chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Feeling abnormal, Gastrointestinal disorder, Headache, Heart rate decreased, Hepatitis C positive
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 17 year old female who on 13-MAR-2007 was vaccinated with a third dose of GARDASIL intramuscularly into the left arm. After the first dose of GARDASIL (administered on 13-SEP-2006) the patient experienced dizziness, light-headed, nauseous, headache, leg cramps and shooting leg pain. After the second dose of GARDASIL (administered on 13-NOV-2006) the patient experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. After the third dose of GARDASIL the patient experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.) The patient was diagnosed with thrombocytopenia, pancytopenia, amenorrhea, hypothyroidism, anemia, low blood pressure, antoimmune disorder, partial organ failure, digestive disorder, Epstein Barre, orthopnoea, hormonal imbalance, urinary tract infection. The patient had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for her. Recently she has been referred to a clinic (Scheduled appointment for 30-Mar-2009). This was originally reported by a consumer. A standard lot check investigation was performed. All in-process quality checks for the lot number 0263U 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: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hormone level abnormal, Hypoaesthesia, Hypothermia, Hypothyroidism, Musculoskeletal stiffness
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 concerning a 17 year old female who on 13-MAR-2007 was vaccinated with a third dose of GARDASIL intramuscularly into the left arm. After the first dose of GARDASIL (administered on 13-SEP-2006) the patient experienced dizziness, light-headed, nauseous, headache, leg cramps and shooting leg pain. After the second dose of GARDASIL (administered on 13-NOV-2006) the patient experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. After the third dose of GARDASIL the patient experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.) The patient was diagnosed with thrombocytopenia, pancytopenia, amenorrhea, hypothyroidism, anemia, low blood pressure, antoimmune disorder, partial organ failure, digestive disorder, Epstein Barre, orthopnoea, hormonal imbalance, urinary tract infection. The patient had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for her. Recently she has been referred to a clinic (Scheduled appointment for 30-Mar-2009). This was originally reported by a consumer. A standard lot check investigation was performed. All in-process quality checks for the lot number 0263U 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: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nausea, Pain in extremity, Pancytopenia, Paraesthesia, Syncope
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 concerning a 17 year old female who on 13-MAR-2007 was vaccinated with a third dose of GARDASIL intramuscularly into the left arm. After the first dose of GARDASIL (administered on 13-SEP-2006) the patient experienced dizziness, light-headed, nauseous, headache, leg cramps and shooting leg pain. After the second dose of GARDASIL (administered on 13-NOV-2006) the patient experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. After the third dose of GARDASIL the patient experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.) The patient was diagnosed with thrombocytopenia, pancytopenia, amenorrhea, hypothyroidism, anemia, low blood pressure, antoimmune disorder, partial organ failure, digestive disorder, Epstein Barre, orthopnoea, hormonal imbalance, urinary tract infection. The patient had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for her. Recently she has been referred to a clinic (Scheduled appointment for 30-Mar-2009). This was originally reported by a consumer. A standard lot check investigation was performed. All in-process quality checks for the lot number 0263U 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: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Thrombocytopenia, Tinnitus
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 concerning a 17 year old female who on 13-MAR-2007 was vaccinated with a third dose of GARDASIL intramuscularly into the left arm. After the first dose of GARDASIL (administered on 13-SEP-2006) the patient experienced dizziness, light-headed, nauseous, headache, leg cramps and shooting leg pain. After the second dose of GARDASIL (administered on 13-NOV-2006) the patient experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. After the third dose of GARDASIL the patient experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.) The patient was diagnosed with thrombocytopenia, pancytopenia, amenorrhea, hypothyroidism, anemia, low blood pressure, antoimmune disorder, partial organ failure, digestive disorder, Epstein Barre, orthopnoea, hormonal imbalance, urinary tract infection. The patient had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for her. Recently she has been referred to a clinic (Scheduled appointment for 30-Mar-2009). This was originally reported by a consumer. A standard lot check investigation was performed. All in-process quality checks for the lot number 0263U 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: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Blood pressure increased, Chest pain, Condition aggravated, Dyspnoea
