chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test normal, Personality change, Pleocytosis
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: 2.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cardio-respiratory arrest, Sudden death
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 (2 of 10) concerns a 2-year-old female patient, who had a medical history of encephalopathy, central apnea, traumatic brain damage, seizures. The patient died of sudden death cardiopulmonary arrest after H1N1 vaccination (type: monovalent inactivated, split-virus vaccine; manufacture: unknown). Time to onset was 0 day. 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: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Colectomy total, Colitis ulcerative, Condition aggravated, Cushingoid
Clinical narrative: This literature report concerns a 52-year-old female patient. In her past medical history she had been passing bloody mucus intermittently for 3 years before a diagnosis of ulcerative proctitis was made at colonoscopy. She improved on sulfasalazine and hydrocortisone enemas, but after stopping medication she had recurrent rectal bleeding and coincident uveitis. She was then treated with oral prednisone and the sulfasalazine was restarted. Sigmoidoscopy showed more extensive friability and exudate and she was hospitalized for intravenous hydrocortisone. The patient was also started on 6-MP at 50 mg/day. She improved quickly and was discharged on sulfasalazine, tapering doses of prednisone, and an increase in 6-MP to 100 mg/day. The sigmoidoscopic appearance had been normal for 4 months when symptoms worsened, with loosening of the stools and reappearance of blood per rectum. On flexible sigmoidoscopy, mucosal friability and edema were again found in the rectum and rectosigmoid. After 3 more months on 6-MP during which the dose was reduced to 50 mg/day because of leukopenia, she was much improved, having formed stools with normal mucosa throughout at colonoscopy. On an unknown date, after 9 months of 6-MP and while in remission, the patient received a subcutaneous injection of influenza vaccine (manufacturer unknown). That night the patient developed abdominal pain and bloody diarrhea and was hospitalized. On examination she had very active UC with friability, ulceration, and exudate. She stated that her earlier exacerbation had also followed a flu shot. She also had recurrence of bilateral uveitis. She was hospitalized and treated with intravenous adrenocorticotropin hormone (ACTH) followed by tapering doses of prednisone. Again she improved, but incompletely. The 6-MP was increased to 150 mg/day and she required larger doses of steroids, becoming very cushingoid. One year after the diagnosis of UC (ulcerative colitis) was established the chronicity of her illness and the complications of steroids warranted surgical intervention. She underwent a total colectomy with establishment of an ileoanal pouch anastomosis. Pathology confirmed the presence of a universal UC and there was no involvement of the terminal ileum. After 1 year with intermittent pouchitis, the pouch and the ileum looked normal. Reporters comment: We acknowledge that the case presented here is probably 1 out of many inflammatory bowel disease patients on 6-MP who received the flu vaccine. Perhaps it was an IgE-mediated reaction (egg allergy). However, we suggest that this case not be ignored since the outcome is a sobering reality.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea haemorrhagic, Food allergy, Intestinal anastomosis, Pathology test, Pouchitis
Clinical narrative: This literature report concerns a 52-year-old female patient. In her past medical history she had been passing bloody mucus intermittently for 3 years before a diagnosis of ulcerative proctitis was made at colonoscopy. She improved on sulfasalazine and hydrocortisone enemas, but after stopping medication she had recurrent rectal bleeding and coincident uveitis. She was then treated with oral prednisone and the sulfasalazine was restarted. Sigmoidoscopy showed more extensive friability and exudate and she was hospitalized for intravenous hydrocortisone. The patient was also started on 6-MP at 50 mg/day. She improved quickly and was discharged on sulfasalazine, tapering doses of prednisone, and an increase in 6-MP to 100 mg/day. The sigmoidoscopic appearance had been normal for 4 months when symptoms worsened, with loosening of the stools and reappearance of blood per