chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Pt received immunizations 8/10/10. 8/11/10 pt came to office with reaction to Varicella #2 Lg welt, red, swelling 44mm x >50mm at site where shot was given, pt was advised by PA - who looked at it to take BENADRYL, use cold packs, if it gets worse to call.
Age: 1.06
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Urticaria
Clinical narrative: Urticaria - generalized, 5 days after MMR-V, Hep A, PCV-13.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Anxiety, Arthralgia, Coordination abnormal, Depression
Clinical narrative: Two weeks after my second GARDASIL shot, I began experiencing excruciating body aches. I also contracted a fever that spiked to 102 and lasted for 3 straight weeks. The body aches were later diagnosed as the condition, Fibromyalgia. This is a lifelong condition that I battle every day. The following are symptoms of Fibromyalgia that I experience: My muscle and joints ache, I can no longer participate in any athletic sports, I have insomnia at night, fatigue during the day, bouts of depression, frequent urination, anxiety, impaired memory and concentration, skin sensitivities, Raynaud's Syndrome, and impaired coordination.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Disturbance in attention, Fatigue, Fibromyalgia, Hyperaesthesia, Insomnia
Clinical narrative: Two weeks after my second GARDASIL shot, I began experiencing excruciating body aches. I also contracted a fever that spiked to 102 and lasted for 3 straight weeks. The body aches were later diagnosed as the condition, Fibromyalgia. This is a lifelong condition that I battle every day. The following are symptoms of Fibromyalgia that I experience: My muscle and joints ache, I can no longer participate in any athletic sports, I have insomnia at night, fatigue during the day, bouts of depression, frequent urination, anxiety, impaired memory and concentration, skin sensitivities, Raynaud's Syndrome, and impaired coordination.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Memory impairment, Myalgia, Pain, Pollakiuria, Pyrexia
Clinical narrative: Two weeks after my second GARDASIL shot, I began experiencing excruciating body aches. I also contracted a fever that spiked to 102 and lasted for 3 straight weeks. The body aches were later diagnosed as the condition, Fibromyalgia. This is a lifelong condition that I battle every day. The following are symptoms of Fibromyalgia that I experience: My muscle and joints ache, I can no longer participate in any athletic sports, I have insomnia at night, fatigue during the day, bouts of depression, frequent urination, anxiety, impaired memory and concentration, skin sensitivities, Raynaud's Syndrome, and impaired coordination.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Raynaud's phenomenon
Clinical narrative: Two weeks after my second GARDASIL shot, I began experiencing excruciating body aches. I also contracted a fever that spiked to 102 and lasted for 3 straight weeks. The body aches were later diagnosed as the condition, Fibromyalgia. This is a lifelong condition that I battle every day. The following are symptoms of Fibromyalgia that I experience: My muscle and joints ache, I can no longer participate in any athletic sports, I have insomnia at night, fatigue during the day, bouts of depression, frequent urination, anxiety, impaired memory and concentration, skin sensitivities, Raynaud's Syndrome, and impaired coordination.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram abnormal, Epilepsy, Nuclear magnetic resonance imaging abnormal, Petit mal epilepsy
Clinical narrative: About a month after receiving the third and final dosage of the GARDASIL medication, I began having absent seizures. I have now been diagnosed with epilepsy. My neurologist says that it is, more than likely, going to stay with me for the rest of my life.
Age: 0.41
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Rash, Rash generalised
Clinical narrative: A bright patchy red rash suddenly appeared on my daughter's cheek with white raised spots.  That outbreak subsided within 30 minutes, but I counted 14 subsequent outbreaks of the rash all over her body over the next 48 hours, each appearing suddenly, then fading slowly, though spreading a bit more before disappearing within half hour.  No treatment given- By the time we purchased Benadryl per our pediatrician's instructions, the first outbreak had subsided, so after consult with the doctor, we decided not to use Benadryl on such a young baby if the rash were subsiding on its own.  We have decided not to complete this vaccination series.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Pt complains of joint pain, fever x 48 days & chills.
Age: 87.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Rash, Urticaria
Clinical narrative: Shot given 5pm. Pt experience rxn at night with hives and leg edema. Pt put HC 1% on rash & elevate legs.
