chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, HPV4
Symptoms: Clumsiness, Electrocardiogram normal, Fatigue, Hypoaesthesia, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a 16 year old female with migraine, poor vision and allergies who on 17-OCT-2011 was vaccinated with the first dose of GARDASIL (Lot# 667866/1437Z, Exp. 25-FEB-2013), (dose and route not reported) and the second dose of GARDASIL (Lot# 666162/0565Z, Exp. 15-SEP-2012), (dose and route not reported) was given on 30-DEC-2011. The physician reported that the patient's father had mild depression, asthma, nearsighted and history of migraines. The patient experienced "migraines, a clumsy feeling, tiredness, weakness, general feeling of unwell, upset stomach, muscle pain" after the vaccination. The patient experienced migraines immediately after both doses were given. Since January she had been having abdominal pain, weakness, anxiety and mental problems which had not gone away and became worse since the second dose was given. The patient felt that she was not able to go to school and was an A+ student and a very advanced student prior to this. The patient sought medical attention by visiting to the physician. The neurology who felt this was an immune reaction from of GARDASIL. Present blood work had now found the patient to be anemic. Lab diagnostics were performed: "negative for mono, Guillain Barre". The patient was started on PROZAC and the physician felt there was improvement but the medication was stopped as the family felt this was not right way to approach the anxiety/mental problems the patient was experiencing. Additional information has been received from the physician (case# US12-008840) concerning the patient's symptoms started about 1 week after the second dose and she had been seen by this health care professional (HCP) approximately every week since. HCP was concerned that patient was either having an "immune reaction" or was having a "teenage mental break", but the family insists it must be GARDASIL and wanted to know when it would end. HCP reported that the anxiety and depression were probably a result of the other symptoms. The patient had stopped going to school. The patient was being evaluated by neurologist, GI (gastroenterologist), psychiatry and possibly others. The above mentioned events were considered to be disabling by the reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, HPV4
Symptoms: Loss of proprioception, Migraine, Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 year old female with migraine, poor vision and allergies who on 17-OCT-2011 was vaccinated with the first dose of GARDASIL (Lot# 667866/1437Z, Exp. 25-FEB-2013), (dose and route not reported) and the second dose of GARDASIL (Lot# 666162/0565Z, Exp. 15-SEP-2012), (dose and route not reported) was given on 30-DEC-2011. The physician reported that the patient's father had mild depression, asthma, nearsighted and history of migraines. The patient experienced "migraines, a clumsy feeling, tiredness, weakness, general feeling of unwell, upset stomach, muscle pain" after the vaccination. The patient experienced migraines immediately after both doses were given. Since January she had been having abdominal pain, weakness, anxiety and mental problems which had not gone away and became worse since the second dose was given. The patient felt that she was not able to go to school and was an A+ student and a very advanced student prior to this. The patient sought medical attention by visiting to the physician. The neurology who felt this was an immune reaction from of GARDASIL. Present blood work had now found the patient to be anemic. Lab diagnostics were performed: "negative for mono, Guillain Barre". The patient was started on PROZAC and the physician felt there was improvement but the medication was stopped as the family felt this was not right way to approach the anxiety/mental problems the patient was experiencing. Additional information has been received from the physician (case# US12-008840) concerning the patient's symptoms started about 1 week after the second dose and she had been seen by this health care professional (HCP) approximately every week since. HCP was concerned that patient was either having an "immune reaction" or was having a "teenage mental break", but the family insists it must be GARDASIL and wanted to know when it would end. HCP reported that the anxiety and depression were probably a result of the other symptoms. The patient had stopped going to school. The patient was being evaluated by neurologist, GI (gastroenterologist), psychiatry and possibly others. The above mentioned events were considered to be disabling by the reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, HPV4
Symptoms: Abdominal discomfort, Abdominal pain, Activities of daily living impaired, Anaemia, Anxiety
Clinical narrative: Information has been received from a physician concerning a 16 year old female with migraine, poor vision and allergies who on 17-OCT-2011 was vaccinated with the first dose of GARDASIL (Lot# 667866/1437Z, Exp. 25-FEB-2013), (dose and route not reported) and the second dose of GARDASIL (Lot# 666162/0565Z, Exp. 15-SEP-2012), (dose and route not reported) was given on 30-DEC-2011. The physician reported that the patient's father had mild depression, asthma, nearsighted and history of migraines. The patient experienced "migraines, a clumsy feeling, tiredness, weakness, general feeling of unwell, upset stomach, muscle pain" after the vaccination. The patient experienced migraines immediately after both doses were given. Since January she had been having abdominal pain, weakness, anxiety and mental problems which had not gone away and became worse since the second dose was given. The patient felt that she was not able to go to school and was an A+ student and a very advanced student prior to this. The patient sought medical attention by visiting to the physician. The neurology who felt this was an immune reaction from of GARDASIL. Present blood work had now found the patient to be anemic. Lab