rectum. On flexible sigmoidoscopy, mucosal friability and edema were again found in the rectum and rectosigmoid. After 3 more months on 6-MP during which the dose was reduced to 50 mg/day because of leukopenia, she was much improved, having formed stools with normal mucosa throughout at colonoscopy. On an unknown date, after 9 months of 6-MP and while in remission, the patient received a subcutaneous injection of influenza vaccine (manufacturer unknown). That night the patient developed abdominal pain and bloody diarrhea and was hospitalized. On examination she had very active UC with friability, ulceration, and exudate. She stated that her earlier exacerbation had also followed a flu shot. She also had recurrence of bilateral uveitis. She was hospitalized and treated with intravenous adrenocorticotropin hormone (ACTH) followed by tapering doses of prednisone. Again she improved, but incompletely. The 6-MP was increased to 150 mg/day and she required larger doses of steroids, becoming very cushingoid. One year after the diagnosis of UC (ulcerative colitis) was established the chronicity of her illness and the complications of steroids warranted surgical intervention. She underwent a total colectomy with establishment of an ileoanal pouch anastomosis. Pathology confirmed the presence of a universal UC and there was no involvement of the terminal ileum. After 1 year with intermittent pouchitis, the pouch and the ileum looked normal. Reporters comment: We acknowledge that the case presented here is probably 1 out of many inflammatory bowel disease patients on 6-MP who received the flu vaccine. Perhaps it was an IgE-mediated reaction (egg allergy). However, we suggest that this case not be ignored since the outcome is a sobering reality.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Ulcer, Uveitis
Clinical narrative: This literature report concerns a 52-year-old female patient. In her past medical history she had been passing bloody mucus intermittently for 3 years before a diagnosis of ulcerative proctitis was made at colonoscopy. She improved on sulfasalazine and hydrocortisone enemas, but after stopping medication she had recurrent rectal bleeding and coincident uveitis. She was then treated with oral prednisone and the sulfasalazine was restarted. Sigmoidoscopy showed more extensive friability and exudate and she was hospitalized for intravenous hydrocortisone. The patient was also started on 6-MP at 50 mg/day. She improved quickly and was discharged on sulfasalazine, tapering doses of prednisone, and an increase in 6-MP to 100 mg/day. The sigmoidoscopic appearance had been normal for 4 months when symptoms worsened, with loosening of the stools and reappearance of blood per rectum. On flexible sigmoidoscopy, mucosal friability and edema were again found in the rectum and rectosigmoid. After 3 more months on 6-MP during which the dose was reduced to 50 mg/day because of leukopenia, she was much improved, having formed stools with normal mucosa throughout at colonoscopy. On an unknown date, after 9 months of 6-MP and while in remission, the patient received a subcutaneous injection of influenza vaccine (manufacturer unknown). That night the patient developed abdominal pain and bloody diarrhea and was hospitalized. On examination she had very active UC with friability, ulceration, and exudate. She stated that her earlier exacerbation had also followed a flu shot. She also had recurrence of bilateral uveitis. She was hospitalized and treated with intravenous adrenocorticotropin hormone (ACTH) followed by tapering doses of prednisone. Again she improved, but incompletely. The 6-MP was increased to 150 mg/day and she required larger doses of steroids, becoming very cushingoid. One year after the diagnosis of UC (ulcerative colitis) was established the chronicity of her illness and the complications of steroids warranted surgical intervention. She underwent a total colectomy with establishment of an ileoanal pouch anastomosis. Pathology confirmed the presence of a universal UC and there was no involvement of the terminal ileum. After 1 year with intermittent pouchitis, the pouch and the ileum looked normal. Reporters comment: We acknowledge that the case presented here is probably 1 out of many inflammatory bowel disease patients on 6-MP who received the flu vaccine. Perhaps it was an IgE-mediated reaction (egg allergy). However, we suggest that this case not be ignored since the outcome is a sobering reality.
