chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MEN
Symptoms: Vaccination failure
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old female patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 43 months after vaccination developed meningitis and sepsis, year reported as 2010 (Q 2). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Bacterial test positive, Death, Meningitis meningococcal, Meningococcal sepsis, Neisseria test positive
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 15 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2008 (Q 4). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. The patient's outcome was fatal. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Polymerase chain reaction, Vaccination failure
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 15 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2008 (Q 4). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. The patient's outcome was fatal. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Bacterial test positive, Meningitis meningococcal, Neisseria test positive, Polymerase chain reaction, Vaccination failure
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 5 months after vaccination developed meningococcal meningitis, year reported as 2008 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Bacterial test positive, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction, Vaccination failure
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective."  According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 3 months after vaccination developed meningococcal sepsis, year reported as 2008 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Bacterial test positive, Meningitis meningococcal, Neisseria test positive, Polymerase chain reaction, Vaccination failure
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and seven months after vaccination developed meningococcal meningitis, year reported as 2006 (Q4). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Bacterial test positive, Meningitis meningococcal, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and one month after vaccination developed meningococcal meningitis and sepsis, year reported as 2006 (Q 3). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Vaccination failure
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and one month after vaccination developed meningococcal meningitis and sepsis, year reported as 2006 (Q 3). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Bacterial test positive, Meningitis meningococcal, Neisseria test positive, Polymerase chain reaction, Vaccination failure
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old trainees and others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19 year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and seven months after vaccination developed meningitis, year reported as 2006 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Bacterial test positive, Death, Meningitis meningococcal, Meningococcal sepsis, Neisseria test positive
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococcal have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old basic trainees and among were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 12 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2006 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. The patient's outcome was fatal (date of death not reported). The reporter for this case is the same as for cases 2012-08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococcal have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old basic trainees and among were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 12 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2006 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. The patient's outcome was fatal (date of death not reported). The reporter for this case is the same as for cases 2012-08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Condition aggravated, Erythema, Fatigue, Headache
Clinical narrative: On Tuesday, 9/11/12, I went to the clinic. The NP there gave me my yearly Flu shot in the Left deltoid and my PNEUMOVAX (I get every 5 years) in the Right deltoid. I get the flu shot every year and the PNEUMOVAX every 5 because I have severe asthma and my PCP recommends that I receive it. The flu shot I get a slightly sore arm. The PNEUMOVAX I generally get a really sore arm. This year within minutes of leaving the clinic my Right arm started to itch. Within an hour it started to get warm, very sore, more itchy and swollen. I went home and immediately started with ice packs. By the evening of 9/11/12, I started getting a really bad headache (I almost never get headaches), fever and malaise. The next day this progressed to severe weakness and fatigue. I got into bed from 1:30PM until 4PM on 9/12/12 (I NEVER take naps) because I felt extremely weak. My glands started to get swollen in my neck and my face was beet red. I am normally 98.2 F as my normal body temp. It was not 99.5F. I called my neighbor for some TYLENOL because I was out. I took (2) 500mg TYLENOL at 6:30PM on 9/12/12 and then 2 more at 12:30AM on 9/13/12. My fever broke by the AM of 9/13/12 but my weakness continued for the next day or so. By 9/14/12 I felt much better, but still felt drained over the weekend. I was completely healthy before this vaccination. The flu shot only got slightly sore, as it does every year. Please advise me what to do going forward. This really scared me. I have never had a reaction to a vaccine like this before. Should I not take the PNEUMOVAX going forward. I had NO allergies to the things questions before the injections. My family PCP. I called him when these side effects initially started.