chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: entire arm swelled that the shot was received in; I put cold compress on 10 minutes of every hour for the entire day after the shot; the 2nd day, I put cold compress in the morning, lunch, dinner and before bed.
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Crying, Diet refusal, Hypophagia, Irritability, Pyrexia
Clinical narrative: Within an hour of the shot (took place on Wed 7/22), very cranky.  For next 48 hrs would not sleep more than 40min- an hour at a time for naps, and was up frequently at night crying. Fever rose to 101 (and that is with Tylenol as a pre-emptive strike). Refused bottle for days - seemed like it was "painful" to drink it. Also refused solid food.  Rash all over body.  It is now Sat 7/25 and he still has the rash, was still up last night, still very fussy, but has finally finished a full bottle today.  Fever is also down.
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Rash generalised, Sleep disorder
Clinical narrative: Within an hour of the shot (took place on Wed 7/22), very cranky.  For next 48 hrs would not sleep more than 40min- an hour at a time for naps, and was up frequently at night crying. Fever rose to 101 (and that is with Tylenol as a pre-emptive strike). Refused bottle for days - seemed like it was "painful" to drink it. Also refused solid food.  Rash all over body.  It is now Sat 7/25 and he still has the rash, was still up last night, still very fussy, but has finally finished a full bottle today.  Fever is also down.
Age: 0.67
Sex: M
Vaccine: HEP
Symptoms: Feeding disorder of infancy or early childhood, Injection site mass, Injection site swelling, Insomnia, Irritability
Clinical narrative: Lump at injection site, lasted 4 wks(tiny nodule still present today), swelling at injection site, extremely cranky, unable to sleep, awoke many times during the night, unable to finish a bottle - seemed "painful" to drink.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Feeling hot, Induration, Pruritus
Clinical narrative: Erythema (14cm X 15cm), itchiness, tender, hot to touch, induration (6cm X 6cm), blistery beginning on 7/23/09. Treated with warm packs, Keflex, & benadryl PRN.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: Erythema (14cm X 15cm), itchiness, tender, hot to touch, induration (6cm X 6cm), blistery beginning on 7/23/09. Treated with warm packs, Keflex, & benadryl PRN.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Slight itching at injection site immedicately after administration, left upper outer arm.  Within a few hours the site was still itching, also slightly painful and redness noted approx. 3mm x 3mm. which felt warm to the touch,  About 24hrs later redness extended to approx 10mm x 10mm and was warm to the touch, left upper arm was slightly swollen with an area of approx. 4mm x 4mm of subcutaneous firmness. I treated with a cold pack to site with temporary relief of itching and pain.  I also felt as if I was getting a "cold."  I felt tired and my nose was runnning slightly.  I took 325mg of acetaminophen one time only.  Within 72 hours my symptoms were abating.  My generalized symtoms were gone, the redness was fading, the subcutaneous firmness was resolving, the pain was diminished and there was still slight itchiness at the injection site.  I continued to improve each day and the final symptom of itchiness resolved completely in 6 days.  All other symptoms had completely resolved within 4 to 5 days.  I did not seek medical advice since I had read that most of these side effects were not uncommon, but I would have contacted my physician if my symptoms had not begun to resolve within 72 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Slight itching at injection site immedicately after administration, left upper outer arm.  Within a few hours the site was still itching, also slightly painful and redness noted approx. 3mm x 3mm. which felt warm to the touch,  About 24hrs later redness extended to approx 10mm x 10mm and was warm to the touch, left upper arm was slightly swollen with an area of approx. 4mm x 4mm of subcutaneous firmness. I treated with a cold pack to site with temporary relief of itching and pain.  I also felt as if I was getting a "cold."  I felt tired and my nose was runnning slightly.  I took 325mg of acetaminophen one time only.  Within 72 hours my symptoms were abating.  My generalized symtoms were gone, the redness was fading, the subcutaneous firmness was resolving, the pain was diminished and there was still slight itchiness at the injection site.  I continued to improve each day and the final symptom of itchiness resolved completely in 6 days.  All other symptoms had completely resolved within 4 to 5 days.  I did not seek medical advice since I had read that most of these side effects were not uncommon, but I would have contacted my physician if my symptoms had not begun to resolve within 72 hours.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainting immediately after MENACTRA. This was the third vaccine given. Patient lied flat and recovered completely within 20 minutes.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia, Pain
