chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.7
Sex: F
Vaccine: HIBV
Symptoms: CSF test abnormal, Drug ineffective, Infection, Meningitis
Clinical narrative: Post third vax, this child developed meningitis and bacteremia due to "vax failure."  It was indicated that the pt survived but no additional information is expected.
Age: 1.8
Sex: M
Vaccine: HIBV
Symptoms: Arthritis bacterial, Bacterial infection
Clinical narrative: Information has been received concerning a 22 month old white male pt who was vaccinated with a 1st, 2nd, 3rd and 4th dose of Haemophilus b conjugate vaccine on 7/1/94, 9/2/94, 11/8/94 and 9/26/95, respectively. The pt developed septic arthritis due to "vaccine failure." From joint fluid the serotype was positive for Haemophilus influenza B. The pt's experiences were considered "other important medical events." Outcome was indicated as "yes". No further information is expected.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Cellulitis, Drug ineffective, Infection
Clinical narrative: Post vax, this pt developed bacteremia and cellulitis due to "vax failure." Lab tests were performed and pt was dxed as having Haemophilus type B.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Convulsion, Tremor
Clinical narrative: Shaking activity, questioned for seizure, 48-72 hours, post vax.
Age: 1.09
Sex: F
Vaccine: HEP, IPV, MMR
Symptoms: Anorexia, Crying, Intracranial pressure increased, Irritability, Nervous system disorder
Clinical narrative: ON 7/1/00, pt broke out with rash and developed incessant crying, irritability with opisthotonos on 7/2/00. Seen in the clinic on 7/3/00, 7/5/00, 7/6/00 and in the ER on 7/8/00 due to persistent crying and poor oral intake. No fever. Transferred to another hospital 7/8/00. Crying and irritability relieved after spinal tap under GA. Diagnosis was abnormal brain anatomy and Seckel's syndrome.
Age: 1.09
Sex: F
Vaccine: HEP, IPV, MMR
Symptoms: Opisthotonus, Rash
Clinical narrative: ON 7/1/00, pt broke out with rash and developed incessant crying, irritability with opisthotonos on 7/2/00. Seen in the clinic on 7/3/00, 7/5/00, 7/6/00 and in the ER on 7/8/00 due to persistent crying and poor oral intake. No fever. Transferred to another hospital 7/8/00. Crying and irritability relieved after spinal tap under GA. Diagnosis was abnormal brain anatomy and Seckel's syndrome.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Abscess, Bacterial infection, Cellulitis, Infection, Oedema genital
Clinical narrative: Chickenpox declared on 7/25/2000; cellulitis began on 07/27/2000; hospitalization and surgery on 7/28/2000. Cellulitis involved the right labia. No other vaccines given 7/24/00. Per F/U 7/2/02: Incision and drainage of right libia abscess. She was then started on Ancef and clindamycin IV. The pt had temperature on 2nd day of hospitalization and required IV antibiotics until she was afebrile. Had a 3 day history of temperature of 102F-103F. Had been seen and started on Keflex 1 day prior to admission.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Chickenpox declared on 7/25/2000; cellulitis began on 07/27/2000; hospitalization and surgery on 7/28/2000. Cellulitis involved the right labia. No other vaccines given 7/24/00. Per F/U 7/2/02: Incision and drainage of right libia abscess. She was then started on Ancef and clindamycin IV. The pt had temperature on 2nd day of hospitalization and required IV antibiotics until she was afebrile. Had a 3 day history of temperature of 102F-103F. Had been seen and started on Keflex 1 day prior to admission.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Abnormal behaviour, Antisocial behaviour, Aphasia, Autism
Clinical narrative: Loss of language, social skills, unusual and repetitive play, "autistic-like behaviors, all within 30 days of vaccine.  Follow up 10/19/2000: "The following is a summary of our evaluation and recommendations.  The evaluation included a speech and language evaluation, psychological evaluation, and physical examination.  A full report will follow in 4-6 weeks.  The patient is a 33 month old male who has a history of speech delays.  He has had a hearing evaluationi which was normal.  According to his mother, he is receiving one hour of speech therapy per week, half hour of physical therapy per week, one hour of developmental time individually per week and one and a half hours of group developmental work per week.  The patient is a very impulsive child both history and evaluation.  He has poor limits and barriers.  He often puts himself and others at risk with his behavior.  He has minimal interactions with others.  He seeks out very tactile stimuli and responds well to deep pressure.  He has many perseverative behaviors and is very poor with transitions.  He does responds to men and male voices more positively.  The patient had a normal physical examination.  He showed strong gross motor skills as well as fine motor skills.  The patient had severe communication difficulties.  He has approximately 10 words, signs or gestures he uses to communicate.  He is jargonning but it is not being used for communication.  He responds better to language with in routines.  He also responds to changes in intonation.  He showed a cognitive level at 14 months by the Bailey evaluation.  He does have a scatter of skills to 24 months.  He is very self-directed and active.  He was able to transition with the use of crayons.  He was very impulsive and indiscriminate with his interactions with strangers.  