chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: C-reactive protein increased, Cast application, Lymphadenopathy, Middle ear effusion, Oedema peripheral
Clinical narrative: Lymph node swelling and cold severe fluid build up in ear on 16 Feb 2012 went to the doctor was given antibiotic for sinusitis. March 6 2012: elbow inflammation and severe pain had to go to the ER. Was suspected bursitis, continued visit to orthopaedic in 2 days. Blood test was ordered Creactive protein was elevated and a cast was put though xray was normal. Next day a rheumatologist asked me to visit cast was removed elbow fluid take no infection was found just inflammation. My leg was swollen by March 18 2012 and elbow started receding on its own. Since I was alone I was forced to resign my job and return home for diagnosis. They have found here its reactive arthritis due to the vaccination and I am still recovering. I am to undergo physiotherapy to regain my elbow movement.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Vaccination complication, X-ray normal
Clinical narrative: Lymph node swelling and cold severe fluid build up in ear on 16 Feb 2012 went to the doctor was given antibiotic for sinusitis. March 6 2012: elbow inflammation and severe pain had to go to the ER. Was suspected bursitis, continued visit to orthopaedic in 2 days. Blood test was ordered Creactive protein was elevated and a cast was put though xray was normal. Next day a rheumatologist asked me to visit cast was removed elbow fluid take no infection was found just inflammation. My leg was swollen by March 18 2012 and elbow started receding on its own. Since I was alone I was forced to resign my job and return home for diagnosis. They have found here its reactive arthritis due to the vaccination and I am still recovering. I am to undergo physiotherapy to regain my elbow movement.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inflammation, Injection site pruritus, Injection site reaction
Clinical narrative: (L) leg inflammatory reaction; c/o itching at injection site; occurred within 24 hrs after initial vaccination.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Rash
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 23 April 2012. A 51-year-old female patient had received an intramuscular injection in the left deltoid of influenza vaccine, sanofi pasteur Inc., lot number not reported on 09 December 2011. On 10 December 2011, the patient broke out in shingles. The patient was not evaluated by a physician. The patient described what the rash looked like over the phone to the physician and was prescribed an antiviral stating it was shingles. The physician explained to the patient that the influenza vaccine did not cause her to develop shingles however the patient is not convinced otherwise. The patient had no relevant diagnostic testing or laboratory data. The patient denied any illness at the time of vaccination. The patient had allergies to bee stings and had the chickenpox as a child. The patient's outcome was recovered. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash macular
Clinical narrative: Information has been received from a 72 year old female registered nurse who was also the patient, with allergy to erythromycin, emphysema and hypertension who on 08-OCT-2007 (also reported as given four years ago) was vaccinated with a dose of ZOSTAVAX (Merck) (route, site, dose and lot number not reported). Concomitant therapy included calcium (unspecified), hypertensive medication and anti-depressant. On 23-FEB-2012 the patient presented with shingles. The patient was seen on 23-FEB-2012 with a rash on her neck on the left side and on the back of the neck on the hairline. There was also a blotch on her jaw and that was when she was diagnosed with shingles. It was prescribed pain medication and two week later prescribed gabapentin, as treatment for the adverse event. The patient did not know of lab diagnostic studies performed. The patient said that she was getting better, she still had pain but it was less than before. At the time of the report, the patient was recovering. Shingles was considered to be disabling by the registered nurse since the pain was pretty incapacitating. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Laboratory test
Clinical narrative: Information has been received from a physician concerning her 21 year old daughter who on unknown dates was vaccinated with the first, second and third dose of GARDASIL (dose, route and lot# not reported). The physician reported that her daughter who completed GARDASIL series might have a cervical cancer. The patient sought unspecified medical attention. At the time of reporting, physician stated that her daughter was going through tests to rule out cervical cancer. Physician reported her daughter completed the series before she became sexually active. At the time of the report, patient's outcome was unknown. Upon internal review cervical cancer was considered to be an other important medical event. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Blood test, Crying, Pyrexia, Swelling
