chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, Injection site pruritus
Clinical narrative: This spontaneous report was received from a registered dietician regarding herself, who was a 75 year old female patient. Patient's concurrent condition included asthma (since past 30 years), chronic obstructive pulmonary disease (COPD) (since past 2 years). Patient has drug reactions or allergies to aspirin which causes bruising and bleeding. On an unknown date in December 2014 the patient was vaccinated with PNEUMOVAX 23 (lot number, dose, frequency and route unspecified), in the left arm. On the same day, the patient was also vaccinated with PREVNAR 13 (dose, frequency and route unspecified) in the right arm. Concomitant therapies included SYNTHROID, SPIRIVA, VENTOLIN, hydrochlorothiazide (manufacturer unknown), NEXIUM, ADVAIR, verapamil, CRESTOR, EVISTA, montelukast sodium (manufacturer unknown), potassium (unspecified), loperamide hydrochloride, benzonatate and albuterol sulfate. On an unknown date the patient experienced continued intermittent itchiness at the PNEUMOVAX 23 injection site. The patient did not sought medical attention. No treatment was given for the adverse events. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray, Pyrexia, Streptococcus test, Urine analysis
Clinical narrative: High fever up to 107 degree. Went to emergency service on 11/21/2014 and 11/24/2014.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Blood prolactin increased, Cognitive disorder, Electrocardiogram ambulatory normal, Generalised tonic-clonic seizure
Clinical narrative: I began the Gardasil 3 dose vaccine series in June 2009, and my first tonic-clonic seizure occurred on 01 Mar 2010. I was hospitalized and began the start of 4+ years of testing to find out the cause of this adult onset seizure disorder. All test were inconclusive. I have been hospitalized three times, but have numerous seizures throughout the year. I take daily anti-epileptic medications. Cardiac disorders were ruled out as I had a loop recorder placed by a cardiolgist, that did not show any heart arrhythmias during my seizure activity. I just recently recalled receiving this vaccine a few months prior to my diagnosis. The first seizure was not witnessed, so it was not fully clear the diagnosis. However, all episodes present the same loss of consciousness, ridgid convulsions, tongue biting and prolactin levels 4x upper limit of normal and severe memory loss. I have lost normal cognitive functioning since 2009.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Muscle rigidity, Tongue biting
Clinical narrative: I began the Gardasil 3 dose vaccine series in June 2009, and my first tonic-clonic seizure occurred on 01 Mar 2010. I was hospitalized and began the start of 4+ years of testing to find out the cause of this adult onset seizure disorder. All test were inconclusive. I have been hospitalized three times, but have numerous seizures throughout the year. I take daily anti-epileptic medications. Cardiac disorders were ruled out as I had a loop recorder placed by a cardiolgist, that did not show any heart arrhythmias during my seizure activity. I just recently recalled receiving this vaccine a few months prior to my diagnosis. The first seizure was not witnessed, so it was not fully clear the diagnosis. However, all episodes present the same loss of consciousness, ridgid convulsions, tongue biting and prolactin levels 4x upper limit of normal and severe memory loss. I have lost normal cognitive functioning since 2009.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Dizziness, near fainting.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Measles, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Pt got measles like symptoms facial rash, fever and runny nose.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Blood calcium normal, Blood magnesium normal, Dyskinesia, Electroencephalogram abnormal, Eye movement disorder
Clinical narrative: Jerking Motion on Right side arm and leg. Eyes deviating to right.  Lasting approximately 30 seconds.  Child first brought in for this by parents on October 17, 2014.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Full blood count normal, Infantile spasms, Metabolic function test normal, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: Jerking Motion on Right side arm and leg. Eyes deviating to right.  Lasting approximately 30 seconds.  Child first brought in for this by parents on October 17, 2014.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Immediate soreness at injection site, followed 2 days later by shoulder and arm pain and reduced range of motion. Burning sensation followed. 09/15/2014 went to primary physician, had an x-ray, then was sent to an orthopedic, went for physical therapy, specialist for few weeks then went for an MRI, after a few more weeks had a cortisone shot. Nothing seemed to help. Am still going to physical therapy. Still no improvement.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray
Clinical narrative: Immediate soreness at injection site, followed 2 days later by shoulder and arm pain and reduced range of motion. Burning sensation followed. 09/15/2014 went to primary physician, had an x-ray, then was sent to an orthopedic, went for physical therapy, specialist for few weeks then went for an MRI, after a few more weeks had a cortisone shot. Nothing seemed to help. Am still going to physical therapy. Still no improvement.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Started with arm soreness; by evening can barely lift arm; 36 hrs after injection started fever. So far 101.2; achy in arms, queasy stomach; achy thighs.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Crying, Developmental delay, Encephalopathy, Pyrexia, Seizure
Clinical narrative: Slept all day, was hard to wake. Fever started creeping up, then started crying inconsolably for hours upon hours. He was finally admitted on 3/4/2010.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Somnolence
Clinical narrative: Slept all day, was hard to wake. Fever started creeping up, then started crying inconsolably for hours upon hours. He was finally admitted on 3/4/2010.
