chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Condition aggravated, Crying, Depression, School refusal
Clinical narrative: On 12/16/13 mom brought patient in to report anxiety/crying bout episodes lasting several weeks after each of three HPV doses on 1/29/13, 4/2/13 and 7/31/13. Seen on our office only once for this problem on 2/19/13 reporting onset of crying and school refusal beginning 2/14/13. Referred to behavioral specialist and note from 4/30/13 reports diagnoses depressive disorder and anxiety.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a healthcare worker (who is also the patient's mother) refers to a 12 year old male patient. On 03-OCT-2013 the patient was vaccinated with GARDASIL (lot # J007354) dose, route not reported. No other co suspects were reported. No concomitant therapy was reported. The reporter stated that the patient experienced soreness at the injection site "about 8 to 12 hours" after the administration. The reporter stated that the soreness went away with about 24 to 48  hours later. Treatment was not given for the event. The patient did not seek medical attention. The reporter stated that an unspecified number of patients received doses of GARDASIL from recalled lot on unspecified dates. No adverse effect reported for any unspecified patients. The outcome of the patient experienced soreness at the injection site was reported as recovered/resolved. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers his male friend of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (Lot # not reported) in the back of his arm. No other co suspects were reported. No concomitant therapy was reported. On an unknown date, the patient experienced soreness at the site of insertion. The outcome of having soreness at the site of insertion was unknown. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patient's concurrent conditions and medical history were not provided. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose, route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days). No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion. This is the one of two reports from the same source MARRS # 1301USA002057. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a female consumer of unknown age and unknown demographics, reporting on herself. The patient's concurrent conditions or medical history were not reported. On 11-DEC-2013, the patient reported she took a pregnancy test at the doctor's office that showed up negative for pregnancy so then the patient was vaccinated with GARDASIL dose 1 (route lot and expiration date were not reported). Co-suspect or concomitant therapies were not reported. On 19-DEC-2013, the patient took an at home pregnancy test that showed up positive for pregnancy. The Last menstrual period (LMP) was in approximately 2013, and the patient's Estimated Due Date (EDD) was not provided. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain of skin
Clinical narrative: This spontaneous report was received from a 62 year old female nurse with asthma and allergy to sulphonamides (reported as sulpha), referring to herself. On 21-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (dose, route and lot not provided). Concomitant therapy included CRESTOR. Ten days after vaccination, approximately on 01-DEC-2013, the patient developed severe pain on her scalp area, with redness, and a feeling of burning. The patient went to her dermatologist who prescribed her FAMVIR, which the patient took for 7 days. The pain returned after stopping FAMVIR; the patient saw another dermatologist and was put on clobetasol propionate on 18-DEC-2013. At the time of the report, the outcome of the adverse events was unknown. No lab diagnostics studies were performed. The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a health professional regarding a patient, demographics unknown, who on an unknown date, was vaccinated with VARIVAX (Merck) lot # J003221, expiration date 15-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination is unknown. "This is a corrected report. On 30-OCT-2013, it was reported that a Registered Nurse, who stated that the doses of VARIVAX (Merck) lot # J00321, expiration date on 15-MAR-2015 were exposed to unknown temperatures for 5 hours during interoffice transport. All vaccines are unsupported and were possibly administered to patients. No adverse symptoms reported. Nurse was unable to provide further temperature excursion details or dates of administration. All patients were revaccinated. No symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy lymph gland abnormal, Chills, Computerised tomogram abnormal, Histiocytic necrotising lymphadenitis, Hypophagia
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns a 45-year old female patient. The patient had no previous medical history (PMH). The patient had been well until she received the influenza vaccination (2 months earlier). On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not reported). On an unspecified date, soon after vaccination, the patient noted repeated spikes in fever with chills. She had tried ibuprofen, acetaminophen and azithromycin course before being admitted to the hospital. The patient also complained of swelling in the left axilla 2 days prior to admission. She was admitted to the hospital with complaints of fever, night sweats and poor oral intake for 2 weeks. A physical exam revealed a temperature of 39.5 degree Celsius with no hepatosplenomegaly and tenderness in the left axilla. She underwent laboratory tests which showed decreased WBC and elevated ESR. CT scan of the chest with contrast revealed multiple enlarged lymph nodes measuring up to 3 cm in largest dimensions, localized in the left axilla. She underwent excisional lymph node biopsy. The pathology report of the lymph node revealed lymphoid tissue with extensive geographic necrosis suggestive of Kikuchi-Fujimoto Disease (KFD). She was discharged home and initially felt better after excisional biopsy. Within a week, there was recurrence of fevers and chills. She was treated with low dose prednisone starting at 0.2mg/kg/day and showed dramatic improvement in symptoms and no recurrence. The outcome was reported as recovering. Reporter's comments: To the best of our knowledge, the above patient encounter was the first reported case of KFD following influenza vaccination.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenectomy, Lymphadenopathy, Night sweats, Oedema peripheral, Pyrexia