Age: 87.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Shot given 5pm. Pt experience rxn at night with hives and leg edema. Pt put HC 1% on rash & elevate legs.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Back pain, Dizziness, Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Pt received FLUZONE HD and PNEUMOVAX 23 in Left Deltoid IM at 2PM on 9/2/10. On 9/3 - pt had lower backache and dizziness. On 9/4 at 8AM he noticed redness & tenderness. He came to see me approx 10AM. (L) anterolateral arm was red & warm from shoulder to elbow. Referred to urgent care. Received Cephalexin 500mg qid & sx resolved by 9/9.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Pt received FLUZONE HD and PNEUMOVAX 23 in Left Deltoid IM at 2PM on 9/2/10. On 9/3 - pt had lower backache and dizziness. On 9/4 at 8AM he noticed redness & tenderness. He came to see me approx 10AM. (L) anterolateral arm was red & warm from shoulder to elbow. Referred to urgent care. Received Cephalexin 500mg qid & sx resolved by 9/9.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Back pain, Dizziness, Erythema, Skin warm, Tenderness
Clinical narrative: Pt received FLUZONE HD and PNEUMOVAX 23 in Left Deltoid IM at 2PM on 9/2/10. On 9/3 - pt had lower backache and dizziness. On 9/4 at 8AM he noticed redness & tenderness. He came to see me approx 10AM. (L) anterolateral arm was red & warm from shoulder to elbow. Referred to urgent care. Received Cephalexin 500mg qid & sx resolved by 9/9.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence, Tracheal oedema
Clinical narrative: 2:26pm 9/10/10 adm. Flu HD shot. 3 pm 9/10/10 she started feeling drowsy trachea swelling. 6 pm 9/10/10 daughter took her to ER.
Age: 1.29
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Erythema, Injection site erythema, Injection site swelling, Macule, Oedema peripheral
Clinical narrative: With red macule on the left arm; with slightly raised red patches around 1cm by 1cm, 2 on the right forearm; 3 on the right anterior thigh with redness, around 1.5cm by 1cm.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at site, heat, redness.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Patient was fine at the time of administration, we sat and chat for a few minutes. We both went to waiting room to meet his wife and chatted for a few minutes. Patient reported feeling weird and fainted. Later reported not having eaten all day and having phobias of needles and a history of syncope. The patient wat stabilized in the seated position, head down between his knees, blood pressure taken 3 times and orange juice and a banana was give to him to boost his blood sugar. I stayed with him for half hour; his wife then drove hime home. I followed up with the patient the next day,he is fine. The incident was reported to his primary care so that the history of syncopes is noted.
Age: 1.82
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Woke up with fever and complaining of soreness at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: PATIENT HOSPTIALIZED FOR FOUR DAYS WHILE RECEIVEING IV THERAPY.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Atrial fibrillation, Cardiac monitoring abnormal, Chest pain, Condition aggravated, Pyrexia
Clinical narrative: Pt developed fever (101.7), chest pain and then monitor showed A fib  with RVR.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: When patient awoke the morning of 9/16/10, pt noted injection site is red from the insertion site down to the crease of the elbow.  No increase in arm soreness.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills, body aches, and headache reported day after vaccination given via patient phone call to pharmacy.  Recommended to take Tylenol for symptoms.  Patient mentioned that she already has an appointment scheduled to visit her doctor.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Urine analysis normal, White blood cell count normal
Clinical narrative: chills, aches, fever
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Chills, Cough, Eye pruritus, Feeling cold
Clinical narrative: Bones hurting throughout body. Mucus build up in throat and nostrils. Coughing. Freezing and teeth were chattering. Eyes were itchy. No complaints with previous flu shots.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: No reaction on previous exposure to drug, Rhinorrhoea
Clinical narrative: Bones hurting throughout body. Mucus build up in throat and nostrils. Coughing. Freezing and teeth were chattering. Eyes were itchy. No complaints with previous flu shots.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Bone pain, Headache, No reaction on previous exposure to drug
Clinical narrative: Bone were hurting throughout entire body. Very weak and complaining of a severe headache. Patient has never complained w/prior flu vaccinations.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Swollen, red, warm at injection site dizziness, headache about 10 minutes post injection rash at injection site and across chest 20 hours after injection.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Rash
Clinical narrative: Swollen, red, warm at injection site dizziness, headache about 10 minutes post injection rash at injection site and across chest 20 hours after injection.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased, Lymphadenopathy
Clinical narrative: Pain in (L) UE @ site, swollen axillary lymph nodes, weakness & decreased ROM.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Anti-GAD antibody positive, Blood glucose increased, Fatigue, Glucose urine, Glycosylated haemoglobin increased
