chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.8
Sex: F
Vaccine: IPV, PNC
Symptoms: Injection site erythema, Pruritus, Pyrexia, Urticaria
Clinical narrative: Pt experienced a fever of 101-102 with redness at injection site. Symptoms started 4 hours post vax and continued for 2 days. Pt then experienced hives all over with intense itching, lasting 5 days.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Ear disorder, Lethargy
Clinical narrative: Pt states he started having problems after 4th Anthrax (10 days post) he started having fluid in right ear, sinuses run clear. Pt experienced same symptoms on 5th and 6th shot. However after 6th shot he started feeling irritable and lethargic. He states it seems he cannot get enough sleep. He experienced lethargy with all of the shots. The lethargy lasts for about two months. Pt states right after the shots he had no energy. Pt was seen by MD and was prescribed Claritin for the fluid in the ear.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site oedema, Nausea
Clinical narrative: Pt experienced edema in the area of shot, nausea. No treatment was given.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Pt experienced hives on both arms, started at the injection site, pt prescribed dipenhydramine.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Jaundice
Clinical narrative: In January 2000, the pt experienced jaundice.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Post vax, the pt experienced an unspecified reaction.
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: Post vax, the pt tested false positive for hepatitis C. The pt sought unspecified medical treatment. Additionally, it was noted that another pt experienced a similar reaction.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Subsequently post vax, the pt experienced a dime size reaction at the injection site and erythema at injection site which has not yet resolved. The reaction is noted as painful with
Age: 5.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Asthma, Injection site oedema, Injection site rash, Pruritus
Clinical narrative: Information has been received from a physician concerning a 5 year old male with a history of asthma who on 1/7/99 was vaccinated with a second dose of Hep B vaccine. Comcomitant vaccinations are MMR. On 1/7/99, the pt experienced redness, swelling, itchiness and a rash at the injection site. The pt was treated with ice and Benadryl.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: On approximately 12/2/99, the pt had a pap smear as well as blood samples performed. The blood tests revealed elevated liver enzymes. The pt sought unspecified medical attention.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Myopathy
Clinical narrative: Information received regarding pt who received vax on 12/04/1998. On approximately 01/14/1999, the pt experienced generalized myopathy. The reporting physician noted that the pt has muscle weakness in the legs and arms, however, she does not have involuntary movements of the arms. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Multiple sclerosis
Clinical narrative: Information received regarding pt who received vax on 09/04/1998. ON 11/07/1998, the pt experienced tingling and numbness in the right arm. On 11/14, the numbness went to the right hand. The physician noted that the pt 'did notice some numbness and lack of feeling in the left leg in late October.' The pt quit her job in November due to 'numbness in left hand and arms.' The physician noted that the pt also noted some numbness in her chest. The pt's symptoms persisted. the reporting physician noted 'suspect possible multiple sclerosis' and also considered the pt's experiences disabling. It was noted that medical intervention was required. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received regarding a pt who, several hours post vax, experienced a rash and itching. The pt sought unspecified medical attention and took diphenhydramine hcl (Benadryl) to ease the itching. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Autoantibody positive
Clinical narrative: Pharmacist reported pt who received vax, and subsequently experienced an 'auto-immune like reaction.' Additionally, it was noted that another pt experienced a similar reaction. No further information is available.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: Pt received first and second doses of vax. Approximately 3 months post second vax, the pt presented with flu-like symptoms, ankle pain and knee pain that began about one month prior to physician's visit. The pt's blood work was negative. Approximately 2-3 months post onset, the pt recovered. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal, Lymphadenopathy
Clinical narrative: Pt received 4th vax on 01/05/1999. It was reported that in 02/1995 the pt received full series of hepatitis B vax. Subsequently, the pt's hepatitis B titer was below 6 IU/mL. Sometime after the booster dose, the pt developed enlarged cervical and axillary lymph nodes. The physician was 'not certain of the relationship to the vax due to the pt's history of lymphoma. The physician will be taking biopsies of the lymph nodes.' Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Hallucination, auditory, Migraine, Sleep disorder
Clinical narrative: Shortly post second dose of vax, pt experienced 'super migraines, disturbed sleep, and auditory hallucinations.' The pt sought unspecified medical attention. No further information is available.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia
Clinical narrative: Fourteen days post vax, this pt experienced pain in the joints of both feet and the knuckle of one thumb. No further information is available.
Age: 0.04
Sex: M
Vaccine: HEP
Symptoms: Agitation neonatal, Diarrhoea, Haematocrit decreased, Haemolysis, Pyrexia
Clinical narrative: In the evening post first Hepatitis B vax, this 14 day old pt developed diarrhea and was fussy overnight. In the following morning, the child had a fever of 102 rectally and was treated with acetaminophen 0.8 ml PO. Lab tests were conducted. The pt was seen for evaluation. On 12/26, the pt recovered from his experiences. No further information is available.