diagnostics were performed: "negative for mono, Guillain Barre". The patient was started on PROZAC and the physician felt there was improvement but the medication was stopped as the family felt this was not right way to approach the anxiety/mental problems the patient was experiencing. Additional information has been received from the physician (case# US12-008840) concerning the patient's symptoms started about 1 week after the second dose and she had been seen by this health care professional (HCP) approximately every week since. HCP was concerned that patient was either having an "immune reaction" or was having a "teenage mental break", but the family insists it must be GARDASIL and wanted to know when it would end. HCP reported that the anxiety and depression were probably a result of the other symptoms. The patient had stopped going to school. The patient was being evaluated by neurologist, GI (gastroenterologist), psychiatry and possibly others. The above mentioned events were considered to be disabling by the reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, HPV4
Symptoms: Asthenia, Blood test abnormal, Clumsiness, Condition aggravated, Depression
Clinical narrative: Information has been received from a physician concerning a 16 year old female with migraine, poor vision and allergies who on 17-OCT-2011 was vaccinated with the first dose of GARDASIL (Lot# 667866/1437Z, Exp. 25-FEB-2013), (dose and route not reported) and the second dose of GARDASIL (Lot# 666162/0565Z, Exp. 15-SEP-2012), (dose and route not reported) was given on 30-DEC-2011. The physician reported that the patient's father had mild depression, asthma, nearsighted and history of migraines. The patient experienced "migraines, a clumsy feeling, tiredness, weakness, general feeling of unwell, upset stomach, muscle pain" after the vaccination. The patient experienced migraines immediately after both doses were given. Since January she had been having abdominal pain, weakness, anxiety and mental problems which had not gone away and became worse since the second dose was given. The patient felt that she was not able to go to school and was an A+ student and a very advanced student prior to this. The patient sought medical attention by visiting to the physician. The neurology who felt this was an immune reaction from of GARDASIL. Present blood work had now found the patient to be anemic. Lab diagnostics were performed: "negative for mono, Guillain Barre". The patient was started on PROZAC and the physician felt there was improvement but the medication was stopped as the family felt this was not right way to approach the anxiety/mental problems the patient was experiencing. Additional information has been received from the physician (case# US12-008840) concerning the patient's symptoms started about 1 week after the second dose and she had been seen by this health care professional (HCP) approximately every week since. HCP was concerned that patient was either having an "immune reaction" or was having a "teenage mental break", but the family insists it must be GARDASIL and wanted to know when it would end. HCP reported that the anxiety and depression were probably a result of the other symptoms. The patient had stopped going to school. The patient was being evaluated by neurologist, GI (gastroenterologist), psychiatry and possibly others. The above mentioned events were considered to be disabling by the reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, HPV4
Symptoms: Fatigue, Immediate post-injection reaction, Immune system disorder, Laboratory test normal, Malaise
Clinical narrative: Information has been received from a physician concerning a 16 year old female with migraine, poor vision and allergies who on 17-OCT-2011 was vaccinated with the first dose of GARDASIL (Lot# 667866/1437Z, Exp. 25-FEB-2013), (dose and route not reported) and the second dose of GARDASIL (Lot# 666162/0565Z, Exp. 15-SEP-2012), (dose and route not reported) was given on 30-DEC-2011. The physician reported that the patient's father had mild depression, asthma, nearsighted and history of migraines. The patient experienced "migraines, a clumsy feeling, tiredness, weakness, general feeling of unwell, upset stomach, muscle pain" after the vaccination. The patient experienced migraines immediately after both doses were given. Since January she had been having abdominal pain, weakness, anxiety and mental problems which had not gone away and became worse since the second dose was given. The patient felt that she was not able to go to school and was an A+ student and a very advanced student prior to this. The patient sought medical attention by visiting to the physician. The neurology who felt this was an immune reaction from of GARDASIL. Present blood work had now found the patient to be anemic. Lab diagnostics were performed: "negative for mono, Guillain Barre". The patient was started on PROZAC and the physician felt there was improvement but the medication was stopped as the family felt this was not right way to approach the anxiety/mental problems the patient was experiencing. Additional information has been received from the physician (case# US12-008840) concerning the patient's symptoms started about 1 week after the second dose and she had been seen by this health care professional (HCP) approximately every week since. HCP was concerned that patient was either having an "immune reaction" or was having a "teenage mental break", but the family insists it must be GARDASIL and wanted to know when it would end. HCP reported that the anxiety and depression were probably a result of the other symptoms. The patient had stopped going to school. The patient was being evaluated by neurologist, GI (gastroenterologist), psychiatry and possibly others. The above mentioned events were considered to be disabling by the reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, HPV4
