chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Neck pain
Clinical narrative: Injection (TDaP) done on 3/7/17. On Wednesday 3/8/17 noted redness and tenderness to injection site. Also, when head was turned to right a sharp pain radiated from right lower neck to top of head on right side. The redness and tenderness spread daily.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Ear pain, Neck pain, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: 3/10/17 2 days after - neck pain 3/11/17 3 day after - fever, runny nose, congestion and ear pain and rash. Treatment has been self medicated with allergy meds and OTC aids to reduce fever.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Rhinorrhoea
Clinical narrative: 3/10/17 2 days after - neck pain 3/11/17 3 day after - fever, runny nose, congestion and ear pain and rash. Treatment has been self medicated with allergy meds and OTC aids to reduce fever.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain, Swelling
Clinical narrative: Pain started 3 days after shot, swelling, neck pain, shoulder pain, then every day my range of motion was limited. Went to the doctor could see swelling told me to go to physical therapy. I started in December and I'm still going. Swelling has decreased but I still have pain and limited motion when I raise my arm to the side or lift anything.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Eye swelling, Headache, Paraesthesia oral, Speech disorder, Swelling face
Clinical narrative: Two hours after vaccination, felt severe headache and noticed right side of face swollen and pushed to the left. Eye (Rt.) was remained unclosed-unable to talk clearly-tongue felt heavy.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Eyelid function disorder, Headache, Speech disorder, Swelling face, Tongue discomfort
Clinical narrative: Two hours after vaccination, felt severe headache and noticed right side of face swollen and pushed to the left. Eye (Rt.) was remained unclosed-unable to talk clearly-tongue felt heavy.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient still feels soreness in arm of injection at this time.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray
Clinical narrative: 6-4-2015 about a week after taking PREVNAR 13 arm (left) started hurting. Lost the use of arm did physical therapy it help me to start moving arm again. Pain does not go away limited use of left arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: Experienced pain in left foot (same side as vaccination) night of vaccination. Upon waking the following day, foot was swollen and red on top. Got worse and was very painful to walk on. In about 1 week, the redness and swelling started to go away.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pneumococcal 23 administered 2/28/17. Pt phoned 3-2-17 to report an injection reaction. Pt C/O soreness at injection site, localized redness, erythema and swelling to the bicep and tricep.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on his right upper extremity and chest and partially on his trunk started approximately 3.5 hours after vaccines given. Patient was given BENADRYL 25 mg by mouth. Instructed to continue BENADRYL as needed. Instructed to go to Emergency department for any facial swelling, tongue swelling, throat tightness or sore throat.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Infantile spitting up, Musculoskeletal stiffness, Sputum abnormal, Tremor
Clinical narrative: 3/2/17: Had well child check up - received Hep A #1, MMR #1, Varicella #1 at 10 AM. Approx 10 PM, was in carseat - started making strange facial expression; appeared "stiff"; hands shaking, had some spitting up and frothy sputum, suspect febrile seizure - went to ER.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Insomnia, Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: Unbearable pain after the flu shot on the same day. Had to take 5 ADVIL at a time. Have trouble to sleep at night due to the pain. Difficult to do computer work and carry stuff/limited motion range. Shoulder is still painful and stiff. Saw 3 doctors, taking pain medications and doing physical therapy now pain is not getting better severely disrupts my way of life.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain, Periarthritis, Tendonitis
Clinical narrative: Unbearable pain after the flu shot on the same day. Had to take 5 ADVIL at a time. Have trouble to sleep at night due to the pain. Difficult to do computer work and carry stuff/limited motion range. Shoulder is still painful and stiff. Saw 3 doctors, taking pain medications and doing physical therapy now pain is not getting better severely disrupts my way of life.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Nasal congestion, Product preparation error, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: The Act Hib was reconstituted with sterile water instead of the specified saline diluent (0.4% sodium chloride). Pt developed upper respiratory infection symptoms over the next 24 hrs. Nasal congestion and discharge. As of 3-3-17 symptoms resolving.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 7.5 cm x 9 cm area of redness with warmth, raised on right deltoid. 3-6-17 - follow up call placed - spoke with grandparent, states swelling has gone down.
