chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pustular, Skin lesion, Skin warm, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 57 year old female patient who was developmentally disabled history of seizure disorder. Current conditions included diabetes, asthma and allergic to SYMMETREL and "cholerasol". The patient's medical history included positive paratoloid (PPD) with no active tuberculosis (TB). On 10-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose not reported, subcutaneously). Concomitant medication included "multiple medications" including steroid inhaler. On an unknown date in December 2013 the patient developed a local reaction just below the site of the injection. The reaction appeared to be a large inflamed lesion on her arm now spreading to the patient's face and torso, with the appearance of chicken pox. Initially the localized reaction was described as a lesion: circular, macular, erythematous and slightly indurated, enlarging over several day reaching a maximum diameter of 7-8 centimeters in diameter. The rash on her face and torso appeared on an unspecified date as macular lesions, with vesicular papules in the center. There was no fever. Initially physician prescribed KEFLEX for a day or two on an unspecified date for the localized reaction, as the physician that it may be cellulitis. As the rash continued to develop and become systemic, the physician prescribed SEPTRA on an unspecified date. No lab work completed. The patient sought medical attention. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Induration, Local reaction, Rash macular, Rash papular
Clinical narrative: This spontaneous report as received from a physician refers to a 57 year old female patient who was developmentally disabled history of seizure disorder. Current conditions included diabetes, asthma and allergic to SYMMETREL and "cholerasol". The patient's medical history included positive paratoloid (PPD) with no active tuberculosis (TB). On 10-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose not reported, subcutaneously). Concomitant medication included "multiple medications" including steroid inhaler. On an unknown date in December 2013 the patient developed a local reaction just below the site of the injection. The reaction appeared to be a large inflamed lesion on her arm now spreading to the patient's face and torso, with the appearance of chicken pox. Initially the localized reaction was described as a lesion: circular, macular, erythematous and slightly indurated, enlarging over several day reaching a maximum diameter of 7-8 centimeters in diameter. The rash on her face and torso appeared on an unspecified date as macular lesions, with vesicular papules in the center. There was no fever. Initially physician prescribed KEFLEX for a day or two on an unspecified date for the localized reaction, as the physician that it may be cellulitis. As the rash continued to develop and become systemic, the physician prescribed SEPTRA on an unspecified date. No lab work completed. The patient sought medical attention. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pruritus
Clinical narrative: Extreme itching at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: KINRIX given 1 - 6 -14 (R) deltoid/upper arm swollen, red and warm starting 1 - 7 - 14 (evening).
Sex: F
Vaccine: HPV4
Symptoms: Tourette's disorder
Clinical narrative: This spontaneous report as received from a physician who saw on the internet (using Google) refers to a female patient (school girl) of unknown age. A couple years ago on an unknown date the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date unknown) and then developed Tourette's Syndrome. The outcome of the event was unknown. The physician had no further information about this school girl or the name of the website where he saw this report. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Tourette's disorder
Clinical narrative: This spontaneous report as received from a physician who saw on the internet (using Google) refers to a female patient (school girl) of unknown age. A couple years ago on an unknown date the patient was vaccinated with GARDASIL (dose, route lot # and expiration date unknown) and then developed Tourette's Syndrome. The outcome of the event was unknown. The physician had no further information about this school girl or the name of the website where he saw this report. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Tourette's disorder
Clinical narrative: This spontaneous report as received from a physician who saw the internet (using Google) refers to a female patient (school girl) of unknown age. A couple of years ago on an unknown date the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date unknown) and then developed Tourette's Syndrome. The outcome of the event was unknown. The physician had no further information about this school girl or the name of the website where he saw this report. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Tourette's disorder