Symptoms: Mental disorder, Migraine, Mononucleosis heterophile test negative, Myalgia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 16 year old female with migraine, poor vision and allergies who on 17-OCT-2011 was vaccinated with the first dose of GARDASIL (Lot# 667866/1437Z, Exp. 25-FEB-2013), (dose and route not reported) and the second dose of GARDASIL (Lot# 666162/0565Z, Exp. 15-SEP-2012), (dose and route not reported) was given on 30-DEC-2011. The physician reported that the patient's father had mild depression, asthma, nearsighted and history of migraines. The patient experienced "migraines, a clumsy feeling, tiredness, weakness, general feeling of unwell, upset stomach, muscle pain" after the vaccination. The patient experienced migraines immediately after both doses were given. Since January she had been having abdominal pain, weakness, anxiety and mental problems which had not gone away and became worse since the second dose was given. The patient felt that she was not able to go to school and was an A+ student and a very advanced student prior to this. The patient sought medical attention by visiting to the physician. The neurology who felt this was an immune reaction from of GARDASIL. Present blood work had now found the patient to be anemic. Lab diagnostics were performed: "negative for mono, Guillain Barre". The patient was started on PROZAC and the physician felt there was improvement but the medication was stopped as the family felt this was not right way to approach the anxiety/mental problems the patient was experiencing. Additional information has been received from the physician (case# US12-008840) concerning the patient's symptoms started about 1 week after the second dose and she had been seen by this health care professional (HCP) approximately every week since. HCP was concerned that patient was either having an "immune reaction" or was having a "teenage mental break", but the family insists it must be GARDASIL and wanted to know when it would end. HCP reported that the anxiety and depression were probably a result of the other symptoms. The patient had stopped going to school. The patient was being evaluated by neurologist, GI (gastroenterologist), psychiatry and possibly others. The above mentioned events were considered to be disabling by the reporter. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Developed a rectal temp of 103.0 24 hrs after administration of vaccinations.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. developed pain, swelling, redness, itch in (L) deltoid 1 day after immunization TDAP.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Pains, redness swelling and itching at site given. Also pains increased arm 90 degrees angler warm to touch.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: TDAP administered, mother called to report patient woke up 9-29-11 at 0300 complaining of nausea; fever vomited while talking to mom. At 0730 when I talked with mom the student was sleeping.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: 2/29/12 pt had inflammation at the site that night along w/ redness, itching, hot to the touch, hard to the touch (size of a small saucer plate) body aches & painful.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain
Clinical narrative: 2/29/12 pt had inflammation at the site that night along w/ redness, itching, hot to the touch, hard to the touch (size of a small saucer plate) body aches & painful.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Cyst, Dyspnoea, Fear, Feeling abnormal, Pain
Clinical narrative: That night after shot I felt strange, I was scared because I never had this reaction before. Breathing was difficult. Pain lasted longer in arm 5 days. Next day the same side I had my shot (read back) I noticed a lg, painful cyst by my collar bone. The pain subsided but the cyst didn't. I moves as I CK it. Finally I started feeling myself again after 2 days and 3 days later pain in arm went away. Scary. Cyst persistent until now.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: That night after shot I felt strange, I was scared because I never had this reaction before. Breathing was difficult. Pain lasted longer in arm 5 days. Next day the same side I had my shot (read back) I noticed a lg, painful cyst by my collar bone. The pain subsided but the cyst didn't. I moves as I CK it. Finally I started feeling myself again after 2 days and 3 days later pain in arm went away. Scary. Cyst persistent until now.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Papule, Pyrexia
Clinical narrative: Not eating, fever, papules.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Palpitations, Pharyngeal oedema
Clinical narrative: Dizzy, swelling in throat, heart racing, lasted 4 hrs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Discomfort, Injection site erythema
Clinical narrative: 3 1/2 x 2 cm red area right upper arm. Watch area, MOTRIN discomfort. No fever, no vomiting/diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, PNC13, VARCEL
Symptoms: Blood culture negative, C-reactive protein increased, Dysstasia, Hypokinesia, Pain
Clinical narrative: 2-27 Child got 6 vaccines (3 to each thigh). Several hrs later, c/o pain, fever, unable to stand, unable to bend right knee. Child was seen in ER 2-28-12 1AM - MOTRIN given. Was seen in office again 2-28-12 2pm - worsening pain was to be admitted, but no beds avail. Seen in ER again 5pm. X-rays normal. Labs done. Given MOTRIN & TYLENOL & discharged at 8pm.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, X-ray of pelvis and hip normal
Clinical narrative: 2-27 Child got 6 vaccines (3 to each thigh). Several hrs later, c/o pain, fever, unable to stand, unable to bend right knee. Child was seen in ER 2-28-12 1AM - MOTRIN given. Was seen in office again 2-28-12 2pm - worsening pain was to be admitted, but no beds avail. Seen in ER again 5pm. X-rays normal. Labs done. Given MOTRIN & TYLENOL & discharged at 8pm.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Convulsion, Electrocardiogram, Electroencephalogram, Juvenile myoclonic epilepsy
