chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Large hives started in the evening of 6/22/10 on small of back, torso and legs. Treatment: BENADRYL and ORAPRED.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: Pt first leaned forward and then leaned back in chair. Unresponsive.  Moved pt to the floor and applied cold compress to forehead.  Pulse was 60.  Pt responded to verbal stimuli after lying on the floor.  Was drowsy and oriented.  After 5 minutes assisted pt to sit up on floor. Pt tolerated well.  8:35 am pt walked out of office without ill effect.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Patient received a Tdap booster on 6-28-2010.  Her last booster was 11-23-2009.  Left arm was red and warm to touch after injection.
Age: 59.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Chest pain, Confusional state, Electrocardiogram normal, Injection site pruritus, Palpitations
Clinical narrative: 2:35 ITCHING @ SITE OF MMR (SQ OVER R TRICEP) & VARICELLA (SQ OVER L TRICEP) VACCINES. 2:40 C/O CONFUSION; PLACED IN RECUMBENT POSITION. 2:45 C/O PALPITATIONS; CALLED 911; BP 157/99; P 66. 3:00 EMTs ARRIVE; 12 LEAD EKG UNREMARKABLE. 3:10 CLIENT C/O CHEST PAIN; EMTs TRANSPORT.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Culture throat, Erythema, Pruritus, Rash
Clinical narrative: Itching, redness, rash on torso, legs and arms, but not at vaccination site. Also stated was slight coughing.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Streptococcus test negative
Clinical narrative: Itching, redness, rash on torso, legs and arms, but not at vaccination site. Also stated was slight coughing.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Acne cystic, Activities of daily living impaired, Alopecia, Arthralgia
Clinical narrative: Information has been received from parents concerning their daughter who in April 2008, was vaccinated with the first dose of GARDASIL (LOT# not reported). The parents reported that their daughter was a healthy, energetic, outgoing, active beautiful girl until the April 2008 when she was administered her first GARDASIL shot. From that day forward, her quality of life has drastically deteriorated. It started when the plunger of the syringe hit the bottom of the tube and she turned pale white, her eyes rolled back in her head; she twitched (as if she was having a seizure) and fainted. For the past two years, their daughter has been suffering debilitating stomach pain, severe migraine headaches, severe hair loss, severe dizziness, severe muscle & joint pain, severe fatigue & weakness, severe seizures & fainting, severe cystic acne and severe menstrual abnormalities, every single one of these painful changes in her life are severe, not mild or normal. The parents stated that they have made numerous trips to doctor's offices, specialists, alternative medicine practitioners, dermatologists and ER room. She has made numerous CT scans of the stomach and brain as well as many blood tests and general evaluations. All of these tests hadn't been able to determine the cause of her problems but they started when she was given the GARDASIL shot. Their daughter's life had greatly deteriorated over the past 2 years and continued to do so. On her good days she felt sick to her stomach, tired and didn't want to do anything but lay around. She was starting to demonstrate signs of depression; she didn't want to go visit with her friends anymore because of the constant pain. She was falling behind in her school work because she couldn't concentrate. Her acne was so bad and she was ashamed to go outside of the house. The parents stated that their daughter (who was an actress) had lost much of her confidence, due to the acne and constant pain, and wasn't able to audition with the same sparkle she once had. She was a very active girl who loved skiing, 4 wheeling and running with her dog in the mountains behind their house. But now, she couldn't enjoy these normal activities because of the muscle pain and joint stiffness. This got much worse when it's cold so she was confined to the house in order to withstand the pain. The patient writhed around on the floor holding her stomach and crying from the pain, or sitting on the couch rubbing her joints to ease the pain. She had to deal with this every day. At this time of reporting, the patient's outcome was unknown. Upon internal review, severe seizures was considered to be an other important medical event and debilitating stomach pain and, joint and muscle pain were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Convulsion, Crying
Clinical narrative: Information has been received from parents concerning their daughter who in April 2008, was vaccinated with the first dose of GARDASIL (LOT# not reported). The parents reported that their daughter was a healthy, energetic, outgoing, active beautiful girl until the April 2008 when she was administered her first GARDASIL shot. From that day forward, her quality of life has drastically deteriorated. It started when the plunger of the syringe hit the bottom of the tube and she turned pale white, her eyes rolled back in her head; she twitched (as if she was having a seizure) and fainted. For the past two years, their daughter has been suffering debilitating stomach pain, severe migraine headaches, severe hair loss, severe dizziness, severe muscle & joint pain, severe fatigue & weakness, severe seizures & fainting, severe cystic acne and severe menstrual abnormalities, every single one of these painful changes in her life are severe, not mild or normal. The parents stated that they have made numerous trips to doctor's offices, specialists, alternative medicine practitioners, dermatologists and ER