Age: 40.0
Sex: M
Vaccine: TYP
Symptoms: Burning sensation, Rash, Rash pruritic
Clinical narrative: He developed a rash on his left forarm area that was itchy and when lotion was applied it burned slightly.  It has not gotten worse since yesterday.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Necrotising colitis
Clinical narrative: Medical necrotizing enterocolitis.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to left deltoid following injection 24hrs prior. Reported to Urgent Care, was seen by a provider and medication rx given.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Blood electrolytes, Electroencephalogram normal, Full blood count normal, Muscle twitching, Nuclear magnetic resonance imaging normal
Clinical narrative: The evening of FluMist booster patient had an episode of vomiting with following unresponsiveness and possible right sided twitching.  Was afebrile during this episode. 1 month following was diagnosed with partial seizure disorder with similar symptoms- vomiting with following unresponsiveness and right sided twitching.  Was afebrile during this episode and had negative MRI, electrolytes, and no history of trauma or ingestion.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Partial seizures, Unresponsive to stimuli, Vomiting
Clinical narrative: The evening of FluMist booster patient had an episode of vomiting with following unresponsiveness and possible right sided twitching.  Was afebrile during this episode. 1 month following was diagnosed with partial seizure disorder with similar symptoms- vomiting with following unresponsiveness and right sided twitching.  Was afebrile during this episode and had negative MRI, electrolytes, and no history of trauma or ingestion.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a healthcare student concerning a 63 year old male patient. No relevant medical history was reported. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX23 (lot#, dose, strength, route not reported). It was reported that the patient developed hives following administration of PNEUMOVAX23 on an unspecified date and recovered from the hives on an unspecified date. Then the patient forgot that he experienced the hives reaction and was administered the second dose of PNEUMOVAX23 (lot#, dose and route unknown) on an unspecified date. The patient developed hives following the administration again but they were worse than before. The outcome of the second episode of hives was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Rash erythematous, Skin induration
Clinical narrative: Red, oval shaped rash approx. 3" near injection site; fatigue. Very painful, feels hard under skin pt. seeking medical attn. today.
Age: 24.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Loss of consciousness
Clinical narrative: Administered vaccine. Patient stated he was fine (previously stated he was "nervous" about getting vaccine. Sat for 2 min in chair, but stated he was ok to get up (I offered to let him stay)- got up, lost consciousness after 1 minute, laid on ground for 2 more min, then sat and drank water x30 min and left without issue.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to two anonymous patients of unknown age and gender. On an unknown date, these two patients were administered a dose of improperly stored VARIVAX (Merck) (strength, lot number, expiry date, route and dose were not reported), which was reconstituted by not improperly stored sterile diluent (strength, lot number, expiry date, route and dose were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On an unknown date, these patients were vaccinated with PEDVAXHIB (strength, lot number, expiry date, route and dose were not reported) post supported excursion. No adverse effects were reported. This is one of two reports received from the same reporter (linked to 1502USA000844). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Two days after administration patient reported to pharmacy redness and swelling at injection site. She described swelling as size of her fist. We referred her to her doctor. She said MD instructed her to monitor over weekend and follow up Monday in his office.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Encephalitis, Muscle spasms
Clinical narrative: Case number PHEH2015US003183, is an initial spontaneous report from a consumer received on 11 Feb 2015. This report refers to an 87-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly on an unknown date. On 06 Oct 2009, the patient had a severe reaction to the influenza vaccine. The patient experienced Guillain Barre symptoms, but the patient was not verified to have Guillain Barre Syndrome (GBS). The patient was hospitalized due to severe cramping and the patient developed encephalitis. The final outcome of the events was unknown. Causality was not reported.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dysarthria, Eye movement disorder, Loss of consciousness, Pallor
Clinical narrative: About 45 seconds after administration of Gardasil (dose #3) to upper right deltoid, client showed circumoral and circumnasal pallor, slurred speech and her eyes rolled back and closed as she lost consciousness.  She was lowered safely to prone position, cool compress applied to forehead and feet elevated.  After about a minute of calling her name and gently tapping her she started to come around.  After a few minutes she was able to sit with support and sipped some cool water.  Within 5-7 minutes she was able to stand with assistance and left about 10 minutes later with her family, walking on her own though still a bit pale.  Parents reported she had not had lunch yet.