Age: 0.6
Sex: M
Vaccine: HEP
Symptoms: Injection site hypersensitivity
Clinical narrative: Information received form a woman concerning her child who was IZ with 1.5 ml of hepatitis B vax recombinant instead of 0.5 ml. The pt experienced redness at the injection site. No further information is available.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Information received from 45 year old female physician who booster dose of hepatitis B for "waning immunity." Within 2 hours of vax, the pt experienced dizziness, lightheadedness and nausea. No further information is available.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity
Clinical narrative: The same day post vax, this pt experienced a rash form the injection site (upper arm) to the elbow. The pt recovered from the injection site rash overnight. She did not experience any other symptoms. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Myalgia
Clinical narrative: This female consumer was vax with Hepatitis B vax and subsequently noted that she had had a reaction in 1992 which she described as numbness, tingling, and muscle pain. The pt noted that she has been 'disabled since that time frame.' Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal, Neuropathy
Clinical narrative: Information from a registered nurse who received Hepatitis B vax series (1989). Subsequently, she experienced 'ulnar neuropathy in the arm where she did not receive the vax.' In 1996, the pt tested seronegative and was given a booster. No further information is available.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Multiple sclerosis
Clinical narrative: In approximately 1994, this 58-year-old female received vax. The pt noted that she was 'formerly a nurse's assistant working around Hepatitis B infected pts.' In approximately 1997 the pt was dx with multiple sclerosis. The pt sought unspecified medical attention. Additionally it was noted that the pt considered his condition life threatening and disabling. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: On 06/15/1998, child received vax and one day post vax experienced soreness at the injection site and nausea and vomiting. The pt's symptoms lasted 4 days. On an unspecified date, the pt recovered from the soreness at the injection site and vomiting. It is not known if the pt recovered from nausea.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Hypoaesthesia, Neck pain, Pain
Clinical narrative: Post vax, this pt experienced tingling of the arm where the injection was given. A few weeks later, the tingling 'progressed to both arms and now the pt has pain in both arms, neck and back.' The pt sought unspecified medical attention. Follow-up information from a registered nurse reported that on 01/15/1999, the pt went to a physician and blood work was done and results were nml. The pt was referred to a rheumatologist. On 01/29/1999, the pt saw the rheumatologist and blood work was done and result were nml. The pt is planning on having a hepatitis B surface antibody test performed. Further information was requested.
Age: 1.6
Sex: M
Vaccine: DTPHIB, HEP, OPV
Symptoms: Cellulitis, Hypersensitivity, Injection site hypersensitivity, Injection site pain
Clinical narrative: Same day post vax, this pt experienced 'right thigh pain, adverse drug reaction versus early cellulitis.' The pt experienced erythema at the injection site. an ER or physician visit was required. Follow-up information was received from a physician. The pt was administered Pediaprofen and cephalexin monohydrate (Keflex) and was sent home. Subsequently, the pt recovered. No further information is available.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chest discomfort, Chest pain, Chills, Cough
Clinical narrative: Same day post vax, this pt awoke from a sound sleep with sudden severe chills and severe stabbing pain in the chest, on the right side of the right shoulder, the right side of the back, and the right side of the neck. The pain continued throughout the night. The pt also experienced pain and chills with a low-grade fever. The pt also experienced frequency of urination (every 1-2 hours) and right earache. There was also a rapid heart rate; 'approximately 100' palpitations were felt. By 6:00 AM, the stabbing pains and chills had lessened. The pt experienced low-grad fever, flushing, lightheadedness, lethargy, and weakness of the right arm. The pt also experienced chest tightness, shortness of breath, and cough. The heart rate was rapid.  The shortness of breath improved by 01/30. The cough and pain in the right neck, arm and shoulder continued. By 02/03, the pain was 'more like an ache.' Some right arm weakness remained and the pt was still coughing. By 02/09, most of the symptoms had improved. The pt recovered from the symptoms. The pt had not  seroconverted after 3 doses of hepatitis B vaccine recombinant in 1979. No further information is available.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Ear pain, Flushing, Heart rate increased
Clinical narrative: Same day post vax, this pt awoke from a sound sleep with sudden severe chills and severe stabbing pain in the chest, on the right side of the right shoulder, the right side of the back, and the right side of the neck. The pain continued throughout the night. The pt also experienced pain and chills with a low-grade fever. The pt also experienced frequency of urination (every 1-2 hours) and right earache. There was also a rapid heart rate; 'approximately 100' palpitations were felt. By 6:00 AM, the stabbing pains and chills had lessened. The pt experienced low-grad fever, flushing, lightheadedness, lethargy, and weakness of the right arm. The pt also experienced chest tightness, shortness of breath, and cough. The heart rate was rapid.  The shortness of breath improved by 01/30. The cough and pain in the right neck, arm and shoulder continued. By 02/03, the pain was 'more like an ache.' Some right arm weakness remained and the pt was still coughing. By 02/09, most of the symptoms had improved. The pt recovered from the symptoms. The pt had not  seroconverted after 3 doses of hepatitis B vaccine recombinant in 1979. No further information is available.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Hemiparesis, Laboratory test abnormal, Lethargy, Neck pain, Pain
