chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, concerning to two patients (unspecified age and gender). On an unspecified date, two patients were vaccinated with ZOSTAVAX, injection. (Unspecified route, dose and lot number). Co-suspect or concomitant therapies were not reported. On an unspecified date, two patients were vaccinated with ZOSTAVAX stored higher than recommended and not supported. No adverse effect reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Electroencephalogram abnormal, Encephalopathy, Full blood count, Hemiplegic migraine, Lactic acidosis
Clinical narrative: Pt. became pale, nausea and vomiting, unresponsive, altered mental status. Paramedics called to hm. Pt transported and admitted to hospital. Abnormal EEG, and also tests Dx: encephalopathy, lactic acidosis hemiplegic migraine.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Lumbar puncture, Mental status changes, Metabolic function test, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Pt. became pale, nausea and vomiting, unresponsive, altered mental status. Paramedics called to hm. Pt transported and admitted to hospital. Abnormal EEG, and also tests Dx: encephalopathy, lactic acidosis hemiplegic migraine.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Pallor, Toxicologic test, Unresponsive to stimuli, Urine analysis, Vomiting
Clinical narrative: Pt. became pale, nausea and vomiting, unresponsive, altered mental status. Paramedics called to hm. Pt transported and admitted to hospital. Abnormal EEG, and also tests Dx: encephalopathy, lactic acidosis hemiplegic migraine.
Sex: F
Vaccine: HPV4
Symptoms: Haematemesis, Hypoaesthesia, Pain in extremity, Retching
Clinical narrative: This spontaneous report as received from a 21 year old (at the time of report) non pregnant female patient with no pertinent medical history and no drug reactions or allergies refers to herself. On an unknown date the patient was vaccinated with a dose of GARDASIL (# J007354, exp. date: 20-FEB-2016) injection (strength, dose and route not provided) for prevention. The patient stated she did not known which dose in series she received and stated she did receive GARDASIL in the past (dates not provided). There was no concomitant medication. The patient stated that she received a GARDASIL recall letter from her physician after she received vaccine that was involved in a recent recall of the product. The patient reported that she had arm pain and numbness that lasted more than one week. She sought medical attention - was seen in the emergency room because she was gagging and had blood in her saliva. The outcome of arm pain and numbness, gagging and blood in her saliva was reported as recovered/resolved on an unspecified date. The relatedness between vaccination with GARDASIL and events was not reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Angina pectoris, Cardiac monitoring normal, Palpitations
Clinical narrative: Information has been received from a consumer regarding her 14 year old son. There was no pertinent medical history, drug reactions or allergies. On 26-OCT-2013, the patient was vaccinated with the first dose of GARDASIL (injection in his arm) (dose, route and lot number were not provided). There was no concomitant medications reported. ON 26-OCT-2013, on the first day after receiving the vaccine, the patient experienced abnormal heart palpitations where he stated that his heart hurt and felt as though it was going to explode. This event then occurred again on the following day. The patient has been seen by a pediatric cardiologist who advised the use of a portable heart monitor which has given normal results at this time. The patient received ADVIL for the adverse events. At the time of the report, the patient's outcome was unknown. On 26-DEC-2013, the patient has had his second dose of GARDASIL (dose, route and lot number were not provided) with no symptom. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a consumer who is the grandmother's patient, referring to a 14 year old female patient with drug reactions/allergies to AUGMENTIN. In the middle of "October 2013" the patient was vaccinated with GARDASIL for the prevention of human papillomavirus (HP). The route was reported as "injection". Dose and lot number were not reported. The second shot of GARDASIL was given on 18-NOV-2013. Dose and lot number were not reported. No co-suspect and concomitant therapies were reported. The reporter stated that the patient was involved in a "dance accident" in "August 2013" and had developed weakness in the left leg, unspecified neurological disorders and shingles after this accident. The reporter also stated that on an unknown date in 2013 after the second dose of GARDASIL, the patient experienced "headache". It was unclear as to whether or not the patient experienced headache after receiving the first shot of GARDASIL. The reporter stated that the patient has not yet received the third shot of GARDASIL. The patient did not seek medical attention. At the time of this report the outcome was unknown. The causality was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site dryness, Injection site nodule, Injection site pruritus, Injection site rash
Clinical narrative: Knot at injection site, rash, bumps at injection site; took APAP and applied Hydrocortisone at present still dry and itchy so advised to take BENADRYL.
