chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Influenza like illness, Memory impairment, Multiple sclerosis, Optic neuritis
Clinical narrative: This report states that in February 2001, the pt fell while skiing. Approximately 3 days later she began experiencing numbness of the entire left side. She received an initial evaluation from local physicians who attributed the symptoms to her fall. She was diagnosed with muscle strain, put on a 2 week profile and prescribed Tylenol. The symptoms only slightly resolved with some residual numbness in the fingers of her left hand. on 06/03/2001 she presented to the medical clinic with complaints of a headache times three weeks with increasing pain in her right eye with decreased and darkened filed of vision. Within a few days she had total loss of vision in her right eye. She was evaluated locally and referred to optometry. That same day, optometry reported a +2-3 afferent papillary defect OD and severe color vision loss OD; fundus esam of healthy retinas OU with cup-to-disk ration approximately 0.4 with physiological cupping and lamina OU. She was treated with Solumedrol 1 gran /IV for five days then put on a Prednisone taper of 60 mg x 5d, 40mg x 3 days, 20 mg x 2 d. Her eyesight slowly returned-initially seeing shadows, then light and eventually full vision. She had not had a recurrence of these symptoms. During the evaluation of the optic neuritis, an MRI of the brain showed findings consistent with a demyelinating disease such as MS or Lyme disease. Further evaluation and lab tests ruled out Lyme disease. A second MRI of the brain two weeks later showed an area of hyper intensity in the spinal cord at C4-5 consistent with demyelinating plaques as in MS. One neurologist remarked that the left-sided numbness the pt experienced in February could not be attributed to a fall that happened five days prior and considered that set of symptoms the first sign of the demyelinating disease. Furthermore, combination of symptoms was definitely multiple sclerosis. During the time of this evaluation, the pt was pregnant; therefore other neurologist were hesitant to make a definite diagnosis of MS. In December 2001, she had a normal vaginal delivery without complications. A MRI done following her delivery showed the plaques were unchanged. Treatment with medication was delayed due to breastfeeding but she is currently on Avonex injections once a week for her symptoms. She has expereinced flu-like symptoms for 24-48 hrs following both of the two Avonex injections she has received. These are fairly common effects of the medication. The pt has a history of migraine headaches; however, these headaches have become more severe. Currently she experiences these pains once or twice a week at the same level of intensity. She noticed increasing fatigue and still experienced daytime somnolence. On July 5, 1999 approximately 5-6 weeks after anthrax vaccine #4, she developed pruritic papules over her entire body and began to experience swelling over her entire body.  She also has short term memory problems.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Rash pruritic, Somnolence, Swelling, Visual disturbance
Clinical narrative: This report states that in February 2001, the pt fell while skiing. Approximately 3 days later she began experiencing numbness of the entire left side. She received an initial evaluation from local physicians who attributed the symptoms to her fall. She was diagnosed with muscle strain, put on a 2 week profile and prescribed Tylenol. The symptoms only slightly resolved with some residual numbness in the fingers of her left hand. on 06/03/2001 she presented to the medical clinic with complaints of a headache times three weeks with increasing pain in her right eye with decreased and darkened filed of vision. Within a few days she had total loss of vision in her right eye. She was evaluated locally and referred to optometry. That same day, optometry reported a +2-3 afferent papillary defect OD and severe color vision loss OD; fundus esam of healthy retinas OU with cup-to-disk ration approximately 0.4 with physiological cupping and lamina OU. She was treated with Solumedrol 1 gran /IV for five days then put on a Prednisone taper of 60 mg x 5d, 40mg x 3 days, 20 mg x 2 d. Her eyesight slowly returned-initially seeing shadows, then light and eventually full vision. She had not had a recurrence of these symptoms. During the evaluation of the optic neuritis, an MRI of the brain showed findings consistent with a demyelinating disease such as MS or Lyme disease. Further evaluation and lab tests ruled out Lyme disease. A second MRI of the brain two weeks later showed an area of hyper intensity in the spinal cord at C4-5 consistent with demyelinating plaques as in MS. One neurologist remarked that the left-sided numbness the pt experienced in February could not be attributed to a fall that happened five days prior and considered that set of symptoms the first sign of the demyelinating disease. Furthermore, combination of symptoms was definitely multiple sclerosis. During the time of this evaluation, the pt was pregnant; therefore other neurologist were hesitant to make a definite diagnosis of MS. In December 2001, she had a normal vaginal delivery without complications. A MRI done following her delivery showed the plaques were unchanged. Treatment with medication was delayed due to breastfeeding but she is currently on Avonex injections once a week for her symptoms. She has expereinced flu-like symptoms for 24-48 hrs following both of the two Avonex injections she has received. These are fairly common effects of the medication. The pt has a history of migraine headaches; however, these headaches have become more severe. Currently she experiences these pains once or twice a week at the same level of intensity. She noticed increasing fatigue and still experienced daytime somnolence. On July 5, 1999 approximately 5-6 weeks after anthrax vaccine #4, she developed pruritic papules over her entire body and began to experience swelling over her entire body.  She also has short term memory problems.