Clinical narrative: Same day post vax, this pt awoke from a sound sleep with sudden severe chills and severe stabbing pain in the chest, on the right side of the right shoulder, the right side of the back, and the right side of the neck. The pain continued throughout the night. The pt also experienced pain and chills with a low-grade fever. The pt also experienced frequency of urination (every 1-2 hours) and right earache. There was also a rapid heart rate; 'approximately 100' palpitations were felt. By 6:00 AM, the stabbing pains and chills had lessened. The pt experienced low-grad fever, flushing, lightheadedness, lethargy, and weakness of the right arm. The pt also experienced chest tightness, shortness of breath, and cough. The heart rate was rapid.  The shortness of breath improved by 01/30. The cough and pain in the right neck, arm and shoulder continued. By 02/03, the pain was 'more like an ache.' Some right arm weakness remained and the pt was still coughing. By 02/09, most of the symptoms had improved. The pt recovered from the symptoms. The pt had not  seroconverted after 3 doses of hepatitis B vaccine recombinant in 1979. No further information is available.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Pollakiuria, Pyrexia
Clinical narrative: Same day post vax, this pt awoke from a sound sleep with sudden severe chills and severe stabbing pain in the chest, on the right side of the right shoulder, the right side of the back, and the right side of the neck. The pain continued throughout the night. The pt also experienced pain and chills with a low-grade fever. The pt also experienced frequency of urination (every 1-2 hours) and right earache. There was also a rapid heart rate; 'approximately 100' palpitations were felt. By 6:00 AM, the stabbing pains and chills had lessened. The pt experienced low-grad fever, flushing, lightheadedness, lethargy, and weakness of the right arm. The pt also experienced chest tightness, shortness of breath, and cough. The heart rate was rapid.  The shortness of breath improved by 01/30. The cough and pain in the right neck, arm and shoulder continued. By 02/03, the pain was 'more like an ache.' Some right arm weakness remained and the pt was still coughing. By 02/09, most of the symptoms had improved. The pt recovered from the symptoms. The pt had not  seroconverted after 3 doses of hepatitis B vaccine recombinant in 1979. No further information is available.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Post vax, this pt experienced rash-like bumps on the back and torso which lasted approximately 3 days. Subsequently, the pt recovered from rash-like bumps. No further information is available.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site infection, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from an RN concerning an 11 year old white female who on 1/25/99, was vaccinated with Hep-B vaccine and on 1/26/99, she was seen at a physician's office with a swollen, painful right deltoid. The pt also experienced itching at the injection site on 1/29/99. The area was red and warm to the touch. The area of swelling on the right upper arm was 6cm X 4cm. This was also noted as a "questionable infection". The pt recovered within 48-72 hours of symptom onset. The pt has not continued the vaccination series. No further information is available.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Information has been received from an RN concerning an 11 year old white female who on 1/25/99, was vaccinated with Hep-B vaccine and on 1/26/99, she was seen at a physician's office with a swollen, painful right deltoid. The pt also experienced itching at the injection site on 1/29/99. The area was red and warm to the touch. The area of swelling on the right upper arm was 6cm X 4cm. This was also noted as a "questionable infection". The pt recovered within 48-72 hours of symptom onset. The pt has not continued the vaccination series. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Difficulty in walking, Influenza like illness, Ocular hyperaemia
Clinical narrative: Information has been received from a health care professional concerning a male who on 11/19/98 was vaccinated with 1 dose of Hep-B vaccine recombinant. On 12/24/98, the pt experienced red eyes and later, the pt also developed flu-like symptoms and trouble walking. He was seen by a physician who sent him for lab work (results not available) and "the school nurse said that he does not have pink eye". No further information is available.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Fatigue, Rash
Clinical narrative: Information has been received from a 42 year old white male who on 9/27/98 and 10/27/98 was vaccinated with the 1st and 2nd dose of Hep-b vaccine recombinant, respectively. "Immediately after getting the shot", the pt experienced extreme fatigue and lost his appetite. In December of 1998, the pt experienced a rash on the back of his head, elbows and wrists. The pt sought unspecified medical treatment. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 15 year old white male pt who in 1993 was vaccinated with a 1st dose of Hep-B. The pt did not receive a 2nd or 3rd dose. The same day of the 1st vaccination, the pt experienced a severe headache, which lasted for 1 day. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Hallucination, Memory impairment
Clinical narrative: Information has been received from a healthcare professional concerning a 21 year old female pt with asthma who on 1/21/99 was vaccinated with the 1st dose of Hep-B. Approximately 1 hour, post vax, the pt "felt spacey and was hallucinating." She stated that she "talked to a friend and 5 minutes later, did not remember either talking to that person or the conversation she had with that person." It was reported that her condition seemed to improve after eating lunch. She did not seek treatment. The pt's experiences completely resolved after approximately 2 hours. No further information is available.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Back pain, Hypertonia, Hypokinesia, Lymphadenopathy, Pain
