chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: FLUX, YF
Symptoms: Basophil percentage increased, Blood alkaline phosphatase normal, Blood cholesterol normal, Blood creatine phosphokinase increased, Blood thyroid stimulating hormone normal
Clinical narrative: 1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
Age: 36.0
Sex: M
Vaccine: FLUX, YF
Symptoms: Blood triglycerides increased, Borrelia test negative, CSF cell count normal, CSF glucose normal, CSF protein increased
Clinical narrative: 1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
Age: 36.0
Sex: M
Vaccine: FLUX, YF
Symptoms: CSF test normal, CSF white blood cell count, Clumsiness, Condition aggravated, Culture throat negative
Clinical narrative: 1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
Age: 36.0
Sex: M
Vaccine: FLUX, YF
Symptoms: Differential white blood cell count normal, Electromyogram normal, Eosinophil percentage decreased, Gait disturbance, Gamma-glutamyltransferase increased
Clinical narrative: 1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
Age: 36.0
Sex: M
Vaccine: FLUX, YF
Symptoms: Gram stain, Gram stain negative, Grip strength decreased, Guillain-Barre syndrome, High density lipoprotein decreased
Clinical narrative: 1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
Age: 36.0
Sex: M
Vaccine: FLUX, YF
Symptoms: Hypoaesthesia, Intensive care, Laboratory test normal, Lymphocyte morphology abnormal, Lymphocyte percentage increased
Clinical narrative: 1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
Age: 36.0
Sex: M
Vaccine: FLUX, YF
Symptoms: Monocyte percentage increased, Mononucleosis heterophile test negative, Muscular weakness, Nasal congestion, Nasopharyngitis
Clinical narrative: 1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
Age: 36.0
Sex: M
Vaccine: FLUX, YF
Symptoms: Nerve conduction studies normal, Neutrophil percentage decreased, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Oropharyngeal pain
Clinical narrative: 1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
Age: 36.0
Sex: M
Vaccine: FLUX, YF
Symptoms: Paraesthesia, Porphyrins urine abnormal, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Streptococcus test negative
Clinical narrative: 1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
Age: 36.0
Sex: M
Vaccine: FLUX, YF
Symptoms: Thyroxine free normal, Treponema test negative, Urine analysis normal, White blood cell count decreased, White blood cell count increased
Clinical narrative: 1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Hypersensitivity, Unresponsive to stimuli, Wheezing
Clinical narrative: Information has been received from a registered nurse (R.N.) and nurse practitioner (N.P.) concerning a 4 year old male with asthma who on 22-MAR-2011, was vaccinated with MMR II (Lot #669017/1250Z expiration date: September 2012). Suspect therapy included a dose of VARIVAX (Lot #668477/1311Z, expiration date: October 2012). Other concomitant vaccinations included a dose of VARIVAX, DAPTACEL (unspecified) (manufacturer by Sanofi) and a dose of IPOL (manufacturer by Sanofi). The R.N reported that the patient lost consciousness. Also, the N.P reported that 15 minutes after the patient received vaccines, the patient began to vomit then the patient experienced "respiratory distress" and eventually the patient became unconscious. The N.P reported that this event was "anaphylactic reaction". The N.P reported that in the Emergency room, the patient was given EPIPEN (manufacturer unknown), albuterol (manufacturer unknown) and Oxygen (manufacturer unknown) was provided until the patient was transported to the emergency room. Also, the N.P reported that while the patient was at the emergency room the patient received "some steroids" (manufacturer unknown), ZANTAC (dose and manufacturer unknown) and BENADRYL (manufacturer unknown). The nurse reported that the patient was in the hospital for about 5 hours. The N.P reported that the patient was referred to an allergist and was not admitted to the hospital. Anaphylactic reaction was considered to be disabling and life threatening. A lot check has been initiated for VARIVAX (lot# 668477/1311Z) and MMR II (Lot #669017/1250Z). At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Loss of consciousness, Respiratory distress, Vomiting
