning a 14 week old inpatient baby girl with anaemia of prematurity, chronic lung disease of prematurity, umbilical hernia, bronchopulmonary dysplasia and retinopathy of prematurity and a history of prematurity, very low birth weight baby, foetal distress, bradycardia, chorioamnionitis, respiration spontaneous decreased, hypotension, apnoea neonatal, metabolic acidosis, necrotizing enterocolitis, infant respiratory distress syndrome, pain, patent ductus arteriosus, renal insufficiency, respiratory failure, sepsis, cardiac operation, eye laser surgery and patent ductus arteriosus ligation (WAES # 0806USA01608) who on 21-DEC-2008 was vaccinated with PEDVAXHIB. Concomitant therapy included PEDIARIX and PREVNAR. On 13-JAN-2009 the baby was diagnosed with aspiration. It was reported that feedings were started on 05-NOV-2008 and were advanced as tolerated. The baby had difficulty transitioning to bottle feedings. The oral feeding readiness was evaluated. The examination was remarkable for oral motor dysfunction and clinical signs of aspiration. A feeding oximetry study (14-JAN-2009) confirmed aspiration. On 21-JAN-2009 the baby was diagnosed with intermittent systolic hypertension and atrial septal defect (ASD), secundum type. The baby developed intermittent episodes of systolic hypertension (systolic blood pressure (SBP) 90-100s). Diagnostic studies were completed. A renal ultrasound showed mild dilation of left renal pelvis without hydronephrosis and otherwise normal anatomy. An echocardiogram (21-JAN-2009) showed a moderate sized ASD secundum and borderline left ventricular hypertrophy. No intervention was required during this hospitalization. Recent systolic blood pressures were 60-80s. Blood pressure monitoring per primary care physician is recommended. On 24-JAN-2009 the baby was given the first dose of SYNAGIS for respiratory syncytial virus (RSV) prophylaxis. On 25-JAN-2009 the baby was discharged home. At the time of discharge, the baby's aspiration, feeding problems, intermittent systolic hypertension and atrial septal defect (ASD) persisted. On 26-JAN-2009 the baby was seen in the office for 2 month well child visit. All the exams presented well. The baby was assessed as premature infant. On 29-JAN-2009 the baby was seen in the office again. It was noted upon examination there was some drainage out of her right ear and the right ear was occluded with wax. The wax was removed. The baby's umbilical hernia was noted to be reducible. The baby was assessed as premature infant as unchanged. Atrial septal defect, secundum type was considered to be a congenital anomaly. Additional information is not expected. All available medical records will be provided upon request. The patient was treated at Health Center.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Left ventricular hypertrophy, Motor dysfunction, Otorrhoea, Oxygen saturation abnormal, Pyelocaliectasis
Clinical narrative: Information has been received from a physician via medical records concerning a 14 week old inpatient baby girl with anaemia of prematurity, chronic lung disease of prematurity, umbilical hernia, bronchopulmonary dysplasia and retinopathy of prematurity and a history of prematurity, very low birth weight baby, foetal distress, bradycardia, chorioamnionitis, respiration spontaneous decreased, hypotension, apnoea neonatal, metabolic acidosis, necrotizing enterocolitis, infant respiratory distress syndrome, pain, patent ductus arteriosus, renal insufficiency, respiratory failure, sepsis, cardiac operation, eye laser surgery and patent ductus arteriosus ligation (WAES # 0806USA01608) who on 21-DEC-2008 was vaccinated with PEDVAXHIB. Concomitant therapy included PEDIARIX and PREVNAR. On 13-JAN-2009 the baby was diagnosed with aspiration. It was reported that feedings were started on 05-NOV-2008 and were advanced as tolerated. The baby had difficulty transitioning to bottle feedings. The oral feeding readiness was evaluated. The examination was remarkable for oral motor dysfunction and clinical signs of aspiration. A feeding oximetry study (14-JAN-2009) confirmed aspiration. On 21-JAN-2009 the baby was diagnosed with intermittent systolic hypertension and atrial septal defect (ASD), secundum type. The baby developed intermittent episodes of systolic hypertension (systolic blood pressure (SBP) 90-100s). Diagnostic studies were completed. A renal ultrasound showed mild dilation of left renal pelvis without hydronephrosis and otherwise normal anatomy. An echocardiogram (21-JAN-2009) showed a moderate sized ASD secundum and borderline left ventricular hypertrophy. No intervention was required during this hospitalization. Recent systolic blood pressures were 60-80s. Blood pressure monitoring per primary care physician is recommended. On 24-JAN-2009 the baby was given the first dose of SYNAGIS for respiratory syncytial virus (RSV) prophylaxis. On 25-JAN-2009 the baby was discharged home. At the time of discharge, the baby's aspiration, feeding problems, intermittent systolic hypertension and atrial septal defect (ASD) persisted. On 26-JAN-2009 the baby was seen in the office for 2 month well child visit. All the exams presented well. The baby was assessed as premature infant. On 29-JAN-2009 the baby was seen in the office again. It was noted upon examination there was some drainage out of her right ear and the right ear was occluded with wax. The wax was removed. The baby's umbilical hernia was noted to be reducible. The baby was assessed as premature infant as unchanged. Atrial septal defect, secundum type was considered to be a congenital anomaly. Additional information is not expected. All available medical records will be provided upon request. The patient was treated at Health Center.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Systolic hypertension, Ultrasound kidney abnormal