Clinical narrative: This spontaneous report as received from a physician who saw on the internet refers to a female patient (school girl) of unknown age. A couple years ago on an unknown date the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date unknown) and then developed Tourette's Syndrome. The outcome of the event was unknown. The physician had no further information about this school girl or the name of the website where he saw this report. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a female patient of unknown age with vaccination. Patient had no drug allergies. On 06-JAN-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J009827 and expiry date 10-AUG-2014, 0.5 m, intramuscular in the left arm. On 07-JAN-2014, patient developed a large red, warm, tender, swollen area at the injection site. It was reported that patient visited office and received BENADRYL for the treatment of events. No laboratory diagnostic study was performed. The outcome of a large, red, warm, tender, swollen area at the injection site was reported as not recovered/not resolved. No further information provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient of unknown age. On an unknown date in May 2010, the patient was vaccinated with CERVARIX. On an unknown date in July 2013, the patient was vaccinated with GARDASIL dose 2. No concomitant medications were reported. No adverse symptoms reported. Outcome and causality were not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient reporting on herself. On 20-DEC-2013, the patient was vaccinated with VARIVAX (Merck) injection 1 shot. Approximately on 26-DEC-2013, 6 days after she had received the chicken pox vaccine, the patient had a positive ovulation and could potentially be pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) is not known. No adverse experiences were reported. The outcome of the events and causality assessment were not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer regarding her brother (patient) of unknown age. Approximately on an unknown date in 2008 (also reported as about 5 to 6 years ago) the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified). Approximately on an unknown date in 2014 (also reported as now he has shingles) the patient experienced shingles. In addition, the reporter stated that she had also received ZOSTAVAX, but she does not know if she has had shingles before receiving ZOSTAVAX. There was no product quality complaint (PQC) involved. The outcome of shingles was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical technologist (MT) via a company representative refers to approximately 78 year old female patient. On 09-NOV-2013, at an unspecified location the patient was administered with a dose of ZOSTAVAX dose 1. The dose, route, lot and expiration date were unspecified. Concomitant therapies included amitriptyline hydrochloride, aspirin (manufacturer unknown), atenolol, BENECOL, calcium (unspecified), DIOVAN, vitamins (unspecified), OMEGA-3, PREMARIN, PRILOSEC, probiotics (unspecified), roseada and valacyclovir hydrochloride. It was reported that these medications were listed as daily and may be recently ordered medication. The medical technologist stated that the patient reported to office 6 weeks after injection, around "Christmas time" (unknown date in December 2013) that she developed shingles. It was unspecified if the patient sought medical attention. The outcome of shingles was unknown. MT informed representative that the physician was interested in identifying viral strain from the patient. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous pregnancy report as received from a physician assistant refers to a 19 year old female patient without a pertinent medical history or drug reactions/allergies. The patient became pregnant with LMP of 23-SEP-2013 and EDD of 30-JUN-2014. On 13-DEC-2013 the patient was vaccinated with M-M-R II (albumin status unknown: dose 1, 0.5 ml, intramuscular, lot # J005846: exp date 17-APR-2015) and an unspecified hepatitis a vaccine (manufacturer unknown) (lot # 4G7P2). Concomitant therapies included ZOFRAN (for nausea; as needed) and prenatal vitamins (unspecified). Initial exposure to M-M-R II and unspecified hepatitis a (manufacturer unknown) was at 11 week(s). The outcome of vaccine exposure during pregnancy is unknown. The patient had been receiving OB GYN care through a nurse midwife but she will be switching to an unspecified physician. No symptoms were reported. No treatment was given, no lab diagnostics were performed for the event. Pregnancy outcome is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 02-JAN-2014 the patient was vaccinated with the third dose of GARDASIL. Dose, route and lot number were not provided. No concomitant medications were reported. It was reported that the patient received the first dose of GARDASIL in November 2012 and the second dose of GARDASIL on 16-NOV-2013. This is considered to be a medication error ("Inappropriate schedule of vaccine administered"). No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Blood test normal, Movement disorder, Tourette's disorder
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient with no pertinent medical history or no drug reactions/allergies. On 14-NOV-2013 the patient was vaccinated with the first dose of GARDASIL injection (dose, route, lot # and expiration date unknown) and a dose of FLUMIST (dose, route, manufacturer unknown). There was no concomitant medication. On 17-NOV-2013, 3 days later the patient developed a movement disorder similar to Tourette's Syndrome. Routine blood work was performed on an unknown date which came back normal. The patient possibly received her vaccinations from another doctor but the reporting physician was not sure. The patient had been to the emergency room and was given intravenous ATIVAN. The reporting physician had prescribed INTUNIV. The patient was not recovered from the event at the time of the report. The physician also mentioned that he saw on the internet (using Google) there were 12 school girls who received GARDASIL a couple of years ago and they then developed Tourette's Syndrome (captured in MARRS# 1401USA001712, 1401USA002947, 1401USA002941, 1401USA002942, 1401USA002943, 1401USA002944, 1401USA002945, 1401USA002946, 1401USA002939, 1401USA002938, 1401USA002937, 1401USA002940). He had no further information about these school girls or the name of the website where he saw this report. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 33 year old female patient with diabetes, high cholesterol, unspecified allergies (no drug allergies), asthma and patient had difficulty getting pregnant. On 03-DEC-2013 the patient was vaccinated with ZOSTAVAX lot # J000447 (expiry date April 2014), subcutaneous. The patient did not use any concomitant medication. The patient was administered ZOSTAVAX since a coworker of hers had developed shingles. On 20-DEC-2013 the patient returned to physician's office stating that she was pregnant (first trimester exposure) and her last menstrual period (LMP) was on unspecified dates during the second week of November 2013. No treatment was given. No lab diagnostics studies were performed. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a number of unspecified patients (demographics unknown). On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route and lot number were not reported). Concomitant medication was not reported. The doses of RECOMBIVAX HB were exposed to a lowest temperature of 24.2 F for "42 minutes". The healthcare worker will confirm the actual time that the vaccines were below 36F, since it was unlikely that the total time below 36 F was only 1 hour. No adverse effect was reported. This case is linked to MARRS# 1401USA002521 and 1401USA003228 by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a number of unspecified patients (demographics unknown). On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (dose, route and lot number were not reported). Concomitant medication was not reported. The doses of GARDASIL were exposed to a lowest temperature of 24.2 for "42 minutes". The healthcare worker will confirm the actual time that the vaccines were below 36F, since it was unlikely that the total time below 36 F was only 1 hour. No adverse effect was reported. This case is linked to MARRS# 1401USA003227 and 1401USA003228 by the same reporter. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Red spot below area where shot was given and soreness.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a number of unspecified patients (demographics unknown). On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, route and lot number were not reported). Concomitant medication was not reported. The doses of PEDVAXHIB  were exposed to lowest temperature of 24.2 F for "42 minutes". The healthcare worker will confirm the actual time that the vaccines were below 36F, since it was unlikely that the total time below 36 F was only 1 hour. No adverse effect was reported. This case is linked to MARRS# 1401USA002521 and 1401USA003227 by the same reporter. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: Patient experienced nausea and dizziness upon taking 1, 2, 3 capsules.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Pt had the flu vaccine before with no reaction. Pt stated that she thinks last time was not FLUZONE HD, but at the same time she was on antibiotic therapy. Dr was trying to rule out if the allergic reaction was to antibiotic hx and not from FLUZONE.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Nystagmus
Clinical narrative: Nystagmus.
Sex: F
Vaccine: FLUX
Symptoms: Acute disseminated encephalomyelitis, Anti-NMDA antibody negative, Asthenia, Bacterial test negative, CSF cell count increased
Clinical narrative: Case number PHHY2013US154709, is an initial literature report received on 31 Dec 2013. The authors discussed about a case of acute disseminated encephalomyelitis (ADEM) as a rare complication post influenza vaccination. This report refers to an 83-year-old female patient. Past medical history included hypertension, ischemic stroke and diabetes. Concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Five days after vaccination, she presented to a hospital with a two day history of altered mental status, weakness and fever. She was admitted to the hospital. On examination, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. On an unknown date computed tomogram of the head was performed and it was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). She was treated with broad spectrum antibiotics for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. On an unknown date, magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, polymerase chain reaction (PCR) for herpes simplex virus, varicella-zoster virus, human herpes virus 6, enterovirus, JC and BK viruses; anti-N-methyl-D-aspartate (NMDA) receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, human immune virus and quantiferon-TB were also negative. She was given a diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. She was treated with steroids, however she did not respond and she required plasmapheresis. It was reported that she showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The author concluded that ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. However, the author stated that in this case it was very likely the patient had post-vaccination ADEM.