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lymphadenopathy, Malaise, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: On Tuesday, 9/11/12, I went to the clinic. The NP there gave me my yearly Flu shot in the Left deltoid and my PNEUMOVAX (I get every 5 years) in the Right deltoid. I get the flu shot every year and the PNEUMOVAX every 5 because I have severe asthma and my PCP recommends that I receive it. The flu shot I get a slightly sore arm. The PNEUMOVAX I generally get a really sore arm. This year within minutes of leaving the clinic my Right arm started to itch. Within an hour it started to get warm, very sore, more itchy and swollen. I went home and immediately started with ice packs. By the evening of 9/11/12, I started getting a really bad headache (I almost never get headaches), fever and malaise. The next day this progressed to severe weakness and fatigue. I got into bed from 1:30PM until 4PM on 9/12/12 (I NEVER take naps) because I felt extremely weak. My glands started to get swollen in my neck and my face was beet red. I am normally 98.2 F as my normal body temp. It was not 99.5F. I called my neighbor for some TYLENOL because I was out. I took (2) 500mg TYLENOL at 6:30PM on 9/12/12 and then 2 more at 12:30AM on 9/13/12. My fever broke by the AM of 9/13/12 but my weakness continued for the next day or so. By 9/14/12 I felt much better, but still felt drained over the weekend. I was completely healthy before this vaccination. The flu shot only got slightly sore, as it does every year. Please advise me what to do going forward. This really scared me. I have never had a reaction to a vaccine like this before. Should I not take the PNEUMOVAX going forward. I had NO allergies to the things questions before the injections. My family PCP. I called him when these side effects initially started.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: On Tuesday, 9/11/12, I went to the clinic. The NP there gave me my yearly Flu shot in the Left deltoid and my PNEUMOVAX (I get every 5 years) in the Right deltoid. I get the flu shot every year and the PNEUMOVAX every 5 because I have severe asthma and my PCP recommends that I receive it. The flu shot I get a slightly sore arm. The PNEUMOVAX I generally get a really sore arm. This year within minutes of leaving the clinic my Right arm started to itch. Within an hour it started to get warm, very sore, more itchy and swollen. I went home and immediately started with ice packs. By the evening of 9/11/12, I started getting a really bad headache (I almost never get headaches), fever and malaise. The next day this progressed to severe weakness and fatigue. I got into bed from 1:30PM until 4PM on 9/12/12 (I NEVER take naps) because I felt extremely weak. My glands started to get swollen in my neck and my face was beet red. I am normally 98.2 F as my normal body temp. It was not 99.5F. I called my neighbor for some TYLENOL because I was out. I took (2) 500mg TYLENOL at 6:30PM on 9/12/12 and then 2 more at 12:30AM on 9/13/12. My fever broke by the AM of 9/13/12 but my weakness continued for the next day or so. By 9/14/12 I felt much better, but still felt drained over the weekend. I was completely healthy before this vaccination. The flu shot only got slightly sore, as it does every year. Please advise me what to do going forward. This really scared me. I have never had a reaction to a vaccine like this before. Should I not take the PNEUMOVAX going forward. I had NO allergies to the things questions before the injections. My family PCP. I called him when these side effects initially started.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Endotracheal intubation, Intensive care, Neck pain
Clinical narrative: Spouse notified pharmacy (9/4/12) that patient began experiencing neck pain on night of 8/17/12. Progressed into breathing issues, ER, intubation, and patient is still currently in ICU.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Spouse notified pharmacy (9/4/12) that patient began experiencing neck pain on night of 8/17/12. Progressed into breathing issues, ER, intubation, and patient is still currently in ICU.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV1
Symptoms: Incorrect route of drug administration, Interchange of vaccine products, Irritability, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of slight temperature in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), PENTACEL (non-gsk) and pneumococcal vaccines (non-gsk). Concurrent vaccination included rotavirus vaccine (non-gsk); non-GSK manufacturer; oral given in 2012. On 4 June 2012 the subject received a dose of ROTARIX (intramuscular, unknown) as 2nd dose in series, unspecified dose of PENTACEL (intramuscular, unknown), unspecified dose of Pneumococcal vaccines (Non-GSK) (intramuscular, unknown) and experienced inappropriate route of vaccination and interchange of vaccine products with ROTARIX. The ROTARIX was administered by intramuscular injection instead of orally as indicated. The subject had received 1st dose of Rotavirus with ROTATEQ (oral route) given correctly (interchange of vaccine products). On 4 June 2012, less than one day after vaccination with PENTACEL, Pneumococcal vaccines (Non-GSK) and ROTARIX, the subject experienced slight temperature and fussiness. A nurse gave the subject ROTARIX vaccine intramuscularly instead of orally. According to the reporter, the subject received other vaccines in addition to the ROTARIX. The subject experienced a mild temperature and some fussiness on the same day that resolved by the end of the day on 04 June 2012. According to the nurse, the mild fever and fussiness could have been caused by the other vaccines. The nurse planned to repeat the Rotavirus vaccine using the oral route. At the time of reporting the events were resolved. The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or read given literature on ROTARIX. She thought she had overheard other staff talking about ROTARIX and thought they had told her to administer intramuscularly. It was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0981435A, A0983050A, A0983051A, A0983052A, and A0983053A for details regarding the other five cases.