Clinical narrative: Redness and itching at injection site at time of injection. Twenty four hours later all signs of redness & itching disappeared. Day 2 Redness and itching returned,also had muscle aches . Redness & swelling was the size of a half dollar. Patient advised to apply cold pack and use benadryl and Tylenol for aches and pains. Day 3 symptoms seem to be subsiding. The patient only used cold pack and did not take any oral medications.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Alpha 2 globulin increased, Asthenia, Blood test, Burning sensation
Clinical narrative: 6 months post shingles vaccine, I began to feel multiple pain issues - sharp pain at bottom of buttock/top of thigh, burning in both shins, tingling in one foot, pain in abdomen and genitals. Weakness lasted for 5 months. I have recovered from weakness but pain persists. Spine MRIs negative. Blood tests and lumbar puncture show acute inflamation.  Neurologist believes I had a viral infection in my spinal cord. Pain is being treated with lyrica.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF immunoglobulin increased, CSF protein increased, Genital pain, Immunoglobulins increased, Inflammation
Clinical narrative: 6 months post shingles vaccine, I began to feel multiple pain issues - sharp pain at bottom of buttock/top of thigh, burning in both shins, tingling in one foot, pain in abdomen and genitals. Weakness lasted for 5 months. I have recovered from weakness but pain persists. Spine MRIs negative. Blood tests and lumbar puncture show acute inflamation.  Neurologist believes I had a viral infection in my spinal cord. Pain is being treated with lyrica.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Lumbar puncture abnormal, Nuclear magnetic resonance imaging, Pain, Paraesthesia, Viral infection
Clinical narrative: 6 months post shingles vaccine, I began to feel multiple pain issues - sharp pain at bottom of buttock/top of thigh, burning in both shins, tingling in one foot, pain in abdomen and genitals. Weakness lasted for 5 months. I have recovered from weakness but pain persists. Spine MRIs negative. Blood tests and lumbar puncture show acute inflamation.  Neurologist believes I had a viral infection in my spinal cord. Pain is being treated with lyrica.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Basophil morphology abnormal, Biopsy bone marrow abnormal, Blood bilirubin normal, Blood electrolytes normal, Blood product transfusion
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. An 88 year old female with bronchiectasis, normal pressure hydrocephalus with VP shunt, diabetes mellitus, peripheral neuropathy, lumbar disc herniation, gastrooesophageal reflux disease (GERD), dementia and no known drug allergies who on 29-MAY-2007 was vaccinated with a first dose of ZOSTAVAX (Merck) (lot # 652947/1411F) subcutaneously (site not reported). Concomitant suspect therapy included nifedipine (dose, duration, and indication not reported). Other concomitant therapy included GLIPIZIDE XL, calcium carbonate, ALLEGRA, vitamins (unspecified), TYLENOL, guaifenesin, aspirin, vitamin E, LANTUS, COLACE, lisinopril (manufacturer unknown), ACTONEL, tolterodine, FLONASE, simethicone, magnesia [milk of], "Refresh eye drops" and metoprolol. On 14-SEP-2007 records were received and indicated new onset of thrombocytopenia purpura and petechiae, patient was admitted in the hospital on 12-JUN-2007. One week after received of ZOSTAVAX (Merck) on 06-JUN-2007 the patient developed purpuric lesions on oral mucosa and tongue. Few days later the patient developed diffuse petechial rash on upper and lower extremities and trunk. On unspecified date the patient received 5 doses of globulin, immune (IVIG). Assessment thrombocytopenia temporally associated to receipt ZOSTAVAX (Merck) and to nifedipine. Laboratory tests showed normal electrolytes and renal function, normal white blood cell count and hematocrit and hemoglobin, normal liver function test, normal total bilirubin, normal coags, platelets < 10,000 (410,000 baseline platelets) bone marrow smear: abnormal appearing basophils and leukocytes, tear drop cells, nucleated red cells, no schistocys, pau. The events were considered to be immediately life-threatening. 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. The original reporting source was not provided. The VAERS ID # is 285901. No further information is available. This report was filed with the FDA. The VAERS ID number is 285901.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Coagulation test normal, Haematocrit normal, Haemoglobin normal, Petechiae, Platelet count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 88 year old female with bronchiectasis, normal pressure hydrocephalus with VP shunt, diabetes mellitus, peripheral neuropathy, lumbar disc herniation, gastrooesophageal reflux disease (GERD), dementia and no known drug allergies who on 29-MAY-2007 was vaccinated with a first dose of ZOSTAVAX (Merck) (lot # 652947/1411F) subcutaneously (site not reported). Concomitant suspect therapy included nifedipine (dose, duration, and indication not reported). Other concomitant therapy included GLIPIZIDE XL, calcium carbonate, ALLEGRA, vitamins (unspecified), TYLENOL, guaifenesin, aspirin, vitamin E, LANTUS, COLACE, lisinopril (manufacturer unknown), ACTONEL, tolterodine, FLONASE, simethicone, magnesia [milk of], "Refresh eye drops" and metoprolol. On 14-SEP-2007 records were received and indicated new onset of thrombocytopenia purpura and petechiae, patient was