chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Rash erythematous, Similar reaction on previous exposure to drug, Urticaria
Clinical narrative: Pt broke out in hives (red, raised) approximately 1.75 hrs post vax. Hives spread to both legs and abdomen and later in the night spread to chest and neck. Mother denies increased temp. Mother phoned ER and was instructed to give Benadryl which she did. On 6/21, hives looked better. Mother took pt to Health Dept on 6/21/01 and was referred to MD's office.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: On the evening of 6/14/01, pt had fever. She had no other signs/symptoms. This resolved. On 6/17/01, she became fussy and on 6/18/01, she had rash on back and face. This lasted 24 hours. Symptoms all resolved.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: At 10 PM on 4/24/01, pt had nausea, vomiting, diarrhea and fever of 100-101. She was improved by 1 PM on 4/25/01.
Age: 1.08
Sex: F
Vaccine: HIBV, IPV
Symptoms: Injection site erythema, Injection site warmth, Irritability, Urticaria
Clinical narrative: Pt developed immediate skin redness, warmth and scattered red welts that erupted after IPV given. Pt became irritable. There was no respiratory distress noted. Vital signs remained stable. Pt referred to MD for evaluation.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Bradycardia, Convulsion, Pallor, Syncope
Clinical narrative: Pt fainted after Hep B vax. Ammonia was used to revive her, and she had a seizure. Pt was lowered to the floor and had a second seizure. Her pulse was 40, and her skin was pale. Pt revived after her feet were elevated. She recovered well after about 60 seconds.
Age: 1.9
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Infection
Clinical narrative: Broke out with 15 pox unilateral face and arm.  Developed 1-2 more pox each day for next two days.  Total 18 pox per mom.  No fever no coryza- (+) cranky/grumpy.  Resolved without incident-some scars per mom.  Fine now. (Pox developed bilateralley after first day).
Age: 35.0
Sex: F
Vaccine: RUB
Symptoms: Diarrhoea, Hypersensitivity, Infection, Swelling face, Wheezing
Clinical narrative: Patient was administered an immunization for Rubella, and a TB skin test at the same time.  Approximately 40 hours later she reported swellling of her bottom lip and diarrhea.  (She had noticed the swelling to her lip on the previous day. )  Patient has a history of childhood allergies up until about ten years ago, and whenever she had a reaction it would elicit this type of response.  She was seen in the hospital emergency room for an evaluation and treatment.  The physician noted the swelling of her lower lip.  There was no edema intraorally.  Her lungs had a prolonged expiratory phase with mild expiratory wheezing.  The diagnosis was an allergic reaction with reactive airway component.  She was treated initially with hydroxyzine 50 mg, to be taken every 4-6 hours; and tagamet 400 mg up to t.i.d.   She was also given a peak flow meter to monitor her respiratory status.  She had no further problems and her reaction subsided after 24 hours.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Headache, Infection, Nausea, Pain, Pyrexia
Clinical narrative: Received TD booster 03/28/01.  Within 10 hours developed fever to 101 and severe headache that lasted about 48 hours.  Arm so sore had decreased range of motion for 4 days.  At time of injection, felt nerve hit with pain down to middle finger (+) nausea.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: Began vomiting sat. am. and has had intermittent stomach cramping, some loose stools.  No fever noted.  No appettite, no energy.  Has kept down toast today, no vomiting since 7am
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Infection, Irritability, Pyrexia, Rash
Clinical narrative: MMR and varicella vaccine given 05/02/01 mom states patient developed spots head to toe apx 05/13/01 with fever. MOM did not take temperature, but patient felt warm, gave, tylenol x1, rash may more generalized with more distinct "dots", fussy, decrease appetite rash also to face and lips. no problems breathing.  Is also cutting teeth.  Advised her to have patient seen by health care provider, follow up on 05/17 - patient seen by physician mom states he felt maybe MMR, wrote medial exemption for patient
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Erythema
Clinical narrative: Immediate skin flushing: red, blotchy areas on upper chest, cheeks, arms, buttocks, ears.  Redness would come and go over 20 min. period. Vital signs WNL.  No resp. dizzness.  Referred to MD 20 min after vaccine given
Age: 13.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Infection, Oedema, Skin ulcer
Clinical narrative: Patient developed PET echial stain lesions and edema in feet and lower extremities.  Diagnosed with HENOCH- SCHONLEIN Purpura.  Symptoms began 2 days after receiving first doses of HEP A and Hep B vaccine
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Erythema, Infection, Pyrexia, Rash
Clinical narrative: 24 hours after IMM's developed rash with fever, generalized erythema, 1 papula left neck no itch no pain no burning no hives. temp 100.5
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Hyperhidrosis, Joint stiffness, Nausea
Clinical narrative: One day post vax pt's arm ached, and she had difficulty dressing. She developed nausea and fever that night and stiffness and headache started the next day. Temp went up to 102. She had chills and sweating on Monday and Tuesday. Fever was gone but headache and stiffness continued. Pt has morning stiffness in neck and shoulders.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia
Clinical narrative: One day post vax pt's arm ached, and she had difficulty dressing. She developed nausea and fever that night and stiffness and headache started the next day. Temp went up to 102. She had chills and sweating on Monday and Tuesday. Fever was gone but headache and stiffness continued. Pt has morning stiffness in neck and shoulders.