Age: 19.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Death, Pneumonia, Respiratory failure
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 (3 of 10) concerns a 19-year-old female patient, who had a medical history of Rett syndrome and severe muscle wasting/physical disability. The patient died of Bilateral pneumonia and respiratory failure, nine 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: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Blood creatine phosphokinase increased, Blood creatinine increased, Cellulitis, Compartment syndrome, Computerised tomogram abdomen abnormal
Clinical narrative: This literature report concerns a 74-year-old male patient with left arm swelling, pain and numbness for the last 1 month. His medical history was significant for renal cell cancer (RCC), which was diagnosed 5 years ago. Appropriate staging was performed at that time which was T2N0M0. Because of absence of disseminated disease, nephrectomy was recommended. The patient underwent left sided nephrectomy and was discharged home. Two months before current admission, the patient received a flu shot (manufacturer unknown) in left upper arm and developed left arm swelling, pain and erythema. He was admitted to hospital and treated for cellulitis for 2 days, and then he was discharged home on oral antibiotics. He improved temporarily and then presented again 1 month after discharge (current admission) with similar complaints. On physical examination, the patient had severe edema involving the entire left upper extremity extending from shoulder to the finger tips. There was oozing of serous fluid without any open wounds along with an area of bluish discoloration in left upper arm. On palpation, he had an area of induration on the anterior aspect of left upper arm and palpable left axillary lymph nodes. On vascular examination, distal radial pulses were present. On neurologic examination, he had decreased sensation of the left arm along with complete wrist drop and inability to perform hand grip. Initial laboratory studies showed serum creatinine of 1.63 mg/dL, creatinine kinase 236 units/L, leukocytes count of 13.2 k/uL, hemoglobin of 11.9 g/dL and platelets count of 55 k/uL. Ultrasound of left upper extremity failed to reveal deep venous thrombosis but did show a large hematoma measuring 13.8 x 7 cm. An initial diagnosis of compartment syndrome with wrist drop was made. The patient was taken to the operating room immediately. He underwent open fasciotomy with incision and drainage. A total of 200 mL of serous fluid was drained, and no pockets of abscess or hematoma were found. Histopathological and microbiological specimens from biceps muscle were obtained. Results showed metastatic RCC in the left upper arm of clear cell type. The patient also underwent radiological imaging including computed tomography scan of abdomen that was consistent with developing metastatic lesions in liver. The event outcome was not reported.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Fasciotomy, Grip strength decreased, Haemoglobin decreased, Hypoaesthesia
Clinical narrative: This literature report concerns a 74-year-old male patient with left arm swelling, pain and numbness for the last 1 month. His medical history was significant for renal cell cancer (RCC), which was diagnosed 5 years ago. Appropriate staging was performed at that time which was T2N0M0. Because of absence of disseminated disease, nephrectomy was recommended. The patient underwent left sided nephrectomy and was discharged home. Two months before current admission, the patient received a flu shot (manufacturer unknown) in left upper arm and developed left arm swelling, pain and erythema. He was admitted to hospital and treated for cellulitis for 2 days, and then he was discharged home on oral antibiotics. He improved temporarily and then presented again 1 month after discharge (current admission) with similar complaints. On physical examination, the patient had severe edema involving the entire left upper extremity extending from shoulder to the finger tips. There was oozing of serous fluid without any open wounds along with an area of bluish discoloration in left upper arm. On palpation, he had an area of induration on the anterior aspect of left upper arm and palpable left axillary lymph nodes. On vascular examination, distal radial pulses were present. On neurologic examination, he had decreased sensation of the left arm along with complete wrist drop and inability to perform hand grip. Initial laboratory studies showed serum creatinine of 1.63 mg/dL, creatinine kinase 236 units/L, leukocytes count of 13.2 k/uL, hemoglobin of 11.9 g/dL and platelets count of 55 k/uL. Ultrasound of left upper extremity failed to reveal deep venous thrombosis but did show a large hematoma measuring 13.8 x 7 cm. An initial diagnosis of compartment syndrome with wrist drop was made. The patient was taken to the operating room immediately. He underwent open fasciotomy with incision and drainage. A total of 200 mL of serous fluid was drained, and no pockets of abscess or hematoma were found. Histopathological and microbiological specimens from biceps muscle were obtained. Results showed metastatic RCC in the left upper arm of clear cell type. The patient also underwent radiological imaging including computed tomography scan of abdomen that was consistent with developing metastatic lesions in liver. The event outcome was not reported.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Incisional drainage, Injection site discharge, Injection site discolouration, Injection site haematoma, Injection site induration