Age: 62.0
Sex: M
Vaccine: TD, YF
Symptoms: Arthralgia, Back pain, Fatigue, Hyperhidrosis, Pain
Clinical narrative: On 04/11/2002 the pt experienced tiredness, joint pains, back pains, arms and legs pain. Took 400 mg of Ibuprofin at 2pm, slept and work up 1.5 hrs later sweating but felt much better.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site oedema, Petechiae
Clinical narrative: The pt's mother noted about 4 hours after the vaccination. Pt's lower extremities were ntoed to be swollen and red. Petechial rash in lower legs below knee.
Age: 0.75
Sex: F
Vaccine: PNC, PNC
Symptoms: Petechiae, Urticaria
Clinical narrative: After 48 hrs post vaccination, the pt broke out into hives for several days. Now with petechia rash.
Age: 0.75
Sex: F
Vaccine: PNC, PNC
Symptoms: Urticaria
Clinical narrative: After 48 hrs post vaccination, the pt broke out into hives for several days. Now with petechia rash.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Injection site erythema, Injection site oedema, Irritability, Pyrexia
Clinical narrative: The pt screamed, unconsolable almost for about 30 mins immediately receiving injections. The sites were red and swollen. The next day the pt had a high temperature of 103.6 deg. F. and remained fussy.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: The pt screamed, unconsolable almost for about 30 mins immediately receiving injections. The sites were red and swollen. The next day the pt had a high temperature of 103.6 deg. F. and remained fussy.
Age: 5.0
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site mass, Pruritus
Clinical narrative: The pt's parent describes 1/2 dollar coin size of redness, hardness with 5-6 bumps that started two days ago with 2-3 bumps with itching. On 04/25/2002, pt still compained but the area is decreasing in size.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Hypokinesia, Pain
Clinical narrative: The pt's parent stated that the pt cried when moving his right arm.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Arthralgia, Diarrhoea, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: On 04/09 the pt was treated for ear infection with antibiotics, also nasal congestion, no fever. On 04/10, varicella like rash developed on abdominal, back and injection site (red, swollen and hot to touch). On 04/13, the pt developed diarrhea and diaper rash. On 04/15, rash faded. On 04/17, larger pustules formed on buttocks, torso, arms and legs.  Knees and elbows swollen and red and painful. On 04/18, seen by a physician and treated with antihistemine and steroids. On 04/22, the pt felt better, elbows and knees look like a bruise now, rash faded with some red dots. Rash never weeped or crusted over.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash pustular, Rash vesicular
Clinical narrative: On 04/09 the pt was treated for ear infection with antibiotics, also nasal congestion, no fever. On 04/10, varicella like rash developed on abdominal, back and injection site (red, swollen and hot to touch). On 04/13, the pt developed diarrhea and diaper rash. On 04/15, rash faded. On 04/17, larger pustules formed on buttocks, torso, arms and legs.  Knees and elbows swollen and red and painful. On 04/18, seen by a physician and treated with antihistemine and steroids. On 04/22, the pt felt better, elbows and knees look like a bruise now, rash faded with some red dots. Rash never weeped or crusted over.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Proctalgia
Clinical narrative: On 04/18/2002, the child refused to bear weight and said that it feels like needles. Parent denied fever or any other symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: The pt developed redness, swelling, and warm to touch on right shoulder (local reaction).
