chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: HEP, HEPA, TTOX, TYP
Symptoms: Asthenia, Delirium, Dizziness, Dyskinesia, Dyspnoea
Clinical narrative: Immediately after vax the patient experienced paleness and slight dizziness. Ten minutes later the patient felt like crying, a deep aching pain began to spread throughout her body and experienced an intense feeling of heaviness. 30 minutes post-vax the patient developed joint stiffness. 60 minutes post-vax the patient experienced difficulty breathing, a frantic feeling, nausea, and numbness in her hands. 90 minutes post-vax the patient experienced slight delirium and flailing arms. 2 and 1/2 hours post-vax she experienced a high fever and weakness. Treated with Vitamin C.
Age: 47.0
Sex: F
Vaccine: HEP, HEPA, TTOX, TYP
Symptoms: Hypoaesthesia, Joint stiffness, Nausea, Pain, Pallor
Clinical narrative: Immediately after vax the patient experienced paleness and slight dizziness. Ten minutes later the patient felt like crying, a deep aching pain began to spread throughout her body and experienced an intense feeling of heaviness. 30 minutes post-vax the patient developed joint stiffness. 60 minutes post-vax the patient experienced difficulty breathing, a frantic feeling, nausea, and numbness in her hands. 90 minutes post-vax the patient experienced slight delirium and flailing arms. 2 and 1/2 hours post-vax she experienced a high fever and weakness. Treated with Vitamin C.
Age: 47.0
Sex: F
Vaccine: HEP, HEPA, TTOX, TYP
Symptoms: Panic reaction, Pyrexia, Sensation of heaviness
Clinical narrative: Immediately after vax the patient experienced paleness and slight dizziness. Ten minutes later the patient felt like crying, a deep aching pain began to spread throughout her body and experienced an intense feeling of heaviness. 30 minutes post-vax the patient developed joint stiffness. 60 minutes post-vax the patient experienced difficulty breathing, a frantic feeling, nausea, and numbness in her hands. 90 minutes post-vax the patient experienced slight delirium and flailing arms. 2 and 1/2 hours post-vax she experienced a high fever and weakness. Treated with Vitamin C.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: On 07/11/2001 the patient's right arm is swollen and red. The child is afebrile.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Information has been received describing a 69 year old female with a history of osteoporosis and rheumatoid arthritis who received an influenza virus vaccine on 1/30/01, the same day that she also received her quarterly infusion of pamidronate. Concomitant therapy included Enbrel (etanercept), prednisone, omeprazole, atenolol, levothyroxine, aspirin and simvastatin. Two days later, on 2/01/01, she developed fever of 106F with joint pains. She was hospitalized and treated with amoxicillin clavulanic acid for 2 days. Therapy was discontinued when the possibility of an infection was ruled out by her physician. The pt recovered. The reporter noted that the treating rheumatologist considered the events to be temporally related to the pamidronate infusion or the influenza virus vaccine. See related Enbrel report HQ0850614MAY2001.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Facial palsy, Hypoaesthesia, Memory impairment, Tremor
Clinical narrative: A wife reported that her 65 yr old husband received an injection of Flu Shield 2000-2001 formula in late November 2000. In January 2001, he developed facial paralysis, numbness, and dizziness. She indicated that her husband related these symptoms to the Flu-Shield. The reporter stated that her husband has recently been dx with a slight elevation in hypertension and was prescribed Atacand. Additional information received from the pt, a physician , on 05/21/2001 indicated that in addition to those symptoms reported by his wife, he is experiencing tremor, foggy memory, blurred vision, and a feeling of heaviness in his face, particularly around the orbital muscles. The pt has consulted with several physicians and stroke was ruled out.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: A wife reported that her 65 yr old husband received an injection of Flu Shield 2000-2001 formula in late November 2000. In January 2001, he developed facial paralysis, numbness, and dizziness. She indicated that her husband related these symptoms to the Flu-Shield. The reporter stated that her husband has recently been dx with a slight elevation in hypertension and was prescribed Atacand. Additional information received from the pt, a physician , on 05/21/2001 indicated that in addition to those symptoms reported by his wife, he is experiencing tremor, foggy memory, blurred vision, and a feeling of heaviness in his face, particularly around the orbital muscles. The pt has consulted with several physicians and stroke was ruled out.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Arthritis
Clinical narrative: A pt who received a dose of Flu-Sheild on 12/20/2000 subsequently experienced pain in all her joints. She was seen by a physician and prescribed oral Prednisone. She indicated that she was allegedly dx with post traumatic arthritis 8 days post vaccination. As of 06/26/2001, she stated that pain persists her right ankle only. Follow-up received from the pt on 9/11/02, stated that a lymph node biopsy will be performed mid-September 2002, for possible sarcoidosis.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint swelling
Clinical narrative: A pt who received a dose of Flu-Sheild on 12/20/2000 subsequently experienced pain in all her joints. She was seen by a physician and prescribed oral Prednisone. She indicated that she was allegedly dx with post traumatic arthritis 8 days post vaccination. As of 06/26/2001, she stated that pain persists her right ankle only. Follow-up received from the pt on 9/11/02, stated that a lymph node biopsy will be performed mid-September 2002, for possible sarcoidosis.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hepatitis C virus
