chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Myalgia, Tenderness
Clinical narrative: Swelling at injection site, next day red blotches, muscle soreness, swelling continues, sore underneath arm. On 6/7 tenderness gone. Underneath arm muscle is tender.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Approx 3" knot with redness at injection site. (R) arm no painful-is a little itchy and hot to touch.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Dyskinesia, Eyelid disorder, Facial palsy, Muscular weakness
Clinical narrative: 5/31/07 developed weakness of right lower arm. Unable to completely close right eye, unable to smile or _. C/W Bells Palsy
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site papule, Rash papular
Clinical narrative: pimple like rash around (R) arm injection site were varicella was given.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Arthralgia, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: 6-1-07 Parent called-Arm red and swollen and warm to touch. Advised by phone will recheck if desire. 6-2-07 Parent called-Arm same-Now with joint pain and neck still-Biaxin 250mg bid x 7 days.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria, Wheezing
Clinical narrative: Within 1/2 hour, patient developed wheezing and urticaria to face/neck/abd. Epinephrine 0.15 ml given subcutaneous at 25 min after vaccine and helped with symptoms. Clarinex 2.5 ml given to. Mom said patient did have similar reaction to her 5yo shots.
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: (L) arm swelling and warm at the touch
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 3x5 inch red swollen, tender and hot area on (R) arm, low deltoid
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: light headed, nausea and vomiting
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: On Saturday patient's (r) arm was red and inflamed, called on call who stated if it gets worse to go to ER. Foster mom brought patient to ER on Sunday. b/c swelling and redness was past the elbow.-Given Benadryl and Motrin in ER.
Age: 5.0
Sex: M
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Vesicular rash on foot in C5 dermatome c/w zoster
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Swelling face, Urticaria, Wheezing
Clinical narrative: face swelling, hives 11:45 AM _> Rx Benadryl tachyneic, wheezing, pulse ox 77%-> Rx ALB, oxygen @ 1152-?Rx SQ Epi given 11:56 -> 12:14 paramedics arrived
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Dyskinesia, Gaze palsy, Lethargy, Pallor
Clinical narrative: Approx 3:00 PM on day of Immunization-child was happing-began thrashing, eyes rolling back, pale, lethargic, limp-taken to medical center ER by mother
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, PNC
Symptoms: Pain, Swelling
Clinical narrative: Both thighs and raised swelling Rt thigh, 5cm (+) pain Lt thigh 3 cm
Age: 7.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Varicella vaccine breakthrough. Diagnosed 6-1-07 with varicella. Had about 20 lesions. No fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin warm, Tenderness
Clinical narrative: Patient develop redness and swelling in left thigh, measuring 12x11.4cm, and a small area of redness in right thigh, measuring 5.7x2.5cm. Mild tenderness and increased warmth on touch. No fever Patient otherwise normal. Received Benadryl and oral Keflex.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Crying, Irritability, Lethargy, Screaming
Clinical narrative: Pt became fussy the afternoon after getting vaccs. At night she screamed constantly. This response continued through week-end (x 3d.) Temp. was elevated x d.s. Pt. was given Ped. Tylenol every 2-3 hours. Vacc. site on (L) thigh causes Pt. to cry. It is red. Pt. is lethargic 1st d. after shot. Advised warm soaks to leg/site u/s to tissue at site.
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Dx with mild case of varicella on 6/4/07
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 1 days after vaccine red and swollen warm to touch. Afebrile x 3 days.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Asthma, Erythema, Musculoskeletal pain
Clinical narrative: Pt stated whole shoulder sore-rash/reddness 3/26/07 he says spread down arm and across shoulder and chest. (Asthma attack mild 5/25) he reported on 5-26-07
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: L Arm reaction swelling hot to the touch and pain
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Td given 5/15/07. Painful (R) deltoid at site of injection. Today very indurated and wheal large (7 cm) ventrally and 5 cm transversally. Very tender and warm Heat Motrin recommended
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: 3x5 inch red swollen, tender and hot area on (R) arm.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Rash / Itching Torso
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL
Symptoms: Cellulitis
Clinical narrative: Pt seen at ER on 01June07 with severe cellulitis to the L upper arm from smallpox vaccination, he was given Erythromycin and Motrin at that time. Follow up at the Clinic on 04June07 with extensive cellulitis to the left upper arm extending to the elbow. Given IV Rocephin and follow up on 05June07 noted worsening of cellulitis, was given Rocephin.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt seen at ER on 01June07 with severe cellulitis to the L upper arm from smallpox vaccination, he was given Erythromycin and Motrin at that time. Follow up at the Clinic on 04June07 with extensive cellulitis to the left upper arm extending to the elbow. Given IV Rocephin and follow up on 05June07 noted worsening of cellulitis, was given Rocephin.