Sex: F
Vaccine: FLUX
Symptoms: CSF glucose increased, CSF protein increased, Computerised tomogram head normal, Depressed level of consciousness, Encephalitis
Clinical narrative: Case number PHHY2013US154709, is an initial literature report received on 31 Dec 2013. The authors discussed about a case of acute disseminated encephalomyelitis (ADEM) as a rare complication post influenza vaccination. This report refers to an 83-year-old female patient. Past medical history included hypertension, ischemic stroke and diabetes. Concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Five days after vaccination, she presented to a hospital with a two day history of altered mental status, weakness and fever. She was admitted to the hospital. On examination, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. On an unknown date computed tomogram of the head was performed and it was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). She was treated with broad spectrum antibiotics for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. On an unknown date, magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, polymerase chain reaction (PCR) for herpes simplex virus, varicella-zoster virus, human herpes virus 6, enterovirus, JC and BK viruses; anti-N-methyl-D-aspartate (NMDA) receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, human immune virus and quantiferon-TB were also negative. She was given a diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. She was treated with steroids, however she did not respond and she required plasmapheresis. It was reported that she showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The author concluded that ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. However, the author stated that in this case it was very likely the patient had post-vaccination ADEM.
Sex: F
Vaccine: FLUX
Symptoms: Enterovirus test negative, Extensor plantar response, Flow cytometry, Fungal test negative, HIV test negative
Clinical narrative: Case number PHHY2013US154709, is an initial literature report received on 31 Dec 2013. The authors discussed about a case of acute disseminated encephalomyelitis (ADEM) as a rare complication post influenza vaccination. This report refers to an 83-year-old female patient. Past medical history included hypertension, ischemic stroke and diabetes. Concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Five days after vaccination, she presented to a hospital with a two day history of altered mental status, weakness and fever. She was admitted to the hospital. On examination, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. On an unknown date computed tomogram of the head was performed and it was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). She was treated with broad spectrum antibiotics for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. On an unknown date, magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, polymerase chain reaction (PCR) for herpes simplex virus, varicella-zoster virus, human herpes virus 6, enterovirus, JC and BK viruses; anti-N-methyl-D-aspartate (NMDA) receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, human immune virus and quantiferon-TB were also negative. She was given a diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. She was treated with steroids, however she did not respond and she required plasmapheresis. It was reported that she showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The author concluded that ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. However, the author stated that in this case it was very likely the patient had post-vaccination ADEM.
Sex: F
Vaccine: FLUX
Symptoms: Herpes simplex serology negative, Human herpes virus 6 serology negative, Hyperreflexia, Laboratory test normal, Mechanical ventilation
Clinical narrative: Case number PHHY2013US154709, is an initial literature report received on 31 Dec 2013. The authors discussed about a case of acute disseminated encephalomyelitis (ADEM) as a rare complication post influenza vaccination. This report refers to an 83-year-old female patient. Past medical history included hypertension, ischemic stroke and diabetes. Concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Five days after vaccination, she presented to a hospital with a two day history of altered mental status, weakness and fever. She was admitted to the hospital. On examination, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. On an unknown date computed tomogram of the head was performed and it was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). She was treated with broad spectrum antibiotics for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. On an unknown date, magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, polymerase chain reaction (PCR) for herpes simplex virus, varicella-zoster virus, human herpes virus 6, enterovirus, JC and BK viruses; anti-N-methyl-D-aspartate (NMDA) receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, human immune virus and quantiferon-TB were also negative. She was given a diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. She was treated with steroids, however she did not respond and she required plasmapheresis. It was reported that she showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The author concluded that ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. However, the author stated that in this case it was very likely the patient had post-vaccination ADEM.