Clinical narrative: a 44 yr old female pt received an injection of Flu Shield 2000-2001 on 12/13/2000. Subsequent to a blood drive on 02/19/2001, her blood tested positive for hepatitis C and HTLV 1 & 2. The Red Cross told the reporter that a false positive reaction laboratory test interference nos with influenza vaccine was possible. The abnormal laboratory results were received on 03/15/2001.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Tremor
Clinical narrative: A physician reported that a 28 yr old female received an injection of Flu Shield on 12/26/2000. On 12/28/2000. she developed  numbness in her left leg and treated with and pins and needles in her left foot. She was seen by the physician and treated with prednisone. She was later seen by a neurologist after her symptoms persisted and treated with more prednisone. She then developed tremors in both legs and received tx with Carbamazepine. Additional info received form the physician on 04/30/2001 indicated that her sx have slowly resolved. MRI imaging of her brain and spine were normal. Additional information have slow received on 04/03/2001 her sx have slowly resolved, but she only has numbness 0f the upper back.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Neuritis, Neuropathy
Clinical narrative: Neuritis - A pharmacist reported that a 55 yo pt rec'd an injection of Flu Shield (2000-2001 Formula) vaccine and, within 48 hrs post vaccine,pt developed neuritis/neuropathy in his R arm. The condition lasted 4 wks and completely resolved. This report was received from Aventis Pasteur (U2001-004830).
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Injection site reaction, Tenderness
Clinical narrative: Injection site reaction - an adult pt rec'd an injection of Flu Shield (2000-2001 Formula) in Oct 2000, and developed soreness at the injection site. With a day or two, the injection site pain extended to his shoulder and to his elbow joint which became sore at full extension or under load. As of 5/17/01, he reported that the condition has stabilized and continues to the current time and affects both shoulders. The second shoulder is affected to a minor degree. No further information was available at the date of this report.
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Influenza - a consumer reported that recently her friend may have inadvertently rec'd a double dose of the influenza virus vaccine (2000-2001 Formula) and subsequently developed a bad case of the flu. The reporter declined to provide further information and declined to grant permission for follow-up investigation.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Palpitations
Clinical narrative: Pt developed marked inflammatory response with 6-8 cm of induration, bullae formation and redness and swelling of arm to elbow.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dermatitis bullous, Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: Pt developed marked inflammatory response with 6-8 cm of induration, bullae formation and redness and swelling of arm to elbow.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Leukocytosis
Clinical narrative: Pt developed marked inflammatory response with 6-8 cm of induration, bullae formation and redness and swelling of arm to elbow.
Age: 3.6
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, PNC, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 6x7cm area of erythema R ant. thigh, 9x11cm area of erythema L ant. thigh. No induration, pain or tenderness, only minimal swelling, no fever - Pt comforting and not fussy or in pain.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Arthritis
Clinical narrative: Swelling of all joints, ongoing, decreasing with time. Pt has taken flu vaccine in the past without adverse reactions.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint swelling
Clinical narrative: Swelling of all joints, ongoing, decreasing with time. Pt has taken flu vaccine in the past without adverse reactions.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Anorexia, Loss of consciousness, Staring, Vomiting
Clinical narrative: Mom stated that child was in a daze at the daycare with no appetite and began vomiting and became unconscious, after arriving home. Transported to ER via EMS. Tests done without significant findings per mom.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Eye movement disorder, Feeding disorder neonatal
Clinical narrative: Rolling eyes, regurgitation of feeding, possible apnea episode. Admitted to hospital. Observation for 24 hour monitoring in hospital.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Cyanosis, Hyperventilation, Oesophageal disorder, Pallor
Clinical narrative: Pt crying, then quiet for about 2 minutes. Found by mom with blue arms and legs, pale face, not breathing. Gasped with vigorous stimulation, then had "shallow" breathing for several minutes.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Respiratory disorder
Clinical narrative: Pt crying, then quiet for about 2 minutes. Found by mom with blue arms and legs, pale face, not breathing. Gasped with vigorous stimulation, then had "shallow" breathing for several minutes.
Age: 3.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Erythema, Injection site discolouration, Injection site warmth, Pruritus
Clinical narrative: Erythematous skin, pruritus 10 cm diameter, non tender blanching - warm to touch - apply ice pack, benadryl , Keflex.
Age: 1.32
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash, Respiratory disorder
Clinical narrative: 6/28/01 - spots on face & back also gums today - white spots on gums. Will not eat solid since yesterday, will take juice. Had fever 101.2F since Monday, tonsil look red, raw meat. Referred to Dr. 6/29/01 reaction to chickenpox per Dr.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever >105.0F in am 7/6/01 (within 24 hrs of vaccine, fussy, but consolable.