Clinical narrative: Information has been received from a consumer concerning his approximately 14 year old daughter who in "2008 or 2009" received the GARDASIL series intramuscularly (dose not reported). She was taking no concomitant medications, had no pertinent medical history and no drug reactions/allergies. The patient was diagnosed with juvenile myoclonic epilepsy after receiving the GARDASIL series. Her symptoms began with mild twitching and shaking and on "July 4th" (year not specified) she experienced a "large" seizure. She was hospitalized many times. The event also required office visits. The patient was treated with KEPPRA XR. She has had multiple unspecified blood and diagnostic tests including electrocardiogram and electroencephalogram (results not specified). The patient's condition was reported as not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Muscle twitching, Tremor
Clinical narrative: Information has been received from a consumer concerning his approximately 14 year old daughter who in "2008 or 2009" received the GARDASIL series intramuscularly (dose not reported). She was taking no concomitant medications, had no pertinent medical history and no drug reactions/allergies. The patient was diagnosed with juvenile myoclonic epilepsy after receiving the GARDASIL series. Her symptoms began with mild twitching and shaking and on "July 4th" (year not specified) she experienced a "large" seizure. She was hospitalized many times. The event also required office visits. The patient was treated with KEPPRA XR. She has had multiple unspecified blood and diagnostic tests including electrocardiogram and electroencephalogram (results not specified). The patient's condition was reported as not recovered. Additional information has been requested.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Convulsion, Crying, Dyskinesia, Eye movement disorder, Irritability
Clinical narrative: Per mother/grandmother on 03-05-12 at office visit. Stated "healthy 4 day old got his 1st dose Hep B, didn't cry, tolerated well initially.... that at 2:15 pm.... about 6 pm he became very fussy.... at 8, 9, 10 pm he crying uncontrollably became stiff whole body, began jerking all over, eyes rolled into head. Lasted only few seconds. But he had 2 more seizures just like the first one during that night.... he had another seizure a week later". No treatments/per our office notes.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Per mother/grandmother on 03-05-12 at office visit. Stated "healthy 4 day old got his 1st dose Hep B, didn't cry, tolerated well initially.... that at 2:15 pm.... about 6 pm he became very fussy.... at 8, 9, 10 pm he crying uncontrollably became stiff whole body, began jerking all over, eyes rolled into head. Lasted only few seconds. But he had 2 more seizures just like the first one during that night.... he had another seizure a week later". No treatments/per our office notes.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Activities of daily living impaired, Cognitive disorder, Electroencephalogram, Loss of consciousness, Memory impairment
Clinical narrative: Information has been received from a consumer concerning her 15 year old son with a history of seizure who on 27-OCT-2011 was vaccinated with first dose of GARDASIL. On 03-FEB-2012 patient was vaccinated with second dose (lot #, route and site were not reported for both doses). There was no concomitant medication. At an unspecified time period after his first dose, her son started to experience tingling in his legs and "moody behavior". Her son was administered his second dose on 03-FEB-2012 and at an unspecified time period experienced tingling in his legs and his short term memory was "bad". Her son also experienced "blackouts". On 14-FEB-2012 her son's teacher sent a letter home to say that he was not grasping concepts at school. Her son had been out of school since 14-FEB-2012. Her son was referred by his primary care Physician. The mother called to office and her son was seen by neurologist. No treatment was given for the adverse event. Two Electroencephalo-graphs (EEG) were performed in which the results were pending. Her son would not be receiving his third dose. At the time of this report, the patient had not recovered from above events. Action taken with GARDASIL was discontinued. Short-term memory impairment, moody behavior, not grasping concepts in school, Loss of consciousness and tingling in his legs which made patient out of school for half a month were considered to be disabling. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Mood altered, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her 15 year old son with a history of seizure who on 27-OCT-2011 was vaccinated with first dose of GARDASIL. On 03-FEB-2012 patient was vaccinated with second dose (lot #, route and site were not reported for both doses). There was no concomitant medication. At an unspecified time period after his first dose, her son started to experience tingling in his legs and "moody behavior". Her son was administered his second dose on 03-FEB-2012 and at an unspecified time period experienced tingling in his legs and his short term memory was "bad". Her son also experienced "blackouts". On 14-FEB-2012 her son's teacher sent a letter home to say that he was not grasping concepts at school. Her son had been out of school since 14-FEB-2012. Her son was referred by his primary care Physician. The mother called to office and her son was seen by neurologist. No treatment was given for the adverse event. Two Electroencephalo-graphs (EEG) were performed in which the results were pending. Her son would not be receiving his third dose. At the time of this report, the patient had not recovered from above events. Action taken with GARDASIL was discontinued. Short-term memory impairment, moody behavior, not grasping concepts in school, Loss of consciousness and tingling in his legs which made patient out of school for half a month were considered to be disabling. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Myalgia, Wheezing
Clinical narrative: Myalgia. Arthralgia. Mild wheezing. All lasted about 12 hours and then resolved. No treatment.
