chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Bone disorder, Epidermal naevus, Fatigue, Fungal infection
Clinical narrative: This report describes joint pain and swelling in a male vaccinee in his fifth decade who received LYMErix. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history included hyperprolactinemia and decreased testosterone concentration. Concurrent conditions and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections was not reported. In a statement of injuries, his attorney alleged that the vaccinee "suffers from pain and swelling in his joints as well as foot pain and he has difficulty sleeping. Also, he suffers from Ichthyosis Vulgaris in his lower legs, Nevi in his left axilla back and chest, and Lentigines in his back, shoulders and chest. In addition, he suffers from Seborrheic Keratoses in his hands, right wrist, right forears, right thigh and left leg." Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. Per F/U 6/28/02: The pt experienced a wart on his right foot, fatigue and distal-lateral subungual onychomycosis bilateral Fallux. These were not reported as adverse events due to vaccine administration but were found during the course of review of the vaccinee's medical records. This following info was from medical records: Chief complaint of fatigue with standing; painful range of motion first metatarsphalangal joint (MPJ) bilateral; early distal-lateral subungual onychomycosis (DOS). Treatment plain: debridement performed and chemical cautery applied, prescription given for bilateral foot X-ray; wishes to self-treat wart. Advised orthotics and return with X-ray for review. The most recent info received on 6/11/02, did not specify the outcome of the reported events. The follow-up states on 2/16/00, Lyme IgG Western blot and rheumaoid factor were negative. On 10/19/00, the vaccinee was his family physician who noted, "still having bilateral feet pain, some arthritis of feet." On 3/8/01, the vaccinee reported to his family physician that he was "having sleeping problems." The physician noted, "Ambien not working anymore, sleeping 2-3 hours/night. Should he see a psychiatrist." The most recent info, received on 8/1/02, did not specify the outcomes of the reported events.
Sex: M
Vaccine: LYME
Symptoms: Ichthyosis, Insomnia, Joint swelling, Pain in extremity, Seborrhoea
Clinical narrative: This report describes joint pain and swelling in a male vaccinee in his fifth decade who received LYMErix. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history included hyperprolactinemia and decreased testosterone concentration. Concurrent conditions and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections was not reported. In a statement of injuries, his attorney alleged that the vaccinee "suffers from pain and swelling in his joints as well as foot pain and he has difficulty sleeping. Also, he suffers from Ichthyosis Vulgaris in his lower legs, Nevi in his left axilla back and chest, and Lentigines in his back, shoulders and chest. In addition, he suffers from Seborrheic Keratoses in his hands, right wrist, right forears, right thigh and left leg." Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. Per F/U 6/28/02: The pt experienced a wart on his right foot, fatigue and distal-lateral subungual onychomycosis bilateral Fallux. These were not reported as adverse events due to vaccine administration but were found during the course of review of the vaccinee's medical records. This following info was from medical records: Chief complaint of fatigue with standing; painful range of motion first metatarsphalangal joint (MPJ) bilateral; early distal-lateral subungual onychomycosis (DOS). Treatment plain: debridement performed and chemical cautery applied, prescription given for bilateral foot X-ray; wishes to self-treat wart. Advised orthotics and return with X-ray for review. The most recent info received on 6/11/02, did not specify the outcome of the reported events. The follow-up states on 2/16/00, Lyme IgG Western blot and rheumaoid factor were negative. On 10/19/00, the vaccinee was his family physician who noted, "still having bilateral feet pain, some arthritis of feet." On 3/8/01, the vaccinee reported to his family physician that he was "having sleeping problems." The physician noted, "Ambien not working anymore, sleeping 2-3 hours/night. Should he see a psychiatrist." The most recent info, received on 8/1/02, did not specify the outcomes of the reported events.