Age: 1.5
Sex: F
Vaccine: DTAPH, PNC
Symptoms: Cellulitis, Fatigue, Hypersensitivity, Injection site erythema, Injection site induration
Clinical narrative: Fussy, tired, rapid heartbeat, induration at sight of injection, red & swollen on legs (at injection site) the swelling was over 2 inches, & fever - symptoms begin that day & continued on till early morning of the 16th, was taken to the ER 6/13/01 for her legs (the swelling). They said it could of been an allergic reaction to the shots or cellulitis. Show was given a prescription for Cephalexin and Children's benadryl. Her fever was 101.5F consistently til the morning of 06/16/01 tylenol helped some.
Age: 1.5
Sex: F
Vaccine: DTAPH, PNC
Symptoms: Injection site swelling, Irritability, Palpitations, Pyrexia
Clinical narrative: Fussy, tired, rapid heartbeat, induration at sight of injection, red & swollen on legs (at injection site) the swelling was over 2 inches, & fever - symptoms begin that day & continued on till early morning of the 16th, was taken to the ER 6/13/01 for her legs (the swelling). They said it could of been an allergic reaction to the shots or cellulitis. Show was given a prescription for Cephalexin and Children's benadryl. Her fever was 101.5F consistently til the morning of 06/16/01 tylenol helped some.
Age: 3.0
Sex: M
Vaccine: IPV, PNC, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Tenderness
Clinical narrative: Extensive erythema over anterior R thigh, slight tender & warm. No fever, walking normally.
Age: 1.25
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: PCV-7 vaccine given in L thigh am of 7/9. Parents noted redness and swelling around vaccine site that evening. Child noted to have scratched area around injection site. Next day, L thigh redness & swelling increased with increased warmth and hardness.  Oral antibiotics started 7/11/01.
Age: 2.6
Sex: F
Vaccine: PNC
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Fever began 7/12/01 PM, highest temp around 101F, lasted approx 2 days, then developed rash spreading over entire body. Described rash as itching with wh? on 3rd day. Mom states child well until Prevnar given.
Age: 0.4
Sex: F
Vaccine: PNC
Symptoms: Face oedema
Clinical narrative: Child seen 6/26/01 for well appt & given Prevnar vaccine. Mom states 2 hrs later child with swelling face and dark circles under eyes. Mom denies giving child any medication that day or introducing new foods, soaps, lotions, plants, animals, etc. Mom reported Rxn 6/29/01
Age: 1.25
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: The pt experienced a rash on body since 7/1/01. Advisedskin care by doctor.
Age: 1.08
Sex: F
Vaccine: IPV, PNC, VARCEL, IPV, MMR, PNC
Symptoms: Lethargy, Muscular weakness, Pyrexia, Stupor
Clinical narrative: Pt developed fever of 104 and was in a hyporesponsive state. She was very lethargic and could not lift her head up.
Age: 1.08
Sex: F
Vaccine: IPV, PNC, VARCEL, IPV, MMR, PNC
Symptoms: Asthenia, Lethargy, Pyrexia, Stupor
Clinical narrative: Pt developed fever of 104 and was in a hyporesponsive state. She was very lethargic and could not lift her head up.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Agitation, Cerebellar ataxia, Difficulty in walking, Nasal congestion, Pyrexia
Clinical narrative: The pt was diagnosed with acute cerebella ataxia. The pt woke with legs shaking, unable to move or walk and crying. The pt started vomiting but had dry heaves. The pt experienced a fever, sinus drainage, sinus infection, raspy voice, congestion for three days.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Retching, Sinusitis, Tremor
Clinical narrative: The pt was diagnosed with acute cerebella ataxia. The pt woke with legs shaking, unable to move or walk and crying. The pt started vomiting but had dry heaves. The pt experienced a fever, sinus drainage, sinus infection, raspy voice, congestion for three days.
Age: 0.6
Sex: F
Vaccine: DTAP, IPV, PNC, DTAP, IPV, PNC
Symptoms: Irritability, Pyrexia, Rash erythematous, Urticaria
Clinical narrative: Pt developed fever 2 hrs post vax. Mom noticed a rash on face and chest that she thought was from bottle spilling. The next morning rash was very red with hives all over pt's body. Pt had fever and was irritable all day. She was treated with Benadryl and Tylenol. On 7/15/01, hives were gone and rash was less red, and pt had no fever. On 7/16/01, pt back to normal with only slight rash still noted.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Several pox lesions, chest, back, legs, face and genital area.
Age: 64.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin discolouration
Clinical narrative: Pt developed a 2.5" x 3" red, hot, swollen area at site of injection in left arm. Discoloration still faintly visible after 1 month. Pt treated with Cyrtex x qd x 5.
Age: 1.4
Sex: F
Vaccine: DTAP, MMR
Symptoms: Convulsion, Dyskinesia, Pyrexia, Rash, Staring
Clinical narrative: High fever, jerking, staring, rash and seizure.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Approx. 2cm red, slightly tender to touch area on left upper leg.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother states on 6/20/01, child developed redness and swelling in left arm, extending from elbow to shoulder. Area warm to touch. Prior to this only a smaller area had been reddened. Child seen by NP who told mother an infection was present and ordered antibiotics (cephalosporin).