Age: 0.26
Sex: M
Vaccine: PNC13, RV5
Symptoms: Cow's milk intolerance, Diarrhoea, Faeces discoloured
Clinical narrative: 4 loose stools green in color x 2 weeks. Developing dairy intolerance requiring breast fed mom to remove dairy from diet to continue to nurse pt.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Electroencephalogram abnormal, Foaming at mouth, Unresponsive to stimuli, Vomiting
Clinical narrative: Family traveling to home. Pt became unresponsive and was foaming at the mouth. This lasted < 5 min, about 40 min, later she vomited. Short time later was acting fine. Sent to ER for eval., EEG is being ordered.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Local reaction 3.5 - 4".
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Skin reaction
Clinical narrative: Pt received ZOSTAVAX injection 12/30/13 SQ right arm. Pt noticed local skin reaction (rash, swelling, and itching) at injection site when showering 12/31/13 at 9 PM. Reported rash at 10:15 AM on 1/1/14. Pt told to use hydrocortisone cream and report worsening of symptoms, signs.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: Left shoulder joint and muscle soreness and pain. That started approx. 2 days after injection, Dr prescribed anti-inflammatory - Nabumetone.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Vaccine given at pharmacy clinic on 12/18/13. Seem at clinic on 12/20/13, c/o swelling/redness at injection site. MD noticed localized itching with 12 cm x 13 cm area of redness warmth and mild induration on (R) thigh. Treated with 10 day course of KEFLEX and cool compresses.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe pain in arm greater than 2 weeks.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Dtap was given instead for Tdap due to miscommunication of another nurse. No effects noted. Contacted agency. They advised pt would not need to received additional vaccination.
Age: 44.0
Sex: F
Vaccine: YF
Symptoms: Pallor, Rash, Rash maculo-papular
Clinical narrative: Blanching maculopapular rash torso and arms and upper legs 9 days after IZ antihistamines prn.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node (right armpit).
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pruritus
Clinical narrative: Patient mentions itchiness on the hands, feet and the posterior part of the thighs. Five minutes after the administration of MCV, Tdap and Varicella.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache - (18-22 hrs). Nausea - beginning a.m. 1/1/14 until noon. Chills, tiredness - all day 1/1/14.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Large red area extending downward from injection site. 4.5in x 4.5inch in diameter. Swollen nodule.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site inflammation, Local reaction
Clinical narrative: Large local inflammatory reaction in left upper arm. BENADRYL PRN. MOTRIN PRN. Ice to area.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: A raised area 11 x 8 cm, with warmness and soreness after receiving Tdap vaccine.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Itchy rash, hives. Reported to ER and was treated with steroid injections which helped. Then he was given Zantac and Atarax in clinic.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Tingling, pain, and numbness in right hand, armpit, and arm.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia, Cholelithiasis, Faeces discoloured, Myalgia, Nausea
Clinical narrative: Muscle aches, nausea, low platelet count, emergency room visit with a black stool. Gall stone, hair loss from prednisone.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count decreased
Clinical narrative: Muscle aches, nausea, low platelet count, emergency room visit with a black stool. Gall stone, hair loss from prednisone.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Site is red and inflammed/right arm- Cephalexin 250mg prescribed (10mL 2x/day).
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphagia, Dyspnoea, Heart rate increased, Ocular hyperaemia, Pain
Clinical narrative: BEGINNING AROUND 11:00 AM, SOME DIFFICULTY SWALLOWING & SEVERE ACHES. LATER IN THE DAY, AROUND 1:00 PM, RAPID HEARTBEAT, TROUBLE BREATHING & SEVERE BLOODSHOT EYES. VISITED EMERGENCY ROOM FOR TREATMENT WITH SYMPTOMS AROUND 2:30 PM.  E.R. VISIT (TREATMENT SEGMENT) LASTED 6+ HOURS. A FEW DAYS LATER, DEVELOPED HIVES THAT LASTED NEARLY ONE WEEK.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: BEGINNING AROUND 11:00 AM, SOME DIFFICULTY SWALLOWING & SEVERE ACHES. LATER IN THE DAY, AROUND 1:00 PM, RAPID HEARTBEAT, TROUBLE BREATHING & SEVERE BLOODSHOT EYES. VISITED EMERGENCY ROOM FOR TREATMENT WITH SYMPTOMS AROUND 2:30 PM.  E.R. VISIT (TREATMENT SEGMENT) LASTED 6+ HOURS. A FEW DAYS LATER, DEVELOPED HIVES THAT LASTED NEARLY ONE WEEK.