Age: 0.13
Sex: M
Vaccine: DTAP, HIBV, PNC, RV1
Symptoms: Diarrhoea, Gastrointestinal haemorrhage
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of gastrointestinal problems in  a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included possible drug allergy to DIFLUCAN. Concurrent vaccination included Haemophilus influenza type b vaccine;manufacturer unspecified given on 3 February 2010; diphtheria and tetanus toxoids and acellular pertussis vaccine; manufacturer unspecified given on 3 February 2010. Concurrent medications included ZANTAC. On 3 February 2010 th subject received 1st dose of ROTARIX. On 11 November 2010, 9 months after vaccination with ROTARIX, the subject experienced gastrointestinal problems and diarrhea. The healthcare professional reported that the subject was first seen for diarrhea problems on 11 November 2010 and had follow-up visits afterwards. At the time of reporting the events were unresolved. The vaccination course with ROTARIX was discontinued. The healthcare professional considered the events were unrelated to vaccination with ROTARIX. The healthcare professional reported that the vaccine was ROTARIX, however the lot number provided (1208Y) is not a legitimate GlaxoSmithKline lot number. Follow-up information received via the reporter on 05 August 2011 indicated that the gastrointestinal problems had nothing to do with ROTARIX treatment. The reporter noted that she planned to return follow-up paperwork stating no further contact. Follow-up information received via the reporter on 15 August 2011 indicated that the events of gastrointestinal problems and diarrhea had nothing to do with ROTARIX vaccination; therefore, no additional information was provided.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Provider drew 0.1cc of Typhoid instead of the PPD vaccination. The Typhoid was then administered to the Left Forearm of the patient where the PPD should have been placed. Pt had no reaction to the vaccination that was placed.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Injection site reaction, Injection site swelling, Joint stiffness
Clinical narrative: Fever, Chills, Swelling at Injection Site; Stiffness and pain from injection site on left deltoid up to jaw; rash left arm below injection site; exhaustion, overall malaise.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Musculoskeletal stiffness, Pyrexia, Rash
Clinical narrative: Fever, Chills, Swelling at Injection Site; Stiffness and pain from injection site on left deltoid up to jaw; rash left arm below injection site; exhaustion, overall malaise.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: PHN noted redness appearing above and below the injection site within ~5 minutes of injection and extending ~ 2 inches above and below. Recheck of arm 15 minutes later showed it remained the same - client denied any itching or pain. Call to family to assess - related that child did complain of itching that evening and family applied Benadryl cream and there were no further complaints.
Age: 37.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Incorrect dose administered, Pain
Clinical narrative: The adverse event was that the live virus vaccine was administered too close to another live virus vaccine. When givning the vaccine I did not realize the patient had received the varicella vaccine on 8-25-2012. When I looked at the immunization record I noticed where it said patient had the actual varicella disease 01/01/1977 and did not notice she had the vaccine also 08/25/2012. The clerks had wrote on the paper that she needed the Hep B and MMR and had listed that she had paid for both vaccines in travel. She had checked that she had vaccines in last 4 weeks but that is what most of my patients do when they have the Hep B 4 weeks earlier before second dose. I administered the vaccines and the patient commented that the mmr stings like the varicella vaccine. I then realized she had the varicella 08/25/2012. I called nurses with the immunization program and was unable to reach them. I then contacted someone who stated that the mmr dose was invalid and would have to be repeated in a month. I let the patient know this and scheduled an appt for the patient to return in one month.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Heart rate increased, Somnolence
Clinical narrative: Rapid heart rate. Colleague stated he was out to eat had 2 beers and was sitting down to eat when he noticed his heart beating fast. He states it was double the rate he usually runs. He did not have any other allergic type symptoms. He stated the next day he felt tired and run down and slept longer than usual.
Age: 3.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Leukopenia, Measles antibody negative, Platelet count decreased, Pyrexia, Rash
Clinical narrative: Rash and fever
Age: 3.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Streptococcus test negative, Thrombocytopenia, White blood cell count decreased
Clinical narrative: Rash and fever
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal distension, Chest pain, Chills, Muscle spasms, Tremor
Clinical narrative: Severe cramping, shakes, teeth chattering, feeling bloated, slight chest pain. Going to see what the Dr. says.