Clinical narrative: Information has been received from a registered nurse (R.N.) and nurse practitioner (N.P.) concerning a 4 year old male with asthma who on 22-MAR-2011, was vaccinated with MMR II (Lot #669017/1250Z expiration date: September 2012). Suspect therapy included a dose of VARIVAX (Lot #668477/1311Z, expiration date: October 2012). Other concomitant vaccinations included a dose of VARIVAX, DAPTACEL (unspecified) (manufacturer by Sanofi) and a dose of IPOL (manufacturer by Sanofi). The R.N reported that the patient lost consciousness. Also, the N.P reported that 15 minutes after the patient received vaccines, the patient began to vomit then the patient experienced "respiratory distress" and eventually the patient became unconscious. The N.P reported that this event was "anaphylactic reaction". The N.P reported that in the Emergency room, the patient was given EPIPEN (manufacturer unknown), albuterol (manufacturer unknown) and Oxygen (manufacturer unknown) was provided until the patient was transported to the emergency room. Also, the N.P reported that while the patient was at the emergency room the patient received "some steroids" (manufacturer unknown), ZANTAC (dose and manufacturer unknown) and BENADRYL (manufacturer unknown). The nurse reported that the patient was in the hospital for about 5 hours. The N.P reported that the patient was referred to an allergist and was not admitted to the hospital. Anaphylactic reaction was considered to be disabling and life threatening. A lot check has been initiated for VARIVAX (lot# 668477/1311Z) and MMR II (Lot #669017/1250Z). At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Loss of consciousness, Respiratory distress, Vomiting
Clinical narrative: Information has been received from a registered nurse (R.N.) and nurse practitioner (N.P.) concerning a 4 year old male with asthma who on 22-MAR-2011, was vaccinated with MMR II (Lot #669017/1250Z expiration date: September 2012). Suspect therapy included a dose of VARIVAX (Lot #668477/1311Z, expiration date: October 2012). Other concomitant vaccinations included a dose of VARIVAX, DAPTACEL (unspecified) (manufacturer by Sanofi) and a dose of IPOL (manufacturer by Sanofi). The R.N reported that the patient lost consciousness. Also, the N.P reported that 15 minutes after the patient received vaccines, the patient began to vomit then the patient experienced "respiratory distress" and eventually the patient became unconscious. The N.P reported that this event was "anaphylactic reaction". The N.P reported that in the Emergency room, the patient was given EPIPEN (manufacturer unknown), albuterol (manufacturer unknown) and Oxygen (manufacturer unknown) was provided until the patient was transported to the emergency room. Also, the N.P reported that while the patient was at the emergency room the patient received "some steroids" (manufacturer unknown), ZANTAC (dose and manufacturer unknown) and BENADRYL (manufacturer unknown). The nurse reported that the patient was in the hospital for about 5 hours. The N.P reported that the patient was referred to an allergist and was not admitted to the hospital. Anaphylactic reaction was considered to be disabling and life threatening. A lot check has been initiated for VARIVAX (lot# 668477/1311Z) and MMR II (Lot #669017/1250Z). At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Autopsy, Cardiac arrest, Cardiomegaly, Convulsion, Culture tissue specimen positive
Clinical narrative: This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A patient (age, sex and race unknown) received a dose of PREVNAR on an unknown date for an unknown indication. Relevant medical history and concomitant medications were unknown. It was reported that on an unknown date, the patient experienced pneumococcal meningitis and died. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported event were unknown. The patient did not recover from the reported event at the time of the death. Follow-up (28MAR2011): This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported that in Jul2010, when the male patient was 7-months-old, the first dose of either PREVNAR or PREVNAR 13 was administered. On 12Oct2010, the 9-month-old patient was seen by the reporting physician. Prior to this date, the patient never was seen by the physician. On 12Oct2010, the physician administered the second dose of PREVNAR 13. After this, the boy never came back until 11Mar2011, when the patient was around 15-months-old (DOB not known), he was taken to the ER, and was diagnosed with ear infection. Treatments were not reported. On 13Mar2011, the patient was taken back to the ER, but they sent him home. On 14Mar2011, the patient was brought back to the physician. He presented with vomiting, fever, and ear infection. The physician admitted the patient to the hospital. At the hospital, the patient had vomiting and seizure. Treatments were not reported. An x-ray was performed, which indicated an enlarged heart. The patient went into arrhythmia, and suffered cardiac arrest. The patient was transferred to a hospital, where they thought the patient had a mild viral carditis. On 15Mar2011, the patient went into Disseminated Intravascular Coagulation (DIC) and organ failure. The patient died on 15Mar2011. An autopsy was performed. In the brain tissue, pneumococcal meningitis was determined. The serotype was not specified. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Death, Meningitis pneumococcal, Neurological infection, Pyrexia, Viral myocarditis