Sex: U
Vaccine: HIBV
Symptoms: Bone marrow transplant
Clinical narrative: This spontaneous report as received from a registered nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with PEDVAXHIB (lot number not reported) and an unspecified Merck vaccine. No other concomitant medications were reported. Approximately on an unknown date in 2013 (reported as last year) the patient had an unspecified diagnosis which required a bone marrow transplant. The outcome of bone marrow transplant is unknown. The causality for bone marrow transplant was not reported. No Product quality complaint (PQC) filed. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein, Connective tissue disorder, Hypoaesthesia, Laboratory test, Muscular weakness
Clinical narrative: 2 weeks after injection deep acne (R) shoulder superior and posterior, migrated pain to (R) breast numbness, tingling 4th and 5th digits, arm fatigue prednisone treatment.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Paraesthesia, Vitamin B12
Clinical narrative: 2 weeks after injection deep acne (R) shoulder superior and posterior, migrated pain to (R) breast numbness, tingling 4th and 5th digits, arm fatigue prednisone treatment.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site pain, Injection site reaction, Musculoskeletal pain, Paraesthesia
Clinical narrative: Pain in posterior (L) shoulder area and scapular region, numbness, tingling (L) deltoid.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: (L) shoulder pain, scapular region, no numbness weakness.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from allergist via company representative refers to a 13 year old female patient. On 12-DEC-2013 the patient was vaccinated with GARDASIL injection 120 y (dose number, dose units, route, lot number and expiry date unknown). Other suspect therapy included influenza virus vaccine (also reported as flu vaccine) (manufacture unknown) (dose number, dose units, route, lot number and expiry date unknown). Concomitant therapy included CORTISPORIN OTIC drops. On 16-DEC-2013, 4 days after administration of GARDASIL patient developed hives on her trunk. The patient was treated with BENADRYL and CLARITIN and the hives resolved within 24 hours. It was reported that he has not seen the patient in his office yet, but was informed by her unspecified healthcare provider that the patient was treated with BENADRYL and CLARITIN. It was reported that laboratory diagnostics studies were not performed. The outcome of hives on trunk was reported as recovered/resolved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pruritus, Throat tightness
Clinical narrative: IM FLUVIRIN, site itching followed by difficulty breathing (throat constriction) EPI-PEN 0.3 administered and referred to ER for additional eval and treatment.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMRV, MNQ, TD
Symptoms: Wrong drug administered
Clinical narrative: Client is 16 years old and was given MMRV inadvertently. Had previously had MMR and varicella 8/15/2013. Per employee imm program doses are valid.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site infection, Injection site swelling, Pyrexia
Clinical narrative: Woke up morning after Pneumovax was given. Patient could not move her left arm as that was the limb the vaccine was given in.  On 1/4/2014 the site became red and swollen. Patient also noted a fever. She then went to the ER and was admitted for injection site infection.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram head normal, Dizziness, Neurological examination
Clinical narrative: Describes episodes lightheadedness approx 10-15 times daily lasting few seconds to a few minutes. Not related to exertion. Eval. included CT head, Neuro, ENT. No MRI head (pt unable to tolerate).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Hypertension, Immediate post-injection reaction
Clinical narrative: Patient received her 1st GARDASIL injection on 12/12/13. She had an immediate headache and lightheadedness. Pt was hypertensive (134/100) -> BP decreased to 112/84 in 15 minutes.
