chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 02-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Rash diphenhydramine 25 mg QID
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 02-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Chest discomfort, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 17 year old male patient. Concurrent conditions, medical history and allergies were not reported. On 08-MAY-2015, the patient was vaccinated with the third dose of GARDASIL, intramuscular injection, (strength, dose, frequency, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The same date, the patient experienced loss of consciousness described as passed out, was non-responsive and experienced "tightening in the chest". The patient sought medical attention in the office, no treatment was given for the adverse event and it was unspecified if lab diagnostics studies were performed. The outcome of loss of consciousness, unresponsive to stimuli and chest discomfort was reported as recovered/resolved on an unspecified date in May 2015. The relatedness between loss of consciousness, unresponsive to stimuli and chest discomfort and therapy with GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Influenza like illness, Pyrexia
Clinical narrative: Fever, flu like symptoms, little blisters. Acyclovir 800mg.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from health profesional refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 06-MAY-2015, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K006137, expiration date: 29-APR-2015, 0.5 ml, subcutaneous. No concomitant therapies were reported. The reporter stated that the patient was vaccinated when urine pregnancy test was negative. On 14-MAY-2015, the patient performd two in-home pregnancy tests that were positive (exposure during pregnancy). The last menstrual period and estimated delivery date were not known. The pregnancy outcome was pending at the time of this report. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 12 year old male patient. Concurrent conditions, medical history and allergies were not provided. On 08-MAY-2015, the patient was vaccinated with the second dose of GARDASIL, intramuscular injection, (strength, dose, frequency, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The same date, the patient experienced loss of consciousness described as passed out. The patient sought medical attention in the office, no treatment was given for the adverse event and it was unspecified if lab diagnostics studies were performed. The outcome of loss of consciousness was reported as recovered/resolved on an unspecified date in May 2015. The relatedness between loss of consciousness and therapy with GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse (L.V.N.) referring to a patient of unknown age and unknown gender. History medication and drug allergies were not reported. On 15-MAY-2015 the patient was vaccinated with a dose of incorrect stored RECOMBIVAX HB (dose, strength and route were not reported) (lot# K017721, expire date 27-AUG-2016). Concomitant drug was not reported. At the time of reporting, no adverse effects were reported and it was unspecified if the patient sought any medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age and gender. On 01-JUN-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # K003596) (dose and route not reported) that had expired on 12-MAR-2015. No adverse effects were reported. Additional information is not expected as there is no consent to contact the physician.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Headache, myalgia and redness, swelling, tenderness at injection site. Ibuprofen bid mg , BAG to affected area PRN.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Blister, Rash, Rash erythematous, Scab
Clinical narrative: Calls with complaint of a red slightly raised rash on his back and legs. This rash started after he had the shingles shot a month ago. The rash on his legs has formed small blister like areas, then scabs that are now falling off. They are not painful or itchy. he has not run a fever.
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Flushing
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of felt faint in a adult female patient who received ENGERIX B adult. On an unknown date, the patient experienced ENGERIX B adult at an unknown dose. On an unknown date, less than a day after receiving ENGERIX B adult, the patient experienced felt faint and flushing. On an unknown date, the outcome of the felt faint and flushing were recovered/resolved. Additional information: The patient became flushed and felt faint after she got the injection. Vital signs were 'normal'. Symptoms resolved. No other details available at time of this report.