Overall based on our evaluation, the patient has global developmental delays.  In addition, he is autistic.  He is a high risk child because of his poor ability to act in a safe manner.  The primary concern of this team is ensuring that the patient has a safe environment to learn and live.  Our recommendations will address these concerns.  RECOMMENDATIONS:  1)  The patient will need to have a TEAM evaluation to determine the appropriate placement within the education system.  He will need to be in a year round autism/pervasive developmental delay program.  2) Secondary to concerns about his safety, the patient will need one to one supervision at least initially.  His safety and the safety of the other children must be guaranteed.  3) In an effort to manage the behaviors and his own safety, the patient will need to work with a behviorist.  He would be helped by an intensive program with intervention involving both his home and school involvement.  4) The patient will need to have a BEAM study to determine whether he is having seizures.  In addition, he will need a MRI of his brain secondary to his previous dermoid cyst. "
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Activated partial thromboplastin time prolonged, Blood creatine phosphokinase increased, Cerebral haemorrhage, Coma, Convulsion
Clinical narrative: Baby found prone by mother at about 10:00, unresponsive and blue in color. After 1 minute, baby's color returned but remained unresponsive; temp 104.3F at outside ER. Transferred to Peds ICU, where pt was observed to have seizure; remained unresponsive; intubated. Pt remains intubated with decrease in activity. Per doc 197659: On 08/22/2000 at 16:00 call from parent, child is fully recovered; lenght of time in hospital: 10 days. Discharged on phenobarbital. No further incidence of seizure. On 09/21//2000, no reply from hospital, letter and consent form sent to parents. On 10/20/2000; second request; letter and consent form sent.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Cyanosis, Hepatic enzyme abnormal, Hypoxia, Prothrombin time prolonged, Pyrexia
Clinical narrative: Baby found prone by mother at about 10:00, unresponsive and blue in color. After 1 minute, baby's color returned but remained unresponsive; temp 104.3F at outside ER. Transferred to Peds ICU, where pt was observed to have seizure; remained unresponsive; intubated. Pt remains intubated with decrease in activity. Per doc 197659: On 08/22/2000 at 16:00 call from parent, child is fully recovered; lenght of time in hospital: 10 days. Discharged on phenobarbital. No further incidence of seizure. On 09/21//2000, no reply from hospital, letter and consent form sent to parents. On 10/20/2000; second request; letter and consent form sent.
Age: 48.0
Sex: F
Vaccine: LYME
Symptoms: Polyarthritis
Clinical narrative: Approximately 10 months, post vax, I developed osteoarthritis in both hands, without any previous symptoms, prior to vaccinations.
Age: 53.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Immune system disorder, Rheumatoid arthritis
Clinical narrative: Joint pain, rheumatoid arthritis, auto-immune disease. One month after receiving 2nd Lymerix vaccine. Treated with prednisone and Naproxen and advised to take Embril. The annual follow-up states that the pt still is experiencing acute joint pain and currently taking plaquonil, sulfasalzis and zantac.      Pt received vaccination for Lyme disease on April 6 and May 19, 1999. About one month later she began to have hip pain. Then, moving the neck became painful. Next, her shoulders became stiff and painful, particulary at night. The pain is worse in the morning or after sitting, but she has pain and stiffness throughout the day. She thinks that her symptoms are generally getting worse. Because of the pain and stiffness in the hip and shoulders, she was diagnosed with polymyalgia rheumatica. Apparently the sedimentation rate was no t elevated. In the fall of 1999 she was started on prednisone 10mg, which was then increased to 15mg a day. She marked improvement on this medication, but not total relief of symptoms. However, she disliked being on prednisone, and the decision was made to taper it. The medication was stopped two months ago. Subsequently she has taken Naprosyn 375mg twice a day. However, she does not think this medication helps. She tells me that she has had x-rays in the past of her shoulders and knees which show degenerative changes in the shoulders. She had a DEXA scab which was normal. The family history includes a son who has Lyme disease, but she has no family history or arthritis psoriasis, or inflammatory bowel disease. There are no allergies. She currently takes Tylenol PM at night, which helps with sleep. On physical examination, she has squeeze tenderness of the PIP joints bilaterally, a swollen and tender left second MCP joint, pain on forced flexion at both wrists, and pain on shoulder abduction greater than 90 degrees, and on internal and external rotation bilaterally. She also has pain on lateral movement of the neck, and pain over the greater trochanteric bursae. Examination of the heart, lungs, and abdomen is normal, as is the neurologic examination.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Dysgeusia, Hypoaesthesia, Pain, Vision blurred
Clinical narrative: 2 days, post vax, pt had pain in buttocks and into right leg, then numbness in anterior right shin and into right foot. He had a metallic taste in mouth and slightly blurred vision. 8/2/00, has improved. No treatment required.
