chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: DTAP, DT
Symptoms: Infection
Clinical narrative: Patient received Diptheria Tetanus 0.5cc/IM on 3/26/08.  Patient returned to ED stating "the DT shot gave her an infection".  Declined treatment: followed up with primary physician (3/28/08).
Age: 60.0
Sex: F
Vaccine: DTAP, DT
Symptoms: Injection site infection
Clinical narrative: Patient received Diptheria Tetanus 0.5cc/IM on 3/26/08.  Patient returned to ED stating "the DT shot gave her an infection".  Declined treatment: followed up with primary physician (3/28/08).
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blood creatine phosphokinase increased, Cardiac stress test, Chest discomfort, Chest pain, Diagnostic procedure
Clinical narrative: VAERS ID #: 16987 - myocarditis On 7/13/07, service member received his initial smallpox vaccine in his left arm (3 jabs) after receiving the DoD Smallpox Briefing.  He reports normal vaccine site progression with a site check about 8 days post-vaccination.  His site was assessed as 'a take'.  He noted increased pruritus at the vaccination site, as well as some mild redness surrounding site and some axillary tenderness.  He denies any significant swelling or streaking surrounding vaccine site.  His scab fell off about 21-22 days post vaccination with site not quite completely healed around day 24.  On the same day, service member also received his initial anthrax vaccine in the triceps area of the right arm.  He reports mild tenderness and redness surrounding anthrax vaccine site, with a small subcutaneous nodule about the size of a quarter not lasting more than 48-72 hours.  Around 7/23/07, service members recalls having 'flu-like' symptoms (body aches, malaise, sore throat, chest discomfort with mild dyspnea and bouts of feeling hot, then cold) which lasted about 24 hours and for which he sought evaluation on 7/24/07.  On 7/25/07, service member woke up around 0100 with substernal, throbbing pressure-type chest pain.  Initially the pain was just 'nagging' (rates as a 2/10), but by 0345, patient describes the chest pain intensity as about 8-9/10, using a pain scale of 0 (=no pain) to 10 (=worse pain ever experienced).  The pain was worse when lying flat.  He denies a change in pain with deep breaths, but said the pain was so intense that it felt like it was 'taking (my) breath away'.  He describes back pain associated with chest pain.  He describes this pain as 'back muscles tense' and says when on all fours and stretching back 'like cat', the pain was significantly decreased.  He thinks the pain was decreased with standing, but does not recall leaning forward while experiencing the pain.  He reports some radiation of pain to the left side of his jaw.  Around 0400, he went to the local hospital.  He was transferred to the local civilian hospital where he was admitted for 3 days and underwent cardiac angiography.  His chest pain resolved after he received medications in the emergency room (Morphine, nitroglycerin and aspirin).  The pain has not returned since treatment in the emergency room.  He denies nausea, diaphoresis, palpitations and peripheral edema.  Since discharge he has had one follow up evaluation with his Flight Surgeon, and has a Cardiology appointment scheduled for 17 August at the Hospital.  He is taking Indocin and CoReg since discharge.  He has been on limited duty, working in an office setting.  The most strenuous activity he has engaged in was climbing 1 flight of stairs.  On day of telephone interview, service member felt like he was back to 90-100% of his baseline health status.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Dyspnoea, Electrocardiogram, Feeling of body temperature change, Impaired work ability, Influenza like illness
Clinical narrative: VAERS ID #: 16987 - myocarditis On 7/13/07, service member received his initial smallpox vaccine in his left arm (3 jabs) after receiving the DoD Smallpox Briefing.  He reports normal vaccine site progression with a site check about 8 days post-vaccination.  His site was assessed as 'a take'.  He noted increased pruritus at the vaccination site, as well as some mild redness surrounding site and some axillary tenderness.  He denies any significant swelling or streaking surrounding vaccine site.  His scab fell off about 21-22 days post vaccination with site not quite completely healed around day 24.  On the same day, service member also received his initial anthrax vaccine in the triceps area of the right arm.  He reports mild tenderness and redness surrounding anthrax vaccine site, with a small subcutaneous nodule about the size of a quarter not lasting more than 48-72 hours.  Around 7/23/07, service members recalls having 'flu-like' symptoms (body aches, malaise, sore throat, chest discomfort with mild dyspnea and bouts of feeling hot, then cold) which lasted about 24 hours and for which he sought evaluation on 7/24/07.  On 7/25/07, service member woke up around 0100 with substernal, throbbing pressure-type chest pain.  Initially the pain was just 'nagging' (rates as a 2/10), but by 0345, patient describes the chest pain intensity as about 8-9/10, using a pain scale of 0 (=no pain) to 10 (=worse pain ever experienced).  The pain was worse when lying flat.  He denies a change in pain with deep breaths, but said the pain was so intense that it felt like it was 'taking (my) breath away'.  He describes back pain associated with chest pain.  He describes this pain as 'back muscles tense' and says when on all fours and stretching back 'like cat', the pain was significantly decreased.  