Clinical narrative: "Deep in my arm pit"-almost chest area of left side (same as injection), extremely tender. Hurts/aches all the time. Hurts to raise arm overhead x 4 days. Tightness, left lwr back-spasm. Has a Dr's appt 11/2/99. Labs drawn 11/4/99.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Flank pain, Hypokinesia, Muscle spasms, Musculoskeletal discomfort, Pain
Clinical narrative: "Deep in my arm pit"-almost chest area of left side (same as injection), extremely tender. Hurts/aches all the time. Hurts to raise arm overhead x 4 days. Tightness, left lwr back-spasm. Has a Dr's appt 11/2/99. Labs drawn 11/4/99.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Coma, Cyanosis, Irritability
Clinical narrative: Same day post vax, the child became lifeless, non breathing, and blue around lips. Child taken to ER and admitted to hospital for overnight observation. A follow up report received 6/12/2000 adds: Nurse relates the following info received by parents. Child was seen by paramedics shortly after resuming respirations. Vital signs were normal but parents advised to have child seen in the ER. Pediatrician on call ordered CXR and CBC and observation overnight <24 hours. No treatment required. Nurse states parents were told that child had a reaction to DTaP and that the child "should never receive this vaccine again". There was no mention of anaphylaxis. Parents did not sign a release so that the health department was unable to get a copy of the ER report. Parents also told nurse that the child "did not cry" for several days after the adverse event. However, this abated by the day the nurse called to follow-up on 4/19/2000. The parents had given the child Tylenol prophylactically on the day of vaccines. They are uncertain about ever having the child vaccinated again with any vaccine. Nurse states child had no apparent illness at time of vaccination and no known history of health problems, allergies, etc. Another follow up report received 6/12/2000 adds: Mother phoned VAERS and verified info given by reporter. Child was in hospital only overnight and <24 hours. States that MD felt pertussis component of DTaP was the source (probable) but she worries about giving any vaccine. She asks if it is OK to give each vaccine individually. I referred her to the child's pediatrician and suggested she obtain more info on the vaccines and importance of them in order to make informed choices.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Cyanosis, Respiratory disorder
Clinical narrative: Same day post vax, the child became lifeless, non breathing, and blue around lips. Child taken to ER and admitted to hospital for overnight observation. A follow up report received 6/12/2000 adds: Nurse relates the following info received by parents. Child was seen by paramedics shortly after resuming respirations. Vital signs were normal but parents advised to have child seen in the ER. Pediatrician on call ordered CXR and CBC and observation overnight <24 hours. No treatment required. Nurse states parents were told that child had a reaction to DTaP and that the child "should never receive this vaccine again". There was no mention of anaphylaxis. Parents did not sign a release so that the health department was unable to get a copy of the ER report. Parents also told nurse that the child "did not cry" for several days after the adverse event. However, this abated by the day the nurse called to follow-up on 4/19/2000. The parents had given the child Tylenol prophylactically on the day of vaccines. They are uncertain about ever having the child vaccinated again with any vaccine. Nurse states child had no apparent illness at time of vaccination and no known history of health problems, allergies, etc. Another follow up report received 6/12/2000 adds: Mother phoned VAERS and verified info given by reporter. Child was in hospital only overnight and <24 hours. States that MD felt pertussis component of DTaP was the source (probable) but she worries about giving any vaccine. She asks if it is OK to give each vaccine individually. I referred her to the child's pediatrician and suggested she obtain more info on the vaccines and importance of them in order to make informed choices.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Apnoea, Cyanosis, Feeling abnormal
Clinical narrative: Same day post vax, the child became lifeless, non breathing, and blue around lips. Child taken to ER and admitted to hospital for overnight observation. A follow up report received 6/12/2000 adds: Nurse relates the following info received by parents. Child was seen by paramedics shortly after resuming respirations. Vital signs were normal but parents advised to have child seen in the ER. Pediatrician on call ordered CXR and CBC and observation overnight <24 hours. No treatment required. Nurse states parents were told that child had a reaction to DTaP and that the child "should never receive this vaccine again". There was no mention of anaphylaxis. Parents did not sign a release so that the health department was unable to get a copy of the ER report. Parents also told nurse that the child "did not cry" for several days after the adverse event. However, this abated by the day the nurse called to follow-up on 4/19/2000. The parents had given the child Tylenol prophylactically on the day of vaccines. They are uncertain about ever having the child vaccinated again with any vaccine. Nurse states child had no apparent illness at time of vaccination and no known history of health problems, allergies, etc. Another follow up report received 6/12/2000 adds: Mother phoned VAERS and verified info given by reporter. Child was in hospital only overnight and <24 hours. States that MD felt pertussis component of DTaP was the source (probable) but she worries about giving any vaccine. She asks if it is OK to give each vaccine individually. I referred her to the child's pediatrician and suggested she obtain more info on the vaccines and importance of them in order to make informed choices.