Clinical narrative: 27 y/o M presented to the ER on 26 Nov 2008 with a 1-week history of significant polyuria and polydipsia.  Also about 1 month history of tiring easily and about 10-15 pound weight loss over 1-2 month period.  Admitted for hydration, electrolyte replacement, and Insulin titration, as well as diabetes self management training.  After 3 days, he was discharged on Glucophage and insulin supplementation with Aspart.  Over the course of the next 12 months, SM was followed up by a civilian Endocrinologist.  During that time, a number of combinations of oral medications were tried, but in Nov 2009, he was placed on an insulin regimen of Lantus with Novolog supplementation before meals and prn for hyperglycemia.  SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis.  He was very active and had a normal BMI (23.92) prior to diagnosis.  SM has no family history of diabetes.  Does not recall any infections in 3-6 months prior to T1DM diagnosis.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Hyperglycaemia, Polydipsia, Polyuria, Type 1 diabetes mellitus, Urine ketone body absent
Clinical narrative: 27 y/o M presented to the ER on 26 Nov 2008 with a 1-week history of significant polyuria and polydipsia.  Also about 1 month history of tiring easily and about 10-15 pound weight loss over 1-2 month period.  Admitted for hydration, electrolyte replacement, and Insulin titration, as well as diabetes self management training.  After 3 days, he was discharged on Glucophage and insulin supplementation with Aspart.  Over the course of the next 12 months, SM was followed up by a civilian Endocrinologist.  During that time, a number of combinations of oral medications were tried, but in Nov 2009, he was placed on an insulin regimen of Lantus with Novolog supplementation before meals and prn for hyperglycemia.  SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis.  He was very active and had a normal BMI (23.92) prior to diagnosis.  SM has no family history of diabetes.  Does not recall any infections in 3-6 months prior to T1DM diagnosis.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Weight decreased
Clinical narrative: 27 y/o M presented to the ER on 26 Nov 2008 with a 1-week history of significant polyuria and polydipsia.  Also about 1 month history of tiring easily and about 10-15 pound weight loss over 1-2 month period.  Admitted for hydration, electrolyte replacement, and Insulin titration, as well as diabetes self management training.  After 3 days, he was discharged on Glucophage and insulin supplementation with Aspart.  Over the course of the next 12 months, SM was followed up by a civilian Endocrinologist.  During that time, a number of combinations of oral medications were tried, but in Nov 2009, he was placed on an insulin regimen of Lantus with Novolog supplementation before meals and prn for hyperglycemia.  SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis.  He was very active and had a normal BMI (23.92) prior to diagnosis.  SM has no family history of diabetes.  Does not recall any infections in 3-6 months prior to T1DM diagnosis.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Blister, Erythema, Lymph node pain, Skin warm, Tenderness
Clinical narrative: Large, 6cm diameter, red - blistered area. Warm to touch, tender. Tender lymph left axilla. Prescribed Cephalexin 250mg 15ml x 10 days.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation, Confusional state, Death, Drug abuse, Endoscopy abnormal
Clinical narrative: This female subject was enrolled in the 2nd year of prophylactic observer-blind study. On 01 October 2009, she received a 2nd dose of preservative-free FLUARIX or FLU NG. The subject's past medical history included osteoarthritis. On 01 July 2010, nine months after the 2nd dose of Blinded vaccine, 15 months after the 1st dose of MOBIC and an unspecified time after the 1st dose of Goody powder, this 68-year-old subject developed upper gastrointestinal hemorrhage. On 05 July 2010, she developed acute renal failure. On 09 July 2010, she developed multisystem organ failure. The subject was hospitalised and the events were life-threatening. The upper gastrointestinal hemorrhage resolved on 01 July 2010. The subject died on 09 July 2010 due to multisystem organ failure. An autopsy was not performed. The investigator considered that there was no reasonable possibility that the multisystem organ failure, upper gastrointestinal hemorrhage and acute renal failure may have been caused by investigational product and that the events were possibly due to the concomitant medication, Goody powder and meloxicam and the subject's medical history of osteoarthritis. Investigator Comments: RE: Goodys Powders on Relevant Medication screen. This medication was not reported to the subject's PCP as being taken so I have no start date, dosage, frequency or unit. Subject was abusing Goodys Powders and developed a bleeding ulcer. Subject admitted to the hospital. Subject was transfused 2 units of packed red blood cells. Initially she was doing well but became confused and agitated and hypotensive. An endoscopy was done which showed a massive bleeding from the pylorus. Subject was taken to surgery and the bleeding stopped. Subject did well until post-op day 5 when she started to deteriorate. Subject went into renal failure, then into multisystem organ failure. Subject succumed to death 09Jul2010. Medical history at study start : Other autoimmune diseases of the skin or subcutaneous tissue, COPD, Other respiratory system disorder, Other gastrointestinal and hepatobiliary system disorder, Other genito-urinary system disorder, Osteoarthritis, Osteoporosis, Gout, Other musculoskeletal system and connective tissue disorder, Other nervous system disorder. .