Age: 21.0
Sex: F
Vaccine: HEPA, TD, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pruritus
Clinical narrative: Red, induration; 5cm X 5cm skin irritation, itch at site of VARIVAX inj. (R) triceps area Symptoms started 3/8/17.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Right arm swollen, red, hot to touch.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Severe moving arm from shoulder to wrist. Just hang. Had to hold up with other arm. Couldn't dress myself. Need help still a little hard certain way to move.
Age: 0.17
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction.
Age: 0.25
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Erythema, Headache, Limb mass, Local reaction
Clinical narrative: Red lump right arm, small; H/A dizziness site GARDASIL administered. Local vaccine reaction.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: (L) deltoid area red, itchy, warm and painful to touch. Giving BENADRYL and MOTRIN.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Swelling, Vaccination site rash, Vaccination site swelling
Clinical narrative: Received vaccine 3/13/17 - swelling/soreness occurred. 3/15 prominent and rash/swelling/redness on arm where vaccine was administered.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haematoma
Clinical narrative: R upper arm hematoma.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Rash macular
Clinical narrative: 10 10/12 who developed a macular rash on face, chest and abdominal area 10 minutes after influenza vaccine was administered. Pt. was treated with diphenhydramine 12.5/5ml 10ml and observed for 30 minutes. Condition improved and patient was released home with an Rx for diphenhydramine
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of numbness of upper extremities in a 34-year-old female patient who received ENGERIX B Adult (batch number 35G7C, expiry date 1st February 2019). Concurrent medical conditions included tuberculosis (tested positive). On 6th February 2016, the patient received the 2nd dose of ENGERIX B Adult (intramuscular) 1 ml. On 7th February 2016, 1 days after receiving ENGERIX B Adult, the patient experienced numbness of upper extremities and tingling of extremity. On an unknown date, the outcome of the numbness of upper extremities and tingling of extremity were not recovered/not resolved. The reporter considered the numbness of upper extremities and tingling of extremity to be possibly related to ENGERIX B Adult. Additional details were provided as follows: The patient received a dose of ENGERIX B Adult on her left arm. The patient experienced numbness and tingling in the left arm. At the date of reporting, the patient reported that the numbness comes and goes and it feels as if it was going up to her neck.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm painful at injection site, later became sl swollen, sl redness extending to elbow. Pain, swelling redness persisted until 2/20, then gradually resolved. No fever.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Haematochezia, Irritability
Clinical narrative: 8 days after 2nd ROTATEQ vaccine had 4 hrs of inconsolable crying at 0830. Then had a "currant jelly stool" at 1630 with resolution of fussiness/inconsolability/crying. No interventions.