Sex: F
Vaccine: FLUX
Symptoms: Mental status changes, Mycobacterium tuberculosis complex test negative, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Plasmapheresis
Clinical narrative: Case number PHHY2013US154709, is an initial literature report received on 31 Dec 2013. The authors discussed about a case of acute disseminated encephalomyelitis (ADEM) as a rare complication post influenza vaccination. This report refers to an 83-year-old female patient. Past medical history included hypertension, ischemic stroke and diabetes. Concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Five days after vaccination, she presented to a hospital with a two day history of altered mental status, weakness and fever. She was admitted to the hospital. On examination, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. On an unknown date computed tomogram of the head was performed and it was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). She was treated with broad spectrum antibiotics for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. On an unknown date, magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, polymerase chain reaction (PCR) for herpes simplex virus, varicella-zoster virus, human herpes virus 6, enterovirus, JC and BK viruses; anti-N-methyl-D-aspartate (NMDA) receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, human immune virus and quantiferon-TB were also negative. She was given a diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. She was treated with steroids, however she did not respond and she required plasmapheresis. It was reported that she showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The author concluded that ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. However, the author stated that in this case it was very likely the patient had post-vaccination ADEM.
Sex: F
Vaccine: FLUX
Symptoms: Pleocytosis, Polymerase chain reaction, Pyrexia, Varicella virus test negative, Viral test negative
Clinical narrative: Case number PHHY2013US154709, is an initial literature report received on 31 Dec 2013. The authors discussed about a case of acute disseminated encephalomyelitis (ADEM) as a rare complication post influenza vaccination. This report refers to an 83-year-old female patient. Past medical history included hypertension, ischemic stroke and diabetes. Concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Five days after vaccination, she presented to a hospital with a two day history of altered mental status, weakness and fever. She was admitted to the hospital. On examination, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. On an unknown date computed tomogram of the head was performed and it was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). She was treated with broad spectrum antibiotics for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. On an unknown date, magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, polymerase chain reaction (PCR) for herpes simplex virus, varicella-zoster virus, human herpes virus 6, enterovirus, JC and BK viruses; anti-N-methyl-D-aspartate (NMDA) receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, human immune virus and quantiferon-TB were also negative. She was given a diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. She was treated with steroids, however she did not respond and she required plasmapheresis. It was reported that she showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The author concluded that ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. However, the author stated that in this case it was very likely the patient had post-vaccination ADEM.
Sex: F
Vaccine: FLUX
Symptoms: White matter lesion
Clinical narrative: Case number PHHY2013US154709, is an initial literature report received on 31 Dec 2013. The authors discussed about a case of acute disseminated encephalomyelitis (ADEM) as a rare complication post influenza vaccination. This report refers to an 83-year-old female patient. Past medical history included hypertension, ischemic stroke and diabetes. Concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Five days after vaccination, she presented to a hospital with a two day history of altered mental status, weakness and fever. She was admitted to the hospital. On examination, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. On an unknown date computed tomogram of the head was performed and it was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). She was treated with broad spectrum antibiotics for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. On an unknown date, magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, polymerase chain reaction (PCR) for herpes simplex virus, varicella-zoster virus, human herpes virus 6, enterovirus, JC and BK viruses; anti-N-methyl-D-aspartate (NMDA) receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, human immune virus and quantiferon-TB were also negative. She was given a diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. She was treated with steroids, however she did not respond and she required plasmapheresis. It was reported that she showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The author concluded that ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. However, the author stated that in this case it was very likely the patient had post-vaccination ADEM.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, DTP, FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain in (L) arm, electrical shock shooting down to fingers.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, DTP, FLUX