Age: 1.26
Sex: M
Vaccine: HIBV, MMRV, TD
Symptoms: Foreign body trauma
Clinical narrative: Chicken Pox Vaccine given to my son(6/6/07) on Upper Right Arm.  After Needle removed from his skin, a foreign body or black piece of rubber? remained under his skin.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL
Symptoms: Blister, Swelling
Clinical narrative: 01June07 seen in ER for severe reaction to smallpox including blisters and swelling. Given erythromycin and Ibuprofen, follow up at the Clinic on 04June07 with improvement noted to site.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: 01June07 seen in ER for severe reaction to smallpox including blisters and swelling. Given erythromycin and Ibuprofen, follow up at the Clinic on 04June07 with improvement noted to site.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Flushing, Headache, Injection site pain, Mobility decreased
Clinical narrative: Extreme pain at injection site. Swelling and red rash from shoulder to elbow.  Chills/headache and flushing first evening.  Unable to move arm to undress or move in bed.  Pain/rash and fever in arm persisted thru 6/09/2007.  Advised to take Benedryl after second call to physician's office. Symptons subsiding today but arm still sore and red.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash, Swelling
Clinical narrative: Extreme pain at injection site. Swelling and red rash from shoulder to elbow.  Chills/headache and flushing first evening.  Unable to move arm to undress or move in bed.  Pain/rash and fever in arm persisted thru 6/09/2007.  Advised to take Benedryl after second call to physician's office. Symptons subsiding today but arm still sore and red.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Headache, Injection site pain, Irritability, Malaise
Clinical narrative: First shot, no problem. Second shot, (3 days ago) extremely painful shot almost passed out from pain of shot given to her.  My arm still hurts 3 days later at site of shot, but for the first day it hurt allot. They had me wait 15 minutes to see if I had a reaction, I felt ok, except pain from shot, so I left.  Soon after I left, I felt groggy and irritable. This groggy lasted the rest of the day. The following day I felt ok fine except for the arm pain. Wednesday 2 days after the shot I was sick and today 6 days after I am still sick.  My symptoms are, head ache, low grade fever, stuffy nose, extremely soar throat, and horrible muscle cramps in my back, arms and stomach, ache in ears too.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Nasal congestion, Pain in extremity, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: First shot, no problem. Second shot, (3 days ago) extremely painful shot almost passed out from pain of shot given to her.  My arm still hurts 3 days later at site of shot, but for the first day it hurt allot. They had me wait 15 minutes to see if I had a reaction, I felt ok, except pain from shot, so I left.  Soon after I left, I felt groggy and irritable. This groggy lasted the rest of the day. The following day I felt ok fine except for the arm pain. Wednesday 2 days after the shot I was sick and today 6 days after I am still sick.  My symptoms are, head ache, low grade fever, stuffy nose, extremely soar throat, and horrible muscle cramps in my back, arms and stomach, ache in ears too.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Somnolence
Clinical narrative: First shot, no problem. Second shot, (3 days ago) extremely painful shot almost passed out from pain of shot given to her.  My arm still hurts 3 days later at site of shot, but for the first day it hurt allot. They had me wait 15 minutes to see if I had a reaction, I felt ok, except pain from shot, so I left.  Soon after I left, I felt groggy and irritable. This groggy lasted the rest of the day. The following day I felt ok fine except for the arm pain. Wednesday 2 days after the shot I was sick and today 6 days after I am still sick.  My symptoms are, head ache, low grade fever, stuffy nose, extremely soar throat, and horrible muscle cramps in my back, arms and stomach, ache in ears too.
Sex: U
Vaccine: ANTH
Symptoms: Erythema, Induration
Clinical narrative: ERYTHEMA, INDURATION OF 4 X 3.5 INCHES, TREATED WITH TYLENOL
Age: 0.33
Sex: M
Vaccine: DTP, HIBV, IPV
Symptoms: Convulsion, Tremor
Clinical narrative: Within 5-10 minutes (actual time not recorded)after receiving ACEL DPT #2, HIB #2, IPV/OPV #2, 4 month old patient exhibited a severe shaking, convulsion-like reaction to immunizations.  Full body convulsions lasted approximately 30 seconds.  Physician documented episode but never completed a VAERS.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Convulsion, Tremor
Clinical narrative: Within 5-10 minutes (actual time not recorded) after receiving MMR and VARIVAX, 12 month old patient exhibited a severe shaking, convulsion-like reaction to immunizations.  Full body convulsions lated approximately 30 seconds.  Physician was not in room at the time of incident but was called back into the room immediately during episode.  Physician did not see reaction however both parents were present at the time and noted reaction to the physician.  Physician did not record episode in his notes and did not file a VAERS.  TC with Mom who states child has regressive autism. 06/18/2007 Comprehensive MR received from PCP beginning age 2 months (8/3/1999) to present. Initial visit shows a healthy 2 mon. old with hydrocele.  After 4 mon. vax (10/7/1999) child had a brief shaking episode in the office (see VAERS 281070).  Again-healthy 4 mon old with hydrocele.  Multiple sick visits. 6 and 9 mon vax given w/o incident.  First developmental issues noted at 12 mon WCC-not saying 3 words or cruising. No mention of any rxn to vax. "Good development" noted at 15 mon WCC, only exception not saying "mama/dada", however noted to be vocalizing alot. Speech delay noted at 18 months.  Febrile seizure noted 3/28/2001. Multiple sick visits. At 2.5 yr visit-variable receptive language skills noted, hearing tested ok. Developmental delays noted. Refered to specialty facility-DX: PDD. Question of absence seizures noted at 3 yr WCC.  Autism Spectrum Disorder noted at 4 yr WCC. Progress noted in speech. 1/11/2010 Autism is still present. Seizure disorder still present.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Alpha 1 globulin normal, Alpha 2 globulin normal, Antinuclear antibody negative, Arthralgia