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns a 45-year old female patient. The patient had no previous medical history (PMH). The patient had been well until she received the influenza vaccination (2 months earlier). On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not reported). On an unspecified date, soon after vaccination, the patient noted repeated spikes in fever with chills. She had tried ibuprofen, acetaminophen and azithromycin course before being admitted to the hospital. The patient also complained of swelling in the left axilla 2 days prior to admission. She was admitted to the hospital with complaints of fever, night sweats and poor oral intake for 2 weeks. A physical exam revealed a temperature of 39.5 degree Celsius with no hepatosplenomegaly and tenderness in the left axilla. She underwent laboratory tests which showed decreased WBC and elevated ESR. CT scan of the chest with contrast revealed multiple enlarged lymph nodes measuring up to 3 cm in largest dimensions, localized in the left axilla. She underwent excisional lymph node biopsy. The pathology report of the lymph node revealed lymphoid tissue with extensive geographic necrosis suggestive of Kikuchi-Fujimoto Disease (KFD). She was discharged home and initially felt better after excisional biopsy. Within a week, there was recurrence of fevers and chills. She was treated with low dose prednisone starting at 0.2mg/kg/day and showed dramatic improvement in symptoms and no recurrence. The outcome was reported as recovering. Reporter's comments: To the best of our knowledge, the above patient encounter was the first reported case of KFD following influenza vaccination.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Red blood cell sedimentation rate increased, Swelling, Tenderness, White blood cell count decreased
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns a 45-year old female patient. The patient had no previous medical history (PMH). The patient had been well until she received the influenza vaccination (2 months earlier). On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not reported). On an unspecified date, soon after vaccination, the patient noted repeated spikes in fever with chills. She had tried ibuprofen, acetaminophen and azithromycin course before being admitted to the hospital. The patient also complained of swelling in the left axilla 2 days prior to admission. She was admitted to the hospital with complaints of fever, night sweats and poor oral intake for 2 weeks. A physical exam revealed a temperature of 39.5 degree Celsius with no hepatosplenomegaly and tenderness in the left axilla. She underwent laboratory tests which showed decreased WBC and elevated ESR. CT scan of the chest with contrast revealed multiple enlarged lymph nodes measuring up to 3 cm in largest dimensions, localized in the left axilla. She underwent excisional lymph node biopsy. The pathology report of the lymph node revealed lymphoid tissue with extensive geographic necrosis suggestive of Kikuchi-Fujimoto Disease (KFD). She was discharged home and initially felt better after excisional biopsy. Within a week, there was recurrence of fevers and chills. She was treated with low dose prednisone starting at 0.2mg/kg/day and showed dramatic improvement in symptoms and no recurrence. The outcome was reported as recovering. Reporter's comments: To the best of our knowledge, the above patient encounter was the first reported case of KFD following influenza vaccination.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Thyroid function test
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 17 year old female patient who carries a marker for autoimmune disease. The patient's medical history was not provided. The patient did not have any drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a second dose of GARDASIL, intramuscular (recommendation from healthcare providers). Dose and lot number were not provided. The patient received the first dose of GARDASIL on 30-JUL-2013. There were no concomitant medications. On 21-OCT-2013 the patient developed hair loss. The patient sought medical attention (doctor's visit). A thyroid test was performed on an unknown date: result not provided. No treatment was given for the event. The outcome of hair loss was reported as not recovered/not resolved. No reporter causality was provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 year old female patient. The patient had no drug allergies or reactions. On 16-DEC-2013, the patient was administered with a dose of ZOSTAVAX, dose 0.65 (unit unknown) lot # J008436, expiry date - 11-OCT-2014, dose 1, subcutaneously in her right arm. Patient called pharmacist on 18-DEC-2013 and stated that she was experiencing swelling at the right arm injection site. Patient sought medical attention at an unspecified physician's office on 19-DEC-2013 and was diagnosed with cellulitis. Treatment prescribed on 19-DEC-2013 was Cephalexin. Patient stated to pharmacist that cellulitis was improving on 21-DEC-2013. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 year old patient. Medical history was not provided. On 16-DEC-2013 the patient was vaccinated with VARIVAX (Merck) subcutaneous. Concomitant medication was not provided. On an unspecified date after injection, the patient experienced induration at injection site, redness and swelling. Treatment information was not provided. The outcome of the injection site reactions was not provided. There were three patients with injection site reactions reported: one other patient experienced the most severe reaction. Case was linked to case 1401USA002342 and 1401USA001254 (same reporter). Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old male patient. Medical history was not provided. On 23-DEC-2013 the patient was vaccinated with VARIVAX (Merck) lot # H018789 exp date 15-OCT-2014, 0.5 ml subcutaneous. Concomitant medication was not provided. On an unspecified date after injection, the patient experienced injection site reaction: a firm area of induration at injection site up to 3.5 cm with area around that of redness and swelling that 2 4 cm. Patient was seen by nurse practitioner and hydroxyzine was prescribed along with hot and cold packs and two doses of BENADRYL. Patient symptoms resolved on an unspecified date. There were three patients with injection site reactions reported: this patient experienced the most severe reaction. Case was linked to case 1401USA002342 and 1401USA002343 (same reporter). Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Acute disseminated encephalomyelitis, Anti-NMDA antibody negative, Asthenia, Bacterial test negative, CSF culture negative
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns an 83-year-old female patient. The patient had a medical history of hypertension, ischemic stroke and diabetes. On an unspecified date, reported as five days ago, the patient received inactivated influenza vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was admitted to the hospital with 2 days of altered mental status, weakness and fever. On examination, the patient was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein at 136 mg/dL, glucose of 108 mg/dL, with lymphocytic pleocytosis (44 cells/microliter). Broad spectrum antibiotics were started for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. 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, PCR for HSV, VZV, HHV-6, enterovirus, JC and BK viruses, anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, the diagnosis of post-vaccination acute disseminated encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. The patient did not respond to the treatment with steroids and required plasmapheresis. The patient showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The outcome was reported as recovered. Reporter's comments: In this case, based on World Health Organization causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: CSF glucose, CSF lymphocyte count increased, CSF protein, Computerised tomogram head normal, Depressed level of consciousness
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns an 83-year-old female patient. The patient had a medical history of hypertension, ischemic stroke and diabetes. On an unspecified date, reported as five days ago, the patient received inactivated influenza vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was admitted to the hospital with 2 days of altered mental status, weakness and fever. On examination, the patient was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein at 136 mg/dL, glucose of 108 mg/dL, with lymphocytic pleocytosis (44 cells/microliter). Broad spectrum antibiotics were started for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. 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, PCR for HSV, VZV, HHV-6, enterovirus, JC and BK viruses, anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, the diagnosis of post-vaccination acute disseminated encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. The patient did not respond to the treatment with steroids and required plasmapheresis. The patient showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The outcome was reported as recovered. Reporter's comments: In this case, based on World Health Organization causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Encephalitis, Enterovirus test negative, Extensor plantar response, Flow cytometry, Fungal test negative
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns an 83-year-old female patient. The patient had a medical history of hypertension, ischemic stroke and diabetes. On an unspecified date, reported as five days ago, the patient received inactivated influenza vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was admitted to the hospital with 2 days of altered mental status, weakness and fever. On examination, the patient was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein at 136 mg/dL, glucose of 108 mg/dL, with lymphocytic pleocytosis (44 cells/microliter). Broad spectrum antibiotics were started for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. 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, PCR for HSV, VZV, HHV-6, enterovirus, JC and BK viruses, anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, the diagnosis of post-vaccination acute disseminated encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. The patient did not respond to the treatment with steroids and required plasmapheresis. The patient showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The outcome was reported as recovered. Reporter's comments: In this case, based on World Health Organization causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: HIV test negative, Herpes simplex serology negative, Human herpes virus 6 serology negative, Hyperreflexia, Laboratory test normal