admitted in the hospital on 12-JUN-2007. One week after received of ZOSTAVAX (Merck) on 06-JUN-2007 the patient developed purpuric lesions on oral mucosa and tongue. Few days later the patient developed diffuse petechial rash on upper and lower extremities and trunk. On unspecified date the patient received 5 doses of globulin, immune (IVIG). Assessment thrombocytopenia temporally associated to receipt ZOSTAVAX (Merck) and to nifedipine. Laboratory tests showed normal electrolytes and renal function, normal white blood cell count and hematocrit and hemoglobin, normal liver function test, normal total bilirubin, normal coags, platelets < 10,000 (410,000 baseline platelets) bone marrow smear: abnormal appearing basophils and leukocytes, tear drop cells, nucleated red cells, no schistocys, pau. The events were considered to be immediately life-threatening. 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. The original reporting source was not provided. The VAERS ID # is 285901. No further information is available. This report was filed with the FDA. The VAERS ID number is 285901.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Purpura, Rash, Thrombocytopenic purpura, White blood cell count normal, White blood cell disorder
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. An 88 year old female with bronchiectasis, normal pressure hydrocephalus with VP shunt, diabetes mellitus, peripheral neuropathy, lumbar disc herniation, gastrooesophageal reflux disease (GERD), dementia and no known drug allergies who on 29-MAY-2007 was vaccinated with a first dose of ZOSTAVAX (Merck) (lot # 652947/1411F) subcutaneously (site not reported). Concomitant suspect therapy included nifedipine (dose, duration, and indication not reported). Other concomitant therapy included GLIPIZIDE XL, calcium carbonate, ALLEGRA, vitamins (unspecified), TYLENOL, guaifenesin, aspirin, vitamin E, LANTUS, COLACE, lisinopril (manufacturer unknown), ACTONEL, tolterodine, FLONASE, simethicone, magnesia [milk of], "Refresh eye drops" and metoprolol. On 14-SEP-2007 records were received and indicated new onset of thrombocytopenia purpura and petechiae, patient was admitted in the hospital on 12-JUN-2007. One week after received of ZOSTAVAX (Merck) on 06-JUN-2007 the patient developed purpuric lesions on oral mucosa and tongue. Few days later the patient developed diffuse petechial rash on upper and lower extremities and trunk. On unspecified date the patient received 5 doses of globulin, immune (IVIG). Assessment thrombocytopenia temporally associated to receipt ZOSTAVAX (Merck) and to nifedipine. Laboratory tests showed normal electrolytes and renal function, normal white blood cell count and hematocrit and hemoglobin, normal liver function test, normal total bilirubin, normal coags, platelets < 10,000 (410,000 baseline platelets) bone marrow smear: abnormal appearing basophils and leukocytes, tear drop cells, nucleated red cells, no schistocys, pau. The events were considered to be immediately life-threatening. 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. The original reporting source was not provided. The VAERS ID # is 285901. No further information is available. This report was filed with the FDA. The VAERS ID number is 285901.
Age: 86.0
Sex: M
Vaccine: FLUX, PPV, VARZOS, FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Anorexia, Asthenia, Fatigue, Lethargy
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. It was reported that an 86 year old male with no pertinent medical history reported and no known drug allergies was vaccinated SC into the left arm with first dose of ZOSTAVAX (Merck) (lot number 663637/1705X) on 02-FEB-2009. Secondary suspect vaccination included first dose of PNEUMOVAX 23 (route: intramuscular, left arm, lot number 662020/0614X). Concomitant vaccination given on the same date included first dose of FLUARIX (route: intramuscular, left arm lot number AFLLA165AA). It was reported that the above mentioned patient died on 06-FEB-2009. The family called on 10-FEB-2009 to report the death. The patient died of a brain hemorrhage. On 13-MAR-2009, records were received for date of service from 06-FEB-2009: the patient presented with a two day history of lethargy. Upon arrival, the patient was oriented and then had an acute descompensation and was intubated. The patient had an Anterior Inferior Cerebellar Artery aneurysm rupture on 04-FEB-2009 or before. The family declined surgical or IR intervention. The patient experienced bradycardia. He did not response to voice or sternal rub. He had no cough or gag reflex. The patient was asystole. A CT scan performed on an unspecified date showed diffuse subarachnoid hemorrhage (SAH). It was reported that the patient recently moved to the country. On 24-MAR-2009, the discharge summary was received: the diagnosis was subarachnoid hemorrhage. Information received on 14-APR-2009 showed that the cause of death was subarachnoid hemorrhage. Aneurysm rupture. The listing indicated that one or more of the events resulted in death. No further information is available. This was originally reported by a consumer. The VAERS ID number is 339119. A standard lot check investigation was performed for lot numbers 663637/1705X and 662020/0614X. 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 lots met the requirements of the Center and were released.
