chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Abasia, Chills, Muscular weakness, Pain, Vasodilation procedure
Clinical narrative: Felt warm and hot post vax administration. Developed body aches and chills. Developed progressive bilateral leg weakness that made her unable to walk on 05/05/2000. She has improved but has not recovered.60 day follow-up dated 10/04/00 provided no additional data.
Age: 1.7
Sex: M
Vaccine: DTP, HIBV, MMR, VARCEL
Symptoms: Bronchitis, Coma, Hypotonia, Nervous system disorder, Pharyngitis
Clinical narrative: Twenty-four hours post vax, developed cold symptoms. Returned to physician's office following day, child appeared to be disoriented - 'out of it.' Physician dx bronchitis and gave Biaxen. Went to ER that day - child was unresponsive (hypotonic). Admitted to hospital and received dx of leukodystrophy. Genetic testing nml.
Age: 1.7
Sex: M
Vaccine: DTP, HIBV, MMR, VARCEL
Symptoms: Rhinitis
Clinical narrative: Twenty-four hours post vax, developed cold symptoms. Returned to physician's office following day, child appeared to be disoriented - 'out of it.' Physician dx bronchitis and gave Biaxen. Went to ER that day - child was unresponsive (hypotonic). Admitted to hospital and received dx of leukodystrophy. Genetic testing nml.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Gaze palsy, Lethargy, Musculoskeletal stiffness
Clinical narrative: Seizure with a 2-3 minute episode of stiffening (body). Had a fixed upper gaze, then "lethargic". Onset 03:00 AM on 3/30/2000. A follow up report received 6/12/2000 adds: Nurse-reporter states pt seen in ER of local hospital then transferred to another hospital. Admission dx: R/O meningitis, right otitis media, seizure. Admitted 3/30/2000 and discharged 3/31. "Neuro-developmentally normal". No mention of anaphylaxis or difficulty breathing. Rectal temps ranged from 98.8 to 101.2. No family history of seizures.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Agitation, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Dad states that the rash began on back area and progressed to abdomen and chest area. Seen by an MD on 5/17/00 and had slightly red, raised papular rash on trunk of body. Pt experienced irritability and an elevated temperature. Tylenol was given.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Febrile convulsion
Clinical narrative: Pt experienced a febrile seizure within 18 hours post vax.
Age: 0.5
Sex: M
Vaccine: PNC
Symptoms: Chest discomfort, Cough, Otitis media, Pyrexia
Clinical narrative: Pt experienced a cough, chest discomfort, fever, otitis media.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Otitis media
Clinical narrative: Pt experienced left otitis media, Given Suprax, Rocephin.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Influenza like illness, Injection site erythema, Joint stiffness, Pain
Clinical narrative: Pt started aching last PM. This AM arm is
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain
Clinical narrative: Pt experienced joint pain, lower back and knee joints.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Palpitations
Clinical narrative: Pt has a hx of premature atrial contractions and paroxysmal, supraventricular tachycardia which is controlled with a beta blocker medication. Shortly after receiving his fourth Anthrax vax, he developed palpitations which lasted 12 hours.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Menstruation irregular
Clinical narrative: 4 months post vax,the pt began having menstrual irregularity and bleeding. Had to change birth control pills twice to regain control. Never had been irregular in the past.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Hypokinesia, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Several hours, post vax, arm started to hurt. Next morning, it was swollen and itchy. Hurts to move arm, joints ache (knees and elbows). No fever. Swelling 12cm X 11cm.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Pruritus
Clinical narrative: Several hours, post vax, arm started to hurt. Next morning, it was swollen and itchy. Hurts to move arm, joints ache (knees and elbows). No fever. Swelling 12cm X 11cm.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Apnoea, Hypotonia, Pallor, Stupor
Clinical narrative: pt recv vax 3MAR99 & was observed to have 4sec apneic episode associated w/pallor, hypotonia, dec responsiveness;
Age: 52.0
Sex: M
Vaccine: HEPA, MMR, OPV, TYP, HEPA, MMR, OPV, TYP
Symptoms: Dyspepsia, Influenza, Myalgia
Clinical narrative: 2days p/vax pt exp flu-like sx consisting of achiness & upset stomach. addl info requested
Age: 21.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Chills, Headache, Hypotension, Malaise
Clinical narrative: rigors, h/a, malaise, hypotension adm to ER for observation;
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: pt c/o redness, pain & swelling @ inj site >usual;MD observed;
Age: 12.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Dizziness, Influenza like illness, Pyrexia, Rash, Thrombocytopenic purpura
Clinical narrative: Twenty-four hours post vax, this pt experienced flu-like symptoms. Vomiting, dizziness, lightheadedness, fever which would not decrease from 101, red spots on the extremities. She was dxed with ITTP. She was given a plasma. Transfusion/surgery on the right leg for clot. Was given blood, thinned by steroids.