Sex: U
Vaccine: MMR
Symptoms: Death
Clinical narrative: Information has been received from a consumer referring to 109 patients of unknown age and gender. The patients' concurrent condition and medical history not reported. The reporter had concerned about the patients were vaccinated with M-M-R II (lot#, dose and route not reported) and (3) live neurotoxin vaccines (manufacturer unknown) (strength, dose, lot# and route were not reported) were given in combination on unknown dates could create adverse effects. Concomitant therapy was not provided. On unknown dates, the patients died from the M-M-R II. It was not confirmed if autopsies were performed or not. The cause of death was unknown. Consumer could not confirm where he received this statistic. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy skin abnormal, Blood bilirubin normal, Blood creatinine increased, Blood culture negative, Culture urine negative
Clinical narrative: This medically confirmed literature case (initial receipt 10-Feb-2015) concerns a 62 year old female patient. The patient had medical history of history of autoimmune hepatitis and was on chronic immunosuppressive therapy. The patient's past medication included mycophenolate mofetil which was switched to azathioprine 10 days prior to hospitalisation. His concomitant medication included prednisone. The patient denied any recent travel, localizing symptoms of infection or known exposure to sick contacts. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, ten days prior to hospitalisation, the patient also received azathioprine (manufacturer and batch number not reported). On an unspecified date, one week after vaccination, the patient was admitted to the hospital with three-day history of fever, fatigue, diffuse myalgia and a new asymptomatic rash. On arrival at the hospital, her temperature was 39.5 degree Celsius with an increased white blood cell count of 27,000 cells/ul with a left shift and turbid urine. Creatinine was elevated to 2.6 mg/dl. Liver enzymes and bilirubin were unchanged from the baseline levels. Physical examination revealed multiple erythematous, edematous papules with central deep-seated pustules on the right upper eyelid, bilateral cheeks, trunk, and proximal extremities. The mucosal surfaces were uninvolved. A punch biopsy was obtained from the right upper arm. Histologic evaluation revealed a subcorneal pustule with interstitial and perivascular neutrophilic inflammation. There was no significant papillary dermal edema. Gram and periodic acid-Schiff stains were negative. Overall findings were thought to be most consistent with a neutrophilic dermatosis secondary to azathioprine hypersensitivity. Azathioprine was stopped shortly after admission. The patient was continued on prednisone 10 mg/d and started on intravenous cefepime for presumed urosepsis. The antibiotic was discontinued after two days as the patient had no symptoms of dysuria, and both blood and urine cultures remained negative. A wound culture obtained from pustular contents was also negative. The patient's rash and laboratory abnormalities improved significantly over the course of a 4 day hospital stay. The outcome was reported as recovering. Reporter comments: The diagnosis was Azathioprine Hypersensitivity Syndrome (AHS).
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Culture wound negative, Drug reaction with eosinophilia and systemic symptoms, Erythema, Fatigue, Gram stain negative
Clinical narrative: This medically confirmed literature case (initial receipt 10-Feb-2015) concerns a 62 year old female patient. The patient had medical history of history of autoimmune hepatitis and was on chronic immunosuppressive therapy. The patient's past medication included mycophenolate mofetil which was switched to azathioprine 10 days prior to hospitalisation. His concomitant medication included prednisone. The patient denied any recent travel, localizing symptoms of infection or known exposure to sick contacts. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, ten days prior to hospitalisation, the patient also received azathioprine (manufacturer and batch number not reported). On an unspecified date, one week after vaccination, the patient was admitted to the hospital with three-day history of fever, fatigue, diffuse myalgia and a new asymptomatic rash. On arrival at the hospital, her temperature was 39.5 degree Celsius with an increased white blood cell count of 27,000 cells/ul with a left shift and turbid urine. Creatinine was elevated to 2.6 mg/dl. Liver enzymes and bilirubin were unchanged from the baseline levels. Physical examination revealed multiple erythematous, edematous papules with central deep-seated pustules on the right upper eyelid, bilateral cheeks, trunk, and proximal extremities. The mucosal surfaces were uninvolved. A punch biopsy was obtained from the right upper arm. Histologic evaluation revealed a subcorneal pustule with interstitial and perivascular neutrophilic inflammation. There was no significant papillary dermal edema. Gram and periodic acid-Schiff stains were negative. Overall findings were thought to be most consistent with a neutrophilic dermatosis secondary to azathioprine hypersensitivity. Azathioprine was stopped shortly after admission. The patient was continued on prednisone 10 mg/d and started on intravenous cefepime for presumed urosepsis. The antibiotic was discontinued after two days as the patient had no symptoms of dysuria, and both blood and urine cultures remained negative. A wound culture obtained from pustular contents was also negative. The patient's rash and laboratory abnormalities improved significantly over the course of a 4 day hospital stay. The outcome was reported as recovering. Reporter comments: The diagnosis was Azathioprine Hypersensitivity Syndrome (AHS).