Age: 38.0
Sex: M
Vaccine: ANTH, MEN
Symptoms: Arthralgia, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Symptoms: low-grade fever (2-3 degrees elevated), muscle aches, joint aches, headaches, chills, malaise. Treatment: 24 hour Quarters (bed rest), Motrin 800mg 3 X day by mouth with food.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Multiple sclerosis
Clinical narrative: Numb feeling in skin within a few hours of shot that resolved within 2 weeks to exactly the half of his body that received the shot. A 15-day follow up report received 11/20/2001 adds: A 32-year-old male, with no previous medical conditions, received the 2nd dose of Anthrax vaccine on 04/25/2000. The pt received the 1st dose of Anthrax vaccine on 01/05/2000 with no adverse reaction. No other vaccinations were given on that date and the pt was taking no concomitant medications. On 04/26/2000 the pt experienced paresthesia. Four to five months later, he experienced joint symptoms. Twelve to 13 months later, he experienced dysequilibrium and a numb sensation. Fourteen to 15 months later, he experienced eye blurring and sleep disturbance. Relevant laboratory/diagnostic tests included magnetic resonance imaging and CSF exam which were consistent with multiple sclerosis. An evaluation on 07/16/2001 revealed the pt continues to have these symptoms. The pt was diagnosed with multiple sclerosis 07/20/2001. Follow-up info received on 10/24/2001: The pt states he had an unremarkable MRI 2 months prior to his Anthrax vaccinations, but since his symptoms started, he had multiple MRI's which have shown lesions all over his spine and brain. He has been taking Avonex since August, but has still experienced paresthesia, allodynia, insomnia, bilateral arthralgias, numbness in right thumb, loss of use of right leg, arm and eye, reduced of left leg, digestive problems, and a problem with his left calf/hamstring.  Follow up on 10/27/2000: "Patient partially recovered from the adverse event.  Continues to have reduced sensitivity in entire right hemisphere of his body.  Patient missed 14 days of work.  Patient did not receive any further shots since reported event."
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Dermatitis allergic, Eosinophilia, Urticaria
Clinical narrative: Pt with recurrent, focal, urticarial plaques localized only to right upper arm (from shoulder to elbow) occurring a few weeks after receiving anthrax vaccine #6 and recurring every 2-5 days and lasting for hours persistent X 5 months since vaccine to right shoulder in March 2000. Still has facial urticaria episodes to right arm.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Eyelid oedema, Face oedema, Irritability, Nasal congestion
Clinical narrative: Fussiness and congestion, post vax. 1 1/2 days later, developed eye and lip swelling. No difficulty breathing and no rash. Given Benadryl with improvement.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Convulsion, Eye movement disorder, Feeling hot, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: At 18:30, felt warm and was given Tylenol. At 19:00 was being put to bed by grandma as she was holding her, she stiffened up and eyes rolled back. Grandma called 911 and she started convulsing. Had 8-10 convulsions. Unconscious 10 minutes in ambulance.
Age: 0.8
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Injection site mass, Injection site pain, Irritability, Pyrexia
Clinical narrative: Fever 101.3F, cranky but consolable. 3/4" firm, indurated area on both thighs, not warm. Right thigh tender. No rash, no meningeal signs. Symptoms resolved by 8/10/2000.
Age: 1.25
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Cough, Febrile convulsion, Nasal congestion, Otitis media
Clinical narrative: Taken to ER for febrile seizure. Had cough and congestion for a few days. Seizure lasted 4-5 minutes and received albuterol en route to ER. Dx'd with ear infection and treated with amoxicillin.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site mass
Clinical narrative: 9cm X 6cm induration on left lateral thigh. Placed on Kelflex.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fibromyalgia, Myalgia, Pyrexia
Clinical narrative: On unspecified dates, the pt received his 1st, 2nd and 3rd Lymerix injections. About 2 to 3 weeks after the 3rd injection, the pt developed a low-grade fever, arthralgia, myalgia and "possible" fibromyalgia. As of 8/9/00, the outcome of the events were ongoing.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site mass
Clinical narrative: Induration of injection site. Physician instructed pt to apply ice to area and talk Motrin for pain.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Oedema peripheral, Pain
Clinical narrative: Swollen, tender arm. Headache and nausea.
Age: 0.7
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Cyanosis, Injection site hypersensitivity, Injection site mass, Pyrexia
Clinical narrative: Two days post vax, on 06/14, the child was observed as his lips turned blue and finger slightly blue. His temperature was 102 and he had a reddened left lateral thigh. He was taken to the ER where his temperature reached 104. He was seen in the clinic for follow up 7/13, and his thigh was noted as having a pea sized knot.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Rash, Urticaria
Clinical narrative: Vaccine below given approximately 1000 AM. Caregiver states child took naps and woke up with rash about 3:45-4:00 PM. Hives, redness, warm to touch right upper arm and right middle thigh noted. Received Tylenol and Benadryl and if symptoms worsen, go to ER.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Syncope
Clinical narrative: Post second vax which was hepatitis A IZ, this child fainted and lost consciousness. BP and pulse remained nml. No respiratory distress or resuscitation was needed. He was placed in supine position with leg elevation. Cold compresses applied. He regained consciousness within two to three minutes and left clinic unassisted.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Otitis media, Pyrexia, Rash
Clinical narrative: 8 to 9 days post vax, the pt developed a rash on chest, arms, and back; then began running a 105 fever. Taken to pediatrician and dx with ear infection. Placed on antibiotics and was ok within 3-4 days.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site mass, Pruritus, Swelling
Clinical narrative: Next day post vax, the pt developed slight itching and swelling. Also, she had a 1" diameter induration and redness which increased in size to 5".