Clinical narrative: Initial report was received from another manufacturer, who received the case from a health care professional, under manufacturer report number 2012081072 on 16 April 2012. A two-month-old female patient, with an unknown medical history, had received an injection of PENTACEL, sanofi pasteur Ltd., lot number C3928AA, PREVNAR 13, Pfizer, lot number F24141 and ROTATEQ, Merck, lot number 1240AA on 26 March 2012 (route, site and dose not reported). On 26 March 2012, the patient experienced extra puffiness, was crying excessively and had a fever. The patient's rectal temperature on 26 March 2012 was 100.4 and on 27 March 2012 the patient's rectal temperature was between 100.5 to 101. The patient was hospitalized on 27 March 2012 and was not discharged at the time of the report. The patient had blood work on an unknown date in March of 2012 while being hospitalized, however the results were unknown. The patient was recovering from the events at the time of the report. It was unknown if the patient took any concomitant medications. No further information was available at the time of the report. The patient's outcome was recovering (not recovered). Documents held by sender: None.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Band neutrophil percentage, C-reactive protein increased, Crying, Culture urine negative, Haematocrit decreased
Clinical narrative: Initial report was received from another manufacturer, who received the case from a health care professional, under manufacturer report number 2012081072 on 16 April 2012. A two-month-old female patient, with an unknown medical history, had received an injection of PENTACEL, sanofi pasteur Ltd., lot number C3928AA, PREVNAR 13, Pfizer, lot number F24141 and ROTATEQ, Merck, lot number 1240AA on 26 March 2012 (route, site and dose not reported). On 26 March 2012, the patient experienced extra puffiness, was crying excessively and had a fever. The patient's rectal temperature on 26 March 2012 was 100.4 and on 27 March 2012 the patient's rectal temperature was between 100.5 to 101. The patient was hospitalized on 27 March 2012 and was not discharged at the time of the report. The patient had blood work on an unknown date in March of 2012 while being hospitalized, however the results were unknown. The patient was recovering from the events at the time of the report. It was unknown if the patient took any concomitant medications. No further information was available at the time of the report. The patient's outcome was recovering (not recovered). Documents held by sender: None.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Haemoglobin normal, Infantile spitting up, Influenza A virus test negative, Influenza B virus test, Irritability
Clinical narrative: Initial report was received from another manufacturer, who received the case from a health care professional, under manufacturer report number 2012081072 on 16 April 2012. A two-month-old female patient, with an unknown medical history, had received an injection of PENTACEL, sanofi pasteur Ltd., lot number C3928AA, PREVNAR 13, Pfizer, lot number F24141 and ROTATEQ, Merck, lot number 1240AA on 26 March 2012 (route, site and dose not reported). On 26 March 2012, the patient experienced extra puffiness, was crying excessively and had a fever. The patient's rectal temperature on 26 March 2012 was 100.4 and on 27 March 2012 the patient's rectal temperature was between 100.5 to 101. The patient was hospitalized on 27 March 2012 and was not discharged at the time of the report. The patient had blood work on an unknown date in March of 2012 while being hospitalized, however the results were unknown. The patient was recovering from the events at the time of the report. It was unknown if the patient took any concomitant medications. No further information was available at the time of the report. The patient's outcome was recovering (not recovered). Documents held by sender: None.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Neutrophil percentage decreased, Platelet count normal, Pyrexia, Red blood cell sedimentation rate increased, Respiratory syncytial virus test negative
Clinical narrative: Initial report was received from another manufacturer, who received the case from a health care professional, under manufacturer report number 2012081072 on 16 April 2012. A two-month-old female patient, with an unknown medical history, had received an injection of PENTACEL, sanofi pasteur Ltd., lot number C3928AA, PREVNAR 13, Pfizer, lot number F24141 and ROTATEQ, Merck, lot number 1240AA on 26 March 2012 (route, site and dose not reported). On 26 March 2012, the patient experienced extra puffiness, was crying excessively and had a fever. The patient's rectal temperature on 26 March 2012 was 100.4 and on 27 March 2012 the patient's rectal temperature was between 100.5 to 101. The patient was hospitalized on 27 March 2012 and was not discharged at the time of the report. The patient had blood work on an unknown date in March of 2012 while being hospitalized, however the results were unknown. The patient was recovering from the events at the time of the report. It was unknown if the patient took any concomitant medications. No further information was available at the time of the report. The patient's outcome was recovering (not recovered). Documents held by sender: None.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Swelling, Urine analysis normal, Vomiting, White blood cell count normal