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: The pt developed erythema, swelling, and fever two days after the vaccine administration involving the area from top of shoulder to elbow lasting 24 hrs.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema induratum, Injection site oedema
Clinical narrative: Noted on Thursday night 6:30 pm during bath. Redness, Swelling-tight, hot. Shoulder to 1 inch above on outer aspect  of left arm. Taken to quick Care. See pmd in a,. State they saw doctor this morning. Swelling down. Tylenol and ice packs. Low Grade Temp.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Urticaria
Clinical narrative: The pt developed fever, and urticaria one day following administration of Hep A #2. Treated with Benadryl and Zyrtec.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Pyrexia, Vomiting
Clinical narrative: On 03/30 in the morning the pt presented fever and vomiting. In the evening, injection site swelling was noted. On 03/31, redness and increased swelling at injection site.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Skin burning sensation
Clinical narrative: Immediately pain and burning sensation upon administration followed by a large painful reddened indurated area involving the right inner aspect of the arm below the elbow that increased over the next 72 to 96 hours.
Age: 1.4
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: The pt returned to the office on 04/05/2002 with left thigh swelling. She received DTaP vaccine on 04/03/2002 on the left thigh. The left thigh was swollen 2" from injection site and 1" in diameter with warm to touch, red and tender to palpatation. She was diagnosed with cellulitis and placed on Augmentin. The symptoms resolved.
Age: 1.4
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site warmth
Clinical narrative: The pt returned to the office on 04/05/2002 with left thigh swelling. She received DTaP vaccine on 04/03/2002 on the left thigh. The left thigh was swollen 2" from injection site and 1" in diameter with warm to touch, red and tender to palpatation. She was diagnosed with cellulitis and placed on Augmentin. The symptoms resolved.
Age: 30.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pain, Pruritus
Clinical narrative: Erythema, induration, itching and pain at injection side within, 1 hr of administration 30 hrs post injection. Pt was seen by PMD for increasing induration 34 hours post vaccination. Pt seen in ED where he received IV Solumedrol, Benadryl and Pepcid. Discharged with Rx for Keflex, Zyrtec, Prednisone and antihistamine ointment.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: The pt presented erythema and induration extending to approximately 2 inches circle around the injection site. Treated with po Benadryl Q8. Reaction started within minutes of vaccine administration.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pain, Pyrexia, Rash, Vomiting
Clinical narrative: The pt was immunized with MMR, IPV, and DTaP. The pt went to the ER on 04/25/2002 and was diagnosed with strep throat. She was prescribed zithromax. Her condition got worse in the night so she was taken back to ER at 3:30am, still vomiting and with a fever of 103 deg. F. Dr. gave her suppositories for vomiting and hydrocodone for pain. Later she developed a rash that looked like hives and/or blisters. The rash started on her hands and arms. The rash faded. On 04/29, the pt was feeling better and began to eat.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Skin ulcer
Clinical narrative: Left shoulder 3 1/2 X 2 inch oval erythematous swollen lesion
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Diffuse papular rash 10-14 days following MMR, Varivax. Treated with Benadryl. Minimal to no systemic signs.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Developed cellulitis at left thigh. Seen at ER and started on Keflex. Area measured 11cm X 7cm.
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Pyrexia, Vaccine positive rechallenge
Clinical narrative: After both DTAP 1 and DTAP 2 at 2 months and 4 months of age, pt experienced prolonged fever and irritability (X 7 days) with symptoms worse after DTAP 2. DTAP 1 lot 966A2/IM/RMLT.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Dermatitis bullous
Clinical narrative: Red macules/vesicles crust on limbs, anterior to right ear and back; a few spot total.
Age: 2.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC
Symptoms: Infection
Clinical narrative: Classic chickenpox with pustulants on body and fever.
Age: 41.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Severe joint pain starting about 6 months after the last vaccination that has become progressively worse. I tried anti-inflammatory medication to east the pain but they didn't help.
Sex: M
Vaccine: UNK
Symptoms: Dermatitis bullous
Clinical narrative: About 8 varicella lesions on trunk and extremities with 3 days of predominant symptoms. Still with lesions.
Age: 3.75
Sex: F
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness and blistering of left upper arm which started on 5/1/02. Area of erythema 7cm X 10cm.
Age: 40.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt states had pain at injection site on 5/1/02 PM. On 5/2/02 the area was reddened and swollen and became worse on 5/3/02. Was advised to go to ER. Seen at ER and given antibiotics and Benadryl. Dx'd with Cellulitis.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within hours of DT injection was having swelling and erythema at the injection site. 2 days after injection, had 4cm diameter X 1/2cm height area of induration that was warm and tender.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Livedo reticularis, Pruritus, Pyrexia
Clinical narrative: Tactile temp for the 1st 12 hours after injection; none since. Marked erythema and induration on entire left anterior thigh with more mottled areas with erythema just superior to knee. Pt complained of itching, not pain.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 5/6/02, pt reports that left deltoid to elbow is swollen, firm, painful and warm to touch X 3 days. Improving slight each day. Treated with Zyrtec 10mg po q 2 X 4 days.