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old female with hypertension and penicillin allergy who on 24-MAR-2009 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot #663175/1553X). Concomitant therapy included TOPROL XL tablets. On 24-MAR-2009 the patient developed swelling to her face and eyes, shortness of breath, chest pain, elevated blood pressure and atrial fibrillation after receiving ZOSTAVAX (Oka/Merck). The patient was transferred to an emergency room and admitted to a hospital. She was discharged on 28-MAR-2009. At time of reporting, the patient was recovering. Follow up information was received from the registered nurse who reported the patient was admitted to the hospital on 24-MAR-2009 and discharged on 28-MAR-2009. The patient recovered and was placed on COUMADIN for atrial fibrillation. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Swelling face
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old female with hypertension and penicillin allergy who on 24-MAR-2009 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot #663175/1553X). Concomitant therapy included TOPROL XL tablets. On 24-MAR-2009 the patient developed swelling to her face and eyes, shortness of breath, chest pain, elevated blood pressure and atrial fibrillation after receiving ZOSTAVAX (Oka/Merck). The patient was transferred to an emergency room and admitted to a hospital. She was discharged on 28-MAR-2009. At time of reporting, the patient was recovering. Follow up information was received from the registered nurse who reported the patient was admitted to the hospital on 24-MAR-2009 and discharged on 28-MAR-2009. The patient recovered and was placed on COUMADIN for atrial fibrillation. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Blood pressure increased, Chest pain, Dyspnoea, Eye swelling
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old female with hypertension and penicillin allergy who on 24-MAR-2009 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot #663175/1553X). Concomitant therapy included TOPROL XL tablets. On 24-MAR-2009 the patient developed swelling to her face and eyes, shortness of breath, chest pain, elevated blood pressure and atrial fibrillation after receiving ZOSTAVAX (Oka/Merck). The patient was transferred to an emergency room and admitted to a hospital. She was discharged on 28-MAR-2009. At time of reporting, the patient was recovering. Follow up information was received from the registered nurse who reported the patient was admitted to the hospital on 24-MAR-2009 and discharged on 28-MAR-2009. The patient recovered and was placed on COUMADIN for atrial fibrillation. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old female with hypertension and penicillin allergy who on 24-MAR-2009 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot #663175/1553X). Concomitant therapy included TOPROL XL tablets. On 24-MAR-2009 the patient developed swelling to her face and eyes, shortness of breath, chest pain, elevated blood pressure and atrial fibrillation after receiving ZOSTAVAX (Oka/Merck). The patient was transferred to an emergency room and admitted to a hospital. She was discharged on 28-MAR-2009. At time of reporting, the patient was recovering. Follow up information was received from the registered nurse who reported the patient was admitted to the hospital on 24-MAR-2009 and discharged on 28-MAR-2009. The patient recovered and was placed on COUMADIN for atrial fibrillation. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Dysphonia, Local swelling, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a Registered Nurse concerning a 39 year old male patient with low rubeola titer in September 2006 who on 24-FEB-2009 was vaccinated with a first dose of MMR II (Lot # not reported). On 24-MAR-2009 he received second dose of MMR II (Lot # not reported). After first dose of vaccine the patient developed neck swelling and his face seem fuller, but he did not reported it to the healthcare provider. On 31-MAR-2009 after second dose of vaccine the patient experienced neck swelling that was affecting his speech. He was seen in the emergency room and was diagnosed with an allergic reaction and was given prednisone dose pack. At the time of the report on 02-APR-2009 the patient had not recovered. Registered nurse considered bilateral neck swelling was affecting his speech, face seem fuller and allergic reaction to be other important medical events. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Speech disorder
Clinical narrative: Information has been received from a Registered Nurse concerning a 39 year old male patient with low rubeola titer in September 2006 who on 24-FEB-2009 was vaccinated with a first dose of MMR II (Lot # not reported). On 24-MAR-2009 he received second dose of MMR II (Lot # not reported). After first dose of vaccine the patient developed neck swelling and his face seem fuller, but he did not reported it to the healthcare provider. On 31-MAR-2009 after second dose of vaccine the patient experienced neck swelling that was affecting his speech. He was seen in the emergency room and was diagnosed with an allergic reaction and was given prednisone dose pack. At the time of the report on 02-APR-2009 the patient had not recovered. Registered nurse considered bilateral neck swelling was affecting his speech, face seem fuller and allergic reaction to be other important medical events. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Haematology test abnormal, Hypersensitivity, Local swelling, Measles antibody, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a Registered Nurse concerning a 39 year old male patient with low rubeola titer in September 2006 who on 24-FEB-2009 was vaccinated with a first dose of MMR II (Lot # not reported). On 24-MAR-2009 he received second dose of MMR II (Lot # not reported). After first dose of vaccine the patient developed neck swelling and his face seem fuller, but he did not reported it to the healthcare provider. On 31-MAR-2009 after second dose of vaccine the patient experienced neck swelling that was affecting his speech. He was seen in the emergency room and was diagnosed with an allergic reaction and was given prednisone dose pack. At the time of the report on 02-APR-2009 the patient had not recovered. Registered nurse considered bilateral neck swelling was affecting his speech, face seem fuller and allergic reaction to be other important medical events. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Speech disorder, Swelling face