Clinical narrative: Initial report was received from another manufacturer, who received the case from a health care professional, under manufacturer report number 2012081072 on 16 April 2012. A two-month-old female patient, with an unknown medical history, had received an injection of PENTACEL, sanofi pasteur Ltd., lot number C3928AA, PREVNAR 13, Pfizer, lot number F24141 and ROTATEQ, Merck, lot number 1240AA on 26 March 2012 (route, site and dose not reported). On 26 March 2012, the patient experienced extra puffiness, was crying excessively and had a fever. The patient's rectal temperature on 26 March 2012 was 100.4 and on 27 March 2012 the patient's rectal temperature was between 100.5 to 101. The patient was hospitalized on 27 March 2012 and was not discharged at the time of the report. The patient had blood work on an unknown date in March of 2012 while being hospitalized, however the results were unknown. The patient was recovering from the events at the time of the report. It was unknown if the patient took any concomitant medications. No further information was available at the time of the report. The patient's outcome was recovering (not recovered). Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Acidosis hyperchloraemic, Anion gap decreased, Asthenia, Blood bicarbonate decreased, Blood calcium increased
Clinical narrative: This literature report concerns a 51-year-old female patient. Her past medical history was significant for HIV (human immunodeficiency virus) with a CD4 count of 656. Her medications at home included atorvastatin 10 mg a day, efavirenz-emtricitabine-tenofovir 600-200-300 mg once a day. On an unknown date the patient received influenza vaccination (manufacturer unknown). The patient presented to the ER (Emergency Room) with the complaints of generalized weakness and non-productive cough. Her symptoms started about three weeks ago when she received Influenza vaccination. After that injection, she started experiencing flu-like symptoms. Her weakness started in all extremities at the same time. She did report mild shortness of breath and a nonproductive cough as well. She took acetaminophen over the counter but unfortunately did not get better. On the day of admission she had been nauseated and had one episode of emesis in the ER. Review of systems was normal except for above. Upon admission, the patient's temperature was 35.2 degrees C; she was tachycardic at 103 beats per minute, blood pressure of 130/56 mmHg, respiratory rate of 18 breaths per minute with oxygen saturation of 100% on room air. Her physical examination was unremarkable. Laboratory workup revealed a normal complete blood count. Metabolic panel showed hyperchloremic metabolic acidosis with a sodium of 143 meq/L, potassium of 3.7 meq/L, chloride of 122 meq/L, bicarbonate of 11.3 meq/L, anion gap of 9.7 meq/L, blood urea nitrogen of 29 mg/100 ml, creatinine of 1.5 mg/100 ml, GFR of 38.9 ml/minute, glucose of 133 mg, and a calcium of 9.1 mg/100 ml. Urinalysis did not show acetones and showed +1 blood, +2 proteinuria, +1 leukocyte esterase. Lactic acid level was 0.3 mmol/L. ABG showed a PH of 7.21, carbon dioxide level of 19.8 mmHg. Urine electrolytes showed sodium of 85 meq/l, potassium level of 24 meq/l, and a chloride of 90 meq/l. Tenofovir was discontinued. The patient was treated with a solution of dextrose 5% plus sodium bicarbonate started at a rate of 18.75 meq/hr, multiple doses of sodium phosphate, potassium chloride, and calcium gluconate. Her condition gradually improved with eventual correction of acidosis and the acute renal failure. The patient was discharged on calcium carbonate 600 mg PO TID (three times daily). HIV clinic was notified about the need to change HAART (highly active anti-retroviral therapy) regimen. The event outcome was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Blood calcium normal, Blood chloride increased, Blood creatinine increased, Blood glucose increased, Blood lactic acid
Clinical narrative: This literature report concerns a 51-year-old female patient. Her past medical history was significant for HIV (human immunodeficiency virus) with a CD4 count of 656. Her medications at home included atorvastatin 10 mg a day, efavirenz-emtricitabine-tenofovir 600-200-300 mg once a day. On an unknown date the patient received influenza vaccination (manufacturer unknown). The patient presented to the ER (Emergency Room) with the complaints of generalized weakness and non-productive cough. Her symptoms started about three weeks ago when she received Influenza vaccination. After that injection, she started experiencing flu-like symptoms. Her weakness started in all extremities at the same time. She did report mild shortness of breath and a nonproductive cough as well. She took acetaminophen over the counter but unfortunately did not get better. On the day of admission she had been nauseated and had one episode of emesis in the ER. Review of systems was normal except for above. Upon admission, the patient's temperature was 35.2 degrees C; she was tachycardic at 103 beats per minute, blood pressure of 130/56 mmHg, respiratory rate of 18 breaths per minute with oxygen saturation of 100% on room air. Her physical examination was unremarkable. Laboratory workup revealed a normal complete blood count. Metabolic panel showed hyperchloremic metabolic acidosis with a sodium of 143 meq/L, potassium of 3.7 meq/L, chloride of 122 meq/L, bicarbonate of 11.3 meq/L, anion gap of 9.7 meq/L, blood urea nitrogen of 29 mg/100 ml, creatinine of 1.5 mg/100 ml, GFR of 38.9 ml/minute, glucose of 133 mg, and a calcium of 9.1 mg/100 ml. Urinalysis did not show acetones and showed +1 blood, +2 proteinuria, +1 leukocyte esterase. Lactic acid level was 0.3 mmol/L. ABG showed a PH of 7.21, carbon dioxide level of 19.8 mmHg. Urine electrolytes showed sodium of 85 meq/l, potassium level of 24 meq/l, and a chloride of 90 meq/l. Tenofovir was discontinued. The patient was treated with a solution of dextrose 5% plus sodium bicarbonate started at a rate of 18.75 meq/hr, multiple doses of sodium phosphate, potassium chloride, and calcium gluconate. Her condition gradually improved with eventual correction of acidosis and the acute renal failure. The patient was discharged on calcium carbonate 600 mg PO TID (three times daily). HIV clinic was notified about the need to change HAART (highly active anti-retroviral therapy) regimen. The event outcome was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pH decreased, Blood potassium normal, Blood sodium normal, Blood urea increased, Blood urine