room. She has made numerous CT scans of the stomach and brain as well as many blood tests and general evaluations. All of these tests hadn't been able to determine the cause of her problems but they started when she was given the GARDASIL shot. Their daughter's life had greatly deteriorated over the past 2 years and continued to do so. On her good days she felt sick to her stomach, tired and didn't want to do anything but lay around. She was starting to demonstrate signs of depression; she didn't want to go visit with her friends anymore because of the constant pain. She was falling behind in her school work because she couldn't concentrate. Her acne was so bad and she was ashamed to go outside of the house. The parents stated that their daughter (who was an actress) had lost much of her confidence, due to the acne and constant pain, and wasn't able to audition with the same sparkle she once had. She was a very active girl who loved skiing, 4 wheeling and running with her dog in the mountains behind their house. But now, she couldn't enjoy these normal activities because of the muscle pain and joint stiffness. This got much worse when it's cold so she was confined to the house in order to withstand the pain. The patient writhed around on the floor holding her stomach and crying from the pain, or sitting on the couch rubbing her joints to ease the pain. She had to deal with this every day. At this time of reporting, the patient's outcome was unknown. Upon internal review, severe seizures was considered to be an other important medical event and debilitating stomach pain and, joint and muscle pain were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Depression, Disturbance in attention, Dizziness, Fatigue, Gaze palsy
Clinical narrative: Information has been received from parents concerning their daughter who in April 2008, was vaccinated with the first dose of GARDASIL (LOT# not reported). The parents reported that their daughter was a healthy, energetic, outgoing, active beautiful girl until the April 2008 when she was administered her first GARDASIL shot. From that day forward, her quality of life has drastically deteriorated. It started when the plunger of the syringe hit the bottom of the tube and she turned pale white, her eyes rolled back in her head; she twitched (as if she was having a seizure) and fainted. For the past two years, their daughter has been suffering debilitating stomach pain, severe migraine headaches, severe hair loss, severe dizziness, severe muscle & joint pain, severe fatigue & weakness, severe seizures & fainting, severe cystic acne and severe menstrual abnormalities, every single one of these painful changes in her life are severe, not mild or normal. The parents stated that they have made numerous trips to doctor's offices, specialists, alternative medicine practitioners, dermatologists and ER room. She has made numerous CT scans of the stomach and brain as well as many blood tests and general evaluations. All of these tests hadn't been able to determine the cause of her problems but they started when she was given the GARDASIL shot. Their daughter's life had greatly deteriorated over the past 2 years and continued to do so. On her good days she felt sick to her stomach, tired and didn't want to do anything but lay around. She was starting to demonstrate signs of depression; she didn't want to go visit with her friends anymore because of the constant pain. She was falling behind in her school work because she couldn't concentrate. Her acne was so bad and she was ashamed to go outside of the house. The parents stated that their daughter (who was an actress) had lost much of her confidence, due to the acne and constant pain, and wasn't able to audition with the same sparkle she once had. She was a very active girl who loved skiing, 4 wheeling and running with her dog in the mountains behind their house. But now, she couldn't enjoy these normal activities because of the muscle pain and joint stiffness. This got much worse when it's cold so she was confined to the house in order to withstand the pain. The patient writhed around on the floor holding her stomach and crying from the pain, or sitting on the couch rubbing her joints to ease the pain. She had to deal with this every day. At this time of reporting, the patient's outcome was unknown. Upon internal review, severe seizures was considered to be an other important medical event and debilitating stomach pain and, joint and muscle pain were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: General physical health deterioration, Joint stiffness, Menstrual disorder, Migraine, Muscle twitching
Clinical narrative: Information has been received from parents concerning their daughter who in April 2008, was vaccinated with the first dose of GARDASIL (LOT# not reported). The parents reported that their daughter was a healthy, energetic, outgoing, active beautiful girl until the April 2008 when she was administered her first GARDASIL shot. From that day forward, her quality of life has drastically deteriorated. It started when the plunger of the syringe hit the bottom of the tube and she turned pale white, her eyes rolled back in her head; she twitched (as if she was having a seizure) and fainted. For the past two years, their daughter has been suffering debilitating stomach pain, severe migraine headaches, severe hair loss, severe dizziness, severe muscle & joint pain, severe fatigue & weakness, severe seizures & fainting, severe cystic acne and severe menstrual abnormalities, every single one of these painful changes in her life are severe, not mild or normal. The parents stated that they have made numerous trips to doctor's