He thinks the pain was decreased with standing, but does not recall leaning forward while experiencing the pain.  He reports some radiation of pain to the left side of his jaw.  Around 0400, he went to the local hospital.  He was transferred to the local civilian hospital where he was admitted for 3 days and underwent cardiac angiography.  His chest pain resolved after he received medications in the emergency room (Morphine, nitroglycerin and aspirin).  The pain has not returned since treatment in the emergency room.  He denies nausea, diaphoresis, palpitations and peripheral edema.  Since discharge he has had one follow up evaluation with his Flight Surgeon, and has a Cardiology appointment scheduled for 17 August at the Hospital.  He is taking Indocin and CoReg since discharge.  He has been on limited duty, working in an office setting.  The most strenuous activity he has engaged in was climbing 1 flight of stairs.  On day of telephone interview, service member felt like he was back to 90-100% of his baseline health status.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Malaise
Clinical narrative: VAERS ID #: 16987 - myocarditis On 7/13/07, service member received his initial smallpox vaccine in his left arm (3 jabs) after receiving the DoD Smallpox Briefing.  He reports normal vaccine site progression with a site check about 8 days post-vaccination.  His site was assessed as 'a take'.  He noted increased pruritus at the vaccination site, as well as some mild redness surrounding site and some axillary tenderness.  He denies any significant swelling or streaking surrounding vaccine site.  His scab fell off about 21-22 days post vaccination with site not quite completely healed around day 24.  On the same day, service member also received his initial anthrax vaccine in the triceps area of the right arm.  He reports mild tenderness and redness surrounding anthrax vaccine site, with a small subcutaneous nodule about the size of a quarter not lasting more than 48-72 hours.  Around 7/23/07, service members recalls having 'flu-like' symptoms (body aches, malaise, sore throat, chest discomfort with mild dyspnea and bouts of feeling hot, then cold) which lasted about 24 hours and for which he sought evaluation on 7/24/07.  On 7/25/07, service member woke up around 0100 with substernal, throbbing pressure-type chest pain.  Initially the pain was just 'nagging' (rates as a 2/10), but by 0345, patient describes the chest pain intensity as about 8-9/10, using a pain scale of 0 (=no pain) to 10 (=worse pain ever experienced).  The pain was worse when lying flat.  He denies a change in pain with deep breaths, but said the pain was so intense that it felt like it was 'taking (my) breath away'.  He describes back pain associated with chest pain.  He describes this pain as 'back muscles tense' and says when on all fours and stretching back 'like cat', the pain was significantly decreased.  He thinks the pain was decreased with standing, but does not recall leaning forward while experiencing the pain.  He reports some radiation of pain to the left side of his jaw.  Around 0400, he went to the local hospital.  He was transferred to the local civilian hospital where he was admitted for 3 days and underwent cardiac angiography.  His chest pain resolved after he received medications in the emergency room (Morphine, nitroglycerin and aspirin).  The pain has not returned since treatment in the emergency room.  He denies nausea, diaphoresis, palpitations and peripheral edema.  Since discharge he has had one follow up evaluation with his Flight Surgeon, and has a Cardiology appointment scheduled for 17 August at the Hospital.  He is taking Indocin and CoReg since discharge.  He has been on limited duty, working in an office setting.  The most strenuous activity he has engaged in was climbing 1 flight of stairs.  On day of telephone interview, service member felt like he was back to 90-100% of his baseline health status.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pain, Pain in jaw, Pharyngolaryngeal pain, Red blood cell sedimentation rate increased, Tenderness
Clinical narrative: VAERS ID #: 16987 - myocarditis On 7/13/07, service member received his initial smallpox vaccine in his left arm (3 jabs) after receiving the DoD Smallpox Briefing.  He reports normal vaccine site progression with a site check about 8 days post-vaccination.  His site was assessed as 'a take'.  He noted increased pruritus at the vaccination site, as well as some mild redness surrounding site and some axillary tenderness.  He denies any significant swelling or streaking surrounding vaccine site.  His scab fell off about 21-22 days post vaccination with site not quite completely healed around day 24.  On the same day, service member also received his initial anthrax vaccine in the triceps area of the right arm.  He reports mild tenderness and redness surrounding anthrax vaccine site, with a small subcutaneous nodule about the size of a quarter not lasting more than 48-72 hours.  Around 7/23/07, service members recalls having 'flu-like' symptoms (body aches, malaise, sore throat, chest discomfort with mild dyspnea and bouts of feeling hot, then cold) which lasted about 24 hours and for which he sought evaluation on 7/24/07.  On 7/25/07, service member woke up around 0100 with substernal, throbbing pressure-type chest pain.  Initially the pain was just 'nagging' (rates as a 2/10), but by 0345, patient describes the chest pain intensity as about 8-9/10, using a pain scale of 0 (=no pain) to 10 (=worse pain ever experienced).  