Age: 86.0
Sex: M
Vaccine: FLUX, PPV, VARZOS, FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Cerebral haemorrhage, Death
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. It was reported that an 86 year old male with no pertinent medical history reported and no known drug allergies was vaccinated SC into the left arm with first dose of ZOSTAVAX (Merck) (lot number 663637/1705X) on 02-FEB-2009. Secondary suspect vaccination included first dose of PNEUMOVAX 23 (route: intramuscular, left arm, lot number 662020/0614X). Concomitant vaccination given on the same date included first dose of FLUARIX (route: intramuscular, left arm lot number AFLLA165AA). It was reported that the above mentioned patient died on 06-FEB-2009. The family called on 10-FEB-2009 to report the death. The patient died of a brain hemorrhage. On 13-MAR-2009, records were received for date of service from 06-FEB-2009: the patient presented with a two day history of lethargy. Upon arrival, the patient was oriented and then had an acute descompensation and was intubated. The patient had an Anterior Inferior Cerebellar Artery aneurysm rupture on 04-FEB-2009 or before. The family declined surgical or IR intervention. The patient experienced bradycardia. He did not response to voice or sternal rub. He had no cough or gag reflex. The patient was asystole. A CT scan performed on an unspecified date showed diffuse subarachnoid hemorrhage (SAH). It was reported that the patient recently moved to the country. On 24-MAR-2009, the discharge summary was received: the diagnosis was subarachnoid hemorrhage. Information received on 14-APR-2009 showed that the cause of death was subarachnoid hemorrhage. Aneurysm rupture. The listing indicated that one or more of the events resulted in death. No further information is available. This was originally reported by a consumer. The VAERS ID number is 339119. A standard lot check investigation was performed for lot numbers 663637/1705X and 662020/0614X. 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 lots met the requirements of the Center and were released.
Age: 86.0
Sex: M
Vaccine: FLUX, PPV, VARZOS, FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Acute respiratory failure, Aneurysm ruptured, Bradycardia, Cardiac arrest, Cerebral haemorrhage
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that an 86 year old male with no pertinent medical history reported and no known drug allergies was vaccinated SC into the left arm with first dose of ZOSTAVAX (Merck) (lot number 663637/1705X) on 02-FEB-2009. Secondary suspect vaccination included first dose of PNEUMOVAX 23 (route: intramuscular, left arm, lot number 662020/0614X). Concomitant vaccination given on the same date included first dose of FLUARIX (route: intramuscular, left arm lot number AFLLA165AA). It was reported that the above mentioned patient died on 06-FEB-2009. The family called on 10-FEB-2009 to report the death. The patient died of a brain hemorrhage. On 13-MAR-2009, records were received for date of service from 06-FEB-2009: the patient presented with a two day history of lethargy. Upon arrival, the patient was oriented and then had an acute descompensation and was intubated. The patient had an Anterior Inferior Cerebellar Artery aneurysm rupture on 04-FEB-2009 or before. The family declined surgical or IR intervention. The patient experienced bradycardia. He did not response to voice or sternal rub. He had no cough or gag reflex. The patient was asystole. A CT scan performed on an unspecified date showed diffuse subarachnoid hemorrhage (SAH). It was reported that the patient recently moved to the country. On 24-MAR-2009, the discharge summary was received: the diagnosis was subarachnoid hemorrhage. Information received on 14-APR-2009 showed that the cause of death was subarachnoid hemorrhage. Aneurysm rupture. The listing indicated that one or more of the events resulted in death. No further information is available. This was originally reported by a consumer. The VAERS ID number is 339119. A standard lot check investigation was performed for lot numbers 663637/1705X and 662020/0614X. 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 lots met the requirements of the Center and were released.
Age: 86.0
Sex: M
Vaccine: FLUX, PPV, VARZOS, FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Computerised tomogram abnormal, Death, Endotracheal intubation, Intracranial aneurysm, Lethargy
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. It was reported that an 86 year old male with no pertinent medical history reported and no known drug allergies was vaccinated SC into the left arm with first dose of ZOSTAVAX (Merck) (lot number 663637/1705X) on 02-FEB-2009. Secondary suspect vaccination included first dose of PNEUMOVAX 23 (route: intramuscular, left arm, lot number 662020/0614X). Concomitant vaccination given on the same date included first dose of FLUARIX (route: intramuscular, left arm lot number AFLLA165AA). It was reported that the above mentioned patient died on 06-FEB-2009. The family called on 10-FEB-2009 to report the death. The patient died of a brain hemorrhage. On 13-MAR-2009, records were received for date of service from 06-FEB-2009: the patient presented with a two day history of lethargy. Upon arrival, the patient was oriented and then had an acute descompensation and was intubated. The patient had an Anterior Inferior Cerebellar Artery aneurysm rupture on 04-FEB-2009 or before. The family declined surgical or IR intervention. The patient experienced bradycardia. He did not response to voice or sternal rub. He had no cough or gag reflex. The patient was asystole. A CT scan performed on an unspecified date showed diffuse subarachnoid hemorrhage (SAH). It was reported that the patient recently moved to the country. On 24-MAR-2009, the discharge summary was received: the diagnosis was subarachnoid hemorrhage. Information received on 14-APR-2009 showed that the cause of death was subarachnoid hemorrhage. Aneurysm rupture. The listing indicated that one or more of the events resulted in death. No further information is available. This was originally reported by a consumer. The VAERS ID number is 339119. A standard lot check investigation was performed for lot numbers 663637/1705X and 662020/0614X. 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 lots met the requirements of the Center and were released.