offices, specialists, alternative medicine practitioners, dermatologists and ER room. She has made numerous CT scans of the stomach and brain as well as many blood tests and general evaluations. All of these tests hadn't been able to determine the cause of her problems but they started when she was given the GARDASIL shot. Their daughter's life had greatly deteriorated over the past 2 years and continued to do so. On her good days she felt sick to her stomach, tired and didn't want to do anything but lay around. She was starting to demonstrate signs of depression; she didn't want to go visit with her friends anymore because of the constant pain. She was falling behind in her school work because she couldn't concentrate. Her acne was so bad and she was ashamed to go outside of the house. The parents stated that their daughter (who was an actress) had lost much of her confidence, due to the acne and constant pain, and wasn't able to audition with the same sparkle she once had. She was a very active girl who loved skiing, 4 wheeling and running with her dog in the mountains behind their house. But now, she couldn't enjoy these normal activities because of the muscle pain and joint stiffness. This got much worse when it's cold so she was confined to the house in order to withstand the pain. The patient writhed around on the floor holding her stomach and crying from the pain, or sitting on the couch rubbing her joints to ease the pain. She had to deal with this every day. At this time of reporting, the patient's outcome was unknown. Upon internal review, severe seizures was considered to be an other important medical event and debilitating stomach pain and, joint and muscle pain were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Pain, Pallor, Psychiatric symptom
Clinical narrative: Information has been received from parents concerning their daughter who in April 2008, was vaccinated with the first dose of GARDASIL (LOT# not reported). The parents reported that their daughter was a healthy, energetic, outgoing, active beautiful girl until the April 2008 when she was administered her first GARDASIL shot. From that day forward, her quality of life has drastically deteriorated. It started when the plunger of the syringe hit the bottom of the tube and she turned pale white, her eyes rolled back in her head; she twitched (as if she was having a seizure) and fainted. For the past two years, their daughter has been suffering debilitating stomach pain, severe migraine headaches, severe hair loss, severe dizziness, severe muscle & joint pain, severe fatigue & weakness, severe seizures & fainting, severe cystic acne and severe menstrual abnormalities, every single one of these painful changes in her life are severe, not mild or normal. The parents stated that they have made numerous trips to doctor's offices, specialists, alternative medicine practitioners, dermatologists and ER room. She has made numerous CT scans of the stomach and brain as well as many blood tests and general evaluations. All of these tests hadn't been able to determine the cause of her problems but they started when she was given the GARDASIL shot. Their daughter's life had greatly deteriorated over the past 2 years and continued to do so. On her good days she felt sick to her stomach, tired and didn't want to do anything but lay around. She was starting to demonstrate signs of depression; she didn't want to go visit with her friends anymore because of the constant pain. She was falling behind in her school work because she couldn't concentrate. Her acne was so bad and she was ashamed to go outside of the house. The parents stated that their daughter (who was an actress) had lost much of her confidence, due to the acne and constant pain, and wasn't able to audition with the same sparkle she once had. She was a very active girl who loved skiing, 4 wheeling and running with her dog in the mountains behind their house. But now, she couldn't enjoy these normal activities because of the muscle pain and joint stiffness. This got much worse when it's cold so she was confined to the house in order to withstand the pain. The patient writhed around on the floor holding her stomach and crying from the pain, or sitting on the couch rubbing her joints to ease the pain. She had to deal with this every day. At this time of reporting, the patient's outcome was unknown. Upon internal review, severe seizures was considered to be an other important medical event and debilitating stomach pain and, joint and muscle pain were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Scan brain, Syncope
Clinical narrative: Information has been received from parents concerning their daughter who in April 2008, was vaccinated with the first dose of GARDASIL (LOT# not reported). The parents reported that their daughter was a healthy, energetic, outgoing, active beautiful girl until the April 2008 when she was administered her first GARDASIL shot. From that day forward, her quality of life has drastically deteriorated. It started when the plunger of the syringe hit the bottom of the tube and she turned pale white, her eyes rolled back in her head; she twitched (as if she was having a seizure) and fainted. For the past two years, their daughter has been suffering debilitating stomach pain, severe migraine headaches, severe hair loss, severe dizziness, severe muscle & joint pain, severe fatigue & weakness, severe seizures & fainting, severe cystic acne and severe menstrual abnormalities, every single one of these painful changes in her life are severe, not mild or normal. The parents stated that they have made numerous trips to doctor's offices, specialists, alternative medicine practitioners, dermatologists