Clinical narrative: Information has been received from a Registered Nurse concerning a 39 year old male patient with low rubeola titer in September 2006 who on 24-FEB-2009 was vaccinated with a first dose of MMR II (Lot # not reported). On 24-MAR-2009 he received second dose of MMR II (Lot # not reported). After first dose of vaccine the patient developed neck swelling and his face seem fuller, but he did not reported it to the healthcare provider. On 31-MAR-2009 after second dose of vaccine the patient experienced neck swelling that was affecting his speech. He was seen in the emergency room and was diagnosed with an allergic reaction and was given prednisone dose pack. At the time of the report on 02-APR-2009 the patient had not recovered. Registered nurse considered bilateral neck swelling was affecting his speech, face seem fuller and allergic reaction to be other important medical events. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a physician concerning an 11 year old patient who was vaccinated with GARDASIL (lot number, route and site not reported). Subsequently the patient died. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Epiglottitis, Haemophilus infection
Clinical narrative: Information has been received from a physician concerning an approximately 30 months old female who received 3 doses of PEDVAXHIB (lot# not reported). In May 2008, the patient experienced "H Flu Type B epiglottitis" which was infection of epiglottis and was hospitalized (unspecified number of days in the hospital). Subsequently, the patient recovered from H Flu Type B epiglottitis. The reporter considered H Flu Type B epiglottitis to be immediately life-threatening. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Incorrect route of drug administration
Clinical narrative: Information has been received from a Doctor of pharmacy concerning a 79 year old male inpatient for decompensate diabetes with hypertension, diabetes and hypercholesterolaemia and no drug reactions or allergies who on 02-APR-2009 was vaccinated inadvertently with PNEUMOVAX (lot # not reported). 0.5ml, intravenously. Concomitant therapy included insulin, lisinopril, NORVASC, GLUCOPHAGE, GLUCOTROL and simvastatin. On 02-APR-2009 the patient experienced abdominal pain, which prolonged hospitalization. At the time of the report on 02-APR-2009 the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for VARIVAX vaccine (MERCK), a Pregnancy Registry product concerning a 17 year old pregnant female with no medical history or allergies (The pregnancy test was performed on unspecified date, last menstrual period: 14-FEB-2009 and estimated delivery date: 21-NOV-2009) who on 04-MAR-2009 was vaccinated with VARIVAX (MERCK) (previous dose administered on 14-APR-1999). There was no concomitant therapy. The patient sought unspecified medical attention. No adverse effect was reported. Follow up information was received from another registered nurse. It was reported the patient was vaccinated with VARIVAX (MERCK) (lot # 662010/1741X). The patient's last menstrual period was 13-FEB-2009 (previously reported as 14-FEB-2009), so the estimated delivery date was changed to 20-NOV-2009. Follow up information was received from a nurse via phone call. It was reported that she received call from the patient's foster parents, and that they informed her that the patient had had a miscarriage. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a registered pharmacist concerning a now 66 year old female who in approximately 2003 "about 4 to 6 years ago", was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). The patient informed the pharmacist that she developed GUILLAIN-BARRE syndrome after getting the flu shot "about 4 to 6 years ago". The patient's doctor told her that she could not get more flu shots. On an unspecified date, the patient recovered from GUILLAIN-BARRE syndrome. The patient consulted with the pharmacist and sought unspecified medical attention. Upon internal review, GUILLAIN-BARRE syndrome was considered to be other important medical event. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Breast cancer, Chemotherapy, Computerised tomogram, Pain, Radiotherapy
Clinical narrative: When the rib cracked went to doctor. She prescribed pain pills, week later it went popped again. Years went by without problems, breast cancer showed up 2007. Went for chemo-radiation treatment. The rib acted up and has ever since.  4/29/09 Received PCP medical records of 9/2003-3/2009. FINAL DX: Type II DM; HTN; hyperlipidemia; hypothyroidism; right breast ductal carcinoma in situ stage 1; arthropathy Records reveal patient stated in 9/07 breast cancer was very small, surgically removed & no chemo or rad tx needed then started chemo 10/07.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Rib fracture