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling right leg with erythema and warmth.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Right leg swollen with warmth on front and back. Swollen left leg with erythema on front and side of leg with rash.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Syncope
Clinical narrative: Approx. 5 minutes, post vax, pt fainted in the lobby with her father at her side. After a few seconds, pt opened her eyes and said "I'm all right". Applied cool compress to forehead and back of neck. Per father, pt did not hit her head. Pt walked with assistance to exam room, with dad at her side. Pt stayed in room for the next 20 minutes, under observation. Per pt, "feel fine". She left clinic with her father. Follow-up call made to pt's home. Spoke to father who stated that pt is doing fine. Stated that she ate after leaving the clinic with no problems.
Age: 1.7
Sex: F
Vaccine: DTAP, HIBV, IPV, UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child received shots on 7/10/01 AM and noted swelling and redness to upper thigh. Warm, moist compress was applied at 21:00. Noted swelling and redness to outer and upper thigh in the AM. Warm and moist compress applied and 30 minutes, looked better. Then child out on visit with parents for several hours. Noted left thigh with a lot of swelling and redness to inner thigh, over and outer thigh at 17:00 on 7/11/01. Sent to ER for evaluation  and had no treatment at ER.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: On 7/3/01, area was red and swollen, post vax. Pt returned on 7/13/01 and presented with redness and "hardness" in area.
Age: 0.9
Sex: M
Vaccine: MMR
Symptoms: Infection
Clinical narrative: Pt received MMR on 6/5/01 and developed acute measles on 6/11/01.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Pruritus, Rash, Vaccine positive rechallenge
Clinical narrative: Phone call received by mother. Child has itching, redness and bumps around injection site. Reports the same thing happened with 1st Hep-B. Advised Benadryl and ice. Recommended she check with PMD prior to receiving 3rd dose.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Headache, Hypoaesthesia, Tremor, Vomiting
Clinical narrative: Vomiting, shakes/tremors, weakness, headache, numbness and extreme tiredness.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chills, Hot flush, Migraine, Nausea
Clinical narrative: 1st HB vaccine administered (deltoid) at about 15:15 on 6/28/01. On 6/29/01 at about 09:00, headache began and it advanced to a migraine associated with nausea. Hot and cold flashes began about 11:30 AM. Was very weak at 16:00 and continued until about 20:00. Was well by Monday.
Age: 38.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Difficulty in walking, Influenza like illness, Joint stiffness
Clinical narrative: Pt developed joint pain which moves throughout body that is so severe it is difficult to walk and to use hands. Pt has no redness or swelling. Pt has very bad hip and knee pain.
Age: 38.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Difficulty in walking
Clinical narrative: Pt developed joint pain which moves throughout body that is so severe it is difficult to walk and to use hands. Pt has no redness or swelling. Pt has very bad hip and knee pain.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Information has been recvd re: 4-month-old male who received his second dose of blinded study vaccine. The pt nursed at 4 AM on 7/5/01 and then fell asleep with his mother. He was found on his back at the edge of the bed at 10:25 AM and was cold and non-responsive. He was pronounced dead by the medical crew that answered the call. The cause of death was "probable" sudden infant death syndrome (SIDS). The investigator reported that SIDS (unexpected per the Investigator Brochure) was not related to study vaccine administration or concomitant vaccines. The medical monitor considered the event to be probably not related to the study vaccine. This case is being submitted as a 15-day expedited report as requested by the FDA. A 15-day follow up report received 4/19/2002 adds: Follow-up info was received on 11/28/2001. An autopsy revealed the cause of death to be Sudden Infant Death Syndrome. The coroner's findings revealed the same. Both the investigator and medical monitor did not consider the event to be related to study vaccine administration or concomitant vaccinations. NOTE: This case is being submitted as a 15-day follow-up, expedited report, as requested by the FDA.
Age: 1.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Balance disorder, Cyanosis, Hypotonia, Opisthotonus, Respiratory disorder
Clinical narrative: Information has been received from a reporting nurse via called correspondence concerning a 12 month old male with an upper respiratory infection "for a few days" who on 6/11/01 at 10:30, was vaccinated SC in the left arm with a 1st dose of varicella virus vaccine live and a 3rd dose SC in the left thigh of poliovirus vaccine. On 6/12/01, at 13:30, the pt experienced a "faint episode" white pushing a toy. It was reported that the pt "looked wobbly", went limp, experienced a "breathless" color of lips, turned purple and his head went back. It was noted that there was no foaming at the mouth. The experience lasted for a few minutes and then the pt took a breath. It was noted that there were no tonic-clonic movements and that the pt recovered from this experience. It was reported that the pt now has right otitis media. "Faint episode" and "breathless" were considered to be "Other Important Medical Events". No further information is available.