Symptoms: Activities of daily living impaired, Discomfort, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Pain in (L) arm, electrical shock shooting down to fingers.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a patient's mother refers to a female patient of unknown age. On 15-FEB-2013 the patient was vaccinated with the first dose of GARDASIL, injection (strength, route, lot number and expiration date not provided). On 31-MAY-2013 the patient was vaccinated with the second dose of GARDASIL, injection (strength, route, lot number and expiration date not provided). On 19-AUG-2013 the patient was vaccinated with the third dose of GARDASIL, injection (strength, route, lot number and expiration date not provided). The reporter stated that her daughter received GARDASIL outside of the recommended dosing schedule. No adverse events were reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unknown age female patient. Pertinent medical history, drug allergies or reaction were not reported. In approximately December 2013/January 2014, reported as "within the last month", the patient was vaccinated with ZOSTAVAX, lot # J005849, expiration date: 17-AUG-2014, subcutaneous. Concomitant medication was not reported. On an unknown date, the patient experienced mild local reaction at injection site. The patient developed an itchy, red, tender "knot" with swelling at site of ZOSTAVAX injection. The patient sought medical attention. The patient's symptoms resolved within 4 - 5 days. Causality was not reported. This case is linked to the same reporter MARRS# 1401USA002531 and 1401USA003341. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unknown age female patient. Pertinent medical history, drug allergies or reaction were not reported. In approximately December 2013/January 2014, reported as "within the last month", the patient was vaccinated with ZOSTAVAX, lot # J005849, expiration date: 17-AUG-2014, subcutaneous. Concomitant medication was not reported. On an unknown date, the patient experienced mild local reaction at injection site. The patient developed an itchy, red, tender "knot" with swelling at site of ZOSTAVAX injection. The patient sought medical attention. The patient's symptoms resolved within 4 - 5 days. Causality was not reported. This case is linked to the same reporter MARRS# 1401USA002531 and 1401USA003341. Additional information has been requested.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Crying, Pyrexia
Clinical narrative: Crying and fever of 102.7 degrees.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, FLUN3, HEPA, MMRV, PNC
Symptoms: Unevaluable event
Clinical narrative: NONE.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Rash, Rash erythematous
Clinical narrative: Raised red rash across face with one vesicle. Started on Valtrex but came back negative for shingles.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyskinesia, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Within 5 minutes, flushed face, tightening of throat.  Then I experienced diaphoretic, itching, face swelling, wheezing, jerking movements (could have been from being cold, we don't really know why), nausea, slight cough.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling face, Throat tightness, Wheezing
Clinical narrative: Within 5 minutes, flushed face, tightening of throat.  Then I experienced diaphoretic, itching, face swelling, wheezing, jerking movements (could have been from being cold, we don't really know why), nausea, slight cough.
Age: 21.0
Sex: M
Vaccine: TYP
Symptoms: No adverse event
Clinical narrative: Patient reported to clinic for Typhoid Immunization on 1/9/2014 and stated that he had already received the vaccination numerous times recently. Upon pulling the electronic record, it was found that the initial record of immunization given Feb 2013 for oral typhoid was documented as only the first pill being given. Subsequently causing the patient to populate on the Medical Readiness Reporting System (MRRS) as needing to complete the rest of the oral series although already complete. Patient then returned to the clinic on 12/3/2013 at which time the vaccinator administered injectable typhoid vaccination. When the 12/3/2013 vaccine was documented in the MRRS, it was documented as the 2nd pill in the oral series in turn causing the patient to again remain on the readiness hit list. Patient has had no adverse reation or side effects noted.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling, tenderness at site of injection (Left deltoid) of about 12cm by 8cm.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pain in upper arm which radiates down to hand. No redness noted.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unknown age female patient. Pertinent medical history, drug allergies or reaction were not reported. In approximately December 2013/January 2014, reported as "within the last month", the patient was vaccinated with ZOSTAVAX, lot # J005849, expiration date: 17-AUG-2014, subcutaneous. Concomitant medication was not reported. On an unknown date, the patient experienced mild local reaction at injection site. The patient developed an itchy, red, tender "knot" with swelling at site of ZOSTAVAX injection. The patient sought medical attention. The patient's symptoms resolved within 4 - 5 days. Causality was not reported. This case is linked to the same reporter MARRS # 1401USA003340 and 1401USA003341. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unknown age female patient. Pertinent medical history, drug allergies or reaction were not reported. In approximately December 2013/January 2014, reported as "within the last month", the patient was vaccinated with ZOSTAVAX, lot # J005849, expiration date: 17-AUG-2014, subcutaneous. Concomitant medication was not reported. On an unknown date, the patient experienced mild local reaction at injection site. The patient developed an itchy, red, tender "knot" with swelling at site of ZOSTAVAX injection. The patient sought medical attention. The patient's symptoms resolved within 4 - 5 days. Causality was not reported. This case is linked to the same reporter MARRS # 1401USA003340 and 1401USA003341. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Poor quality sleep, Sleep disorder
Clinical narrative: Patient experienced disturbed sleep for several days after varicella. She was unable to nap and was up every hour during the night for 2 days.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unknown age female patient. Pertinent medical history, drug allergies or reaction were not reported. In approximately December 2013/January 2014, reported as "within the last month", the patient was vaccinated with ZOSTAVAX, lot # J005849, expiration date: 17-AUG-2014, 0.65 ml, subcutaneous. Concomitant medication was not reported. On an unknown date, the patient experienced mild local reaction at injection site. The patient developed an itchy, red, tender "knot" with swelling at site of ZOSTAVAX injection. The patient sought medical attention. The patient's symptoms resolved within 4-5 days. Causality was not reported. This case is linked to the same reporter MARRS# 1401USA002531 and 1401USA003340. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unknown age female patient. Pertinent medical history, drug allergies or reaction were not reported. In approximately December 2013/January 2014, reported as "within the last month", the patient was vaccinated with ZOSTAVAX, lot # J005849, expiration date: 17-AUG-2014, 0.65 ml, subcutaneous. Concomitant medication was not reported. On an unknown date, the patient experienced mild local reaction at injection site. The patient developed an itchy, red, tender "knot" with swelling at site of ZOSTAVAX injection. The patient sought medical attention. The patient's symptoms resolved within 4-5 days. Causality was not reported. This case is linked to the same reporter MARRS# 1401USA002531 and 1401USA003340. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash on buttocks. Dr. prescribed acyclovir 400 mg 1 PO Q 8 hours tat on 12/30/13. This is 20 days after the vaccine was administered.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Muscle twitching, Paraesthesia
Clinical narrative: Pt states that immediately after receiving flu vaccine that her arm started twitching. Pt has also experienced some tingling in affected arm since then, pt states it has not stopped and is around the clock. Spoke with pt on 12-30-13 and she will see physician on 1/1/14 if not resolved per his orders.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Muscle twitching, Paraesthesia
Clinical narrative: Pt states that immediately after receiving flu vaccine that her arm started twitching. Pt has also experienced some tingling in affected arm since then, pt states it has not stopped and is around the clock. Spoke with pt on 12-30-13 and she will see physician on 1/1/14 if not resolved per his orders.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Headache, Influenza virus test negative, Nausea
Clinical narrative: Low grade fever, nausea - extreme, vomiting, aches and pains, headache, diarrhea, chills -> injection of PHENERGAN, nurse tried to admin IV fluids but couldn't find vein.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Low grade fever, nausea - extreme, vomiting, aches and pains, headache, diarrhea, chills -> injection of PHENERGAN, nurse tried to admin IV fluids but couldn't find vein.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Injection site - large area of redness, swelling with hard tissue at center - raised, hot to touch, itching, tingling, chilling and fever, generalized achiness of muscles, and flu like symptoms, headache - mild.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Myalgia, Paraesthesia
Clinical narrative: Injection site - large area of redness, swelling with hard tissue at center - raised, hot to touch, itching, tingling, chilling and fever, generalized achiness of muscles, and flu like symptoms, headache - mild.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection site - large area of redness, swelling with hard tissue at center - raised, hot to touch, itching, tingling, chilling and fever, generalized achiness of muscles, and flu like symptoms, headache - mild.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Headache, Nausea, Rhinorrhoea, Vomiting
Clinical narrative: Approximately 1/2 hr after vaccine, pnt noticed her eyes were swelling and her nose was runny. About 2 or 30 m felt nauseous/vomiting felt slightly "headachey". Swelling resolved in about 4 days. No reaction at injection site or to previous flu shots (has not had HD before) - No egg allergy known.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: The patient describes pain in her arm, she cant lift her arm. There is also a tingling sensation going from her elbow to her wrist, and along forearm.