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain, Headache, Hypotonia, Musculoskeletal stiffness, Pallor
Clinical narrative: Within 15 to 30 seconds post vax, the pt went limp in his chair, eyes fixed and staring, then he stiffened straight out and started shaking for 1 to 3 minutes. When he awoke he complained of headache and stomachache; appeared ashen.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Staring, Tremor
Clinical narrative: Within 15 to 30 seconds post vax, the pt went limp in his chair, eyes fixed and staring, then he stiffened straight out and started shaking for 1 to 3 minutes. When he awoke he complained of headache and stomachache; appeared ashen.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Broke out with vesicular rash on wrist, stomach, and face. Itchy on wrist area.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Next day post vax, the pt began to have raised areas on back, buttocks, and legs. Since that time they have steadily improved. On 8/11/00, 2 small raised areas on lower back and 1 raised area on buttock and 3-4 small areas on thighs appeared.
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Infection, Pyrexia, Swelling
Clinical narrative: Swelling, redness, fever, and pus. Incision and drainage was performed.
Age: 1.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Dystonia
Clinical narrative: 2 days post vax, the pt had a dystonic reaction which repeated over the following 6 days.
Age: 11.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Headache, vomiting, and light-headed.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Injection site inflammation, Injection site oedema
Clinical narrative: Extended localized allergic reaction 5 cm area of inflammation, swelling on days 3-9 following injection.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Chest discomfort, Cough, Dyspnoea, Pneumonitis, Pyrexia
Clinical narrative: Post vax, the pt experienced chest tightness, dyspnea, productive cough with low grade fever correlated to increased smoke in the area from massive forest fires. Pt felt it was due to her vaccine.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Severe local erythema and swelling.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Severe local erythema, swelling, and cellulitis.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Developed red, maculopapular rash over much of body within 2 hours of vax. Referred to ER, no action was taken.
Age: 41.0
Sex: F
Vaccine: RUB
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: In August 99, there was the onset of moderate to moderate/severe joint pain and stiffness in wrists, hips, knees, and ankles. At the time of this report, there remains mild-moderate joint pain and stiffness primarily in knees. The pain makes activities involving repetative knee bending difficult.  Follow up 10/17/2000: "The administrator of the vaccine did not document the Lot #."
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt complains of soreness, redness, and swelling.
Age: 0.5
Sex: M
Vaccine: DTP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea began the morning after vax and is at present ongoing.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Vaccine positive rechallenge
Clinical narrative: Post vax, the pt experienced 2 weeks period of severe neck soreness without any trauma or illness.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt developed chickenpox.
Age: 7.0
Sex: M
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt developed chickenpox.
Age: 73.0
Sex: F
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site oedema
Clinical narrative: Local induration, redness, and swelling.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Mom noted red, swollen, hard lump the size of a golf ball at the injection site. At 10 pm it was hot, red, hard lump the size of a baseball, and tender to the touch. Went to ER and started on Augmentin to rule out cellulitis.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Rash
Clinical narrative: Rash over entire body.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Next day post vax, the pt noticed swelling of left arm around triceps area. Area was swollen, red, and blotchy but child was not complaining. Advised parents to treat with acetaminaphen and cold packs to swelling. On 7/19, the parents called and reported that the swelling was whole arm from wrist to shoulder. No redness except back of upper arm. Advised to see physician in ER and treat with Benadryl, acetaminaphen and cold packs.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia
Clinical narrative: States noted a pain in her shoulders within a couple of days after vax. States it was an achy joint kind of pain and symptoms lasted 1 month total. Pain moved to various joints in head to toe sequence; first shoulders, then elbows, wrists, fingers, hips, and knees.
Age: 1.08
Sex: F
Vaccine: HBHEPB, IPV, MMR
Symptoms: Febrile convulsion, Liver function test abnormal, White blood cell count increased
Clinical narrative: The next day post vax, the pt developed a fever and seizures. Taken to ER and dx with febrile seizures. Treated with Tylenol and Motrin.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: Erythema and induration at injection site.
Age: 10.0
Sex: F
Vaccine: HEP, HIBV, TTOX
Symptoms: Asthenia, Pyrexia, Vomiting
Clinical narrative: The next morning post vax, the pt vomited times three, had fever most of the day to 103 and felt weak. By the evening, the pt felt much better. Able to eat a light dinner. Fever gone by next morning and feeling fine. Motrin given day 1 for increased temperature.
Age: 2.0
Sex: M
Vaccine: RV
Symptoms: Dehydration, Diarrhoea, Influenza like illness, Viral infection, Vomiting
Clinical narrative: On 3/1/00, the child developed vomiting, diarrhea, and flu-like symptoms. He was seen by his pediatrician and a dx of dehydration and rotavirus was made. The pediatrician sent the child to an ER where he was given IV hydration for 5 hours.
Age: 0.2
Sex: M
Vaccine: RV
Symptoms: Anorexia, Constipation, Screaming
Clinical narrative: Within 24 hours post vax, the pt experienced screaming, constipation, would not straighten out his legs, and did not eat or drink for 4 days.