Clinical narrative: This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A patient (age, sex and race unknown) received a dose of PREVNAR on an unknown date for an unknown indication. Relevant medical history and concomitant medications were unknown. It was reported that on an unknown date, the patient experienced pneumococcal meningitis and died. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported event were unknown. The patient did not recover from the reported event at the time of the death. Follow-up (28MAR2011): This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported that in Jul2010, when the male patient was 7-months-old, the first dose of either PREVNAR or PREVNAR 13 was administered. On 12Oct2010, the 9-month-old patient was seen by the reporting physician. Prior to this date, the patient never was seen by the physician. On 12Oct2010, the physician administered the second dose of PREVNAR 13. After this, the boy never came back until 11Mar2011, when the patient was around 15-months-old (DOB not known), he was taken to the ER, and was diagnosed with ear infection. Treatments were not reported. On 13Mar2011, the patient was taken back to the ER, but they sent him home. On 14Mar2011, the patient was brought back to the physician. He presented with vomiting, fever, and ear infection. The physician admitted the patient to the hospital. At the hospital, the patient had vomiting and seizure. Treatments were not reported. An x-ray was performed, which indicated an enlarged heart. The patient went into arrhythmia, and suffered cardiac arrest. The patient was transferred to a hospital, where they thought the patient had a mild viral carditis. On 15Mar2011, the patient went into Disseminated Intravascular Coagulation (DIC) and organ failure. The patient died on 15Mar2011. An autopsy was performed. In the brain tissue, pneumococcal meningitis was determined. The serotype was not specified. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A patient (age, sex and race unknown) received a dose of PREVNAR on an unknown date for an unknown indication. Relevant medical history and concomitant medications were unknown. It was reported that on an unknown date, the patient experienced pneumococcal meningitis and died. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported event were unknown. The patient did not recover from the reported event at the time of the death. Follow-up (28MAR2011): This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported that in Jul2010, when the male patient was 7-months-old, the first dose of either PREVNAR or PREVNAR 13 was administered. On 12Oct2010, the 9-month-old patient was seen by the reporting physician. Prior to this date, the patient never was seen by the physician. On 12Oct2010, the physician administered the second dose of PREVNAR 13. After this, the boy never came back until 11Mar2011, when the patient was around 15-months-old (DOB not known), he was taken to the ER, and was diagnosed with ear infection. Treatments were not reported. On 13Mar2011, the patient was taken back to the ER, but they sent him home. On 14Mar2011, the patient was brought back to the physician. He presented with vomiting, fever, and ear infection. The physician admitted the patient to the hospital. At the hospital, the patient had vomiting and seizure. Treatments were not reported. An x-ray was performed, which indicated an enlarged heart. The patient went into arrhythmia, and suffered cardiac arrest. The patient was transferred to a hospital, where they thought the patient had a mild viral carditis. On 15Mar2011, the patient went into Disseminated Intravascular Coagulation (DIC) and organ failure. The patient died on 15Mar2011. An autopsy was performed. In the brain tissue, pneumococcal meningitis was determined. The serotype was not specified. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Arrhythmia, Autopsy, Cardiac arrest, Cardiomegaly, Convulsion