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a 61-year-old female patient who received Lymerix injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received Lymerix. At an unknown time after receiving Lymerix, the patient experienced "joint pain, clawing and other neurologic complaints and abnormal MRI. Time to onset, treatment, and outcome were not reported. Follow-up received on 25 May 2007 via the lawyer. Statement of injuries indicated that the subject experienced pain and swelling in her joints, fatigue, muscle weakness, clawing of hands, tingling in her extremities, numbness and decreased activities of daily life. Subject also experienced rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune medicated or other mechanism. Follow up information was received on 06 June 2007 via medical records. The subject was reportedly vaccinated with Lymerix in May 1999 and June 1999. Following the second vaccination, she developed flu-like symptoms, diffuse joint pain, and swelling and weakness of the hands. She developed weakness in her hands and diffuse joint pain which gradually progressed. The subject was evaluated by a neurologist on 05 April 2002. At that time, complaints included weakness and intermittent numbness and "electric shock like feelings" in her hands especially at night, aching pains in her arms and shoulders, and difficulty keeping her arms up for any length of time. Examination revealed bilateral hand grip weakness and "weakness of the opponent muscles" in both hands. She exhibited difficulty rising on the left heel, hopping on the left foot, and getting up from a kneeling position with either leg. Sensory examination revealed severely impaired vibration at the toes and mildly impaired vibration in the ankles, fingers, and clavicles. Light touch was impaired in the left hand and pin-prick sensation was impaired in both hands. Assessment included weakness of the hands and left legs with sensory loss in the hands and feet. The neurologist stated "neuropathy or myelopathy should be considered". On 05 May 2002, magnetic resonance imaging of the brain showed white matter disease "which is likely on the basis of ischemia". On 04 June 2002, electromyelograph/nerve conduction findings did not support a generalized neuropathy or a generalized myopathy. The event of white matter disease was considered by GSK to be medically significant.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Autoimmune disorder, Beta globulin increased, Blood immunoglobulin A, Blood immunoglobulin G normal, Blood immunoglobulin M
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a 61-year-old female patient who received Lymerix injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received Lymerix. At an unknown time after receiving Lymerix, the patient experienced "joint pain, clawing and other neurologic complaints and abnormal MRI. Time to onset, treatment, and outcome were not reported. Follow-up received on 25 May 2007 via the lawyer. Statement of injuries indicated that the subject experienced pain and swelling in her joints, fatigue, muscle weakness, clawing of hands, tingling in her extremities, numbness and decreased activities of daily life. Subject also experienced rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune medicated or other mechanism. Follow up information was received on 06 June 2007 via medical records. The subject was reportedly vaccinated with Lymerix in May 1999 and June 1999. Following the second vaccination, she developed flu-like symptoms, diffuse joint pain, and swelling and weakness of the hands. She developed weakness in her hands and diffuse joint pain which gradually progressed. The subject was evaluated by a neurologist on 05 April 2002. At that time, complaints included weakness and intermittent numbness and "electric shock like feelings" in her hands especially at night, aching pains in her arms and shoulders, and difficulty keeping her arms up for any length of time. Examination revealed bilateral hand grip weakness and "weakness of the opponent muscles" in both hands. She exhibited difficulty rising on the left heel, hopping on the left foot, and getting up from a kneeling position with either leg. Sensory examination revealed severely impaired vibration at the toes and mildly impaired vibration in the ankles, fingers, and clavicles. Light touch was impaired in the left hand and pin-prick sensation was impaired in both hands. Assessment included weakness of the hands and left legs with sensory loss in the hands and feet. The neurologist stated "neuropathy or myelopathy should be considered". On 05 May 2002, magnetic resonance imaging of the brain showed white matter disease "which is likely on the basis of ischemia". On 04 June 2002, electromyelograph/nerve conduction findings did not support a generalized neuropathy or a generalized myopathy. The event of white matter disease was considered by GSK to be medically significant.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Cognitive disorder, Electromyogram normal, Fatigue, Globulin, Hepatitis C antibody negative
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a 61-year-old female patient who received Lymerix injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received Lymerix. At an unknown time after receiving Lymerix, the patient experienced "joint pain, clawing and other neurologic complaints and abnormal MRI. Time to onset, treatment, and outcome were not reported. Follow-up received on 25 May 2007 via the lawyer. Statement of injuries indicated that the subject experienced pain and swelling in her joints, fatigue, muscle weakness, clawing of hands, tingling in her extremities, numbness and decreased activities of daily life. Subject also experienced rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune medicated or other mechanism. Follow up information was received on 06 June 2007 via medical records. The subject was reportedly vaccinated with Lymerix in May 1999 and June 1999. Following the second vaccination, she developed flu-like symptoms, diffuse joint pain, and swelling and weakness of the hands. She developed weakness in her hands and diffuse joint pain which gradually progressed. The subject was