Age: 1.03
Sex: M
Vaccine: MMRV, PPV
Symptoms: Irritability, Pharyngitis streptococcal, Pyrexia, Rash, Scarlet fever
Clinical narrative: Friday- fever of 101, irritability, rash on face ibuprofen and Tylenol. Saturday, fever and rash worsen. Sunday, fever up to 104 while on meds, rash worsen.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Hyperglycaemia, Hyperhidrosis, Nausea
Clinical narrative: Nausea, hyperglycemic, sweating.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Pain, Pyrexia, Sleep disorder
Clinical narrative: Gradual onset body aches, fatigue w/fitful sleep that night, w/fever of 102F by patient report the next day, w/gradual, complete resolution of symptoms in 24 hours. No sequelae. Used OTC ibuprofen for symptom control.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Differential white blood cell count, Full blood count, Headache, Induration, Influenza A virus test
Clinical narrative: Myalgias, headache, fever (highest temp = 101 degrees F), and swelling of arm.   Still has a large hardened area on her arm.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Influenza B virus test, Metabolic function test, Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: Myalgias, headache, fever (highest temp = 101 degrees F), and swelling of arm.   Still has a large hardened area on her arm.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Urine analysis
Clinical narrative: Myalgias, headache, fever (highest temp = 101 degrees F), and swelling of arm.   Still has a large hardened area on her arm.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: Left arm has red area bout 4 inches in diameter that is warm to touch. Pt. advised to ice and MOTRIN or TYLENOL for comfort.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Hypoaesthesia, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt: 23-Feb-2012) concerns a 56-year-old male patient, who had a medical history of hypertension and diabetes. Concomitant medications included lisinopril and glimepiride. On 04-Nov-2011 the patient received one dose of AFLURIA injection. It was the first influenza vaccine he ever received. Following vaccination with AFLURIA the patient's left arm and hand were numb and felt as if they were exposed to the cold for too long. The patient stated that his arm and hand hurt, as well as felt numb. Shortly after the vaccination the patient was hoarse, then he experienced neck stiffness, which transitioned to shoulder pain, and then resulted in numbness and pain in his arm and hand. An x-ray performed on the arm showed the joints appeared to be intact and undamaged. He had been scheduled to undergo an MRI (magnetic resonance imaging) to assess the muscles in his arm. The patient was treated with unspecified anti-inflammatories. The events persisted to the time of the report on 23-Feb-2012. The event outcome was not recovered.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray limb normal
Clinical narrative: This spontaneous consumer report (initial receipt: 23-Feb-2012) concerns a 56-year-old male patient, who had a medical history of hypertension and diabetes. Concomitant medications included lisinopril and glimepiride. On 04-Nov-2011 the patient received one dose of AFLURIA injection. It was the first influenza vaccine he ever received. Following vaccination with AFLURIA the patient's left arm and hand were numb and felt as if they were exposed to the cold for too long. The patient stated that his arm and hand hurt, as well as felt numb. Shortly after the vaccination the patient was hoarse, then he experienced neck stiffness, which transitioned to shoulder pain, and then resulted in numbness and pain in his arm and hand. An x-ray performed on the arm showed the joints appeared to be intact and undamaged. He had been scheduled to undergo an MRI (magnetic resonance imaging) to assess the muscles in his arm. The patient was treated with unspecified anti-inflammatories. The events persisted to the time of the report on 23-Feb-2012. The event outcome was not recovered.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: On 7th day red bump developed. On 11th day seen at clinic bump was red, slightly warm, elevated & hard. Red area measured apx 20mm x 28mm. Evaluated by employee, determined to be site of PCV13 or influenza. Evaluated by Dr. determined to be vaccine reaction. Area marked, advised to call in if bigger. Ibuprofen & TYLENOL for pain/discomfort.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, X-ray of pelvis and hip
Clinical narrative: Flu vaccine 10-2-11. Joint pain in thumb & hip joint starting 10-16-11. Now ambulates with dysfunctional gait. Hip pain is now severe.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Local reaction, Pruritus
Clinical narrative: Localized reaction - with erythema, (7 x 10 cm) induration & itching started within hours of vaccination.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Full blood count normal
Clinical narrative: Pt received MMR #2 2/24/12 - reports dizziness developed w/i 1h - has lasted ever since. PE - normal 2/27/12.