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Hepatic enzyme, Histology abnormal, Inflammation, Liver function test normal, Myalgia
Clinical narrative: This medically confirmed literature case (initial receipt 10-Feb-2015) concerns a 62 year old female patient. The patient had medical history of history of autoimmune hepatitis and was on chronic immunosuppressive therapy. The patient's past medication included mycophenolate mofetil which was switched to azathioprine 10 days prior to hospitalisation. His concomitant medication included prednisone. The patient denied any recent travel, localizing symptoms of infection or known exposure to sick contacts. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, ten days prior to hospitalisation, the patient also received azathioprine (manufacturer and batch number not reported). On an unspecified date, one week after vaccination, the patient was admitted to the hospital with three-day history of fever, fatigue, diffuse myalgia and a new asymptomatic rash. On arrival at the hospital, her temperature was 39.5 degree Celsius with an increased white blood cell count of 27,000 cells/ul with a left shift and turbid urine. Creatinine was elevated to 2.6 mg/dl. Liver enzymes and bilirubin were unchanged from the baseline levels. Physical examination revealed multiple erythematous, edematous papules with central deep-seated pustules on the right upper eyelid, bilateral cheeks, trunk, and proximal extremities. The mucosal surfaces were uninvolved. A punch biopsy was obtained from the right upper arm. Histologic evaluation revealed a subcorneal pustule with interstitial and perivascular neutrophilic inflammation. There was no significant papillary dermal edema. Gram and periodic acid-Schiff stains were negative. Overall findings were thought to be most consistent with a neutrophilic dermatosis secondary to azathioprine hypersensitivity. Azathioprine was stopped shortly after admission. The patient was continued on prednisone 10 mg/d and started on intravenous cefepime for presumed urosepsis. The antibiotic was discontinued after two days as the patient had no symptoms of dysuria, and both blood and urine cultures remained negative. A wound culture obtained from pustular contents was also negative. The patient's rash and laboratory abnormalities improved significantly over the course of a 4 day hospital stay. The outcome was reported as recovering. Reporter comments: The diagnosis was Azathioprine Hypersensitivity Syndrome (AHS).
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Neutrophilic dermatosis, Oedema, Papule, Pyrexia, Rash
Clinical narrative: This medically confirmed literature case (initial receipt 10-Feb-2015) concerns a 62 year old female patient. The patient had medical history of history of autoimmune hepatitis and was on chronic immunosuppressive therapy. The patient's past medication included mycophenolate mofetil which was switched to azathioprine 10 days prior to hospitalisation. His concomitant medication included prednisone. The patient denied any recent travel, localizing symptoms of infection or known exposure to sick contacts. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, ten days prior to hospitalisation, the patient also received azathioprine (manufacturer and batch number not reported). On an unspecified date, one week after vaccination, the patient was admitted to the hospital with three-day history of fever, fatigue, diffuse myalgia and a new asymptomatic rash. On arrival at the hospital, her temperature was 39.5 degree Celsius with an increased white blood cell count of 27,000 cells/ul with a left shift and turbid urine. Creatinine was elevated to 2.6 mg/dl. Liver enzymes and bilirubin were unchanged from the baseline levels. Physical examination revealed multiple erythematous, edematous papules with central deep-seated pustules on the right upper eyelid, bilateral cheeks, trunk, and proximal extremities. The mucosal surfaces were uninvolved. A punch biopsy was obtained from the right upper arm. Histologic evaluation revealed a subcorneal pustule with interstitial and perivascular neutrophilic inflammation. There was no significant papillary dermal edema. Gram and periodic acid-Schiff stains were negative. Overall findings were thought to be most consistent with a neutrophilic dermatosis secondary to azathioprine hypersensitivity. Azathioprine was stopped shortly after admission. The patient was continued on prednisone 10 mg/d and started on intravenous cefepime for presumed urosepsis. The antibiotic was discontinued after two days as the patient had no symptoms of dysuria, and both blood and urine cultures remained negative. A wound culture obtained from pustular contents was also negative. The patient's rash and laboratory abnormalities improved significantly over the course of a 4 day hospital stay. The outcome was reported as recovering. Reporter comments: The diagnosis was Azathioprine Hypersensitivity Syndrome (AHS).
