chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Bacterial test positive, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and one month after vaccination developed meningococcal sepsis, year reported as 2010 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: M
Vaccine: MNQ
Symptoms: Bacterial test positive, Meningitis meningococcal, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19 year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and 3 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2010 (Q 3). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Sex: F
Vaccine: MNQ
Symptoms: Bacterial test positive, Meningitis meningococcal, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 25-29-year-old female patient who had received MENACTRA (lot number, route, site and date of administration not reported) and 8 months after vaccination developed meningococcal meningitis, year reported as 2010 (Q 3). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08254, -08255, and -08256. Documents held by sender: None.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Initial report was received on 04 September 2012 via a search of the scientific literature. The following is verbatim per the report: "Background: Annually, over 2 million are administered influenza vaccinations. As of the 2010-2011 influenza season, the safety of the influenza vaccine was actively monitored nationally. Possible associations between potential adverse events of interest and influenza vaccination were evaluated at the end of the influenza season. Objectives: The goal of this study was to determine the safety of the 2010-2011 influenza vaccinations in the population treated. Methods: Integrated automated databases were used to identify patients who were diagnosed with Guillain-Barre Syndrome (GBS), idiopathic thrombocytopenic purpura (ITP), and Bell's palsy from 10/1/10 to 3/31/11 as identified by ICD-9 code. The influenza vaccination status for these patients was determined using the Immunization Package database in addition to the integrated automated and prescription databases. Adverse event rates in the risk period (within 1-42 days) were compared to rates in the non-risk period (43 days or after) in terms of incidence rate ratios (IRR) using the self controlled case series method. Only vaccinated cases were included. Seasonality was included to account for possible fluctuation of disease occurrence over the calendar time. Results: Approximately 2.1 million received the influenza vaccines (including 42,375 high-dose vaccines) from 10/1/10 to 3/31/11. A total of 38 GBS, 81 ITP, and 575 Bell's palsy post-vaccinated cases were identified. No significant risks for GBS (IRR = 2.07 and 95% CIs =0.59-7.24), ITP (IRR = 0.71, 95% CIs = 0.32-1.59), and Bell's palsy (IRR = 0.90, 95% CIs = 0.67-1.22) were observed for patients who received the regular dose influenza vaccines. Similarly, no significant increased risk for Bell's palsy (IRR = 1.13, 95% CIs = 0.21-6.02) was observed for patients who received high-dose influenza vaccines. There were no GBS and ITP cases after high dose vaccines. Conclusions: There was no evidence of increased risks of GBS, ITP, and Bell's palsy following 2010-2011 influenza vaccinations in the population treated in the health care system. The reporter for this case is the same as for case number 2012-08478. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood creatine phosphokinase increased, Dyspnoea, Hyperacusis, Hypersensitivity, Parosmia
Clinical narrative: Since vaccine patient has had recurrent allergic sxs of throat tightness & difficulty breathing. She has required at least 10 EPIPEN injections & ER visits since the vaccine was given. She also has hyperacute hearing & smell.
Age: 49.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Throat tightness
Clinical narrative: Since vaccine patient has had recurrent allergic sxs of throat tightness & difficulty breathing. She has required at least 10 EPIPEN injections & ER visits since the vaccine was given. She also has hyperacute hearing & smell.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Resuscitation
Clinical narrative: Patient found at home not breathing, CPR started. EMS continued CPR & brought patient to our ED. Patient still in full cardiopulmonary arrest. Patient never recovered heart rate.