Sex: F
Vaccine: TD
Symptoms: Contusion, Erythema, Headache, Hypoaesthesia, Infection
Clinical narrative: TD given 05/11/2001 approx. 3p.m. adm. with biojector "Burned"  as soon as administered and continued on.  Bruised immediatly redness and aching Sunday.  Fingers began going numb Sunday.  Went to ER Monday am (Headache after injection intermittent now)
Sex: F
Vaccine: TD
Symptoms: Pain, Skin burning sensation
Clinical narrative: TD given 05/11/2001 approx. 3p.m. adm. with biojector "Burned"  as soon as administered and continued on.  Bruised immediatly redness and aching Sunday.  Fingers began going numb Sunday.  Went to ER Monday am (Headache after injection intermittent now)
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Erythema, Feeling hot, Infection, Joint swelling
Clinical narrative: 7 days after routine td boaster client experienced extreme soreness (awaken by soreness X 3 nights), itching, swollen and hot x 3-4 days, and pinpoint rash (start) to large redden blotch area x 4 inches below injection site (4 X 3 size area) X 3 weeks, relieved with ibprofen and ice packs X 4 days, per advice of private MD (telephone)
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Rash
Clinical narrative: 7 days after routine td boaster client experienced extreme soreness (awaken by soreness X 3 nights), itching, swollen and hot x 3-4 days, and pinpoint rash (start) to large redden blotch area x 4 inches below injection site (4 X 3 size area) X 3 weeks, relieved with ibprofen and ice packs X 4 days, per advice of private MD (telephone)
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on trunk and face appeared 5/25/00 - presented to hospital out patient dept 5/26. No fever, coryza, cough or conjunctivitis. Pt seen by PHN 5/29/01 no rash apparent.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Headache, Lacrimation increased, Myalgia, Nausea
Clinical narrative: The pt experienced a high fever of 102, chills, muscle aches, joint pain, left arm pain, headache, watery eyes, nausea. The pt was referred to the ER.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia
Clinical narrative: The pt experienced a high fever of 102, chills, muscle aches, joint pain, left arm pain, headache, watery eyes, nausea. The pt was referred to the ER.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Arthralgia, Joint stiffness, Pain, Pruritus
Clinical narrative: The pt experienced arthralgia to the elbows, hands and knees occurring 4 days post vax. Pain and stiffness was worse when placing pressure on joints. Itching of hands and feet. No fever or other symptoms.
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Erythema multiforme
Clinical narrative: The pt developed erythema multiforme rash on 5/18/01. The rash resolved over a 5 day period.
Age: 0.3
Sex: F
Vaccine: DTAP, IPV
Symptoms: Irritability, Pyrexia, Screaming
Clinical narrative: One day post vax the pt became irritable, crying, screaming for 7 hours with only brief periods when she could be consoled. Possibly low grade temp and had Tylenol.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: The pt experienced a 3cm red area around the area where she received her shot.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Cold sweat, Irritability, Lethargy, Pyrexia, Respiratory rate increased
Clinical narrative: Same day of vax, the pt became lethargic, fever, cold and clammy, starred into space. It was noted increased respirations and wheezing. Pulse was 168, respirations 58. Paramedic examined child and the child was acting normal. Lungs are cleared and the child was given Motrin. Child began acting fussy and decreased fever.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Staring, Tachycardia, Wheezing
Clinical narrative: Same day of vax, the pt became lethargic, fever, cold and clammy, starred into space. It was noted increased respirations and wheezing. Pulse was 168, respirations 58. Paramedic examined child and the child was acting normal. Lungs are cleared and the child was given Motrin. Child began acting fussy and decreased fever.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Decreased appetite, Respiratory disorder, Somnolence
Clinical narrative: The pt experienced decreased appetite and slept allot. Mother gave Tylenol. The pt experienced "funny" breathing, irregular respiration for about 1/2 hour. The pt then developed hives.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Dehydration, Dizziness, Hallucination, Headache, Hypersensitivity
Clinical narrative: One day post vax, the pt experienced a fever up to 104, redness to arm and tightness to the site with minimal swelling. Complained of dizziness, stiff neck, achiness, hallucinations, head "tight". The pt was advised to see physician. ER administered IV for dehydration and the pt was told is "allergic to vaccine". No further symptoms.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: One day post vax, the pt experienced a fever up to 104, redness to arm and tightness to the site with minimal swelling. Complained of dizziness, stiff neck, achiness, hallucinations, head "tight". The pt was advised to see physician. ER administered IV for dehydration and the pt was told is "allergic to vaccine". No further symptoms.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: On 6/25/98 pt received Varivax, on 10/4/00 had chicken pox with approximately 100 lesions. Treated with Benadryl and Tylenol.
Age: 1.6
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: The pt experienced red whelp like areas on legs, arms and trunk. No blisters. Whelps vary in size from 1-2 cm. The child is active and alert.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Parotitis
Clinical narrative: The pt experienced parotitis.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The pt experienced left thigh swelling and erythema.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling, Pruritus, Rash
Clinical narrative: 24 hours post vax, the pt developed an itchy rash on back, chest, and arms. The pt also experienced a quarter sized swelling at the injection site. Pt treated with Benadryl.