Clinical narrative: This literature report concerns a 51-year-old female patient. Her past medical history was significant for HIV (human immunodeficiency virus) with a CD4 count of 656. Her medications at home included atorvastatin 10 mg a day, efavirenz-emtricitabine-tenofovir 600-200-300 mg once a day. On an unknown date the patient received influenza vaccination (manufacturer unknown). The patient presented to the ER (Emergency Room) with the complaints of generalized weakness and non-productive cough. Her symptoms started about three weeks ago when she received Influenza vaccination. After that injection, she started experiencing flu-like symptoms. Her weakness started in all extremities at the same time. She did report mild shortness of breath and a nonproductive cough as well. She took acetaminophen over the counter but unfortunately did not get better. On the day of admission she had been nauseated and had one episode of emesis in the ER. Review of systems was normal except for above. Upon admission, the patient's temperature was 35.2 degrees C; she was tachycardic at 103 beats per minute, blood pressure of 130/56 mmHg, respiratory rate of 18 breaths per minute with oxygen saturation of 100% on room air. Her physical examination was unremarkable. Laboratory workup revealed a normal complete blood count. Metabolic panel showed hyperchloremic metabolic acidosis with a sodium of 143 meq/L, potassium of 3.7 meq/L, chloride of 122 meq/L, bicarbonate of 11.3 meq/L, anion gap of 9.7 meq/L, blood urea nitrogen of 29 mg/100 ml, creatinine of 1.5 mg/100 ml, GFR of 38.9 ml/minute, glucose of 133 mg, and a calcium of 9.1 mg/100 ml. Urinalysis did not show acetones and showed +1 blood, +2 proteinuria, +1 leukocyte esterase. Lactic acid level was 0.3 mmol/L. ABG showed a PH of 7.21, carbon dioxide level of 19.8 mmHg. Urine electrolytes showed sodium of 85 meq/l, potassium level of 24 meq/l, and a chloride of 90 meq/l. Tenofovir was discontinued. The patient was treated with a solution of dextrose 5% plus sodium bicarbonate started at a rate of 18.75 meq/hr, multiple doses of sodium phosphate, potassium chloride, and calcium gluconate. Her condition gradually improved with eventual correction of acidosis and the acute renal failure. The patient was discharged on calcium carbonate 600 mg PO TID (three times daily). HIV clinic was notified about the need to change HAART (highly active anti-retroviral therapy) regimen. The event outcome was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature decreased, Carbon dioxide, Cough, Dyspnoea, Full blood count normal
Clinical narrative: This literature report concerns a 51-year-old female patient. Her past medical history was significant for HIV (human immunodeficiency virus) with a CD4 count of 656. Her medications at home included atorvastatin 10 mg a day, efavirenz-emtricitabine-tenofovir 600-200-300 mg once a day. On an unknown date the patient received influenza vaccination (manufacturer unknown). The patient presented to the ER (Emergency Room) with the complaints of generalized weakness and non-productive cough. Her symptoms started about three weeks ago when she received Influenza vaccination. After that injection, she started experiencing flu-like symptoms. Her weakness started in all extremities at the same time. She did report mild shortness of breath and a nonproductive cough as well. She took acetaminophen over the counter but unfortunately did not get better. On the day of admission she had been nauseated and had one episode of emesis in the ER. Review of systems was normal except for above. Upon admission, the patient's temperature was 35.2 degrees C; she was tachycardic at 103 beats per minute, blood pressure of 130/56 mmHg, respiratory rate of 18 breaths per minute with oxygen saturation of 100% on room air. Her physical examination was unremarkable. Laboratory workup revealed a normal complete blood count. Metabolic panel showed hyperchloremic metabolic acidosis with a sodium of 143 meq/L, potassium of 3.7 meq/L, chloride of 122 meq/L, bicarbonate of 11.3 meq/L, anion gap of 9.7 meq/L, blood urea nitrogen of 29 mg/100 ml, creatinine of 1.5 mg/100 ml, GFR of 38.9 ml/minute, glucose of 133 mg, and a calcium of 9.1 mg/100 ml. Urinalysis did not show acetones and showed +1 blood, +2 proteinuria, +1 leukocyte esterase. Lactic acid level was 0.3 mmol/L. ABG showed a PH of 7.21, carbon dioxide level of 19.8 mmHg. Urine electrolytes showed sodium of 85 meq/l, potassium level of 24 meq/l, and a chloride of 90 meq/l. Tenofovir was discontinued. The patient was treated with a solution of dextrose 5% plus sodium bicarbonate started at a rate of 18.75 meq/hr, multiple doses of sodium phosphate, potassium chloride, and calcium gluconate. Her condition gradually improved with eventual correction of acidosis and the acute renal failure. The patient was discharged on calcium carbonate 600 mg PO TID (three times daily). HIV clinic was notified about the need to change HAART (highly active anti-retroviral therapy) regimen. The event outcome was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Glomerular filtration rate decreased, Influenza like illness, Metabolic function test, Muscular weakness, Nausea