Clinical narrative: When the rib cracked went to doctor. She prescribed pain pills, week later it went popped again. Years went by without problems, breast cancer showed up 2007. Went for chemo-radiation treatment. The rib acted up and has ever since.  4/29/09 Received PCP medical records of 9/2003-3/2009. FINAL DX: Type II DM; HTN; hyperlipidemia; hypothyroidism; right breast ductal carcinoma in situ stage 1; arthropathy Records reveal patient stated in 9/07 breast cancer was very small, surgically removed & no chemo or rad tx needed then started chemo 10/07.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cyanosis, Electrocardiogram normal, Fatigue, Lethargy, Loss of consciousness
Clinical narrative: Patient is a 16-year-old female who presents today with mother. The patient states she was with her mom earlier getting her prom dress fitted when she blacked out. Her mom states her face when pale and her lips turned blue in color. The patient was out for about 2 minutes. She did not fall to the floor, because her mom was able to hold her up. The patient did stated that she had her knees locked while she was standing. She did say everything went black. When she woke up she did remember where she was at. She was very tired upon waking up and is still very lethargic. She did receive a GARDASIL shot in her right shoulder yesterday and meningitis shot in her left shoulder yesterday. Patient did have a similar episode back in November, the day after her first GARDASIL shot was given. The patient denies any vision changes, headache, nausea, chest pain, shortness of breath, bladder or bowel changes. She states she is still very tired and her legs feel very heavy.  4/10/09 ER record received for DOS 3/13-14/2009 with D/C DX:  Syncopal event 2' to Gardasil. Depression. Pt presented after episode where pt had episode of pallor then LOC with lip cyanosis.  Similar event after receiving 1st Gardasil vax. PE (+) for pallor and leg heaviness with difficulty lifting legs. Admitted for observation. D/C'd in am after ambulating.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pallor, Sensation of heaviness, Similar reaction on previous exposure to drug
Clinical narrative: Patient is a 16-year-old female who presents today with mother. The patient states she was with her mom earlier getting her prom dress fitted when she blacked out. Her mom states her face when pale and her lips turned blue in color. The patient was out for about 2 minutes. She did not fall to the floor, because her mom was able to hold her up. The patient did stated that she had her knees locked while she was standing. She did say everything went black. When she woke up she did remember where she was at. She was very tired upon waking up and is still very lethargic. She did receive a GARDASIL shot in her right shoulder yesterday and meningitis shot in her left shoulder yesterday. Patient did have a similar episode back in November, the day after her first GARDASIL shot was given. The patient denies any vision changes, headache, nausea, chest pain, shortness of breath, bladder or bowel changes. She states she is still very tired and her legs feel very heavy.  4/10/09 ER record received for DOS 3/13-14/2009 with D/C DX:  Syncopal event 2' to Gardasil. Depression. Pt presented after episode where pt had episode of pallor then LOC with lip cyanosis.  Similar event after receiving 1st Gardasil vax. PE (+) for pallor and leg heaviness with difficulty lifting legs. Admitted for observation. D/C'd in am after ambulating.
Age: 27.0
Sex: F
Vaccine: HEPA, MNQ, YF
Symptoms: Diarrhoea, Disorientation, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Received vaccines on 3-16-09.  The evening of vaccine she got a fever + slept poorly.  In the morning after the vaccine was disoriented + needed help watching her child due to "spacey" feeling.  "I couldn't feel the ground I was walking on".  Even her legs felt weak and spacey.  She pinched herself to make sure she had feeling.  Feeling was diminished but present.  Pt also had diarrhea.  Spacey feeling lasted 3 days- Fever lasted 4 days.  Today (11 days later) she feels weak, slightly dizzy + fatigued, but getting better able to eat + drink today with difficulty.
Age: 27.0
Sex: F
Vaccine: HEPA, MNQ, YF
Symptoms: Insomnia, Muscular weakness, Pyrexia, Sensory loss
Clinical narrative: Received vaccines on 3-16-09.  The evening of vaccine she got a fever + slept poorly.  In the morning after the vaccine was disoriented + needed help watching her child due to "spacey" feeling.  "I couldn't feel the ground I was walking on".  Even her legs felt weak and spacey.  She pinched herself to make sure she had feeling.  Feeling was diminished but present.  Pt also had diarrhea.  Spacey feeling lasted 3 days- Fever lasted 4 days.  Today (11 days later) she feels weak, slightly dizzy + fatigued, but getting better able to eat + drink today with difficulty.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Induration, Injection site erythema, Injection site swelling, Injection site vesicles, Tenderness
Clinical narrative: Right thigh swollen, red with blisters. Looks like a 2nd degree burn. Almost entire thigh swollen. Very tender to touch. Swollen area very hard. Received a MMR shot in this thigh.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: 24 hours dizziness, vomiting low grade fever resolved spontaneously.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Bacterial DNA test, Bronchial obstruction, Computerised tomogram, Cough, Dyspnoea