The pain was worse when lying flat.  He denies a change in pain with deep breaths, but said the pain was so intense that it felt like it was 'taking (my) breath away'.  He describes back pain associated with chest pain.  He describes this pain as 'back muscles tense' and says when on all fours and stretching back 'like cat', the pain was significantly decreased.  He thinks the pain was decreased with standing, but does not recall leaning forward while experiencing the pain.  He reports some radiation of pain to the left side of his jaw.  Around 0400, he went to the local hospital.  He was transferred to the local civilian hospital where he was admitted for 3 days and underwent cardiac angiography.  His chest pain resolved after he received medications in the emergency room (Morphine, nitroglycerin and aspirin).  The pain has not returned since treatment in the emergency room.  He denies nausea, diaphoresis, palpitations and peripheral edema.  Since discharge he has had one follow up evaluation with his Flight Surgeon, and has a Cardiology appointment scheduled for 17 August at the Hospital.  He is taking Indocin and CoReg since discharge.  He has been on limited duty, working in an office setting.  The most strenuous activity he has engaged in was climbing 1 flight of stairs.  On day of telephone interview, service member felt like he was back to 90-100% of his baseline health status.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Troponin I increased
Clinical narrative: VAERS ID #: 16987 - myocarditis On 7/13/07, service member received his initial smallpox vaccine in his left arm (3 jabs) after receiving the DoD Smallpox Briefing.  He reports normal vaccine site progression with a site check about 8 days post-vaccination.  His site was assessed as 'a take'.  He noted increased pruritus at the vaccination site, as well as some mild redness surrounding site and some axillary tenderness.  He denies any significant swelling or streaking surrounding vaccine site.  His scab fell off about 21-22 days post vaccination with site not quite completely healed around day 24.  On the same day, service member also received his initial anthrax vaccine in the triceps area of the right arm.  He reports mild tenderness and redness surrounding anthrax vaccine site, with a small subcutaneous nodule about the size of a quarter not lasting more than 48-72 hours.  Around 7/23/07, service members recalls having 'flu-like' symptoms (body aches, malaise, sore throat, chest discomfort with mild dyspnea and bouts of feeling hot, then cold) which lasted about 24 hours and for which he sought evaluation on 7/24/07.  On 7/25/07, service member woke up around 0100 with substernal, throbbing pressure-type chest pain.  Initially the pain was just 'nagging' (rates as a 2/10), but by 0345, patient describes the chest pain intensity as about 8-9/10, using a pain scale of 0 (=no pain) to 10 (=worse pain ever experienced).  The pain was worse when lying flat.  He denies a change in pain with deep breaths, but said the pain was so intense that it felt like it was 'taking (my) breath away'.  He describes back pain associated with chest pain.  He describes this pain as 'back muscles tense' and says when on all fours and stretching back 'like cat', the pain was significantly decreased.  He thinks the pain was decreased with standing, but does not recall leaning forward while experiencing the pain.  He reports some radiation of pain to the left side of his jaw.  Around 0400, he went to the local hospital.  He was transferred to the local civilian hospital where he was admitted for 3 days and underwent cardiac angiography.  His chest pain resolved after he received medications in the emergency room (Morphine, nitroglycerin and aspirin).  The pain has not returned since treatment in the emergency room.  He denies nausea, diaphoresis, palpitations and peripheral edema.  Since discharge he has had one follow up evaluation with his Flight Surgeon, and has a Cardiology appointment scheduled for 17 August at the Hospital.  He is taking Indocin and CoReg since discharge.  He has been on limited duty, working in an office setting.  The most strenuous activity he has engaged in was climbing 1 flight of stairs.  On day of telephone interview, service member felt like he was back to 90-100% of his baseline health status.
Age: 62.0
Sex: F
Vaccine: FLUX, TDAP, FLU3, TDAP
Symptoms: Asthenia, Gait disturbance, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Beginning 10/30/07, rash, redness, tingling, numbness of left arm. Photos provided, taken on Nov. 5, 2007 given to Dr on 11/13/07. Cannot lift left arm over head without pain - neck, rt arm, legs (wobbly gait). Excruciating pain in left arm constantly.
Age: 62.0
Sex: F
Vaccine: FLUX, TDAP, FLU3, TDAP
Symptoms: Injection site swelling, Pain, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: Beginning 10/30/07, rash, redness, tingling, numbness of left arm. Photos provided, taken on Nov. 5, 2007 given to Dr on 11/13/07. Cannot lift left arm over head without pain - neck, rt arm, legs (wobbly gait). Excruciating pain in left arm constantly.
Age: 62.0
Sex: F
Vaccine: FLUX, TDAP, FLU3, TDAP
Symptoms: Chest X-ray, Erythema, Gait disturbance, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Beginning 10/30/07, rash, redness, tingling, numbness of left arm. Photos provided, taken on Nov. 5, 2007 given to Dr on 11/13/07. Cannot lift left arm over head without pain - neck, rt arm, legs (wobbly gait). Excruciating pain in left arm constantly.