Age: 0.4
Sex: U
Vaccine: RV5, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 5 month old patient. On 08-APR-2015, the patient was inadvertently vaccinated with oral, ROTATEQ. On an unknown date, approximately in 2015, the patient experienced unspecified adverse event. The outcome of adverse event was unknown. Relatedness between the event and vaccination with Oral, ROTATEQ was not reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5, RV5
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 5 month old patient. On 08-APR-2015, the patient was inadvertently vaccinated with oral, ROTATEQ. On an unknown date, approximately in 2015, the patient experienced unspecified adverse event. The outcome of adverse event was unknown. Relatedness between the event and vaccination with Oral, ROTATEQ was not reported. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Skin discolouration, Unresponsive to stimuli
Clinical narrative: 9-week-old infant male received 2-month-old vaccines prior to discharge from hospital on 22 APR 2015. Approximately, 12 hours post-vaccination receipt, patient returned to the Emergency Room unresponsive, pulseless and apneic. Symptoms started 30 min prior to arrival. In ER, immediately started chest compressions and provided epinephrine via intraosseous access at 21:49. Intubated at 21:53. Pulse returned, confirmed cardiac activity on bedside US at 22:05. Blood sugar read as "low", provided D10. Also provided multiple fluid boluses for hypotension. CXR negative for infiltrate, pneumothorax, hemothorax or large effusions. CBC remarkable for anemia, thrombocytopenia and leukocytosis. ABG remarkable for metabolic acidosis. Transferred patient to Medical Center on 23 Apr 2015: After transfer to Medical Center, pt had 3 episodes of cardiac arrest; was resuscitated, however very unstable. Friday, 15 MAY - Patient expired.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Anaemia, Apnoea neonatal, Blood gases abnormal, Blood glucose decreased, Cardiac arrest
Clinical narrative: 9-week-old infant male received 2-month-old vaccines prior to discharge from hospital on 22 APR 2015. Approximately, 12 hours post-vaccination receipt, patient returned to the Emergency Room unresponsive, pulseless and apneic. Symptoms started 30 min prior to arrival. In ER, immediately started chest compressions and provided epinephrine via intraosseous access at 21:49. Intubated at 21:53. Pulse returned, confirmed cardiac activity on bedside US at 22:05. Blood sugar read as "low", provided D10. Also provided multiple fluid boluses for hypotension. CXR negative for infiltrate, pneumothorax, hemothorax or large effusions. CBC remarkable for anemia, thrombocytopenia and leukocytosis. ABG remarkable for metabolic acidosis. Transferred patient to Medical Center on 23 Apr 2015: After transfer to Medical Center, pt had 3 episodes of cardiac arrest; was resuscitated, however very unstable. Friday, 15 MAY - Patient expired.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Chest X-ray normal, Culture, Death, Echocardiogram normal, Endotracheal intubation
Clinical narrative: 9-week-old infant male received 2-month-old vaccines prior to discharge from hospital on 22 APR 2015. Approximately, 12 hours post-vaccination receipt, patient returned to the Emergency Room unresponsive, pulseless and apneic. Symptoms started 30 min prior to arrival. In ER, immediately started chest compressions and provided epinephrine via intraosseous access at 21:49. Intubated at 21:53. Pulse returned, confirmed cardiac activity on bedside US at 22:05. Blood sugar read as "low", provided D10. Also provided multiple fluid boluses for hypotension. CXR negative for infiltrate, pneumothorax, hemothorax or large effusions. CBC remarkable for anemia, thrombocytopenia and leukocytosis. ABG remarkable for metabolic acidosis. Transferred patient to Medical Center on 23 Apr 2015: After transfer to Medical Center, pt had 3 episodes of cardiac arrest; was resuscitated, however very unstable. Friday, 15 MAY - Patient expired.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Full blood count abnormal, Haemoglobin decreased, Hypotension, Laboratory test, Leukocytosis
Clinical narrative: 9-week-old infant male received 2-month-old vaccines prior to discharge from hospital on 22 APR 2015. Approximately, 12 hours post-vaccination receipt, patient returned to the Emergency Room unresponsive, pulseless and apneic. Symptoms started 30 min prior to arrival. In ER, immediately started chest compressions and provided epinephrine via intraosseous access at 21:49. Intubated at 21:53. Pulse returned, confirmed cardiac activity on bedside US at 22:05. Blood sugar read as "low", provided D10. Also provided multiple fluid boluses for hypotension. CXR negative for infiltrate, pneumothorax, hemothorax or large effusions. CBC remarkable for anemia, thrombocytopenia and leukocytosis. ABG remarkable for metabolic acidosis. Transferred patient to Medical Center on 23 Apr 2015: After transfer to Medical Center, pt had 3 episodes of cardiac arrest; was resuscitated, however very unstable. Friday, 15 MAY - Patient expired.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Metabolic acidosis, Pulse absent, Resuscitation, Thrombocytopenia, Unresponsive to stimuli
