chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. In February 2016 reported as "1 year ago", the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscularly, dose and frequency reported as "single dose" (strength, anatomical location, lot number and expiration date were not provided) for prophylaxis. Subsequently, on 21-FEB-2017, the patient was vaccinated with a second dose of RECOMBIVAX HB intramuscularly, dose and frequency reported as "single dose" (strength, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HIBV, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 06-MAR-2017 from a certified medical assistant regarding an unspecified number of patients. Medical history, concurrent conditions and concomitant medications were not reported. The unspecified number of patients received unspecified doses of PEDVAXHIB (lot number M027882, expiration date 14-APR-2019; lot number M006709, expiration date 06-DEC-2018; lot number M020101, expiration date 07-MAR-2019; and lot number M032147, expiration date 14-APR-2019), and M-M-R-II (lot number L015280, expiration date 30-APR-2017) that were improperly stored. PEDVAXHIB temperature 10.8 Celsius. Time frame: cumulative 3 hours and 51 minutes. Previous temperature excursion yes 12.8 Celsius, 4 hours and 30 minutes. Call was because of data logger. M-M-R-II temperature 12.8 Celsius. Time frame 4 hours and 30 minutes that occurred in Nov 16. Call was made  because of a data logger. Vaccinations may have occurred between 18-NOV-2016 and present, 06-MAR-2017. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles
Clinical narrative: This solicited report was received from a 60 year old female patient via Market Research referring to herself. There was no information about concurrent condition, concomitant medication and medical history. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced measles. The outcome of the event was unknown. The causality between the event and M-M-R II was not reported. Upon internal review, measles was determined to be medically significant. Additional information has been requested. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the therapy and the reported event cannot be established. The date of vaccination as well as the date of onset for the reported event are not provided. Company Comment- No changes to the product safety information are warranted at this time.  Merck and Co., Inc., known as MSD outside of the country, continues to monitor the safety profile of the product.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This reporting consumer of an unspecified age, race/ethnicity and gender received PREVNAR 13 on an unspecified date in 2017, at single dose, for immunisation. Medical history and concomitant medications were not reported. The consumer experienced pneumonia 2 days after vaccination, on an unspecified date in 2017. Pneumonia outcome was unknown at the time of report. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported the same event for two patients. This is the first of two reports. A female patient of unknown age and race/ethnicity received on 02Mar2017 PREVNAR 13 (lot number R48403, Expiration date: Apr2018, NDC#00005197102) at 0.5 ml single dose to prevent infection by pneumococcus. Concomitant medications and medical history were not reported. In Mar2017, the patient experienced a little bit of red area at the injection site. Outcome was not recovered. Sender's Comments: Linked Report(s): US-PFIZER INC-2017109175 same reporter/drug/event different patients.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: This is a spontaneous report from a contactable physician who reported for himself through a Pfizer sales representative. This male patient (in his late 60's, early 70's) of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient became deathly ill, severe weakness, severe dizziness. The outcome of the events was recovering.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient said her arm (at the site of injection) began itching and was swollen and slightly red.  Patient woke up this morning to find that the area was better. The swelling had reduced and the itching was mostly gone. She was going to apply ice to help with the swelling and redness.
Age: 57.0
Sex: F
Vaccine: TYP, YF
Symptoms: Erythema, Injection site erythema, Pruritus, Vaccination site pain, Vaccination site papule
Clinical narrative: Pt had Yellow Fever vaccine on 3/2/17; she rpts for 3-4 days after vaccine given she had some redness and itching and then sxs went away. Last night, 3/13/17, she noticed site where vaccine was given on Lt arm was red and w/some mild tenderness. Today she came by clinic and at site where vaccine givne she has 7.5 cm X 6.5 cm area of erythema, mild swelling & warmth; a 1 mm faint yellow papule in center. Rxed doxycycline 100mg BID; Zyrtec during day and Benadryl at PM x 5 days. She denies fever, NV. In clinic, her Temp was 97.8, pulse 52 and O2 sat 98%.
Age: 57.0
Sex: F
Vaccine: TYP, YF
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt had Yellow Fever vaccine on 3/2/17; she rpts for 3-4 days after vaccine given she had some redness and itching and then sxs went away. Last night, 3/13/17, she noticed site where vaccine was given on Lt arm was red and w/some mild tenderness. Today she came by clinic and at site where vaccine givne she has 7.5 cm X 6.5 cm area of erythema, mild swelling & warmth; a 1 mm faint yellow papule in center. Rxed doxycycline 100mg BID; Zyrtec during day and Benadryl at PM x 5 days. She denies fever, NV. In clinic, her Temp was 97.8, pulse 52 and O2 sat 98%.
Age: 24.0
Sex: F
Vaccine: FLU3, HPV9, PPV
Symptoms: Erythema, Hypersensitivity, Mobility decreased, Pain, Swelling
Clinical narrative: Patient describes pain, swelling, redness, difficulty moving arm.  Doctor documented it as an allergic reaction to the PSV23.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling of arm extending from injection site down to elbow.  Itching and aching at site.
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: Vaccines were given 03-09-17 in am. By that evening R-arm was swollen, red, warm and pruritic. Concurrent rash developed on both calves, R-wrist. The rash on legs and wrist burned. Applied moisturizer. I saw her 03-13-17 and all things had improved.
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Skin warm
Clinical narrative: Vaccines were given 03-09-17 in am. By that evening R-arm was swollen, red, warm and pruritic. Concurrent rash developed on both calves, R-wrist. The rash on legs and wrist burned. Applied moisturizer. I saw her 03-13-17 and all things had improved.
Age: 25.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine given morning of 2/21/17. Pt called morning of 2/23/17, stated this morning she noted a "knot" (hard mass) at injection site, "about the size of a 50 cent piece", red, swollen, warm to the touch. Onset just this morning 2/23/17. (VARIVAX vaccine).