Age: 62.0
Sex: F
Vaccine: FLUX, TDAP, FLU3, TDAP
Symptoms: Pain, Paraesthesia, Rash
Clinical narrative: Beginning 10/30/07, rash, redness, tingling, numbness of left arm. Photos provided, taken on Nov. 5, 2007 given to Dr on 11/13/07. Cannot lift left arm over head without pain - neck, rt arm, legs (wobbly gait). Excruciating pain in left arm constantly.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Asthma, Dehydration, Dyspepsia, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: Upon arriving in another country in March of 2003, I was very sick. With flu like symptoms that lasted 3 weeks. Doctor at clinic said I may have flu, but was not sure. Severe dehydration followed a few days after. I fainted after eating lunch while walking back to barracks with no ruck sack. In April of 2003 I started having acid reflux, and severe heartburn issues. Neither of which I have ever had. I got sick again with flu like symptoms in April. The official said it looked like the flu but was not sure. Upon returning back to the states in August of 2003 I was severely ill, and had lost so much weight. Before being deployed I was never sick but once or twice a year with hay fever and the flu usually around December. I weighed 235 before deploying and upon my return I weighed 175. Since then I have been maintaining 180 to 190 but have not been able to get over that. I have tried but not able to. I have spoken to my physician Doctor at the hospital and she has only done a few blood test with no negative results. I have asthma now which no one in my family has, and I never had it during my military career. I have been sick probably about 4 or more times a year. Other issues have risen. I only get severe heartburn when I become sick almost like a heart attack. I also have chronic fatigue which is not diagnosed at the facility and I am not understanding that. Restless leg syndrome. Sweats in while sleeping and a skin rash diagnosed as kerotosis. Which I never had.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Hyperkeratosis, Influenza like illness, Malaise, Night sweats, Rash
Clinical narrative: Upon arriving in another country in March of 2003, I was very sick. With flu like symptoms that lasted 3 weeks. Doctor at clinic said I may have flu, but was not sure. Severe dehydration followed a few days after. I fainted after eating lunch while walking back to barracks with no ruck sack. In April of 2003 I started having acid reflux, and severe heartburn issues. Neither of which I have ever had. I got sick again with flu like symptoms in April. The official said it looked like the flu but was not sure. Upon returning back to the states in August of 2003 I was severely ill, and had lost so much weight. Before being deployed I was never sick but once or twice a year with hay fever and the flu usually around December. I weighed 235 before deploying and upon my return I weighed 175. Since then I have been maintaining 180 to 190 but have not been able to get over that. I have tried but not able to. I have spoken to my physician Doctor at the hospital and she has only done a few blood test with no negative results. I have asthma now which no one in my family has, and I never had it during my military career. I have been sick probably about 4 or more times a year. Other issues have risen. I only get severe heartburn when I become sick almost like a heart attack. I also have chronic fatigue which is not diagnosed at the facility and I am not understanding that. Restless leg syndrome. Sweats in while sleeping and a skin rash diagnosed as kerotosis. Which I never had.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Restless legs syndrome, Syncope, Weight decreased
Clinical narrative: Upon arriving in another country in March of 2003, I was very sick. With flu like symptoms that lasted 3 weeks. Doctor at clinic said I may have flu, but was not sure. Severe dehydration followed a few days after. I fainted after eating lunch while walking back to barracks with no ruck sack. In April of 2003 I started having acid reflux, and severe heartburn issues. Neither of which I have ever had. I got sick again with flu like symptoms in April. The official said it looked like the flu but was not sure. Upon returning back to the states in August of 2003 I was severely ill, and had lost so much weight. Before being deployed I was never sick but once or twice a year with hay fever and the flu usually around December. I weighed 235 before deploying and upon my return I weighed 175. Since then I have been maintaining 180 to 190 but have not been able to get over that. I have tried but not able to. I have spoken to my physician Doctor at the hospital and she has only done a few blood test with no negative results. I have asthma now which no one in my family has, and I never had it during my military career. I have been sick probably about 4 or more times a year. Other issues have risen. I only get severe heartburn when I become sick almost like a heart attack. I also have chronic fatigue which is not diagnosed at the facility and I am not understanding that. Restless leg syndrome. Sweats in while sleeping and a skin rash diagnosed as kerotosis. Which I never had.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Central nervous system inflammation, Clumsiness, Computerised tomogram abnormal, Dysaesthesia, Gait disturbance
Clinical narrative: Information has been received from a physician concerning a 26 year old female with an allergy to DEMEROL who was vaccinated in December 2007 with her first dose of Gardasil (lot# not reported). The patient had severe headaches after receiving this vaccine. In February 2008 the patient was vaccinated with her second dose of Gardasil (lot# not reported). Subsequently the patient experienced neurological symptoms within the first couple of weeks after receiving the vaccine. The patient was referred to a neurologist and she had either a cat scan or MRI. The test was positive for inflammation. The patient's outcome was not reported. Follow-up information was received from a physician. The patient had no pertinent medical history or no family history of adverse reactions in siblings. There was no illness at the time of vaccination. The patient was vaccinated with her first dose of Gardasil on approximately 30-OCT-2007. On 30-OCT-2007 the patient developed severe headaches "right after the vaccination". On 14-JAN-2008 the patient was vaccinated with a second dose of Gardasil (lot# 659653/1448U) in the deltoid. There was no concomitant medications at the time of the vaccine. On 08-MAR-2008 the patient developed progressive dysesthesias and numbness of limbs and trunk, clumsiness of hands and gait and was hospitalized. On an unspecified date magnetic resonance imaging of c-spine showed an inflammatory lesion and MRI of the brain revealed one other inflammed spot. A lumbar puncture was abnormal. The physician reported that this is all consistent with an acute central nervous system inflammatory condition which occurred about 2 to 3 weeks after the second Gardasil. At the time of reporting the patient had not recovered from the CNS inflammation. The reporter felt that central nervous system inflammation was disabling. Additional information is not expected. 