and ER room. She has made numerous CT scans of the stomach and brain as well as many blood tests and general evaluations. All of these tests hadn't been able to determine the cause of her problems but they started when she was given the GARDASIL shot. Their daughter's life had greatly deteriorated over the past 2 years and continued to do so. On her good days she felt sick to her stomach, tired and didn't want to do anything but lay around. She was starting to demonstrate signs of depression; she didn't want to go visit with her friends anymore because of the constant pain. She was falling behind in her school work because she couldn't concentrate. Her acne was so bad and she was ashamed to go outside of the house. The parents stated that their daughter (who was an actress) had lost much of her confidence, due to the acne and constant pain, and wasn't able to audition with the same sparkle she once had. She was a very active girl who loved skiing, 4 wheeling and running with her dog in the mountains behind their house. But now, she couldn't enjoy these normal activities because of the muscle pain and joint stiffness. This got much worse when it's cold so she was confined to the house in order to withstand the pain. The patient writhed around on the floor holding her stomach and crying from the pain, or sitting on the couch rubbing her joints to ease the pain. She had to deal with this every day. At this time of reporting, the patient's outcome was unknown. Upon internal review, severe seizures was considered to be an other important medical event and debilitating stomach pain and, joint and muscle pain were considered to be disabling. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Small cell carcinoma
Clinical narrative: Information has been received from a 70 year old female consumer who about two years ago, in approximately 2008 was vaccinated with a dose of ZOSTAVAX (Merck). It was reported that within the past 6 months she developed shingles on abdomen and right rib cage with itching. The patient recently was diagnosed with small cell cancer. At the time of the report, the patient had not recovered. The patient was seen by the physician. Upon internal review small cell cancer was considered to be an other important medical event. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood test, Lumbar puncture, Myelitis transverse, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: Contracted transverse myelitis-acute symptoms occurring on 1-23-10, took 1 hour to cause paraplegia from first symptoms. Treated with Prednisone steroids and Physical rehabilitation.
Age: 44.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Paraplegia
Clinical narrative: Contracted transverse myelitis-acute symptoms occurring on 1-23-10, took 1 hour to cause paraplegia from first symptoms. Treated with Prednisone steroids and Physical rehabilitation.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Cough, Hypophagia, Irritability, Rhinorrhoea
Clinical narrative: Pt. presents with intermittent dry cough that began 24 hours after vaccine administration. Mother also reports green nasal discharge since onset of cough. He has been irritable and feeding less than usual.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Dyspnoea, Feeling hot, Headache, Nausea
Clinical narrative: Awoke with headache, hot, nausea, short of breath, body aches, temperature at 7 AM 103 degrees. Instructed to take TYLENOL and/or Ibuprofen. Office check 4 PM 6/22 - improved.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pain
Clinical narrative: Awoke with headache, hot, nausea, short of breath, body aches, temperature at 7 AM 103 degrees. Instructed to take TYLENOL and/or Ibuprofen. Office check 4 PM 6/22 - improved.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Body temperature increased
Clinical narrative: Pt developed a temp greater than 100 following vaccines.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: 10:15 - PT was given 3 vaccines: HPV in (R) thigh, and MCV and hepatitis A in (L) thigh. She was in supine position. Afterwards Pt stood up and became dizzy and pale. Sat down with water, voiced concerns of vomiting, and then said she felt better. 10:25 - MD was brought into room, talked to PT. MD said common s/e of HPV are dizziness, paleness. Pt soon then bent over and vomited twice. Pt was helped onto exam table. 10:30 - PT was given a cold cloth for her forehead, and immediately voiced, "I feel better." Vitals were monitored. Pt remained in office x 10 minutes for observation. She was slowly brought into standing position again. MD asked father to keep PT's activities "light for the day." Father agreed, and Pt left clinic with father.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4, MNQ, TDAP, VARCEL
Symptoms: Confusional state, Erythema, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: Red swollen arm, neck stiffness, confusion lasted 3 days +
Age: 47.0
Sex: U
Vaccine: HEP
Symptoms: Computerised tomogram, Fatigue, Infection, Malaise, X-ray
Clinical narrative: 4 months multiple infection, sickness, fatigue etc etc. Severe adverse reaction, almost fatal 1 xray, 3 panoramic X rays, 1 CAT scan, 1 CAT scan with dye, AVELOX, CLINDAMYCIN, PREDNISONE, ERYTHROMYCIN, DELODIN, etc etc.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal behaviour, Convulsion, Pupils unequal
Clinical narrative: 6-10-10 well check and immz done upon visit mom states she thinks (R) pupil is larger than left. 6-14-10 mom put in and states she believed childs personality has changed and question if he has autism. 6-21-10 pt was taken to ER for seizures.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Heart rate normal, Hyperhidrosis, Vision blurred