Clinical narrative: Developed bilateral pulmonary embolisms and moderate to severe right ventrical heart dysfunction. Misdiagnosed originally as "walking pneumonia", and blood being coughed up as bronchial inflammation from bad cough. Began having trouble breathing about one week after GARDASIL injection.  4/17/09 Received hospital medical records of 2/26-3/1/2009. FINAL DX: bilateral pulmonary emboli; SOB Records reveal patient experienced worsening dyspnea & chest pain x 2 days.  Fatigue had increased since 11/08 & around 12/25 began to have bouts of coughing which had continued & now w/dyspnea & hemoptysis.  Seen by PCP multiple times & had been on several courses of antibiotics for pneumonia.  Had developed dull pain in both LEs & chest pressure when lying down.  Now difficult to walk even across a room.  Seen at outlying ER, tx w/anticoagulant & transferred to higher level of care for heme admit when CT scan revealed bilateral PE.  Cardio consult done.  Hypercoaguability w/u done.  OCPs d/c.  D/C to home on continued anticoagulant therapy, heme/coag clinic & referred to pulm HTN clinic on d/c.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Factor V Leiden mutation, Heart valve incompetence, Pulmonary embolism, Right ventricular dysfunction, X-ray
Clinical narrative: Developed bilateral pulmonary embolisms and moderate to severe right ventrical heart dysfunction. Misdiagnosed originally as "walking pneumonia", and blood being coughed up as bronchial inflammation from bad cough. Began having trouble breathing about one week after GARDASIL injection.  4/17/09 Received hospital medical records of 2/26-3/1/2009. FINAL DX: bilateral pulmonary emboli; SOB Records reveal patient experienced worsening dyspnea & chest pain x 2 days.  Fatigue had increased since 11/08 & around 12/25 began to have bouts of coughing which had continued & now w/dyspnea & hemoptysis.  Seen by PCP multiple times & had been on several courses of antibiotics for pneumonia.  Had developed dull pain in both LEs & chest pressure when lying down.  Now difficult to walk even across a room.  Seen at outlying ER, tx w/anticoagulant & transferred to higher level of care for heme admit when CT scan revealed bilateral PE.  Cardio consult done.  Hypercoaguability w/u done.  OCPs d/c.  D/C to home on continued anticoagulant therapy, heme/coag clinic & referred to pulm HTN clinic on d/c.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Chest pain, Cough, Factor V Leiden mutation, Pain in extremity, Pulmonary embolism
Clinical narrative: Developed bilateral pulmonary embolisms and moderate to severe right ventrical heart dysfunction. Misdiagnosed originally as "walking pneumonia", and blood being coughed up as bronchial inflammation from bad cough. Began having trouble breathing about one week after GARDASIL injection.  4/17/09 Received hospital medical records of 2/26-3/1/2009. FINAL DX: bilateral pulmonary emboli; SOB Records reveal patient experienced worsening dyspnea & chest pain x 2 days.  Fatigue had increased since 11/08 & around 12/25 began to have bouts of coughing which had continued & now w/dyspnea & hemoptysis.  Seen by PCP multiple times & had been on several courses of antibiotics for pneumonia.  Had developed dull pain in both LEs & chest pressure when lying down.  Now difficult to walk even across a room.  Seen at outlying ER, tx w/anticoagulant & transferred to higher level of care for heme admit when CT scan revealed bilateral PE.  Cardio consult done.  Hypercoaguability w/u done.  OCPs d/c.  D/C to home on continued anticoagulant therapy, heme/coag clinic & referred to pulm HTN clinic on d/c.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Factor V Leiden mutation, Haematocrit, Unevaluable event
Clinical narrative: Developed bilateral pulmonary embolisms and moderate to severe right ventrical heart dysfunction. Misdiagnosed originally as "walking pneumonia", and blood being coughed up as bronchial inflammation from bad cough. Began having trouble breathing about one week after GARDASIL injection.  4/17/09 Received hospital medical records of 2/26-3/1/2009. FINAL DX: bilateral pulmonary emboli; SOB Records reveal patient experienced worsening dyspnea & chest pain x 2 days.  Fatigue had increased since 11/08 & around 12/25 began to have bouts of coughing which had continued & now w/dyspnea & hemoptysis.  Seen by PCP multiple times & had been on several courses of antibiotics for pneumonia.  Had developed dull pain in both LEs & chest pressure when lying down.  Now difficult to walk even across a room.  Seen at outlying ER, tx w/anticoagulant & transferred to higher level of care for heme admit when CT scan revealed bilateral PE.  Cardio consult done.  Hypercoaguability w/u done.  OCPs d/c.  D/C to home on continued anticoagulant therapy, heme/coag clinic & referred to pulm HTN clinic on d/c.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Erythema, Headache, Oedema peripheral, Pain in extremity
Clinical narrative: Redness, pain and swelling in arm. Headache and temperature 100.2 degrees 24 hours after vaccine. 5 cm swelling and erythema.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood test normal, Computerised tomogram normal, Ultrasound Doppler normal