Age: 0.5
Sex: F
Vaccine: DTPHIB, HEP, OPV, RV
Symptoms: Diarrhoea, Viral infection, Vomiting
Clinical narrative: On 4/6/00, pt developed vomiting and diarrhea, she was seen by the vaccine provider.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Injection site hypersensitivity, Nausea, Pyrexia, Vomiting
Clinical narrative: On 5/14/00, the pt developed sores around the injection site. The pt had been taking antibiotic Keflex orally for the sores but the sores did not improve. On 5/17/00, she began experiencing nausea and vomiting, a fever of 101. Treatment of the fever and nausea/vomiting was unknown.
Sex: F
Vaccine: RAB
Symptoms: Headache, Lethargy, Malaise, Nausea, Pyrexia
Clinical narrative: Fever and chills, nausea and vomiting, malaise, mild lethargy, headache. Reported she was possibly exposed to rabies when she removed the head of a dog found to be positive for rabies. Fever reached 104 F. Treatment was APAP and ASA.
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Fever and chills, nausea and vomiting, malaise, mild lethargy, headache. Reported she was possibly exposed to rabies when she removed the head of a dog found to be positive for rabies. Fever reached 104 F. Treatment was APAP and ASA.
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Lymphadenopathy, Pruritus
Clinical narrative: Pt developed bilateral lymphadenopathy post vax, for post exposure prophylaxis. Following day he complained of itchiness of the right and left axillary areas left more than right, as well as swelling unilaterally in axilla. On June 30, 2000 the pt received Benadryl and Solu-Medrol prior to 2nd dose. No reaction, reporter assessed the event as related to RabAvert.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Post vax, the pt developed tingling in her left arm and leg after receiving vax.
Sex: F
Vaccine: RAB
Symptoms: Injection site urticaria
Clinical narrative: Post vax, the pt developed hives on the arm at the injection site.
Age: 10.0
Sex: F
Vaccine: RAB
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Post third dose of vax, the pt's mother stated that pinkness developed at the injection site which was hot and swollen for two days.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Post vax, the pt's right upper thigh became swollen, hard, and painful.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Post vax, the pt developed a local reaction of redness and swelling.
Sex: U
Vaccine: DTP
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Post vax, the pt developed swelling of the leg, that was red and warm to the touch.
Age: 1.4
Sex: M
Vaccine: DTP
Symptoms: Rash
Clinical narrative: Post vax, the pt developed a rash over body a few hours post vax.
Sex: M
Vaccine: OPV
Symptoms: Nonspecific reaction
Clinical narrative: A mother reported that her son received a dose of Orimune in 1997 and has subsequently experienced unspecified problems.
Sex: F
Vaccine: FLU3, MEN, OPV, YF
Symptoms: Pharyngitis, Rhinitis
Clinical narrative: Post vax, the vaccinee developed cold symptoms.
Age: 57.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Breast neoplasm
Clinical narrative: It was reported, pt developed lumps in her breast after receiving the flu vaccine. Went to a specialist. From follow-up of 7/28/98, it was reported that the pt recovered from this experience.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Myalgia, Rash maculo-papular
Clinical narrative: October 3, 1997 the pt developed red blotches and could not use the arm shot was administered in. February 23, 1998, muscle aches in arms, buttocks, legs, knees, 3-4 red blotches continues to have symptoms of aches/stiffiness. They say I have Palymyalgia Rheumatica. This came overnight the week I got the flu shot. On Prednisone, States diagnosed with fibromyalgia. States doctor said couldn't say problems were or were not related to Flu shot. States she doesn't have the pain she had.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: It was reported that a 52 year old female received Fluzone WV 98-99 on September 15, 1998. Reportedly on September 16, 1998 the patient experienced localized redness (5cm in width), swelling (0.5 cm), itching and pain at site of injection. Applied cool pack to site. Claritin Reditab 10 mg one sublingually while in ofice. One tab a day for three days.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Reportedly on 09/20/1998 the pt experienced redness, soreness, itching and swelling at injection site, size of 50 cent piece. Cool pack to be applied to site. Injection site NYSN, Pain, Edema, Pruritus.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Reportedly on September 20, 1998 the pt experienced localized redness, pain and swelling at site of injection. Size 50 cent piece.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Laryngospasm, Rash
Clinical narrative: Fifteen minutes post vax, the pt experienced throat thightening, coughing and erythema. Reportedly responded to Benadryl 500 IM and Epi 1cc IM x 2 and Dexametharone IM and now on oral steroids.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site hypersensitivity, Injection site oedema, Vasodilatation
Clinical narrative: Redness, swelling, hot to touch, localized reaction size of a quarter. (Verbal report per pt, 2 wks after incident)
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: Six hours post vax, the pt experienced fever, muscle aches which progressed through 10/6/98.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia
Clinical narrative: Two days post vax, the pt was not able to lift her arm over the weekend.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Face oedema, Pyrexia
Clinical narrative: Same day post vax, the pt experienced fever, shortness of breath, and facial swelling.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: 5 minutes post vax, the pt experienced severe wrist pain; 2 days later muscle pain. Also, numbness in extremities; then severe burning feeling in legs.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Myasthenic syndrome, Pain