evaluated by a neurologist on 05 April 2002. At that time, complaints included weakness and intermittent numbness and "electric shock like feelings" in her hands especially at night, aching pains in her arms and shoulders, and difficulty keeping her arms up for any length of time. Examination revealed bilateral hand grip weakness and "weakness of the opponent muscles" in both hands. She exhibited difficulty rising on the left heel, hopping on the left foot, and getting up from a kneeling position with either leg. Sensory examination revealed severely impaired vibration at the toes and mildly impaired vibration in the ankles, fingers, and clavicles. Light touch was impaired in the left hand and pin-prick sensation was impaired in both hands. Assessment included weakness of the hands and left legs with sensory loss in the hands and feet. The neurologist stated "neuropathy or myelopathy should be considered". On 05 May 2002, magnetic resonance imaging of the brain showed white matter disease "which is likely on the basis of ischemia". On 04 June 2002, electromyelograph/nerve conduction findings did not support a generalized neuropathy or a generalized myopathy. The event of white matter disease was considered by GSK to be medically significant.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Hypoaesthesia, Hypokinesia, Immunoglobulins normal, Influenza like illness, Ischaemia
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a 61-year-old female patient who received Lymerix injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received Lymerix. At an unknown time after receiving Lymerix, the patient experienced "joint pain, clawing and other neurologic complaints and abnormal MRI. Time to onset, treatment, and outcome were not reported. Follow-up received on 25 May 2007 via the lawyer. Statement of injuries indicated that the subject experienced pain and swelling in her joints, fatigue, muscle weakness, clawing of hands, tingling in her extremities, numbness and decreased activities of daily life. Subject also experienced rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune medicated or other mechanism. Follow up information was received on 06 June 2007 via medical records. The subject was reportedly vaccinated with Lymerix in May 1999 and June 1999. Following the second vaccination, she developed flu-like symptoms, diffuse joint pain, and swelling and weakness of the hands. She developed weakness in her hands and diffuse joint pain which gradually progressed. The subject was evaluated by a neurologist on 05 April 2002. At that time, complaints included weakness and intermittent numbness and "electric shock like feelings" in her hands especially at night, aching pains in her arms and shoulders, and difficulty keeping her arms up for any length of time. Examination revealed bilateral hand grip weakness and "weakness of the opponent muscles" in both hands. She exhibited difficulty rising on the left heel, hopping on the left foot, and getting up from a kneeling position with either leg. Sensory examination revealed severely impaired vibration at the toes and mildly impaired vibration in the ankles, fingers, and clavicles. Light touch was impaired in the left hand and pin-prick sensation was impaired in both hands. Assessment included weakness of the hands and left legs with sensory loss in the hands and feet. The neurologist stated "neuropathy or myelopathy should be considered". On 05 May 2002, magnetic resonance imaging of the brain showed white matter disease "which is likely on the basis of ischemia". On 04 June 2002, electromyelograph/nerve conduction findings did not support a generalized neuropathy or a generalized myopathy. The event of white matter disease was considered by GSK to be medically significant.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Joint swelling, Liver function test normal, Metabolic function test normal, Movement disorder, Muscular weakness
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a 61-year-old female patient who received Lymerix injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received Lymerix. At an unknown time after receiving Lymerix, the patient experienced "joint pain, clawing and other neurologic complaints and abnormal MRI. Time to onset, treatment, and outcome were not reported. Follow-up received on 25 May 2007 via the lawyer. Statement of injuries indicated that the subject experienced pain and swelling in her joints, fatigue, muscle weakness, clawing of hands, tingling in her extremities, numbness and decreased activities of daily life. Subject also experienced rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune medicated or other mechanism. Follow up information was received on 06 June 2007 via medical records. The subject was reportedly vaccinated with Lymerix in May 1999 and June 1999. Following the second vaccination, she developed flu-like symptoms, diffuse joint pain, and swelling and weakness of the hands. She developed weakness in her hands and diffuse joint pain which gradually progressed. The subject was evaluated by a neurologist on 05 April 2002. At that time, complaints included weakness and intermittent numbness and "electric shock like feelings" in her hands especially at night, aching pains in her arms and shoulders, and difficulty keeping her arms up for any length of time. Examination revealed bilateral hand grip weakness and "weakness of the opponent muscles" in both hands. She exhibited difficulty rising on the left heel, hopping on the left foot, and getting up from a kneeling position with either leg. Sensory examination revealed severely impaired vibration at the toes and mildly impaired vibration in the ankles, fingers, and clavicles. Light touch was impaired in the left hand and pin-prick sensation was impaired in both hands. Assessment included weakness of the hands and left legs with sensory loss in the hands and feet. The neurologist stated "neuropathy or myelopathy should be considered". On 05 May 2002, magnetic resonance imaging of the brain showed white matter disease "which is likely on the basis of ischemia". On 04 June 2002, electromyelograph/nerve conduction findings did not support a generalized neuropathy or a generalized myopathy. The event of white matter disease was considered by GSK to be medically significant.