Age: 1.01
Sex: F
Vaccine: HEP, MMR, PNC
Symptoms: Macule, Papule, Scab, Skin lesion, Varicella
Clinical narrative: Patient received vaccine at 12 mos of age. Patient presented in office today with "chicken pox". Multiple lesions in various stages from papules, flattened macules, crusted lesions.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Abdominal pain, Cough, Culture, Culture urine, Full blood count
Clinical narrative: Runny nose, cough, congestion, abdominal pain, HA, vomiting.. Began day after vaccinations. Lasted 2 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Headache, Influenza A virus test, Influenza B virus test, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose, cough, congestion, abdominal pain, HA, vomiting.. Began day after vaccinations. Lasted 2 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Streptococcus test, Urine analysis, Vomiting
Clinical narrative: Runny nose, cough, congestion, abdominal pain, HA, vomiting.. Began day after vaccinations. Lasted 2 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Nausea, Pain
Clinical narrative: Light headedness, weakness, queasiness, then nauseousness, severe shaking from from head to toe (lasting several hours) achiness all over, head pressure checked in emergency room, where they felt that as my husband & I both had vaccines & these strange symptoms w/in 20-30 mins following vaccination, it must be a reaction.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vaccination complication
Clinical narrative: Light headedness, weakness, queasiness, then nauseousness, severe shaking from from head to toe (lasting several hours) achiness all over, head pressure checked in emergency room, where they felt that as my husband & I both had vaccines & these strange symptoms w/in 20-30 mins following vaccination, it must be a reaction.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Convulsion, Dizziness, Vomiting
Clinical narrative: Dizzy, seizure, vomiting. Weak. (My wife had vaccine at same time and had similar occurrence).
Age: 29.0
Sex: M
Vaccine: ANTH, DTP, HEPA, SMALL, ANTH, HEPA, SMALL, TDAP
Symptoms: Erythema, Infection, Robust take following exposure to vaccinia virus, Skin warm, Vaccination site swelling
Clinical narrative: Robust take vs secondary infection, increased redness and warmth extending to elbow. Swelling of entire upper arm. Vaccine site approx 3cm in diam day 14.
Age: 29.0
Sex: M
Vaccine: ANTH, DTP, HEPA, SMALL, ANTH, HEPA, SMALL, TDAP
Symptoms: Infection, Injection site erythema, Robust take following exposure to vaccinia virus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Robust take vs secondary infection, increased redness and warmth extending to elbow. Swelling of entire upper arm. Vaccine site approx 3cm in diam day 14.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, hot to touch. Area around injection site; physician treated with cephalexin to prevent possible cellulitis.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dysuria, Neuralgia
Clinical narrative: Blisters on abdomen and legs. Nerve pain in legs. Painful urination (slight).
Age: 50.0
Sex: M
Vaccine: ANTH, TDAP
Symptoms: Condition aggravated, Rash
Clinical narrative: Vaccine given on 26Jan12, day of deployment.  Seen by medical provider in deployed location on 24Feb12 where he reported having a rash on his right arm and flank that began 6 days after receiving the Anthrax vaccine and believed it was brought on by the vaccine. Given po prednisone for tx that cleared the acute rash.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Electromyogram, Neuropathy peripheral
Clinical narrative: Left ulnar neuropathy.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Abasia, Cerebrovascular accident, Feeling abnormal
Clinical narrative: Patient stated that on 09/17 she went to restroom during middle of night and started feeling funny, so she went to kitchen to get a glass of water.  She was unable to walk so she called 911 and Paramedics informed her it is a stroke and Dr. diagnosed it as a stroke also.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Emotional distress, Screaming
Clinical narrative: Went down for nap, woke up screaming off and on x5 hrs, inconsolable.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis on left thigh, 2/29/12, seen ER 3/2/12, improved on antibiotics.
Age: 0.12
Sex: M
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: My son got a rash from head to toe (see attached photos) the day after getting vaccinations on 2 different occasions. Took 2 weeks for reaction to totally clear up.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reaction to varicella shot #2. Vaccine site is red and swollen, no medication or fever. No other vaccines were given on this date 02/28/2012.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Muscle rigidity
Clinical narrative: Started as pain at injection site 4 hours post injection. Swelling began shortly after. (R) deltoid now rigid and painful.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Vomiting
Clinical narrative: Approximately 9 hours after vaccine - patient reported having diarrhea x 1. Approximately 15 hours after vaccine - patient reported having vomiting x 1. Approximately 20 hours after vaccine - patient reported having headache lasting approximately 2 hours then patient able to resume normal activities.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Palpitations
Clinical narrative: Severe breathing difficulty, dizziness, heart palpitations. Went to emergency room at hospital.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site reaction
Clinical narrative: Depigmentation & atrophy at site of injection per patient.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: HPV vaccine given 2/20/12 -> Pt. called 2/22/12 to report elevated fever & rash since Monday 2/20/12 evening. "No S.O.B.". Temperature 100 degrees with 102 degrees as highest. Reports taking ibuprofen/BENADRYL as directed & cannot afford to go do MD or the emergency room. Rash is "blotching" on arms, legs, thighs - "no itching, no swelling".