Age: 1.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a reporting nurse via called correspondence concerning a 12 month old male with an upper respiratory infection "for a few days" who on 6/11/01 at 10:30, was vaccinated SC in the left arm with a 1st dose of varicella virus vaccine live and a 3rd dose SC in the left thigh of poliovirus vaccine. On 6/12/01, at 13:30, the pt experienced a "faint episode" white pushing a toy. It was reported that the pt "looked wobbly", went limp, experienced a "breathless" color of lips, turned purple and his head went back. It was noted that there was no foaming at the mouth. The experience lasted for a few minutes and then the pt took a breath. It was noted that there were no tonic-clonic movements and that the pt recovered from this experience. It was reported that the pt now has right otitis media. "Faint episode" and "breathless" were considered to be "Other Important Medical Events". No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Lymphocytic leukaemia, Thrombocytopenia
Clinical narrative: Information has been received from a physician concerning a "young" male who on approx. 6/11/01, was vaccinated with a dose of varicella virus vaccine live. The pt was reported to be "now" in the hospital with an acute lymphocytic leukemia-type picture. It was reported that the pt had early cells in lymph line and was being worked up for acute lymphocytic leukemia. The pt was also reported to be thrombocytopenic. The physician reported he was not sure if the pt's problems were related to the vaccine. The pt was reported to be still in the hospital and was "being worked up for ALL". Additional information has been requested. The child did develop thrombocytopenia. The child did not have lymphocytic leukemia.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: The patient was taken to the ER with a fever of 104.5F (rectal) and difficulty breathing. The patient was diagnosed with acute febrile reaction due to vaccines. The patient was treated with Tylenol.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Urticaria
Clinical narrative: The patient developed localized hives at the injection site with redness and warmth. The patient was treated with ice compresses and Benadryl.
Age: 2.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Urticaria
Clinical narrative: Within 30 minutes of receiving vax, the patient developed generalized urticaria.
Age: 0.75
Sex: M
Vaccine: PNC, PNC
Symptoms: Breath odour, Cyanosis, Hypotonia, Somnolence, Stupor
Clinical narrative: Patient was seen in the ER on 07/15/2001 due to being sleepy, limp and blue extremities. The patient could be wakened by shaking, but fell back to sleep quickly. The patient could not be awakened enough to eat breakfast but did take 12 oz of formula at 9:30 am, more than usual. The patient's breath had a ketone odor. Glucose was 73 to 85. Diagnosis is possibly hyporesponsive hypotonic episode of 1 1/2 hours.
Age: 0.75
Sex: M
Vaccine: PNC, PNC
Symptoms: Blood glucose increased, Breath odour, Cyanosis, Hypotonia, Peripheral vascular disorder
Clinical narrative: Patient was seen in the ER on 07/15/2001 due to being sleepy, limp and blue extremities. The patient could be wakened by shaking, but fell back to sleep quickly. The patient could not be awakened enough to eat breakfast but did take 12 oz of formula at 9:30 am, more than usual. The patient's breath had a ketone odor. Glucose was 73 to 85. Diagnosis is possibly hyporesponsive hypotonic episode of 1 1/2 hours.
Age: 0.75
Sex: M
Vaccine: PNC, PNC
Symptoms: Somnolence
Clinical narrative: Patient was seen in the ER on 07/15/2001 due to being sleepy, limp and blue extremities. The patient could be wakened by shaking, but fell back to sleep quickly. The patient could not be awakened enough to eat breakfast but did take 12 oz of formula at 9:30 am, more than usual. The patient's breath had a ketone odor. Glucose was 73 to 85. Diagnosis is possibly hyporesponsive hypotonic episode of 1 1/2 hours.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient presented in the office with a firm knot on his right thigh (palpable) and an erythemic area at the injection site.
Age: 0.25
Sex: M
Vaccine: IPV, PNC
Symptoms: Injection site pain, Pyrexia
Clinical narrative: The patient developed a rectal fever of 100.8F with mild soreness at the injection site. The patient was treated with Tylenol or Motrin.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: The patient developed hives within 24 hours after receiving vaccines. The patient was treated with Benadryl. On 7/12/2001 the mother called and advised the patient's hives are worse.