Clinical narrative: Pt light headed states vision blurry. Sat down for a bit then layed down. Parents with pt. Pt felt better and went home. Some sweating.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: After shot had some local soreness after 3 months still hurting whole upper arm muscle cannot raise arm or put behind back really sore and getting worse. Whole upper arm now hurting. ALEVE or TYLENOL not working for pain. She reported to us first time 6/15/2010.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: After shot had some local soreness after 3 months still hurting whole upper arm muscle cannot raise arm or put behind back really sore and getting worse. Whole upper arm now hurting. ALEVE or TYLENOL not working for pain. She reported to us first time 6/15/2010.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: *Left upper arm pain for 3 months - then soreness and pain of left upper arm, unable to have upper arm - backward and forward and upward the pain and soreness become worse to this date - (8 months) 6/26/10.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: *Left upper arm pain for 3 months - then soreness and pain of left upper arm, unable to have upper arm - backward and forward and upward the pain and soreness become worse to this date - (8 months) 6/26/10.
Age: 1.97
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Swelling face, Urticaria
Clinical narrative: Urticaria, facial swelling.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Half of vaccine dosage was administered.
Age: 10.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Half of vaccine dosage was administered.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Half of vaccine dosage was administered.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Half of vaccine dosage was administered.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Half of vaccine dosage was administerd.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Nurse administered half of vaccine dosage.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Migraine, Uveitis, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a 37-year-old female subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified). Concurrent medications included PREDNISOLONE. On an unspecified date the subject received 1st dose of HEPATITIS B vaccine (unknown). Two days after vaccination with HEPATITIS B vaccine, the subject experienced uveitis, confusion, migraine and vomiting. This case was assessed as medically serious by GSK. This is one of the 32 reported cases of uveitis which occurred after HEPATITIS B vaccine between 1982 and 2009 (B0662267A till B0662297A). It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of HEPATITIS B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Optic neuritis, Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a 36-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent medications included LEVOTHYROXINE. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced uveitis, arthritis and optic neuritis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. (B0662267 till B0662297A). It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis b antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Choroiditis
Clinical narrative: This case was reported in a literature article and described the occurrence of posterior uveitis in a 29-year-old male subject who was vaccinated with Hepatitis B (manufacturer unspecified). On an unspecified date the subject received 1st dose of Hepatitis B (unknown). Ten days after vaccination with Hepatitis B, the subject experienced posterior uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis B vaccine between 1982 and 2009. It appeared that all subjects recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a 52-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received 1st dose of Hepatitis B vaccine (unknown). One day after vaccination with Hepatitis B vaccine, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurred because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Influenza like illness, Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a 35-year-old female subject who was vaccinated with Hepatitis B (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B (unknown). At an unspecified time after vaccination with Hepatitis B, the subject experienced uveitis, influenza like symptoms, arthralgia and arthritis. This case was assessed as medically serious by GSK. This is one of 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis B vaccine between 1982 and 2009. It appeared that all subjects recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Pyrexia, Uveitis
Clinical narrative: This case was reported and described the occurrence of uveitis in a 45-year-old female subject who was vaccinated with Hepatitis B vaccine, (manufacture unspecified). Concurrent medications included Fluoxetine. On an unspecified date the subject received 1st dose of Hepatitis B vaccine (unknown). Two days after vaccination with Hepatitis B vaccine, the subject experienced uveitis, fatigue and fever. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complexes deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Chest pain, Diarrhoea, Dizziness, Pain
Clinical narrative: Pain, fever w/diarrhea on 4/24/10 AM very bad swelling w/pain all day fever of 101 and 103 on 4/25/10 began to burn, light chest pain, dizziness. 4/26/10 unbearable went to hospital.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: Pain, fever w/diarrhea on 4/24/10 AM very bad swelling w/pain all day fever of 101 and 103 on 4/25/10 began to burn, light chest pain, dizziness. 4/26/10 unbearable went to hospital.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Muscle spasms