Age: 20.0
Sex: F
Vaccine: HEP, MEN, MMR, TD
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: The pt experienced flu-like symptoms, sore, swollen left arm, redness and a fever of 101 with chills.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: The pt experienced a fever of 104 the evening of the vax with nausea and vomiting. The next day a low grade temp was experienced.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Decreased appetite, Liver function test abnormal, Malaise, Nausea
Clinical narrative: One day post vax, the pt experienced malaise, nausea, decreased appetite, stomach cramps, symptoms would resolve and then start again. Mom took child to ER. The pt was dx with increased liver enzymes, probably secondary to Hep B vaccine. Released to home.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: The pt experienced an injection site reaction which was hard and hot to touch with redness and pain. No fever was reported. The pt was treated with cool pack, Benadryl, Tylenol.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy, Pain, Rash
Clinical narrative: The pt experienced swollen lymph glands, purple like bumps, within 24 hours of vax. No fever was experienced, the pt was just uncomfortable. The bumps spread from arm to groin to knees. Swollen lymph nodes were under the arm.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Nasal congestion, Rash maculo-papular
Clinical narrative: The pt experienced a cough, congestion, maculo-papular rash, no vesicles.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Rash erythematous
Clinical narrative: The pt experienced a raised red area on neck, trunk, arms, and behind left ear.
Age: 33.0
Sex: F
Vaccine: YF
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: The pt experienced extreme diarrhea for 3 weeks plus. Given a prescription to control fever of 102.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Pyrexia, Skin disorder
Clinical narrative: The pt experienced herpes zoster on right arm with C-6 dermatome on 5/10/01. The pt was seen on 5/15/01, had a fever to 102 that day only. Lesions are healing. Symptoms are treated with acyclovir.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Vaccine positive rechallenge
Clinical narrative: The pt experienced an itchy rash on skin all over. No respiratory symptoms. Resolved with Benadryl.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, Pyrexia, Rash
Clinical narrative: The pt experienced a fever of 101-102, rash to left upper extremity and right wrist, joint pain and stiffness. Saw an MD on 6/19/01.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site hypersensitivity
Clinical narrative: After receiving vaccinations the pt developed hives at the injection site within 24 hours. The pt was treated with Benadryl an on 05/28/1999 the pt was reported as recovered.
Age: 2.0
Sex: F
Vaccine: DTP, HIBV, IPV, RV
Symptoms: Abdominal pain, Anorexia, Diarrhoea, Gastrointestinal disorder, Gastrointestinal haemorrhage
Clinical narrative: Melena, Anorexia, Rhinitis, A report from Wyeth Labs (KQ1802208OCT1999) regarding events in Massachusetts.  "A mother reported that her 2-month-old daughter received the first dose of Rota shield, as well as, Hib-Titer, IPV (Aventis Pasteur SA) and DTP (manufacturer unknown) in July 1999.  At 4-months of age, the infant developed loose, bloody stools, decreased appetite and nasal congestion. She was seen by the physician who has attempted to rule out food allergies and GERD (gastroesophageal reflux disease)." From additonal information received on 5-Jan-2000, it was reported that the patient also developed stomach cramps and experienced uncomfortable sleepness nights.  Reportedly the patient has been to a GI (gastrointestinal) doctor about 8 times as well as a various number of other doctors.  At almost 8-months of age the patient continues to have GI problems.
Age: 2.0
Sex: F
Vaccine: DTP, HIBV, IPV, RV
Symptoms: Insomnia, Melaena, Rhinitis
Clinical narrative: Melena, Anorexia, Rhinitis, A report from Wyeth Labs (KQ1802208OCT1999) regarding events in Massachusetts.  "A mother reported that her 2-month-old daughter received the first dose of Rota shield, as well as, Hib-Titer, IPV (Aventis Pasteur SA) and DTP (manufacturer unknown) in July 1999.  At 4-months of age, the infant developed loose, bloody stools, decreased appetite and nasal congestion. She was seen by the physician who has attempted to rule out food allergies and GERD (gastroesophageal reflux disease)." From additonal information received on 5-Jan-2000, it was reported that the patient also developed stomach cramps and experienced uncomfortable sleepness nights.  Reportedly the patient has been to a GI (gastrointestinal) doctor about 8 times as well as a various number of other doctors.  At almost 8-months of age the patient continues to have GI problems.