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Feeling hot, Joint swelling
Clinical narrative: This report describes swollen knees of a 40 year old male who received Lymerix. This report was received from the vaccinee, who is a physician. The vaccinee engaged in recreational running. He self-administered 3 injections of Lymerix; the 3rd was given 1 month, rather that 1 year, following the 2nd injection. Dates of vaccine administration, as well as, vaccine lot numbers, were not recalled by the vaccinee. Approx. 6 months, following the 3rd injection, he experienced the acute onset of bilateral knee pain. The pain soon progressed in intensity and prevented him from participating in recreational running. The pain was described as a diffuse aching' however, it never extended to the popliteal fossa, did not radiate, and did not affect other joints. It sometimes localized deep to the patellas. The knee pain worsened with activity, but there was no diurnal variation in the severity or character of the pain. No erythema was noted. "Slight" intermittent local warmth was noted around the anterior aspect of the left knee. He reported that there had been slight swelling of both knees, but no effusions had been noted. He did not experience fever, morning stiffness, or constitutional symptoms. The vaccinee had not been evaluated by a physician other than himself. Bilateral knee x-rays were reportedly normal. No lab evaluations were performed. The vaccinee treated himself with rofecoxib (Vioxx), celecoxib (Celebrex) and Glucosamine; Glucosamine therapy was continued for over a year. None of the treatments were affective and the bilateral knee swelling, pain, and warmth persisted as of 7/13/01. The adverse events of knee swelling, pain and warmth do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00, letter. Additonal info was received on 07/24/2001. Although the vaccinee denied pre-existing arthritis when reporting his symptoms, he said that he experienced an increase in arthritis symptoms following receipt of LYMErix. The vaccinee told the manufacturer that he had not been evaluated by a physician other than himself, but he told the other manuf. tha the had "sought unspecified medical attention. No outcome was provided.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning several patients who were exposed to their vaccinated family member who developed shingles. It was not reported if the patients were vaccinated. The family member was vaccinated on 08/18/1995. Subsequently, the patients experienced secondary transmission and it was reported that they developed shingles. The patient's again in approximately 1998 developed shingles for a second time and secondary transmission after exposure to another family member who developed shingles following vaccination with varicella virus vaccine live on 03/14/1998. No further information is available.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema peripheral
Clinical narrative: One day post vax, pt's leg was red. Two days post vax, pt's leg started swelling and became warm to touch. Three days post vax, pt diagnosed with cellulitis and given Keflex.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Bone pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 7/11/01, pt developed generalized bone pain and left deltoid swelling and pain. She c/o redness in area. On 7/12/01, she developed a feeling of heat in right upper deltoid and also c/o itching. On 7/13/01, symptoms inc in severity. On 7/14/01, she developed temp of 102. On 7/16/01, she returned to work. She was treated with Augmentin 500mg x 10 days.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Pyrexia
Clinical narrative: On 7/11/01, pt developed generalized bone pain and left deltoid swelling and pain. She c/o redness in area. On 7/12/01, she developed a feeling of heat in right upper deltoid and also c/o itching. On 7/13/01, symptoms inc in severity. On 7/14/01, she developed temp of 102. On 7/16/01, she returned to work. She was treated with Augmentin 500mg x 10 days.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Irritability, Rash papular
Clinical narrative: Pt broke out in a papular rash (which blanched on pressure) 72 hrs post vax. She was afebrile but irritable.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt developed an 8 x 10 area of erythema and tenderness around injection site.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Haematoma, Injection site pain, Shoulder pain
Clinical narrative: Pt c/o left shoulder pain 7 wks post vax. She states it is an ache and that she has had it since vax was administered. It was reported to male nurse at clinic who stated it could be a blood pocket. She has soreness in left upper arm.
Age: 1.9
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, MMR
Symptoms: Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Pt's grandmother reported on 7/12/01 that pt's arm was very swollen from the elbow to the shoulder and hot to the touch. She was referred to PMD. PMD reported that pt had a severe localized reaction with induration and pallor from clavicle to elbow. MD requested that pt receive no further DTAP. MD request charted and highlighted on immunization card.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: The patient had redness, swelling, pain and warmth of the left arm, possible cellulitis.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema, Oral mucosal eruption, Pyrexia, Rash
Clinical narrative: Ten days post-vax the patient developed erythema, papular eruption, fever, and Koplik spots in his mouth. Atypical measles are suspected.
Age: 1.75
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pruritus
Clinical narrative: The patient experienced swelling of the right arm from the shoulder to the wrist. The area was red and hot to the touch, with itchiness that began 24 hours after the vax and persisted for 5 days after.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: On 7/12/2001 the patient developed redness and swelling at the injection site. The patient was seen in the ER and diagnosed with a local reaction to the vaccination. The patient was treated with Ibuprofen and Benadryl. The patient experience a tympanic fever of 99.8.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: The patient developed hives on her arms, legs, abdomen, chest and lips and experienced itching.
Age: 12.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Convulsion, Disorientation, Pallor, Syncope
Clinical narrative: Approximately 5 minutes post-vax the patient had a seizure and fainted. The seizure was not confirmed by the nurses. The patient was pale and slightly disoriented lying down on chairs when observed.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Had varivax on 8/17/00. Suspected outbreak of varicella on 7/16/01.
Age: 36.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Back pain, Erythema, Lymphadenopathy, Myalgia
Clinical narrative: Began having mid to lower back discomfort on 4/7/01 around  2 PM. Continued with joint pain in knee and hip and general muscles aches. On 4/10/01 around 12 noon noted rash on face and neck with temperature  if 99.5 F. On 4/11 the rash was on arms and hands with a temperature of 100 F. Rash had spread to chest and back. Noted swollen glands behind ears and back of neck on both sides. On 4/12 stated was feeling better but itchy and she had some pain in her right ear. Pt. recovered.