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Gastric ulcer haemorrhage, Haemoglobin decreased, Hypotension, Immunoglobulin therapy, Multi-organ failure
Clinical narrative: This female subject was enrolled in the 2nd year of prophylactic observer-blind study. On 01 October 2009, she received a 2nd dose of preservative-free FLUARIX or FLU NG. The subject's past medical history included osteoarthritis. On 01 July 2010, nine months after the 2nd dose of Blinded vaccine, 15 months after the 1st dose of MOBIC and an unspecified time after the 1st dose of Goody powder, this 68-year-old subject developed upper gastrointestinal hemorrhage. On 05 July 2010, she developed acute renal failure. On 09 July 2010, she developed multisystem organ failure. The subject was hospitalised and the events were life-threatening. The upper gastrointestinal hemorrhage resolved on 01 July 2010. The subject died on 09 July 2010 due to multisystem organ failure. An autopsy was not performed. The investigator considered that there was no reasonable possibility that the multisystem organ failure, upper gastrointestinal hemorrhage and acute renal failure may have been caused by investigational product and that the events were possibly due to the concomitant medication, Goody powder and meloxicam and the subject's medical history of osteoarthritis. Investigator Comments: RE: Goodys Powders on Relevant Medication screen. This medication was not reported to the subject's PCP as being taken so I have no start date, dosage, frequency or unit. Subject was abusing Goodys Powders and developed a bleeding ulcer. Subject admitted to the hospital. Subject was transfused 2 units of packed red blood cells. Initially she was doing well but became confused and agitated and hypotensive. An endoscopy was done which showed a massive bleeding from the pylorus. Subject was taken to surgery and the bleeding stopped. Subject did well until post-op day 5 when she started to deteriorate. Subject went into renal failure, then into multisystem organ failure. Subject succumed to death 09Jul2010. Medical history at study start : Other autoimmune diseases of the skin or subcutaneous tissue, COPD, Other respiratory system disorder, Other gastrointestinal and hepatobiliary system disorder, Other genito-urinary system disorder, Osteoarthritis, Osteoporosis, Gout, Other musculoskeletal system and connective tissue disorder, Other nervous system disorder. .
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count decreased, Renal failure acute, Surgery, Upper gastrointestinal haemorrhage
Clinical narrative: This female subject was enrolled in the 2nd year of prophylactic observer-blind study. On 01 October 2009, she received a 2nd dose of preservative-free FLUARIX or FLU NG. The subject's past medical history included osteoarthritis. On 01 July 2010, nine months after the 2nd dose of Blinded vaccine, 15 months after the 1st dose of MOBIC and an unspecified time after the 1st dose of Goody powder, this 68-year-old subject developed upper gastrointestinal hemorrhage. On 05 July 2010, she developed acute renal failure. On 09 July 2010, she developed multisystem organ failure. The subject was hospitalised and the events were life-threatening. The upper gastrointestinal hemorrhage resolved on 01 July 2010. The subject died on 09 July 2010 due to multisystem organ failure. An autopsy was not performed. The investigator considered that there was no reasonable possibility that the multisystem organ failure, upper gastrointestinal hemorrhage and acute renal failure may have been caused by investigational product and that the events were possibly due to the concomitant medication, Goody powder and meloxicam and the subject's medical history of osteoarthritis. Investigator Comments: RE: Goodys Powders on Relevant Medication screen. This medication was not reported to the subject's PCP as being taken so I have no start date, dosage, frequency or unit. Subject was abusing Goodys Powders and developed a bleeding ulcer. Subject admitted to the hospital. Subject was transfused 2 units of packed red blood cells. Initially she was doing well but became confused and agitated and hypotensive. An endoscopy was done which showed a massive bleeding from the pylorus. Subject was taken to surgery and the bleeding stopped. Subject did well until post-op day 5 when she started to deteriorate. Subject went into renal failure, then into multisystem organ failure. Subject succumed to death 09Jul2010. Medical history at study start : Other autoimmune diseases of the skin or subcutaneous tissue, COPD, Other respiratory system disorder, Other gastrointestinal and hepatobiliary system disorder, Other genito-urinary system disorder, Osteoarthritis, Osteoporosis, Gout, Other musculoskeletal system and connective tissue disorder, Other nervous system disorder. .
Age: 21.0
Sex: M
Vaccine: FLUN(H1N1), FLUN3, HEPAB, IPV, TDAP
Symptoms: Cardiac stress test normal, Computerised tomogram normal, Confusional state, Dizziness, Echocardiogram normal
Clinical narrative: Pt denied problems with previous vaccinations; reported that his health was good, and reported a negative family history. He was vaccinated with below immunizations in Jan and Feb. He stated that in early July he began to notice headaches and not feeling well just after his physical training and sx continued to worsen. SX include confusion, headaches, dizziness.
Age: 21.0
Sex: M
Vaccine: FLUN(H1N1), FLUN3, HEPAB, IPV, TDAP
Symptoms: Electroencephalogram normal, Exercise electrocardiogram normal, Headache, Malaise, Nuclear magnetic resonance imaging normal
Clinical narrative: Pt denied problems with previous vaccinations; reported that his health was good, and reported a negative family history. He was vaccinated with below immunizations in Jan and Feb. He stated that in early July he began to notice headaches and not feeling well just after his physical training and sx continued to worsen. SX include confusion, headaches, dizziness.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Electrocardiogram, Malaise, Nausea
Clinical narrative: Pt had vaccine at 9:28 AM. Went home, went for a walk, not feeling well, had chills, fever 101 degrees, nausea, wife thought he was having heart attack, took to E.R., no high blood pressure, ran EKG pt. seems OK now. ER thought this was reaction to vaccine.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Pt had vaccine at 9:28 AM. Went home, went for a walk, not feeling well, had chills, fever 101 degrees, nausea, wife thought he was having heart attack, took to E.R., no high blood pressure, ran EKG pt. seems OK now. ER thought this was reaction to vaccine.