Age: 0.3
Sex: F
Vaccine: HBHEPB, IPV
Symptoms: Crying, Pyrexia
Clinical narrative: It was reported that a 4 mo rec'd an IPOL and a Comvax (Merck) vaccination on 1/29/00. Reportedly that same day the pt developed inconsolable crying, indented area at injection site and a fever which lasted for 4 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Skin atrophy
Clinical narrative: It was reported that a 5 year old male received an IPV-IPOL and a DTAP Acel-Imune vaccination on 2/15/00 at 10:30 AM. Reportedly that evening, the pt developed a local reaction of redness, swelling, induration and excoriation for 72 hours. The pt reportedly recovered from this experience.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: It was reported that a 4 year old male received an IPOL and a Tripedia vaccination on 3/10/00. Reportedly, the IPV was administered into area over right bicep instead of subcutaneously. The pt's arm became edematous and erythematous 24 to 48 hours, post vax. The pt was in seen in ER and physician's office and treatment of warm compresses was provided. The pt reportedly, recovered from this experience.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Irritability
Clinical narrative: AGITATION A report was received from Wyeth (8=99173-036A) regarding events in Iowa.  "A nurse reported that a 2-month-old male received Acel-Immune, Hib-Titer, IPV (Aventis Pasteur SA) and Recombivax HB (Merck) vaccines on 24-Nov-1998.  Two to three hours post-immunization, the infant became very fussy and inconsolable.  This continued on and off through the night.  On 25-NOV-1998, the infant was seen by the physician and was noted to be less irritable.  He recovered."
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, IPV, TYP, HEP, HEPA, RAB, TYP
Symptoms: Erythema, Feeling hot, Injection site reaction, Pyrexia
Clinical narrative: A nurse reported that a 20-year-old female received Typhoid Vaccine, USP, Heat Phenol Inactivated. Recombivax (Merck). Vaqta (Merck) and IPV (PMC) vaccines on 24-NOV-1999 and that evening, developed fever and an injection site reaction characterized by a c-cm by 6-cm area of redness and warmth. The patient recovered within 36 hours. Copies of this report have been forwarded to Merck and PMC, manufacturers of the concomitantly administered vaccines.
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, IPV, TYP, HEP, HEPA, RAB, TYP
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: A nurse reported that a 20-year-old female received Typhoid Vaccine, USP, Heat Phenol Inactivated. Recombivax (Merck). Vaqta (Merck) and IPV (PMC) vaccines on 24-NOV-1999 and that evening, developed fever and an injection site reaction characterized by a c-cm by 6-cm area of redness and warmth. The patient recovered within 36 hours. Copies of this report have been forwarded to Merck and PMC, manufacturers of the concomitantly administered vaccines.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV
Symptoms: Drug ineffective, Grand mal convulsion, Infection
Clinical narrative: Grand Mal Convulsion:  A reported from Wyeth Labs (HQ2680218OCT1999) regarding events in Michigan.  A father reported that his 2 month old daughter received Rota Shield.  DTP (manufacturer unknown), Hib (manufacturer unknown), hepatitis B (manufacturer unknown), and IPV (PMC France) vaccines on 23 JUn 1999.  In October 1999, she experienced a grand mal seizure and a petit mal seizure.  She was seen by a physician who prescribed phenobarbital.  The caller reports that the infant develops a blank look on her face at times.  From additional information received on December 21, 1999, it was reported that the patient received Smithkline's hepatitis B vaccine Engerix and Aventis Pasteur US Tripedia vaccine.  Additional vaccine lot number information was also provided.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Urticaria
Clinical narrative: Two to three minutes post-vaccination the patient developed small hives on his legs and lower trunk. The patient has no history of know allergies. The patient was treated with Benadryl elixir and the hives resolved.
Age: 63.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Blister, Blood pressure increased, Dizziness, Headache, Vomiting
Clinical narrative: It was reported that a 63 yr old female received an IPOL vaccination. Sometime after the pt experienced dizziness, headache, increased blood pressure, vomiting and open blistering on her hands and her legs below the knees. Reportedly this events reportedly this events resolved.
Age: 1.25
Sex: F
Vaccine: IPV, MMR, VARCEL, IPV, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Laryngitis, Vaccine positive rechallenge, Wheezing
Clinical narrative: On 5/12/00, the pt developed wheezing. The pt was given Prelone on 5/12/00 and the pt reportedly recovered from this experience in three days.
Age: 1.25
Sex: F
Vaccine: IPV, MMR, VARCEL, IPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: On 5/12/00, the pt developed wheezing. The pt was given Prelone on 5/12/00 and the pt reportedly recovered from this experience in three days.
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV
Symptoms: Diarrhoea, Infection, Rash
Clinical narrative: A report was received from Wyeth (8-99200-027A) concerning events.  A nurse reported that a 2 month old female received her first doses of Rota Shield, Acel-Imune, IPV (Aventis Pasteur SA), and Comvax (Merck) vaccines on 02-Jul -1999.  On 04 Jul 1999, the infant developed diarrhea and a generalized rash, which started on her arms legs and groin.  The rash spread everywhere including, fingers and heels of her feet.  The rash was described as hive beginning as dots, and within minutes, became raised and red with a white center.  She was seen by a dermatologist who questioned whether this was a viral rash.  The infant recovered on 15 Jul 1999 without threatment.  From correspondence received at Aventis Pasteur Inc. on 31 Jan 2000, it was reported.  20 Jan 2000, Reviewed no additional information at this time.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site rash, Injection site reaction
Clinical narrative: INJECTION SITE REACTION- A report received from Wyeth (8=99225-120A) regarding events in Florida.  "A nurse reported that a 3-month-old infant received Hib-Titer, Acel-Imune and IPV (Aventis Pasteur SA) vaccines on 12-NOV-1998.  Five minutes post immunization, the infant developed an injection site reaction, at the site of the Hib-Titer administration, characterized by redness and rash.  The infant recovered."