Clinical narrative: Reportedly the injection appeared to be normal on November 9, 1997 but his triceps muscle area became sore and by November 12, 1997 he favors his left arm with marked avoidance of lifting. The pt especially gets weak with arm abduction. On exam the pt is tender at posterior deltoid triceps left side. No fluctuance, local ulcer or enlargement or induration. There is no atrophy or distinct paresis and no paresis or vascular change.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Back pain, Chest pain, Dyspnoea, Hypertonia, Myalgia
Clinical narrative: It was reported that a 44 year old female received Fluzone, TD and Pneumovax vaccines on 10/6/98. Reportedly, on 10/7/98, the pt complained of chest tightness, myalgia and muscle cramping. From additional information of 10/13/98, it was reported that the pt experienced shortness of breath, pain under her right arm and across her back; feels as though someone beat her. Numbness in arms and fingers, back spasms and nauseated. Treatment of Benadryl IM and Toradol IM was given. Reportedly, the pt recovered from this experience. From additional information received on 12/8/98, it was reported that the pt recovered in 24 hours.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Nausea, Pain, Paraesthesia
Clinical narrative: It was reported that a 44 year old female received Fluzone, TD and Pneumovax vaccines on 10/6/98. Reportedly, on 10/7/98, the pt complained of chest tightness, myalgia and muscle cramping. From additional information of 10/13/98, it was reported that the pt experienced shortness of breath, pain under her right arm and across her back; feels as though someone beat her. Numbness in arms and fingers, back spasms and nauseated. Treatment of Benadryl IM and Toradol IM was given. Reportedly, the pt recovered from this experience. From additional information received on 12/8/98, it was reported that the pt recovered in 24 hours.
Age: 0.3
Sex: F
Vaccine: DTPHIB, IPV
Symptoms: Cyanosis, Dyspnoea, Hyperventilation, Injection site oedema, Oedema peripheral
Clinical narrative: A physician reported that a 4 month old female received an injection of Tetramune and IPV vaccines on 7/30/99. Within 5 minutes, post vax, the infant developed cyanosis above the wasteline, difficulty breathing, tachypnea, and red rashes on lower extremities. The infant was carried approx. 200 yards to the ER where she presented with an altered level of consciousness, lethargy, poor inspiratory effort, rash of the extremities and mid-chest, and swelling at the site of IPV administration. A physician attempted to stimulate the infant by rubbing her on the chest. Cardiac monitor revealed heart rate of 140; oxygen saturation was 99% on room air and 100% on high-flow oxygen. The infant was treated with IV Solu-Medrol, epinephrine and Benadryl. Within 10 minutes, erythema and swelling of the extremities began to resolve, inspiratory effort increased and physician attributed these events to an acute allergic reaction "probably" secondary to IZ. The infant was observed for an additional 30 minutes in the ER, then transferred to another hospital for hospitalization. The infant recovered.
Age: 0.3
Sex: F
Vaccine: DTPHIB, IPV
Symptoms: Rash, Somnolence, Stridor, Stupor, Tachycardia
Clinical narrative: A physician reported that a 4 month old female received an injection of Tetramune and IPV vaccines on 7/30/99. Within 5 minutes, post vax, the infant developed cyanosis above the wasteline, difficulty breathing, tachypnea, and red rashes on lower extremities. The infant was carried approx. 200 yards to the ER where she presented with an altered level of consciousness, lethargy, poor inspiratory effort, rash of the extremities and mid-chest, and swelling at the site of IPV administration. A physician attempted to stimulate the infant by rubbing her on the chest. Cardiac monitor revealed heart rate of 140; oxygen saturation was 99% on room air and 100% on high-flow oxygen. The infant was treated with IV Solu-Medrol, epinephrine and Benadryl. Within 10 minutes, erythema and swelling of the extremities began to resolve, inspiratory effort increased and physician attributed these events to an acute allergic reaction "probably" secondary to IZ. The infant was observed for an additional 30 minutes in the ER, then transferred to another hospital for hospitalization. The infant recovered.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blood creatine phosphokinase increased, Blood creatinine increased, Blood potassium increased, Blood urea increased
Clinical narrative: This pt developed rhabdomyolysis and subsequent acute renal failure after receiving an influenza virus vax while being treated with cerivastatin and bezafibrate for hyperlipidaemia.  He began experiencing myalgia within 24 hours post vax. The man was admitted to the hospital with extreme weakness and diffuse muscle pain 5 days post vax. He was treated with forced diuresis and urinary alkalisation. During days following admission, his renal function returned to normal. The combined use of statins and fibrates is associated with risk of muscle injury.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Laboratory test abnormal, Myalgia, Renal impairment, Rhabdomyolysis
Clinical narrative: This pt developed rhabdomyolysis and subsequent acute renal failure after receiving an influenza virus vax while being treated with cerivastatin and bezafibrate for hyperlipidaemia.  He began experiencing myalgia within 24 hours post vax. The man was admitted to the hospital with extreme weakness and diffuse muscle pain 5 days post vax. He was treated with forced diuresis and urinary alkalisation. During days following admission, his renal function returned to normal. The combined use of statins and fibrates is associated with risk of muscle injury.