Sex: U
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: This case was reported in a literature article and described the occurrence of headache in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed headache. Serious criteria included other: Serious per reporter. The outcome of headache was unknown. It was unknown if the investigator considered the 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 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 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 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: Gross motor delay, Hypotonia
Clinical narrative: This case was reported in a literature article and described the occurrence of gross motor delay in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed gross motor delay. Serious criteria included GSK medically significant and other: Serious per reporter. Additional event(s) included hypotonia with serious criteria of other: Serious per reporter. The outcome of gross motor delay was unknown. The outcome(s) of the additional event(s) included hypotonia (unknown). It was unknown if the investigator considered the gross motor delay and hypotonia 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 hypotonia/motor delay 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, in 1380 of 2614 reports, other vaccines were given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9, of all MENVEO reports in age group) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and HPV (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, between 0-734 days after vaccination, the patient developed hypotonia/motor delay. (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 hypotonia/motor delay 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: Myocarditis, Pericarditis
Clinical narrative: This case was reported in a literature article and described the occurrence of myocarditis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed myocarditis. Serious criteria included GSK medically significant and other: Serious per reporter. Additional event(s) included pericarditis with serious criteria of GSK medically significant and other: Serious per reporter. The outcome of myocarditis was unknown. The outcome(s) of additional event(s) included pericarditis (unknown). It was unknown if the investigator considered the myocarditis and pericarditis 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 myocarditis and pericarditis 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 myocarditis and pericarditis. (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 myocarditis and pericarditis 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: Pneumonia streptococcal
Clinical narrative: This case was reported in a literature article and described the occurrence of pneumonia streptococcal in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed pneumonia streptococcal. Serious criteria included GSK medically significant and other: Serious per reporter. The outcome of pneumonia streptococcal was unknown. It was unknown if the investigator considered the pneumonia streptococcal 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 streptococcal pneumonia 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 streptococcal pneumonia. (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 streptococcal pneumonia 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: Polyneuropathy
Clinical narrative: This case was reported in a literature article and described the occurrence of polyneuritis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed polyneuritis. Serious criteria included GSK medically significant and other: Serious per reporter. The outcome of polyneuritis was unknown. It was unknown if the investigator considered the polyneuritis 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 Polyneuritis 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 Polyneuritis. (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 Polyneuritis 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: Neuromyopathy
Clinical narrative: This case was reported in a literature article and described the occurrence of neuromyopathy in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed neuromyopathy. Serious criteria included GSK medically significant and other: Serious per reporter. The outcome of neuromyopathy was unknown. It was unknown if the investigator considered the neuromyopathy 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 neuromyopathy 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 neuromyopathy. (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 neuromyopathy 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: Appendicitis
Clinical narrative: This case was reported in a literature article and described the occurrence of appendicitis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed appendicitis. Serious criteria included GSK medically significant and other: Serious per reporter. The outcome of appendicitis was unknown. It was unknown if the investigator considered the appendicitis 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 appendicitis 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 appendicitis. (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 appendicitis 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.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Electroencephalogram normal, Muscle twitching, Neurological examination normal, Seizure