Age: 20.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Grand mal convulsion
Clinical narrative: This spontaneous report as received from a physician refers to a 20 years old female patient. On 12-OCT-2007 the patient was vaccinated with dose 1 GARDASIL (Dose not reported) (Lot # 01714 Exp 29-JUN-2009) (IM). On 12-DEC-2007 the patient was vaccinated with dose 2 GARDASIL (Dose not reported) (Lot # 12674 Exp 18-JUL-2010) (IM). On 05-SEP-2012 the patient was vaccinated with dose 3 GARDASIL (Dose not reported) (Lot # 0101AE Exp 10-OCT-2014) (IM). Concomitant medications included: MENACTRA. The physician stated that a patient began having seizures around the time of her first doses of GARDASIL, the reporter was unsure if this seizure activity occurred in 2007 or at a later time. The patient suffered from a grand mal seizure after receiving her last dose of the product. The patient sought unspecified medical attention. At the time of the report, the patient was under the care of a neurologist. The patient was put on treatment with anti seizure medication (unspecified). At the time of the report the patient was recovering from seizure. Additional information has been requested. Upon internal review seizures and Grand mal seizure were considered medically significant.
Sex: M
Vaccine: MNQ
Symptoms: Bacterial test positive, Meningitis meningococcal, Neisseria test positive, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24-year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and 7 months after vaccination developed meningococcal meningitis, year reported as 2010 (Q 4). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08255, and -08256. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Arthralgia, Condition aggravated, Feeling abnormal, Headache
Clinical narrative: Patient states she did not realize she was getting GARDASIL with vaccine visit last month believes her Lyme symptoms have flared since and has been having all of the symptoms listed on site except for seizure: swollen glands, joint pain, fatigue, weakness and stomachache family feels like she can hardly function from the time of shot admin on 6/20/12, started feeling poorly 10 hours later with pain in stomach, head, and joints pain fever, night sweats all are worse like 2 years ago when she was diagnosed with her Chronic Lyme disease. Highest temp measured following vaccine was 102. not that high with Lyme prior more typically 99.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Lyme disease, Night sweats, Pyrexia
Clinical narrative: Patient states she did not realize she was getting GARDASIL with vaccine visit last month believes her Lyme symptoms have flared since and has been having all of the symptoms listed on site except for seizure: swollen glands, joint pain, fatigue, weakness and stomachache family feels like she can hardly function from the time of shot admin on 6/20/12, started feeling poorly 10 hours later with pain in stomach, head, and joints pain fever, night sweats all are worse like 2 years ago when she was diagnosed with her Chronic Lyme disease. Highest temp measured following vaccine was 102. not that high with Lyme prior more typically 99.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Fatigue, Feeling abnormal, Muscular weakness, Nausea, Pain
Clinical narrative: Patient states she did not realize she was getting GARDASIL with vaccine visit last month believes her Lyme symptoms have flared since and has been having all of the symptoms listed on site except for seizure: swollen glands, joint pain, fatigue, weakness and stomachache family feels like she can hardly function from the time of shot admin on 6/20/12, started feeling poorly 10 hours later with pain in stomach, head, and joints pain fever, night sweats all are worse like 2 years ago when she was diagnosed with her Chronic Lyme disease. Highest temp measured following vaccine was 102. not that high with Lyme prior more typically 99.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient states she did not realize she was getting GARDASIL with vaccine visit last month believes her Lyme symptoms have flared since and has been having all of the symptoms listed on site except for seizure: swollen glands, joint pain, fatigue, weakness and stomachache family feels like she can hardly function from the time of shot admin on 6/20/12, started feeling poorly 10 hours later with pain in stomach, head, and joints pain fever, night sweats all are worse like 2 years ago when she was diagnosed with her Chronic Lyme disease. Highest temp measured following vaccine was 102. not that high with Lyme prior more typically 99.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Having prolonged pressure (feels like band around arm at shot site); aching like sore muscle - has continued for several weeks (still having this date).