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Swollen tongue, Tremor
Clinical narrative: Pt rec'd Influenza Immunization at 930 am. At 1005 pt complains of swollen tongue and shaky handwriting. Pt escorted to MD. 10:20 am  VS: 98.3 degrees BP 230/130 HR 94 O2 99% RA. Dr. ordered med admin by RN 1020 am SOLUMEDROL 125 mg IM x 1. 10:23 am BENADRYL 20 mg IM x 1 by RN, 1025 BP: 220/110 felt decreased tingling & swelling of tongue 1040 EMS arrive & transport pt to hospital.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Body temperature increased, Chills, Culture throat negative, Dysphagia
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no known drug reactions or allergies who in July 2010, was vaccinated with a first dose of GARDASIL (Lot# unknown). Second dose of GARDASIL (Lot# unknown) was given on 01-SEP-2010. Concomitant therapy included unspecified birth control pill. The consumer stated that after the first dose of GARDASIL the patient did not have any adverse effect. The consumer reported that in the evening of 02-SEP-2010, her daughter became very ill with a fever of 103F, viral sores in mouth, sore throat and chills. The consumer stated that her daughter was bleeding in her throat and could not swallow. The patient was taking to the emergency room Monday, on 06-SEP-2010, and a tested for strep throat was done which was negative. The mother said that her daughter had missed college classes, and was taking MOTRIN and TYLENOL, and could not swallow. She also stated that she was planning to contact her daughter's physician. The mother adds that her daughter declines her third dose of GARDASIL. At the time of the report, the patient had not recovered. Patient's fever of 103F, viral sores in mouth, sore throat, chills, bleeding in her throat and cannot swallow were considered to be disabling by the reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Malaise, Oropharyngeal pain, Pyrexia, Stomatitis
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no known drug reactions or allergies who in July 2010, was vaccinated with a first dose of GARDASIL (Lot# unknown). Second dose of GARDASIL (Lot# unknown) was given on 01-SEP-2010. Concomitant therapy included unspecified birth control pill. The consumer stated that after the first dose of GARDASIL the patient did not have any adverse effect. The consumer reported that in the evening of 02-SEP-2010, her daughter became very ill with a fever of 103F, viral sores in mouth, sore throat and chills. The consumer stated that her daughter was bleeding in her throat and could not swallow. The patient was taking to the emergency room Monday, on 06-SEP-2010, and a tested for strep throat was done which was negative. The mother said that her daughter had missed college classes, and was taking MOTRIN and TYLENOL, and could not swallow. She also stated that she was planning to contact her daughter's physician. The mother adds that her daughter declines her third dose of GARDASIL. At the time of the report, the patient had not recovered. Patient's fever of 103F, viral sores in mouth, sore throat, chills, bleeding in her throat and cannot swallow were considered to be disabling by the reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test negative
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no known drug reactions or allergies who in July 2010, was vaccinated with a first dose of GARDASIL (Lot# unknown). Second dose of GARDASIL (Lot# unknown) was given on 01-SEP-2010. Concomitant therapy included unspecified birth control pill. The consumer stated that after the first dose of GARDASIL the patient did not have any adverse effect. The consumer reported that in the evening of 02-SEP-2010, her daughter became very ill with a fever of 103F, viral sores in mouth, sore throat and chills. The consumer stated that her daughter was bleeding in her throat and could not swallow. The patient was taking to the emergency room Monday, on 06-SEP-2010, and a tested for strep throat was done which was negative. The mother said that her daughter had missed college classes, and was taking MOTRIN and TYLENOL, and could not swallow. She also stated that she was planning to contact her daughter's physician. The mother adds that her daughter declines her third dose of GARDASIL. At the time of the report, the patient had not recovered. Patient's fever of 103F, viral sores in mouth, sore throat, chills, bleeding in her throat and cannot swallow were considered to be disabling by the reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female patient with depression and anxiety disorder, and VICODIN allergy and a history of pregnancy, who on an unspecified date was vaccinated with the complete series of GARDASIL (Lots# not reported). The nurse practitioner stated that on an unspecified time in the past, the patient had since developed a seizure disorder and was ongoing abdominal pain. The patient was evaluated at an unspecified emergency room at some unspecified time in the past and was seen by a neurologist. At the time of the report, the patient had not recovered. Upon internal review, seizure disorder was determined to be an other important medical event. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Cough, Diarrhoea, Feeling abnormal
Clinical narrative: Diarrhea, Sweating, Chills, Feeling very Bad, Body Aches, Cough, not being able to work.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pain
Clinical narrative: Diarrhea, Sweating, Chills, Feeling very Bad, Body Aches, Cough, not being able to work.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Back pain, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Catheterisation cardiac, Chest pain
Clinical narrative: Also had Chest Pain starting on 9/2/2010.  Woke up at 0200 have severe chest pain, shortness of breath, mid-back pain, dizzy.  Patient went to ED at approximately 0800AM, transferred to another facility and was admitted into ICU.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Computerised tomogram, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Also had Chest Pain starting on 9/2/2010.  Woke up at 0200 have severe chest pain, shortness of breath, mid-back pain, dizzy.  Patient went to ED at approximately 0800AM, transferred to another facility and was admitted into ICU.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Intensive care, Nuclear magnetic resonance imaging, Troponin I
Clinical narrative: Also had Chest Pain starting on 9/2/2010.  Woke up at 0200 have severe chest pain, shortness of breath, mid-back pain, dizzy.  Patient went to ED at approximately 0800AM, transferred to another facility and was admitted into ICU.