Clinical narrative: This is a follow-up to a previously submitted VAERS Report 657596-1. Pt. had convulsions on 9/27/16 and was admitted. F/U: Review of notes only reports healthy child with mother of patient (MOP) reporting infant had been breast feed x2 weeks then bottle feed W/O issues. MOP reported 1 episode of watery stool prior to receiving routine 2 month old immunizations (PEDIARIX, HIB, PCV13 and rotavirus) at 1100 hr on 9/27/16. Approximately 3 hours later (1400 hr) while asleep MOP saw infants legs twitching about 30 sec x 4 over a 5 min period and she had difficulty awakening him. Infant was taken to nearby ER 9/27/2016 where MOP reported that infant had "convulsions in legs only" 1 hour prior to arrival in ER with diarrhea x1 and she was not able to see his eyes. Providers documented infant normal vital signs with T99.5 rectally (1710 hr), alert, happy, smiling, interactive and playful, consolable, well hydrated and in no acute distress. Neuro exam was normal and child admitted about 1800 hr for observation overnight. His 1 hour EEG (awake/asleep) 9/28/2016 was normal EEG. Infant has not had any further convulsions since and has not been placed on any medication. His HCP/pediatricians held DTaP at 4 months of age with all other routine vaccination administered W/O reactions (12/6/2016). HCP was concerned for encephalopathy with DTaP and was awaiting clearance by neurology. Neurology exam 12/12/2016 suggested reactions could "represent normal sleep behavior, sleep myoclonus or epileptic seizure, but he had limited information on Infants reactions (MOP not available-dad brought infant into this exam). Neurologist diagnosed "convulsions in newborn" with a normal exam. Neurologist wrote S/S were not suggestive of DTaP encephalitis; however he was wary to claim reactions were due to immunizations and will leave decision up to pediatrician regarding use of DTaP. A repeat EEG on 1/30/2017 was normal, however the technician documented the exam was limited during wakefulness due to profuse movement and muscle artifact. There were no epileptiform discharges and no EEG evidence of a seizure disorder. This negative EEG did not exclude epilepsy and recommended F/U EEG as needed. 2/17/2017: F/U with neurology shows normal EEG's. F/U with HCP discussed use of DTaP again, father agreeable -- Child given PEDIARIX, HIB, rotavirus, and PCV13...monitored x 1 hour and released. He will receive 3rd DTaP in 3 months following catch up series.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Somnolence
Clinical narrative: This is a follow-up to a previously submitted VAERS Report 657596-1. Pt. had convulsions on 9/27/16 and was admitted. F/U: Review of notes only reports healthy child with mother of patient (MOP) reporting infant had been breast feed x2 weeks then bottle feed W/O issues. MOP reported 1 episode of watery stool prior to receiving routine 2 month old immunizations (PEDIARIX, HIB, PCV13 and rotavirus) at 1100 hr on 9/27/16. Approximately 3 hours later (1400 hr) while asleep MOP saw infants legs twitching about 30 sec x 4 over a 5 min period and she had difficulty awakening him. Infant was taken to nearby ER 9/27/2016 where MOP reported that infant had "convulsions in legs only" 1 hour prior to arrival in ER with diarrhea x1 and she was not able to see his eyes. Providers documented infant normal vital signs with T99.5 rectally (1710 hr), alert, happy, smiling, interactive and playful, consolable, well hydrated and in no acute distress. Neuro exam was normal and child admitted about 1800 hr for observation overnight. His 1 hour EEG (awake/asleep) 9/28/2016 was normal EEG. Infant has not had any further convulsions since and has not been placed on any medication. His HCP/pediatricians held DTaP at 4 months of age with all other routine vaccination administered W/O reactions (12/6/2016). HCP was concerned for encephalopathy with DTaP and was awaiting clearance by neurology. Neurology exam 12/12/2016 suggested reactions could "represent normal sleep behavior, sleep myoclonus or epileptic seizure, but he had limited information on Infants reactions (MOP not available-dad brought infant into this exam). Neurologist diagnosed "convulsions in newborn" with a normal exam. Neurologist wrote S/S were not suggestive of DTaP encephalitis; however he was wary to claim reactions were due to immunizations and will leave decision up to pediatrician regarding use of DTaP. A repeat EEG on 1/30/2017 was normal, however the technician documented the exam was limited during wakefulness due to profuse movement and muscle artifact. There were no epileptiform discharges and no EEG evidence of a seizure disorder. This negative EEG did not exclude epilepsy and recommended F/U EEG as needed. 2/17/2017: F/U with neurology shows normal EEG's. F/U with HCP discussed use of DTaP again, father agreeable -- Child given PEDIARIX, HIB, rotavirus, and PCV13...monitored x 1 hour and released. He will receive 3rd DTaP in 3 months following catch up series.
Age: 71.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Pruritus, Rash, Varicella
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a currently 71 year-old patient of an unknown gender. The patient's concurrent conditions, medical history, drug reactions or allergies or concomitant medications were not reported. On 19-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route and frequency were not reported) lot # reported as M003910 with an  expiration date of 17-OCT-2017, for prophylaxis. On an unspecified date, the patient experienced a "severe case of chicken pox". The outcome of the mentioned adverse event was unknown. No product quality complaint was involved (PQC). The causality between the mentioned adverse event and ZOSTAVAX was unknown. Lot # M0003910 is not a valid lot for ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a currently 71 year-old patient of an unknown gender. The patient's concurrent conditions, medical history, drug reactions or allergies or concomitant medications were not reported. On 19-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route and frequency were not reported) lot # reported as M003910 with an  expiration date of 17-OCT-2017, for prophylaxis. On an unspecified date, the patient experienced a "severe case of chicken pox". The outcome of the mentioned adverse event was unknown. No product quality complaint was involved (PQC). The causality between the mentioned adverse event and ZOSTAVAX was unknown. Lot # M0003910 is not a valid lot for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Death, Meningococcal infection, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient died on an unknown date. The pharmacist called to ask for the mailing address to the company. He was provided with the address when he mentioned the patient's death and BEXSERO. An attempt was made to try and collect the information about the adverse event, however, he preferred to mail the report to the company. The pharmacist asked again to document the death, but he refused. An attempt was made to offer faxing the report, however the pharmacist was unable to locate the fax number at the time of the report. The pharmacist was going to mail the report because he felt the company would want to know what happened.