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site urticaria, Pruritus generalised, Throat irritation
Clinical narrative: Itchy throat, 2 inch red wheel around injection site that became larger-zyrtec and ice applied in urgent care. Followed by itching all over and epinephrine administered in urgent care.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Off label intradermal vaccine given.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Blood test, Borrelia test, Cardiac disorder
Clinical narrative: Fatigue, thirst. Went to bed. Woke up couple hours later and had throat pain, trouble swallowing. Next day, weakness, fatigue, dehydration, diarrhea, chills, sllght fever, upset stomach, cold feet, heart laboring, slight labor in breathing with slight cough.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dehydration, Diarrhoea, Dysphagia
Clinical narrative: Fatigue, thirst. Went to bed. Woke up couple hours later and had throat pain, trouble swallowing. Next day, weakness, fatigue, dehydration, diarrhea, chills, sllght fever, upset stomach, cold feet, heart laboring, slight labor in breathing with slight cough.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram abnormal, Fatigue, Oropharyngeal pain, Peripheral coldness
Clinical narrative: Fatigue, thirst. Went to bed. Woke up couple hours later and had throat pain, trouble swallowing. Next day, weakness, fatigue, dehydration, diarrhea, chills, sllght fever, upset stomach, cold feet, heart laboring, slight labor in breathing with slight cough.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Thirst, Urine analysis normal
Clinical narrative: Fatigue, thirst. Went to bed. Woke up couple hours later and had throat pain, trouble swallowing. Next day, weakness, fatigue, dehydration, diarrhea, chills, sllght fever, upset stomach, cold feet, heart laboring, slight labor in breathing with slight cough.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Left shoulder joint pain/soreness (same arm as where vaccine was given). Pain worsened over 10d period. Pain limited range of motion. No neurological deficits. No treatment initially, then when patient presented at day 10 recommended rest, ice, NSAIDs prn.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Detected two chicken pox on upper right arm. Later developed another on right forearm and one on lower left back and behind right leg. Also a single lesion in the mouth.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Pinkish around the site, Normal pain as usual. There is a big lump at sight.
Age: 17.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Obstructive airways disorder, Syncope
Clinical narrative: Became faint lasting 5 seconds. Airway opened, upon becoming more alert, juice given, observed x 10 minutes, discharged ambulatory with parent.
Age: 46.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Pain, Pyrexia, Skin warm
Clinical narrative: Patient has an induration of appp. 3 cm at vaccine site on left arm, redness, heat and pain in an area app. 10 X 12 cm. Reports fever of 101. Reports pain interferes with sleep and use of arm. Patient reported this reaction on 9/17/2012 when we found it to be as above. Patient saw a private MD 9/17/2012 and was given "a cream and an antibiotic".  Pt has a recheck with PMD in a few days. Patient had small induration on Right Arm, with no redness or swelling.
Age: 46.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Sleep disorder, Vaccination site induration
Clinical narrative: Patient has an induration of appp. 3 cm at vaccine site on left arm, redness, heat and pain in an area app. 10 X 12 cm. Reports fever of 101. Reports pain interferes with sleep and use of arm. Patient reported this reaction on 9/17/2012 when we found it to be as above. Patient saw a private MD 9/17/2012 and was given "a cream and an antibiotic".  Pt has a recheck with PMD in a few days. Patient had small induration on Right Arm, with no redness or swelling.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Acne, Dermatitis diaper, Diarrhoea, Pyrexia, Rash generalised
Clinical narrative: Approx. 9/3/12 my son spiked a fever under 101*. During this time he had one LARGE episode of vomiting. On 9/4/12  he cont.d' with fever of 101* started with diarrhoea and what looked to me like diaper rash.  9/5/12 low grade fever and rash ALL over his body. This includes inside his mouth, ears, diaper area, in his hair, his eye lids. 9/6/12 I took him to the Hospital they said it was a viral rash which was also said by Dr.  By evening the rash had DOUBLED, raised, and my son was in agony!!  I took him to my husbands pediatrician. He confirmed that the rash was indeed a case of the chicken pox. He prescribed him acyclovir. I also gave him Tylenol and Benadryl per Dr. He still has SOME pimples.  They no longer bother him and are still fading.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Varicella post vaccine, Viral rash, Vomiting
Clinical narrative: Approx. 9/3/12 my son spiked a fever under 101*. During this time he had one LARGE episode of vomiting. On 9/4/12  he cont.d' with fever of 101* started with diarrhoea and what looked to me like diaper rash.  9/5/12 low grade fever and rash ALL over his body. This includes inside his mouth, ears, diaper area, in his hair, his eye lids. 9/6/12 I took him to the Hospital they said it was a viral rash which was also said by Dr.  By evening the rash had DOUBLED, raised, and my son was in agony!!  I took him to my husbands pediatrician. He confirmed that the rash was indeed a case of the chicken pox. He prescribed him acyclovir. I also gave him Tylenol and Benadryl per Dr. He still has SOME pimples.  They no longer bother him and are still fading.