Age: 1.07
Sex: M
Vaccine: FLUX, MMR
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash generalised
Clinical narrative: Cranky, reduced appetite, fever (under 102 F), non-itchy rash over body & face.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Acute respiratory failure, Ataxia, Hemiparesis, Nuclear magnetic resonance imaging
Clinical narrative: Patient developed ataxia, left-sided weakness, was admitted to hospital 9/13/2010. She ultimately had acute respiratory failure related to her weakness. Weakness was progressive, imaging (MRI) with possible demyelinating process.
Age: 22.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Chest discomfort, Dysgeusia, Dysphagia, Eyelid margin crusting, Swollen tongue
Clinical narrative: PATIENT REPORTED SWOLLEN TONGUE WITH DIFFICULTY IN SWALLOWING. RIB TIGHTNESS. ALTERED TASTE WITHIN 24 HOURS OF VACCINE. CRUSTY EYE NEXT MORNING FOLLOWING VACCINATION.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Eye pruritus, Injection site erythema, Injection site swelling
Clinical narrative: Ache, pain, swelling, redness, trouble breathing, itchy eyes.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: Ache, pain, swelling, redness, trouble breathing, itchy eyes.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site reaction, Injection site urticaria, Muscle twitching
Clinical narrative: Muscle twitching at injection site, "welt" at injection site, nausea, headache, dizziness.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Muscle twitching at injection site, "welt" at injection site, nausea, headache, dizziness.
Age: 66.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Hyperhidrosis, Malaise
Clinical narrative: Felt generally sick.  Intestinal distress, violent BM.  Nauseous. Sweating. Then chills, vomiting, high fever of 102.1 for several hours despite Tylenol and 2 hours later aspirin. Gave fever reducers two more times. At 2:00AM fever was down to 101.1. By 8:00AM on following morning, 9/16/10 fever was normal.
Age: 66.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Felt generally sick.  Intestinal distress, violent BM.  Nauseous. Sweating. Then chills, vomiting, high fever of 102.1 for several hours despite Tylenol and 2 hours later aspirin. Gave fever reducers two more times. At 2:00AM fever was down to 101.1. By 8:00AM on following morning, 9/16/10 fever was normal.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection
Clinical narrative: Patient left on the bandaid that had been applied at time of vaccine for over a week. Patient's wife noticed a small sore on the upper arm of patient during the weekend. Approximately half an inch wet sore with some reddness on upper left arm viewed by two pharmacists at this location on Monday. Advised patient to apply neosporin twice daily and replace bandaid at each application.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Cellulitis at site of injection.  Severe swelling and erythema.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Pyrexia
Clinical narrative: Light headed, very weak, chills & fever.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Myalgia, Pain
Clinical narrative: Soreness, Muscle pain, numbness, difficulty moving arm.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Injection site swelling, Skin irritation
Clinical narrative: Local redness and irritation. Swelling and soreness around the injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Injected limb mobility decreased, Injection site induration, Injection site oedema, Neck pain
Clinical narrative: Mother describes day after vaccination left arm pronounced hard raised edema most severe around injection site, but edema extended from shoulder to elbow of left arm. Also pain extending into neck. Reports limited range of motion in arm during most pronounced edema. Edema lasted for 2 weeks after vaccine administered. Also mother reports her daughter had a headache and vomiting for 3 days after vaccines administered, and a fever that started night after vaccination with a duration of 2 days.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mother describes day after vaccination left arm pronounced hard raised edema most severe around injection site, but edema extended from shoulder to elbow of left arm. Also pain extending into neck. Reports limited range of motion in arm during most pronounced edema. Edema lasted for 2 weeks after vaccine administered. Also mother reports her daughter had a headache and vomiting for 3 days after vaccines administered, and a fever that started night after vaccination with a duration of 2 days.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Vomiting
Clinical narrative: Severe vomiting, lasting overnight.  Pt is still feeling sick today 9/16/10.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Ecchymosis, Haemoglobin normal, Immunoglobulin therapy, Mouth haemorrhage
Clinical narrative: Received vaccine 9/04/2010 at approximately 3:00 pm.  The following day he was doing yard work at home at the end of the day when he noted what he thought were hives on his upper arms and trunk area and some bruising on his legs.  During the night, he awoke with what he describes as a blister inside his mouth.  He ruptured this and it continued to spread and bleed throughout the night.  The following day (9/06/2010) he awoke with some ecchymosis on his face.  He also stated that when brushing his teeth that morning he noted that his buccal membrane was sloughing off as well as bleeding.  He presented to the ED where he was found to have a platelet count of 3,000 with a normal hemoglobin and white count.  He denies any bleeding from the nose, GI tract, urine.  No headaches, cough, SOB, bone pain.  Treatment:  Rho (D) immune globulin 1400 mcg IV, immune globulin gamma, dexamethasone 40 mg IV