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns an 83-year-old female patient. The patient had a medical history of hypertension, ischemic stroke and diabetes. On an unspecified date, reported as five days ago, the patient received inactivated influenza vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was admitted to the hospital with 2 days of altered mental status, weakness and fever. On examination, the patient was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein at 136 mg/dL, glucose of 108 mg/dL, with lymphocytic pleocytosis (44 cells/microliter). Broad spectrum antibiotics were started for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. 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, PCR for HSV, VZV, HHV-6, enterovirus, JC and BK viruses, anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, the diagnosis of post-vaccination acute disseminated encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. The patient did not respond to the treatment with steroids and required plasmapheresis. The patient showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The outcome was reported as recovered. Reporter's comments: In this case, based on World Health Organization causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mechanical ventilation, Mental status changes, Mycobacterium tuberculosis complex test negative, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns an 83-year-old female patient. The patient had a medical history of hypertension, ischemic stroke and diabetes. On an unspecified date, reported as five days ago, the patient received inactivated influenza vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was admitted to the hospital with 2 days of altered mental status, weakness and fever. On examination, the patient was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein at 136 mg/dL, glucose of 108 mg/dL, with lymphocytic pleocytosis (44 cells/microliter). Broad spectrum antibiotics were started for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. 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, PCR for HSV, VZV, HHV-6, enterovirus, JC and BK viruses, anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, the diagnosis of post-vaccination acute disseminated encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. The patient did not respond to the treatment with steroids and required plasmapheresis. The patient showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The outcome was reported as recovered. Reporter's comments: In this case, based on World Health Organization causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Plasmapheresis, Pleocytosis, Polymerase chain reaction, Pyrexia, Varicella virus test negative
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns an 83-year-old female patient. The patient had a medical history of hypertension, ischemic stroke and diabetes. On an unspecified date, reported as five days ago, the patient received inactivated influenza vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was admitted to the hospital with 2 days of altered mental status, weakness and fever. On examination, the patient was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein at 136 mg/dL, glucose of 108 mg/dL, with lymphocytic pleocytosis (44 cells/microliter). Broad spectrum antibiotics were started for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. 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, PCR for HSV, VZV, HHV-6, enterovirus, JC and BK viruses, anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, the diagnosis of post-vaccination acute disseminated encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. The patient did not respond to the treatment with steroids and required plasmapheresis. The patient showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The outcome was reported as recovered. Reporter's comments: In this case, based on World Health Organization causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Viral test negative, White matter lesion
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns an 83-year-old female patient. The patient had a medical history of hypertension, ischemic stroke and diabetes. On an unspecified date, reported as five days ago, the patient received inactivated influenza vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was admitted to the hospital with 2 days of altered mental status, weakness and fever. On examination, the patient was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein at 136 mg/dL, glucose of 108 mg/dL, with lymphocytic pleocytosis (44 cells/microliter). Broad spectrum antibiotics were started for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. 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, PCR for HSV, VZV, HHV-6, enterovirus, JC and BK viruses, anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, the diagnosis of post-vaccination acute disseminated encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. The patient did not respond to the treatment with steroids and required plasmapheresis. The patient showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The outcome was reported as recovered. Reporter's comments: In this case, based on World Health Organization causality assessment criteria, post vaccination ADEM was "very likely".