Age: 19.0
Sex: M
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Convulsion, Pallor
Clinical narrative: Seizure affecting arms and legs, patient became very pale. Seizure lasted approx 15 sec.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Fall, Heart rate increased
Clinical narrative: I got the shot, I got up to leave. My heart started beating  fast, suddenly I fell down, I did not have time to even feel dizzy, I just fell down. I did not get hurt. I felt fine after I fell down, I waited in the lobby 20 minutes, felt fine the whole time and went home. I suppose it would have been life threatening if I fell the wrong way or in the wrong place. So that is why I will check life threatening. I fell in a good way. Also I don't remember the exact date or time, but it was my first ever flu shot and it was on about that date.
Age: 1.35
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Discomfort, Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: Started with a fever of 101 and lead into the next day. By 9/16/2012, woke up in AM with little red bumps on chest, back and neck and progressed throughout the day. By 9/17/2012, with rash had spread to face, arms, lower torso, and legs. Started experiencing itching and uncomfortable appearance by this time. He rash appears to be significate and covers most of the torso and face.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Dyspnoea, Eye swelling, Feeling abnormal, Lacrimation increased
Clinical narrative: 0905 eye started to get watery. 1100 eyes started to swell and started feeling bad- sore throat. 1200pm went to Occ Health office and reported sore throat, release from work and followed up with my PCP. 200pm started to have shortness of breath and feeling worse.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: 0905 eye started to get watery. 1100 eyes started to swell and started feeling bad- sore throat. 1200pm went to Occ Health office and reported sore throat, release from work and followed up with my PCP. 200pm started to have shortness of breath and feeling worse.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Contusion, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Left arm sore, warm to the touch, swollen and red, itchy, fever, chills, bruising. Taking Advil and Benadryl for the itching. Pt went to ER the gave her Prednizone, Claritin, and Pepcid for stomach reaction from other medications. Pt has a dr appt on 9/20/12.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Pyrexia, Skin warm
Clinical narrative: Left arm sore, warm to the touch, swollen and red, itchy, fever, chills, bruising. Taking Advil and Benadryl for the itching. Pt went to ER the gave her Prednizone, Claritin, and Pepcid for stomach reaction from other medications. Pt has a dr appt on 9/20/12.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: PER PATIENT SHE STARTED TO FEEL SOMETHING DIFFERENT NOT TOO LONG AFTER RECEIVING THE SHOT. AT NIGHT SHE NOTICED HER ARM GOT SWOLLEN. PATIENT CAME BACK TO SEE US THE NEXT DAY (09/16/2012). I NOTICED THE AREA RIGHT BELOW THE INJECTION SITE ALL THE WAY TO THE ELBOW SWOLLEN. PATIENT COMPLAINED OF PAIN IN THAT AREA. THE SWOLLEN AREA WAS WARM.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site swelling, Paraesthesia, Tenderness
Clinical narrative: Symtoms: left upper arm swollen, arm & fingers numbness and tingling, pain to the touch; Lasting 3 days. Treatment: applied ice ibuprofen 3xday.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Malaise, Ocular hyperaemia, Rash
Clinical narrative: 8/18 & 8/19 didn't feel well.  8/20:  red eye & spots on face near eye.  Opthamalogist saw him 8/27/12 & diagnosed shingles. Tx with Acyclovir and Advil. Severe headaches continue as of today - 9/18/12.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Abnormal behaviour, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: Fever up to 100.5 continues, dry cough to wet cough causing sleep disturbances severity progrssing to gagging and vomiting at times. Complaints of severe headache, muscle aches in arms/legs/abdomen. Lack of appetite, 2lb weight loss in 2 weeks. Continued fatigue, change of behavior and disruption of behavior patterns.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia, Retching, Sleep disorder, Vomiting