4/28/08-records received for DOS 3/9-3/15/08- DC DX: Transverse myelitis. Admitted with paresthesia in limbs. Symptoms gradually getting worse and moved over to trunk.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Lumbar puncture abnormal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Information has been received from a physician concerning a 26 year old female with an allergy to DEMEROL who was vaccinated in December 2007 with her first dose of Gardasil (lot# not reported). The patient had severe headaches after receiving this vaccine. In February 2008 the patient was vaccinated with her second dose of Gardasil (lot# not reported). Subsequently the patient experienced neurological symptoms within the first couple of weeks after receiving the vaccine. The patient was referred to a neurologist and she had either a cat scan or MRI. The test was positive for inflammation. The patient's outcome was not reported. Follow-up information was received from a physician. The patient had no pertinent medical history or no family history of adverse reactions in siblings. There was no illness at the time of vaccination. The patient was vaccinated with her first dose of Gardasil on approximately 30-OCT-2007. On 30-OCT-2007 the patient developed severe headaches "right after the vaccination". On 14-JAN-2008 the patient was vaccinated with a second dose of Gardasil (lot# 659653/1448U) in the deltoid. There was no concomitant medications at the time of the vaccine. On 08-MAR-2008 the patient developed progressive dysesthesias and numbness of limbs and trunk, clumsiness of hands and gait and was hospitalized. On an unspecified date magnetic resonance imaging of c-spine showed an inflammatory lesion and MRI of the brain revealed one other inflammed spot. A lumbar puncture was abnormal. The physician reported that this is all consistent with an acute central nervous system inflammatory condition which occurred about 2 to 3 weeks after the second Gardasil. At the time of reporting the patient had not recovered from the CNS inflammation. The reporter felt that central nervous system inflammation was disabling. Additional information is not expected. 4/28/08-records received for DOS 3/9-3/15/08- DC DX: Transverse myelitis. Admitted with paresthesia in limbs. Symptoms gradually getting worse and moved over to trunk.
Age: 21.0
Sex: F
Vaccine: HPV4
Clinical narrative: Information has been received from a a registered pharmacist concerning a 21 year old female who with no pertinent medical history who "7-8 days ago" on approximately 21-MAR-2008 was vaccinated with a dose of GARDASIL (lot number, route and site of administration not specified). There was no concomitant medications. On an unspecified date the patient presented with bacterial meningitis and the only medication she was given was GARDASIL before this occurred. The patient was hospitalized on an unspecified date for an unspecified amount of time. At the time of reporting the patient was recovering. The reporter felt that bacterial meningitis was life threatening. Additional information has been requested. 4/24/08-records received for DOS 3/25-3/31/08-DC DX: meningitis, resolved. Presented with frontal headache. Progressive headache and at ER lethargic and obtunded. ICU- One episode ventricular tachycardia. Temperature 100.4.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a consumer about Gardasil therapy. The reporter was told by a pediatric neurologist who examined her daughter for syncopal episodes/seizure-like episodes (reported in WAES # 0803USA04544) that he had seen similar episodes related to Gardasil. The outcome was unknown. Upon internal review "seizure-like activities" was determined to be other important medical events. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Convulsion, Heart rate, Loss of consciousness, Oxygen supplementation
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with no pertinent medical history and no history of drug reactions/allergies who on 03-APR-2008 was vaccinated with a first dose of GARDASIL (lot # 658219/0755U) 0.5 ml IM. There was no concomitant medication. On 03-APR-2008, within seconds of receiving the vaccination, the patient had a seizure and lost consciousness for 30 seconds. The patient was treated with oxygen. Her blood pressure was 95/56 and pulse 131. The patient was transported to a local emergency room via ambulance. The outcome of the events was not reported. The reporter felt that the seizure and loss of consciousness were immediately life-threatening and required intervention (Other Important Medical Events). Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Combined immunodeficiency, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 4 month old male with a pertinent medical history who was vaccinated PO with his second dose of ROTATEQ (lot# not provided). subsequently the patient experienced diarrhea. The patient was treated for diarrhea but nothing helped so the patient was hospitalized. While hospitalized the patient was diagnosed with SCID immune disorder. It was unknown if the patient was still hospitalized. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested.  5/13/2008 MR received for DOS 3/16-5/1/2008 with D/C DX: Severe Combined Immunodeficiency s/p haploidentical stem cell transplant.  Rotavirus, Rhinovirus, Adenovirus, Giardia and PCP pneumonia, feeding intolerance, torticollis. Pt presented to local hospital on 3/13/08 with 1 week hx of diarrhea, one episode of emesis, and on the day of admission with lethargy, pallor, decreased responsiveness, and sunken eyes. TX with abx and IVF and transfered to current facility for management of dehydration. Upon admission infant had cool, mottled skin, a sunken anterior fontanelle, and poor tone. Shocky and in respiratory distress with labored breathing and metabolic acidosis.  Improved with fluid bolus, NaHCO3, and albumin. Pt intubated and extubated on 3/26/08. Stable on RA. Pt had a stem cell transplant on 4/07/2008 and started on Rotavirus and Adenovirus Immunoglobulins PO as well as abx, antifungals and antiparasitics. Some motor developmental delays 2' to long hospital stay. By d/c most cultures/titres were (-) or decreasing. D/C home with NG tube for feeds. Found to have a mild disaccharidase deficiency.