Clinical narrative: This literature report concerns a 51-year-old female patient. Her past medical history was significant for HIV (human immunodeficiency virus) with a CD4 count of 656. Her medications at home included atorvastatin 10 mg a day, efavirenz-emtricitabine-tenofovir 600-200-300 mg once a day. On an unknown date the patient received influenza vaccination (manufacturer unknown). The patient presented to the ER (Emergency Room) with the complaints of generalized weakness and non-productive cough. Her symptoms started about three weeks ago when she received Influenza vaccination. After that injection, she started experiencing flu-like symptoms. Her weakness started in all extremities at the same time. She did report mild shortness of breath and a nonproductive cough as well. She took acetaminophen over the counter but unfortunately did not get better. On the day of admission she had been nauseated and had one episode of emesis in the ER. Review of systems was normal except for above. Upon admission, the patient's temperature was 35.2 degrees C; she was tachycardic at 103 beats per minute, blood pressure of 130/56 mmHg, respiratory rate of 18 breaths per minute with oxygen saturation of 100% on room air. Her physical examination was unremarkable. Laboratory workup revealed a normal complete blood count. Metabolic panel showed hyperchloremic metabolic acidosis with a sodium of 143 meq/L, potassium of 3.7 meq/L, chloride of 122 meq/L, bicarbonate of 11.3 meq/L, anion gap of 9.7 meq/L, blood urea nitrogen of 29 mg/100 ml, creatinine of 1.5 mg/100 ml, GFR of 38.9 ml/minute, glucose of 133 mg, and a calcium of 9.1 mg/100 ml. Urinalysis did not show acetones and showed +1 blood, +2 proteinuria, +1 leukocyte esterase. Lactic acid level was 0.3 mmol/L. ABG showed a PH of 7.21, carbon dioxide level of 19.8 mmHg. Urine electrolytes showed sodium of 85 meq/l, potassium level of 24 meq/l, and a chloride of 90 meq/l. Tenofovir was discontinued. The patient was treated with a solution of dextrose 5% plus sodium bicarbonate started at a rate of 18.75 meq/hr, multiple doses of sodium phosphate, potassium chloride, and calcium gluconate. Her condition gradually improved with eventual correction of acidosis and the acute renal failure. The patient was discharged on calcium carbonate 600 mg PO TID (three times daily). HIV clinic was notified about the need to change HAART (highly active anti-retroviral therapy) regimen. The event outcome was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Oxygen saturation normal, Protein urine present, Proteinuria, Renal failure acute, Tachycardia
Clinical narrative: This literature report concerns a 51-year-old female patient. Her past medical history was significant for HIV (human immunodeficiency virus) with a CD4 count of 656. Her medications at home included atorvastatin 10 mg a day, efavirenz-emtricitabine-tenofovir 600-200-300 mg once a day. On an unknown date the patient received influenza vaccination (manufacturer unknown). The patient presented to the ER (Emergency Room) with the complaints of generalized weakness and non-productive cough. Her symptoms started about three weeks ago when she received Influenza vaccination. After that injection, she started experiencing flu-like symptoms. Her weakness started in all extremities at the same time. She did report mild shortness of breath and a nonproductive cough as well. She took acetaminophen over the counter but unfortunately did not get better. On the day of admission she had been nauseated and had one episode of emesis in the ER. Review of systems was normal except for above. Upon admission, the patient's temperature was 35.2 degrees C; she was tachycardic at 103 beats per minute, blood pressure of 130/56 mmHg, respiratory rate of 18 breaths per minute with oxygen saturation of 100% on room air. Her physical examination was unremarkable. Laboratory workup revealed a normal complete blood count. Metabolic panel showed hyperchloremic metabolic acidosis with a sodium of 143 meq/L, potassium of 3.7 meq/L, chloride of 122 meq/L, bicarbonate of 11.3 meq/L, anion gap of 9.7 meq/L, blood urea nitrogen of 29 mg/100 ml, creatinine of 1.5 mg/100 ml, GFR of 38.9 ml/minute, glucose of 133 mg, and a calcium of 9.1 mg/100 ml. Urinalysis did not show acetones and showed +1 blood, +2 proteinuria, +1 leukocyte esterase. Lactic acid level was 0.3 mmol/L. ABG showed a PH of 7.21, carbon dioxide level of 19.8 mmHg. Urine electrolytes showed sodium of 85 meq/l, potassium level of 24 meq/l, and a chloride of 90 meq/l. Tenofovir was discontinued. The patient was treated with a solution of dextrose 5% plus sodium bicarbonate started at a rate of 18.75 meq/hr, multiple doses of sodium phosphate, potassium chloride, and calcium gluconate. Her condition gradually improved with eventual correction of acidosis and the acute renal failure. The patient was discharged on calcium carbonate 600 mg PO TID (three times daily). HIV clinic was notified about the need to change HAART (highly active anti-retroviral therapy) regimen. The event outcome was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Urine analysis abnormal, Urine chloride, Urine electrolytes, Urine ketone body absent, Urine leukocyte esterase positive