Age: 12.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Thrombosis, Vomiting
Clinical narrative: Twenty-four hours post vax, this pt experienced flu-like symptoms. Vomiting, dizziness, lightheadedness, fever which would not decrease from 101, red spots on the extremities. She was dxed with ITTP. She was given a plasma. Transfusion/surgery on the right leg for clot. Was given blood, thinned by steroids.
Age: 12.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Dizziness, Influenza like illness, Pyrexia, Rash, Thrombocytopenia
Clinical narrative: Twenty-four hours post vax, this pt experienced flu-like symptoms. Vomiting, dizziness, lightheadedness, fever which would not decrease from 101, red spots on the extremities. She was dxed with ITTP. She was given a plasma. Transfusion/surgery on the right leg for clot. Was given blood, thinned by steroids.
Age: 12.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Thrombocytopenic purpura, Thrombosis, Vomiting
Clinical narrative: Twenty-four hours post vax, this pt experienced flu-like symptoms. Vomiting, dizziness, lightheadedness, fever which would not decrease from 101, red spots on the extremities. She was dxed with ITTP. She was given a plasma. Transfusion/surgery on the right leg for clot. Was given blood, thinned by steroids.
Age: 12.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Dizziness, Influenza like illness, Platelet count decreased, Pyrexia, Rash maculo-papular
Clinical narrative: Twenty-four hours post vax, this pt experienced flu-like symptoms. Vomiting, dizziness, lightheadedness, fever which would not decrease from 101, red spots on the extremities. She was dxed with ITTP. She was given a plasma. Transfusion/surgery on the right leg for clot. Was given blood, thinned by steroids.
Age: 11.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Dizziness, Influenza like illness, Pyrexia, Rash, Thrombocytopenic purpura
Clinical narrative: Patient had a flu-like symptoms 24 hours after the Hepatitis B #3 shot was given. Vomiting, dizziness, light-headedness, fever will not go down from 101. Red spots on the extremities. Diagnosed with ITTP. Was given plasma. Transfusion/surgery on the right leg from clot. Was given blood thinner and steroids.
Age: 11.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Thrombosis, Vomiting
Clinical narrative: Patient had a flu-like symptoms 24 hours after the Hepatitis B #3 shot was given. Vomiting, dizziness, light-headedness, fever will not go down from 101. Red spots on the extremities. Diagnosed with ITTP. Was given plasma. Transfusion/surgery on the right leg from clot. Was given blood thinner and steroids.
Age: 11.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Dizziness, Influenza like illness, Pyrexia, Rash, Thrombocytopenia
Clinical narrative: Patient had a flu-like symptoms 24 hours after the Hepatitis B #3 shot was given. Vomiting, dizziness, light-headedness, fever will not go down from 101. Red spots on the extremities. Diagnosed with ITTP. Was given plasma. Transfusion/surgery on the right leg from clot. Was given blood thinner and steroids.
Age: 11.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Thrombocytopenic purpura, Thrombosis, Vomiting
Clinical narrative: Patient had a flu-like symptoms 24 hours after the Hepatitis B #3 shot was given. Vomiting, dizziness, light-headedness, fever will not go down from 101. Red spots on the extremities. Diagnosed with ITTP. Was given plasma. Transfusion/surgery on the right leg from clot. Was given blood thinner and steroids.