Sex: F
Vaccine: LYME, LYME
Symptoms: Fibromyalgia
Clinical narrative: Report A0359813A describes fibromyalgia in a female vaccine of unspecified age who received Lyme disease vaccine recombinant Ospa (Lymerix). This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions and concurrent medications were not provided. The vaccinee reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the vaccinee "experiences joint pain in her hands, shoulder, neck and back and throughout her entire body".  She also experiences muscle pain throughout her body. In addition, she suffers from fatigue and insomnia. She also experience pain when applies any pressure to her skin. She has been diagnosed with severe fibromyalgia syndrome. She also suffers from degenerative osteoarthritis. In addition she suffers from bilateral upper quarter myofacial syndrome with prominent clinical activity of trapezius and scalene which produces a supraclavicular thoracic outlet syndrome. Time to onset following immunization, treatment and outcomes of the alleged events were not reported.  The adverse event "osteoarthritis" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: F
Vaccine: LYME, LYME
Symptoms: Arthralgia, Arthritis, Asthenia, Back pain, Bone disorder
Clinical narrative: Report A0359813A describes fibromyalgia in a female vaccine of unspecified age who received Lyme disease vaccine recombinant Ospa (Lymerix). This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions and concurrent medications were not provided. The vaccinee reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the vaccinee "experiences joint pain in her hands, shoulder, neck and back and throughout her entire body".  She also experiences muscle pain throughout her body. In addition, she suffers from fatigue and insomnia. She also experience pain when applies any pressure to her skin. She has been diagnosed with severe fibromyalgia syndrome. She also suffers from degenerative osteoarthritis. In addition she suffers from bilateral upper quarter myofacial syndrome with prominent clinical activity of trapezius and scalene which produces a supraclavicular thoracic outlet syndrome. Time to onset following immunization, treatment and outcomes of the alleged events were not reported.  The adverse event "osteoarthritis" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: F
Vaccine: LYME, LYME
Symptoms: Bursitis, Dizziness, Fatigue, Fibromyalgia, Hypoaesthesia
Clinical narrative: Report A0359813A describes fibromyalgia in a female vaccine of unspecified age who received Lyme disease vaccine recombinant Ospa (Lymerix). This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions and concurrent medications were not provided. The vaccinee reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the vaccinee "experiences joint pain in her hands, shoulder, neck and back and throughout her entire body".  She also experiences muscle pain throughout her body. In addition, she suffers from fatigue and insomnia. She also experience pain when applies any pressure to her skin. She has been diagnosed with severe fibromyalgia syndrome. She also suffers from degenerative osteoarthritis. In addition she suffers from bilateral upper quarter myofacial syndrome with prominent clinical activity of trapezius and scalene which produces a supraclavicular thoracic outlet syndrome. Time to onset following immunization, treatment and outcomes of the alleged events were not reported.  The adverse event "osteoarthritis" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: F
Vaccine: LYME, LYME
Symptoms: Injection site pain, Injection site warmth, Insomnia, Malaise, Myositis
Clinical narrative: Report A0359813A describes fibromyalgia in a female vaccine of unspecified age who received Lyme disease vaccine recombinant Ospa (Lymerix). This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions and concurrent medications were not provided. The vaccinee reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the vaccinee "experiences joint pain in her hands, shoulder, neck and back and throughout her entire body".  She also experiences muscle pain throughout her body. In addition, she suffers from fatigue and insomnia. She also experience pain when applies any pressure to her skin. She has been diagnosed with severe fibromyalgia syndrome. She also suffers from degenerative osteoarthritis. In addition she suffers from bilateral upper quarter myofacial syndrome with prominent clinical activity of trapezius and scalene which produces a supraclavicular thoracic outlet syndrome. Time to onset following immunization, treatment and outcomes of the alleged events were not reported.  The adverse event "osteoarthritis" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: F
Vaccine: LYME, LYME
Symptoms: Neck pain, Oedema peripheral, Pain, Red blood cell sedimentation rate increased, Rotator cuff syndrome
Clinical narrative: Report A0359813A describes fibromyalgia in a female vaccine of unspecified age who received Lyme disease vaccine recombinant Ospa (Lymerix). This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions and concurrent medications were not provided. The vaccinee reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the vaccinee "experiences joint pain in her hands, shoulder, neck and back and throughout her entire body".  She also experiences muscle pain throughout her body. In addition, she suffers from fatigue and insomnia. She also experience pain when applies any pressure to her skin. She has been diagnosed with severe fibromyalgia syndrome. She also suffers from degenerative osteoarthritis. In addition she suffers from bilateral upper quarter myofacial syndrome with prominent clinical activity of trapezius and scalene which produces a supraclavicular thoracic outlet syndrome. Time to onset following immunization, treatment and outcomes of the alleged events were not reported.  The adverse event "osteoarthritis" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: F
Vaccine: LYME, LYME
Symptoms: Vertigo
Clinical narrative: Report A0359813A describes fibromyalgia in a female vaccine of unspecified age who received Lyme disease vaccine recombinant Ospa (Lymerix). This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions and concurrent medications were not provided. The vaccinee reportedly received Lymerix; the number of injections administered was not reported. In a Statement of Injuries, her attorney alleged that the vaccinee "experiences joint pain in her hands, shoulder, neck and back and throughout her entire body".  She also experiences muscle pain throughout her body. In addition, she suffers from fatigue and insomnia. She also experience pain when applies any pressure to her skin. She has been diagnosed with severe fibromyalgia syndrome. She also suffers from degenerative osteoarthritis. In addition she suffers from bilateral upper quarter myofacial syndrome with prominent clinical activity of trapezius and scalene which produces a supraclavicular thoracic outlet syndrome. Time to onset following immunization, treatment and outcomes of the alleged events were not reported.  The adverse event "osteoarthritis" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: The vaccinee reportedly received Lymerix, the number of injections were not provided. In a Statement of Injuries, her attorney alleged that the vaccinee "suffers from severe back and neck pain, as well as, severe pain in the joints of several of her fingers". Time to onset following immunization, treatment and outcomes of the alleged events were not reported. The adverse event "joint pain" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter.