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, C-reactive protein increased, Myalgia, Red blood cell sedimentation rate increased
Clinical narrative: Myalgia and Arthralgia. Ibuprofen PRN, Acetaminophen PRN.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Pain that radiated to left axillary. ADVIL PRN and warm compress. Pt reports arm pain 4 days after receiving vaccination. Denies any rash, redness, swelling, weakness or numbness. Pain resolved in 1 day with ADVIL.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: Developed rash to (L) thigh-macular/papular that progressed to full body. Fever concurrently symptoms to same area (L thigh) as vaccine given: Two day after vaccines given and one day amoxicillin ended. No vesicles. Unclear if vaccine related vs amox related-rash progressed to more dusky/purplish,? erythema multiforme. Fever resolved in 3 days, rash improving. Recovering.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh has redness and swelling at injection site. Noted on 3/13/17.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Patient developed hives on immz site 5 mins after immz were administered. 10 mins after immz hives spread to arms, chest and hack. Breathing normal. Pt was released 30  mins after hives no longer spreading.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Father in law reported no adverse events/symptoms when notified and asked.
Sex: U
Vaccine: MNQ
Symptoms: Kawasaki's disease
Clinical narrative: This case was reported in a literature article and described the occurrence of Kawasaki's disease in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed Kawasaki's disease. Serious criteria included GSK medically significant. The outcome of Kawasaki's disease was unknown. It was unknown if the investigator considered the Kawasaki's disease to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of Kawasaki's disease in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed Kawasaki's disease. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of Kawasaki's disease and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Irritable bowel syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of irritable bowel syndrome in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed irritable bowel syndrome. Serious criteria included other: serious per reporter. The outcome of irritable bowel syndrome was unknown. It was unknown if the investigator considered the irritable bowel syndrome to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of irritable bowel syndrome in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed irritable bowel syndrome. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of irritable bowel syndrome and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Meningitis viral
Clinical narrative: This case was reported in a literature article and described the occurrence of viral meningitis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed viral meningitis. Serious criteria included GSK medically significant and other: serious per author. The outcome of viral meningitis was unknown. It was unknown if the investigator considered the viral meningitis to be related to Meningococcal ACWY-CRM vaccine. Additional information was reported. This case was reported in a literature article and described the occurrence of viral meningitis in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed viral meningitis. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of viral meningitis and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Intestinal obstruction
Clinical narrative: This case was reported in a literature article and described the occurrence of intestinal obstruction in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed intestinal obstruction. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of intestinal obstruction was unknown. It was unknown if the investigator considered the intestinal obstruction to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of intestinal obstruction in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed intestinal obstruction. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of intestinal obstruction and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Juvenile idiopathic arthritis
Clinical narrative: This case was reported in a literature article and described the occurrence of juvenile idiopathic arthritis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed juvenile idiopathic arthritis. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of juvenile idiopathic arthritis was unknown. It was unknown if the investigator considered the juvenile idiopathic arthritis to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of Juvenile idiopathic arthritis in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed Juvenile idiopathic arthritis. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of Juvenile idiopathic arthritis and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: This case was reported in a literature article and described the occurrence of fever in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed fever. Serious criteria included other: serious per reporter. Additional event(s) included headache with serious criteria of other: serious per reporter. The outcome of fever was unknown. The outcome(s) of the additional event(s) included headache (unknown). It was unknown if the investigator considered the fever and headache to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of fever and headache in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient had fever accompanied by headache. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of fever and headache and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Abdominal pain
Clinical narrative: This case was reported in a literature article and described the occurrence of abdominal pain in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed abdominal pain. Serious criteria included other: serious per reporter. The outcome of abdominal pain was unknown. It was unknown if the investigator considered the abdominal pain to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of abdominal pain in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed abdominal pain. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of abdominal pain and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Fibromyalgia
Clinical narrative: This case was reported in a literature article and described the occurrence of fibromyalgia in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed fibromyalgia. Serious criteria included other: serious per reporter. The outcome of fibromyalgia was unknown. It was unknown if the investigator considered the fibromyalgia to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of fibromyalgia in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed fibromyalgia. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of fibromyalgia and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Pyomyositis
Clinical narrative: This case was reported in a literature article and described the occurrence of pyomyositis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed pyomyositis. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of pyomyositis was unknown. It was unknown if the investigator considered the pyomyositis to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of pyomyositis in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed pyomyositis. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of pyomyositis and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Immune thrombocytopenic purpura
Clinical narrative: This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed idiopathic thrombocytopenic purpura. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of idiopathic thrombocytopenic purpura was unknown. It was unknown if the investigator considered the idiopathic thrombocytopenic purpura to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed idiopathic thrombocytopenic purpura. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of  idiopathic thrombocytopenic Purpura and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Muscular weakness
Clinical narrative: This case was reported in a literature article and described the occurrence of muscle weakness in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed muscle weakness. Serious criteria included other: serious per reporter. The outcome of muscle weakness was unknown. It was unknown if the investigator considered the muscle weakness to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of muscular weakness in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed muscular weakness. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of muscular weakness and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Sex: U
Vaccine: MNQ
Symptoms: Osteosarcoma
Clinical narrative: This case was reported in a literature article and described the occurrence of osteosarcoma in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a day after receiving Meningococcal ACWY-CRM vaccine, the subject developed osteosarcoma. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of osteosarcoma was unknown. It was unknown if the investigator considered the osteosarcoma to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of osteosarcoma in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (n=32), Tdap (n=776) and HPV (n=608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (n=43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed osteosarcoma. (In this study, day 0 set as the day of vaccination). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of osteosarcoma and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.