Clinical narrative: 9-week-old infant male received 2-month-old vaccines prior to discharge from hospital on 22 APR 2015. Approximately, 12 hours post-vaccination receipt, patient returned to the Emergency Room unresponsive, pulseless and apneic. Symptoms started 30 min prior to arrival. In ER, immediately started chest compressions and provided epinephrine via intraosseous access at 21:49. Intubated at 21:53. Pulse returned, confirmed cardiac activity on bedside US at 22:05. Blood sugar read as "low", provided D10. Also provided multiple fluid boluses for hypotension. CXR negative for infiltrate, pneumothorax, hemothorax or large effusions. CBC remarkable for anemia, thrombocytopenia and leukocytosis. ABG remarkable for metabolic acidosis. Transferred patient to Medical Center on 23 Apr 2015: After transfer to Medical Center, pt had 3 episodes of cardiac arrest; was resuscitated, however very unstable. Friday, 15 MAY - Patient expired.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: ADAMTS13 activity decreased, Abdominal pain, Blood creatinine normal, Blood fibrinogen increased, Blood lactate dehydrogenase increased
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 40 year old female who had a medical history of hypertension, hyperlipidaemia and type 2 diabetes. Concomitant medications included simvastatin, metformin, lisinopril/hydrochlorothiazide, lansoprazole and metoprolol. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) at a local pharmacy. Immediately, the patient developed a cough and flu-like symptoms for one week. During the second week, she began experiencing fatigue, headaches, dizziness, abdominal pain, confusion, dark urine which rendered her unable to complete her tasks at work. Two weeks after vaccination, she admitted to an outside facility with diarrhoea and severe light-headedness. Her vitals on admission were within normal limits with an unremarkable physical exam. Her labs were significant for a platelet count of 10,000, LDH (lactate dehydrogenase) of 800, fibrinogen of 419, and schistocytes on peripheral smear. ADAMTS13 level was <3%. Other work-up including the direct Coombs test, HIV and hepatitis panel were negative. Her presentation was felt to be consistent with TTP (Thrombotic Thrombocytopenic Purpura) though she had normal creatinine. She underwent four rounds of plasmapheresis but continued to have recurrent thrombocytopenia. During her fourth treatment, she had an anaphylactic reaction. She was started on high dose prednisone and was able to tolerate two additional rounds of plasmapheresis with good response. At the time of discharge, her platelet count was above 200 and her symptoms had resolved. The patient was diagnosed with acute TTP caused by autoantibody-mediated ADAMTS-13 deficiency. The patient responded to plasmapheresis and corticosteroids, the known treatments for acquired TTP, and her platelet count recovered. Outcome was not reported. Reporter comments: The reporter stated that after extensive work-up, the development of the patient's TTP was attributed to the influenza vaccine. Vaccines have been associated with autoimmune events in rare instances. In this particular patient, the reporters believed that the patient acquired TTP since the vaccine produced anti-ADAMTS IgG inhibitor.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chromaturia, Confusional state, Coombs test negative, Cough, Diarrhoea
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 40 year old female who had a medical history of hypertension, hyperlipidaemia and type 2 diabetes. Concomitant medications included simvastatin, metformin, lisinopril/hydrochlorothiazide, lansoprazole and metoprolol. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) at a local pharmacy. Immediately, the patient developed a cough and flu-like symptoms for one week. During the second week, she began experiencing fatigue, headaches, dizziness, abdominal pain, confusion, dark urine which rendered her unable to complete her tasks at work. Two weeks after vaccination, she admitted to an outside facility with diarrhoea and severe light-headedness. Her vitals on admission were within normal limits with an unremarkable physical exam. Her labs were significant for a platelet count of 10,000, LDH (lactate dehydrogenase) of 800, fibrinogen of 419, and schistocytes on peripheral smear. ADAMTS13 level was <3%. Other work-up including the direct Coombs test, HIV and hepatitis panel were negative. Her presentation was felt to be consistent with TTP (Thrombotic Thrombocytopenic Purpura) though she had normal creatinine. She underwent four rounds of plasmapheresis but continued to have recurrent thrombocytopenia. During her fourth treatment, she had an anaphylactic reaction. She was started on high dose prednisone and was able to tolerate two additional rounds of plasmapheresis with good response. At the time of discharge, her platelet count was above 200 and her symptoms had resolved. The patient was diagnosed with acute TTP caused by autoantibody-mediated ADAMTS-13 deficiency. The patient responded to plasmapheresis and corticosteroids, the known treatments for acquired TTP, and her platelet count recovered. Outcome was not reported. Reporter comments: The reporter stated that after extensive work-up, the development of the patient's TTP was attributed to the influenza vaccine. Vaccines have been associated with autoimmune events in rare instances. In this particular patient, the reporters believed that the patient acquired TTP since the vaccine produced anti-ADAMTS IgG inhibitor.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Dyspnoea, Fatigue, HIV test negative, Headache