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Pruritus
Clinical narrative: Received vax at about 17:30 on 3/26/02. States signs and symptoms started about 22:00 on 3/26/02. His left arm was "red and hot", "swollen down to elbow", "itchy, no rash" and "stiff". Tx: Instructed to take Advil with food. Apply ice and elevate. On 4/1/02 his wife stated, "It looks great". Pt denied previous pneumonia vax when asked. When entering vax into computer, (it was noted that the pt had received pneumonia vax in 1996, 2000 and now in 2002.
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Medication error, Musculoskeletal stiffness, Oedema peripheral, Pruritus
Clinical narrative: Received vax at about 17:30 on 3/26/02. States signs and symptoms started about 22:00 on 3/26/02. His left arm was "red and hot", "swollen down to elbow", "itchy, no rash" and "stiff". Tx: Instructed to take Advil with food. Apply ice and elevate. On 4/1/02 his wife stated, "It looks great". Pt denied previous pneumonia vax when asked. When entering vax into computer, (it was noted that the pt had received pneumonia vax in 1996, 2000 and now in 2002.
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Skin warm
Clinical narrative: Received vax at about 17:30 on 3/26/02. States signs and symptoms started about 22:00 on 3/26/02. His left arm was "red and hot", "swollen down to elbow", "itchy, no rash" and "stiff". Tx: Instructed to take Advil with food. Apply ice and elevate. On 4/1/02 his wife stated, "It looks great". Pt denied previous pneumonia vax when asked. When entering vax into computer, (it was noted that the pt had received pneumonia vax in 1996, 2000 and now in 2002.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Aphthous stomatitis, Influenza like illness, Sinusitis, Viral infection
Clinical narrative: The pt went to MD about 1 hour after receiving shot. She had canker sores on left side of tongue that appeared. She received a steroid shot and then was on Prednisone and an antihistamine for 4 days. She didn't have any difficulty breathing. She ended up back to the MD with flu symptoms, 2 weeks later and then ended up with a sinus infection. The MD suspected that she had a virus in her system on the day she received the vaccine.
Age: 1.5
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Febrile convulsion, Musculoskeletal stiffness, Opisthotonus, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Hyperpyrexia to 104.7F. Possible febrile seizure witnessed by parents. Child stiffened, without shaking, arched her head back.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Impetigo, Injection site reaction
Clinical narrative: Received SP vaccine on 3/15/02. On 3/22/02, primary response. On 4/4/02, continued drainage. No lymphangitis. Impetiginous eruption around resolving primary reaction to vaccinia vaccination. No scab. On 4/8, resolved.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Received small pox vaccine on 01/28/2002. On 02/04/2002 developed arm swelling, warmth, redness at site, tender, cellulitis left arm. On 02/05/2002 drainage, lymphadenopathy. and went to ER. 02/08/2002 cellulitis resolved. Augmentin was prescribed.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy
Clinical narrative: Received small pox vaccine on 01/28/2002. On 02/04/2002 developed arm swelling, warmth, redness at site, tender, cellulitis left arm. On 02/05/2002 drainage, lymphadenopathy. and went to ER. 02/08/2002 cellulitis resolved. Augmentin was prescribed.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Chills, Headache, Injection site erythema, Lymphadenopathy
Clinical narrative: Received SP vaccinee 1/28/02, 2/5/02 developed chills, shooting pain down arm swelling headaches backache nausea  erythmatous area surrounding vaccine site- left supraclavicular lymphadenopathy Treatment- Tequin 400 mg 1 gd X 5D; 02/22/02-cellulitis resolved
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Swelling
Clinical narrative: Received SP vaccinee 1/28/02, 2/5/02 developed chills, shooting pain down arm swelling headaches backache nausea  erythmatous area surrounding vaccine site- left supraclavicular lymphadenopathy Treatment- Tequin 400 mg 1 gd X 5D; 02/22/02-cellulitis resolved
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Injection site pain, Injection site reaction, Lymphangitis, Pain
Clinical narrative: Received SP vaccine 3/7/2002; on 03/15/02 Developed erythema, lymphangites, body aches, increased drainage @ site, pain  left arm 2 degree swelling. Treated with Ceftin 250mg BID X 5d; 3/18/02 Reevaluated - cellulitis lymphadenopathy resolving
Age: 50.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction
Clinical narrative: SP vaccine administered 1/28/02; 2/11/02-continue with increased drainage, no scab formation  purulent drainage, no lymphadenopathy, crust-rim around site r/0 impetigo Treated with Tequin 400 Mg x 5d- resolved
Age: 54.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: SP vaccine 1/28/02; 02/04/2002-redness, swelling, increased drainage, 1 cm lymphadenopathy, Ceftin 250 mg 1 bid x 5d; 2/6/02-cellulitis -resolved.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Lymphadenopathy, Pyrexia
Clinical narrative: Vaccinated on 02/08/2002. Primary response on 02/15/2002. On 02/17, the pt developed redness, swelling with red streaking to left axilla, fever of 102 deg. F., lymphaderopathy. Prescribed with Augmentin. On 02/19/2002, resolving cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Left deltoid area red, swollen, no fever. Pt complained of itching only. Given Benadryl chewable every 8 hrs as needed.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Forty-eight hrs redness around injection site, tenderness extending under arm and into neck.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Agitation
Clinical narrative: Mother of infant called health dept on 04/03/2002 reporting periods of prolonged crying up to two hrs which began the next day.