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Myelopathy, Neurological examination abnormal, Neurological symptom, Neuropathy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a 61-year-old female patient who received Lymerix injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received Lymerix. At an unknown time after receiving Lymerix, the patient experienced "joint pain, clawing and other neurologic complaints and abnormal MRI. Time to onset, treatment, and outcome were not reported. Follow-up received on 25 May 2007 via the lawyer. Statement of injuries indicated that the subject experienced pain and swelling in her joints, fatigue, muscle weakness, clawing of hands, tingling in her extremities, numbness and decreased activities of daily life. Subject also experienced rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune medicated or other mechanism. Follow up information was received on 06 June 2007 via medical records. The subject was reportedly vaccinated with Lymerix in May 1999 and June 1999. Following the second vaccination, she developed flu-like symptoms, diffuse joint pain, and swelling and weakness of the hands. She developed weakness in her hands and diffuse joint pain which gradually progressed. The subject was evaluated by a neurologist on 05 April 2002. At that time, complaints included weakness and intermittent numbness and "electric shock like feelings" in her hands especially at night, aching pains in her arms and shoulders, and difficulty keeping her arms up for any length of time. Examination revealed bilateral hand grip weakness and "weakness of the opponent muscles" in both hands. She exhibited difficulty rising on the left heel, hopping on the left foot, and getting up from a kneeling position with either leg. Sensory examination revealed severely impaired vibration at the toes and mildly impaired vibration in the ankles, fingers, and clavicles. Light touch was impaired in the left hand and pin-prick sensation was impaired in both hands. Assessment included weakness of the hands and left legs with sensory loss in the hands and feet. The neurologist stated "neuropathy or myelopathy should be considered". On 05 May 2002, magnetic resonance imaging of the brain showed white matter disease "which is likely on the basis of ischemia". On 04 June 2002, electromyelograph/nerve conduction findings did not support a generalized neuropathy or a generalized myopathy. The event of white matter disease was considered by GSK to be medically significant.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Oedema peripheral, Paraesthesia, Sjogren's syndrome, Skin test, Vitamin B12 normal
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a 61-year-old female patient who received Lymerix injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received Lymerix. At an unknown time after receiving Lymerix, the patient experienced "joint pain, clawing and other neurologic complaints and abnormal MRI. Time to onset, treatment, and outcome were not reported. Follow-up received on 25 May 2007 via the lawyer. Statement of injuries indicated that the subject experienced pain and swelling in her joints, fatigue, muscle weakness, clawing of hands, tingling in her extremities, numbness and decreased activities of daily life. Subject also experienced rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune medicated or other mechanism. Follow up information was received on 06 June 2007 via medical records. The subject was reportedly vaccinated with Lymerix in May 1999 and June 1999. Following the second vaccination, she developed flu-like symptoms, diffuse joint pain, and swelling and weakness of the hands. She developed weakness in her hands and diffuse joint pain which gradually progressed. The subject was evaluated by a neurologist on 05 April 2002. At that time, complaints included weakness and intermittent numbness and "electric shock like feelings" in her hands especially at night, aching pains in her arms and shoulders, and difficulty keeping her arms up for any length of time. Examination revealed bilateral hand grip weakness and "weakness of the opponent muscles" in both hands. She exhibited difficulty rising on the left heel, hopping on the left foot, and getting up from a kneeling position with either leg. Sensory examination revealed severely impaired vibration at the toes and mildly impaired vibration in the ankles, fingers, and clavicles. Light touch was impaired in the left hand and pin-prick sensation was impaired in both hands. Assessment included weakness of the hands and left legs with sensory loss in the hands and feet. The neurologist stated "neuropathy or myelopathy should be considered". On 05 May 2002, magnetic resonance imaging of the brain showed white matter disease "which is likely on the basis of ischemia". On 04 June 2002, electromyelograph/nerve conduction findings did not support a generalized neuropathy or a generalized myopathy. The event of white matter disease was considered by GSK to be medically significant.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count normal, Haematology test normal, Paraesthesia
Clinical narrative: 2/14/07 - Tingle in hands, legs, feet, and arms, 2/18/07 Fever, 2/20/07 - stiff neck, loss of feeling in arms, legs, hands and feet. 11/13/07-records received for DOS 2/21-2/26/07-DC DX: Infection polyneuritis. Spontaneous Ecchymoses. Epistaxis. Cardiac Dysrhythmias. Seen in ED for C/O bloody nose since Sunday, fever, numbness, tingling of hands and feet for several days, day seen in ED C/O neck stiffness, areas of ecchymosis of arm, leg and breast.  PE: decrease to pinprick sensation distally hands and feet.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Laboratory test abnormal, Musculoskeletal stiffness, Paraesthesia, Pyrexia
Clinical narrative: 2/14/07 - Tingle in hands, legs, feet, and arms, 2/18/07 Fever, 2/20/07 - stiff neck, loss of feeling in arms, legs, hands and feet. 11/13/07-records received for DOS 2/21-2/26/07-DC DX: Infection polyneuritis. Spontaneous Ecchymoses. Epistaxis. Cardiac Dysrhythmias. Seen in ED for C/O bloody nose since Sunday, fever, numbness, tingling of hands and feet for several days, day seen in ED C/O neck stiffness, areas of ecchymosis of arm, leg and breast.  PE: decrease to pinprick sensation distally hands and feet.