Age: 0.59
Sex: M
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Nasopharyngitis, Stool analysis, Vomiting
Clinical narrative: Cold symptoms, vomiting, diarrhea
Age: 0.59
Sex: M
Vaccine: RV5, RV5
Symptoms: Pyrexia
Clinical narrative: Cold symptoms, vomiting, diarrhea
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema nodosum, Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Arm was sore immediately. The next morning, developed painful red, large, raised irregular lumps around injection site. Lumps were approximately 1cmx2cm, and were scattered around and below the injection point in an area that was 10cm x 10cm. There were approximately 5-6 lumps. No fever, no itching, no breaks in the skin, no shortness or breath, otherwise felt ok. Saw Occupational medicine MD who thought that the condition looked like erythema nodusum. Saw dermatologist (curbside consult) who agreed. Appt schedule for 4 days later, rash had resolved by then.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: Arm was sore immediately. The next morning, developed painful red, large, raised irregular lumps around injection site. Lumps were approximately 1cmx2cm, and were scattered around and below the injection point in an area that was 10cm x 10cm. There were approximately 5-6 lumps. No fever, no itching, no breaks in the skin, no shortness or breath, otherwise felt ok. Saw Occupational medicine MD who thought that the condition looked like erythema nodusum. Saw dermatologist (curbside consult) who agreed. Appt schedule for 4 days later, rash had resolved by then.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Rash generalised, Rash macular
Clinical narrative: About 1 hour after receiving vaccine, became extremely hot, red and had a rash from head to toe that looked like a blotchy sunburn. These symptoms lasted for 2 days. Did take OTC benadryl.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Injection site swelling, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Shots given 8/16/2012 - in ER 8/18/2012 with fever, headache, body aches, forehead swollen, right arm, forearm, and shoulder swollen.  Client received steroids and antibiotic Benadryl.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Swelling face
Clinical narrative: Shots given 8/16/2012 - in ER 8/18/2012 with fever, headache, body aches, forehead swollen, right arm, forearm, and shoulder swollen.  Client received steroids and antibiotic Benadryl.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN "HIGH DOSE" AND SHE IS NOT OVER 65.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Pain, Sensation of pressure, Sneezing
Clinical narrative: Patient who is allergic to sulfur received flu vaccine on 9/05/2012.  Patient states that at 10:30 PM sneezing, awoke at 3:30 AM with horrible headache at the top of head. Felt pressure, spasm like pain.  Patient took Claritin at 5:00 AM. Went back to sleep, got up at 10:30 AM still had a headache. Took a Bentyl. Had diarrhea  X 1 at 2:00 PM (odor of sulfur).
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red hot swollen rt arm, back of arm about a 4 inches above elbow.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Vaccination site cellulitis, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Cellulitis at vaccination site 7cm x 9cm, warm, tender indurated swollen area. Treated with Keflex 500, 2 PO BID x10 days.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Induration, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Pain, itching, hard lump, and warmth at injection site. Arm of injection "feels funny", tingling. Vein area in crook of arm feels hard, unsure if it is related. Told patient to take Benadryl and Ibuprofen to aleviate symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Sensory disturbance
Clinical narrative: Pain, itching, hard lump, and warmth at injection site. Arm of injection "feels funny", tingling. Vein area in crook of arm feels hard, unsure if it is related. Told patient to take Benadryl and Ibuprofen to aleviate symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, itching, hard lump, and warmth at injection site. Arm of injection "feels funny", tingling. Vein area in crook of arm feels hard, unsure if it is related. Told patient to take Benadryl and Ibuprofen to aleviate symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Pain, itching, hard lump, and warmth at injection site. Arm of injection "feels funny", tingling. Vein area in crook of arm feels hard, unsure if it is related. Told patient to take Benadryl and Ibuprofen to aleviate symptoms.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered wrong dose should have been 0.25. No reaction reported.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Paleness, sweating, weakness/lightheadedness
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Painful, swelling from above the right elbow to 4 inches below the elbow in iner arm.
Age: 24.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Musculoskeletal pain, Nerve injury, Nerve stimulation test, Nuclear magnetic resonance imaging
Clinical narrative: Started with right shoulder and arm pain, numbness-by 08/03 patient couldn't lift her arm. Patient saw primary physician, orthopedic surgeon, neurologist (who diagnosed it)-patient is getting physical therapy and is still in a lot of pain and still has numbness mostly in right shoulder and bicep area. Now taking Percocet, Cymbalta, gabapentin. Neurologist told patient it will take a long time to recover from nerve damage but she should expect eventual recovery.