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 40 year old female who had a medical history of hypertension, hyperlipidaemia and type 2 diabetes. Concomitant medications included simvastatin, metformin, lisinopril/hydrochlorothiazide, lansoprazole and metoprolol. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) at a local pharmacy. Immediately, the patient developed a cough and flu-like symptoms for one week. During the second week, she began experiencing fatigue, headaches, dizziness, abdominal pain, confusion, dark urine which rendered her unable to complete her tasks at work. Two weeks after vaccination, she admitted to an outside facility with diarrhoea and severe light-headedness. Her vitals on admission were within normal limits with an unremarkable physical exam. Her labs were significant for a platelet count of 10,000, LDH (lactate dehydrogenase) of 800, fibrinogen of 419, and schistocytes on peripheral smear. ADAMTS13 level was <3%. Other work-up including the direct Coombs test, HIV and hepatitis panel were negative. Her presentation was felt to be consistent with TTP (Thrombotic Thrombocytopenic Purpura) though she had normal creatinine. She underwent four rounds of plasmapheresis but continued to have recurrent thrombocytopenia. During her fourth treatment, she had an anaphylactic reaction. She was started on high dose prednisone and was able to tolerate two additional rounds of plasmapheresis with good response. At the time of discharge, her platelet count was above 200 and her symptoms had resolved. The patient was diagnosed with acute TTP caused by autoantibody-mediated ADAMTS-13 deficiency. The patient responded to plasmapheresis and corticosteroids, the known treatments for acquired TTP, and her platelet count recovered. Outcome was not reported. Reporter comments: The reporter stated that after extensive work-up, the development of the patient's TTP was attributed to the influenza vaccine. Vaccines have been associated with autoimmune events in rare instances. In this particular patient, the reporters believed that the patient acquired TTP since the vaccine produced anti-ADAMTS IgG inhibitor.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Impaired work ability, Increased tendency to bruise, Influenza like illness, Liver function test normal, Plasmapheresis
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 40 year old female who had a medical history of hypertension, hyperlipidaemia and type 2 diabetes. Concomitant medications included simvastatin, metformin, lisinopril/hydrochlorothiazide, lansoprazole and metoprolol. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) at a local pharmacy. Immediately, the patient developed a cough and flu-like symptoms for one week. During the second week, she began experiencing fatigue, headaches, dizziness, abdominal pain, confusion, dark urine which rendered her unable to complete her tasks at work. Two weeks after vaccination, she admitted to an outside facility with diarrhoea and severe light-headedness. Her vitals on admission were within normal limits with an unremarkable physical exam. Her labs were significant for a platelet count of 10,000, LDH (lactate dehydrogenase) of 800, fibrinogen of 419, and schistocytes on peripheral smear. ADAMTS13 level was <3%. Other work-up including the direct Coombs test, HIV and hepatitis panel were negative. Her presentation was felt to be consistent with TTP (Thrombotic Thrombocytopenic Purpura) though she had normal creatinine. She underwent four rounds of plasmapheresis but continued to have recurrent thrombocytopenia. During her fourth treatment, she had an anaphylactic reaction. She was started on high dose prednisone and was able to tolerate two additional rounds of plasmapheresis with good response. At the time of discharge, her platelet count was above 200 and her symptoms had resolved. The patient was diagnosed with acute TTP caused by autoantibody-mediated ADAMTS-13 deficiency. The patient responded to plasmapheresis and corticosteroids, the known treatments for acquired TTP, and her platelet count recovered. Outcome was not reported. Reporter comments: The reporter stated that after extensive work-up, the development of the patient's TTP was attributed to the influenza vaccine. Vaccines have been associated with autoimmune events in rare instances. In this particular patient, the reporters believed that the patient acquired TTP since the vaccine produced anti-ADAMTS IgG inhibitor.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Platelet count decreased, Red blood cell schistocytes present, Thrombotic thrombocytopenic purpura
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 40 year old female who had a medical history of hypertension, hyperlipidaemia and type 2 diabetes. Concomitant medications included simvastatin, metformin, lisinopril/hydrochlorothiazide, lansoprazole and metoprolol. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) at a local pharmacy. Immediately, the patient developed a cough and flu-like symptoms for one week. During the second week, she began experiencing fatigue, headaches, dizziness, abdominal pain, confusion, dark urine which rendered her unable to complete her tasks at work. Two weeks after vaccination, she admitted to an outside facility with diarrhoea and severe light-headedness. Her vitals on admission were within normal limits with an unremarkable physical exam. Her labs were significant for a platelet count of 10,000, LDH (lactate dehydrogenase) of 800, fibrinogen of 419, and schistocytes on peripheral smear. ADAMTS13 level was <3%. Other work-up including the direct Coombs test, HIV and hepatitis panel were negative. Her presentation was felt to be consistent with TTP (Thrombotic Thrombocytopenic Purpura) though she had normal creatinine. She underwent four rounds of plasmapheresis but continued to have recurrent thrombocytopenia. During her fourth treatment, she had an anaphylactic reaction. She was started on high dose prednisone and was able to tolerate two additional rounds of plasmapheresis with good response. At the time of discharge, her platelet count was above 200 and her symptoms had resolved. The patient was diagnosed with acute TTP caused by autoantibody-mediated ADAMTS-13 deficiency. The patient responded to plasmapheresis and corticosteroids, the known treatments for acquired TTP, and her platelet count recovered. Outcome was not reported. Reporter comments: The reporter stated that after extensive work-up, the development of the patient's TTP was attributed to the influenza vaccine. Vaccines have been associated with autoimmune events in rare instances. In this particular patient, the reporters believed that the patient acquired TTP since the vaccine produced anti-ADAMTS IgG inhibitor.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: ADAMTS13 activity decreased, Abdominal pain, Anaphylactic reaction, Blood creatinine normal, Blood fibrinogen increased