Clinical narrative: Fever up to 100.5 continues, dry cough to wet cough causing sleep disturbances severity progrssing to gagging and vomiting at times. Complaints of severe headache, muscle aches in arms/legs/abdomen. Lack of appetite, 2lb weight loss in 2 weeks. Continued fatigue, change of behavior and disruption of behavior patterns.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Weight decreased
Clinical narrative: Fever up to 100.5 continues, dry cough to wet cough causing sleep disturbances severity progrssing to gagging and vomiting at times. Complaints of severe headache, muscle aches in arms/legs/abdomen. Lack of appetite, 2lb weight loss in 2 weeks. Continued fatigue, change of behavior and disruption of behavior patterns.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Child received vaccines on 9/14/12. Parent reported found child unresponsive on 9/15/12. Taken by ambulance to ER and pronounced.
Age: 16.0
Sex: F
Vaccine: TD, TDAP, VARCEL
Symptoms: Abdominal pain upper, Chills, Pain, Vomiting
Clinical narrative: Vomiting, chills, body aches, stomach ache.
Age: 73.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Erythema, Headache, Pain, Skin warm, Swelling
Clinical narrative: Swollen, red, very warm to touch, painful when sun shines on it and headaches.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Lower lip swelling, required Benadryl.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Limited ROM and pain beginning the same day that the vaccine was given.
Age: 27.0
Sex: M
Vaccine: ANTH, FLU3, TYP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Blackout, sweating, and pale skin.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysgeusia, Hypoaesthesia oral, Swollen tongue
Clinical narrative: Tongue swelled up and started to numb. Taste of metallic in her mouth.
Age: 22.0
Sex: M
Vaccine: FLUN3, SMALL
Symptoms: Musculoskeletal pain
Clinical narrative: Left shoulder started hurting while laying down.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Headache, Malaise, Myalgia, Pharyngeal oedema
Clinical narrative: Fever (took APAP), Throat swelling (took Benadryl), muscle aches. 9/18/12: Malaise, headache, fever, poor appetite.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever (took APAP), Throat swelling (took Benadryl), muscle aches. 9/18/12: Malaise, headache, fever, poor appetite.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Injection site cellulitis, Pyrexia, Ultrasound scan, X-ray
Clinical narrative: Fever, chills, cellulitis at injection site.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Fever, chills, cellulitis at injection site.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: The morning after the vaccination, the patient states, "she has trouble raising her arm above her head, and there are severe pains radiating from her shoulder. It takes some time before the pain resides."
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: - Itching, redness, and swelling to site started 2 days after vaccine lasted 4 days. - Headache 2 days: Treatment TYLENOL.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site pain
Clinical narrative: Sore arm at pneumonia vaccine site. Chills.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Dyspnoea, Dysstasia, Palpitations, Pyrexia
Clinical narrative: - High fever, trouble breathing, could not stand up, knee pain, racing heart rate.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: On 8/9/12 child complained of nausea & headache - TYLENOL given & felt better & went to school. Night of 8/9/12 area around the injection site had swelling, redness, hardness, & hot to touch - gave BENADRYL & MOTRIN. 8/10/12 - swelling, redness, & hot to touch was down front of (L) arm - taken to walk in clinic & prescribed prednisolone 15 mg x 10 days. Mother states injection site was "upper (L) arm below the shoulder."