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: CSF glucose increased, CSF lymphocyte count increased, CSF protein increased, Computerised tomogram head normal, Depressed level of consciousness
Clinical narrative: This literature report (initial receipt 30-Dec-2013) concerns an 83-year-old female patient. The patient had a medical history of hypertension, ischemic stroke and diabetes. On an unspecified date, reported as five days ago, the patient received inactivated influenza vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was admitted to the hospital with 2 days of altered mental status, weakness and fever. On examination, the patient was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein at 136 mg/dL, glucose of 108 mg/dL, with lymphocytic pleocytosis (44 cells/microliter). Broad spectrum antibiotics were started for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. 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, PCR for HSV, VZV, HHV-6, enterovirus, JC and BK viruses, anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, the diagnosis of post-vaccination acute disseminated encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. The patient did not respond to the treatment with steroids and required plasmapheresis. The patient showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. The outcome was reported as recovered. Reporter's comments: In this case, based on World Health Organization causality assessment criteria, post vaccination ADEM was "very likely".
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Lung operation, Rash vesicular
Clinical narrative: This spontaneous report as received from the physician/husband refers to a 78 year old female patient with allergy to epinephrine (possible reaction). The patient's medical history included shingles, which was severe and caused neuropathy (prior to receiving ZOSTAVAX in 2006). In 2006 the patient was vaccinated with ZOSTAVAX. Route, dose, dose number, frequency and lot number were not reported. Concomitant medication: CRESTOR, ZETIA, fish oil and baby aspirin. The physician reported that his wife, the patient experienced six recurrences of shingles (dates not reported) after receiving ZOSTAVAX. The shingles was described as "a couple spots, like chicken pox, not a full blown rash". The patient experienced the last recurrence of shingles after lung surgery (medically significant), on 19-NOV-2013. Patient had been treated with VALTREX or (also reported as and) prednisone, by physician husband. The outcome of lung surgery and six recurrences of shingles were unknown. Reporter causality assessment was not reported. Case was linked to case MARRS# 1401USA001348 (same reporter link) (the physician experienced a mild case of shingles after receiving ZOSTAVAX). Upon internal review the event lung surgery was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Arthralgia, Asthenia, Back pain, Corrective lens user
Clinical narrative: Severe low back pain, abdominal cramps, migraines, brain fog, fatigue, pain all over body, pelvic pain, leg pain, muscle spasms, lightheartedness, weakness, fibromyalgia, possible nerve damage, insomnia, light and temperature sensivity, head pain and need for glasses when eyes were good previously, inability to handle loud noise, abnormal menstrual cycles, nausea/vomiting. Weight loss/weight gain/ wrist and finger pain, pudendal nerve entrapment? I have been seeing doctors for two years, been on pain medication, birth control and no certain diagnosis except for fibromyalgia, liver problems.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Fatigue, Feeling abnormal, Fibromyalgia, Full blood count
Clinical narrative: Severe low back pain, abdominal cramps, migraines, brain fog, fatigue, pain all over body, pelvic pain, leg pain, muscle spasms, lightheartedness, weakness, fibromyalgia, possible nerve damage, insomnia, light and temperature sensivity, head pain and need for glasses when eyes were good previously, inability to handle loud noise, abnormal menstrual cycles, nausea/vomiting. Weight loss/weight gain/ wrist and finger pain, pudendal nerve entrapment? I have been seeing doctors for two years, been on pain medication, birth control and no certain diagnosis except for fibromyalgia, liver problems.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Hyperacusis, Insomnia, Laboratory test, Liver disorder
Clinical narrative: Severe low back pain, abdominal cramps, migraines, brain fog, fatigue, pain all over body, pelvic pain, leg pain, muscle spasms, lightheartedness, weakness, fibromyalgia, possible nerve damage, insomnia, light and temperature sensivity, head pain and need for glasses when eyes were good previously, inability to handle loud noise, abnormal menstrual cycles, nausea/vomiting. Weight loss/weight gain/ wrist and finger pain, pudendal nerve entrapment? I have been seeing doctors for two years, been on pain medication, birth control and no certain diagnosis except for fibromyalgia, liver problems.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Liver function test, Menstrual disorder, Migraine, Muscle spasms, Nausea