Sex: U
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Death
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient died on an unknown date. The pharmacist called to ask for the mailing address to the company. He was provided with the address when he mentioned the patient's death and BEXSERO. An attempt was made to try and collect the information about the adverse event, however, he preferred to mail the report to the company. The pharmacist asked again to document the death, but he refused. An attempt was made to offer faxing the report, however the pharmacist was unable to locate the fax number at the time of the report. The pharmacist was going to mail the report because he felt the company would want to know what happened.
Sex: U
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Adrenal haemorrhage, Adrenocortical insufficiency acute, Anaemia, Arthralgia, Autopsy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient died on an unknown date. The pharmacist called to ask for the mailing address to the company. He was provided with the address when he mentioned the patient's death and BEXSERO. An attempt was made to try and collect the information about the adverse event, however, he preferred to mail the report to the company. The pharmacist asked again to document the death, but he refused. An attempt was made to offer faxing the report, however the pharmacist was unable to locate the fax number at the time of the report. The pharmacist was going to mail the report because he felt the company would want to know what happened.
Sex: U
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Back pain, Bacterial toxaemia, Bone pain, Cardiac arrest, Death
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient died on an unknown date. The pharmacist called to ask for the mailing address to the company. He was provided with the address when he mentioned the patient's death and BEXSERO. An attempt was made to try and collect the information about the adverse event, however, he preferred to mail the report to the company. The pharmacist asked again to document the death, but he refused. An attempt was made to offer faxing the report, however the pharmacist was unable to locate the fax number at the time of the report. The pharmacist was going to mail the report because he felt the company would want to know what happened.
Sex: U
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: General physical health deterioration, Haemolysis, Headache, Hypotension, Hypovolaemic shock
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient died on an unknown date. The pharmacist called to ask for the mailing address to the company. He was provided with the address when he mentioned the patient's death and BEXSERO. An attempt was made to try and collect the information about the adverse event, however, he preferred to mail the report to the company. The pharmacist asked again to document the death, but he refused. An attempt was made to offer faxing the report, however the pharmacist was unable to locate the fax number at the time of the report. The pharmacist was going to mail the report because he felt the company would want to know what happened.
Sex: U
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Meningococcal bacteraemia, Meningococcal infection, Necrosis, Neisseria test positive, Neutrophil count increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient died on an unknown date. The pharmacist called to ask for the mailing address to the company. He was provided with the address when he mentioned the patient's death and BEXSERO. An attempt was made to try and collect the information about the adverse event, however, he preferred to mail the report to the company. The pharmacist asked again to document the death, but he refused. An attempt was made to offer faxing the report, however the pharmacist was unable to locate the fax number at the time of the report. The pharmacist was going to mail the report because he felt the company would want to know what happened.
Sex: U
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Pain in extremity, Paroxysmal nocturnal haemoglobinuria, Purpura, Resuscitation, Stupor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient died on an unknown date. The pharmacist called to ask for the mailing address to the company. He was provided with the address when he mentioned the patient's death and BEXSERO. An attempt was made to try and collect the information about the adverse event, however, he preferred to mail the report to the company. The pharmacist asked again to document the death, but he refused. An attempt was made to offer faxing the report, however the pharmacist was unable to locate the fax number at the time of the report. The pharmacist was going to mail the report because he felt the company would want to know what happened.