Age: 12.0
Sex: M
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Posture abnormal, Staring, Tremor
Clinical narrative: Phone call from mother, stated client's father told her after receiving shots today, pt got into car, began to shake, arms extended out, and eyes open and staring. Episode lasted 30 seconds. Father reported patient doesn't remember what happened and was alert after episode. Client hadn't eaten prior to immunizations and he "had been worked up for past couple days about getting immunizations" per mother. I advised mother to follow up with her PCP if she is concerned.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Back pain, Nausea, Neck pain, Pain in extremity, Poor quality sleep
Clinical narrative: Low back and thigh pain at 1700. He then did not sleep well. On March 3, 2012 he had fever to 101F, queasiness, upper and lower back pain with some neck pain.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Low back and thigh pain at 1700. He then did not sleep well. On March 3, 2012 he had fever to 101F, queasiness, upper and lower back pain with some neck pain.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Back pain, Chest pain, Diagnostic procedure
Clinical narrative: Weakness, nausea & vomiting, tingling of bilateral arms and legs, severe back pain, chest pain, shortness of breath, right sided upper abdominal pain.  Hospitalized with above symptoms, diagnosed with Guillain Barre on 11/28/2011; transferred to ICU and intubated on 11/29/2011.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Laboratory test
Clinical narrative: Weakness, nausea & vomiting, tingling of bilateral arms and legs, severe back pain, chest pain, shortness of breath, right sided upper abdominal pain.  Hospitalized with above symptoms, diagnosed with Guillain Barre on 11/28/2011; transferred to ICU and intubated on 11/29/2011.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia, Vomiting
Clinical narrative: Weakness, nausea & vomiting, tingling of bilateral arms and legs, severe back pain, chest pain, shortness of breath, right sided upper abdominal pain.  Hospitalized with above symptoms, diagnosed with Guillain Barre on 11/28/2011; transferred to ICU and intubated on 11/29/2011.
Age: 50.0
Sex: M
Vaccine: JEV1
Symptoms: Chills, Conjunctivitis, Dry mouth, Headache, Malaise
Clinical narrative: Chills, Fever (100-101.2), 5/10 Headaches, DRY Mouth, sore throat, body aches, L eye conjunctivitis (not bacterial, not viral), malaise.
Age: 50.0
Sex: M
Vaccine: JEV1
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Chills, Fever (100-101.2), 5/10 Headaches, DRY Mouth, sore throat, body aches, L eye conjunctivitis (not bacterial, not viral), malaise.
Age: 29.0
Sex: M
Vaccine: JEV1
Symptoms: Back pain, Chest pain, Chills, Cough, Headache
Clinical narrative: Severe headache. Burning in chest, coughing up thick yellow sputum, very painful cough, fever/chills, achiness in lower back.
Age: 29.0
Sex: M
Vaccine: JEV1
Symptoms: Productive cough, Pyrexia, Sputum discoloured
Clinical narrative: Severe headache. Burning in chest, coughing up thick yellow sputum, very painful cough, fever/chills, achiness in lower back.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMR
Symptoms: Erythema, Induration
Clinical narrative: Pt developed erythematous indurated area below vaccination site approximately 8-10cm diameter lasting about 48 hours.  Tx with anti-histamine and ice.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Joint injection, Pain in extremity, Tenderness, Ultrasound scan, X-ray
Clinical narrative: Pt c/o pain and tenderness in arm vaccinations were placed in.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Red rash at injection site slightly larger than a quarter.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: MOTHER STATES SHE HAD A HARD REDDENED AREA ON HER RIGHT THIGH.  PT STOPPED BY AND AREA WAS MEASURED on 3/5/2012, 50X55mm dark reddened hard area and 80x80mm raised area.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Asthenia, Decreased appetite, Pyrexia, Rash, Rash erythematous
Clinical narrative: High Fevers 105 degrees, shaking, Weak, Loss of appetite. On day 4 of fevers, broke out in rash. Tiny red dots on trunk of body treated around the clock with fever reducing medications in order to keep fever less than 104-105 degrees.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Tremor
Clinical narrative: High Fevers 105 degrees, shaking, Weak, Loss of appetite. On day 4 of fevers, broke out in rash. Tiny red dots on trunk of body treated around the clock with fever reducing medications in order to keep fever less than 104-105 degrees.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity, Quality of life decreased
Clinical narrative: PAIN IN ARM AND SHOULDER DURING THE DAY, WITH EXTREME PAIN IN THE ARM AND SHOULDER RADIATING DOWN TO THE HAND UPON RECLINING AT NIGHT. PAIN CONTINUES TO THIS DAY AND INTERFERS WITH MY QUALITY OF LIFE. DOCTOR PRESCRIBED PHYSICAL THERAPY BUT THIS ONLY MADE IT WORSE.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: OCCASIONAL PAIN IN ARM AND SHOULDER DURING THE DAY, BUT EXTREME PAIN IN SHOULDER RADIATING DOWN THE ARM INTO MY HAND UPON RECLINING EVERY NIGHT. I DID NOT SEEK TREATMENT BECAUSE I WITNESSED MY MOTHER, WHO RECEIVED THE SAME SHOT ON THE SAME DAY, AT THE SAME DOCTORS OFFICE BE TOLD OUR SAME SYMPTOMS WERE NOT RELATED TO THE SHOT. SHE ALSO FILED A REPORT TODAY.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Eschar, Scab, Vaccination complication