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, RV
Symptoms: Abdominal pain, Diarrhoea, Infection, Irritability, Sleep disorder
Clinical narrative: ABDOMINAL PAIN A report was received from Wyeth (A-99207-003A) regarding events in Minnenota.  "A parent reported that her 6-week-old daughter received the first doses of Rota Shield, DTaP (manufacturer unknown), Hib (manufacturer unknown) and IPV (Aventia Pasteur SA) vaccines on 18-Jun-1999.  Approximately two weeks post-immunization, the infant developed abdominal pain and irritability which lasted two weeks mucus was seen in the stool for the first two days.  As of 23-Jul-1999, the infant continued to awake nightly with abdominal pain."
Age: 0.3
Sex: M
Vaccine: DTAP, IPV, RV
Symptoms: Constipation, Crying, Irritability, Nervousness, Pyrexia
Clinical narrative: NERVOUSNESS, FEVER, CONSTIPATION, A report was received from Wyeth (8-99202-037A) regarding events in Minnesota.  "A mother reported that her 4-month-old son received Rota Shield, IPV (Aventis Pasteur SA), and DTP (manufacturer unknown) vaccines on 22-JUN_1999.  On 02-JUL-1999, the infant experienced irritability, inconsolable crying, a slight fever (body temperature not provided), and constipation."
Age: 0.25
Sex: M
Vaccine: DTP, HIBV, IPV, RV
Symptoms: Constipation, Faeces pale
Clinical narrative: A report was received from Wymth (8-99232-043A) regarding events in Virginia.  " A physician reported that a 3-month-old male developed constipation after the first dose of Rota Shield.  The stool was bluish in color on occasion and guaiac negative.  The mother gave the infant prune juice, and the constipation resolved within  4 to 5 weeks."
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, RV
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Diarrhea, Abdominal Pain, A report was received from Wyeth (8-99214-013A) regarding events in New York.  "A nurse reported that a 4-month-old male received Rota Shield, Acel-Imune, Hib-Titer and IPV (Aventis Pasteur SA) vaccines on 14-JUL-1999 and subsequently, developed 2 to 3 episodes of diarrhea daily.  On 24-JUL-1999, he experienced colic."
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, RV
Symptoms: Diarrhoea, Gastroenteritis, Pain, Vomiting
Clinical narrative: It was reported, "A mother reported that her 3-month-old daughter received Rota Shield, DTaP (manufacturer unknown), Hib (manufacturer unknown), IPV (Aventis Pasteur SA) and hepatitis B (manufacturer unknown) vaccines on 07/12/99.  She subsequently developed vomiting and diarrhea, and draws her knees to her chest as if in pain.  She was seen by the physician on 08/16/99." From follow-up #1 correspondence received on 01/24/00, it was reported, "reviewed, no additional information at this time". Mailed follow up # 2 correspondence from 05/31/01 stated the patient's recovery ststus is unknown. No further information available regarding this patient or this case. This case is closed
Age: 0.2
Sex: F
Vaccine: DTAP, IPV, RV
Symptoms: Rash maculo-papular
Clinical narrative: MACULOPAPULAR RASH - A report from Wyeth Labs (899165118A) regarding events in New York.  It was reported, "A physician reported that a 2-month-old female received Rota Shield, DTap (manufacturer unknown) and IPV (Aventis Pasteur SA) vaccines on 06-Jun-1999.  Two days later, she developed a generalized macular rash which resolved within 72 hours.
Age: 2.0
Sex: F
Vaccine: DTP, HEP, HIBV, IPV, RV
Symptoms: Diarrhoea neonatal, Haematochezia
Clinical narrative: DIARRHEA A report from Myath Labs (8-99198-146A) regarding events in Texas.  It was reported, "A mother reported that her 2-month-old daughter received Rota Shield, Hib (manufacturer unknown), IPV (Aventis Pasteur SA), DTP (manufacturer unknown) and hepatitis B (manufacturer unknown) vaccines on 22-Jun-1999.  The next day, she developed diarrhea.  Three days later, she had a blood-tinged stool.  The physician reportedly suspects milk protein allergy."
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV
Symptoms: Abdominal pain, Diarrhoea, Haematochezia, Irritability, Melaena
Clinical narrative: Hemorrhagia - a report from Wyath Labs regarding events in Utah. It was reported, a physician reported that a 2 mo old pt rec'd RotaShield, Acel-immune, Comvax (Merck) and IPV (Aventis Pasteur) vaccines on 7/9/99. Within 5 days, the infant developed diarrhea which lasted 1 week followed by 3 episodes of bloody stools, and then mucus in the stools which lasted 5 weeks. The infant was fussy or colicky, and was seen by the physician on 8/24/99. A stool specimen was positive. On 8/26/99, the mother reported that the infant was more colicky and continued to have blood in her stools.