Age: 71.0
Sex: M
Vaccine: LYME
Symptoms: Atrioventricular block second degree, Dyspnoea, Pyrexia, Tremor
Clinical narrative: On 4/25/99, 5/14/99 and 2/23/00, the vaccines received his 1st, 2nd and 3rd doses of Lymerix, respectively. Within hours after the 3rd vaccine, he expeerienced uncontrolled shaking and fever. He was seen in the ER "some" hours after the 3rd shot, was treated (NOS) and released on 2/23/00. He complained of shortness of breath with exercise. He was referred to a cardiologist. The pt reported the dx as 2nd degree heart block. As of 7/9/00, the outcome of the event is unknown.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Injury, Joint swelling, Nerve injury
Clinical narrative: In March, 1999, the pt received her 1st dose of Lymerix and 3 weeks, post vax, she experienced fatigue, which continued and worsened. After her 2nd dose in April, 1999 and subsequently, her fatigue worsened. Additionally, she fell on her right shoulder and developed pain starting in June, 1999. In July, 1999, a physician recommended NSAIDS and an internist injected shoulder with steroids and confirmed dx of tendonitis. Outcome of tendonitis resolved but fatigue contintued. In April, 2000, the pt received her 3rd dose of Lymerix and her fatigue continued and she had pain in her left ankle and foot. An orthopedist evaluated her left foot pain as being a pinched nerve and casted it for 6 weeks. The orthopedist took cast off but the pain came back after 1 week, so he injected the ankle with steroids. In May, 2000, post vax, the right foot and wrist started to swell. The orthopedist prescribed Cataflam. The pt stated her joints were never warm or red, just swollen and painful. As of 8/7/00, the outcome of the event is ongoing.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Tendonitis
Clinical narrative: In March, 1999, the pt received her 1st dose of Lymerix and 3 weeks, post vax, she experienced fatigue, which continued and worsened. After her 2nd dose in April, 1999 and subsequently, her fatigue worsened. Additionally, she fell on her right shoulder and developed pain starting in June, 1999. In July, 1999, a physician recommended NSAIDS and an internist injected shoulder with steroids and confirmed dx of tendonitis. Outcome of tendonitis resolved but fatigue contintued. In April, 2000, the pt received her 3rd dose of Lymerix and her fatigue continued and she had pain in her left ankle and foot. An orthopedist evaluated her left foot pain as being a pinched nerve and casted it for 6 weeks. The orthopedist took cast off but the pain came back after 1 week, so he injected the ankle with steroids. In May, 2000, post vax, the right foot and wrist started to swell. The orthopedist prescribed Cataflam. The pt stated her joints were never warm or red, just swollen and painful. As of 8/7/00, the outcome of the event is ongoing.
Sex: U
Vaccine: LYME
Symptoms: Arthralgia, Infection parasitic, Pyrexia, Rash
Clinical narrative: On an unspecified date, the pt received 1st dose of Lymerix with no reported events. On 6/28/00, the pt received 2nd dose of Lymerix and 4 to 6 hours later, the vaccinee experienced a fever > 102F, rash and arthralgia. The pt was dx'd with acute Lyme disease. The pt was treated with doxycycline hyclate and "responded".
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Headache, Pneumonia, Pyrexia, White blood cell count decreased
Clinical narrative: Pt received Pneumovax vaccine on 9/10/99 and had onset of fever, headache and diarrhea on 9/13/99. He was admitted to the hospital on 9/15/99 with dx of pneumonia. He was treated withlevofloxacin. On 9/22/99, temperature was 104.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Agitation, Bruxism, Convulsion, Cyanosis, Disorientation
Clinical narrative: Seizure activity-Was found in bathroom with vomitus and seizure-like activity noted. Was cyanotic and noted with tonic/clonic activity, grinding of the teeth. After cessation of seizure activity, was agitated, disoriented and confused.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Hypertonia, Hypochromic anaemia, Hypokalaemia, Thrombocytopenia, Vomiting
Clinical narrative: Seizure activity-Was found in bathroom with vomitus and seizure-like activity noted. Was cyanotic and noted with tonic/clonic activity, grinding of the teeth. After cessation of seizure activity, was agitated, disoriented and confused.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Urticaria
Clinical narrative: Hives-full body.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Abdominal pain, Abdominal pain upper, Anorexia, Arthralgia, Asthenia
Clinical narrative: Within the first three weeks, the pt experienced pain and weakness in the right wrist, within one month, the pt experienced tendonitis type pain, next the pain developed in the left elbow and knee. The pt then experienced intermittent pain in the groin area.  Several mornings the pt awoke with a numb or tingling sensation in one or both arms. Within the 1st  two months, the pt experienced back pain, stomach discomfort, nausea and severe cramping, loss of appetite. The pt also experienced severe chest pain, depression, or loss of balance and mental clarity.  The sensation that the skin was burning or stinging. These symptoms have subsided, but remain in a lessened degree.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Back pain, Balance disorder, Chest pain, Depression, Groin pain
Clinical narrative: Within the first three weeks, the pt experienced pain and weakness in the right wrist, within one month, the pt experienced tendonitis type pain, next the pain developed in the left elbow and knee. The pt then experienced intermittent pain in the groin area.  Several mornings the pt awoke with a numb or tingling sensation in one or both arms. Within the 1st  two months, the pt experienced back pain, stomach discomfort, nausea and severe cramping, loss of appetite. The pt also experienced severe chest pain, depression, or loss of balance and mental clarity.  The sensation that the skin was burning or stinging. These symptoms have subsided, but remain in a lessened degree.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Mental impairment, Myalgia, Paraesthesia
Clinical narrative: Within the first three weeks, the pt experienced pain and weakness in the right wrist, within one month, the pt experienced tendonitis type pain, next the pain developed in the left elbow and knee. The pt then experienced intermittent pain in the groin area.  Several mornings the pt awoke with a numb or tingling sensation in one or both arms. Within the 1st  two months, the pt experienced back pain, stomach discomfort, nausea and severe cramping, loss of appetite. The pt also experienced severe chest pain, depression, or loss of balance and mental clarity.  The sensation that the skin was burning or stinging. These symptoms have subsided, but remain in a lessened degree.