Clinical narrative: This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A patient (age, sex and race unknown) received a dose of PREVNAR on an unknown date for an unknown indication. Relevant medical history and concomitant medications were unknown. It was reported that on an unknown date, the patient experienced pneumococcal meningitis and died. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported event were unknown. The patient did not recover from the reported event at the time of the death. Follow-up (28MAR2011): This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported that in Jul2010, when the male patient was 7-months-old, the first dose of either PREVNAR or PREVNAR 13 was administered. On 12Oct2010, the 9-month-old patient was seen by the reporting physician. Prior to this date, the patient never was seen by the physician. On 12Oct2010, the physician administered the second dose of PREVNAR 13. After this, the boy never came back until 11Mar2011, when the patient was around 15-months-old (DOB not known), he was taken to the ER, and was diagnosed with ear infection. Treatments were not reported. On 13Mar2011, the patient was taken back to the ER, but they sent him home. On 14Mar2011, the patient was brought back to the physician. He presented with vomiting, fever, and ear infection. The physician admitted the patient to the hospital. At the hospital, the patient had vomiting and seizure. Treatments were not reported. An x-ray was performed, which indicated an enlarged heart. The patient went into arrhythmia, and suffered cardiac arrest. The patient was transferred to a hospital, where they thought the patient had a mild viral carditis. On 15Mar2011, the patient went into Disseminated Intravascular Coagulation (DIC) and organ failure. The patient died on 15Mar2011. An autopsy was performed. In the brain tissue, pneumococcal meningitis was determined. The serotype was not specified. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Death, Disseminated intravascular coagulation, Ear infection, Meningitis pneumococcal, Organ failure
Clinical narrative: This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A patient (age, sex and race unknown) received a dose of PREVNAR on an unknown date for an unknown indication. Relevant medical history and concomitant medications were unknown. It was reported that on an unknown date, the patient experienced pneumococcal meningitis and died. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported event were unknown. The patient did not recover from the reported event at the time of the death. Follow-up (28MAR2011): This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported that in Jul2010, when the male patient was 7-months-old, the first dose of either PREVNAR or PREVNAR 13 was administered. On 12Oct2010, the 9-month-old patient was seen by the reporting physician. Prior to this date, the patient never was seen by the physician. On 12Oct2010, the physician administered the second dose of PREVNAR 13. After this, the boy never came back until 11Mar2011, when the patient was around 15-months-old (DOB not known), he was taken to the ER, and was diagnosed with ear infection. Treatments were not reported. On 13Mar2011, the patient was taken back to the ER, but they sent him home. On 14Mar2011, the patient was brought back to the physician. He presented with vomiting, fever, and ear infection. The physician admitted the patient to the hospital. At the hospital, the patient had vomiting and seizure. Treatments were not reported. An x-ray was performed, which indicated an enlarged heart. The patient went into arrhythmia, and suffered cardiac arrest. The patient was transferred to a hospital, where they thought the patient had a mild viral carditis. On 15Mar2011, the patient went into Disseminated Intravascular Coagulation (DIC) and organ failure. The patient died on 15Mar2011. An autopsy was performed. In the brain tissue, pneumococcal meningitis was determined. The serotype was not specified. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, PNC13
Symptoms: Pyrexia, Streptococcus test positive, Vomiting, X-ray abnormal
Clinical narrative: This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A patient (age, sex and race unknown) received a dose of PREVNAR on an unknown date for an unknown indication. Relevant medical history and concomitant medications were unknown. It was reported that on an unknown date, the patient experienced pneumococcal meningitis and died. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported event were unknown. The patient did not recover from the reported event at the time of the death. Follow-up (28MAR2011): This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported that in Jul2010, when the male patient was 7-months-old, the first dose of either PREVNAR or PREVNAR 13 was administered. On 12Oct2010, the 9-month-old patient was seen by the reporting physician. Prior to this date, the patient never was seen by the physician. On 12Oct2010, the physician administered the second dose of PREVNAR 13. After this, the boy never came back until 11Mar2011, when the patient was around 15-months-old (DOB not known), he was taken to the ER, and was diagnosed