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: Initial report was received from the scientific literature on 28 December 2013. An 83-year-old female was admitted with 2 days of altered mental status, weakness and fever. She had past medical history of hypertension, ischemic stroke and diabetes. She received inactivated influenza vaccine five days ago. On exam, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/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, we made the diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. DISCUSSION: ADEM is a rare inflammatory demyelinating disease of the central nervous system with an incidence of 0.4/100.000. Infection is the most common etiology; post-vaccination ADEM for 5% of cases. However, ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. In our patient, based on World Health Organization causality assessment criteria, post vaccination ADEM was very likely. Daily methylprednisolone for 3 - 5 days followed by prednisone taper is the accepted first line therapy. Plasmapheresis is recommended for steroid unresponsive patients. With early treatment initiation, full recovery is seen in 50% to 75% of patients, within 1 - 6 months. Our patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. CONCLUSIONS: Clinicians should consider post - vaccination acute disseminated encephalomyelitis in patients with encephalopathy, multifocal neurological findings and recent vaccination after carefully excluding other causes.
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: Initial report was received from the scientific literature on 28 December 2013. An 83-year-old female was admitted with 2 days of altered mental status, weakness and fever. She had past medical history of hypertension, ischemic stroke and diabetes. She received inactivated influenza vaccine five days ago. On exam, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/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, we made the diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. DISCUSSION: ADEM is a rare inflammatory demyelinating disease of the central nervous system with an incidence of 0.4/100.000. Infection is the most common etiology; post-vaccination ADEM for 5% of cases. However, ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. In our patient, based on World Health Organization causality assessment criteria, post vaccination ADEM was very likely. Daily methylprednisolone for 3 - 5 days followed by prednisone taper is the accepted first line therapy. Plasmapheresis is recommended for steroid unresponsive patients. With early treatment initiation, full recovery is seen in 50% to 75% of patients, within 1 - 6 months. Our patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. CONCLUSIONS: Clinicians should consider post - vaccination acute disseminated encephalomyelitis in patients with encephalopathy, multifocal neurological findings and recent vaccination after carefully excluding other causes.
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Encephalitis, Enterovirus test negative, Extensor plantar response, Flow cytometry, Fungal test negative
Clinical narrative: Initial report was received from the scientific literature on 28 December 2013. An 83-year-old female was admitted with 2 days of altered mental status, weakness and fever. She had past medical history of hypertension, ischemic stroke and diabetes. She received inactivated influenza vaccine five days ago. On exam, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/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, we made the diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. DISCUSSION: ADEM is a rare inflammatory demyelinating disease of the central nervous system with an incidence of 0.4/100.000. Infection is the most common etiology; post-vaccination ADEM for 5% of cases. However, ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. In our patient, based on World Health Organization causality assessment criteria, post vaccination ADEM was very likely. Daily methylprednisolone for 3 - 5 days followed by prednisone taper is the accepted first line therapy. Plasmapheresis is recommended for steroid unresponsive patients. With early treatment initiation, full recovery is seen in 50% to 75% of patients, within 1 - 6 months. Our patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. CONCLUSIONS: Clinicians should consider post - vaccination acute disseminated encephalomyelitis in patients with encephalopathy, multifocal neurological findings and recent vaccination after carefully excluding other causes.
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: Initial report was received from the scientific literature on 28 December 2013. An 83-year-old female was admitted with 2 days of altered mental status, weakness and fever. She had past medical history of hypertension, ischemic stroke and diabetes. She received inactivated influenza vaccine five days ago. On exam, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/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, we made the diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. DISCUSSION: ADEM is a rare inflammatory demyelinating disease of the central nervous system with an incidence of 0.4/100.000. Infection is the most common etiology; post-vaccination ADEM for 5% of cases. However, ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. In our patient, based on World Health Organization causality assessment criteria, post vaccination ADEM was very likely. Daily methylprednisolone for 3 - 5 days followed by prednisone taper is the accepted first line therapy. Plasmapheresis is recommended for steroid unresponsive patients. With early treatment initiation, full recovery is seen in 50% to 75% of patients, within 1 - 6 months. Our patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. CONCLUSIONS: Clinicians should consider post - vaccination acute disseminated encephalomyelitis in patients with encephalopathy, multifocal neurological findings and recent vaccination after carefully excluding other causes.