Clinical narrative: This literature report concerns a 74-year-old male patient with left arm swelling, pain and numbness for the last 1 month. His medical history was significant for renal cell cancer (RCC), which was diagnosed 5 years ago. Appropriate staging was performed at that time which was T2N0M0. Because of absence of disseminated disease, nephrectomy was recommended. The patient underwent left sided nephrectomy and was discharged home. Two months before current admission, the patient received a flu shot (manufacturer unknown) in left upper arm and developed left arm swelling, pain and erythema. He was admitted to hospital and treated for cellulitis for 2 days, and then he was discharged home on oral antibiotics. He improved temporarily and then presented again 1 month after discharge (current admission) with similar complaints. On physical examination, the patient had severe edema involving the entire left upper extremity extending from shoulder to the finger tips. There was oozing of serous fluid without any open wounds along with an area of bluish discoloration in left upper arm. On palpation, he had an area of induration on the anterior aspect of left upper arm and palpable left axillary lymph nodes. On vascular examination, distal radial pulses were present. On neurologic examination, he had decreased sensation of the left arm along with complete wrist drop and inability to perform hand grip. Initial laboratory studies showed serum creatinine of 1.63 mg/dL, creatinine kinase 236 units/L, leukocytes count of 13.2 k/uL, hemoglobin of 11.9 g/dL and platelets count of 55 k/uL. Ultrasound of left upper extremity failed to reveal deep venous thrombosis but did show a large hematoma measuring 13.8 x 7 cm. An initial diagnosis of compartment syndrome with wrist drop was made. The patient was taken to the operating room immediately. He underwent open fasciotomy with incision and drainage. A total of 200 mL of serous fluid was drained, and no pockets of abscess or hematoma were found. Histopathological and microbiological specimens from biceps muscle were obtained. Results showed metastatic RCC in the left upper arm of clear cell type. The patient also underwent radiological imaging including computed tomography scan of abdomen that was consistent with developing metastatic lesions in liver. The event outcome was not reported.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site oedema, Laboratory test abnormal, Lymph node palpable, Metastases to liver, Metastatic renal cell carcinoma
Clinical narrative: This literature report concerns a 74-year-old male patient with left arm swelling, pain and numbness for the last 1 month. His medical history was significant for renal cell cancer (RCC), which was diagnosed 5 years ago. Appropriate staging was performed at that time which was T2N0M0. Because of absence of disseminated disease, nephrectomy was recommended. The patient underwent left sided nephrectomy and was discharged home. Two months before current admission, the patient received a flu shot (manufacturer unknown) in left upper arm and developed left arm swelling, pain and erythema. He was admitted to hospital and treated for cellulitis for 2 days, and then he was discharged home on oral antibiotics. He improved temporarily and then presented again 1 month after discharge (current admission) with similar complaints. On physical examination, the patient had severe edema involving the entire left upper extremity extending from shoulder to the finger tips. There was oozing of serous fluid without any open wounds along with an area of bluish discoloration in left upper arm. On palpation, he had an area of induration on the anterior aspect of left upper arm and palpable left axillary lymph nodes. On vascular examination, distal radial pulses were present. On neurologic examination, he had decreased sensation of the left arm along with complete wrist drop and inability to perform hand grip. Initial laboratory studies showed serum creatinine of 1.63 mg/dL, creatinine kinase 236 units/L, leukocytes count of 13.2 k/uL, hemoglobin of 11.9 g/dL and platelets count of 55 k/uL. Ultrasound of left upper extremity failed to reveal deep venous thrombosis but did show a large hematoma measuring 13.8 x 7 cm. An initial diagnosis of compartment syndrome with wrist drop was made. The patient was taken to the operating room immediately. He underwent open fasciotomy with incision and drainage. A total of 200 mL of serous fluid was drained, and no pockets of abscess or hematoma were found. Histopathological and microbiological specimens from biceps muscle were obtained. Results showed metastatic RCC in the left upper arm of clear cell type. The patient also underwent radiological imaging including computed tomography scan of abdomen that was consistent with developing metastatic lesions in liver. The event outcome was not reported.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Microbiology test abnormal, Neurological examination abnormal, Oedema peripheral, Pain in extremity, Platelet count decreased