with ear infection. Treatments were not reported. On 13Mar2011, the patient was taken back to the ER, but they sent him home. On 14Mar2011, the patient was brought back to the physician. He presented with vomiting, fever, and ear infection. The physician admitted the patient to the hospital. At the hospital, the patient had vomiting and seizure. Treatments were not reported. An x-ray was performed, which indicated an enlarged heart. The patient went into arrhythmia, and suffered cardiac arrest. The patient was transferred to a hospital, where they thought the patient had a mild viral carditis. On 15Mar2011, the patient went into Disseminated Intravascular Coagulation (DIC) and organ failure. The patient died on 15Mar2011. An autopsy was performed. In the brain tissue, pneumococcal meningitis was determined. The serotype was not specified. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apnoea, Blood culture, CSF cell count, CSF culture, CSF glucose
Clinical narrative: Fever to 102.4 and then siezure like activity for about 4 min. Baby then had a second episode of apnea.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: CSF protein, Chest X-ray, Culture urine, Full blood count, Metabolic function test
Clinical narrative: Fever to 102.4 and then siezure like activity for about 4 min. Baby then had a second episode of apnea.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Movement disorder, Pyrexia, Urine analysis
Clinical narrative: Fever to 102.4 and then siezure like activity for about 4 min. Baby then had a second episode of apnea.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, localized fever to injection sight. Redness continued to spread and cellulitis set in. Sight became sore and itched, but no rash appeared. Redness and area of swelling continued to spread. Currently, the area is approximately 6cm around with a raised hot red center.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Redness, swelling, localized fever to injection sight. Redness continued to spread and cellulitis set in. Sight became sore and itched, but no rash appeared. Redness and area of swelling continued to spread. Currently, the area is approximately 6cm around with a raised hot red center.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Chills, Disorientation, Injection site cellulitis
Clinical narrative: Information has been received from a registered pharmacist concerning a 75 year old male patient with myelodysplastic syndrome who on 09-MAR-2011 was vaccinated on his left upper extremity with a dose of PNEUMOVAX 23 (Lot number 667690/1158Z, Exp. 26-JAN-2012). Concomitant therapy included Z-PAK, lovastatin (manufacturer unknown) and PROTONIX. The pharmacist reported that the patient received PNEUMOVAX 23 at his primary care physician's office and was reported to had tolerated it well. On 10-MAR-2011, the patient presented episodes of shaking, chills, two episodes of emesis and feeling some "what" disoriented for the next "2-3 days". It was reported that on 12-MAR-2011, the patient's daughter checked out on him and his temperature was 103.4 and he was "so weak he could not get out of bed". The patient told his daughter then that he had some left arm soreness, which the daughter looked at and later told emergency room personnel that "there was no obvious redness, swelling, or anything that looked abnormal". It was noted that the emergency room record report that the patient confirmed this statement. On 13-MAR-2011, the patient noted large bright red areas with swelling and worsening pain in left upper extremity. He went to an urgency care facility and he was sent to the hospital. The patient was admitted to the general medical unit with a diagnosis of cellulitis in his left upper extremity. The physician noted that he was concerned about the possibility of necrotizing fascitis. While inpatient, the patient received ZOSYN, 4.5g, IV and vancomycin, 1g, IV. The patient was discharged from the hospital on 17-MAR-2011. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity, Tremor