Age: 86.0
Sex: M
Vaccine: FLUX, PPV, VARZOS, FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Subarachnoid haemorrhage, Unresponsive to stimuli
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. It was reported that an 86 year old male with no pertinent medical history reported and no known drug allergies was vaccinated SC into the left arm with first dose of ZOSTAVAX (Merck) (lot number 663637/1705X) on 02-FEB-2009. Secondary suspect vaccination included first dose of PNEUMOVAX 23 (route: intramuscular, left arm, lot number 662020/0614X). Concomitant vaccination given on the same date included first dose of FLUARIX (route: intramuscular, left arm lot number AFLLA165AA). It was reported that the above mentioned patient died on 06-FEB-2009. The family called on 10-FEB-2009 to report the death. The patient died of a brain hemorrhage. On 13-MAR-2009, records were received for date of service from 06-FEB-2009: the patient presented with a two day history of lethargy. Upon arrival, the patient was oriented and then had an acute descompensation and was intubated. The patient had an Anterior Inferior Cerebellar Artery aneurysm rupture on 04-FEB-2009 or before. The family declined surgical or IR intervention. The patient experienced bradycardia. He did not response to voice or sternal rub. He had no cough or gag reflex. The patient was asystole. A CT scan performed on an unspecified date showed diffuse subarachnoid hemorrhage (SAH). It was reported that the patient recently moved to the country. On 24-MAR-2009, the discharge summary was received: the diagnosis was subarachnoid hemorrhage. Information received on 14-APR-2009 showed that the cause of death was subarachnoid hemorrhage. Aneurysm rupture. The listing indicated that one or more of the events resulted in death. No further information is available. This was originally reported by a consumer. The VAERS ID number is 339119. A standard lot check investigation was performed for lot numbers 663637/1705X and 662020/0614X. 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 lots met the requirements of the Center and were released.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Anorexia, Appetite disorder, Arthralgia, Basedow's disease, Chest pain
Clinical narrative: 7/23/09 Subject reports that one month after receiving his third dose of AVA he reportedly lost 25-30 pounds and passed out during physical training. He reportedly had hand tremors and tachycardia. he was seen by a physician. Tests were ordered including an EKG, Echocardiogram and blood tests. He was reportedly diagnosed with a MI and Graves' disease. Other symptoms include redness of the eyes, bulging eyes, double vision, joint swelling, joint pain, muscle swelling, muscle pain, walks with a cane due to unsteady gait, decreased memory, anxiety and elevated cholesterol. He reportedly has had eye surgery because the Graves' disease has affected his optic muscles and sinus surgery due to cysts identified by CT of his eyes. Subject states that his current health problems are related to his receiving the ANTHRAX vaccine in some way. He reports that he received multiple immunizations while in the military in the 1980's and did not have any problems. Subject states that he has been declared permanently disabled. He states that a VAERS report has been filed.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Dyspnoea, Fatigue, Headache, Insomnia, Myocardial infarction
Clinical narrative: 7/23/09 Subject reports that one month after receiving his third dose of AVA he reportedly lost 25-30 pounds and passed out during physical training. He reportedly had hand tremors and tachycardia. he was seen by a physician. Tests were ordered including an EKG, Echocardiogram and blood tests. He was reportedly diagnosed with a MI and Graves' disease. Other symptoms include redness of the eyes, bulging eyes, double vision, joint swelling, joint pain, muscle swelling, muscle pain, walks with a cane due to unsteady gait, decreased memory, anxiety and elevated cholesterol. He reportedly has had eye surgery because the Graves' disease has affected his optic muscles and sinus surgery due to cysts identified by CT of his eyes. Subject states that his current health problems are related to his receiving the ANTHRAX vaccine in some way. He reports that he received multiple immunizations while in the military in the 1980's and did not have any problems. Subject states that he has been declared permanently disabled. He states that a VAERS report has been filed.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Nausea, Palpitations, Pyrexia, Tremor, Vomiting
Clinical narrative: 7/23/09 Subject reports that one month after receiving his third dose of AVA he reportedly lost 25-30 pounds and passed out during physical training. He reportedly had hand tremors and tachycardia. he was seen by a physician. Tests were ordered including an EKG, Echocardiogram and blood tests. He was reportedly diagnosed with a MI and Graves' disease. Other symptoms include redness of the eyes, bulging eyes, double vision, joint swelling, joint pain, muscle swelling, muscle pain, walks with a cane due to unsteady gait, decreased memory, anxiety and elevated cholesterol. He reportedly has had eye surgery because the Graves' disease has affected his optic muscles and sinus surgery due to cysts identified by CT of his eyes. Subject states that his current health problems are related to his receiving the ANTHRAX vaccine in some way. He reports that he received multiple immunizations while in the military in the 1980's and did not have any problems. Subject states that he has been declared permanently disabled. He states that a VAERS report has been filed.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Weight decreased