Age: 0.75
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Inappropriate schedule of drug administration, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 9 month old male was vaccinated PO with his first, second and third doses (dates unavailable) of ROTATEQ. Subsequently the patient experienced a severe case of rotavirus and was hospitalized. Lab diagnostic studies included a culture taken in the hospital that confirmed rotavirus. The patient was treated with IV rehydration. Subsequently, the patient recovered. There was no product quality complaint. Rotavirus was considered an other important medical event by the physician. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Blood test, Headache, Lumbar puncture, Mydriasis
Clinical narrative: This report was received from a consumer on 27 March 2008.  A 53-year-old female patient, with a history of asthma, received a right deltoid intramuscular injection of FLUZONE (lot number U2489AA) on 08 February 2008.  Approximately one week after vaccination, on 13 February 2008, the patient began experiencing a severe headache.  Her vision initially became blurry, then deteriorated so that she was only able to see shadows and light.  She was seen by her physician, who prescribed Prednisone and ordered a series of tests including MRI, lumbar puncture, temporal artery biopsy, and blood work (results not provided).  She was subsequently seen by an ophthalmologist, who noted that her "optic nerve was swollen".  Per the reporter, the patient's pupils were dilated for six weeks.  Her vision was reported to be slowly returning.  At the time of the report, the patient was being treated with Prednisone 60 mg/day for five days, then 40 mg/day for five days.  She was scheduled to follow-up with the treating physician after Prednisone therapy had concluded.  No change in vision had been noted since the previous office visit.  This consumer also reported that the patient's sister experienced flu-like symptoms following vaccination with FLUZONE; this non-serious event is captured in case 200800894.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Optic nerve disorder, Vision blurred
Clinical narrative: This report was received from a consumer on 27 March 2008.  A 53-year-old female patient, with a history of asthma, received a right deltoid intramuscular injection of FLUZONE (lot number U2489AA) on 08 February 2008.  Approximately one week after vaccination, on 13 February 2008, the patient began experiencing a severe headache.  Her vision initially became blurry, then deteriorated so that she was only able to see shadows and light.  She was seen by her physician, who prescribed Prednisone and ordered a series of tests including MRI, lumbar puncture, temporal artery biopsy, and blood work (results not provided).  She was subsequently seen by an ophthalmologist, who noted that her "optic nerve was swollen".  Per the reporter, the patient's pupils were dilated for six weeks.  Her vision was reported to be slowly returning.  At the time of the report, the patient was being treated with Prednisone 60 mg/day for five days, then 40 mg/day for five days.  She was scheduled to follow-up with the treating physician after Prednisone therapy had concluded.  No change in vision had been noted since the previous office visit.  This consumer also reported that the patient's sister experienced flu-like symptoms following vaccination with FLUZONE; this non-serious event is captured in case 200800894.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects reported.  Given extra dose of Tdap.
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Erythema and induration 10 cm around injection site.  No tenderness.  Site is itchy.  No treatment except to monitor site.
Age: 0.1
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Disturbance in attention, Feeling abnormal, Lethargy, Respiratory rate decreased
Clinical narrative: After vaccines dazed; quiet; poor eye control; decreased respirations, lethargic, no LOC.  Stimulated, 6L O2/min by mask, ->improved respirations, better eye contact, fed bottle.  Sent via ambulance to STCH ER.
Age: 37.0
Sex: M
Vaccine: YF
Symptoms: Alanine aminotransferase increased, Diarrhoea, Fatigue, Full blood count, Headache
Clinical narrative: One week after Yellow Fever vaccine had fever, diarrhea, fatigue, myalgia, headache, and nausea.
Age: 37.0
Sex: M
Vaccine: YF
Symptoms: Laboratory test, Myalgia, Nausea, Parasite blood test, Pyrexia
Clinical narrative: One week after Yellow Fever vaccine had fever, diarrhea, fatigue, myalgia, headache, and nausea.