Clinical narrative: Secondary inoculation approx 1/2" inferior to the patients left lower lip from the vermilion border. Eschar appears to be healing at the same stage as the primary vaccine. Patient first noticed sore, self applied pro activ cream (thinking it was acne) then the following morning sore was scabbed and appeared healing normally.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Eschar, Post vaccination autoinoculation, Scab
Clinical narrative: Secondary inoculation approx 1/2" inferior to the patients left lower lip from the vermilion border. Eschar appears to be healing at the same stage as the primary vaccine. Patient first noticed sore, self applied pro activ cream (thinking it was acne) then the following morning sore was scabbed and appeared healing normally.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: (L) axillary lymphadenopathy.
Age: 73.0
Sex: F
Vaccine: DTP
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Redness & swelling & itching to left upper arm. On 3/2/12 redness moved to lower inner arm & warm to touch, swelling & itching resolved 3/5/12.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Hypophagia, Irritability, Lethargy, Pyrexia
Clinical narrative: Onset of fever 6pm 1/10/12 to 102.7 ax. Slightly lethargic, fussy. Acetaminophen given. Fever decreased, fussiness decreased. Fever returned at 4 hours. Highest fever 103.3 ax. Fevers on and off through 1-16-12. Throughout all 6 days took breast feeding well with decreased solid food intake. Acetaminophen only treatment.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle twitching, Tic
Clinical narrative: Within 24 hrs of vaccine, pt developed multiple facial tics - twitching, almost constant.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Chills, Headache, Injection site haematoma
Clinical narrative: Onset - chills, joint pain, headache. Decreased limb movement 24 hrs after onset, headache worsened, joint pain increased, increased bruising at injection site. 72 hrs headache still present. Cellulitis, swelling, warm to the touch. She now denies joint pain and moves her left arm well. She is recovering.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Onset - chills, joint pain, headache. Decreased limb movement 24 hrs after onset, headache worsened, joint pain increased, increased bruising at injection site. 72 hrs headache still present. Cellulitis, swelling, warm to the touch. She now denies joint pain and moves her left arm well. She is recovering.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site, 4 days after admit: 14 1/2 cm x 12 1/2 cm.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Rheumatoid arthritis, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional (a nurse who was a friend of the subject) and described the occurrence of rheumatoid arthritis in a 56-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). In 2002 the subject received a dose of Influenza vaccine (details unknown). In 2002, less than one year after vaccination with Influenza vaccine, the subject experienced rheumatoid arthritis. The nurse reported that her friend received an unknown influenza vaccine in 2002 and developed "severe RA" [rheumatoid arthritis] that the physician thought was related to the vaccine. The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the event was improved. The vaccination course with Influenza vaccine was discontinued. The healthcare professional considered the event was probably related to vaccination with Influenza vaccine.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Rash generalised
Clinical narrative: My son once again woke up with a rash from head to toe, the day after his vaccination. Rash last two weeks. See attached pictures.
Sex: U
Vaccine: SMALL
Symptoms: Pericarditis
Clinical narrative: This study case was received from the investigator on 23 February 2012. An unidentified subject whose medical history was not available was found to have on 15 March 2009 acute pericarditis, unspecified after he had received an injection of ACAM2000 (lot number, route, site and date of administration not reported). Relevant laboratory tests and treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blepharospasm, Computerised tomogram head, Hypoaesthesia, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Began to feel numbness/tingling in extremities, fatigue, back pain, weakness/heaviness in limbs, slowed thinking and other strange neurological symptoms. This progressed to facial involvement so I went to the ER.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Bradyphrenia, Central nervous system lesion, Fatigue, Hypoaesthesia
Clinical narrative: Began to feel numbness/tingling in extremities, fatigue, back pain, weakness/heaviness in limbs, slowed thinking and other strange neurological symptoms. This progressed to facial involvement so I went to the ER.