Age: 0.3
Sex: M
Vaccine: DTP, HEP, HIBV, IPV, RV
Symptoms: Constipation, Irritability
Clinical narrative: It was reported, "A mother reported that her 2-month-old son received Rota Shield, Hib-Titer.  DTP (manufacturer unknown), hepatitis b (manufacturer unknown) and IPV (Aventis Pasteur SA) vaccines on 02/26/99.  One to two weeks later, the infant devloped constipation and was irritable.  He recovered. from follow-up #1 correspondence received on 01/24/00, an amendment in the itial reporter and patient's address was provided. From mailed follow-up #2 received on 06/04/00, it was stated that the patient recovered from this experience and is doing fine. No further information is anticipated for this report.Case is closed. From additional correspondence received at Aventis Pasteur Inc.on 12/03/01 no new medicaaly significant information was provided. This case is closed.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, RV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: A report from Wyeth labs (8-99207-006A) regarding events in Texas, It was reported, a physician assistant reported that a 2 mo child received RotaShield, DTaP (Wyeth-Lederle), Hib (Wyeth-Lederle, IPV (PMC France) and hepatitis B (manufacturer unknown)  vaccines on 11/24/98. On 11/30/98, the infant vomited twice. He was seen by the reporter who prescribed pedialyte. The infant was seen again on12/3/98, because he had developed watery diarrhea (3-4 watery brown stools per day), which began 11/30/98 after leaving the office. Stool specimens were negative for ova and parasites, red and white blood cells and rotavirus antigens. Stool cultures neg. The infant formula was changed from similac to isomil. On 12/4/98, the mother reported that the infant had one firm stool. On 12/7/98, the mother reported that the infant recovered. From additional correspondence rec'd 1/24/00, the responsible physician's name was provided.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Drug administration error
Clinical narrative: A nurse reported that a 9 month old female inadvertently received 3 doses of Acel-Immune on 07/10/1999. The infant also received Hib-titer and IPV vaccines. This report was received on date of immunization; no adverse experience at this time.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, RV
Symptoms: Constipation, Crying, Diarrhoea, Flatulence, Hernia
Clinical narrative: A reporter form Wyeth (899228-004L) regarding events in Pennsylvania. A nsg reported that a 2 mo child rec'd RotaShield, DTaP (Wyeth-Lederle), Hib (Wyeth-Lederle) and IPV (PMC France) vaccines on 4/26/99 and subsequently developed loose stools with gas and pain, and crying. He was seen by the physician on 5/6/99. A diagnosis of formula intolerance, umbilical hernia and constipation was made. The mother was instructed to decrease administration of mineral oil and change the formula to Nutramigen. From correspondence received on 1/17/00, additional pt, vaccine and vaccine administrator information was provided.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, RV
Symptoms: Lactose intolerance
Clinical narrative: A reporter form Wyeth (899228-004L) regarding events in Pennsylvania. A nsg reported that a 2 mo child rec'd RotaShield, DTaP (Wyeth-Lederle), Hib (Wyeth-Lederle) and IPV (PMC France) vaccines on 4/26/99 and subsequently developed loose stools with gas and pain, and crying. He was seen by the physician on 5/6/99. A diagnosis of formula intolerance, umbilical hernia and constipation was made. The mother was instructed to decrease administration of mineral oil and change the formula to Nutramigen. From correspondence received on 1/17/00, additional pt, vaccine and vaccine administrator information was provided.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: One day post vax, pt developed itching and redness. On exam 6/26/00, pt's right arm was slightly reddened, warm, indurated and swollen anterior to injection site. MD advised treatment with Benadryl. On 6/27/00, redness was gone and swelling was down. The pt recovered from this experience. No addtl info was provided.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A 5-year-old female received Acel-Imune and IPV (PMC France)  vaccines on 02-Dec-1999.   Within 24 hours, she developed an injection site reaction characterized by redness warmth, and swelling.  This is 1 or 4 patients from this facility who experience this event following receipt of Acel-Imune lot 466-022.  A copy of this report has been forwarded to PMC.  Manufacturer of IPV.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within 24 hours, after vaccinations, the pt developed an injection site reaction characterized by redness, warmth and swelling.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Erythema, Injection site reaction, Irritability, Swelling
Clinical narrative: Two days post vax, pt was taken to the ER after he developed an injection site reaction characterized by a 9 cm by 8 cm area of redness, warmth, and swelling in the leg. The circumference of the right thigh was 30 cm while the circumference of the left thigh was 26 cm. He also became fussy. He recovered. No further info is expected. The case is closed.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Two days post vax, pt was taken to the ER after he developed an injection site reaction characterized by a 9 cm by 8 cm area of redness, warmth, and swelling in the leg. The circumference of the right thigh was 30 cm while the circumference of the left thigh was 26 cm. He also became fussy. He recovered. No further info is expected. The case is closed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The pt was vaccinated on 11/29/99 and within 24 hours she developed  a 3 in by 3 3/4 inches area of redness, warmth, and swelling on the leg injection site. By 12/01/1999 the swelling had doubled in size. From correspondence received at Aventis  Pasteur Inc on 02/28/2000, it was reported that the pt recovered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The pt was vaccinated on12/09/99 and within 24 hours, she developed an injection site reaction with redness, warmth and swelling.