Age: 4.0
Sex: F
Vaccine: MMR, PNC, DTAP, HEPA, IPV, MMR, PNC
Symptoms: Injection site induration, Pruritus, Swelling
Clinical narrative: None Stated
Age: 4.0
Sex: F
Vaccine: MMR, PNC, DTAP, HEPA, IPV, MMR, PNC
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Body temperature increased, Chills, Dizziness, Headache, Nausea
Clinical narrative: Tdap vaccine received on 4/30/07 started to feel ill on 5/1 and 5/2/07. 100-103 deg temp, nausea, headache, generalized achiness and soreness at injection site. Felt fine 5/3 and 5/4 then had severe pain on 5/6/07. She was seen on 5/7/07 and admitted to hospital on 5/7/07.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pain, Pallor
Clinical narrative: Tdap vaccine received on 4/30/07 started to feel ill on 5/1 and 5/2/07. 100-103 deg temp, nausea, headache, generalized achiness and soreness at injection site. Felt fine 5/3 and 5/4 then had severe pain on 5/6/07. She was seen on 5/7/07 and admitted to hospital on 5/7/07.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Body temperature increased, Computerised tomogram normal, Headache, Injection site pain, Laboratory test
Clinical narrative: Tdap vaccine received on 4/30/07 started to feel ill on 5/1 and 5/2/07. 100-103 deg temp, nausea, headache, generalized achiness and soreness at injection site. Felt fine 5/3 and 5/4 then had severe pain on 5/6/07. She was seen on 5/7/07 and admitted to hospital on 5/7/07.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Lumbar puncture normal, Malaise, Nausea, Pain
Clinical narrative: Tdap vaccine received on 4/30/07 started to feel ill on 5/1 and 5/2/07. 100-103 deg temp, nausea, headache, generalized achiness and soreness at injection site. Felt fine 5/3 and 5/4 then had severe pain on 5/6/07. She was seen on 5/7/07 and admitted to hospital on 5/7/07.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Blood electrolytes normal, Body temperature increased, Computerised tomogram normal, Full blood count normal, Headache
Clinical narrative: Tdap vaccine received on 4/30/07 started to feel ill on 5/1 and 5/2/07. 100-103 deg temp, nausea, headache, generalized achiness and soreness at injection site. Felt fine 5/3 and 5/4 then had severe pain on 5/6/07. She was seen on 5/7/07 and admitted to hospital on 5/7/07.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Kernig's sign, Laboratory test normal, Lumbar puncture normal, Malaise, Musculoskeletal stiffness
Clinical narrative: Tdap vaccine received on 4/30/07 started to feel ill on 5/1 and 5/2/07. 100-103 deg temp, nausea, headache, generalized achiness and soreness at injection site. Felt fine 5/3 and 5/4 then had severe pain on 5/6/07. She was seen on 5/7/07 and admitted to hospital on 5/7/07.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Nausea
Clinical narrative: Tdap vaccine received on 4/30/07 started to feel ill on 5/1 and 5/2/07. 100-103 deg temp, nausea, headache, generalized achiness and soreness at injection site. Felt fine 5/3 and 5/4 then had severe pain on 5/6/07. She was seen on 5/7/07 and admitted to hospital on 5/7/07.