Clinical narrative: 7/23/09 Subject reports that one month after receiving his third dose of AVA he reportedly lost 25-30 pounds and passed out during physical training. He reportedly had hand tremors and tachycardia. he was seen by a physician. Tests were ordered including an EKG, Echocardiogram and blood tests. He was reportedly diagnosed with a MI and Graves' disease. Other symptoms include redness of the eyes, bulging eyes, double vision, joint swelling, joint pain, muscle swelling, muscle pain, walks with a cane due to unsteady gait, decreased memory, anxiety and elevated cholesterol. He reportedly has had eye surgery because the Graves' disease has affected his optic muscles and sinus surgery due to cysts identified by CT of his eyes. Subject states that his current health problems are related to his receiving the ANTHRAX vaccine in some way. He reports that he received multiple immunizations while in the military in the 1980's and did not have any problems. Subject states that he has been declared permanently disabled. He states that a VAERS report has been filed.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Anxiety, Arthralgia, Basedow's disease, Blood cholesterol increased, Computerised tomogram abnormal
Clinical narrative: 7/23/09 Subject reports that one month after receiving his third dose of AVA he reportedly lost 25-30 pounds and passed out during physical training. He reportedly had hand tremors and tachycardia. he was seen by a physician. Tests were ordered including an EKG, Echocardiogram and blood tests. He was reportedly diagnosed with a MI and Graves' disease. Other symptoms include redness of the eyes, bulging eyes, double vision, joint swelling, joint pain, muscle swelling, muscle pain, walks with a cane due to unsteady gait, decreased memory, anxiety and elevated cholesterol. He reportedly has had eye surgery because the Graves' disease has affected his optic muscles and sinus surgery due to cysts identified by CT of his eyes. Subject states that his current health problems are related to his receiving the ANTHRAX vaccine in some way. He reports that he received multiple immunizations while in the military in the 1980's and did not have any problems. Subject states that he has been declared permanently disabled. He states that a VAERS report has been filed.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Diplopia, Echocardiogram abnormal, Electrocardiogram abnormal, Exophthalmos, Gait disturbance
Clinical narrative: 7/23/09 Subject reports that one month after receiving his third dose of AVA he reportedly lost 25-30 pounds and passed out during physical training. He reportedly had hand tremors and tachycardia. he was seen by a physician. Tests were ordered including an EKG, Echocardiogram and blood tests. He was reportedly diagnosed with a MI and Graves' disease. Other symptoms include redness of the eyes, bulging eyes, double vision, joint swelling, joint pain, muscle swelling, muscle pain, walks with a cane due to unsteady gait, decreased memory, anxiety and elevated cholesterol. He reportedly has had eye surgery because the Graves' disease has affected his optic muscles and sinus surgery due to cysts identified by CT of his eyes. Subject states that his current health problems are related to his receiving the ANTHRAX vaccine in some way. He reports that he received multiple immunizations while in the military in the 1980's and did not have any problems. Subject states that he has been declared permanently disabled. He states that a VAERS report has been filed.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Joint swelling, Loss of consciousness, Memory impairment, Muscle swelling, Myalgia
Clinical narrative: 7/23/09 Subject reports that one month after receiving his third dose of AVA he reportedly lost 25-30 pounds and passed out during physical training. He reportedly had hand tremors and tachycardia. he was seen by a physician. Tests were ordered including an EKG, Echocardiogram and blood tests. He was reportedly diagnosed with a MI and Graves' disease. Other symptoms include redness of the eyes, bulging eyes, double vision, joint swelling, joint pain, muscle swelling, muscle pain, walks with a cane due to unsteady gait, decreased memory, anxiety and elevated cholesterol. He reportedly has had eye surgery because the Graves' disease has affected his optic muscles and sinus surgery due to cysts identified by CT of his eyes. Subject states that his current health problems are related to his receiving the ANTHRAX vaccine in some way. He reports that he received multiple immunizations while in the military in the 1980's and did not have any problems. Subject states that he has been declared permanently disabled. He states that a VAERS report has been filed.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Myocardial infarction, Ocular hyperaemia, Sinus disorder, Surgery, Tachycardia