Age: 1.0
Sex: U
Vaccine: HIBV, IPV, MMR, PNC, HIBV, IPV, MMR, UNK
Symptoms: Pyrexia
Clinical narrative: Fever- a report from Lederle labs (HQ389320APR2000) regarding events in Florida. A 12 mo rec'd Prevnar, Hib-Titer, MMRII (Merck) and IPV (Aventis Pasteur SA) on 4/11/00. On 4/12/00, the pt developed a fever of 102 to 103F. The pt was treated with motrin and tylenol. The pt recovered.
Age: 1.0
Sex: U
Vaccine: HIBV, IPV, MMR, PNC, HIBV, IPV, MMR, UNK
Symptoms: Infection, Pyrexia
Clinical narrative: Fever- a report from Lederle labs (HQ389320APR2000) regarding events in Florida. A 12 mo rec'd Prevnar, Hib-Titer, MMRII (Merck) and IPV (Aventis Pasteur SA) on 4/11/00. On 4/12/00, the pt developed a fever of 102 to 103F. The pt was treated with motrin and tylenol. The pt recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site warmth, Irritability, Screaming
Clinical narrative: Within 2-3 hrs post vax, pt developed redness and warmth at injection site with crying and irritability lasting approximately 5 hours. No further info is anticipated for this report. This case is closed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Skin discolouration
Clinical narrative: Two days post vax, pt developed a 6 x 7 cm discolored area at the injection site. The reaction disappeared within 3 wks. From addtl correspondence recvd on 10/30/00, it was reported that the pt recovered from this experience. No further info is expected. This case is closed.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV
Symptoms: Irritability, Lethargy, Pyrexia
Clinical narrative: "A sales representative reported that a 4 month old infant received Rota Shield, DTAP, HIB and Hep-B vaccines and subsequently, developed a fever. The fever persisted and the infant was hospitalized for 5 days. Lumbar puncture was negative. No further information was available at the date of this report. Follow-up information received 8/26/99, from the physician indicated that the infant also received IPV and Comvax vaccines on 1/15/99. On 1/18/99, he developed fever of 104F, irritability and lethargy. The infant was seen in the ER where 2 full septic work-ups were performed; he was not hospitalized. The infant recovered." From additional correspondence received on 1/19/00, it was reported, "Reviewed, no additional information at this time, 1/13/00."
Age: 48.0
Sex: M
Vaccine: IPV
Symptoms: Hot flush, Hypoaesthesia, Hypovitaminosis, Pain, Peripheral coldness
Clinical narrative: After receiving vaccination pt reports a few hours later he developed numbness in both feet for 2 months. Originally began as hot and cold sensations to feet for 15 minutes only. Pt developed generalized body aches for 24 hrs. The pt's recovery status is improving.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Reportedly on 03/31/2000, post-vax, the patient was "not himself", and developed a red mark around the area of the shot. Additional information is being requested.  Reported on 03/14/2003: "Follow-up #1 (06/14/2002)- During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (Added agitation).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abnormal behaviour, Agitation, Injection site erythema
Clinical narrative: Reportedly on 03/31/2000, post-vax, the patient was "not himself", and developed a red mark around the area of the shot. Additional information is being requested.  Reported on 03/14/2003: "Follow-up #1 (06/14/2002)- During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (Added agitation).
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Myocarditis
Clinical narrative: The baby was found dead in the crib. Autopsy report states death due to myocarditis.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Body temperature decreased, Guillain-Barre syndrome, Neuritis, Neurological symptom, Viral infection
Clinical narrative: Medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, in early May, 2001, the pt received his 3rd injection of Havrix and his 1st dose of Hep-B (Engerix-B, see report 20010157291). Three weeks later, he experienced unspecified neurological symptoms and subnormal temperatures. The vaccinee was seen by a physician, who suggested that the pt might be experiencing Guillain-Barre syndrome. The pt felt that his symptoms were possibly related to an unspecified sexually transmitted disease. This report is considered to be "Medically Serious". As of 6/27/01, the outcome of the event was unknown. F/U states the pt was seen by a neurologist. Nerve conduction studies were performed, which led to a dx of brachial plexitis. The pt stated that "other factors were involved" in the development of this event and that his symptoms were possibly related to an unspecified sexually transmitted disease or unspecified virus. The pt stated that his neurologist does not consider the brachial neuritis to be related to IZ. However, as a precaustion, the pt has elected to discontinue the Engerix-B IZ series. The most recent information received on 7/13/01, indicated that the brachial plexitis and subnormal temperatures were ongoing. Brachial plexitis is considered "Medically Serious".
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Crohn's disease
Clinical narrative: I began the Anthrax series as an active duty member of the Air Force on 8/11/99. The 2nd on 8/25/99, 3rd on 9/8/99 and the 4th on 2/8/00. Symptoms of Crohn's dx'd in 4/00, began in 9/99.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, PNC
Symptoms: Aphasia, Crying, Dyskinesia, Pyrexia, Staring
Clinical narrative: The second week following vax the patient developed a fever and episodes of staring. Three weeks post-vax patient had jerking at times, high pitched cries and squeals and wouldn't try to speak as before.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Rash
Clinical narrative: The patient developed a rash on the same day as the vaccine. Patient was treated with Benadryl for 2 days.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Crying, Pyrexia
Clinical narrative: Following vax, patient was crying and developed a fever of 102F. Patient has a red area, approx. the size of a dime, at the injection site. ER doctor prescribed Motrin. The follow up confirmed site was at left upper thigh site Varivax-no other AE. Hx no other vaccination previous 4 weeks.