Clinical narrative: During the course on the vaccines, patient has developed debilitating abdominal pain.  4/15/09 MR received 5/5/08 to 4/13/09. 15 yr WCC 6/13/08 with normal exam.  Recent US (+) for splenomegaly. HPV#1 given. HPV and MCV4 given 8/18/08. Retuned 9/2/08 with c/o ST, chest congestion. DX: LOM, pharyngitis, pneumonia. Returned 9/8/08 with fatigue, nausea and dry heaves. Wheezing on PE. DX:  wheezing.  improved with nebs.  Returned 9/11/08 with stomach and back pain near rib cage. ? gas/constipation.  Returned 10/7/08 with cold sx, chest pain/heaviness and hard to breath.  DX:  URI. Returned 11/19/08 with ST, neck swelling and fatigue. DX:  Pharyngitis/Fatigue. ? Reactivated Mono. 11/21/08 LOM, Pharyngitis. Returned 12/10/08 with c/o stomach and back pain x 1 month.  sharp pains near kidneys. PE (+) for abd tenderness. DX:  Abd pain.  Referred to GI.  Seen 12/24/08. PE WNL.  Impression: Chronic Abd Pain.  Sent for tests. Back to PCP 1/29/09 with UTI. Returned 2/23/09 with c/o lower abd pain, severe x 4 days.  Low grade temp. Pt reports missing a lot of school.  Some constipation. Return to GI 2/25/09. PE (+) for tenderness to palpation of RLQ. DX: Recurrent abd pain. By 4/4/09 pt homebound.  Continued sx.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Full blood count, Insomnia, Pyrexia, Tremor
Clinical narrative: Fever 103 at 10:45 am 3/26/09, shaking. Poor sleep night of 3/25/09.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Urticaria, Wheezing
Clinical narrative: 410PM LPE complete immunization given (DTAP IPV MMR Varicella) 415P child started cough. 4:20pm wheeze A-P lungs. Benadryl 12.5mg / 5ml Sig 15 ml given. 4:25pm epinephrine 1:1000 0.3ml given SQ (wt 62 pounds). 911 called - Ambulance transported to ER @ 5:00 pm at time of transport lungs CTA. Hives R arm to wrist.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Local reaction
Clinical narrative: Local reaction lasting 4 days.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Erythema, Haematocrit decreased, Haemoglobin normal, Pain
Clinical narrative: Pt received PREVNAR vaccine @ thigh on 4/12/09 at 1021 AM.  Awoke from nap approx 3PM & cried as if in pain.  Mom noticed R leg (thigh->toes) very red.  Rx with TYLENOL + cool compress & redness disappeared but pt developed spots on lower leg and fever.  Pt noticed to have petechine on shin at 4:30. CBC done No treatment needed.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Petechiae, Platelet count normal, Pyrexia, White blood cell count increased
Clinical narrative: Pt received PREVNAR vaccine @ thigh on 4/12/09 at 1021 AM.  Awoke from nap approx 3PM & cried as if in pain.  Mom noticed R leg (thigh->toes) very red.  Rx with TYLENOL + cool compress & redness disappeared but pt developed spots on lower leg and fever.  Pt noticed to have petechine on shin at 4:30. CBC done No treatment needed.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Positive redness and swelling of left upper thigh, plus erythema approximately 12cm.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Pruritus, Rash
Clinical narrative: Patient received the Zoster vaccine at the clinic 2/5/09. At his f/u visit 3/3/09 he reported he'd developed a shingles rash approx 10 days after the vaccine. An exam noted a rash on the tight mid-back and on anterior right chest approximately the T3 dermatome - consistent with a shingles rash. Patient reported mild pain (pins and needles type) and itching.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection, Rash
Clinical narrative: I had an injection of ZOSTAVAX on 03/25/2009 about six days later developed red spots on my right leg on the inside between ankle and knee.  The spots numbered about twenty.  These spots did have small pockets of infection.  I went back to my medical doctor on 04/07/2009 and he confirmed that I possibly had a minor case of shingles.  These blotches did not itch or hurt.  I never had shingles in the past.
Age: 1.06
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Pt. developed rash after vaccines were given.  I'm sure of due to Varivax n MMR.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Fatigue, Oxygen supplementation, Pallor
Clinical narrative: Patient came to pick up a sticker and she looked pale, lips were white. She said she was tired and laid down on the floor. I picked up patient and carried her to an exam room and got doctor from a room. Dr. came into the room told me to get oxygen and started to exam patient. Also, said to call her EMS. Oxygen was administered to the patient. Doctor splash water on patient face. We got the Admon bag and doctor used this on patient. Doctor checked patients heart and listened. EMS arrived and doctor informed EMS. patient was alert and stable, oxygen level was between 98 - 100 and heart rate 70 without oxygen. Patient was given orange juice twice while being observed before going home with grandma/guardian. Grandma and doctor discussed no taking patient to the hospital since patient was doing better. Grandma is a RN and said she would keep an eye on her.
Age: 1.7
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Rash, Scab
Clinical narrative: Rash, several scattered vesicles.  Some already crusting over.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Cough, Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Urticaria broke out on left thigh as soon as the MMR was pushed. Patient was given BENADRYL 12/5mg and thigh was observed for 15 minutes. They seemed to improve. Baby had some dry cough (which she never had before), but lung examination was normal.
Age: 40.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site erythema, Myalgia
Clinical narrative: Large are of redness to the right deltoid, muscle aches in right arm patient unable to lift arm above his right shoulder. Patient states " I just do not feel right". Patient seen by family physician and was given ATARAX and SEPTRA (PC) on 6 APR 2009. Still being treated. Patient received waiver not to receive any future anthrax vaccinations.