Age: 11.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Urticaria
Clinical narrative: Developed urticaria 2 hours post vax which continued for 24 hours.
Age: 17.0
Sex: M
Vaccine: HEP, TD
Symptoms: Convulsion, Pallor, Syncope, Vomiting
Clinical narrative: Post vax, pt fainted and had short seizure which lasted a few seconds. He became very pale and vomited. No treatment received other than lying down with feet elevated.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Post vax, the pt became very dizzy and had to sit down on the waiting room floor. He did not lose consciousness.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Feeling hot, Swelling
Clinical narrative: Mom called complaining of child's left leg being swollen and hot to the touch. Told mom to use cold packs and massage area. If no better in a few days to call back.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Injection site rash
Clinical narrative: Mild red rash around injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: Left thigh had 14.5 x 8 cm erythema and induration. Treated with Prelone, Benadryl, and cold compresses.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site mass
Clinical narrative: Post vax, the pt's mom noticed induration in left thigh. Seen by physician.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Arthralgia, Headache, Injection site pain, Myalgia
Clinical narrative: Within 24 hours post vax, the pt developed local symptoms consisting of pain and pruritus lasting 1-3 days. Then he developed systemic symptoms-muscle aches, joint pain, headache, neck pain, abdominal pain, and nausea.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Neck pain, Pruritus
Clinical narrative: Within 24 hours post vax, the pt developed local symptoms consisting of pain and pruritus lasting 1-3 days. Then he developed systemic symptoms-muscle aches, joint pain, headache, neck pain, abdominal pain, and nausea.
Age: 0.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV, DTP, HBHEPB, IPV
Symptoms: Cardiomegaly, Cardiomyopathy, Cough, Irritability, Pyrexia
Clinical narrative: On 7/21/00, the pt experienced a slight fever. ON 7/28/00, the pt experienced a cough and a fever. Medical attention was sought. He was sent to the hospital for possible pneumonia. A chest x-ray revealed cardiomegaly (heart size was normal at birth). The pt experienced myocarditis. He was waiting for a heart transplant at the time of the report. No further information is available.
Age: 0.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV, DTP, HBHEPB, IPV
Symptoms: Cardiomegaly, Cough, Myocarditis, Pneumonia, Pyrexia
Clinical narrative: On 7/21/00, the pt experienced a slight fever. ON 7/28/00, the pt experienced a cough and a fever. Medical attention was sought. He was sent to the hospital for possible pneumonia. A chest x-ray revealed cardiomegaly (heart size was normal at birth). The pt experienced myocarditis. He was waiting for a heart transplant at the time of the report. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Dermatitis bullous, Pyrexia, Rash
Clinical narrative: The pt developed a low grade fever and then a rash of about 4-5 spots, four days later 4-5 more pox spots broke out. The spots had healed within 2 weeks. The child experienced a fever for 3 days.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: The pt developed a low grade fever and then a rash of about 4-5 spots, four days later 4-5 more pox spots broke out. The spots had healed within 2 weeks. The child experienced a fever for 3 days.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Pain, Pancreatitis
Clinical narrative: On 7/28/00, the pt was hospitalized for pancreatitis and pain control. She was discharged 5 days later and has recovered.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Gait disturbance, Laboratory test abnormal
Clinical narrative: Subsequently in July 2000, the pt developed wide-based unsteady gait and his trunk deviated from side to side when he sat. These experiences were considered other medical events. He was taken to the ER.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Paraesthesia
Clinical narrative: At the unspecified time, the pt was vaccinated with Lymerix. Sometime afterward, the pt experienced paresthesias. Information received on 8/9/00 provided no additional details. Additional information has been requested. A follow up report received 2/2/2001 adds: This report was received from a primary care physician. On 7/9/2000 the pt was vaccinated with his 1st Lymerix 30 mcg with no untoward effects. One month later 08/09/2000, he received his 2nd dose of Lymerix. Afterward in August 2000, the pt experienced mild paresthesias in his legs and right mid back. The info received on 10/17/2000 reported the symptoms were ongoing but intermittent. The reporter indicated he believed the event was possibly related to vaccine. The event of paresthesia does not meet ICH serious criteria but is being submitted as an expedite report by special FDA request per 6/28/2000 letter.