Age: 0.21
Sex: M
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Apnoea, Cardiac arrest, Coma, Feeling abnormal, Sudden infant death syndrome
Clinical narrative: On 5/11/00, the pt was found lifeless and unresponsive. The pt was transported to a hospital, resussitation was unsuccessful. The pt died on 5/11/00. The death was dx as SIDS.
Age: 0.21
Sex: M
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Coma, Sudden infant death syndrome
Clinical narrative: On 5/11/00, the pt was found lifeless and unresponsive. The pt was transported to a hospital, resussitation was unsuccessful. The pt died on 5/11/00. The death was dx as SIDS.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Two month old died of SIDS 5 days post vax (1st set).
Age: 17.0
Sex: M
Vaccine: IPV, MMR, TD
Symptoms: Pain
Clinical narrative: It was reported that a 17 year old male received 3 vaccinations on 4/17/2000. Reportedly 24 hours after the vax, the pt developed soreness in both legs. It was reported that the pt was admitted to the hospital and the diagnosis eliminated any relationship to the vaccines given. Exact diagnosis unspecified. Additional information is being requested. Follow up information received 05/25/2001 reported the patient recovered form this experience. Was found not to be a reaction to vaccines. No further information available regarding this patient or this case.
Age: 31.0
Sex: M
Vaccine: TD, TD
Symptoms: Abscess, Arthralgia, Asthenia, Dizziness, Headache
Clinical narrative: The wife of this pt reported that he received vax on 04/25/2000. One day post vax, he developed a red type of abscess on the back of neck at hairline, lymphadenopathy all through body, severe headaches, neck and joint pain, dizziness, muscles spasms and generalized weakness. He was hospitalized. The reporter stated that her husband's initial CT scan was negative. CBC and WBC - nml. However, a repeat of the the CT revealed sinus infection. ON 05/11/2000, a spinal tap was performed and found negative. Upon admission to the hospital, the pt was initially treated with IV Ancef for 5 days and experienced severe neck pain and worsening of headache for which he was treated with Vicodin. The pt was later treated with Rocephin. An MRI has been scheduled by neurologist to rule out inflammation of meninges.   Follow up information received on 5/25/00 from the pt's wife indicated that the pt was hospitalized twice of which each lasted 5 days.  60 Day FU states he still has bad head and neck pain, swollen glands, night sweats. Until the vaccine this pt was a very healthy person.
Age: 31.0
Sex: M
Vaccine: TD, TD
Symptoms: Infection, Lymphadenopathy, Muscle spasms, Neck pain, Night sweats
Clinical narrative: The wife of this pt reported that he received vax on 04/25/2000. One day post vax, he developed a red type of abscess on the back of neck at hairline, lymphadenopathy all through body, severe headaches, neck and joint pain, dizziness, muscles spasms and generalized weakness. He was hospitalized. The reporter stated that her husband's initial CT scan was negative. CBC and WBC - nml. However, a repeat of the the CT revealed sinus infection. ON 05/11/2000, a spinal tap was performed and found negative. Upon admission to the hospital, the pt was initially treated with IV Ancef for 5 days and experienced severe neck pain and worsening of headache for which he was treated with Vicodin. The pt was later treated with Rocephin. An MRI has been scheduled by neurologist to rule out inflammation of meninges.   Follow up information received on 5/25/00 from the pt's wife indicated that the pt was hospitalized twice of which each lasted 5 days.  60 Day FU states he still has bad head and neck pain, swollen glands, night sweats. Until the vaccine this pt was a very healthy person.
Age: 31.0
Sex: M
Vaccine: TD, TD
Symptoms: Arthralgia, Asthenia, Back pain, Dizziness, Dyspnoea
Clinical narrative: The wife of this pt reported that he received vax on 04/25/2000. One day post vax, he developed a red type of abscess on the back of neck at hairline, lymphadenopathy all through body, severe headaches, neck and joint pain, dizziness, muscles spasms and generalized weakness. He was hospitalized. The reporter stated that her husband's initial CT scan was negative. CBC and WBC - nml. However, a repeat of the the CT revealed sinus infection. ON 05/11/2000, a spinal tap was performed and found negative. Upon admission to the hospital, the pt was initially treated with IV Ancef for 5 days and experienced severe neck pain and worsening of headache for which he was treated with Vicodin. The pt was later treated with Rocephin. An MRI has been scheduled by neurologist to rule out inflammation of meninges.   Follow up information received on 5/25/00 from the pt's wife indicated that the pt was hospitalized twice of which each lasted 5 days.  60 Day FU states he still has bad head and neck pain, swollen glands, night sweats. Until the vaccine this pt was a very healthy person.