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: Initial report was received from the scientific literature on 28 December 2013. An 83-year-old female was admitted with 2 days of altered mental status, weakness and fever. She had past medical history of hypertension, ischemic stroke and diabetes. She received inactivated influenza vaccine five days ago. On exam, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/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, we made the diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. DISCUSSION: ADEM is a rare inflammatory demyelinating disease of the central nervous system with an incidence of 0.4/100.000. Infection is the most common etiology; post-vaccination ADEM for 5% of cases. However, ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. In our patient, based on World Health Organization causality assessment criteria, post vaccination ADEM was very likely. Daily methylprednisolone for 3 - 5 days followed by prednisone taper is the accepted first line therapy. Plasmapheresis is recommended for steroid unresponsive patients. With early treatment initiation, full recovery is seen in 50% to 75% of patients, within 1 - 6 months. Our patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. CONCLUSIONS: Clinicians should consider post - vaccination acute disseminated encephalomyelitis in patients with encephalopathy, multifocal neurological findings and recent vaccination after carefully excluding other causes.
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Plasmapheresis, Pleocytosis, Polymerase chain reaction, Pyrexia, Varicella virus test negative
Clinical narrative: Initial report was received from the scientific literature on 28 December 2013. An 83-year-old female was admitted with 2 days of altered mental status, weakness and fever. She had past medical history of hypertension, ischemic stroke and diabetes. She received inactivated influenza vaccine five days ago. On exam, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/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, we made the diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. DISCUSSION: ADEM is a rare inflammatory demyelinating disease of the central nervous system with an incidence of 0.4/100.000. Infection is the most common etiology; post-vaccination ADEM for 5% of cases. However, ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. In our patient, based on World Health Organization causality assessment criteria, post vaccination ADEM was very likely. Daily methylprednisolone for 3 - 5 days followed by prednisone taper is the accepted first line therapy. Plasmapheresis is recommended for steroid unresponsive patients. With early treatment initiation, full recovery is seen in 50% to 75% of patients, within 1 - 6 months. Our patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. CONCLUSIONS: Clinicians should consider post - vaccination acute disseminated encephalomyelitis in patients with encephalopathy, multifocal neurological findings and recent vaccination after carefully excluding other causes.
Age: 83.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Viral test negative, White matter lesion
Clinical narrative: Initial report was received from the scientific literature on 28 December 2013. An 83-year-old female was admitted with 2 days of altered mental status, weakness and fever. She had past medical history of hypertension, ischemic stroke and diabetes. She received inactivated influenza vaccine five days ago. On exam, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/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, we made the diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. DISCUSSION: ADEM is a rare inflammatory demyelinating disease of the central nervous system with an incidence of 0.4/100.000. Infection is the most common etiology; post-vaccination ADEM for 5% of cases. However, ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. In our patient, based on World Health Organization causality assessment criteria, post vaccination ADEM was very likely. Daily methylprednisolone for 3 - 5 days followed by prednisone taper is the accepted first line therapy. Plasmapheresis is recommended for steroid unresponsive patients. With early treatment initiation, full recovery is seen in 50% to 75% of patients, within 1 - 6 months. Our patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. CONCLUSIONS: Clinicians should consider post - vaccination acute disseminated encephalomyelitis in patients with encephalopathy, multifocal neurological findings and recent vaccination after carefully excluding other causes.
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: Initial report was received from the scientific literature on 28 December 2013. An 83-year-old female was admitted with 2 days of altered mental status, weakness and fever. She had past medical history of hypertension, ischemic stroke and diabetes. She received inactivated influenza vaccine five days ago. On exam, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/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, we made the diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. DISCUSSION: ADEM is a rare inflammatory demyelinating disease of the central nervous system with an incidence of 0.4/100.000. Infection is the most common etiology; post-vaccination ADEM for 5% of cases. However, ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. In our patient, based on World Health Organization causality assessment criteria, post vaccination ADEM was very likely. Daily methylprednisolone for 3 - 5 days followed by prednisone taper is the accepted first line therapy. Plasmapheresis is recommended for steroid unresponsive patients. With early treatment initiation, full recovery is seen in 50% to 75% of patients, within 1 - 6 months. Our patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. CONCLUSIONS: Clinicians should consider post - vaccination acute disseminated encephalomyelitis in patients with encephalopathy, multifocal neurological findings and recent vaccination after carefully excluding other causes.