Age: 53.0
Sex: M
Vaccine: TTOX
Symptoms: Cellulitis
Clinical narrative: Cellulitis; treated with Keflex 500mg bid X 7 days.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pain
Clinical narrative: Client states that the day after she received injection, she started to feel pain in the left shoulder which has progressively worsened and now radiates up to the neck and back of neck when she moves. States there is no pain at injection site and no swelling. Informed to see MD if pain continues to worsen.
Age: 1.7
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Given DTAP vaccine on 5/7/02. Returned to office on 5/9/02 with red and slightly swollen on left thigh.
Age: 2.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: This report describes cellulitis in a 30 month old male who received Infanrix. The medical history included an upper respiratory tract infection. Concurrent conditions were not provided. Concurrent medications included pentoxyvarine, chlorpheniramine, and phenylephrine. On 12/18/2001, the child received an injection of Infanrix in the right thigh; the number of previous injections of Infanrix was not provided. On that date, the child also received injections of Prevnar in the left thigh and Hib-TITER in the right thigh. On 12/20/2002, two days post-immunization, the child developed erythema and pain in both thighs; the erythema and pain were "significantly greater on his left than right." The Prevnar injection site was surrounded by a 24 cm by 12 cm area of redness, swelling, warmth, hardness, and three large bullae. On 12/20/2001, he was seen by his physician, who prescribed Augmentin, paracetamol, and warm compresses. Later that day, he developed increased erythema and more bullae in his left leg. He was taken to the local ER and hospitalized with a diagnosis of cellulitis of both thighs. The child was treated with intravenous cefazolin and diphenhydramine. On 12/21/2001, the child was seen by a pediatric infectious disease specialist, who made a diagnosis of possible hypersensitivity reaction. Fluid was obtained from the bullae for Gram stain and culture; the results were not available as of 04/17/2002. Outcomes of the events were not provided.
Age: 2.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site pain, Injection site reaction, Laboratory test abnormal
Clinical narrative: This report describes cellulitis in a 30 month old male who received Infanrix. The medical history included an upper respiratory tract infection. Concurrent conditions were not provided. Concurrent medications included pentoxyvarine, chlorpheniramine, and phenylephrine. On 12/18/2001, the child received an injection of Infanrix in the right thigh; the number of previous injections of Infanrix was not provided. On that date, the child also received injections of Prevnar in the left thigh and Hib-TITER in the right thigh. On 12/20/2002, two days post-immunization, the child developed erythema and pain in both thighs; the erythema and pain were "significantly greater on his left than right." The Prevnar injection site was surrounded by a 24 cm by 12 cm area of redness, swelling, warmth, hardness, and three large bullae. On 12/20/2001, he was seen by his physician, who prescribed Augmentin, paracetamol, and warm compresses. Later that day, he developed increased erythema and more bullae in his left leg. He was taken to the local ER and hospitalized with a diagnosis of cellulitis of both thighs. The child was treated with intravenous cefazolin and diphenhydramine. On 12/21/2001, the child was seen by a pediatric infectious disease specialist, who made a diagnosis of possible hypersensitivity reaction. Fluid was obtained from the bullae for Gram stain and culture; the results were not available as of 04/17/2002. Outcomes of the events were not provided.
Age: 27.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: The pt received varicella #1 on 01/16/2002. He developed maculo-papular rash-some vesicles-24-30 lesions multiple body sites. Seen by the physician on 01/21/2002 and was diagnosed with chickenpox.
Age: 27.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Drug ineffective, Rash maculo-papular, Viral infection
Clinical narrative: The pt received varicella #1 on 01/16/2002. He developed maculo-papular rash-some vesicles-24-30 lesions multiple body sites. Seen by the physician on 01/21/2002 and was diagnosed with chickenpox.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Bacterial infection, Brain oedema, Cerebral haemorrhage, Hypersensitivity
Clinical narrative: The pt died suddenly at the babysitter's; dx on death certificate is nodular pneumonitis with allergic component. Mother is concerned that child's allergic reaction was possibly related to vaccine. Received HIB, MMR, PCV-7 on 3/5/02. Per F/U 6/10/02 also had cerebral edema and congestion, scattered colonies of bacterial-type elements within these nodular areas and intra-alveolar hemorrhage.