Clinical narrative: Severe low back pain, abdominal cramps, migraines, brain fog, fatigue, pain all over body, pelvic pain, leg pain, muscle spasms, lightheartedness, weakness, fibromyalgia, possible nerve damage, insomnia, light and temperature sensivity, head pain and need for glasses when eyes were good previously, inability to handle loud noise, abnormal menstrual cycles, nausea/vomiting. Weight loss/weight gain/ wrist and finger pain, pudendal nerve entrapment? I have been seeing doctors for two years, been on pain medication, birth control and no certain diagnosis except for fibromyalgia, liver problems.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Pain, Pain in extremity, Pelvic pain, Photophobia, Temperature intolerance
Clinical narrative: Severe low back pain, abdominal cramps, migraines, brain fog, fatigue, pain all over body, pelvic pain, leg pain, muscle spasms, lightheartedness, weakness, fibromyalgia, possible nerve damage, insomnia, light and temperature sensivity, head pain and need for glasses when eyes were good previously, inability to handle loud noise, abnormal menstrual cycles, nausea/vomiting. Weight loss/weight gain/ wrist and finger pain, pudendal nerve entrapment? I have been seeing doctors for two years, been on pain medication, birth control and no certain diagnosis except for fibromyalgia, liver problems.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Thyroid function test, Vomiting, Weight decreased, Weight increased
Clinical narrative: Severe low back pain, abdominal cramps, migraines, brain fog, fatigue, pain all over body, pelvic pain, leg pain, muscle spasms, lightheartedness, weakness, fibromyalgia, possible nerve damage, insomnia, light and temperature sensivity, head pain and need for glasses when eyes were good previously, inability to handle loud noise, abnormal menstrual cycles, nausea/vomiting. Weight loss/weight gain/ wrist and finger pain, pudendal nerve entrapment? I have been seeing doctors for two years, been on pain medication, birth control and no certain diagnosis except for fibromyalgia, liver problems.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Aortic aneurysm, Cardiac disorder, Gastrointestinal haemorrhage, Laboratory test
Clinical narrative: GI Bleed, associate heart problems, and associated AAA.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 31-DEC-2013 the patient was mistakenly administered with VARIVAX (Merck) (lot number, dose, route and injection site were not reported) instead of ZOSTAVAX. No adverse effects reported. The outcome and action taken were not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 11 years old female patient. On 16-AUG-2013 the patient was vaccinated with first dose of GARDASIL (lot # J006236 exp. date: 25-FEB-2016, dose, strength, site and route of administration not reported). On an unknown date in 2013 the patient experienced swelling, soreness, and tenderness at the injection site. When the patient informed the healthcare  worker that she had the injection site reaction, she had already recovered (date not reported0. There was no treatment of the events. On 22-OCT-2013 the patient was vaccinated with second dose of GARDASIL (lot # J007354 exp. date: 20-FEB-2016, dose, strength, site and route of administration not reported). There were no adverse events reported after second dose of GARDASIL. The relatedness between GARDASIL and the events was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 02-AUG-2013, 02-OCT-2013 and 03-DEC-2013 the patient was vaccinated with first, second and third dose of GARDASIL injection 120Y (lot #, expiration date, dose, route, indication not reported). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to a baby patient of unknown age. On 24-NOV-2012 and 24-JAN-2013 the patient was vaccinated with the first and second dose of RECOMBIVAX HB (5 mcg/0.5 mL) (lot#, dose and route not reported). Concomitant therapies included PEDIARIX (on 12-JUN-2013). On 12-NOV-2013 a hepatitis B titer was negative. The outcome of patient was reported as not recovered/not resolved. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 year old patient. Medical history was not provided. On 09-DEC-2013 the patient was vaccinated with VARIVAX (Merck) subcutaneous. Concomitant medication was not provided. On an unspecified date after injection, the patient experienced induration at injection site, redness and swelling. Treatment information was not provided. The outcome of the injection site reactions was not provided. There were three patients with injection site reactions reported: one other patient experienced the most severe reaction. Case was linked to case 1401USA002343 and 1401USA001254 (same reporter). Additional information is not expected.