Clinical narrative: This literature report concerns a 51-year-old female patient. Her past medical history was significant for HIV (human immunodeficiency virus) with a CD4 count of 656. Her medications at home included atorvastatin 10 mg a day, efavirenz-emtricitabine-tenofovir 600-200-300 mg once a day. On an unknown date the patient received influenza vaccination (manufacturer unknown). The patient presented to the ER (Emergency Room) with the complaints of generalized weakness and non-productive cough. Her symptoms started about three weeks ago when she received Influenza vaccination. After that injection, she started experiencing flu-like symptoms. Her weakness started in all extremities at the same time. She did report mild shortness of breath and a nonproductive cough as well. She took acetaminophen over the counter but unfortunately did not get better. On the day of admission she had been nauseated and had one episode of emesis in the ER. Review of systems was normal except for above. Upon admission, the patient's temperature was 35.2 degrees C; she was tachycardic at 103 beats per minute, blood pressure of 130/56 mmHg, respiratory rate of 18 breaths per minute with oxygen saturation of 100% on room air. Her physical examination was unremarkable. Laboratory workup revealed a normal complete blood count. Metabolic panel showed hyperchloremic metabolic acidosis with a sodium of 143 meq/L, potassium of 3.7 meq/L, chloride of 122 meq/L, bicarbonate of 11.3 meq/L, anion gap of 9.7 meq/L, blood urea nitrogen of 29 mg/100 ml, creatinine of 1.5 mg/100 ml, GFR of 38.9 ml/minute, glucose of 133 mg, and a calcium of 9.1 mg/100 ml. Urinalysis did not show acetones and showed +1 blood, +2 proteinuria, +1 leukocyte esterase. Lactic acid level was 0.3 mmol/L. ABG showed a PH of 7.21, carbon dioxide level of 19.8 mmHg. Urine electrolytes showed sodium of 85 meq/l, potassium level of 24 meq/l, and a chloride of 90 meq/l. Tenofovir was discontinued. The patient was treated with a solution of dextrose 5% plus sodium bicarbonate started at a rate of 18.75 meq/hr, multiple doses of sodium phosphate, potassium chloride, and calcium gluconate. Her condition gradually improved with eventual correction of acidosis and the acute renal failure. The patient was discharged on calcium carbonate 600 mg PO TID (three times daily). HIV clinic was notified about the need to change HAART (highly active anti-retroviral therapy) regimen. The event outcome was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Urine potassium decreased, Urine sodium normal, Vomiting
Clinical narrative: This literature report concerns a 51-year-old female patient. Her past medical history was significant for HIV (human immunodeficiency virus) with a CD4 count of 656. Her medications at home included atorvastatin 10 mg a day, efavirenz-emtricitabine-tenofovir 600-200-300 mg once a day. On an unknown date the patient received influenza vaccination (manufacturer unknown). The patient presented to the ER (Emergency Room) with the complaints of generalized weakness and non-productive cough. Her symptoms started about three weeks ago when she received Influenza vaccination. After that injection, she started experiencing flu-like symptoms. Her weakness started in all extremities at the same time. She did report mild shortness of breath and a nonproductive cough as well. She took acetaminophen over the counter but unfortunately did not get better. On the day of admission she had been nauseated and had one episode of emesis in the ER. Review of systems was normal except for above. Upon admission, the patient's temperature was 35.2 degrees C; she was tachycardic at 103 beats per minute, blood pressure of 130/56 mmHg, respiratory rate of 18 breaths per minute with oxygen saturation of 100% on room air. Her physical examination was unremarkable. Laboratory workup revealed a normal complete blood count. Metabolic panel showed hyperchloremic metabolic acidosis with a sodium of 143 meq/L, potassium of 3.7 meq/L, chloride of 122 meq/L, bicarbonate of 11.3 meq/L, anion gap of 9.7 meq/L, blood urea nitrogen of 29 mg/100 ml, creatinine of 1.5 mg/100 ml, GFR of 38.9 ml/minute, glucose of 133 mg, and a calcium of 9.1 mg/100 ml. Urinalysis did not show acetones and showed +1 blood, +2 proteinuria, +1 leukocyte esterase. Lactic acid level was 0.3 mmol/L. ABG showed a PH of 7.21, carbon dioxide level of 19.8 mmHg. Urine electrolytes showed sodium of 85 meq/l, potassium level of 24 meq/l, and a chloride of 90 meq/l. Tenofovir was discontinued. The patient was treated with a solution of dextrose 5% plus sodium bicarbonate started at a rate of 18.75 meq/hr, multiple doses of sodium phosphate, potassium chloride, and calcium gluconate. Her condition gradually improved with eventual correction of acidosis and the acute renal failure. The patient was discharged on calcium carbonate 600 mg PO TID (three times daily). HIV clinic was notified about the need to change HAART (highly active anti-retroviral therapy) regimen. The event outcome was not reported.