Age: 2.0
Sex: F
Vaccine: HBHEPB, MMR
Symptoms: Rash pruritic
Clinical narrative: Started with very itchy rash starting on 04/02/2002. appeared as clusters papules 2-3mm on area and much more on trunk, and extremities.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever of 104.2 deg. F. started 48 hrs after vaccination. Fever controlled with Ibuprofen. Fever lasted 3 days at time of this report. No other symptoms.
Age: 6.0
Sex: F
Vaccine: RAB
Symptoms: Convulsion, Loss of consciousness, Paralysis, Pyrexia
Clinical narrative: A 6 year old female was vaccinated with Rabipur (batch 587) 1ml, IM, (deltoid) on 12/20/01 at 17:30, 12/23/01, 12/27/01, 1/3/02 and on 1/19/02, due to a dog bite (3rd category) into the deltoid region of her left arm on 12/19/01 at 10:30. The wound was covered with gauze and a tetanus toxoid was not applied. On 12/27/01, she suffered from a fever; on 1/4/02 she developed convulsion; on 1/15/02 she showed paralytic symptoms and on 1/18/02 she became unconscious. The pt was hospitalized. Some improvement after admission in the hospital on 1/23/02. As on 3/14/02, the pt is unconscious. The stray dog is still alive on 3/14/02 and did not have any symptoms of rabies. On 2/4/02 she was discharged with some improvement. Nasogastric tube feeding. The pt was advised for admission after 1 month follow-up. As of 3/14/02, the pt is unconscious and may be admitted again. Additional info has been requested. Assessment: Seriousness criteria: life threatening; hospitalization. Causality-pending. As no rabies specific immunoglobulin was administered, atypical rabies cannot be ruled out (convulsion, paralysis, fever), though the dog is supposed to be well. As the 5th dose was administered, despite onset of all events reported, it seems that the treating physician did not assume that Rabipur was the cause.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Asthma, Bronchiolitis, Condition aggravated
Clinical narrative: Information has been received from an investigator concerning a 4 month old male child who received his second injection of Prevnar on 10/12/2000 as part of Prevnar post-marketing safety surveillance trial. The following day, the child was hospitalized for asthma. It was noted that the child "partially" recovered. Both the investigator and the medical monitor agree that this event was "possibly" related to vaccine administration. Follow-up info received on 01/25/2002 from the study investigator noted that the child was born prematurely, and had a history of asthma, bronchiolitis, and wheezing prior to vaccination. The child also received DTaP, IPV, HbOC and Hep B vaccines the same day as Prevnar vaccination. A diagnosis upon hospital discharge was "asthma and bronchiolitis with acute exacerbation." The child was treated with Albuterol, sodium chloride, and prednisolone. The investigator considered the events "possibly" related to the receipt of any of the vaccines. The medical monitor's assessment was unknown.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Affect lability, Antisocial behaviour, Aphasia, Hostility, Mental retardation severity unspecified
Clinical narrative: The mother of a 15 year old male alleges that her son received a dose of Hib in 8/91, at the age of 4 years, and subsequently developed mental retardation. In 1/87, 3/87, 9/87 and 8/91, at the ages of 2, 4 and 10 months and 4 years respectively, the child received doses of DTAP. It is alleged that, shortly after he received the vaccine doses in 1991, his language abilities, emotional affect and overall ability to function gradually regressed and deteriorated. It is alleged that he is mentally retarded; he is unable to care for himself, cannot learn to read or write, injures himself, is often hostile or violent toward others and is incapable of normal emotional interaction with others. This event was considered "Medically Important". No further information was available at the date of this report.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Cardiac arrest, Cerebral atrophy, Coma, Crying
Clinical narrative: On 04/27-cold symptoms-cogesting, runny nose, fussy, etc. On 04/28 the symptoms got gradually worse. On 04/30, extremely fussy when eating (very little). On 05/01, in the early morning, the pt started high pitched screams and fever. COD as per autopsy report: Global hypoxic-ischemic brain injury, remote; RSV. Per F/U 5/13/02, At 8:00 AM on 2/27/02, she was found unresponsive. EMS arrived and she was asystolic and unresponsive to resuscitation. She was pronounced dead in the ER. Final DX: Global hypoxic-ischemic brain injury, remote; static encephalopathy due to remote meningoencephalitis (clinically); severe bilater cortical laminar necrosis; bilateral atrophy of cerebral hemispheres with subdural membrane formation; neuronal loss and gliosis of thalamus and basal ganglia; centrolobular cerebellar sclerosis; respiratory syncytial virus (RSV) bronchitis/bronchiolitis.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Dementia, Irritability, Nasal congestion, Pharyngitis, Pyrexia