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Shift to the left, Subcorneal pustular dermatosis, Urine abnormality, Urosepsis, White blood cell count increased
Clinical narrative: This medically confirmed literature case (initial receipt 10-Feb-2015) concerns a 62 year old female patient. The patient had medical history of history of autoimmune hepatitis and was on chronic immunosuppressive therapy. The patient's past medication included mycophenolate mofetil which was switched to azathioprine 10 days prior to hospitalisation. His concomitant medication included prednisone. The patient denied any recent travel, localizing symptoms of infection or known exposure to sick contacts. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, ten days prior to hospitalisation, the patient also received azathioprine (manufacturer and batch number not reported). On an unspecified date, one week after vaccination, the patient was admitted to the hospital with three-day history of fever, fatigue, diffuse myalgia and a new asymptomatic rash. On arrival at the hospital, her temperature was 39.5 degree Celsius with an increased white blood cell count of 27,000 cells/ul with a left shift and turbid urine. Creatinine was elevated to 2.6 mg/dl. Liver enzymes and bilirubin were unchanged from the baseline levels. Physical examination revealed multiple erythematous, edematous papules with central deep-seated pustules on the right upper eyelid, bilateral cheeks, trunk, and proximal extremities. The mucosal surfaces were uninvolved. A punch biopsy was obtained from the right upper arm. Histologic evaluation revealed a subcorneal pustule with interstitial and perivascular neutrophilic inflammation. There was no significant papillary dermal edema. Gram and periodic acid-Schiff stains were negative. Overall findings were thought to be most consistent with a neutrophilic dermatosis secondary to azathioprine hypersensitivity. Azathioprine was stopped shortly after admission. The patient was continued on prednisone 10 mg/d and started on intravenous cefepime for presumed urosepsis. The antibiotic was discontinued after two days as the patient had no symptoms of dysuria, and both blood and urine cultures remained negative. A wound culture obtained from pustular contents was also negative. The patient's rash and laboratory abnormalities improved significantly over the course of a 4 day hospital stay. The outcome was reported as recovering. Reporter comments: The diagnosis was Azathioprine Hypersensitivity Syndrome (AHS).
Sex: F
Vaccine: FLUX
Symptoms: Death, Dyskinesia, Encephalitis, Guillain-Barre syndrome, Hypertension
Clinical narrative: This spontaneous consumer report (initial receipt 11-Feb-2015) concerns a female patient. On the 06-Oct-2009, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient became very sick. The patient went into fetal position within 24 hours after vaccination and became hypersensitive, slided her legs out and moved her head in circles for weeks. Weeks later, the patient went to the medical centre and the doctor stated that she experienced Guillain Barre Syndrome and encephalitis. She was treated with antibiotics. The patient did not recover and passed away in Feb-2014. The exact cause of death was unknown. The outcome was reported as not recovered. Reporter's comments: It was reported that the exact cause of death was unknown. The reporter did not specify how her mother passed away or if it was related to the flu vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This spontaneous consumer report (initial receipt 11-Feb-2015) concerns a female patient. On the 06-Oct-2009, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient became very sick. The patient went into fetal position within 24 hours after vaccination and became hypersensitive, slided her legs out and moved her head in circles for weeks. Weeks later, the patient went to the medical centre and the doctor stated that she experienced Guillain Barre Syndrome and encephalitis. She was treated with antibiotics. The patient did not recover and passed away in Feb-2014. The exact cause of death was unknown. The outcome was reported as not recovered. Reporter's comments: It was reported that the exact cause of death was unknown. The reporter did not specify how her mother passed away or if it was related to the flu vaccine.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Arm was swollen at and around injection site.  Son said it was itchy and there was a red rash 2 inches in diameter around the injection site.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Burning sensation, Carpal tunnel syndrome, Hypoaesthesia, Migraine
Clinical narrative: I began vomiting violently after a couple of hours of getting home. I vomited for about 6 hours. I was unable to go to work the next day, and the day after I felt better. The next week, the same thing happened. One day I vomited from about 12:30 PM until 2:30 AM. The week after that the same thing happened. I made an appointment to see my Dr. to find out what was going on. On my way to the appointment I got a migraine. The appointment turned into be about the migraine instead of my vomiting. They gave me a shot of toradol. A few hours after I got home I began to swell. I removed all of my jewelry. My hands began to feel as if they were burning. I went to the ER and they gave me a shot of Valium, and sent me home. Ever since then on my Right hand all of my fingers, except for my pinky have been numb and tingling. On my Left hand my ring, and middle finger have been numb and tingling. They tell me I have carpal tunnel, with severe nerve damage. I had surgery on my Right hand on 2/4/15. There has been no change in how my hand feels.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve injury, Paraesthesia, Surgery, Swelling, Vomiting
Clinical narrative: I began vomiting violently after a couple of hours of getting home. I vomited for about 6 hours. I was unable to go to work the next day, and the day after I felt better. The next week, the same thing happened. One day I vomited from about 12:30 PM until 2:30 AM. The week after that the same thing happened. I made an appointment to see my Dr. to find out what was going on. On my way to the appointment I got a migraine. The appointment turned into be about the migraine instead of my vomiting. They gave me a shot of toradol. A few hours after I got home I began to swell. I removed all of my jewelry. My hands began to feel as if they were burning. I went to the ER and they gave me a shot of Valium, and sent me home. Ever since then on my Right hand all of my fingers, except for my pinky have been numb and tingling. On my Left hand my ring, and middle finger have been numb and tingling. They tell me I have carpal tunnel, with severe nerve damage. I had surgery on my Right hand on 2/4/15. There has been no change in how my hand feels.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Patient came into pharmacy complaining of large red bumps and itching in the arm that the Prevnar injection was administered.  Patient showed the area to me (the pharmacist on duty) which was distinctively hives on the arm in which the injection was given.  I gave patient a couple diphenhydramine 25mg to help with the itching for the next couple days and told patient we would follow up with her on Monday (the next day the pharmacy is open).