Clinical narrative: 7/23/09 Subject reports that one month after receiving his third dose of AVA he reportedly lost 25-30 pounds and passed out during physical training. He reportedly had hand tremors and tachycardia. he was seen by a physician. Tests were ordered including an EKG, Echocardiogram and blood tests. He was reportedly diagnosed with a MI and Graves' disease. Other symptoms include redness of the eyes, bulging eyes, double vision, joint swelling, joint pain, muscle swelling, muscle pain, walks with a cane due to unsteady gait, decreased memory, anxiety and elevated cholesterol. He reportedly has had eye surgery because the Graves' disease has affected his optic muscles and sinus surgery due to cysts identified by CT of his eyes. Subject states that his current health problems are related to his receiving the ANTHRAX vaccine in some way. He reports that he received multiple immunizations while in the military in the 1980's and did not have any problems. Subject states that he has been declared permanently disabled. He states that a VAERS report has been filed.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Thyroid function test abnormal, Tremor, Walking aid user, Weight decreased
Clinical narrative: 7/23/09 Subject reports that one month after receiving his third dose of AVA he reportedly lost 25-30 pounds and passed out during physical training. He reportedly had hand tremors and tachycardia. he was seen by a physician. Tests were ordered including an EKG, Echocardiogram and blood tests. He was reportedly diagnosed with a MI and Graves' disease. Other symptoms include redness of the eyes, bulging eyes, double vision, joint swelling, joint pain, muscle swelling, muscle pain, walks with a cane due to unsteady gait, decreased memory, anxiety and elevated cholesterol. He reportedly has had eye surgery because the Graves' disease has affected his optic muscles and sinus surgery due to cysts identified by CT of his eyes. Subject states that his current health problems are related to his receiving the ANTHRAX vaccine in some way. He reports that he received multiple immunizations while in the military in the 1980's and did not have any problems. Subject states that he has been declared permanently disabled. He states that a VAERS report has been filed.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5, RV5
Symptoms: Culture stool positive, Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 2 month old male infant who was vaccinated with a dose of ROTATEQ at 2 month of age. It was reported that the child developed severe diarrhea and dehydration shortly after receive the vaccine. Presence of rotavirus vaccine strain in stool samples was confirmed by sequencing of the VP6 and NSP4 genes (which showed that the virus in the stool was indeed vaccine). Infant also developed pneumonia and P. jiroveci was identified. Child was diagnosed with severe combined immunodeficiency (RAG1 mutation). Child underwent bone marrow transplant and continue to have chronic diarrhea. At 9 months of age, the stool samples were still positive for rotavirus (unclear whether the virus detected in the stool was confirmed to be vaccine virus or wild type virus) and chronic diarrhea continued. Additional information has been requested. 11/5/09 ICD9  279.2
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5, RV5
Symptoms: Blood test, Primary immunodeficiency syndrome
Clinical narrative: Information has been received from a physician concerning a 2 month old male infant who was vaccinated with a dose of ROTATEQ at 2 month of age. It was reported that the child developed severe diarrhea and dehydration shortly after receive the vaccine. Presence of rotavirus vaccine strain in stool samples was confirmed by sequencing of the VP6 and NSP4 genes (which showed that the virus in the stool was indeed vaccine). Infant also developed pneumonia and P. jiroveci was identified. Child was diagnosed with severe combined immunodeficiency (RAG1 mutation). Child underwent bone marrow transplant and continue to have chronic diarrhea. At 9 months of age, the stool samples were still positive for rotavirus (unclear whether the virus detected in the stool was confirmed to be vaccine virus or wild type virus) and chronic diarrhea continued. Additional information has been requested. 11/5/09 ICD9  279.2
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5, RV5
Symptoms: Bone marrow transplant, Combined immunodeficiency, Dehydration, Diarrhoea, Pneumocystis jiroveci infection
Clinical narrative: Information has been received from a physician concerning a 2 month old male infant who was vaccinated with a dose of ROTATEQ at 2 month of age. It was reported that the child developed severe diarrhea and dehydration shortly after receive the vaccine. Presence of rotavirus vaccine strain in stool samples was confirmed by sequencing of the VP6 and NSP4 genes (which showed that the virus in the stool was indeed vaccine). Infant also developed pneumonia and P. jiroveci was identified. Child was diagnosed with severe combined immunodeficiency (RAG1 mutation). Child underwent bone marrow transplant and continue to have chronic diarrhea. At 9 months of age, the stool samples were still positive for rotavirus (unclear whether the virus detected in the stool was confirmed to be vaccine virus or wild type virus) and chronic diarrhea continued. Additional information has been requested. 11/5/09 ICD9  279.2
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5, RV5