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Nausea
Clinical narrative: On 8/9/12 child complained of nausea & headache - TYLENOL given & felt better & went to school. Night of 8/9/12 area around the injection site had swelling, redness, hardness, & hot to touch - gave BENADRYL & MOTRIN. 8/10/12 - swelling, redness, & hot to touch was down front of (L) arm - taken to walk in clinic & prescribed prednisolone 15 mg x 10 days. Mother states injection site was "upper (L) arm below the shoulder."
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Mother called at about 9:30-9:45 am on 8-1-12 an stated child's arm had a swollen reddened whelp at site of "chicken pox shot" that was size of baseball in diameter which began before child went to bed on night of 7-31-12, had given child a dose of BENADRYL, marked the area and when child awoke this am, the area had passed the marked area by about 1/2". Instructed them to give child BENADRYL every 4 hours & if worsens to take child to MD or to ER.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site warmth, Skin irritation, Skin swelling
Clinical narrative: Patient had heat/fever at site of injection. Patient also had redness and swelling arranged in a circle and radiating approximately 3-4 inches from the center. After 3 days, the patient had a large blister (about 2 inches long and 1 inch wide) filled with fluid. The skin surface almost looked burned and very swollen. The patient had to be seen by physician, given a round of antibiotics, steroid dose pack, and also a cream to help with skin irritation/burn. The doctor dressed the arm with a compression wrap and had patient followup 2 days later for redressing.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient had heat/fever at site of injection. Patient also had redness and swelling arranged in a circle and radiating approximately 3-4 inches from the center. After 3 days, the patient had a large blister (about 2 inches long and 1 inch wide) filled with fluid. The skin surface almost looked burned and very swollen. The patient had to be seen by physician, given a round of antibiotics, steroid dose pack, and also a cream to help with skin irritation/burn. The doctor dressed the arm with a compression wrap and had patient followup 2 days later for redressing.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Full blood count, Malaise, Metabolic function test, Pyrexia
Clinical narrative: Feeling warm and malaise. Fever less than 100F.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Oedema peripheral, Skin warm
Clinical narrative: Patient's arm had a fever, very hot to touch and swollen. The heat radiated from the injection in a circular area and spanned approximately 4-5 inches across. Patient complained of itching and soreness in area. Patient started Benadryl 25 mg every 6 hours and cool compresses to the area. The patient plans to proceed to the doctor tomorrow AM since the area is still the same as of 9/18/12.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Dizziness postural, Fall, Head injury, Pallor, Syncope
Clinical narrative: After vaccination, pt. felt dizzy when she tried to stand. She sat down in chair and face appeared pale. She fell forward out of the chair and fainted hitting her head on ground. Did not lose consiousness. Ice applied and juice given. Layed on ground for 10 minutes after fainting. Sat in chair for 15 minutes and was monitored. Clear speech and remained orientated. Denied pain on head.
Age: 4.0
Sex: M
Vaccine: DTPIPV, FLU3, MMR, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: ARM SWELLING/NO TREATMENT.
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Drug administered at inappropriate site
Clinical narrative: Patient was given intramuscular shot too low on the arm (not in the deltoid muscle).
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Abdominal pain upper, Fatigue, Headache, Lethargy, Nausea
Clinical narrative: Patient was given intramuscular shot too low on the arm (not in the deltoid muscle).
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Pain in extremity
Clinical narrative: Patient was given intramuscular shot too low on the arm (not in the deltoid muscle).
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Drug administered at inappropriate site
Clinical narrative: Headache, sore arm, lethargy/fatigue, nausea, stomach pain.
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Abdominal pain upper, Fatigue, Headache, Lethargy, Nausea
Clinical narrative: Headache, sore arm, lethargy/fatigue, nausea, stomach pain.
Age: 49.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Pain in extremity
Clinical narrative: Headache, sore arm, lethargy/fatigue, nausea, stomach pain.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: 9/12/12 - Immunization given in afternoon. 9/13/12 - Sore arm, feeling "tired". 9/14/12 Feeling tired, achy, headache, fever to 101 degrees. 9/15/12 - Feeling tired, achy, headache, fever to 101 degrees. 9/16/12 - Fever down to 99-100 degrees.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash at injection site.