Clinical narrative: This literature report concerns a 74-year-old male patient with left arm swelling, pain and numbness for the last 1 month. His medical history was significant for renal cell cancer (RCC), which was diagnosed 5 years ago. Appropriate staging was performed at that time which was T2N0M0. Because of absence of disseminated disease, nephrectomy was recommended. The patient underwent left sided nephrectomy and was discharged home. Two months before current admission, the patient received a flu shot (manufacturer unknown) in left upper arm and developed left arm swelling, pain and erythema. He was admitted to hospital and treated for cellulitis for 2 days, and then he was discharged home on oral antibiotics. He improved temporarily and then presented again 1 month after discharge (current admission) with similar complaints. On physical examination, the patient had severe edema involving the entire left upper extremity extending from shoulder to the finger tips. There was oozing of serous fluid without any open wounds along with an area of bluish discoloration in left upper arm. On palpation, he had an area of induration on the anterior aspect of left upper arm and palpable left axillary lymph nodes. On vascular examination, distal radial pulses were present. On neurologic examination, he had decreased sensation of the left arm along with complete wrist drop and inability to perform hand grip. Initial laboratory studies showed serum creatinine of 1.63 mg/dL, creatinine kinase 236 units/L, leukocytes count of 13.2 k/uL, hemoglobin of 11.9 g/dL and platelets count of 55 k/uL. Ultrasound of left upper extremity failed to reveal deep venous thrombosis but did show a large hematoma measuring 13.8 x 7 cm. An initial diagnosis of compartment syndrome with wrist drop was made. The patient was taken to the operating room immediately. He underwent open fasciotomy with incision and drainage. A total of 200 mL of serous fluid was drained, and no pockets of abscess or hematoma were found. Histopathological and microbiological specimens from biceps muscle were obtained. Results showed metastatic RCC in the left upper arm of clear cell type. The patient also underwent radiological imaging including computed tomography scan of abdomen that was consistent with developing metastatic lesions in liver. The event outcome was not reported.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Radial nerve palsy, Secretion discharge, Sensory disturbance, Ultrasound scan abnormal, White blood cell count increased
Clinical narrative: This literature report concerns a 74-year-old male patient with left arm swelling, pain and numbness for the last 1 month. His medical history was significant for renal cell cancer (RCC), which was diagnosed 5 years ago. Appropriate staging was performed at that time which was T2N0M0. Because of absence of disseminated disease, nephrectomy was recommended. The patient underwent left sided nephrectomy and was discharged home. Two months before current admission, the patient received a flu shot (manufacturer unknown) in left upper arm and developed left arm swelling, pain and erythema. He was admitted to hospital and treated for cellulitis for 2 days, and then he was discharged home on oral antibiotics. He improved temporarily and then presented again 1 month after discharge (current admission) with similar complaints. On physical examination, the patient had severe edema involving the entire left upper extremity extending from shoulder to the finger tips. There was oozing of serous fluid without any open wounds along with an area of bluish discoloration in left upper arm. On palpation, he had an area of induration on the anterior aspect of left upper arm and palpable left axillary lymph nodes. On vascular examination, distal radial pulses were present. On neurologic examination, he had decreased sensation of the left arm along with complete wrist drop and inability to perform hand grip. Initial laboratory studies showed serum creatinine of 1.63 mg/dL, creatinine kinase 236 units/L, leukocytes count of 13.2 k/uL, hemoglobin of 11.9 g/dL and platelets count of 55 k/uL. Ultrasound of left upper extremity failed to reveal deep venous thrombosis but did show a large hematoma measuring 13.8 x 7 cm. An initial diagnosis of compartment syndrome with wrist drop was made. The patient was taken to the operating room immediately. He underwent open fasciotomy with incision and drainage. A total of 200 mL of serous fluid was drained, and no pockets of abscess or hematoma were found. Histopathological and microbiological specimens from biceps muscle were obtained. Results showed metastatic RCC in the left upper arm of clear cell type. The patient also underwent radiological imaging including computed tomography scan of abdomen that was consistent with developing metastatic lesions in liver. The event outcome was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Condition aggravated, Death, Influenza A virus test negative, Pulmonary embolism