Symptoms: Rotavirus infection, Sputum culture positive, Stool analysis abnormal
Clinical narrative: Information has been received from a physician concerning a 2 month old male infant who was vaccinated with a dose of ROTATEQ at 2 month of age. It was reported that the child developed severe diarrhea and dehydration shortly after receive the vaccine. Presence of rotavirus vaccine strain in stool samples was confirmed by sequencing of the VP6 and NSP4 genes (which showed that the virus in the stool was indeed vaccine). Infant also developed pneumonia and P. jiroveci was identified. Child was diagnosed with severe combined immunodeficiency (RAG1 mutation). Child underwent bone marrow transplant and continue to have chronic diarrhea. At 9 months of age, the stool samples were still positive for rotavirus (unclear whether the virus detected in the stool was confirmed to be vaccine virus or wild type virus) and chronic diarrhea continued. Additional information has been requested. 11/5/09 ICD9  279.2
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Myelitis transverse
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with a "history of illicit drug use" who on 24-JUN-2009 was vaccinated IM with her third 0.5mL dose of GARDASIL. On 30-JUN-2009, the patient "went to the ER (hospital unspecified) with numbness and paralysis in her lower limbs" and was hospitalized. At the time of reporting the patient had not recovered from paralysis and numbness. It was noted that there were no adverse events with the first two doses. Additional information has been requested.   10/23/09 Hospital records received DOS 6/30/09. Diagnosis: tranverse myelitis, hypertension, anxiety, constipation, urinary retention. Patient presented with worsening neck pain and weakness below the waist. Numbness left side of neck, shoulder, arm. Babinski (+) No patellar reflex on right. Tremor in hands. Weakness, paresthesias, brisk tendon reflexes, clonus ankles, alterations in temperature and vibration sense. Neck stiffness.    10/21/09 Vaccine records received. No changes to VAERS
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diplegia, Hypoaesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with a "history of illicit drug use" who on 24-JUN-2009 was vaccinated IM with her third 0.5mL dose of GARDASIL. On 30-JUN-2009, the patient "went to the ER (hospital unspecified) with numbness and paralysis in her lower limbs" and was hospitalized. At the time of reporting the patient had not recovered from paralysis and numbness. It was noted that there were no adverse events with the first two doses. Additional information has been requested.   10/23/09 Hospital records received DOS 6/30/09. Diagnosis: tranverse myelitis, hypertension, anxiety, constipation, urinary retention. Patient presented with worsening neck pain and weakness below the waist. Numbness left side of neck, shoulder, arm. Babinski (+) No patellar reflex on right. Tremor in hands. Weakness, paresthesias, brisk tendon reflexes, clonus ankles, alterations in temperature and vibration sense. Neck stiffness.    10/21/09 Vaccine records received. No changes to VAERS
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Full blood count, Haematocrit decreased, Haemoglobin normal, Injection site pain, Metabolic function test
Clinical narrative: Initial report received on 15 July 2009 from a health care professional in the country. A copy of an online VAERS report was provided VAERS E-report number E-30400. A 42-year-old female patient, who has allergy to Penicillin and history of situational stress, and who was also experiencing a lot of stress from recent death of father, had received (at an annual exam) on 30 June 2009 at 15:00 pm a 0.5 mL intramuscular left deltoid injection of ADACEL (lot number C3158AA). The patient was taking concomitant medications of ATIVAN 0.5 mg (less than five tablets/month) and was using NUVARING. The patient called the reporter the evening of the vaccination around 17:00 pm, complaining of pain at the injection site. The patient used ice and took ibuprofen with some relief. The following day, the patient was examined by a physician and no redness or swelling was noted at the injection site, but the patient had some tenderness on moving the shoulder. Two days later, the patient went to the emergency room and was evaluated by a physician who consulted with an orthopedist on call. The patient received steroids (trade name and route not reported) and pain medications (trade name, route any type not reported). The physician's note stated "Lab Ok, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa synovial joint inflamed 2nd to high placement of DT." Diagnostic laboratory data from the emergency room visit was reported as CBC: 4,200, WBC (L), H/H 12.1/35.1, grans 45.6 (L), Monos 12.1 (H); and the CMP was unremarkable. Five days later, the patient reported she had been taking pain medications and using a sling which helped some, but it was hard for her to work. She was still having considerable pain but was better than before the emergency room visit. The patient reported she was to have an appointment with orthopedics on 13 July 2009; however the result of that visit was not reported. At the time of this report the patient had not recovered. The reporter for this case is the same as for case 2009-03133. Documents held by sender: None.