Age: 27.0
Sex: M
Vaccine: MEA
Symptoms: Acne, Blindness, Contusion, Cushing's syndrome, Cushingoid
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning a 27 year old black male with folliculitis keloidalis, acne and dermatitis papillaris capillitii who on 1/2/91 was vaccinated with measles virus vaccine live. Concomitant therapy included measles-rubella vaccine (duration, dose and indication not reported), yellow fever virus vaccine live, influenza virus vaccine, BCG vaccine, MGc vaccine, poliovirus vaccine, adenovirus vaccine, PLG vaccines I, II and III, typhoid vaccine, diphtheria toxoid/tetanus toxoid. It is alleged that subsequently, the pt experienced abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis. The pt's abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis. The pt's abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis persisted. Upon internal medical review, the pt's alleged blindness was considered an "Other Important Medical Event". Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: MEA
Symptoms: Folliculitis, Fracture, Growth retardation, Hirsutism, Hypotrichosis
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning a 27 year old black male with folliculitis keloidalis, acne and dermatitis papillaris capillitii who on 1/2/91 was vaccinated with measles virus vaccine live. Concomitant therapy included measles-rubella vaccine (duration, dose and indication not reported), yellow fever virus vaccine live, influenza virus vaccine, BCG vaccine, MGc vaccine, poliovirus vaccine, adenovirus vaccine, PLG vaccines I, II and III, typhoid vaccine, diphtheria toxoid/tetanus toxoid. It is alleged that subsequently, the pt experienced abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis. The pt's abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis. The pt's abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis persisted. Upon internal medical review, the pt's alleged blindness was considered an "Other Important Medical Event". Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: MEA
Symptoms: Impaired healing, Infection, Keloid scar, Mood swings, Muscular weakness
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning a 27 year old black male with folliculitis keloidalis, acne and dermatitis papillaris capillitii who on 1/2/91 was vaccinated with measles virus vaccine live. Concomitant therapy included measles-rubella vaccine (duration, dose and indication not reported), yellow fever virus vaccine live, influenza virus vaccine, BCG vaccine, MGc vaccine, poliovirus vaccine, adenovirus vaccine, PLG vaccines I, II and III, typhoid vaccine, diphtheria toxoid/tetanus toxoid. It is alleged that subsequently, the pt experienced abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis. The pt's abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis. The pt's abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis persisted. Upon internal medical review, the pt's alleged blindness was considered an "Other Important Medical Event". Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: MEA
Symptoms: Osteoporosis, Rash papular, Skin atrophy, Vision blurred, Weight increased
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning a 27 year old black male with folliculitis keloidalis, acne and dermatitis papillaris capillitii who on 1/2/91 was vaccinated with measles virus vaccine live. Concomitant therapy included measles-rubella vaccine (duration, dose and indication not reported), yellow fever virus vaccine live, influenza virus vaccine, BCG vaccine, MGc vaccine, poliovirus vaccine, adenovirus vaccine, PLG vaccines I, II and III, typhoid vaccine, diphtheria toxoid/tetanus toxoid. It is alleged that subsequently, the pt experienced abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis. The pt's abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis. The pt's abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis persisted. Upon internal medical review, the pt's alleged blindness was considered an "Other Important Medical Event". Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: PNC
Symptoms: Abdominal pain, Dehydration, Intussusception, Vomiting
Clinical narrative: The pt developed vomiting, dehydration, and abdominal pain; diagnosis of intussuseption was made. Treatment with air enema for reduction. per doc 213832, T.C. to grand-mother, clarifications that child had G.I. SXS prior to receiving the vaccine. He was on 4/29/02 evaluated for the purpose of the SXS and was coincidentally given prevnar at that time due to chronic O.M.'s
Age: 12.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Abdominal pain, Chest pain, Glycosuria, Pain, Pneumonia
Clinical narrative: Seen in our office on 4/1/02 with fever, shoulder/chest pain, abdominal pain and vomiting. Transferred to another hospital with sepsis. Admitted to ICU with overwhelming sepsis, pneumonia. Required pressor support briefly. Discharged on 4/4/02.