Clinical narrative: On 04/27-cold symptoms-cogesting, runny nose, fussy, etc. On 04/28 the symptoms got gradually worse. On 04/30, extremely fussy when eating (very little). On 05/01, in the early morning, the pt started high pitched screams and fever. COD as per autopsy report: Global hypoxic-ischemic brain injury, remote; RSV. Per F/U 5/13/02, At 8:00 AM on 2/27/02, she was found unresponsive. EMS arrived and she was asystolic and unresponsive to resuscitation. She was pronounced dead in the ER. Final DX: Global hypoxic-ischemic brain injury, remote; static encephalopathy due to remote meningoencephalitis (clinically); severe bilater cortical laminar necrosis; bilateral atrophy of cerebral hemispheres with subdural membrane formation; neuronal loss and gliosis of thalamus and basal ganglia; centrolobular cerebellar sclerosis; respiratory syncytial virus (RSV) bronchitis/bronchiolitis.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Respiratory syncytial virus infection, Rhinorrhoea
Clinical narrative: On 04/27-cold symptoms-cogesting, runny nose, fussy, etc. On 04/28 the symptoms got gradually worse. On 04/30, extremely fussy when eating (very little). On 05/01, in the early morning, the pt started high pitched screams and fever. COD as per autopsy report: Global hypoxic-ischemic brain injury, remote; RSV. Per F/U 5/13/02, At 8:00 AM on 2/27/02, she was found unresponsive. EMS arrived and she was asystolic and unresponsive to resuscitation. She was pronounced dead in the ER. Final DX: Global hypoxic-ischemic brain injury, remote; static encephalopathy due to remote meningoencephalitis (clinically); severe bilater cortical laminar necrosis; bilateral atrophy of cerebral hemispheres with subdural membrane formation; neuronal loss and gliosis of thalamus and basal ganglia; centrolobular cerebellar sclerosis; respiratory syncytial virus (RSV) bronchitis/bronchiolitis.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Asthenia, Pain
Clinical narrative: Arthritis, weakening of both hands, and pain pretty much continual. Splints prescribed from late April 2000 up to now.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Screaming
Clinical narrative: Inconsolable crying for several hours after 2 month shots-DTaP, IPV, Hib, and Prevnar.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Mother called this am 01/29/2002 stating that the child ran 101 deg. F. temp last night and was difficult to be awaken, right on the left thing. No fever at the time of call.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: Pt was given a shot at work and showed up here and had aches at injection site.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Screaming
Clinical narrative: The pt presented irritability and cried for three hours non-stop.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Irritability
Clinical narrative: A two month old pt was immunized on 04/02/2002. Fussier pm of 04/02/2002 but by 9pm 04/03/2002 developed high pitched cry and inconsolable, afebrile. Seen by the physician on at 17:00 with normal exam and no fever. By 04/04/2002 back to worsened behavior.
Age: 67.0
Sex: M
Vaccine: TYP, YF
Symptoms: Pyrexia
Clinical narrative: The pt developed fever lasting 3-5 days.
Age: 83.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Guillain-Barre syndrome, Hypoaesthesia, Hypokinesia
Clinical narrative: Pt experienced numbness and partial loss of function of lower extremities approx. two weeks following fluvax. Initially a diagnosis of Guillaine Barr syndrome was made. The pt was given IV and initially improved, but then worsened to the point he was a complete paraplegie. MRI, CT scan was suggestive of spinal tumor and fracture. Also states that he had a history of hypertension, left cva and a fib. Pt was see by his PCP on 11/1 and had no complaints of weakness or any neuro sxs. He was given flu vaccination on review of electronic notes. Pt states couple days after that appt (15-18 days) back he noted he was stumbling and getting weaker in his le. He also noted some numbness in his both feet. He continued to ambulate until last week when he had to start using wheel chair due to progressive LE weakness and truncal weakness with inability to support himself. He had several falls in the past week and came to see his PCP on 11/13 for evaluation of his LE weakness. A lumber ct spine was ordered and pt returned yesterday for the follow up. He was noted to be even weaker in his LE with complete inability to get up and transfer himself as he could even two days back. Pt's provider was advised to admit him to medicine for further work up and monitoring. Pt states his weakness has not progressed any further in the past 24 hrs since the admission. He denies any UE weakness, facial weakness, dysphagia, blurred or double vision or any breathing difficulties. NO speech impairment, dizziness, palpitations. He does report numbness in his feet and some paresthesia around his trunk and no complaints of bladder bowel impairment or incontinence.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pruritus
Clinical narrative: Erythema and induration measuring 15 1/2cm x 15 1/2cm over right deltoid at Hep B injection site. pruritis and pain noted superficially.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash pruritic