Age: 0.3
Sex: F
Vaccine: DT, HEP, IPV, PNC
Symptoms: Irritability, Pyrexia, Sleep disorder
Clinical narrative: Three days post-vax the patient ran a fever of 104.7F and was irritable. The patient did not sleep well for 2-3 more days.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right leg red warm and swollen with raised area 9mm X 8mm wide. Area noted at approximately 6pm on 6/13/01. Doctor gave pt benadryl and applied cold compresses. Leg free of S&S of adverse reactions on 6/14/01 reports pt's mother.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Pt was vaccinated approximately 9:30am without difficulty and well tolerated. acetaminophen given prior to vaccine and again at 7:30pm. Temp taken 8:00pm with reading of 103.1F approximately 8:30pm pt had the 1st grand mal seizure lasting for 2-3 minutes & the 2nd occurring in the car on the way to KDMC ER lasting 1.5 minutes. Tests run & spinal tap performed to rule out meningitis. Pt given A-Cillin and discharged.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Screaming
Clinical narrative: Vaccines given 6/20/01, the night of 6/20/01 pt screamed inconsolable for 3-4 hrs, temp 102.9F. In office next day for evaluation exam was negative temp 99.9F (ear). CBC all WNL
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Rash
Clinical narrative: After about 2nd vaccine, started to notice migrating polyarthralgia comes and goes. Has recurrent rash at one area inner R elbow.
Age: 38.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Hypokinesia, Injection site pain
Clinical narrative: Joint Pain, Soreness at the injection site: Report 2001015472-1 described joint pain in a pt who rec'd Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme disease. This report was rec'd from the vaccines and has not been verified by a physician or other HCP. Reportedly, the pt had no known drug allergies. Per medical history included psoriasis,. The pt did not have gout or Crohn's disease. Pt had no history of Lyme disease. There was no family history of rheumatoid arthritis or lupus. She rec'd birth control medication (NOS). In 9/99, the pt rec'd her 1st Lymerix L arm, within 24 hrs post vaccine, the injection site was very sore. Her arm was difficult to move. In approximately 1/00, she reportedly began experiencing R hip soreness, bilateral knee problems of soreness and grinding noise and bilateral elbow soreness. She stated that none of her joints have been swollen, warm or red. The pt stated that her joint complaints have not been evaluated by a physician, and she has not rec'd any medical treatment for the joint pain. As of 6/27/01, her joint pt was getting worse. The outcome of the soreness at the injection site was not specified. The adverse event of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA per the 6/28/00 letter.
Age: 71.0
Sex: F
Vaccine: LYME
Symptoms: Asthenia, Confusional state, Fatigue, Feeling cold, Flank pain
Clinical narrative: Foggy headed (confusion), felt cold, leg pain, low pulse rate, maladministration (above recommended age), tired, weak - report 2001015290-1 described foggy headedness in a pt who rec'd Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme disease. This report was rec'd from the pt and has not been verified by a physician or other HCP. Reportedly, the pt is allergic to all narcotics and to Robaxol. Reportedly she has had arrhythmia's (NOS) for approximately 5 years which were treated with metoprolol (Toprol XL). On 5/31/01, the pt rec'd her 1st dose of Lymerix, she was above the maximum recommended age for immunization. Subsequently, on 5/31/01 she reportedly felt weak and tired. On 6/1/01, reported, she experienced extreme fatigue and felt cold to the bone. The fatigue and coldness persisted on 6/2/01, and she then experienced leg pains and a low pulse rate (50-52 beats per min) all day. She contacted her physician who reportedly feels all adverse events (were) related to vaccine. On 6/3/01, all symptoms continued and she reported that she began feeling very foggy headed. On 6/4/01, she reportedly started to feel better. However, her symptoms did not completely resolve for approximately 2 wks after the vaccine was administered. As of 6/20/01, the adverse events had resolved. The adverse event of foggy headedness does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter. The follow up states that the vaccinee was allergic to "all" narcotics, to Robaxil, and to sulfa. Her medical history included hysterectomy, upper back mass NOS, osteoporosis and plantar fasciitis. She received montelukast sodium. On 05/23/2001, the vaccinee received her first .5cc right deltoid dose of LYMErix; she was above the maximum recommended age for immunization. When seen by the physician on 05/23/2001, she complained of a sore right heel and a tick bite. She had a macular rash on the thigh and right abdomen. Impression: rule out Lyme secondary to tick. Amoxicillin three times daily for three weeks was prescribed. Subsequently, on 05/31/2001, she reportedly felt weak and tired. On 06/01/2001, she experienced extreme fatigue and felt "cold to the bone." The fatigue and coldness persisted on 06/02/2001, and she then experienced leg pains and a low pulse rate all day. She contacted her physician, who reportedly "feels all adverse events were related to vaccine." On 06/03/2001, all her symptoms continued and she reported that she began "feeling very foggy headed." On 06/04/2001, she reportedly started to feel better. However, her symptoms did not completely resolve for approximately two weeks afterthe vaccine was administered. As of 06/20/2001, the adverse events had resolved.