Age: 12.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Sepsis, Vomiting
Clinical narrative: Seen in our office on 4/1/02 with fever, shoulder/chest pain, abdominal pain and vomiting. Transferred to another hospital with sepsis. Admitted to ICU with overwhelming sepsis, pneumonia. Required pressor support briefly. Discharged on 4/4/02.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: CSF test abnormal, Leukocytosis, Pyrexia
Clinical narrative: Five hours following immunization, pt developed high fever. He was taken to ER and was admitted for meningitis.
Age: 1.2
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Injection site oedema
Clinical narrative: In the am of 02/14/2002 (10:00) a large swollen red outside of left leg area was noticed . By noon, the swelling had spread. Mom phone both the Health Department and physician and finally went to the ER (HD referred) (see ER notes).
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left arm redness and hot to touch. A follow up report received 6/4/2002 adds: Only left arm affected site.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Local induration redness, swelling to size of baseball, Zyrtec, Ice.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pruritus, Urticaria
Clinical narrative: A few hives-neck down to bottom of buttocks-itch occasionally. They are fading away as of 1/31/02. Joints hurt very bad. Taking an antahistamines.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Loss of consciousness
Clinical narrative: The day after the vaccination, the pt walked into the living room and fell to the floor. She states that she blacked out. NO dizziness, headache, confusion before or after the incident. She felt fine afterwards did not go to the doctor's till two days later. Doctor started her on baby asprin 1 daily.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: The pt developed a temperature of > 38 deg. C.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: The pt develped swelling, redness and lump on the injection site.
Sex: U
Vaccine: PNC
Symptoms: Pyrexia, Rash
Clinical narrative: The pt developed fever (102 deg. F) and rash  eight hours post Prevnar vaccination.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Screaming
Clinical narrative: After the vaccine was given the pt cried for two hours non-stop. The pt didn't have a temperature and was better that evening.
Age: 3.9
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: The pt developed an area of redness 2x2cm around the injection site 2nd day after vaccination. Resolving spontaneously during the 3rd day.
Age: 2.08
Sex: M
Vaccine: HEPA, PNC
Symptoms: Cough, Pharyngitis, Rhinitis, Vomiting
Clinical narrative: The pt presented cold symptoms on 04/30/2002, cough on 05/02/2002, coughing and vomiting on 05/05/2002.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hypotonia, Lethargy, Pallor, Stupor, Vomiting
Clinical narrative: The pt presented hypotonic-hyporesponsive episode (pale, vomited, very lethargic, no loss of consciousness). Per doc 214038, observation only, child recovered in 5 minutes.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, PNC
Symptoms: Hepatitis
Clinical narrative: child born to HBV positive mother, despite receiving HBIg and 3 doses HBV vaccine, child tested HBs Ag positive on 3/22/2002
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Eye movement disorder, Pyrexia
Clinical narrative: On 05/06/2002 mother stated that when the pt received her immunization on 03/04/2002 she develoed a temp of 104 deg. F, rolled her eyes back several times. Mother reported baby's condition to the doctor and was instructed to give her Tylenol and Advil. Temperature lasted for about one hour.
Age: 0.8
Sex: M
Vaccine: HEP, IPV, PNC
Symptoms: Urticaria
Clinical narrative: The pt developed hives which began 48 hours after vaccination. Pt seen 72 hours after injection and improved. A follow up report received 5/17/2002 adds: No local site reaction.
Age: 0.22
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Sudden infant death syndrome
Clinical narrative: Pt found not breathing at 6am on 04/20/2002. Medical examiner expect from the autopsy to be SIDS. Per F/U autopsy; deceased found unresponsive in bed with an adult. SIDS confirmed.  Follow up on 06/19/2002: "Follow up telephone call from manufacturer on 06/03/2002 to Dr at care center for additional information on patient, Dr stated that without patient's full name she is unable to provide any information.  Dr also stated that the administered product was IPOL and not IPV.  As per regulatory affairs, the lot # (U0179) that had been originally reported for IPV was that of Yellow Fever.  The lot number for the IPOL product was not reported.  From faxed correspondence received at the manufacturer, it was reported: "This report was received from Wyeth-Ayerst for Streptococcus pneumoniae vaccine and was assigned manufacturer control number HQ2420023MAY2002.  Information has also been received from a physician concerning an 11-week old male patient with a history of one previous episode of wheezing (time not specified, treated with albuterol), no other significant past medical history and no concurrent conditions, who on 04/19/2002 at 15:00 was vaccinated in the right thigh with the first dose (Lot # 152K reported, invalid for the product) of Haemophilus B conjugate vaccine (reported as "Hib(PRP-OMP)).  Concomitant therapy that same day at 15:00 included the second dose (illegible lot number reported) in the right thigh of hepatitis B vaccine recombinant vaccine/tetanus toxoid (INFANRIX), and the first dose (Lot # 485-043) in the right thigh of Streptococcus pneumoniae vaccine (PREVNAR).  It was reported taht the patient had a mild upper respiratory infection at the time of vaccination, and that the patient did not have any wheezing on the day of vaccination.  The patient was not on any medications to the physician's knowledge.  It was noted that the episode of wheezing has not been in the several days prior to the vaccinations.  On 04/20/2002, at 06:00 the patient was found not breathing.  The patient died on 04/20/2002.  The patient had no history of adverse events after prior vaccination.  It was reported that an autopsy was done, but that the results were pending."  Additional information has been requested.