Clinical narrative: Information has been received from a physician via medical records concerning a 14 week old inpatient baby girl with anaemia of prematurity, chronic lung disease of prematurity, umbilical hernia, bronchopulmonary dysplasia and retinopathy of prematurity and a history of prematurity, very low birth weight baby, foetal distress, bradycardia, chorioamnionitis, respiration spontaneous decreased, hypotension, apnoea neonatal, metabolic acidosis, necrotizing enterocolitis, infant respiratory distress syndrome, pain, patent ductus arteriosus, renal insufficiency, respiratory failure, sepsis, cardiac operation, eye laser surgery and patent ductus arteriosus ligation (WAES # 0806USA01608) who on 21-DEC-2008 was vaccinated with PEDVAXHIB. Concomitant therapy included PEDIARIX and PREVNAR. On 13-JAN-2009 the baby was diagnosed with aspiration. It was reported that feedings were started on 05-NOV-2008 and were advanced as tolerated. The baby had difficulty transitioning to bottle feedings. The oral feeding readiness was evaluated. The examination was remarkable for oral motor dysfunction and clinical signs of aspiration. A feeding oximetry study (14-JAN-2009) confirmed aspiration. On 21-JAN-2009 the baby was diagnosed with intermittent systolic hypertension and atrial septal defect (ASD), secundum type. The baby developed intermittent episodes of systolic hypertension (systolic blood pressure (SBP) 90-100s). Diagnostic studies were completed. A renal ultrasound showed mild dilation of left renal pelvis without hydronephrosis and otherwise normal anatomy. An echocardiogram (21-JAN-2009) showed a moderate sized ASD secundum and borderline left ventricular hypertrophy. No intervention was required during this hospitalization. Recent systolic blood pressures were 60-80s. Blood pressure monitoring per primary care physician is recommended. On 24-JAN-2009 the baby was given the first dose of SYNAGIS for respiratory syncytial virus (RSV) prophylaxis. On 25-JAN-2009 the baby was discharged home. At the time of discharge, the baby's aspiration, feeding problems, intermittent systolic hypertension and atrial septal defect (ASD) persisted. On 26-JAN-2009 the baby was seen in the office for 2 month well child visit. All the exams presented well. The baby was assessed as premature infant. On 29-JAN-2009 the baby was seen in the office again. It was noted upon examination there was some drainage out of her right ear and the right ear was occluded with wax. The wax was removed. The baby's umbilical hernia was noted to be reducible. The baby was assessed as premature infant as unchanged. Atrial septal defect, secundum type was considered to be a congenital anomaly. Additional information is not expected. All available medical records will be provided upon request. The patient was treated at Health Center.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Autism, Laboratory test abnormal
Clinical narrative: Information has been received from a consumer concerning her 36 month old son with no pertinent medical history reported and no known drug allergies who in March 2007, was vaccinated with a dose of PROQUAD (Merck) (dose, route and lot number not reported). There was no concomitant medication. "Five months after receiving the vaccine", in August 2007, the consumer reported her son became autistic. Lab tests performed included "general autism testing". At the time of reporting, the patient had not recovered from the event. The patient sought medical attention by contacting many physicians. Upon internal review, became autistic was considered to be an other important medical event. No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Acrochordon, Blister, Herpes zoster, Laboratory test, Pain
Clinical narrative: Information has been received from an approximately 73 years old female patient with unspecified medical history, who "about one or one and a half years ago" in 2008 was vaccinated with a dose of ZOSTAVAX (Merck). In June 2009 the patient developed an excruciating pain under both breast and extending into the arm pit. Three weeks after the pain began she developed blisters under both breasts that have resolved into "skin tabs". On an unknown date the patient was admitted to the hospital because of the pain that she was experiencing. The patient stated that she was hospitalized a second time due to a reaction to NEURONTIN that she was given for the pain. The patient mentioned that shingles went undiagnosed for a while and physicians believed that she may have had pleural effusions or "fluid in the lungs" but they could not find fluid. The patient mentioned that she was admitted to the hospital a third time since her physician wanted to get immediate diagnostic studies performed, results were not reported. The patient stated that now she is consulting a dermatologist and that has been taking VALTREX. At the time of reporting the patient had not recovered. No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pleural effusion