Clinical narrative: Pt was administered routine 4 year old vaccines and developed rash and itching approx 5-10 mins after vaccination. pediatrician was notified and was instructions received to give Benadryl.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Pt received varivax on 03/14/2000. Pt diagnosed with varicella on 03/11/2002.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: On 4-4-02 right arm swollen, red, hot. Mom applied ice to area and gave Tylenol. Seen at clinic 4-5-02; redness measured 4" long x 3" wide, swollen, hot. Nurse practitioner recommended Tylenol, Benadryl and ice
Age: 2.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site oedema
Clinical narrative: Forty hrs post vaccine (DTaP), left thigh swelling, erythema, very warm to touch extending over full antero-lat thigh and very tender.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Rash, itching.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site inflammation, Pruritus
Clinical narrative: The pt had a large, red, indurated area on left arm. It was reported to be hot and itchy. Pt's MD instructed to use Benadryl and ice packs. The symptoms resolved as of 03/28/2002 at 3:30pm.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Pt had rash all over trunk, arm sports on cheeks and no fever.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Child broke out with 15-20 vesicles
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site reaction
Clinical narrative: On 04/01/2002 DTap and MMR given on right arm. In the evening 25 cent coin size area red and warm. On Tues afternoon, redness, swelling increased. Wed, appt for physical. right arm red, swollem warm to touch from elbow to shoulder. The occupational health placed the pt on erythemomycin.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Nausea, Oedema, Rash
Clinical narrative: Rash, nausea, throat feels like swelling up. Benadryl given and sent to ER.
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Generalized rash-itching, requiring Benadryl for relief.
Age: 0.75
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia, Skin discolouration
Clinical narrative: Comvax given @ 2 pm 4-1-02. 1:30 am on 4-3-02 fever 104 degrees F. Resolved with Tylenol. 4-3-02 injection site red, war, indurated 72 in diameter. 4-8-02 injection site indurated, slight discolored 1" diameter induration.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic
Clinical narrative: Itchy rash all over-erupted on 3/21/2002. Started in hands, spread to back and legs seen in office on 3/25/o2. rash description scattered pink macules, papules, vesicles, crusts all over. Few look infected. Exposed to chickenpox on 3/11/2002  (goes to daycare)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Erythema multiforme localized rash over right deltoid arm.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Brain neoplasm, Convulsion
Clinical narrative: Pt received the Varicella shot on 7/17/2001, had a seizure on 7/20/01 then was diagnosed with a Choroid Plexus Carcinoma Brain Tumor on 9/16/01. No doctor has mentioned a connection, just a "mom's gut feeling" (I knew he had the brain tumor too, before doing the CT scan.) having a hard time ignoring my gut! I did read on the CDC Vaccine Information Statement that "severe brain reaction" is listed as a side effect of varicella.
Sex: M
Vaccine: MMR
Symptoms: Bacterial infection, Immunoglobulins increased, Lymphadenopathy
Clinical narrative: Information has been received on 3/26/02 from an RN concerning a male child who in 9/01 was vaccinated with a dose of MMRII. It was reported that "later", the pt had a positive IgM and had a swollen gland. The pt was reportedly taken to the hospital, was dx'd with mumps and had "drainage and culture" of the gland. The reporter did not think this was a vaccine failure and was concerned how long an IgM and IgG remained elevated, post vax. Follow-up information received on 4/1/02, reported that the child was admitted to the hospital for a staphylococcal infection, "that had nothing to do with the MMRII vaccination and that he child did not have the mumps". Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a physician's client concerning a friend's child who was vaccinated with MMRII and developed autism. This physician indicated that this was a case of hearsay only. Upon internal review, autism was determined to be an "Other Important Medical Event". No further information is available.
Sex: M
Vaccine: HEP, DTP, HIBV, MMR
Symptoms: Drug toxicity, Emotional disorder, Nervous system disorder, Pain
Clinical narrative: Information has been received from a legal firm concerning a child who received a series of vaccinations in 1995, 1996 and 1997, which contained the mercury-based preservative thimerosal, (specific vaccines not reported). The alleged result of these vaccinations is that the pt suffered damages relating to mercury poisoning. As a result of the mercury poisoning, the pt suffered neurologic damage, which resulted in hospitalization and medical treatment, physical pain and emotional anguish, a dimunition of quality of life and life expectancy and a loss of earnings capacity. All of these alleged damages are permanent and progressive. Upon internal review, the mercury poisoning, neurologic damage, emotional anguish and physical pain were considered to be "Other Medical Events". Additional information has been requested.