Clinical narrative: Information has been received from a registered pharmacist concerning a 75 year old male patient with myelodysplastic syndrome who on 09-MAR-2011 was vaccinated on his left upper extremity with a dose of PNEUMOVAX 23 (Lot number 667690/1158Z, Exp. 26-JAN-2012). Concomitant therapy included Z-PAK, lovastatin (manufacturer unknown) and PROTONIX. The pharmacist reported that the patient received PNEUMOVAX 23 at his primary care physician's office and was reported to had tolerated it well. On 10-MAR-2011, the patient presented episodes of shaking, chills, two episodes of emesis and feeling some "what" disoriented for the next "2-3 days". It was reported that on 12-MAR-2011, the patient's daughter checked out on him and his temperature was 103.4 and he was "so weak he could not get out of bed". The patient told his daughter then that he had some left arm soreness, which the daughter looked at and later told emergency room personnel that "there was no obvious redness, swelling, or anything that looked abnormal". It was noted that the emergency room record report that the patient confirmed this statement. On 13-MAR-2011, the patient noted large bright red areas with swelling and worsening pain in left upper extremity. He went to an urgency care facility and he was sent to the hospital. The patient was admitted to the general medical unit with a diagnosis of cellulitis in his left upper extremity. The physician noted that he was concerned about the possibility of necrotizing fascitis. While inpatient, the patient received ZOSYN, 4.5g, IV and vancomycin, 1g, IV. The patient was discharged from the hospital on 17-MAR-2011. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered pharmacist concerning a 75 year old male patient with myelodysplastic syndrome who on 09-MAR-2011 was vaccinated on his left upper extremity with a dose of PNEUMOVAX 23 (Lot number 667690/1158Z, Exp. 26-JAN-2012). Concomitant therapy included Z-PAK, lovastatin (manufacturer unknown) and PROTONIX. The pharmacist reported that the patient received PNEUMOVAX 23 at his primary care physician's office and was reported to had tolerated it well. On 10-MAR-2011, the patient presented episodes of shaking, chills, two episodes of emesis and feeling some "what" disoriented for the next "2-3 days". It was reported that on 12-MAR-2011, the patient's daughter checked out on him and his temperature was 103.4 and he was "so weak he could not get out of bed". The patient told his daughter then that he had some left arm soreness, which the daughter looked at and later told emergency room personnel that "there was no obvious redness, swelling, or anything that looked abnormal". It was noted that the emergency room record report that the patient confirmed this statement. On 13-MAR-2011, the patient noted large bright red areas with swelling and worsening pain in left upper extremity. He went to an urgency care facility and he was sent to the hospital. The patient was admitted to the general medical unit with a diagnosis of cellulitis in his left upper extremity. The physician noted that he was concerned about the possibility of necrotizing fascitis. While inpatient, the patient received ZOSYN, 4.5g, IV and vancomycin, 1g, IV. The patient was discharged from the hospital on 17-MAR-2011. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Arrhythmia, Electrocardiogram ambulatory, Ventricular extrasystoles
Clinical narrative: Heart arrythmias, PVCs
Sex: M
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician concerning a male baby was born to a 23 year old female patient who on 11-JAN-2010 was vaccinated with the third dose of GARDASIL (lot # 662299/1099Y). It was reported that the baby was a healthy male, with a clubfoot. At the time of the report, the outcome was unknown. The reporting physician stated that "the clubfoot had nothing to do with GARDASIL". It was unknown if the patient sought medical attention. The mother's experience was previously reported in WAES 1002USA01532. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 9 week old male patient with "none" drug allergies or reactions and who had diarrhea "the day before the vaccine was administered" (on 24-MAR-2011). On 25-MAR-2011, the patient was vaccinated orally with the first 2 ml dose of ROTATEQ (Lot#669084/1653Z, expiration date unspecified). Concomitant therapy included ACTHIB and TRIPEDIA administered on the same day. The nurse reported that "a few hours later" after the patient was vaccinated, he experienced vomiting. On 25-MAR-2011, the patient was taken to the emergency room and was admitted to the hospital. It was reported that the patient's stool was positive for Rotavirus but no blood noted; the patient also had "numerous unnamed tests" performed in the hospital (results not provided). As treatment the patient received Intravenous fluids (unspecified). On 27-MAR-2011 the patient was discharged from the hospital. On 28-MAR-2011 the patient went to the physician office for follow up. At the time of the report the patient was recovering. The reporter considered vomiting and stool was positive for Rotavirus as other important medical events. The reporter did not consider the events as disabling or life threatening. The reporter felt that vomiting and the stool was positive for Rotavirus were not related to therapy with ROTATEQ. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: area of injection (left arm) red, swollen, tender