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Oral mucosal exfoliation, Oropharyngeal blistering, Platelet count decreased, White blood cell count normal
Clinical narrative: Received vaccine 9/04/2010 at approximately 3:00 pm.  The following day he was doing yard work at home at the end of the day when he noted what he thought were hives on his upper arms and trunk area and some bruising on his legs.  During the night, he awoke with what he describes as a blister inside his mouth.  He ruptured this and it continued to spread and bleed throughout the night.  The following day (9/06/2010) he awoke with some ecchymosis on his face.  He also stated that when brushing his teeth that morning he noted that his buccal membrane was sloughing off as well as bleeding.  He presented to the ED where he was found to have a platelet count of 3,000 with a normal hemoglobin and white count.  He denies any bleeding from the nose, GI tract, urine.  No headaches, cough, SOB, bone pain.  Treatment:  Rho (D) immune globulin 1400 mcg IV, immune globulin gamma, dexamethasone 40 mg IV
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis of left arm
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Injection site pain, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Stiffness and pain in vaccinated arm (left) within hours of injection. Stiffness subsided, but deep pain at injection site with movement and non-weighted or weighted lifting of arm. I cannot sleep on my left side and I have pain when removing clothing by lifting up over my head. I have a fairly high pain threshold normally, but I have had to take Advil before sleeping to be comfortable. I have not sen a doctor because I am currently changing health coverage and I am hesitant to report something that might be considered an pre-existing condition, precluding coverage. Please advise.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Stiffness and pain in vaccinated arm (left) within hours of injection. Stiffness subsided, but deep pain at injection site with movement and non-weighted or weighted lifting of arm. I cannot sleep on my left side and I have pain when removing clothing by lifting up over my head. I have a fairly high pain threshold normally, but I have had to take Advil before sleeping to be comfortable. I have not sen a doctor because I am currently changing health coverage and I am hesitant to report something that might be considered an pre-existing condition, precluding coverage. Please advise.
Age: 24.0
Sex: F
Vaccine: FLUN3, MMRV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: 09/14/2010 Mild other patient was supposed to receive MMR, but was given PROQUAD instead.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Joint fluid drainage, Joint range of motion decreased, Joint swelling, Oedema peripheral
Clinical narrative: 24 hours after vaccines administered both knees began to swell. After 5 days R. knee swelling subsided but L. knee worsened to include L. thigh, calf and ankle/foot. SynviscOne Injections both knees 8-19-2010. Eight days before vaccines. These injections were done by orthopedic surgeon. Both knees were still inflamed from these injections when vaccines administered 8-27-2010. Left knee was drained by doctor on 9-1-2010 and knee fluid sent for testing. Informed by doctor on 9-7-2010 (while in hospital) that tests were negative and there is no infection. Must be vaccines. Went to ER on 9-4-2010 and admitted due to high white blood cell count, +18,000. Antibiotics administered by IV until 9-7-2010 when it was determined there was no infection. Began Colchicine meds (in case of gout) and VOLTAREN Gel 9-7-2010, per doctor. Released from hospital 9-8-2010. Left knee drained and joint fluid tested on 9-7-2010 and 9-13-2010 by doctor (rheumatologist). Currently under his care. Tests have shown no gout or pseudo-gout. As of 9-15-2010 swelling in left thigh, calf and ankle/foot has subsided. Left knee is still somewhat swollen and cannot bend knee more than 90 degrees. Currently taking 600 mg. Ibuprofen and PROPOXYPHEN-APAP. Left arm muscle where pneumococcal vaccine was administered is still sore.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Synovial fluid analysis normal, White blood cell count increased
Clinical narrative: 24 hours after vaccines administered both knees began to swell. After 5 days R. knee swelling subsided but L. knee worsened to include L. thigh, calf and ankle/foot. SynviscOne Injections both knees 8-19-2010. Eight days before vaccines. These injections were done by orthopedic surgeon. Both knees were still inflamed from these injections when vaccines administered 8-27-2010. Left knee was drained by doctor on 9-1-2010 and knee fluid sent for testing. Informed by doctor on 9-7-2010 (while in hospital) that tests were negative and there is no infection. Must be vaccines. Went to ER on 9-4-2010 and admitted due to high white blood cell count, +18,000. Antibiotics administered by IV until 9-7-2010 when it was determined there was no infection. Began Colchicine meds (in case of gout) and VOLTAREN Gel 9-7-2010, per doctor. Released from hospital 9-8-2010. Left knee drained and joint fluid tested on 9-7-2010 and 9-13-2010 by doctor (rheumatologist). Currently under his care. Tests have shown no gout or pseudo-gout. As of 9-15-2010 swelling in left thigh, calf and ankle/foot has subsided. Left knee is still somewhat swollen and cannot bend knee more than 90 degrees. Currently taking 600 mg. Ibuprofen and PROPOXYPHEN-APAP. Left arm muscle where pneumococcal vaccine was administered is still sore.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever slowly moving from 100.4 to 101.9 over the course of a few hours. Shivers with it. My temp is usually 96.8 not 98.6 so this was a high fever for me.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Unconsolable crying, redness and swelling of left leg.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Body temperature normal, Herpes zoster, Pain, Rash erythematous