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Groin pain, Headache, Herpes zoster, Laboratory test normal, Meningitis viral
Clinical narrative: 4-24-07: Received 4 vaccines: Hep A, Gardasil, Menactra, Tdap. 4-25-07: Myalgia, pain over Right buttock, right leg area, R ST joint - no rash. 4-29-07: rash over right L-3 and L-4 area HA started 5/3/07 Hospitalized for viral meningitis
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Rash
Clinical narrative: 4-24-07: Received 4 vaccines: Hep A, Gardasil, Menactra, Tdap. 4-25-07: Myalgia, pain over Right buttock, right leg area, R ST joint - no rash. 4-29-07: rash over right L-3 and L-4 area HA started 5/3/07 Hospitalized for viral meningitis
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: CSF lymphocyte count, Feeling abnormal, Headache, Herpes zoster, Lumbar puncture
Clinical narrative: 4-24-07: Received 4 vaccines: Hep A, Gardasil, Menactra, Tdap. 4-25-07: Myalgia, pain over Right buttock, right leg area, R ST joint - no rash. 4-29-07: rash over right L-3 and L-4 area HA started 5/3/07 Hospitalized for viral meningitis
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Meningitis viral, Pain, Polymerase chain reaction
Clinical narrative: 4-24-07: Received 4 vaccines: Hep A, Gardasil, Menactra, Tdap. 4-25-07: Myalgia, pain over Right buttock, right leg area, R ST joint - no rash. 4-29-07: rash over right L-3 and L-4 area HA started 5/3/07 Hospitalized for viral meningitis
Age: 12.0
Sex: F
Vaccine: HEPA, HIBV, HPV4, MNQ, HEPA, HIBV, HPV4, MNQ, HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Meningitis viral, Myalgia, Pain, Rash
Clinical narrative: 4-24-07: Received 4 vaccines: Hep A, Gardasil, Menactra, Tdap. 4-25-07: Myalgia, pain over Right buttock, right leg area, R ST joint - no rash. 4-29-07: rash over right L-3 and L-4 area HA started 5/3/07 Hospitalized for viral meningitis
Age: 57.0
Sex: U
Vaccine: TD, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Monoplegia, Nuclear magnetic resonance imaging, Oedema peripheral
Clinical narrative: Pain with the injection which continued for several weeks. Described as "ache" accompanied by decreased movement and weakness in arm. Symptoms still significant one month after injection.
Age: 57.0
Sex: U
Vaccine: TD, TDAP
Symptoms: Pain in jaw, X-ray
Clinical narrative: Pain with the injection which continued for several weeks. Described as "ache" accompanied by decreased movement and weakness in arm. Symptoms still significant one month after injection.
Age: 57.0
Sex: U
Vaccine: TD, TDAP
Symptoms: Hypokinesia, Muscular weakness, Pain in extremity
Clinical narrative: Pain with the injection which continued for several weeks. Described as "ache" accompanied by decreased movement and weakness in arm. Symptoms still significant one month after injection.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Medication error, Talipes, Umbilical cord abnormality
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 15-JAN-2007 was vaccinated with a dose of Gardasil that had been improperly stored. It was noted that the patient was not experiencing any symptoms. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information has been received through the Merck pregnancy registry from a nurse concerning an 18 year old female who on 27-OCT-2006 was vaccinated with Gardasil, when she was 17 1/7 weeks pregnant, LMP 29-JUN-2006, EDD 05-APR-2007). Subsequently, the infant was born with a left club foot and two vessel umbilical cord. The nurse felt that the left club foot and two vessel umbilical cord were other important medical events. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Epistaxis, Henoch-Schonlein purpura, Leukocytoclastic vasculitis, Parvovirus infection
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who on 05-JAN-2007 was vaccinated with a 0.5 ml dose of Gardasil. Concomitant therapy included penicillin, prednisone and hormonal contraceptives (unspecified). On approximately 15-FEB-2007 the patient experienced strep throat. On 21-FEB-2007 the patient sought medical treatment for rash/purpura and nose bleeds. On 28-FEB-2007 the patient had a sinus biopsy and was diagnosed with leukocytoclastic vasculitis. It was determined that the patient had been exposed to parvovirus. The patient was referred to an infectious disease physician who was "ruling out" the parvovirus. At the time of the report, the results of the parvovirus are unknown. After seeing several specialist, the patient was diagnosed with Henoch-Schonlein purpura. At the time of the report, the patient had not recovered.  Upon internal review, Henoch-Schonlein purpura was considered to be an other important medical event. Additional information has been requested. 6/21/07-records received for DOS 2/27-5/17/07-office visits. Presented on 2/27/07 with complaint of generalized maculopapular rash. Ecchymosis around ankles pruritic. Some resolving areas on thighs and trunk and shoulders. Started superiorly and moved inferiorly. Likely viral exanthem. Seen on 3/8/07-rash continues, assessment:leukocytoclastic vasculitis confirmed with biopsy. Seen on 3/29/07-continues to have intermittent episodes of joing swelling and stiffness, no rash at present. CT scan sinuses negative. Recent infectious history included cold in late December, on a cruise in January and developed a sore throat. HPV vaccine early January. Patient had a pet hedgehog and a python. Visit on 5/17/07-vasculitis substanitally improved.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngitis streptococcal, Purpura