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 (5 of 10) concerns a 46-year-old female patient, who had a medical history of hypertension, hyperlipidemia, pulmonary embolism and deep vein thrombosis. The patient died of pulmonary embolus (negative for H1N1 in lung tissue) two days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine;manufacturer: unknown). VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipts 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: 56.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Accidental death, Road traffic accident
Clinical narrative: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involve 2 children, 7 adults and 1 elderly reported. This case (7 of 10) concerns a 56-year-old female patient, who was involved in motor vehicle crash leaving clinic after H1N1 vaccination and died of trauma. Vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Time to onset was 0 day. Reporter's comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of death 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: FLUX(H1N1)
Symptoms: CSF immunoglobulin G index, CSF white blood cell count increased, Demyelination, Gait disturbance, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This literature report concerns a previously healthy 14 year-old male patient. On an unknown date the patient received H1N1 (manufacturer unknown). Two weeks after receiving the vaccine the patient developed a 7-10 day history of urinary retention, progressive sensory and gait abnormalities. T2-weighted MRI (magnetic resonance imaging) scan of the brain and spine revealed longitudinally extensive demyelinating lesions of the cervical/thoracic cord with marked cord swelling together with multiple smaller hyperintensities in the brain. Cerebrospinal fluid revealed WBC (white blood cell) 1295/mm3 and IgG index was 0.65. The event outcome was not reported. Reporter's comment: Neurologic complications of H1N1 vaccine are rare, but may occur. Further studies are needed to help clarify the incidence of demyelinating complications related to this vaccine as well as the environmental, genetic and other risk factors of acute demyelination in children.
Age: 14.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Nuclear magnetic resonance imaging spinal cord abnormal, Sensory disturbance, Spinal cord oedema, Urinary retention
Clinical narrative: This literature report concerns a previously healthy 14 year-old male patient. On an unknown date the patient received H1N1 (manufacturer unknown). Two weeks after receiving the vaccine the patient developed a 7-10 day history of urinary retention, progressive sensory and gait abnormalities. T2-weighted MRI (magnetic resonance imaging) scan of the brain and spine revealed longitudinally extensive demyelinating lesions of the cervical/thoracic cord with marked cord swelling together with multiple smaller hyperintensities in the brain. Cerebrospinal fluid revealed WBC (white blood cell) 1295/mm3 and IgG index was 0.65. The event outcome was not reported. Reporter's comment: Neurologic complications of H1N1 vaccine are rare, but may occur. Further studies are needed to help clarify the incidence of demyelinating complications related to this vaccine as well as the environmental, genetic and other risk factors of acute demyelination in children.
Age: 61.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Bacterial sepsis, Cardio-respiratory arrest, Death
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. This case (9 of 10) concerns a 61-year-old male patient, who had a medical history of hypertension, diabetes, peripheral vascular disease and end stage renal disease. The patient died of cardiac / respiratory arrest and gram-negative sepsis, 13 days after H1N1 vaccination (type: monovalent, inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comments: 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: 77.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Death, Myocardial infarction
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. This case (10 of 10) concerns a 77-year-old male patient, who had a medical history of lung cancer, atrial fibrillation, recurrent deep venous thrombosis, hypertension and hyperlipidemia. The patient died of suspected myocardial infarction, two 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: 10.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blindness, CSF oligoclonal band absent, CSF protein normal, CSF white blood cell count positive, Central nervous system lesion
Clinical narrative: This literature case concerns a previously healthy 10 year-old male patient. On an unknown date the patient received H1N1 (manufacturer unknown). One week after receiving the vaccine the patient developed bilateral, progressive visual loss over 48 hours. Visual Evoked Response showed markedly delayed p100 bilaterally. MRI (magnetic resonance imaging) scan of the brain and spine showed multiple demyelinating lesions in the brain. Cerebrospinal fluid revealed RBC (red blood cell) 1/mm3, WBC (white blood cell) 14/mm3, and protein 66 mg/dl. Oligoclonal bands were negative. The event outcome was not reported. Reporter's comment: Neurologic complications of H1N1 vaccine are rare, but may occur. Further studies are needed to help clarify the incidence of demyelinating complications related to this vaccine as well as the environmental, genetic and other risk factors of acute demyelination in children.