Age: 31.0
Sex: M
Vaccine: TD, TD
Symptoms: Fatigue, Headache, Infection, Lymphadenopathy, Muscle spasms
Clinical narrative: The wife of this pt reported that he received vax on 04/25/2000. One day post vax, he developed a red type of abscess on the back of neck at hairline, lymphadenopathy all through body, severe headaches, neck and joint pain, dizziness, muscles spasms and generalized weakness. He was hospitalized. The reporter stated that her husband's initial CT scan was negative. CBC and WBC - nml. However, a repeat of the the CT revealed sinus infection. ON 05/11/2000, a spinal tap was performed and found negative. Upon admission to the hospital, the pt was initially treated with IV Ancef for 5 days and experienced severe neck pain and worsening of headache for which he was treated with Vicodin. The pt was later treated with Rocephin. An MRI has been scheduled by neurologist to rule out inflammation of meninges.   Follow up information received on 5/25/00 from the pt's wife indicated that the pt was hospitalized twice of which each lasted 5 days.  60 Day FU states he still has bad head and neck pain, swollen glands, night sweats. Until the vaccine this pt was a very healthy person.
Age: 31.0
Sex: M
Vaccine: TD, TD
Symptoms: Myalgia, Neck pain, Phlebitis
Clinical narrative: The wife of this pt reported that he received vax on 04/25/2000. One day post vax, he developed a red type of abscess on the back of neck at hairline, lymphadenopathy all through body, severe headaches, neck and joint pain, dizziness, muscles spasms and generalized weakness. He was hospitalized. The reporter stated that her husband's initial CT scan was negative. CBC and WBC - nml. However, a repeat of the the CT revealed sinus infection. ON 05/11/2000, a spinal tap was performed and found negative. Upon admission to the hospital, the pt was initially treated with IV Ancef for 5 days and experienced severe neck pain and worsening of headache for which he was treated with Vicodin. The pt was later treated with Rocephin. An MRI has been scheduled by neurologist to rule out inflammation of meninges.   Follow up information received on 5/25/00 from the pt's wife indicated that the pt was hospitalized twice of which each lasted 5 days.  60 Day FU states he still has bad head and neck pain, swollen glands, night sweats. Until the vaccine this pt was a very healthy person.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Psychotic disorder
Clinical narrative: 08/28/1998. the vaccinee received her first left deltoid dose of Hepatitis B vax. Twenty-four hours later she became psychotic and was hospitalized. She was treated with Zyprexa for 2 months and recovered. The most recent information received on 05/11 reports the vaccinee well since the event.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Coordination abnormal, Neuropathy, Neuropathy peripheral
Clinical narrative: Report received from a neurologist concerning a pt who experienced peripheral neuropathy 5 days post vax. Reported date of vax and reaction start date were approximate. Case reassessed to be serious on receipt of follow-up information form the neurologist. This pt developed neuropathy and loss of coordination and reflex strength. The vaccinee was also reported as 'dysesthetic poor'. The vaccinee was treated with steroids. Symptoms were stated by the reporter to be disabling/incapacitating. No stop date was given for the symptoms. Numerous labs and tests were consistent with neuropathy.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Convulsion, Diarrhoea, Pyrexia
Clinical narrative: 6 month baby girl with history of lactose intolerence, who 1 week prior to vaccination, had URI, no fever and being treated. The same day of vaccination, had fever and diarrhea from 4/25/2000 to 4/27/2000. On 4/30/2000, pt developed seizure, tonic/clonic. Seizure without fever x 2, treated with Ativan and Dilantin.
Age: 2.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Infection, Meningitis, Purpura, Pyrexia, Rash macular
Clinical narrative: 02/14 Became ill, fever, vomiting, rash crusted dark lesions. 02/15 went to hospital. Spinal tap performed. Transferred to another facility and dx with meningococcal meningitis. Spinal fluid non reactive to antigen. Rash purpuric at this time. Discharged 02/22/2000
Age: 2.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: 02/14 Became ill, fever, vomiting, rash crusted dark lesions. 02/15 went to hospital. Spinal tap performed. Transferred to another facility and dx with meningococcal meningitis. Spinal fluid non reactive to antigen. Rash purpuric at this time. Discharged 02/22/2000
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection, Pyrexia, Rash
Clinical narrative: On 4/26/00, the pt started running a fever of 101-103. On 4/27/00, she continued with a fever and was treated with Tylenol every 4 hours. Mom noticed rash under armpits and the child seemed very uneasy and uncomfortable. On 4/28/00, she was seen by a physician who said she had a red throat. They did not know what the rash was from. Treated her with Cefzil. On 4/30, the mother noticed that the pt had a rash everywhere on her body. On 5/1/00, the pt was seen by physician again and he dx her with rubella.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Leukocytosis, Nasal congestion, Nasopharyngitis, Pyrexia, Vomiting neonatal
Clinical narrative: Pt began spitting up formula, developed a cold and congestion, fever of 102.4 and a pulse of 160.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Cellulitis, Injection site reaction, Leukocytosis
Clinical narrative: Pt returned to ER on 4/2/2000, post vax, with cellulitis in right upper extremity. Pt was then admitted to the hospital on 4/2/2000. Pt was treated with Ancef. Pt was afebrile and discharged on 4/3/2000.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Antisocial behaviour, Asthenia, Encephalitis, Hypotonia, Lethargy