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who on 05-JAN-2007 was vaccinated with a 0.5 ml dose of Gardasil. Concomitant therapy included penicillin, prednisone and hormonal contraceptives (unspecified). On approximately 15-FEB-2007 the patient experienced strep throat. On 21-FEB-2007 the patient sought medical treatment for rash/purpura and nose bleeds. On 28-FEB-2007 the patient had a sinus biopsy and was diagnosed with leukocytoclastic vasculitis. It was determined that the patient had been exposed to parvovirus. The patient was referred to an infectious disease physician who was "ruling out" the parvovirus. At the time of the report, the results of the parvovirus are unknown. After seeing several specialist, the patient was diagnosed with Henoch-Schonlein purpura. At the time of the report, the patient had not recovered.  Upon internal review, Henoch-Schonlein purpura was considered to be an other important medical event. Additional information has been requested. 6/21/07-records received for DOS 2/27-5/17/07-office visits. Presented on 2/27/07 with complaint of generalized maculopapular rash. Ecchymosis around ankles pruritic. Some resolving areas on thighs and trunk and shoulders. Started superiorly and moved inferiorly. Likely viral exanthem. Seen on 3/8/07-rash continues, assessment:leukocytoclastic vasculitis confirmed with biopsy. Seen on 3/29/07-continues to have intermittent episodes of joing swelling and stiffness, no rash at present. CT scan sinuses negative. Recent infectious history included cold in late December, on a cruise in January and developed a sore throat. HPV vaccine early January. Patient had a pet hedgehog and a python. Visit on 5/17/07-vasculitis substanitally improved.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Rotateq. Subsequently the patient experienced hematochezia. It was noted that the hematochezia lasted about a week. The outcome was recovered. Upon internal review, hematochezia was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Rotateq. Subsequently the patient experienced hematochezia. Upon internal review, hematochezia was considered to be an other important medical event. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Dyspnoea, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 56 year old male who in February 2007, was vaccinated with a dose of Zostavax. Subsequently the patient developed shortness of breath and 3 months later developed congestive heart failure after getting the vaccine. The patient was hospitalized. There was no product quality involved. No further information was provided. The patient's events were considered life threatening and serious for hospitalization. Additional information is expected.  07/10/2007 MR received for 3 day admission 5/17-19/2007 for increasing dyspnea and tachycardia. Pt began noticing increasing SOB > in the am beginning in Jan 2007 (per cardiac consult). Pt presented to MD day of admission for increasing SOB. O2 sat was 84%.  Pt also c/o persistant cough x 1 month and increasing fatigue.  PE: (+) for decreased breath sounds. Soft apical S4 heart sound upon auscultation. (+) obesity.  Discharge DX: CHF.
Age: 0.2
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Culture stool negative, Dehydration, Diarrhoea, Fluid replacement, Occult blood positive
Clinical narrative: Fever 103, profuse diarrhea and dehydration within 24 hours of vaccine administration. No gross blood in stool, but guiac-positive stools found in hospital. Stool culture negative to date. Admitted to hospital for 48 hours for rehydration.  6/12/07 Received hospital medical records which reveal patient experienced fever, vomiting & diarrhea x 1 day.  Seen by PCP on 6/1 who advised ER if condition worsened.  All symptoms increased & presented to ER on 6/2.  Admitted 6/2-6/4/07.  Tx w/IVF for rehydration.  Continued w/vomiting/diarrhea & fever in hospital.  Day before d/c, improved & was able to tolerate oral feeds.  D/C to home FINAL DX: Viral gastroenteritis. 7/12/07 Received vax records from pcp which confirm RO dose & lot # as reported.
Age: 0.2
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 103, profuse diarrhea and dehydration within 24 hours of vaccine administration. No gross blood in stool, but guiac-positive stools found in hospital. Stool culture negative to date. Admitted to hospital for 48 hours for rehydration.  6/12/07 Received hospital medical records which reveal patient experienced fever, vomiting & diarrhea x 1 day.  Seen by PCP on 6/1 who advised ER if condition worsened.  All symptoms increased & presented to ER on 6/2.  Admitted 6/2-6/4/07.  Tx w/IVF for rehydration.  Continued w/vomiting/diarrhea & fever in hospital.  Day before d/c, improved & was able to tolerate oral feeds.  D/C to home FINAL DX: Viral gastroenteritis. 7/12/07 Received vax records from pcp which confirm RO dose & lot # as reported.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception.  6/12/07 Received vax record which confirms RO lot & dose # as correct.  7/31/07 Received hospital medical records which reveal patient experienced emesis & bloody stools.  Admitted 6/3-6/7/07.  Surgical consult & taken to OR for reduction of IS & right hemicolectomy w/ileocolostomy.  Cardio consult done for heart murmur.  Recovery uneventful.  Surg & cardio f/u on d/c. FINAL DX: Intussusception, s/p right hemicolectomy & ileocolostomy; VSD.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Intussusception.  6/12/07 Received vax record which confirms RO lot & dose # as correct.  7/31/07 Received hospital medical records which reveal patient experienced emesis & bloody stools.  Admitted 6/3-6/7/07.  Surgical consult & taken to OR for reduction of IS & right hemicolectomy w/ileocolostomy.  Cardio consult done for heart murmur.  Recovery uneventful.  Surg & cardio f/u on d/c. FINAL DX: Intussusception, s/p right hemicolectomy & ileocolostomy; VSD.