Age: 38.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Death, Respiratory failure
Clinical narrative: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (4 of 10) concerns a 38-year-old male patient, who had a medical history of immunodeficiency. The patient died of respiratory failure (under review), nineteen days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Consciousness fluctuating, Grand mal convulsion, Tremor
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old male patient with attention deficit/hyperactivity disorder and a history of pain in calf and stroke during birth and with no known drug reactions or allergies, who on 18-Oct-2011 and 19-DEC-2011 was vaccinated with the first and the second dose of GARDASIL (doses, routes and lot numbers not reported). On 19-APR-2012, the patient was vaccinated with the third dose of GARDASIL (doses, route not reported, lot number 671994/1537AA, expiry date: 30-JUN-2014). Concomitant therapy included VYVANSE and TOPAMAX. It was reported that on 19-APR-2012 ("today"), the patient stayed 15 minutes after vaccination in the office and, on the way home, he had a "major seizure in the car, he was shaking and in and out of consciousness". The patient was being taken to the an emergency room of a hospital. It was unknown if the patient was admitted. At the time of the report, the patient's outcome was unknown. Upon internal review, the major seizure was determined to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Sudden death
Clinical narrative: This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (1 of 10) concerns a 1-year-old male patient, who had a medical history of febrile seizures after mumps/measles/rubella. The patient died of sudden death, with no evidence of trauma, one day after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporter comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).
Sex: M
Vaccine: TDAP
Symptoms: Abortion spontaneous, Foetal death, Maternal exposure during pregnancy
Clinical narrative: Initial case was received from a health care professional on 16 April 2012. This case contains information to describe the fetal death; information for the mother was captured in case number 2011-12525. A male fetus was exposed while in utero to ADACEL, lot number C3984AA. His mother was vaccinated on 22 December 2011 (weeks gestation was not reported). The mother's last menstrual period was on 04 November 2011. On 08 April 2012, the mother had a miscarriage which resulted in an early fetal death between 20-27 weeks gestation (exact weeks gestation not reported). The outcome was fatal. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Amnesia, Conversion disorder, Convulsion, Headache
Clinical narrative: Information has been received from a consumer concerning currently 15 year old female patient with no pertinent medical history and no drug reactions/allergies who on an unspecified date, was vaccinated with the second dose of GARDASIL (lot # and route not reported) 0.5 ml. There was no concomitant medication. Consumer reported that on an unspecified date, minutes after getting her second GARDASIL dose, the patient had a seizure and was taken to the emergency room (ER) of an unspecified hospital. They did a magnetic resonance imaging (MRI) of her brain and the diagnosis was a conversion, which was a misfiring of the electrons in her brain due to traumatic bodily injury. Since this happened, she had had headaches, passed out all the time. she had tingling in her hands and feet, blurry vision, pain in her rib area, and a loss of memory of the last three years. She went to an unspecified neurologist, who could not pin it to the vaccine. She had missed 55 days of school since the event started. The patient's mother said that physician dismissed the idea that it was due to the vaccine, so she switched to an unspecified doctor in the same practice. The consumer had been to the emergency room (ER) multiple times. It was reported that the events occurred after reintroduction. It was also reported that these events were a significant disability. It was not know if the days of school the consumer missed were consecutive and if the patient was ever admitted to the hospital. At the time of the report, the patient's outcome was unknown. Therapy with GARDASIL was discontinued after the events happened. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injury, Loss of consciousness, Musculoskeletal chest pain, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning currently 15 year old female patient with no pertinent medical history and no drug reactions/allergies who on an unspecified date, was vaccinated with the second dose of GARDASIL (lot # and route not reported) 0.5 ml. There was no concomitant medication. Consumer reported that on an unspecified date, minutes after getting her second GARDASIL dose, the patient had a seizure and was taken to the emergency room (ER) of an unspecified hospital. They did a magnetic resonance imaging (MRI) of her brain and the diagnosis was a conversion, which was a misfiring of the electrons in her brain due to traumatic bodily injury. Since this happened, she had had headaches, passed out all the time. she had tingling in her hands and feet, blurry vision, pain in her rib area, and a loss of memory of the last three years. She went to an unspecified neurologist, who could not pin it to the vaccine. She had missed 55 days of school since the event started. The patient's mother said that physician dismissed the idea that it was due to the vaccine, so she switched to an unspecified doctor in the same practice. The consumer had been to the emergency room (ER) multiple times. It was reported that the events occurred after reintroduction. It was also reported that these events were a significant disability. It was not know if the days of school the consumer missed were consecutive and if the patient was ever admitted to the hospital. At the time of the report, the patient's outcome was unknown. Therapy with GARDASIL was discontinued after the events happened. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from a consumer concerning currently 15 year old female patient with no pertinent medical history and no drug reactions/allergies who on an unspecified date, was vaccinated with the second dose of GARDASIL (lot # and route not reported) 0.5 ml. There was no concomitant medication. Consumer reported that on an unspecified date, minutes after getting her second GARDASIL dose, the patient had a seizure and was taken to the emergency room (ER) of an unspecified hospital. They did a magnetic resonance imaging (MRI) of her brain and the diagnosis was a conversion, which was a misfiring of the electrons in her brain due to traumatic bodily injury. Since this happened, she had had headaches, passed out all the time. she had tingling in her hands and feet, blurry vision, pain in her rib area, and a loss of memory of the last three years. She went to an unspecified neurologist, who could not pin it to the vaccine. She had missed 55 days of school since the event started. The patient's mother said that physician dismissed the idea that it was due to the vaccine, so she switched to an unspecified doctor in the same practice. The consumer had been to the emergency room (ER) multiple times. It was reported that the events occurred after reintroduction. It was also reported that these events were a significant disability. It was not know if the days of school the consumer missed were consecutive and if the patient was ever admitted to the hospital. At the time of the report, the patient's outcome was unknown. Therapy with GARDASIL was discontinued after the events happened. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abortion induced, Maternal exposure during pregnancy, No adverse event
Clinical narrative: Initial report was received from a health care professional on 07 October 2011. A 4 to 5 weeks pregnant female (age not reported) had received an ADACEL injection (lot number and site of administration not reported). The patient Medical History and Estimated Date of Delivery were not reported. Last Menstrual Period was reposted as 09 April 2011. The patient did not experience an adverse event. The outcome was not reported. Follow-up information was received from a healthcare professional on 16 April 2012. Based upon the new information provided, this case has been upgraded to serious. The reporter corrected the patient's first initial of her first name. The patient's Date of Last Menstrual Period was 04 September 2011 (previously reported as 09 April 2011). The reporter stated the patient terminated pregnancy. The patient's outcome was unknown. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Initial report was received from a health care professional on 16 April 2012. A three-year-old patient had received a dose one intramuscular injection of IPOL, sanofi pasteur SA, lot number H1330, on 12 April 2012 (site not reported). On 12 April 2012, the patient broke out in hives at the injection site that spread to his back and became generalized over his entire body. The physician prescribed BENADRYL and had to supplement with prednisone. The patient had no illness at the time of vaccination and had no past medical history. The patient's outcome was unknown. Documents held by sender: None.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site vesicles, Similar reaction on previous exposure to drug
Clinical narrative: Blisters at the left thigh noted after vaccines given. Mother states that similar reaction occurred after 1/30/12 vaccines (she did not report). Received HIB/PCV-13 at left thigh.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Dizziness, Headache
Clinical narrative: Headache, dizziness, severe stomach pain, knee pain and knee weakness, nausea.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea
Clinical narrative: Headache, dizziness, severe stomach pain, knee pain and knee weakness, nausea.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: No adverse effects. Gave vaccine 4 mo after completion of radiation therapy for breast cancer.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Condition aggravated, Eczema, Rash
Clinical narrative: Rash developed within hours of vaccination which gradually evolved into severe eczema over 2 months and has since persisted. Has history of mild eczema prior to this, but was described as moderately - severe 2 months before vaccines.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: (R) arm swelled to 16 x 10 cm, very red & warm to the touch. Came to to office for assessment. Treated with Antihistamines.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Acute disseminated encephalomyelitis, Ataxia, CSF immunoglobulin G index, CSF oligoclonal band absent, CSF protein increased
Clinical narrative: This literature report concerns a healthy 36-year old female patient. On an unknown date the patient received influenza vaccination (manufacturer unknown). Two weeks after influenza vaccination, the patient developed headache, personality change and encephalopathy. She worsened over 1 week and developed gait ataxia and a dense left hemiparesis. CSF (cerebrospinal fluid) showed lymphocytic pleocytosis (white blood cell count 20/uL), elevated total protein (53 mg/dL), elevated IgG index (0.65) and absence of oligoclonal bands. Laboratory studies excluded infectious etiologies. The patient was diagnosed with ADEM (acute disseminated encephalomyelitis) and received a 5-day course of IV (intravenous) methylprednisolone. The patient stabilised and made a substantial recovery with rehabilitation. After 3 years of clinical and imaging follow-up (without further treatment), no additional relapses occurred.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: CSF white blood cell count increased, Encephalopathy, Headache, Hemiparesis, Immunoglobulin therapy
Clinical narrative: This literature report concerns a healthy 36-year old female patient. On an unknown date the patient received influenza vaccination (manufacturer unknown). Two weeks after influenza vaccination, the patient developed headache, personality change and encephalopathy. She worsened over 1 week and developed gait ataxia and a dense left hemiparesis. CSF (cerebrospinal fluid) showed lymphocytic pleocytosis (white blood cell count 20/uL), elevated total protein (53 mg/dL), elevated IgG index (0.65) and absence of oligoclonal bands. Laboratory studies excluded infectious etiologies. The patient was diagnosed with ADEM (acute disseminated encephalomyelitis) and received a 5-day course of IV (intravenous) methylprednisolone. The patient stabilised and made a substantial recovery with rehabilitation. After 3 years of clinical and imaging follow-up (without further treatment), no additional relapses occurred.