Age: 19.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse events noted; pt was given TDaP vaccine and Hep B vaccine though not due for either.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Nausea, Pyrexia
Clinical narrative: Fever, chills, malaise, nausea.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC13
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Pt. woke on 9-17-12 with a red rash over body. No pain, fever or swelling. Dr. prescribed BENADRYL.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Increased upper airway secretion
Clinical narrative: Breathing difficulty, phlegm production, and headache. Patient took excedrin for headache and upon supine position breathing difficulty worsened. Advised patient to take diphenhydramine to stop any allergic reaction from worsening and would follow up with him hourly to check status.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Pallor, Pruritus
Clinical narrative: Pt was red and itchy on neck and forehead. Pt was also pale and complained of dizziness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Cold sweat, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Heart started racing severely, tingling throughout my body, headache, sore throat, clammy with slight stomach ache. Also,the injection site was beet red, hot to the touch but had been ok just a few hours before. This event lasted for three hours and finally subsided. If I was working, I would have called 911 but we couldn't afford an ambulance drive to the hospital. I'm still dealing with headaches, feeling feverish and in general, not like my old self!!
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Oropharyngeal pain, Palpitations, Paraesthesia
Clinical narrative: Heart started racing severely, tingling throughout my body, headache, sore throat, clammy with slight stomach ache. Also,the injection site was beet red, hot to the touch but had been ok just a few hours before. This event lasted for three hours and finally subsided. If I was working, I would have called 911 but we couldn't afford an ambulance drive to the hospital. I'm still dealing with headaches, feeling feverish and in general, not like my old self!!
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Heart started racing severely, tingling throughout my body, headache, sore throat, clammy with slight stomach ache. Also,the injection site was beet red, hot to the touch but had been ok just a few hours before. This event lasted for three hours and finally subsided. If I was working, I would have called 911 but we couldn't afford an ambulance drive to the hospital. I'm still dealing with headaches, feeling feverish and in general, not like my old self!!
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Speech disorder, Swelling face, Swollen tongue
Clinical narrative: Returned to office 1 hour after vaccine, with complaint of facial swelling and tongue swelling, face neck upper chest both ears red and warm patient had difficulty talking  At 2:59 pm Patient given Benadryl 12.5mg/5ml -12.5ml & Epi Pen @ 3:02 pm given albuterol inhalation solution 1ml with 2 ml saline @ 3:12 pm Prednisolone 15ml was given@ 3:16 pm Benadryl 12.5ml given.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Aspiration bone marrow normal, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased, Rash
Clinical narrative: Patient had petechiae all over the body three weeks after vaccination. Pt was diagnosed as "Idiopathic Thrombocytopenic Purpura" in hospital. Patient's platelet count was between 20,000 to 30,000 for 1 month, checked bone marrow sample, there was no abnormality for producing platelet. On 18Sept2012 patient's primary care doctor suggested Pt's mother to vaccinate patient just one vaccine at a time, to identify if that was from immunization. Hospital will monitor patient's CBC after vaccine.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Muscular weakness
Clinical narrative: Pronounced swelling, redness, heat or hardness at the site of the injection; muscle weakness.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Dysphonia, Injection site erythema, Injection site warmth
Clinical narrative: Pain in joints and especially elbow. Red and hot at site of vaccine. Hoarse voice - could barely speak for 1-2 days.
Age: 1.06
Sex: F
Vaccine: MMRV
Symptoms: Measles, Pyrexia, Rash erythematous, Rash generalised, Rhinorrhoea
Clinical narrative: 8 days after MMR/Pox shot patient developed high fever, runny nose.  Fever broke, but she has had 5 days now red bump rash all over body with Kopliks in throat.