Sex: M
Vaccine: HEP, DTP, HIBV, MMR
Symptoms: Drug toxicity
Clinical narrative: Information has been received from a legal firm concerning a child who received a series of vaccinations in 1995, 1996 and 1997, which contained the mercury-based preservative thimerosal, (specific vaccines not reported). The alleged result of these vaccinations is that the pt suffered damages relating to mercury poisoning. As a result of the mercury poisoning, the pt suffered neurologic damage, which resulted in hospitalization and medical treatment, physical pain and emotional anguish, a dimunition of quality of life and life expectancy and a loss of earnings capacity. All of these alleged damages are permanent and progressive. Upon internal review, the mercury poisoning, neurologic damage, emotional anguish and physical pain were considered to be "Other Medical Events". Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Infection, Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: On 3/15/02, arm red and hive-like, hot to touch, localize, 3" in diameter. Legs and thighs felt achy. On 3/20/02, to ER because of increasing pain and loss of mobility in legs. Treated and discharged but on anti-inflammatories. On 3/31/02, to different ER and admitted. Symptoms were worse. Also had swelling on thighs and knee. Partially full recovery in one month. Transferred to a larger hospital. Hospitalized on 4/3/02. Concerned that she had rheumatoid arthritis or Guillain-Barre. Did pain control. Now doing stretching exercises. Symptoms were pain and decreased strength. Had flu-like symptoms on 3/16/02 and URI symptoms. Was given Z-pack on 3/28/02 for URI symptoms. Did tell doctor about leg symptoms. Did huge battery of test, X-rays and MRI's at another hospital. Fever to 100F X 1 day. On 3/12/02 after injections into occipital area for pain of migraine headache. Now on Vioxx, Vitamin B and ice seems to help. The follow up received on 4/17/02 states, "out chart lists pt as having an allergy to Erythromycin. It does not state how she reacts. pt was given 2 pack on 3/28/02."
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Migraine, Muscular weakness, Myopathy, Neuritis, Pain
Clinical narrative: On 3/15/02, arm red and hive-like, hot to touch, localize, 3" in diameter. Legs and thighs felt achy. On 3/20/02, to ER because of increasing pain and loss of mobility in legs. Treated and discharged but on anti-inflammatories. On 3/31/02, to different ER and admitted. Symptoms were worse. Also had swelling on thighs and knee. Partially full recovery in one month. Transferred to a larger hospital. Hospitalized on 4/3/02. Concerned that she had rheumatoid arthritis or Guillain-Barre. Did pain control. Now doing stretching exercises. Symptoms were pain and decreased strength. Had flu-like symptoms on 3/16/02 and URI symptoms. Was given Z-pack on 3/28/02 for URI symptoms. Did tell doctor about leg symptoms. Did huge battery of test, X-rays and MRI's at another hospital. Fever to 100F X 1 day. On 3/12/02 after injections into occipital area for pain of migraine headache. Now on Vioxx, Vitamin B and ice seems to help. The follow up received on 4/17/02 states, "out chart lists pt as having an allergy to Erythromycin. It does not state how she reacts. pt was given 2 pack on 3/28/02."
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Swelling, Upper respiratory tract infection, Urticaria
Clinical narrative: On 3/15/02, arm red and hive-like, hot to touch, localize, 3" in diameter. Legs and thighs felt achy. On 3/20/02, to ER because of increasing pain and loss of mobility in legs. Treated and discharged but on anti-inflammatories. On 3/31/02, to different ER and admitted. Symptoms were worse. Also had swelling on thighs and knee. Partially full recovery in one month. Transferred to a larger hospital. Hospitalized on 4/3/02. Concerned that she had rheumatoid arthritis or Guillain-Barre. Did pain control. Now doing stretching exercises. Symptoms were pain and decreased strength. Had flu-like symptoms on 3/16/02 and URI symptoms. Was given Z-pack on 3/28/02 for URI symptoms. Did tell doctor about leg symptoms. Did huge battery of test, X-rays and MRI's at another hospital. Fever to 100F X 1 day. On 3/12/02 after injections into occipital area for pain of migraine headache. Now on Vioxx, Vitamin B and ice seems to help. The follow up received on 4/17/02 states, "out chart lists pt as having an allergy to Erythromycin. It does not state how she reacts. pt was given 2 pack on 3/28/02."
Age: 20.0
Sex: M
Vaccine: TD
Symptoms: CSF test abnormal, Hypoxia, Meningitis aseptic, Pyrexia, Status epilepticus
Clinical narrative: Pt had MVA and fractured left humerus and was given TD IM in ER on 2/28/02. He was admitted on 3/9/02 with febrile, aseptic meningitis and developed status epilepticus requiring intubation.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Laboratory test abnormal, Otitis media, Pyrexia, Rash
Clinical narrative: Child experienced low-grade fevers X 2 weeks. Seen by MD and dx'd with otitis media. Child took 1 dose of amoxicillin and 1 dose of Tylenol and broke out with rash starting on arms and then legs and then it was generalized. Foster grandmother states rash escalated after giving Tylenol. MD dx'd as viral exanthem.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Injection site pain, Sleep disorder
Clinical narrative: In 10/01, the pt received Fluvirin, after which, the pt experienced a painful, burning sensation and edema in the injected arm, finding it difficult to sleep on that side. The pt then received physiotherapy and an injection of betamethasone. At the time of reporting, it was not known whether or not the pt had recovered. The reporter has assessed the relationship of Flurvirin to the event as possible.