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Migraine, Musculoskeletal stiffness
Clinical narrative: Weakness tired stiff neck at first migraine headaches developed on the 24th and have continued through present.  Have taked excedrine migraine prednisone 20mg for 5 days now on muscle relaxers 4xs a day.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Influenza, Influenza virus test positive
Clinical narrative: Initial pregnancy unsolicited literature report received on 03 Feb 2015. This case is linked to 2015SA020610 (same reported). Forty two pregnant female patients (age not reported) whose medical history and concomitant medication were not reported, had received a dose of Seasonal Influenza Vaccine (batch number, route and site of vaccination was not reported) on an unspecified date. CONCLUSION: Influenza had a greater negative impact on pregnant women than non-influenza ARIs, as indicated by symptom severity and greater likelihood of elevated temperature. These results highlight the importance of preventing and treating influenza illnesses in pregnant women. The case concerns with forty two pregnant female patients who were identified to be influenza positive on an unspecified date. Corrective treatment and laboratory investigations were not reported. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited case received from a consumer, who is also the patient, on 16 February 2015. A female patient (age not reported) with a history of soy intolerance received a dose of Influenza vaccine (manufacturer and lot number not reported) on an unspecified date, and subsequently experienced an anaphylactic reaction. According to the patient, she started on ALLEGRA Allergy 24 Hours after this to "help with her allergies". No additional information was provided regarding the anaphylactic reaction. Outcome was not reported. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Asthenia, CSF oligoclonal band present, Central nervous system lesion, Demyelination
Clinical narrative: Patient is an ICU nurse who experienced acute demyelination within the central nervous system within one week of vaccination for influenza. MRI brain: focal areas of T2 signal around frontal horns and atria of lateral ventricles and (L) cerebellum with at least 1 enhancing lesion. MRI cervical spine: multiple demyelinating lesions with cord expansion. MRI thoracic spine: multiple demyelinating lesions.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Multiple sclerosis, Muscle spasticity, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Pain
Clinical narrative: Patient is an ICU nurse who experienced acute demyelination within the central nervous system within one week of vaccination for influenza. MRI brain: focal areas of T2 signal around frontal horns and atria of lateral ventricles and (L) cerebellum with at least 1 enhancing lesion. MRI cervical spine: multiple demyelinating lesions with cord expansion. MRI thoracic spine: multiple demyelinating lesions.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: CSF test normal, Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal, Paralysis flaccid, Sensory loss
Clinical narrative: Patient developed acute thoracic transverse myelitis with flaccid paralysis of bladder and legs and loss of sensation below T10. Treated as inpatient with SOLU MEDROL 1g IV daily x 5 days with partial recovery.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Hypoaesthesia, Hypokinesia, Muscular weakness, Myelitis transverse
Clinical narrative: Onset right leg weakness over 4 days - then severe leg numbness and loss of movement - Diagnosis: Transverse Myelitis.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Onset right leg weakness over 4 days - then severe leg numbness and loss of movement - Diagnosis: Transverse Myelitis.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Burning sensation, CSF oligoclonal band present, Hemiparesis, Hyperaesthesia
Clinical narrative: (L)-sided numbness/weakness/burning pain in back/legs/feet. Muscle spasm. Hypersensitivity to light touch.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Muscle spasms, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity
Clinical narrative: (L)-sided numbness/weakness/burning pain in back/legs/feet. Muscle spasm. Hypersensitivity to light touch.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Back pain, Burning sensation, CSF oligoclonal band present, Central nervous system lesion