Age: 87.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a consumer regarding himself, an 87 year old male patient with a pertinent medical history of weak legs, arthritis, bursitis and carpal tunnel. The patient's medical history included a case of shingles on the forehead on unspecified dates in 1992 and the patient still experiences pain when cold air comes in contact with that spot on his forehead. On 25-NOV-2013 the patient was vaccinated with ZOSTAVAX and an unspecified pneumococcal vaccine. Dosages and routes of administration were not reported. Concomitant therapy included SPIRIVA. On 02-DEC-2013 (reported as "about a week after vaccination") the patient experienced itching on his feet that traveled up his legs to above the knee. The itching was worse at night. The patient called the physician's office and spoke with a nurse. Treatment included an unspecified topical hydrocortisone cream which helped reduce the itching. The outcome was reported as recovering/resolving. No causality assessment was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot # and dosage regimen unspecified). The reporter stated that he had a question concerning a possible side effect of GARDASIL in a patient. No further information was provided at this time. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On an unknown date in 2013, (reported as about a year ago), the patient was vaccinated with ZOSTAVAX. There were no concomitant medications, medical history or drug allergies. On an unknown date in 2013, the day after receiving the ZOSTAVAX, the patient experienced increased heart rate, redness, pain and slight swelling at the injection site, and shortness of breath. The patient stated that she had no history of cardiac problems or symptoms. No treatment was given for the events. The patient stated that she did not have an anaphylactic reaction. The patient did not seek medical attention for the events. The outcome of increased heart rate, redness, pain and slight swelling at the injection site and shortness of breath was reported as recovered/resolved on the same day. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pediatrician refers to a 9 month old female patient. The patient's medical history included work-up for possible macrocephaly. On an unknown date the nurse's assistant accidentally gave the patient an injected of 0.5mL VAQTA (lot # and expiration were not reported), in the left thigh. The patient did not have any relevant concomitant medications and past drug history. The pediatrician was unaware of any adverse reactions. there was no relevant laboratory data. As of 21-DEC-2013, she would not continue to be injected with VAQTA. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 14 year old female patient. On 02-JAN-2014 the patient was vaccinated with GARDASIL (dose, frequency, route and lot number were not provided) dose 1. On 02-JAN-2014 the patient passed out and vomited after receiving the injection. No treatment was given. After further observation the patient left the office. The outcome of passed out and vomited was reported as recovered/resolved. The relatedness was not provided. Upon internal review the event passed out was assessed as medically significant. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Nausea, Vomiting
Clinical narrative: Injection site swollen, hurt the day after. By Sunday he was really sore and started vomiting and nauseated.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Pyrexia, Swelling
Clinical narrative: A few hrs after vaccine got arm redness and warmth and swelling and fever. 5 days later seen at urgent care dx cellulitis.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Condition aggravated, Rhonchi, Wheezing
Clinical narrative: Pt had an exacerbation of her asthma a few hours after the PNEUMOVAX PPSV23 on 11/19/13. Pt return to clinic on 11/22/13 with wheezes and rhonchi. Pt tx with SOLU-MEDROL 125mg, BENADRYL 50mg and MEDROL.
Age: 0.34
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 4 month old patient. Pertinent medical history, drug reactions or allergies were not reported. On 06-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number were not reported) instead of PREVNAR. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Patient's arm was a bit red/pink around where the vaccine was given. As a precaution, I administered Benadryl 25mg to the patient and monitored for some time.  I counselled on the signs and symptoms of a severe reaction, and parents were aware. I continued to monitor. The patient felt fine the entire time, but the parents were a bit concerned with the redness.
Age: 43.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Rash
Clinical narrative: Member called the Clinic and spoke to someone. They explained that he was experiencing a rash on his forearms and upper thighs that was not itchy after receiving the smallpox vaccine.  He also said that the vaccination site was not forming a scab. He told the patient to come to the clinic for further examination.  Upon examination, it was determined that he be seen by a provider at Medical Facility.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inflammation, Local swelling
Clinical narrative: Woke up with extremely swollen and inflamed knuckle on hand.  Saw pediatrician who put splint on finger could find no injury, sent for xrays no injury.