Age: 1.2
Sex: M
Vaccine: HEP, MMR
Symptoms: Agitation, Autism, Oral intake reduced, Pyrexia, Rash
Clinical narrative: 10 days after receiving the MMR, the pt ran a high fever of 105F and would not eat solids (got sick). He had a rash on his body and face, swelled (cheek area), screaming and we could not comfort him. Called MD and gave Tylenol and fever would not break. Was told to take him to the ER. Diagnosed with Autistic Spectrum Disorder.
Age: 1.2
Sex: M
Vaccine: HEP, MMR
Symptoms: Swelling face, Vomiting
Clinical narrative: 10 days after receiving the MMR, the pt ran a high fever of 105F and would not eat solids (got sick). He had a rash on his body and face, swelled (cheek area), screaming and we could not comfort him. Called MD and gave Tylenol and fever would not break. Was told to take him to the ER. Diagnosed with Autistic Spectrum Disorder.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Pyrexia, Screaming, Tongue disorder
Clinical narrative: Temp (tactile), high pitched cry for one night head lag, tongue thrust lasting on and off for two days; always alert. Seen in ER on 01/21/2002.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC
Symptoms: Difficulty in walking, Pyrexia
Clinical narrative: The pt received total of five vaccines on 04/01/2002. He developed inability to walk for 24 hrs and fever up to 102 deg. F.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: Received Hep A vaccine on 04/09/2002 at approx. 1pm, pt developed nausea with vomiting at approx. 8-9pm and during the night. Headache on 04/10/2002. Complaints of achiness in fingers (rt) in am of 04/10/2002.
Age: 62.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Joint stiffness, Pain
Clinical narrative: After receiving shot #2, the pt developed pain and stiffness of hands and pain to left joint when walking and stiffness to neck after third shot in addition to the above. Started to develop pain in his elbows and lower back, hand joint pain continues to increase with time. He received his first shot on 04/25/1999, his second on 05/24/1999 and his third on 05/25/2000.
Age: 38.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Myalgia, Night sweats, Vasculitis
Clinical narrative: Slow onset of various symptoms ranging from joint, muscle pain, fatigue, memory/dyslexia, caused by vasculitis. Most prominent persistent night sweats. Been on various antibiotics, pain medication for 1 yr plus. Symptoms still persist and moving throughout body.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: The pt received the vaccine on 10/16/1995. Developed chicken pox on 04/05/2002.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: The pt developed shingles severe at left arm on 03/27/2002. Received varicella vaccine on 12/13/1996.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Local reaction with redness and swelling at injection site on right arm noted on 03/27/2002 and the injection was given on 03/25/2002.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site oedema, Injection site pain
Clinical narrative: Right arm hurts, red, hot, tender, swollen at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Right arm hurts, red, hot, tender, swollen at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Eye swelling, Sneezing, Wheezing
Clinical narrative: Child received immunizations approximately 4pm. Mom returned to office and stated that the pt was having trouble breathing, eyes were swelling. Sneezing in exam room. Wheeze cleared.
Age: 29.0
Sex: M
Vaccine: MU
Symptoms: Anxiety, Feeling hot, Oedema peripheral, Pharyngeal oedema, Pruritus
Clinical narrative: Five mins after vaccination, the pt complained of itching in throat then feeling hot and funny. Then swelling of the throat, tongue, lips and hands. Became anxious. Ordered Epinephrine 0.5ml SQ administration. 25 mins; Benadryl 50 mgm IM given.
Age: 29.0
Sex: M
Vaccine: MU
Symptoms: Swelling face, Tongue oedema
Clinical narrative: Five mins after vaccination, the pt complained of itching in throat then feeling hot and funny. Then swelling of the throat, tongue, lips and hands. Became anxious. Ordered Epinephrine 0.5ml SQ administration. 25 mins; Benadryl 50 mgm IM given.
Age: 61.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Neck pain
Clinical narrative: On 04/03, pt developed swollen and red down arm. and on 04/09 she developed horrible shooting pain in arm and neck.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Arthritis, Injection site erythema, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: Temp of 102 deg. F. on 1st day with myalgias, arthritis, erythema, warmth and pain at injection site. Tylenol, Advil, and Benadryl was used .
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Temp of 102 deg. F. on 1st day with myalgias, arthritis, erythema, warmth and pain at injection site. Tylenol, Advil, and Benadryl was used .
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt has chicken pox even though he received varivax four years ago.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Chicken pox on trunk multiple (papulovesicular).