Clinical narrative: (L)-sided numbness/weakness/burning pain in back/legs/feet. Muscle spasm. Hypersensitivity to light touch.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Demyelination, Hyperaesthesia, Hypoaesthesia, Muscle spasms, Nuclear magnetic resonance imaging brain normal
Clinical narrative: (L)-sided numbness/weakness/burning pain in back/legs/feet. Muscle spasm. Hypersensitivity to light touch.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity
Clinical narrative: (L)-sided numbness/weakness/burning pain in back/legs/feet. Muscle spasm. Hypersensitivity to light touch.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Bladder dysfunction, Demyelination, Functional gastrointestinal disorder, Hypoaesthesia, Muscle spasms
Clinical narrative: Bilateral lower extremity weakness/numbness/pain. Bladder dysfunction. Received IV SOLU MEDROL x 5 days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Spinal cord oedema, Vitamin B12 normal
Clinical narrative: Bilateral lower extremity weakness/numbness/pain. Bladder dysfunction. Received IV SOLU MEDROL x 5 days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Walking aid user
Clinical narrative: Bilateral lower extremity weakness/numbness/pain. Bladder dysfunction. Received IV SOLU MEDROL x 5 days.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Cough, Culture throat positive, Decreased appetite, Eye discharge, Irritability
Clinical narrative: 01/23/2015 after returning from Childcare became fussy and developed fever. 01/25/2015 rash started on face and spread down to the remainder of the body. Developed eye drainage, rhinorrhea, cough, malaise, decreased appetite. Was taken to ER. Treated with antipyretics and testing for measles done. 02/03/2015 symptoms improved and able to return to childcare.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Malaise, Morbillivirus test positive, Pyrexia, Rash, Rash generalised
Clinical narrative: 01/23/2015 after returning from Childcare became fussy and developed fever. 01/25/2015 rash started on face and spread down to the remainder of the body. Developed eye drainage, rhinorrhea, cough, malaise, decreased appetite. Was taken to ER. Treated with antipyretics and testing for measles done. 02/03/2015 symptoms improved and able to return to childcare.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Rhinorrhoea
Clinical narrative: 01/23/2015 after returning from Childcare became fussy and developed fever. 01/25/2015 rash started on face and spread down to the remainder of the body. Developed eye drainage, rhinorrhea, cough, malaise, decreased appetite. Was taken to ER. Treated with antipyretics and testing for measles done. 02/03/2015 symptoms improved and able to return to childcare.
Age: 26.0
Sex: F
Vaccine: IPV, TYP
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was pregnant at time of vaccination. Pt evaluated on 17Feb2015 and was 6weeks/6days pregnant.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Fever (~103) for 24 hours and swollen cervical lymph nodes and leg pain.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Hyperaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Mother stated that the L upper arm was "really red and swollen". She had two vaccinations on 2/17 (both in the Left arm (IM and SQ). Area of redness and swelling was noted "between the two" injection sites. Phone call to Public Health to Report Adverse Reaction 2/19 at 3:45 PM. At this time, Mom states the swelling and redness is better, but not completely gone. Denies pain, itching or dyspnea at any time and noted "Really sensitive skin".
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Bronchiolitis, Influenza virus test negative, Irritability, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: High fever, irritability, restlessness, took to the doctor who tested for flu and RSV.  He ended up wheezing over the weekend so we took him to the ER on 03/30/2014 and was diagnosed with bronchiolitis.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Restlessness, Wheezing
Clinical narrative: High fever, irritability, restlessness, took to the doctor who tested for flu and RSV.  He ended up wheezing over the weekend so we took him to the ER on 03/30/2014 and was diagnosed with bronchiolitis.
Age: 2.0
Sex: M
Vaccine: HEPA, IPV
Symptoms: Condition aggravated, Eczema, Rash generalised
Clinical narrative: Rash over joints, knees, wrist, and over thighs, looks like eczema breakout.
Age: 50.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: FAINTED, LOST CONSCIOUSNESS FOR APOX. 1 MINUTE, REGAINED CONSCIOUSNESS AND RESTED FOR 30 MINUTES AND DRANK SOME ORANGE JUICE AND FULLY RECOVERED.