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: This case is a part of cluster of 2 cases (same reporter and vaccine) and is linked to case number 2013SA136389. Initial report received from a healthcare professional on 26 December 2013: A female patient (age between 21-50), had received a dose of FLUZONE ID, (batch number, dose number, route and site of administration not reported) on an unspecified date of November 2013. The patient had no illness at the time of vaccination and pre-existing medical conditions were not available. It was reported that the patient was suspected to have H1N1 influenza on 24 December 2013. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chapped lips, Dry mouth, Dry skin, Dysgeusia, Gingival bleeding
Clinical narrative: Swollen split tongue, blisters in mouth, inflamed bleeding gums, swollen chapped lips, cannot taste food, all food tastes greasy. On 12/31 broke out with rash all over body, dry and itchy. Acyclovir 400mg/pilocarpine HCL 5mg/nystatin 100000unit/ml susp. I have seen my doctor 2x.  My mouth is still dry and gums are very tender..still bleeding.  My lips are still swollen and chapped.. some days worse than others, but never normal. Bumps or rash on arms, hands, legs, and back and neck.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Gingival inflammation, Gingival pain, Lip swelling, Oral mucosal blistering, Rash generalised
Clinical narrative: Swollen split tongue, blisters in mouth, inflamed bleeding gums, swollen chapped lips, cannot taste food, all food tastes greasy. On 12/31 broke out with rash all over body, dry and itchy. Acyclovir 400mg/pilocarpine HCL 5mg/nystatin 100000unit/ml susp. I have seen my doctor 2x.  My mouth is still dry and gums are very tender..still bleeding.  My lips are still swollen and chapped.. some days worse than others, but never normal. Bumps or rash on arms, hands, legs, and back and neck.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash pruritic, Rheumatoid arthritis, Rheumatoid factor positive, Swollen tongue, Tongue ulceration
Clinical narrative: Swollen split tongue, blisters in mouth, inflamed bleeding gums, swollen chapped lips, cannot taste food, all food tastes greasy. On 12/31 broke out with rash all over body, dry and itchy. Acyclovir 400mg/pilocarpine HCL 5mg/nystatin 100000unit/ml susp. I have seen my doctor 2x.  My mouth is still dry and gums are very tender..still bleeding.  My lips are still swollen and chapped.. some days worse than others, but never normal. Bumps or rash on arms, hands, legs, and back and neck.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: 3 hours after vaccine administration, developed a raised, red, warm, urticarial, pruritic rash on the leg in which she got the shot.  She did not have a rash anywhere else and had no other symptoms.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: 3 hours after vaccine administration, developed a raised, red, warm, urticarial, pruritic rash on the leg in which she got the shot.  She did not have a rash anywhere else and had no other symptoms.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Urticaria
Clinical narrative: Hives; Dizziness. Benadryl.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Influenza, Pain, Pyrexia
Clinical narrative: This case for 3 patients is part of cluster of 2 cases and linked with case number 2013SA136392 (one patient). Initial report received from a healthcare professional on 26 December 2013. 3 female patients in the age group of 21-50 had received an intradermal dose of FLUZONE ID (lot number, dose number and anatomical site of administration were not reported) on an unspecified date of November 2013. The patient had no illness at the time of vaccination and concomitant medications were not reported. On 24 December 2013, the patients were suspected to have flu with symptoms of fever (103), achiness and weakness. Laboratory details and corrective treatments were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: none.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age (adult) and gender). In 2007 the patient was vaccinated with PNEUMOVAX 23 dose 1, 0.5 ml, subcutaneous, at less than 65 years of age. In 2010 the patient was vaccinated with PNEUMOVAX 23 dose 2, 0.5 ml, subcutaneous, at less than 65 years of age. On 09-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 dose 3, 0.5 ml, subcutaneous, when the patient was older than 65 years of age. At the time of administration of the third dose, the nurse did not know that the patient had already received a dose of PNEUMOVAX 23 in 2010. The nurse stated that doses of PNEUMOVAX 23 were documented under a different medical record number. No adverse effects were reported. Action taken regarding to the use of PNEUMOVAX 23 was not reported. The outcome of the patient received a dose of PNEUMOVAX 23 2007 and 2010, dose administered on 09-DEC-2013, patient already received a dose of PNEUMOVAX 23 in 2007 and in 2010 and no adverse effect reported was unknown. Reporter causality assessment was not reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Feeling hot, Local swelling, Pain