Age: 0.22
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Pt found not breathing at 6am on 04/20/2002. Medical examiner expect from the autopsy to be SIDS. Per F/U autopsy; deceased found unresponsive in bed with an adult. SIDS confirmed.  Follow up on 06/19/2002: "Follow up telephone call from manufacturer on 06/03/2002 to Dr at care center for additional information on patient, Dr stated that without patient's full name she is unable to provide any information.  Dr also stated that the administered product was IPOL and not IPV.  As per regulatory affairs, the lot # (U0179) that had been originally reported for IPV was that of Yellow Fever.  The lot number for the IPOL product was not reported.  From faxed correspondence received at the manufacturer, it was reported: "This report was received from Wyeth-Ayerst for Streptococcus pneumoniae vaccine and was assigned manufacturer control number HQ2420023MAY2002.  Information has also been received from a physician concerning an 11-week old male patient with a history of one previous episode of wheezing (time not specified, treated with albuterol), no other significant past medical history and no concurrent conditions, who on 04/19/2002 at 15:00 was vaccinated in the right thigh with the first dose (Lot # 152K reported, invalid for the product) of Haemophilus B conjugate vaccine (reported as "Hib(PRP-OMP)).  Concomitant therapy that same day at 15:00 included the second dose (illegible lot number reported) in the right thigh of hepatitis B vaccine recombinant vaccine/tetanus toxoid (INFANRIX), and the first dose (Lot # 485-043) in the right thigh of Streptococcus pneumoniae vaccine (PREVNAR).  It was reported taht the patient had a mild upper respiratory infection at the time of vaccination, and that the patient did not have any wheezing on the day of vaccination.  The patient was not on any medications to the physician's knowledge.  It was noted that the episode of wheezing has not been in the several days prior to the vaccinations.  On 04/20/2002, at 06:00 the patient was found not breathing.  The patient died on 04/20/2002.  The patient had no history of adverse events after prior vaccination.  It was reported that an autopsy was done, but that the results were pending."  Additional information has been requested.
Age: 0.22
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Pt found not breathing at 6am on 04/20/2002. Medical examiner expect from the autopsy to be SIDS. Per F/U autopsy; deceased found unresponsive in bed with an adult. SIDS confirmed.  Follow up on 06/19/2002: "Follow up telephone call from manufacturer on 06/03/2002 to Dr at care center for additional information on patient, Dr stated that without patient's full name she is unable to provide any information.  Dr also stated that the administered product was IPOL and not IPV.  As per regulatory affairs, the lot # (U0179) that had been originally reported for IPV was that of Yellow Fever.  The lot number for the IPOL product was not reported.  From faxed correspondence received at the manufacturer, it was reported: "This report was received from Wyeth-Ayerst for Streptococcus pneumoniae vaccine and was assigned manufacturer control number HQ2420023MAY2002.  Information has also been received from a physician concerning an 11-week old male patient with a history of one previous episode of wheezing (time not specified, treated with albuterol), no other significant past medical history and no concurrent conditions, who on 04/19/2002 at 15:00 was vaccinated in the right thigh with the first dose (Lot # 152K reported, invalid for the product) of Haemophilus B conjugate vaccine (reported as "Hib(PRP-OMP)).  Concomitant therapy that same day at 15:00 included the second dose (illegible lot number reported) in the right thigh of hepatitis B vaccine recombinant vaccine/tetanus toxoid (INFANRIX), and the first dose (Lot # 485-043) in the right thigh of Streptococcus pneumoniae vaccine (PREVNAR).  It was reported taht the patient had a mild upper respiratory infection at the time of vaccination, and that the patient did not have any wheezing on the day of vaccination.  The patient was not on any medications to the physician's knowledge.  It was noted that the episode of wheezing has not been in the several days prior to the vaccinations.  On 04/20/2002, at 06:00 the patient was found not breathing.  The patient died on 04/20/2002.  The patient had no history of adverse events after prior vaccination.  It was reported that an autopsy was done, but that the results were pending."  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Erectile dysfunction, Faecal incontinence, Myelitis, Urinary incontinence