Clinical narrative: Information has been received from a physician assistant concerning a 72 year old female with allergy to sulfa, XYLOCAINE, morphine and erythromycin and no pertinent medical history who on 02-NOV-2000 was vaccinated with ZOSTAVAX (Merck) (Lot# 664627/0876Y, SC). Concomitant therapy included NEXIUM, ALLEGRA, LEVOXYL, calcium (unspecified), vitamin D (unspecified), aspirin and finasteride (manufacturer unknown). On 13-AUG-2010 the patient developed zoster. The patient had a raised red blister rash on her back. The patient had been seen by the physician. The physician prescribed VALTREX and NEURONTIN. There was no lab or diagnostic test performed. At the time of the report, the patient had not recovered from the events. Follow-up information received from a physician assistant concerning a 72 year old female with no illness at time of vaccination, who on 02-NOV-2000 at 9:00 am was vaccinated with a single dose of ZOSTAVAX (Merck) (lot# 664627/0876Y) SC in the left deltoid. On 16-AUG-2010 the patient developed shingles in the left thoracic trunk distribution (T5-6 dermatomal distribution). The patient had maximum temperature 98F, pain (4 degree), and no other systemic symptoms. No rash occurred at the site of injection or else where within 42 days of the vaccination. The patient had a history of chickenpox and there was no recent exposure to chickenpox or herpes zoster. There were no direct fluorescent antibody done and no specimen collected for PCR. No photo was taken. The patient required medical/surgical intervention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: After vaccines child vomited x5 (@ home).
Age: 1.52
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Fever & diffuse maculopapular rash.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Hyperhidrosis, Lethargy, Night sweats
Clinical narrative: Flu vaccine received 9/13/10. Patient contacted MD office 9/15/10 at 1030 stating on 9/14/10 he had chills, shivering, lethargy, low grade temp. and body aches. Did not take temperature. Slept from 4:00pm to 9:00 pm, woke up to eat supper, went back to bed at 9:30 pm and slept until 5:30 am on 9/15/10. Bed was soaking wet in the morning. Took Motrin 600 mg 9/14/10. Stated felt fine when called.    Pt. called back at 1500 on 9/15/10 stating he had a temperature of 101 (tympanic)and aches in legs and lt arm where injection received. Took 1 gram of tylenol 15 minutes prior to call and stated was starting to feel better.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Flu vaccine received 9/13/10. Patient contacted MD office 9/15/10 at 1030 stating on 9/14/10 he had chills, shivering, lethargy, low grade temp. and body aches. Did not take temperature. Slept from 4:00pm to 9:00 pm, woke up to eat supper, went back to bed at 9:30 pm and slept until 5:30 am on 9/15/10. Bed was soaking wet in the morning. Took Motrin 600 mg 9/14/10. Stated felt fine when called.    Pt. called back at 1500 on 9/15/10 stating he had a temperature of 101 (tympanic)and aches in legs and lt arm where injection received. Took 1 gram of tylenol 15 minutes prior to call and stated was starting to feel better.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Abdominal discomfort, Dizziness
Clinical narrative: Mother states patient had dizziness and upset stomach the day following vaccination. Called family doctor but did not seek medical care nor report symptoms to health department. Report of adverse event received by health department on 9/16/2010.
Age: 34.0
Sex: F
Vaccine: MMRV, TD
Symptoms: Hypoventilation, Local reaction
Clinical narrative: Mild sensation of inability to take deep breath.  Small local reaction at sites of injection.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Confusional state, Crying, Decreased appetite, Diarrhoea
Clinical narrative: Fever for 2 days up to 102 degrees.  Loss of appetite, agitation, confusion, diarrhea, hallucinations, irritability, mood/mental changes when she tries to sleep.  Wakes up 30-40 times per night very confused and crying stating that the "house is shaking"...very agitated.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Hallucination, Irritability, Mental status changes, Mood altered, Pyrexia
Clinical narrative: Fever for 2 days up to 102 degrees.  Loss of appetite, agitation, confusion, diarrhea, hallucinations, irritability, mood/mental changes when she tries to sleep.  Wakes up 30-40 times per night very confused and crying stating that the "house is shaking"...very agitated.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Fever for 2 days up to 102 degrees.  Loss of appetite, agitation, confusion, diarrhea, hallucinations, irritability, mood/mental changes when she tries to sleep.  Wakes up 30-40 times per night very confused and crying stating that the "house is shaking"...very agitated.