Age: 37.0
Sex: M
Vaccine: YF
Symptoms: Ultrasound scan normal
Clinical narrative: One week after Yellow Fever vaccine had fever, diarrhea, fatigue, myalgia, headache, and nausea.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Body temperature, Heart rate, Rash
Clinical narrative: Rash on upper chest, neck & cheeks.  No SOD, edema.  Took Benadryl 25 mg at workplace.  Rash resolved by 4 pm.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Painful left arm, swollen.  Prednisone.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Rash, Skin warm
Clinical narrative: Patient seen Wednesday, 4-2-08, given PNEUMOVAX injection.  By Thursday night her left arm was fiery red, red rash, warm to the touch and sore.  No treatment.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Erythema, Induration
Clinical narrative: Erythema & induration 30 x30 mm over R arm.  No treatment except for warm compress.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever night 103-104 degrees, tired.  Continued fever >24 hours 104.4.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Oedema peripheral
Clinical narrative: On 3/21/08 - mother returned to clinic - noted patient complained of left arm swelling, tenderness, and redness at injection site.
Age: 60.0
Sex: F
Vaccine: DT
Symptoms: Infection
Clinical narrative: Pt received Diphtheria Tetanus 0.5 cc/IM on 3/26/08. Pt returned to ED stating "the DT shot gave her an infection. Declined treatment: followed up with Primary physician (3/28/08).
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pt. received DT immunization (0.5 cc) for prophylaxis treatment s/p laceration on 04/05/08.  Returned to ED c/o pain, swelling, redness right arm on 04/07/08.  Treated and released.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity, Reaction to previous exposure to any vaccine
Clinical narrative: Swelling, redness, induration and soreness to whole upper arm now resolving.  Started day of shot.  Currently ~6 cm diameter patch remains 3 days after shot.  Mom mentions today had similar after last DTaP on leg.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site 3/27 left upper arm from pt of shoulder to mid-arm, blotchy erythema, scratch marks, warm to touch.  No significant nodes.
Age: 1.3
Sex: U
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Night of vaccination child developed swelling and redness at site of DTaP.  Noted to have generalized urticaria worsening over 2 days until taken to ER and given oral steroids.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness & warmth noted to the left thigh.  No induration noted.  No infection or De noted.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Pain, Swelling
Clinical narrative: Redness at site of Varicella vaccine noted 4/1/08, progressed to heat and pain on 4/2/08.  Seen in office by M.D. 4/2/08, induration 8 x 10cm.  Diagnosed as Cellulitis.  Patient placed on Augmentin.  Seen again in office 4/3/08, swelling decreasing, pain improved.  Follow-up call 4/8/08 - parent reports all symptoms "almost gone".
Age: 1.52
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMRV
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: VARICELLA VACCINE BREAKTHROUGH. DIAGNOSED ON 4/7/08 WITH VARICELLA.  HAD ABOUT A DOZEN VESICULO-PAPULAR LESIONS ON TRUNK.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Body temperature increased, Cellulitis, Drug toxicity, Injection site erythema, Injection site warmth
Clinical narrative: Pt presented to the MC on 4/3/08 with c/o red area on uppper right arm. Pt had received Anthrax vaccination on 4/1/08 in the afternoon. He reported feeling warm the following day. Nausea, body aches, and lethargy were also noted. Temperature 38.2 at time of ER visit, pulse 113. Diagnosed with cellulitis to the right arm at that time. Keflex 500mg q 6 hours and Tylenol 500mg 2 q 6 hours was ordered. Pt followed up the next day at the Medical Clinic, continued to c/o the above sx. MD noted a single red macule of 120mm. Diagnosed as drug toxicity vaccines, LR5 reaction localized with sx reaction to anthrax vaccine. Orders given for Triamcinolone topical 0.1% cream bid. hydroxyzine 25mg po qid prn, and Ibuprofen 800mg tid with food.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Lethargy, Nausea, Pain
Clinical narrative: Pt presented to the MC on 4/3/08 with c/o red area on uppper right arm. Pt had received Anthrax vaccination on 4/1/08 in the afternoon. He reported feeling warm the following day. Nausea, body aches, and lethargy were also noted. Temperature 38.2 at time of ER visit, pulse 113. Diagnosed with cellulitis to the right arm at that time. Keflex 500mg q 6 hours and Tylenol 500mg 2 q 6 hours was ordered. Pt followed up the next day at the Medical Clinic, continued to c/o the above sx. MD noted a single red macule of 120mm. Diagnosed as drug toxicity vaccines, LR5 reaction localized with sx reaction to anthrax vaccine. Orders given for Triamcinolone topical 0.1% cream bid. hydroxyzine 25mg po qid prn, and Ibuprofen 800mg tid with food.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Reports 2 days after vaccine given, arm very sore radiating to shoulder, swollen lymph node above clavicle, not resolved, very painful.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Sneezing, Wheezing
Clinical narrative: CHILD STARTED TO SNEEZE, RUB NOSE, WHEEZE & COUGH. DR ADMINISTERED .15 MG WITHIN 5 MINUTES OF RETURNING TO THE EXAM ROOM, THE REACTION WAS ALMOST IMMEDIATELY.  EMS WAS CALLED AT 1137, ARR. 1143. 110/70, P 170'S, O2 SAT INITIALLY WAS 83 - AFTER NEB TX 2.5MG/3ML SAT INCREASED TO 96 PERCENT. SENT VIA EMS. APPEARED TO BE SOMEWHAT RECOVERED.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Injection site erythema, Injection site pain
Clinical narrative: On follow up visit of 4/1/08 patient stated after vaccine experienced pain, redness at injection site and exacerbation of asthma symptoms with improved after using inhalers.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: FEVER FOR FOUR DAYS FOLLOWING IMMUNIZATION.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: I was to give pt dtap, I gave the child dtap but it was the adult dose(Adacel).