Clinical narrative: 12 hours after Prevnar #1, pt developed fever of 102 and it was on and off x 3 days with increased lethargy, decreased tone and gross motor strength and esotropia (both eyes). Pt was somnolent but arousable with pain and refusing to sit up, not social.60 day follow-up dated 09/27/00 provided no additional data.  Diagnosed with acute disseminated encephalomyelitis.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Pain, Pyrexia, Somnolence neonatal, Strabismus, White blood cell count increased
Clinical narrative: 12 hours after Prevnar #1, pt developed fever of 102 and it was on and off x 3 days with increased lethargy, decreased tone and gross motor strength and esotropia (both eyes). Pt was somnolent but arousable with pain and refusing to sit up, not social.60 day follow-up dated 09/27/00 provided no additional data.  Diagnosed with acute disseminated encephalomyelitis.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Cold sweat, Opisthotonus, Peripheral coldness, Somnolence, Staring
Clinical narrative: Vomiting, arching of back, pale, clammy and cool extremities, not 100% responsive and has a distant gaze.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Vomiting
Clinical narrative: Vomiting, arching of back, pale, clammy and cool extremities, not 100% responsive and has a distant gaze.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Cold sweat, Coma, Cough, Feeling cold, Irritability
Clinical narrative: Vomiting, arching of back, pale, clammy and cool extremities, not 100% responsive and has a distant gaze.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Opisthotonus, Pallor, Staring, Vomiting
Clinical narrative: Vomiting, arching of back, pale, clammy and cool extremities, not 100% responsive and has a distant gaze.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site mass
Clinical narrative: 7cm X 11cm area of erythema and induration around injection site.
Age: 29.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Dyspnoea, Rash
Clinical narrative: Pt experienced a rash, shortness of breath and arthralgias
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema
Clinical narrative: Pt experienced erythematous area 9.5 x 16.5 cm ovoid patch.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Cellulitis, Rash
Clinical narrative: Pt developed a small rash 1-2 days post vax. Pt was immunized in the left arm. Rash on right hip with a small area of cellulitis at probable bug bite. MD doesn't think it is related to vaccine.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea, Ear pain, Hyperhidrosis, Nasal congestion, Pharyngolaryngeal pain
Clinical narrative: Flu like symptoms-fever, congested, sinus headache, sweating, sore throat, ear ache, diarrhea which lasted for over 2 weeks.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia, Sinus headache
Clinical narrative: Flu like symptoms-fever, congested, sinus headache, sweating, sore throat, ear ache, diarrhea which lasted for over 2 weeks.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt had erythema, swelling and pain. This was an adverse event, not an unusual event. The pt however was very concerned but was reassured easily.
Age: 41.0
Sex: M
Vaccine: ANTH, HBHEPB
Symptoms: Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site of dose 6 that was received on 5/6/00. Area is bruised and tender, firm but no nodule.
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site inflammation
Clinical narrative: Pt experienced local inflammation.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Visual acuity reduced
Clinical narrative: A few days post initial vaccination, pt noticed a sudden and marked vision change. Pt went from 20/20 to needing corrective lenses all the time. One eye is near sighted and the other is far sighted and getting progressively worse. Prior to receiving the 4th vaccine in the series the pt requested a complete military physical. The physical indicated nothing was wrong. The only way the pt was to stop receiving the vaccine was to retire as soon as he completed 20 years of service.
Age: 20.0
Sex: M
Vaccine: ANTH, JEV, YF
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Pt experienced a rash that was comprised of a 6cm raised circular erythema accompanied by pruritus reportedly greater than 10 cm on initial onset by pt.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Pain, Rash
Clinical narrative: 10/02/99 -Onset of local soreness, Aching from shoulder to elbow, lasting 10 days; 10/04/99 -Rash along waist line, Lasting6 weeks
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Angioneurotic oedema, Face oedema, Laryngospasm
Clinical narrative: Pt recv vax on 4/8/99; on 4/9/99 pt exp progressive facial & throat swelling-angioedema
Age: 0.3
Sex: F
Vaccine: DTP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV
Symptoms: Ecchymosis, Erythema multiforme, Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: p/vax pt devel erythema multiforme;MD intended to hosp infant;pt vomited once per day every day for 3 days p/vax;fever of 101 ax erythema multiforme on the face, neck, chest & extremities;ecchymosis & peripheral edema;pt not hosp; Follow up: A report from lab(E98357-063A) regarding events. It was reported, "A physician reported that a 3 month old male received Rota Shield on 18-Dec-1998. On 22-Dec-1998, he developed erythema mulitiforme. The physician intended to hosptalize the infant. no further information was available at the date of this report(08/16/2002). Follow up information was received on 11-Feb-1999. The pt is a female who also received HIB (PMC France), DTP(PMC France), IPV(PMC France), and hepatitis B(Merck) vaccines. She vomited once per day ever day for 3 days following immunization. On 21-Dec-1998, she developed a fever of 101 degrees F(axillary) and erythema mulitiforme on the face, neck, chest, and extremities. On 23-Dec-1998, the rash progressed to confluent erythema multiforme with ecchymoses and peripheral edema. the infant was not hospitalized. She recovered. Follow up # 1 (2-Jul-1999) lot number reportes for DTP 0970140 corresponds to a lot number for DTAP-Tripedia. Follow up (08-Aug-2002) During internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added peripheral edema).