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 40 year old female who had a medical history of hypertension, hyperlipidaemia and type 2 diabetes. Concomitant medications included simvastatin, metformin, lisinopril/hydrochlorothiazide, lansoprazole and metoprolol. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) at a local pharmacy. Immediately, the patient developed a cough and flu-like symptoms for one week. During the second week, she began experiencing fatigue, headaches, dizziness, abdominal pain, confusion, dark urine which rendered her unable to complete her tasks at work. Two weeks after vaccination, she admitted to an outside facility with diarrhoea and severe light-headedness. Her vitals on admission were within normal limits with an unremarkable physical exam. Her labs were significant for a platelet count of 10,000, LDH (lactate dehydrogenase) of 800, fibrinogen of 419, and schistocytes on peripheral smear. ADAMTS13 level was <3%. Other work-up including the direct Coombs test, HIV and hepatitis panel were negative. Her presentation was felt to be consistent with TTP (Thrombotic Thrombocytopenic Purpura) though she had normal creatinine. She underwent four rounds of plasmapheresis but continued to have recurrent thrombocytopenia. During her fourth treatment, she had an anaphylactic reaction. She was started on high dose prednisone and was able to tolerate two additional rounds of plasmapheresis with good response. At the time of discharge, her platelet count was above 200 and her symptoms had resolved. The patient was diagnosed with acute TTP caused by autoantibody-mediated ADAMTS-13 deficiency. The patient responded to plasmapheresis and corticosteroids, the known treatments for acquired TTP, and her platelet count recovered. Outcome was not reported. Reporter comments: The reporter stated that after extensive work-up, the development of the patient's TTP was attributed to the influenza vaccine. Vaccines have been associated with autoimmune events in rare instances. In this particular patient, the reporters believed that the patient acquired TTP since the vaccine produced anti-ADAMTS IgG inhibitor.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood lactate dehydrogenase increased, Chromaturia, Confusional state, Coombs direct test negative, Cough
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 40 year old female who had a medical history of hypertension, hyperlipidaemia and type 2 diabetes. Concomitant medications included simvastatin, metformin, lisinopril/hydrochlorothiazide, lansoprazole and metoprolol. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) at a local pharmacy. Immediately, the patient developed a cough and flu-like symptoms for one week. During the second week, she began experiencing fatigue, headaches, dizziness, abdominal pain, confusion, dark urine which rendered her unable to complete her tasks at work. Two weeks after vaccination, she admitted to an outside facility with diarrhoea and severe light-headedness. Her vitals on admission were within normal limits with an unremarkable physical exam. Her labs were significant for a platelet count of 10,000, LDH (lactate dehydrogenase) of 800, fibrinogen of 419, and schistocytes on peripheral smear. ADAMTS13 level was <3%. Other work-up including the direct Coombs test, HIV and hepatitis panel were negative. Her presentation was felt to be consistent with TTP (Thrombotic Thrombocytopenic Purpura) though she had normal creatinine. She underwent four rounds of plasmapheresis but continued to have recurrent thrombocytopenia. During her fourth treatment, she had an anaphylactic reaction. She was started on high dose prednisone and was able to tolerate two additional rounds of plasmapheresis with good response. At the time of discharge, her platelet count was above 200 and her symptoms had resolved. The patient was diagnosed with acute TTP caused by autoantibody-mediated ADAMTS-13 deficiency. The patient responded to plasmapheresis and corticosteroids, the known treatments for acquired TTP, and her platelet count recovered. Outcome was not reported. Reporter comments: The reporter stated that after extensive work-up, the development of the patient's TTP was attributed to the influenza vaccine. Vaccines have been associated with autoimmune events in rare instances. In this particular patient, the reporters believed that the patient acquired TTP since the vaccine produced anti-ADAMTS IgG inhibitor.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Diarrhoea, Dizziness, Fatigue, HIV test negative, Headache