Age: 1.06
Sex: F
Vaccine: MMRV
Symptoms: Vaccination complication
Clinical narrative: 8 days after MMR/Pox shot patient developed high fever, runny nose.  Fever broke, but she has had 5 days now red bump rash all over body with Kopliks in throat.
Age: 0.03
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Chicken pox spots all over.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Headache, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Was very sore. By the next day my entire body hurt. I had a severe headache. I was barely able to walk on Thursday evening. My knee and elbow joints were swelled. On Saturday my left arm was very swelled where I received the shot. My lymph nodes under my left arm were swelled and very sore. Today is the 18th and the site of my shot is still hot and red also it has a knot still. I. Never went back to the Dr because I don't have health insurance.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Joint swelling, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Was very sore. By the next day my entire body hurt. I had a severe headache. I was barely able to walk on Thursday evening. My knee and elbow joints were swelled. On Saturday my left arm was very swelled where I received the shot. My lymph nodes under my left arm were swelled and very sore. Today is the 18th and the site of my shot is still hot and red also it has a knot still. I. Never went back to the Dr because I don't have health insurance.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia, Skin warm, Urticaria
Clinical narrative: Fever, chills and by morning a hot sore upper arm with a 4" x 3" welt.
Age: 37.0
Sex: M
Vaccine: FLUN3
Symptoms: Confusional state, Presyncope, Unresponsive to stimuli
Clinical narrative: Vasovagal response with no evidence of complete loss of consciousness. Pt was not replying to verbal commands for approx 20 seconds until pt was placed on the ground supine position with feet elevated approx 12 inches. Immediately after legs elevated, member was responsive but was confused as to why people were asking him if was okay. States does not recall any events after sitting down for approx 10-15 minutes of receiving vaccine. Member was observed for another 45 min to 1 hour before released. No other signs and symptoms.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Apparent life threatening event, Computerised tomogram normal, Convulsion, Diet refusal, Electroencephalogram normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 4-month-old male subject who was vaccinated with ROTARIX lyophilized formulation (GlaxoSmithKline), PENTACEL (non-gsk). Concurrent medical conditions included gastroesophageal reflux disease, spitting up described as "expelling formula" and vomiting. Concurrent vaccination included pneumococcal vaccines (non-gsk); Wyeth Labs; unknown; unknown given on 8 September 2012. The healthcare professional reported that 4 month old subject received routine pediatric vaccines at age 2 and 4 months of age. No adverse events were reported after the first vaccine. On 06 July 2012, the subject started ZANTAC at 22.5 mg (oral) twice daily for gastroesophageal reflux disease. On 8 September 2012 at 09:30 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral) and on 8 September 2012 the subject received 2nd dose of PENTACEL (details unknown). On 9 September 2012, 24 hours after vaccination with PENTACEL and ROTARIX lyophilized formulation and 65 days after starting ZANTAC, the subject experienced seizure described as, repetitive head turning, refusal to eat, arm rigidity and stared blankly into space. The subject was seen at 4 months for routine vaccination and developed seizures 24 hours after the vaccinations. He was still on ZANTAC at this time as well. The subject was reported to "turn his head to the right repeatedly" (repetitive head turning) and refused to eat. While being changed his right arm became rigid and he "developed a blank stare" (stared blankly into space). The episode lasted for about 20-30 seconds and was repeated a total of four times that morning. The subject was hospitalized for 2 days and there was no evidence of reason for seizures. He was afebrile, WNL [within normal limits] EEG [Electroencephalogram], CT scan [Computerized tomogram], and labwork. Seizures were considered to be secondary to immunization with DTaP vaccine from another manufacturer, PENTACEL. The subject was hospitalised and the healthcare professional considered the events were life threatening. At the time of reporting the events were resolved. The healthcare professional considered the events were unrelated to vaccination with ROTARIX lyophilized formulation and ZANTAC. The healthcare professional considered the events were related to the vaccination with PENTACEL due to the DTaP component of the vaccine.