Age: 28.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: Patient called 4/9/09 AM to notify us approximately two hrs after vacc. She felt "weak and with headache"; this morning after 15 min run she c/o sweats, chills, weakness and nausea. Patient referred to PMD if sx persist. Vacc given 4/8/09 PM.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Facial palsy, Physical examination abnormal
Clinical narrative: VARICELLA vaccine (along with TDAP & HEP A, and MENATRA) given 3/31/09 (1388 IM VERIVAX lot) onset (acute) Bell Palsy VII on 4/4/09.
Age: 31.0
Sex: M
Vaccine: HEPAB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Gave pediatric/adolescent dose of Hepatitis A instead of adult dose. Dr notified at 16:04, 3/31/09.
Age: 15.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was inadvertently given DTap instead of Tdap. Patient contacted today and has had no adverse events.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: L arm swelling - Pt reported fever to 101 x 2 days after 2 days on 4/3/09 redness- swelling inner L arm 5"X3" - No fever - Tx BENADRYL and KEFLEX.
Age: 51.0
Sex: U
Vaccine: ANTH, HEP, HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever.
Age: 64.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus
Age: 1.3
Sex: F
Vaccine: HIBV
Symptoms: Blood culture negative, Blood glucose increased, CSF culture negative, CSF lymphocyte count normal, CSF neutrophil count increased
Clinical narrative: 16 month old female presents with fever starting 4 days after vaccination.  Patient continued to fever for 6 days with 102-104.7t with no other symptoms, later developed lethargy and stiff neck and back.  Full septic work up was done including blood, urine and CSF.  CSF was positive for meningitis and she was placed on IV Ceftriaxone while the cultures were pending.  During inpatient stay she remained afebrile and tolerated good PO.  She was discharged afebrile after her blood and CSF cultures were negative for 48 hours.  5/4/09 Received hospital medical records of 3/16-3/18/2009. FINAL DX: no d/c summary available.  Admitted w/probable viral meningitis; left otitis media. Records reveal patient experienced fever x 4 days, decreased appetite,  Exam WNL in ER x 2 & d/c to home w/dx viral syndrome.   Had persistent fever, sleepiness, decreased activity.  Seen by PCP who sent to another ER where dx w/viral syndrome & d/c to home.  Symptoms persisted & admitted.  LP done.  Tx w/steroids, antibiotics & antivirals.  ID consult done.
Age: 1.3
Sex: F
Vaccine: HIBV
Symptoms: CSF protein normal, CSF white blood cell count increased, Glucose urine absent, Herpes simplex serology negative, Lethargy
Clinical narrative: 16 month old female presents with fever starting 4 days after vaccination.  Patient continued to fever for 6 days with 102-104.7t with no other symptoms, later developed lethargy and stiff neck and back.  Full septic work up was done including blood, urine and CSF.  CSF was positive for meningitis and she was placed on IV Ceftriaxone while the cultures were pending.  During inpatient stay she remained afebrile and tolerated good PO.  She was discharged afebrile after her blood and CSF cultures were negative for 48 hours.  5/4/09 Received hospital medical records of 3/16-3/18/2009. FINAL DX: no d/c summary available.  Admitted w/probable viral meningitis; left otitis media. Records reveal patient experienced fever x 4 days, decreased appetite,  Exam WNL in ER x 2 & d/c to home w/dx viral syndrome.   Had persistent fever, sleepiness, decreased activity.  Seen by PCP who sent to another ER where dx w/viral syndrome & d/c to home.  Symptoms persisted & admitted.  LP done.  Tx w/steroids, antibiotics & antivirals.  ID consult done.
Age: 1.3
Sex: F
Vaccine: HIBV
Symptoms: Lymphocyte count normal, Meningitis aseptic, Musculoskeletal stiffness, Protein urine absent, Pyrexia
Clinical narrative: 16 month old female presents with fever starting 4 days after vaccination.  Patient continued to fever for 6 days with 102-104.7t with no other symptoms, later developed lethargy and stiff neck and back.  Full septic work up was done including blood, urine and CSF.  CSF was positive for meningitis and she was placed on IV Ceftriaxone while the cultures were pending.  During inpatient stay she remained afebrile and tolerated good PO.  She was discharged afebrile after her blood and CSF cultures were negative for 48 hours.  5/4/09 Received hospital medical records of 3/16-3/18/2009. FINAL DX: no d/c summary available.  Admitted w/probable viral meningitis; left otitis media. Records reveal patient experienced fever x 4 days, decreased appetite,  Exam WNL in ER x 2 & d/c to home w/dx viral syndrome.   Had persistent fever, sleepiness, decreased activity.  Seen by PCP who sent to another ER where dx w/viral syndrome & d/c to home.  Symptoms persisted & admitted.  LP done.  Tx w/steroids, antibiotics & antivirals.  ID consult done.