Age: 24.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, X-ray
Clinical narrative: Started with right shoulder and arm pain, numbness-by 08/03 patient couldn't lift her arm. Patient saw primary physician, orthopedic surgeon, neurologist (who diagnosed it)-patient is getting physical therapy and is still in a lot of pain and still has numbness mostly in right shoulder and bicep area. Now taking Percocet, Cymbalta, gabapentin. Neurologist told patient it will take a long time to recover from nerve damage but she should expect eventual recovery.
Age: 24.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Brachial plexopathy, Musculoskeletal pain, Nerve conduction studies, Neuralgic amyotrophy
Clinical narrative: Started with right shoulder and arm pain, numbness-by 08/03 patient couldn't lift her arm. Patient saw primary physician, orthopedic surgeon, neurologist (who diagnosed it)-patient is getting physical therapy and is still in a lot of pain and still has numbness mostly in right shoulder and bicep area. Now taking Percocet, Cymbalta, gabapentin. Neurologist told patient it will take a long time to recover from nerve damage but she should expect eventual recovery.
Age: 24.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal, Pain in extremity, Paraesthesia
Clinical narrative: Started with right shoulder and arm pain, numbness-by 08/03 patient couldn't lift her arm. Patient saw primary physician, orthopedic surgeon, neurologist (who diagnosed it)-patient is getting physical therapy and is still in a lot of pain and still has numbness mostly in right shoulder and bicep area. Now taking Percocet, Cymbalta, gabapentin. Neurologist told patient it will take a long time to recover from nerve damage but she should expect eventual recovery.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Swollen left deltoid area along with pain in left arm: patient unable to lift left arm due to increased amount of pain. Hurts from left deltoid area down to left elbow and left midaxillary area. Pain is unbearable at times and has not stopped since the date of injection.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope and fainting for a few seconds, recovered quickly and was ambulatory upon discharge from clinic.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Long recovery to feet post vaccination. Symptoms consists of nausea, sweating, and lightheadedness. Ambulatory upon leaving clinic after recovering in office.
Age: 32.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Three days of severe pain and redness at injection site, fever, sweats, chills, dizzy, decreased appetite, serve headaches, high fever. Contacted doctor and pharmacist. They suggested I drinking a lot of fluid and take Tylenol or aspirin. Also, was very disappoints by the pharmacist that administered the shot to me. He said because of my thyroid I'm high risk for pneumonia however after talking to the physician he said that is totally false and I should of never gotten the shot. I know I should have been more educated on the shot however the pharmacist that admin it was wrong.  Three days later and still really sick
Age: 32.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Malaise, Pyrexia
Clinical narrative: Three days of severe pain and redness at injection site, fever, sweats, chills, dizzy, decreased appetite, serve headaches, high fever. Contacted doctor and pharmacist. They suggested I drinking a lot of fluid and take Tylenol or aspirin. Also, was very disappoints by the pharmacist that administered the shot to me. He said because of my thyroid I'm high risk for pneumonia however after talking to the physician he said that is totally false and I should of never gotten the shot. I know I should have been more educated on the shot however the pharmacist that admin it was wrong.  Three days later and still really sick
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Diagnosed with cellulitis. Right upper/outer arm was red.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Pyrexia
Clinical narrative: Low grade fever, tiredness. Tylenol.
Age: 18.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Computerised tomogram normal, Confusional state, Fatigue, Full blood count normal, Headache
Clinical narrative: 09/14/2012-Headache. 09/15/2012- Fever 101.3; absence seizure; confusion; subsequent fatigue.
Age: 18.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Petit mal epilepsy, Pyrexia
Clinical narrative: 09/14/2012-Headache. 09/15/2012- Fever 101.3; absence seizure; confusion; subsequent fatigue.
Age: 35.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Local swelling, Lymphadenopathy, Lymphocyte count increased, Pyrexia
Clinical narrative: Reported to Nurse 9/11/12. States has swelling at bilateral collar bone area, left lymh node enlargement in groin and under left are. Ran low grade fever. She states got antibiotics and CDC on 6/14/12. Had elevated lymph count. States she went to a "med serve place on June 14, 2012." Doctor name nor clinic name given.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat, itchiness and swelling from shoulder to elbow surrounding injection site.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Sore and swollen throat, couldn't swallow.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Ocular hyperaemia, Vision blurred
Clinical narrative: Patient said that she began to have trouble breathing and also noticed an allergic reaction in her eyes as manifested by redness and a thin film covering the eyes. After about an hour, she decided to head to the emergency care where she was treated for what was thought to be an allergic reaction to the vaccination. She was then sent home with prescriptions for a ProAir inhaler, a course of prednisone, and eye drops.