Clinical narrative: Warmth, pain, swelling and redness to (R) arm distal to injection site. Pt given TYLENOL and warm packs. Pt escorted to ER for assessment/treatment.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, redness and swelling in involved area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Localized erythema, swelling, pruritus and urticaria of left lateral thigh started 24 hours post injection. Increased in size 48 hours post injection. Increase in size and pain 70 hours post injection. Topical triamcinolone at 48 hours prescribed, Cephalexin 250 mg/5 ml take 8 ml BID prescribed as 70 hours.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Idiopathic angioedema, Local reaction, Swollen tongue, Throat tightness
Clinical narrative: Pt having angioedema (rear of tongue), complained of tightness in throat. Pt has had idiopathic angioedema in past. The patient came back approximately 10 minutes after I gave her the shot and said she was having angioedema (specifically tongue swelling toward the back of tongue) and that she felt like her throat was closing. She did not have swelling, redness or warmth at site of injection. She said she had had angioedema in the past and said that her doctor said when she had it to use an epipen but did not have one. She stated that last year she got a localized reaction last year when she got a flu shot but attributed that to "the person giving the shot" I administered epinephrine 0.3 mg into the muscle of right thigh. Pt said she thought swelling had gone down and was feeling better. Pt stayed in area with me for approximately 20 minutes so I could assess whether or not shot working. Declined ambulance/ driving her home. Epipen lot 2mg670 exp 5/14.
Age: 1.34
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Erythema, Local reaction, Urticaria
Clinical narrative: Hives on legs, arms and torso; redness; local reaction.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Dizziness, Dysphonia, Headache, Injection site erythema
Clinical narrative: Temp 99.5 degrees, dizzy, throat is tight, some hoarseness but didn't last past a few sentences, injection site on arm red and hard about the size of an orange, mild headache, mucus in throat - symptoms are very mild, still having symptoms today Jan 7, 2014.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Throat tightness
Clinical narrative: Temp 99.5 degrees, dizzy, throat is tight, some hoarseness but didn't last past a few sentences, injection site on arm red and hard about the size of an orange, mild headache, mucus in throat - symptoms are very mild, still having symptoms today Jan 7, 2014.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Chills, Gait disturbance, Myalgia, Spinal X-ray
Clinical narrative: Chills and extreme aches up and down the spine as well as the muscles from neck down through the legs.  I have had continuing bouts with chills and difficulty recovering from muscle pain as well as difficulty with walking.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Spinal pain, X-ray of pelvis and hip
Clinical narrative: Chills and extreme aches up and down the spine as well as the muscles from neck down through the legs.  I have had continuing bouts with chills and difficulty recovering from muscle pain as well as difficulty with walking.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Started w/red spot @ point of injection, progressed next day to a larger red spot about 2.5" in diameter, swollen, sore, w/some itching.
Age: 18.0
Sex: M
Vaccine: FLU3, JEV1, PPV
Symptoms: Asthenia, Disorientation, Dysphagia, Dyspnoea, Pallor
Clinical narrative: Shortness of breath, low energy, paleness, weakness, slight trouble swallowing, disorientation, fever.
Age: 18.0
Sex: M
Vaccine: FLU3, JEV1, PPV
Symptoms: Pyrexia
Clinical narrative: Shortness of breath, low energy, paleness, weakness, slight trouble swallowing, disorientation, fever.
Age: 2.0
Sex: M
Vaccine: HIBV, PPV
Symptoms: Erythema, Urticaria
Clinical narrative: Red hives on whole body.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Anxiety, Crying, Depression, School refusal
Clinical narrative: On 12/16/13, the mother reported that days after each of the three HPV vaccines on 1/29/13, 4/2/13 and 7/31/13, the patient developed crying, school refusal and anxiety that lasted several weeks. After the dose # 1, patient presented to office on 2/19/13 reporting onset of crying 2/14/13. He was referred to behavioral health specialist and diagnoses with anxiety and depressive disorder.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Crying, Depression, School refusal
Clinical narrative: On 12/16/13 mom brought patient into office reporting anxiety and crying bouts lasting several weeks and triggered by going to school after each of three HPV doses 1/29/13, 4/2/13 and 7/31/13 seen 2/19/13 with onset crying 2/14/13 and school refusal. Behavioral health specialist diagnosed depressive disorder and anxiety and treated with REMERON 4/30/13