Age: 1.3
Sex: F
Vaccine: HIBV
Symptoms: Red blood cells CSF positive, Urine analysis normal, White blood cell count normal
Clinical narrative: 16 month old female presents with fever starting 4 days after vaccination.  Patient continued to fever for 6 days with 102-104.7t with no other symptoms, later developed lethargy and stiff neck and back.  Full septic work up was done including blood, urine and CSF.  CSF was positive for meningitis and she was placed on IV Ceftriaxone while the cultures were pending.  During inpatient stay she remained afebrile and tolerated good PO.  She was discharged afebrile after her blood and CSF cultures were negative for 48 hours.  5/4/09 Received hospital medical records of 3/16-3/18/2009. FINAL DX: no d/c summary available.  Admitted w/probable viral meningitis; left otitis media. Records reveal patient experienced fever x 4 days, decreased appetite,  Exam WNL in ER x 2 & d/c to home w/dx viral syndrome.   Had persistent fever, sleepiness, decreased activity.  Seen by PCP who sent to another ER where dx w/viral syndrome & d/c to home.  Symptoms persisted & admitted.  LP done.  Tx w/steroids, antibiotics & antivirals.  ID consult done.
Age: 40.0
Sex: U
Vaccine: HEPAB
Symptoms: Eye swelling, Rash, Skin irritation, Urticaria
Clinical narrative: Pt called the dept and left message. Pt was contacted at 2:15pm of 04/07/2009, stated"03/26/2009 got injection in clinic, started to act out on Friday morning, forehead bumps and hives-like, itchy and irritationg with eyes swelling,later that day, spreaded out the whole face, but forehead mostly affected. Took Benadryl 25mg Q4 hr that day, eased off itch, bumps still there. Benadryl cream applied, soothing some. It took the whole week to get out of that. The following Friday, almost totally recovered. Now, no signs or symtoms, I am fine."
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient immunized with Varivax vaccine on 3/4/09.  Over the next 48 hours, she developed redness and warmth at injection site, and surrounding area measuring 13cm.x14cm. Referred to Occ. Med. MD.  Diagnosis- Cellulitis secondary to recent vaccination.  Treated with Keflex 500 mg. TID, with reassessment in 72 hours.  Pt. fully recovered.
Age: 76.0
Sex: U
Vaccine: PPV
Symptoms: Death
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD died on 1/30/09. Vaccination took place 4/17/2008. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.  3/14/2009 SAE received from reporter. Pt experienced L sided pain and increasing SOB on 1/22/09 x 2 days.  Presented to ER where dx with L Pneumothorax and Pneumonia. Unresponsive to tx.  Pt died 1/30/09.
Age: 43.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Silver dollar sized redness and warm to touch at administration site.
Age: 44.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Allergy to vaccine, Blood pressure increased, Burning sensation, Dizziness, Dyspnoea
Clinical narrative: Reports felt "woozy,dizzy" when got home. approx 1 1/2 hr later had some difficulty breathing along with burning sensation of face and eyes. did not call or seek care at that time. Went to school health nusre where she works next am:continued with above symptoms, along whith heart racing and rising BP; EMT called went to ER
Age: 44.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Eye irritation, Palpitations
Clinical narrative: Reports felt "woozy,dizzy" when got home. approx 1 1/2 hr later had some difficulty breathing along with burning sensation of face and eyes. did not call or seek care at that time. Went to school health nusre where she works next am:continued with above symptoms, along whith heart racing and rising BP; EMT called went to ER
Age: 1.18
Sex: F
Vaccine: MMR
Symptoms: Autopsy, Cough, Death, Heart rate increased, Pharyngitis
Clinical narrative: developed fever and rash approx. 10 to 12 days after mmr was giver on Jan. 1, 1998, after rash was gone they developed cough around Feb 11, 1998. Mother took patient to doctor on Feb 16. Dx w/ pharyngitis and told increase heart rate due to infection. Sent home w/ antibiotic. On Feb 17, patient vomiting, mother called doctor, MD orderde suppository over phone. Mother tried suppository for vomiting, did not work. Patient appeared to be getting worse. By 3:00 am Feb 18 mother took patient to ER. Patient died by 4:ooam. Autopsy ordered.  4/17/09 Autopsy report states COD as acute viral myocarditis & manner of death as natural.  Report also states patient had been seen by PCP for cold symptoms on 2/16/1998, dx w/pharyngitis & tx w/antibiotics.  Later that day, began vomiting, called clinic & tx w/suppositories. Coughing & vomiting continued & developed fever on 2/18.  Presented to ER on 2/18/98 w/very labored respirations & fever.  Shortly after arrival, went into cardiopulmonary arrest, resuscitation unsuccessful.