Age: 36.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Began having mid to lower back discomfort on 4/7/01 around  2 PM. Continued with joint pain in knee and hip and general muscles aches. On 4/10/01 around 12 noon noted rash on face and neck with temperature  if 99.5 F. On 4/11 the rash was on arms and hands with a temperature of 100 F. Rash had spread to chest and back. Noted swollen glands behind ears and back of neck on both sides. On 4/12 stated was feeling better but itchy and she had some pain in her right ear. Pt. recovered.
Age: 36.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Ear pain, Lymphadenopathy, Musculoskeletal discomfort, Myalgia
Clinical narrative: Began having mid to lower back discomfort on 4/7/01 around  2 PM. Continued with joint pain in knee and hip and general muscles aches. On 4/10/01 around 12 noon noted rash on face and neck with temperature  if 99.5 F. On 4/11 the rash was on arms and hands with a temperature of 100 F. Rash had spread to chest and back. Noted swollen glands behind ears and back of neck on both sides. On 4/12 stated was feeling better but itchy and she had some pain in her right ear. Pt. recovered.
Age: 0.6
Sex: U
Vaccine: DTAP, IPV, PNC, DTAP, IPV, PNC
Symptoms: Irritability, Pyrexia, Rash erythematous, Urticaria
Clinical narrative: Two hours post vax, mom noticed a rash on face and chest. Mom thought it was from bottle spilling. Next morning rash was very red with hives all over body. Infant had fever and was irritable all day. Mom gave Benadryl and Tylenol. On 7/15/01, hives were gone, the rash was less red and she had no fever. Mom states back to normal on 7/16/01 with only slight rash still noted.
Age: 1.5
Sex: M
Vaccine: IPV, PNC
Symptoms: Convulsion, Diarrhoea, Gastroenteritis, Vomiting
Clinical narrative: Pt had 1st seizure, 2 days, post vax, at 13:00; 2nd seizure was at 19:00 on the same day and a 3rd seizure at 11:00 on 7/1/01. Pt had continued vomiting and diarrhea from early morning (before vaccination) up to 1 week after. Pt is now required to take Tegretol "anti-epileptic" drug for 1 year. Pt seems to have returned to a healthy state. As he is only 18 months, who knows if and when any other symptoms/seizures will occur again.  Nurse follow up on 07/27/04 states: "gastroenteritis."
Age: 1.3
Sex: M
Vaccine: MMR, PNC
Symptoms: Atelectasis, Febrile convulsion, Hypoxia, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: On 04/22/2001 the pt presented to the ER with a temperature of 104.9F and seizing. Seizure lasted 45 minutes. He was riding in the back seat of the family car when his father noticed stiffening of his limbs and an irregular breathing pattern. Did have 2 to 3 days of intermittent nasal congestion, rhinorrhea and cough. Intubated for subsequent respiratory failure using vecuronium and thiopental for 12 hours. Transported by EMS to PICU for stay overnight. Discharge dx: Status epilepticus, mechanical ventilation for less than 12 hours and probable complex febrile seizures. Treatment: IV antibiotics (lorazepam and fosphenytoin) and Neurology consult. Because of findings on the CXR, there were concerns about a possible aspiration pneumonia. The only neurologic finding was some wobbliness with walking consistent with postictal ataxia versus medication intoxication. Plan is to continue on Dilantin until follow-up with Neurology, 1 month post discharge. The Dilantin was discontinued about 1 week after discharge, with rapid resumption of his normal gait, mental status, and coordination. The patient developed another fever 2 weeks after discharge with the temperature ranging from 100F to 102F. This persisted for 3 days and was treated with alternating Tylenol and ibuprofen.
Age: 1.3
Sex: M
Vaccine: MMR, PNC
Symptoms: Pneumonia aspiration, Postictal state, Respiratory disorder, Respiratory failure
Clinical narrative: On 04/22/2001 the pt presented to the ER with a temperature of 104.9F and seizing. Seizure lasted 45 minutes. He was riding in the back seat of the family car when his father noticed stiffening of his limbs and an irregular breathing pattern. Did have 2 to 3 days of intermittent nasal congestion, rhinorrhea and cough. Intubated for subsequent respiratory failure using vecuronium and thiopental for 12 hours. Transported by EMS to PICU for stay overnight. Discharge dx: Status epilepticus, mechanical ventilation for less than 12 hours and probable complex febrile seizures. Treatment: IV antibiotics (lorazepam and fosphenytoin) and Neurology consult. Because of findings on the CXR, there were concerns about a possible aspiration pneumonia. The only neurologic finding was some wobbliness with walking consistent with postictal ataxia versus medication intoxication. Plan is to continue on Dilantin until follow-up with Neurology, 1 month post discharge. The Dilantin was discontinued about 1 week after discharge, with rapid resumption of his normal gait, mental status, and coordination. The patient developed another fever 2 weeks after discharge with the temperature ranging from 100F to 102F. This persisted for 3 days and was treated with alternating Tylenol and ibuprofen.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Pt developed fever to > 105 within 24 hours post vax.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Screaming, Vaccine positive rechallenge
Clinical narrative: Pt started with high pitched cry and was inconsolable 30 min post vax. It lasted for about 3 hrs. He was taken to MD's office and was given Benadryl and Infant Tylenol. Pt experienced high pitch cry (3 hrs) after first DTAP.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Pt developed fever for 24 hrs with a maximum temp of 102.4.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Irritability, Pruritus, Rash maculo-papular, Similar reaction on previous exposure to drug
Clinical narrative: Pt developed mac-pap rash on both thighs the day immunizations given. He was very fussy and scratching legs. He had similar rash 1-2 days after 2 month immunizations.