Age: 38.0
Sex: U
Vaccine: ANTH, ANTH
Symptoms: Injection site pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: 8 x 3 rash covering whole tricep area. Rash area was hotter than surrounding area. Rash and localized fever lasted 4 days. Arm felt normal 12-14 days after shot.
Age: 38.0
Sex: U
Vaccine: ANTH, ANTH
Symptoms: Feeling hot, Rash
Clinical narrative: 8 x 3 rash covering whole tricep area. Rash area was hotter than surrounding area. Rash and localized fever lasted 4 days. Arm felt normal 12-14 days after shot.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Chest discomfort, Headache, Myalgia, Vision blurred
Clinical narrative: Information has been received from a healthcare professional concerning a 31 year old female who on 4/25/00 was vaccinated with the second dose of varicella. 45 minutes post vax, the pt experienced chest tightness, headache, blurred vision. On 4/26/00, the pt experienced muchal rigidity, "gripping problems", and myalgias. The pt sought medical treatment at an ER and from occupational health and received treatment with Benadryl. Upon medical review it was determined that the pt's chest tightness was an "other medical event."  Follow up information received on 5/12/00 from a healthcare professional indicated that the pt had followed up with the Occupational Health Department and that she had recovered from her experiences and was reportedly doing fine. The reporter stated that to her knowledge, the pt had not had any further events or complications. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Coma, Convulsion, Pulmonary congestion, Pulmonary oedema
Clinical narrative: Pt was found dead at home on 5/3/00. Pt was taking Dilantin on a regular basis. Pts mother died of aneurysm at age 40. Pt was otherwise healthy, but had a hx of seizures. Cause of death was determined to be a terminal seizure. Autopsy shows she was found unresponsive, lungs congested with edema.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Received 4th Anthrax vaccine Tuesday 5/3/00. By Thursday of same week, injection site had redness, swelling, intense itching in an approximately 4 inch diameter welt. Saw physician 5/5/00 to determine reaction in medical records.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Headache, Injection site mass, Malaise, Myalgia
Clinical narrative: Received vaccine on 5/3/00 and then had a headache, diarrhea, myalgia with nausea and vomiting. Temperature was up to 100.2. Malaise persisted for 1 week. Had induation of 15cm X 8cm.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Received vaccine on 5/3/00 and then had a headache, diarrhea, myalgia with nausea and vomiting. Temperature was up to 100.2. Malaise persisted for 1 week. Had induation of 15cm X 8cm.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour
Clinical narrative: Possible seizure activity on 2/1/00. She has since been seen and examined and dx'd as having had a behavioral type occurance. A follow up report received 8/1/2000 adds: Child was not actually known to have a seizure. Mother reports that she fell over and couldn't crawl as usual. She put the baby to bed for a nap - when she awoke 2 hours later, all was normal. Seen by neurologist - EEG done, WNL. No more incidences. Child did not have a fever at the time she presented symptoms. Follow up needed.
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated with 1 dose of Hep-B vaccine recombinant. Subsequently, the pt experienced injection site soreness which lasted for "2 weeks following vaccination." No further information is available.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Constipation, Dizziness, Fatigue, Headache
Clinical narrative: Information has been received from a 38 year old white female who on 1/16/99, was vaccinated with the 6th dose of Hep-B vaccine recombinant. Concomitant therapy included fluoxetine hydrochloride (Prozac), 10 mg for the last year. On 1/17/99, the pt experienced extreme fatigue, dizziness, headaches, a stiff neck, some constipation, fever and elevated blood pressure and pulse. Laboratory tests with normal results included a test for mononucleiosis, a thyroid function test, a complete blood cell count and a chem 7. Subsequently, the pt was treated with azithromycin (Zithromax) for 5 days for possible infection. The pt sought unspecified medical attention. No further information is available.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Heart rate increased, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Information has been received from a 38 year old white female who on 1/16/99, was vaccinated with the 6th dose of Hep-B vaccine recombinant. Concomitant therapy included fluoxetine hydrochloride (Prozac), 10 mg for the last year. On 1/17/99, the pt experienced extreme fatigue, dizziness, headaches, a stiff neck, some constipation, fever and elevated blood pressure and pulse. Laboratory tests with normal results included a test for mononucleiosis, a thyroid function test, a complete blood cell count and a chem 7. Subsequently, the pt was treated with azithromycin (Zithromax) for 5 days for possible infection. The pt sought unspecified medical attention. No further information is available.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: On 10/29/98, the pt developed a widespread urticarial rash. There are no itchiness or fever. The pt sought unspecified medical attention and was treated with Zyrtec. Subsequently, she recovered from her experience.