Clinical narrative: Had bad chest pain - felt like spasms - started wed 5/26/10 - Thurs 5/27/10 was worse - Fri 5/28/10 it subsided - not stopped. I was away from home - and didn't want to go to strange hospital & doctor.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a 16-year-old female subject who was vaccinated with HEPATITIS B (manufacturer unspecified). On an unspecified date the subject received unspecified dose of HEPATITIS B vaccine (unknown). At an unspecified time after vaccination with HEPATITIS B vaccine, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 20.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Local reaction
Clinical narrative: VARIVAX vaccine given in (R) arm subq. local reaction to vaccine.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Dyspnoea, Pyrexia, Urticaria
Clinical narrative: Pt. got 2 yr vaccinations. About 2 - 3 hrs later started with hives all over the body with difficulty in breathing. Went to ER. Got DECADRON & ALBUTEROL after which recovered. Also had fever of 103.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Optic neuritis, Retinitis, Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a 11-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). On an unspecified date the subject received 1st dose of Hepatitis B vaccine (unknown). One day after vaccination with Hepatitis B vaccine, the subject experienced uveitis, optic neuritis and retinitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after Hepatitis B vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Erythema, Skin warm
Clinical narrative: (R) thigh: 5" area erythema and warmth no induration on 6/23/10.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Cough, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: Cough, weakness, dizziness, fatigue, diaphoresis. Onset Sx shortly after immunization given (per pt hx). Sx all consistent with hypersensitivity to vaccine.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Fibrin D dimer normal, Full blood count, Hyperhidrosis, Hypersensitivity, Metabolic function test
Clinical narrative: Cough, weakness, dizziness, fatigue, diaphoresis. Onset Sx shortly after immunization given (per pt hx). Sx all consistent with hypersensitivity to vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Approximately 24 hours after vaccination patient developed 4" x 6" area of redness, swelling, and tenderness. This area began about 3' below injection site. No open areas or blistering. Pain 2-3 on 0-10 scale. Treatment advised elevation, cold compress, TYLENOL and BENADRYL.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence on uveitis in a 12-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurred because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed  immune complexes which initiated the ocular response of uveitis.
Age: 0.61
Sex: F
Vaccine: HEP, HIBV, PNC13
Symptoms: Diarrhoea, Platelet count decreased, Pyrexia, Rash
Clinical narrative: Fever started eight hours after vaccine. Rash 12 hours after vaccine. 3 soft stools 24 hours after vaccine.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a 35-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received 1st dose of Hepatitis B vaccine (unknown). One day after vaccination with Hepatitis B vaccine, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A). It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Lymphangitis
Clinical narrative: VZV received 6-17-10 - 24 hours later site started swelling and started with red streaking & worsened over next 2 days - seen in Dr office 6-21-10 - lymphangitis diagnosis at site.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a 11-year-old male subject who was vaccinated with Hepatitis B (manufacturer unspecified). On an unspecified date the subject received 2nd dose of Hepatitis B (unknown). Two days after vaccination with Hepatitis B, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis B vaccine between 1982 and 2009. It appeared that all subjects recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None.  No adverse reaction was noted before she left.
Age: 10.0
Sex: M
Vaccine: HEPA, MEN, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Painful, localized erythema over injection site.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a 16-year-old female subject who was vaccinated with Hepatitis B (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B (unknown). At an unspecified time after vaccination with Hepatitis B, the subject experienced uveitis,. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Age: 1.33
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Body temperature increased, Drooling, Gaze palsy, Muscle twitching
Clinical narrative: Per mom approx. 7 hours after receiving vaccines. Patient had temperature at home of 101.8 and then eyes rolled in back of head, drooling from mouth and body twitching. Mom immediately took patient to hospital ER and pt. was examined and no treatment necessary.
Age: 1.33
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Per mom approx. 7 hours after receiving vaccines. Patient had temperature at home of 101.8 and then eyes rolled in back of head, drooling from mouth and body twitching. Mom immediately took patient to hospital ER and pt. was examined and no treatment necessary.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a 44-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received 1st dose of Hepatitis B vaccine (unknown). One day after vaccination with Hepatitis B vaccine, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A). It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.