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 40 year old female who had a medical history of hypertension, hyperlipidaemia and type 2 diabetes. Concomitant medications included simvastatin, metformin, lisinopril/hydrochlorothiazide, lansoprazole and metoprolol. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) at a local pharmacy. Immediately, the patient developed a cough and flu-like symptoms for one week. During the second week, she began experiencing fatigue, headaches, dizziness, abdominal pain, confusion, dark urine which rendered her unable to complete her tasks at work. Two weeks after vaccination, she admitted to an outside facility with diarrhoea and severe light-headedness. Her vitals on admission were within normal limits with an unremarkable physical exam. Her labs were significant for a platelet count of 10,000, LDH (lactate dehydrogenase) of 800, fibrinogen of 419, and schistocytes on peripheral smear. ADAMTS13 level was <3%. Other work-up including the direct Coombs test, HIV and hepatitis panel were negative. Her presentation was felt to be consistent with TTP (Thrombotic Thrombocytopenic Purpura) though she had normal creatinine. She underwent four rounds of plasmapheresis but continued to have recurrent thrombocytopenia. During her fourth treatment, she had an anaphylactic reaction. She was started on high dose prednisone and was able to tolerate two additional rounds of plasmapheresis with good response. At the time of discharge, her platelet count was above 200 and her symptoms had resolved. The patient was diagnosed with acute TTP caused by autoantibody-mediated ADAMTS-13 deficiency. The patient responded to plasmapheresis and corticosteroids, the known treatments for acquired TTP, and her platelet count recovered. Outcome was not reported. Reporter comments: The reporter stated that after extensive work-up, the development of the patient's TTP was attributed to the influenza vaccine. Vaccines have been associated with autoimmune events in rare instances. In this particular patient, the reporters believed that the patient acquired TTP since the vaccine produced anti-ADAMTS IgG inhibitor.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hepatitis viral test negative, Immediate post-injection reaction, Impaired work ability, Influenza like illness, Plasmapheresis
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 40 year old female who had a medical history of hypertension, hyperlipidaemia and type 2 diabetes. Concomitant medications included simvastatin, metformin, lisinopril/hydrochlorothiazide, lansoprazole and metoprolol. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) at a local pharmacy. Immediately, the patient developed a cough and flu-like symptoms for one week. During the second week, she began experiencing fatigue, headaches, dizziness, abdominal pain, confusion, dark urine which rendered her unable to complete her tasks at work. Two weeks after vaccination, she admitted to an outside facility with diarrhoea and severe light-headedness. Her vitals on admission were within normal limits with an unremarkable physical exam. Her labs were significant for a platelet count of 10,000, LDH (lactate dehydrogenase) of 800, fibrinogen of 419, and schistocytes on peripheral smear. ADAMTS13 level was <3%. Other work-up including the direct Coombs test, HIV and hepatitis panel were negative. Her presentation was felt to be consistent with TTP (Thrombotic Thrombocytopenic Purpura) though she had normal creatinine. She underwent four rounds of plasmapheresis but continued to have recurrent thrombocytopenia. During her fourth treatment, she had an anaphylactic reaction. She was started on high dose prednisone and was able to tolerate two additional rounds of plasmapheresis with good response. At the time of discharge, her platelet count was above 200 and her symptoms had resolved. The patient was diagnosed with acute TTP caused by autoantibody-mediated ADAMTS-13 deficiency. The patient responded to plasmapheresis and corticosteroids, the known treatments for acquired TTP, and her platelet count recovered. Outcome was not reported. Reporter comments: The reporter stated that after extensive work-up, the development of the patient's TTP was attributed to the influenza vaccine. Vaccines have been associated with autoimmune events in rare instances. In this particular patient, the reporters believed that the patient acquired TTP since the vaccine produced anti-ADAMTS IgG inhibitor.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Platelet count decreased, Red blood cell schistocytes present, Smear site unspecified abnormal, Thrombotic thrombocytopenic purpura
Clinical narrative: This medically confirmed literature report (initial receipt 19-May-2015) concerns a 40 year old female who had a medical history of hypertension, hyperlipidaemia and type 2 diabetes. Concomitant medications included simvastatin, metformin, lisinopril/hydrochlorothiazide, lansoprazole and metoprolol. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) at a local pharmacy. Immediately, the patient developed a cough and flu-like symptoms for one week. During the second week, she began experiencing fatigue, headaches, dizziness, abdominal pain, confusion, dark urine which rendered her unable to complete her tasks at work. Two weeks after vaccination, she admitted to an outside facility with diarrhoea and severe light-headedness. Her vitals on admission were within normal limits with an unremarkable physical exam. Her labs were significant for a platelet count of 10,000, LDH (lactate dehydrogenase) of 800, fibrinogen of 419, and schistocytes on peripheral smear. ADAMTS13 level was <3%. Other work-up including the direct Coombs test, HIV and hepatitis panel were negative. Her presentation was felt to be consistent with TTP (Thrombotic Thrombocytopenic Purpura) though she had normal creatinine. She underwent four rounds of plasmapheresis but continued to have recurrent thrombocytopenia. During