Age: 10.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Demyelination, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Red blood cells CSF positive, Visual evoked potentials abnormal
Clinical narrative: This literature case concerns a previously healthy 10 year-old male patient. On an unknown date the patient received H1N1 (manufacturer unknown). One week after receiving the vaccine the patient developed bilateral, progressive visual loss over 48 hours. Visual Evoked Response showed markedly delayed p100 bilaterally. MRI (magnetic resonance imaging) scan of the brain and spine showed multiple demyelinating lesions in the brain. Cerebrospinal fluid revealed RBC (red blood cell) 1/mm3, WBC (white blood cell) 14/mm3, and protein 66 mg/dl. Oligoclonal bands were negative. The event outcome was not reported. Reporter's comment: Neurologic complications of H1N1 vaccine are rare, but may occur. Further studies are needed to help clarify the incidence of demyelinating complications related to this vaccine as well as the environmental, genetic and other risk factors of acute demyelination in children.
Age: 49.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cardiovascular disorder, 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 (6 of 10) concerns a 49-year-old patient, who had a medical history of Type 2 diabetes, stroke, chronic obstructive pulmonary disease, emphysema and substance abuse. The patient died of a suspected cardiovascular event three days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacturer: 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: 53.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: 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 (7 of 10) concerns a 53-year-old female patient, who had a medical history of end-stage renal disease and atrial fibrillation. The patient died (of unknown cause) (under review), five 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).
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Arthritis, Condition aggravated
Clinical narrative: This literature report concerns a prospective study on safety and efficacy of H1N1 vaccination in children with chronic inflammatory rheumatic diseases. Patients who had received at least one dose of the H1N1, were included. Fifty six (54%) of the subjects received the vaccine in the clinic and were assessed prospectively; the remainder received their vaccinations elsewhere are were administered questionnaires during their clinic visit. Information gathered included vaccination side effects and the incidence of flu in study subjects. A male patient (further identification not available) developed a flare of his arthritis following the immunization. Time to onset is not clear but reporter stated the event occurred within 6 months. The patient did not have persistent sequelae or complications requiring hospitalization. The event outcome was not reported. Reporter's comment: H1N1 was well tolerated and apparently effective in children with chronic inflammatory rheumatic diseases. The findings support the recommendation that children with rheumatologic conditions should receive the H1N1 vaccine.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Vaccine was administered IM to patient in right arm and nurse noticed right arm swelling, below the vaccine site.  Cool compress was provided.  Patient stated they previously had vaccine and never experienced this reaction.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test normal, Insomnia, Nausea
Clinical narrative: Nausea, unable to sleep. Nausea is now 24hrs a day. No vomiting.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site itched patient at 7pm 4/25/12. Per mother redness and swelling and heat at injection site in Left Deltoid noted the next morning about 8am 4/26/12.
Age: 1.73
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Mother called 4/27/12 per advise of CNP. On 4/19/2012 child received 2nd dose of Hep A IM in Left Thigh. That evening, the child developed a rash under her left arm. The rash progressed and the mother took the child to CNP on 4/23. No cause identified. No fever. Rash limited area underarm and behind knees but pruritis causing child to scratch intensely. 4/27 CNP ordered steroid for child and ask mother to call Health Department.