Age: 47.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient states "within a couple of hours" of vaccination, Right upper arm became "itchy" and "stiff". No interventions were done at this time. Following morning, Right upper arm was "red, swollen, itchy & painful".  Patient denies any interventions and states he "continued with his daily activities".  Patient states symptoms continued over next several days with redness and swelling forming a "band-like" area around his Right upper arm.  At this time, he noted his Right upper arm was also warm to touch and hard around injection site.  Patient denies doing any interventions to alleviate symptoms.  On April 9, 2008 @ 1300, he returned to site of vaccination and asked to speak with head nurse.  Senior Nurse for Immunizations pulled client's record, assessed injection site, educated client on possible causes and gave intervention recommendations for symptom relief as well as provided contact information for follow-up.
Age: 47.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Patient states "within a couple of hours" of vaccination, Right upper arm became "itchy" and "stiff". No interventions were done at this time. Following morning, Right upper arm was "red, swollen, itchy & painful".  Patient denies any interventions and states he "continued with his daily activities".  Patient states symptoms continued over next several days with redness and swelling forming a "band-like" area around his Right upper arm.  At this time, he noted his Right upper arm was also warm to touch and hard around injection site.  Patient denies doing any interventions to alleviate symptoms.  On April 9, 2008 @ 1300, he returned to site of vaccination and asked to speak with head nurse.  Senior Nurse for Immunizations pulled client's record, assessed injection site, educated client on possible causes and gave intervention recommendations for symptom relief as well as provided contact information for follow-up.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient states extreme pain in arm, warmth and swelling stated the night she received the vaccination. Her whole arm and into her neck were extremely painful. Patient states the Advil helped.
Age: 22.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dizziness, Erythema, Headache, Injection site inflammation, Injection site rash
Clinical narrative: Headache, dizziness, nausea, redness, itchy, and inflammation at injection site.  Measured at 3 inches raised at injection site.  "Sick feeling".
Age: 22.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Malaise, Nausea, Pruritus
Clinical narrative: Headache, dizziness, nausea, redness, itchy, and inflammation at injection site.  Measured at 3 inches raised at injection site.  "Sick feeling".
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: Nearly inconsolable crying for most of a six hour period that began about an hour after receiving DTaP.
Age: 0.87
Sex: F
Vaccine: PNC
Symptoms: Blood glucose normal, Blood test normal, Body temperature, Chest X-ray normal, Computerised tomogram normal
Clinical narrative: On March 17, 2008, mother and father was awaken by a cry that was described as "not normal" coming from their 11 month old daughter's room. They found their daughter asleep but crying with her eyes closed and no other movement was noted. When approaching the child, they suspected that she was having a nightmare so the father proceeded to pick up the child from the crib. The child did not respond to neither one of the parents' voices and the child had no muscle tone in her arms, legs, or neck. The child continued to cry with eyes closed and no muscle tone. The parents noted that the child was breathing normally but her face and lips were swollen. The child remained in that condition for a total of 45 minutes. // 2nd event// April 2, 2008: Child was found in the crib at 7:00 am having full "body convulsions" with eyes open and non-responsive to parents. Again, face and lips looked abnormally swollen but breathing was regular. Father caught incident on tape to report to the doctor in the emergency room. Incident lasted for 10 minutes and child responded by crying for a minute and then was laid down on the parents bed for further examination of child. Mother noticed that the child had no muscle tone from the neck down. Child was alert, normal baby talking, smiling and laughing took place but child could not move arms or legs. Child regained full muscle tone an hour later upon reaching emergency room. Doctor diagnosed child with having seizures and proceeded to write precription for Diastat. Neurologist prescribed Keppra. Parents noted that these two incidents happened only when child was drinking whole milk. Doctors stated that a milk allergy could not have caused her seizure-like incidents. If milk could not have caused incident then the child's vaccination could have caused this adverse action. Vaccine was given less than a month of the first incident.// 4/10/08-records received from ED for DOS 03/17/08-DX: Altered level of consciousness. C/O acting differently, lethargic, weak cry, irritable. Appeared clenched.