Clinical narrative: Information has been received from an approximately 73 years old female patient with unspecified medical history, who "about one or one and a half years ago" in 2008 was vaccinated with a dose of ZOSTAVAX (Merck). In June 2009 the patient developed an excruciating pain under both breast and extending into the arm pit. Three weeks after the pain began she developed blisters under both breasts that have resolved into "skin tabs". On an unknown date the patient was admitted to the hospital because of the pain that she was experiencing. The patient stated that she was hospitalized a second time due to a reaction to NEURONTIN that she was given for the pain. The patient mentioned that shingles went undiagnosed for a while and physicians believed that she may have had pleural effusions or "fluid in the lungs" but they could not find fluid. The patient mentioned that she was admitted to the hospital a third time since her physician wanted to get immediate diagnostic studies performed, results were not reported. The patient stated that now she is consulting a dermatologist and that has been taking VALTREX. At the time of reporting the patient had not recovered. No further information is available.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abasia, Biopsy skin abnormal, Pemphigoid, Rash generalised
Clinical narrative: Information has been received from a consumer concerning her 77 year old husband with neuromuscular disorder and no known drug allergies who in April 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (route and lot number not reported). About a month later, in approximately May 2009, he started to develop a rash on his elbow which then spread all over his body. The patient's wife reported that the patient saw his physician who sent him to a dermatologist who then sent him to have blood test and a biopsy and the patient was diagnosed with bullous pemphigoid. The consumer reported that the patient already had a neuromuscular disorder and was walking with a cane, then to a walker and after receiving ZOSTAVAX (Merck) he could not walk at all and was in a nursing home to do rehab, but because of the rash, the patient could not do the rehab. At the time of reporting, the patient had not recovered from the events. Upon internal review, he could not walk at all was considered to be disabling. No further information is available.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Lung infiltration, No reaction on previous exposure to drug, Wheezing
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of difficulty breathing in a 5-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On 28 July 2009 the subject received 2nd dose of HAVRIX at 0.5 ml (720 elisa units). At an unspecified time after vaccination with HAVRIX, the subject was taken to the emergency room due to wheezing and difficulty breathing. The reporting nurse indicated that a small infiltrate in the right lung was noted. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The child was not hospitalized. At the time of reporting the events were resolved. It was stated that the child had no reaction following the first injection with HAVRIX.
Sex: U
Vaccine: HEPA
Symptoms: Pneumonia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pneumonia in a child subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On an unspecified date the subject received a dose of HAVRIX. At an unspecified time after vaccination with HAVRIX, the subject was taken to the hospital where a diagnosis of pneumonia was reported. It was suggested that the child was admitted to the hospital. At the time of reporting the outcome of the event was not specified.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Anxiety, Aphasia, Arthralgia
Clinical narrative: Dizziness, chronic flu like symptoms, progressive fatigue, joint & muscle pain-severe pain throughout body- headaches & throbbing, brain fog, body throbbing. Disorientation, memory loss-unable to formulate words or think coherently, "brain fog"- heart palpitations, nausea, inability to perform job, insomnia-inability to function-many days would remain in bed, feeling like I had been hit or run over by a truck- constant feeling that I was going to cry & frequent weeping, social isolation, severe anxiety & depression.  8/27/09 PCP medical records received 8/7/03 to 10/03/05. Assessment: musculoskeletal pain. Patient presents with post traumatic stress, hypoglycemia, insomnia, menopause and diffuse musculoskeletal pain. Low energy, feels like crying. achy. Acupuncture treatment.  Melanoma dx'd on back - surgery.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Bedridden, Crying, Depression, Disorientation, Dizziness
Clinical narrative: Dizziness, chronic flu like symptoms, progressive fatigue, joint & muscle pain-severe pain throughout body- headaches & throbbing, brain fog, body throbbing. Disorientation, memory loss-unable to formulate words or think coherently, "brain fog"- heart palpitations, nausea, inability to perform job, insomnia-inability to function-many days would remain in bed, feeling like I had been hit or run over by a truck- constant feeling that I was going to cry & frequent weeping, social isolation, severe anxiety & depression.  8/27/09 PCP medical records received 8/7/03 to 10/03/05. Assessment: musculoskeletal pain. Patient presents with post traumatic stress, hypoglycemia, insomnia, menopause and diffuse musculoskeletal pain. Low energy, feels like crying. achy. Acupuncture treatment.  Melanoma dx'd on back - surgery.