Age: 9.0
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Cataplexy, Narcolepsy, Somnolence, Weight increased
Clinical narrative: This literature report concerns a case of a 9-year-old patient (further identification not available) from a series (16 cases) among patients treated for narcolepsy in three major centers of reference for narcolepsy. All cases were HLA DQB1*0602 positive with severe sleepiness and definite/severe cataplexy. The most striking features of the sample were the abrupt onset and the unusual severity of both sleepiness and cataplexy. Rapid weight gain was frequently noted, as is typical with abrupt onset cases. This case potentially involved CSL product (unbranded H1N1 / no adjuvant (injectable)). Date of vaccination was 12-Sep-2009. Date of EDS (excessive daytime somnolence) was 01-Oct-2009. Date of cataplexy was 01-Oct-2009. Time between H1N1 exposure to cataplexy onset was 2 weeks. All cases were examined for past H1N1 exposure or vaccination. The event outcome was not reported. Reporters comment: Cases reported here with their temporal link between vaccination and disease onset and unusual clinical presentation, with rapid development and severity of both excessive daytime somnolence and cataplexy, suggest that H1N1 vaccination or exposure may trigger narcolepsy. However, there are several limitations and potential confounding factors, such as increased awareness of narcolepsy and more efficient diagnostic processes leading to faster diagnosis and increased identification of recent-onset cases. Another limitation is that a large portion of the population was either vaccinated or had H1N1 infection, including many unrecognized instances of infection, increasing the difficulty to document a specific association between narcolepsy onset and H1N1 infection or vaccination.
Age: 0.34
Sex: M
Vaccine: DTAPH
Symptoms: Injection site warmth, Nasal congestion, Pyrexia, Somnolence
Clinical narrative: Fever 100.2 at 12:30 AM, gave Tylenol. At 6 AM fever went up to 101.1, gave Tylenol. At 10 AM fever rose to 103.7, gave Tylenol. Also dressed infant in only diaper and onesie with a cool cloth on head/neck. Very sleepy. Other side affects included stuffy nose and injection area warm to touch. Still treating infant for fever today.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV, PNC13, VARCEL
Symptoms: Crying, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Mom stated site discomfort day of vaccinations but she noticed the next morning 4/26/12 site redness and patient cried when anyone touched it. No heat or swelling noted. Gave cold compress with Tylenol instructions.  I told mother this was caused by combining the Prevnar and flu in the same arm and since she will not be getting any more Prevnar, this reaction should not reoccur with her next flu vaccine.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site erythema, Injection site warmth, Oedema peripheral, Pain in extremity
Clinical narrative: Pt reports that she started experiencing severe pain in her left arm about 3 hrs after vaccination. She states this pain remained in severe intensity for about 4 days following, then slowly resolved. She also complained of redness at injection site, mild warmth at site achiness in her deltoid region and top of forearm into top of hand with occasional burning sensations. She states upper arm area was "swollen and bumpy". She did remark she felt that vaccine was given "to the side" of deltoid.
Age: 1.61
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: VOMITING, FEVER, RASH.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Rash, Swelling
Clinical narrative: Swelling, rash, pain.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Patient spoke with PCP on 4/20/12. She reported that she had a febrile reaction to Tdap along with chills and myalgias that lasted a few days. Pt has had boosters in the past without problems. ? relation to Pertussis component?
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient asked for a flu shot; flu shot was admin in left deltoid. Patient tolerated vaccine well. - 1 checked pt. file and noticed pt received a INFLUENZA vaccine 10/5/2011. FLULAVAL: AFLLA664BA manufacturer: GlaxoSmithKline.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Vaccination site swelling
Clinical narrative: Area Red approx. 2-3 inches round. Arm swollen in area of vaccination. Some itching.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Vertigo, Visual impairment
Clinical narrative: Severe HA, vision disturbance, nausea, vertigo.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis, Leukocytoclastic vasculitis, Purpura, Rash
Clinical narrative: Developed severe purpuric "rash" on legs diagnosed by dermatologist as hypersensitivity vasculitis most likely cause being Tdap vaccine. Treated with steroids. Then dealt with severe joint inflammation lasting for more than a month. With occasional vasculitis flares affecting the lower legs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Petechiae
Clinical narrative: Petechiae around eyes and on forehead.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient developed a fever to 102.7 the night after the vaccine was given and had significant left leg pain (4 of shots given in left thigh with 1 approximately 3 inches above the knee). Returned to clinic the next day for evaluation and no other source of fever identified.