Age: 0.8
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: One day post vax, pt awoke with rash all over and fever but no respiratory problems or face swelling. He was seen on 6/29/01 for negative PPD and had improved.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt developed fever and rash.
Age: 0.2
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability, Petechiae
Clinical narrative: Pt developed irritability > 4 hrs post vax. Pt developed petechiae to bilateral lower legs.
Age: 1.0
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Listless, Pyrexia, Urticaria
Clinical narrative: Pt developed fever of 102-103 starting about 4 hrs post vax. She was listless. This lasted 2-3 days. She then had hives for 1-2 days.
Age: 7.0
Sex: M
Vaccine: PNC
Symptoms: Injection site reaction
Clinical narrative: Mom reported very bad reaction. Mom refused appt for pt to be seen. Per phone call on date of report, area had resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site reaction
Clinical narrative: Mom stated pt had bad reaction but refused appt for pt to be seen. Mom was called on date of report and stated area had resolved.
Sex: F
Vaccine: ANTH
Symptoms: Eczema, Pruritus, Rash
Clinical narrative: Numerous unexplained skin rashes (eczema) all over legs, arms and back. Will fade and reappear and itch.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site haemorrhage, Injection site mass, Injection site reaction
Clinical narrative: Pt had bruising, 2" around site of shot with a dime-sized nodule, that is ? still present.
Age: 10.0
Sex: M
Vaccine: DT
Symptoms: Erythema, Rash pruritic, Urticaria
Clinical narrative: Six hours post-vax the patient developed a diffuse erythematous, urticaria, pruriticl rash over his entire body. The patient was treated with Benadryl.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Dysarthria, Eye swelling, Memory impairment, Movement disorder
Clinical narrative: Two days post vax pt had severe pain in right wrist. Three wks post vax, pt had red rash with hives over entire body. She couldn't write or control the pen. She had a short term memory defect. Her speech was unclear. She had terrible, constant itching and developed rough skin after hives went away. She awoke with eyes swollen shut and face badly swollen. She is almost recovered. Her eyes, skin and short term memory are still slightly affected.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash erythematous, Skin disorder, Urticaria
Clinical narrative: Two days post vax pt had severe pain in right wrist. Three wks post vax, pt had red rash with hives over entire body. She couldn't write or control the pen. She had a short term memory defect. Her speech was unclear. She had terrible, constant itching and developed rough skin after hives went away. She awoke with eyes swollen shut and face badly swollen. She is almost recovered. Her eyes, skin and short term memory are still slightly affected.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP
Symptoms: Blister, Erythema, Oedema peripheral
Clinical narrative: On 07/11/2001 the parents reported the patient developed a red swollen grapefruit size area on his left leg. Instructed by RN to administer warm compresses and monitor for increased swelling or streaking. On the evening of 07/11/2001 the patient developed a softball size, blistering center.  On 07/12/2001 the patient had a 2x1/2 cm central small blistered area in the left thigh with a 16x10 area of erythema. Doctor advised application of heat to the area and take ibuprofen.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: The patient states two days after each vaccine she developed a rash and hives. After the second vaccine the patient went to the ER with hives all over her body and face, and difficulty breathing when sleeping. ER doctor states the patient either received too much vaccine or it reacted with her system.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: The patient experienced swelling and redness of the right thigh.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling hot, Nausea, Pain, Vomiting
Clinical narrative: On 06/28/2001 the patient experienced nausea, vomiting, aching and was warm. These symptoms were treated with ice chips.
Age: 3.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Post vax the patient experienced redness and swelling from the elbow down and a fever. The mother applied ice and elevated his arm. The doctor said it was a local reaction, and treated it with a steroid injection. The doctor advisede all future shots to be given in the hip.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Chest pain, Hypertension, Pyrexia
Clinical narrative: The patient experienced a fever, chest pain, abdominal pain and eleveated blood pressure.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pyrexia, Viral infection
Clinical narrative: On 07/19/2001 the patient's step mom called to verify chicken pox outbreak. On 7/20/2001 the patient developed 39 fluid filled areas with red rings around them. The patient has a slight fever with no itching. The patient is being treated with Calamine lotion and Tylenol for the fever.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Vomiting
Clinical narrative: The patient experienced dizziness, vomiting and fatigue.