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia, Rash
Clinical narrative: Developed a rash after first typhoid oral pill. Rash disappeared after several hours. No rash appeared with subsequent doses, though a low grade fever (99.6) developed an hour after administration of the second pill. It disappeared with ibuprofen.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: No adverse event, just RN gave wrong vaccine.  Needed to get Tdap, but flu was adminstered instead.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia, Tremor
Clinical narrative: About a day or so after the shot, patient spiked a 103 degree temp, followed by shaking in the night and febrile like seizures.  Since this day, about every 3 days or so, she has continued to have a yo-yo fever, and at night she sometimes shakes.  She has not been sick or had any other isolated events except the MMR vaccine, which is why I think there is a high possibility for the cause.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient stated that arm has been sore since she recieved the vaccination. It is still sore.  She states that it was sore because it was administered too high.
Age: 16.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Rash, Rash pruritic
Clinical narrative: RASH WITH ITCHING ON NECK LEFT ARM.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Blood thyroid stimulating hormone normal, Chills, Fatigue, Full blood count normal
Clinical narrative: Chills x 4 weeks; fatigue x 4 weeks. Initially given Tamiflu.
Age: 1.73
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Developed fever around 7:30 PM five 1/2 days after MMR and had febrile seizure at 1:27am.
Age: 25.0
Sex: M
Vaccine: ANTH, MMR, RAB, TYP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: MEMBER HAD SYNCOPE EPISODE AFTER RECEIVING 4 VACCINES.  MEMBER HAD POSITIVE LOC FOR 20 TO 30 SECONDS. MEMBER WAS THEN MONITORED AND GIVEN ORAL HYDRATION.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: The immunized area on left arm became swollen, red, and warm to touch.  Patient went to a nurse practitioner and got a prescription for Cephalexin 500mg to be taken 4 times daily for 7 days to treat skin infection.  She was given the medication at no cost from pharmacy, counseled on usage, and we will follow up with her in a couple of days.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Started as small pain in area of flu vaccine, then grew to serious pain in arm of vaccine during late January of 2015 and persists currently.  Unable to diagnose with neurologist and primary MD.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Oxygen saturation decreased, Pyrexia, Rash, Respiratory disorder
Clinical narrative: Fever of 105, breathing issues, fatigue, rash, oxygen dropped to 74. Fevers lasted for 9 days. On Day 11 high fever returned with rash.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Asthma, Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: Day 2-Day 5: High fever, breathing issues, fatigue, loss of appetite... Day 11- High fever, fatigue, aches, asthma.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Respiratory disorder
Clinical narrative: Day 2-Day 5: High fever, breathing issues, fatigue, loss of appetite... Day 11- High fever, fatigue, aches, asthma.
Age: 1.53
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema multiforme, Rash, Urticaria
Clinical narrative: Broke out in hives/rash. Went to Emergency Department. Followed up at PCP 02/23/2015. Presented with Erythema Minor. Treatment consists of 5 days oral steroid, ranitidine and hydroxyzine until rash is gone plus 3 days.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Extreme pain and stiffness in neck.  Has persisted four months later.  Am in the care of an orthopedic physician and a physical therapist as a result.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Started with weakness, then runny nose and cough the next day with a fever of 99.5 which lasted 3 days, then 104 fever and severe coughing for 3 more days.  The Dr prescribed oral steroids for cough, continued Advil and Tylenol, and antibiotics.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Decreased appetite, Lethargy, Pyrexia, Rash
Clinical narrative: Started with fever of 100.5, loss of appetite, extreme lethargy, runny nose, cough for 5 days.  Then a rash for a week.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Rhinorrhoea
Clinical narrative: Started with fever of 100.5, loss of appetite, extreme lethargy, runny nose, cough for 5 days.  Then a rash for a week.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pallor, Rash, Swelling
Clinical narrative: Client given PPSV23 in L deltoid, within minutes face became pale, swelling under both eyes, lips became pale, both arms reddened and rash present.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster, Rash
Clinical narrative: Patient developed shingles - Abdominal rash and pain, treated with valacyclovir and gabapentin.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Inflammation, Injection site erythema, Injection site inflammation, Injection site irritation
Clinical narrative: Patient called within 24 hours of admin and complained of inj site being 'slightly irritated.' Discussed some first aid measures if needed. Told him to call back later that day to check in. He didn't feel it had gotten worse but told him to call back tomorrow if it had.  Another pharmacist on duty (imz pharmacist) took the call on Sunday (48 hours post inj) and didn't realizie the severity of the reaction.  He called his health ins nurse line with concerns of it becoming raised and redness spreading with the skin feeling coarse. He complained of lines of inflammation spreading up toward his neck and down his arm. He did take ibuprofen but didn't feel it was helping.  He appeared at the pharmacy today 2/23 5pm to show a pharmacist his reaction site and it was clearly inflamed and elevated, but he felt it had improved the last 24 hours. The patient was informed we would report the ADR and followed by more discussion about medical attention needed if it didn't improve.  Following up with him tomorrow.