Clinical narrative: The vaccinee had no known concurrent conditions or relevant medical history. On an unknown date in 2001 the vaccinee received Engerix B vaccine. The reporter stated that in the weeks and months following vaccination the vaccinee gradually dveloped problems at a sensory level so that he was unable to tell when he needed to urinate or defecate which led to urinary and fecal incontinence. He also developed erectile dysfunction. The vaccinee was referred to a neurologist who diagnosed post vaccination myeloradioulopathy (myelitis). The vaccinee has been unable to work and the reporting physician considered his condition to be incapacitating. The most recent information received on 29 April 2002 reports the outcome of the vaccinee as unknown. No other details were given. Additional information has been requested. The follow up info received on 8/6/02 states myeloradiculopathy. The reporting GP siad he had received the info third hand from a priviliged source and so could not provide further info.
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Bronchial obstruction, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Report A0359940A describes joint pain in a male vaccinee of unspecified age who received Lyme disease vaccine recombinant OspA (Lymerix). This report was received as part of litigation proceedings, with forwarding of limited medical records. This report has not been verified by a physician or other health care professional. The medical history included snoring, elongated uvula, partial upper airway obstruction, obstructive sleep apnea, and chronic fatigue. In the winter of 1994, the vaccinee injured his right shoulder while sledding.  He experienced numbness and tingling radiating from the right shoulder to the right thumb and first finger soon after the accident. The numbness and tingling persisted as of 17 May 1994, when he was evaluated by a neurologist. the neurologist made a diagnosis of mild thoracic outlet syndrome. Concurrent conditions and medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a Statement of Injuries, his attorney alleged thast the vaccinee suffers from joint pain, in particular in his shoulders and neck. He also experiences numbness in his hands and arms. In addition, he experiences fatigue. Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. The adverse events joint pain and numbness do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: M
Vaccine: LYME, LYME
Symptoms: Sleep apnoea syndrome
Clinical narrative: Report A0359940A describes joint pain in a male vaccinee of unspecified age who received Lyme disease vaccine recombinant OspA (Lymerix). This report was received as part of litigation proceedings, with forwarding of limited medical records. This report has not been verified by a physician or other health care professional. The medical history included snoring, elongated uvula, partial upper airway obstruction, obstructive sleep apnea, and chronic fatigue. In the winter of 1994, the vaccinee injured his right shoulder while sledding.  He experienced numbness and tingling radiating from the right shoulder to the right thumb and first finger soon after the accident. The numbness and tingling persisted as of 17 May 1994, when he was evaluated by a neurologist. the neurologist made a diagnosis of mild thoracic outlet syndrome. Concurrent conditions and medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a Statement of Injuries, his attorney alleged thast the vaccinee suffers from joint pain, in particular in his shoulders and neck. He also experiences numbness in his hands and arms. In addition, he experiences fatigue. Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. The adverse events joint pain and numbness do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Report A0359940A describes joint pain in a male vaccinee of unspecified age who received Lyme disease vaccine recombinant OspA (Lymerix). This report was received as part of litigation proceedings, with forwarding of limited medical records. This report has not been verified by a physician or other health care professional. The medical history included snoring, elongated uvula, partial upper airway obstruction, obstructive sleep apnea, and chronic fatigue. In the winter of 1994, the vaccinee injured his right shoulder while sledding.  He experienced numbness and tingling radiating from the right shoulder to the right thumb and first finger soon after the accident. The numbness and tingling persisted as of 17 May 1994, when he was evaluated by a neurologist. the neurologist made a diagnosis of mild thoracic outlet syndrome. Concurrent conditions and medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a Statement of Injuries, his attorney alleged thast the vaccinee suffers from joint pain, in particular in his shoulders and neck. He also experiences numbness in his hands and arms. In addition, he experiences fatigue. Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. The adverse events joint pain and numbness do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.