her fourth treatment, she had an anaphylactic reaction. She was started on high dose prednisone and was able to tolerate two additional rounds of plasmapheresis with good response. At the time of discharge, her platelet count was above 200 and her symptoms had resolved. The patient was diagnosed with acute TTP caused by autoantibody-mediated ADAMTS-13 deficiency. The patient responded to plasmapheresis and corticosteroids, the known treatments for acquired TTP, and her platelet count recovered. Outcome was not reported. Reporter comments: The reporter stated that after extensive work-up, the development of the patient's TTP was attributed to the influenza vaccine. Vaccines have been associated with autoimmune events in rare instances. In this particular patient, the reporters believed that the patient acquired TTP since the vaccine produced anti-ADAMTS IgG inhibitor.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Antinuclear antibody, Asthenia, Blood culture, C-reactive protein increased, Chest X-ray normal
Clinical narrative: I am unsure of exact time course above. Likely will have to contact patient. He has been working here since April. Today, his sister-in-law found him and he appeared confused. He said he tried to use his phone but was unable to work it because he was weak. Patient is a poor historian during my exam. He says he feels "Relaxed" and much  better than when he came in but is very sleepy. He initially reports to me that he has had shoulder pain for 2 weeks. Then when clarified with his sister in law, reports that shoulder pain started recently after his Hep B vaccination. He received a hep B immunization approx 1 week ago. Since that time, he reports HA, body ache. Was seen on May 30th (two days ago) and treated for migraine headache and muscle aches. Given fluids, diphenhydramine, metoclopramide, and ketorolac with some immediate relief of his headache. Today he reports that symptoms are worse. Feels like his body "won't work." + Cough productive of black sputum. Fevers and chills for 2 days. Coughing makes his HA worse. Decreased appetite. + Hives starting today. No N/V/D/abdominal pain. Worst pain is in his shoulders bilaterally. He denies new sexual partner. No pain with urination, but develops a HA when he urinates. No discharge from his penis. No new sexual partners. Patient was treated with IV fluids and IV Benadryl in ER on 6/1/15. Given IV Solumedrol 125mg IV on admission. Sx much improved on day of dischrage (6/2/15.)
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Chlamydia test, Computerised tomogram head abnormal, Confusional state, Decreased appetite
Clinical narrative: I am unsure of exact time course above. Likely will have to contact patient. He has been working here since April. Today, his sister-in-law found him and he appeared confused. He said he tried to use his phone but was unable to work it because he was weak. Patient is a poor historian during my exam. He says he feels "Relaxed" and much  better than when he came in but is very sleepy. He initially reports to me that he has had shoulder pain for 2 weeks. Then when clarified with his sister in law, reports that shoulder pain started recently after his Hep B vaccination. He received a hep B immunization approx 1 week ago. Since that time, he reports HA, body ache. Was seen on May 30th (two days ago) and treated for migraine headache and muscle aches. Given fluids, diphenhydramine, metoclopramide, and ketorolac with some immediate relief of his headache. Today he reports that symptoms are worse. Feels like his body "won't work." + Cough productive of black sputum. Fevers and chills for 2 days. Coughing makes his HA worse. Decreased appetite. + Hives starting today. No N/V/D/abdominal pain. Worst pain is in his shoulders bilaterally. He denies new sexual partner. No pain with urination, but develops a HA when he urinates. No discharge from his penis. No new sexual partners. Patient was treated with IV fluids and IV Benadryl in ER on 6/1/15. Given IV Solumedrol 125mg IV on admission. Sx much improved on day of dischrage (6/2/15.)
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Feeling abnormal, HIV test negative, HLA marker study, Headache, Laboratory test
Clinical narrative: I am unsure of exact time course above. Likely will have to contact patient. He has been working here since April. Today, his sister-in-law found him and he appeared confused. He said he tried to use his phone but was unable to work it because he was weak. Patient is a poor historian during my exam. He says he feels "Relaxed" and much  better than when he came in but is very sleepy. He initially reports to me that he has had shoulder pain for 2 weeks. Then when clarified with his sister in law, reports that shoulder pain started recently after his Hep B vaccination. He received a hep B immunization approx 1 week ago. Since that time, he reports HA, body ache. Was seen on May 30th (two days ago) and treated for migraine headache and muscle aches. Given fluids, diphenhydramine, metoclopramide, and ketorolac with some immediate relief of his headache. Today he reports that symptoms are worse. Feels like his body "won't work." + Cough productive of black sputum. Fevers and chills for 2 days. Coughing makes his HA worse. Decreased appetite. + Hives starting today. No N/V/D/abdominal pain. Worst pain is in his shoulders bilaterally. He denies new sexual partner. No pain with urination, but develops a HA when he urinates. No discharge from his penis. No new sexual partners. Patient was treated with IV fluids and IV Benadryl in ER on 6/1/15. Given IV Solumedrol 125mg IV on admission. Sx much improved on day of dischrage (6/2/15.)
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Migraine, Mononucleosis heterophile test negative, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: I am unsure of exact time course above. Likely will have to contact patient. He has been working here since April. Today, his sister-in-law found him and he appeared confused. He said he tried to use his phone but was unable to work it because he was weak. Patient is a poor historian during my exam. He says he feels "Relaxed" and much  better than when he came in but is very sleepy. He initially reports to me that he has had shoulder pain for 2 weeks. Then when clarified with his sister in law, reports that shoulder pain started recently after his Hep B vaccination. He received a hep B immunization approx 1 week ago. Since that time, he reports HA, body ache. Was seen on May 30th (two days ago) and treated for migraine headache and muscle aches. Given fluids, diphenhydramine, metoclopramide, and ketorolac with some immediate relief of his headache. Today he reports that symptoms are worse. Feels like his body "won't work." + Cough productive of black sputum. Fevers and chills for 2 days. Coughing makes his HA worse. Decreased appetite. + Hives starting today. No N/V/D/abdominal pain. Worst pain is in his shoulders bilaterally. He denies new sexual partner. No pain with urination, but develops a HA when he urinates. No discharge from his penis. No new sexual partners. Patient was treated with IV fluids and IV Benadryl in ER on 6/1/15. Given IV Solumedrol 125mg IV on admission. Sx much improved on day of dischrage (6/2/15.)
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Productive cough, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor, Sinusitis
Clinical narrative: I am unsure of exact time course above. Likely will have to contact patient. He has been working here since April. Today, his sister-in-law found him and he appeared confused. He said he tried to use his phone but was unable to work it because he was weak. Patient is a poor historian during my exam. He says he feels "Relaxed" and much  better than when he came in but is very sleepy. He initially reports to me that he has had shoulder pain for 2 weeks. Then when clarified with his sister in law, reports that shoulder pain started recently after his Hep B vaccination. He received a hep B immunization approx 1 week ago. Since that time, he reports HA, body ache. Was seen on May 30th (two days ago) and treated for migraine headache and muscle aches. Given fluids, diphenhydramine, metoclopramide, and ketorolac with some immediate relief of his headache. Today he reports that symptoms are worse. Feels like his body "won't work." + Cough productive of black sputum. Fevers and chills for 2 days. Coughing makes his HA worse. Decreased appetite. + Hives starting today. No N/V/D/abdominal pain. Worst pain is in his shoulders bilaterally. He denies new sexual partner. No pain with urination, but develops a HA when he urinates. No discharge from his penis. No new sexual partners. Patient was treated with IV fluids and IV Benadryl in ER on 6/1/15. Given IV Solumedrol 125mg IV on admission. Sx much improved on day of dischrage (6/2/15.)
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Somnolence, Sputum discoloured, Streptococcus test, Urticaria
Clinical narrative: I am unsure of exact time course above. Likely will have to contact patient. He has been working here since April. Today, his sister-in-law found him and he appeared confused. He said he tried to use his phone but was unable to work it because he was weak. Patient is a poor historian during my exam. He says he feels "Relaxed" and much  better than when he came in but is very sleepy. He initially reports to me that he has had shoulder pain for 2 weeks. Then when clarified with his sister in law, reports that shoulder pain started recently after his Hep B vaccination. He received a hep B immunization approx 1 week ago. Since that time, he reports HA, body ache. Was seen on May 30th (two days ago) and treated for migraine headache and muscle aches. Given fluids, diphenhydramine, metoclopramide, and ketorolac with some immediate relief of his headache. Today he reports that symptoms are worse. Feels like his body "won't work." + Cough productive of black sputum. Fevers and chills for 2 days. Coughing makes his HA worse. Decreased appetite. + Hives starting today. No N/V/D/abdominal pain. Worst pain is in his shoulders bilaterally. He denies new sexual partner. No pain with urination, but develops a HA when he urinates. No discharge from his penis. No new sexual partners. Patient was treated with IV fluids and IV Benadryl in ER on 6/1/15. Given IV Solumedrol 125mg IV on admission. Sx much improved on day of dischrage (6/2/15.)
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat to L upper arm. Erythema about 10cm. Per ER physician reaction vs. cellulitis, prescribed clindamycin for 30 days.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Extreme pain and swelling, hot to touch at injection site. Swelling subsided after 2 weeks. Contacted Dr. and was seen over 30 days later for same symptoms. June 3, 2015 still have inability to lift or use arm normally. Terrible pain, sore, stiff arm muscle, causing nausea and inability to sleep. Unable to do daily chores, my daughter helps me dress, she is only 8 years old.