Age: 11.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Dizziness, Influenza like illness, Platelet count decreased, Pyrexia, Rash maculo-papular
Clinical narrative: Patient had a flu-like symptoms 24 hours after the Hepatitis B #3 shot was given. Vomiting, dizziness, light-headedness, fever will not go down from 101. Red spots on the extremities. Diagnosed with ITTP. Was given plasma. Transfusion/surgery on the right leg from clot. Was given blood thinner and steroids.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Apnoea, Injection site rash, Pallor
Clinical narrative: A consultant MD reported that a 2 month old female received her first dose of Acel-Immune on 12/29/1998. On 4/16/99, her mother reported to the pediatrician that the infant had an apneic episode 11 to 12 hours post immunization. The apneic episode lasted 15 seconds and was associated with pallor. The mother reported to the consultant that her daughter also had a small red spot at the injection site. The mother treated her daughter with acetaminophen and applications of ice to the injections site. The infant recovered. The apneic episode is considered medically important.  Additional information received from the vaccine provider on 10/17/00 indicated that the infant also received Hib-Titer and IPV vaccines.
Age: 27.0
Sex: M
Vaccine: MMR
Symptoms: Face oedema, Hypoxia, Lymphoma, Mouth ulceration, Pyrexia
Clinical narrative: On 4/12/00, the pt developed facial swelling on the right followed by a rash which spread over the face, neck, chest, back, and some areas of the arms and legs. The reporter noted that the pt had a fever of 104-105 but he did not have lesions in his mouth. The reporter indicated that the pt received therapy with cephalexin for treatment of the swollen cheek after the vax. At the time of the report, 5/18/00, the reporter indicated that the pt was intubated and hospitalized in an ICU. The reporter indicated that the events were life threatening.  Follow-up information dated 9/26/00 stated that a bone marrow biopsy showed Natural Killer Cell Lymphoma. The pt died in the hospital on 5/25/00 after a 10 day admission. It was noted that the final cause of death was Natural Killer Cell Lymphoma.
Age: 27.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: On 4/12/00, the pt developed facial swelling on the right followed by a rash which spread over the face, neck, chest, back, and some areas of the arms and legs. The reporter noted that the pt had a fever of 104-105 but he did not have lesions in his mouth. The reporter indicated that the pt received therapy with cephalexin for treatment of the swollen cheek after the vax. At the time of the report, 5/18/00, the reporter indicated that the pt was intubated and hospitalized in an ICU. The reporter indicated that the events were life threatening.  Follow-up information dated 9/26/00 stated that a bone marrow biopsy showed Natural Killer Cell Lymphoma. The pt died in the hospital on 5/25/00 after a 10 day admission. It was noted that the final cause of death was Natural Killer Cell Lymphoma.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Headache, Hypoaesthesia, Optic neuritis, Vision blurred
Clinical narrative: Optic neuritis in right eye, numbness in legs, and blurry vision in right eye. Treated with Solu-Medrol. Numbness was gone in a week but blurry vision has not changed on 5/13/00. Annual follow up states blurred vision in right eye. Per F/U 7/24/00; also treated with Methyl Prednisone. Pt also had a headache and pain with eye movement.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Osteomyelitis
Clinical narrative: Pt received Pnu-immune in right deltoid on 5/12/2000. On 5/13/00, pt experienced redness, swelling at injection site. On 5/14/00 pt became progressively worse. Went to ER on 5/14/00 and was admitted. Rule out cellulitis, osteomyelitis, allergy.
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Dizziness, Glossodynia, Hypokinesia, Lymphadenopathy, Nausea
Clinical narrative: Late in the evening post vax, the pt's arm became sore and swollen. By morning the swelling doubled in size. Very limited range of motion without discomfort. On 5/9, the pt had to leave work due to severe nausea, dizziness, palpitations, and limited arm movement. Pt was seen by a dr and dx with a severe reaction. Benadryl and Motrin taken per dr's request. Pt was also seen in the ER on 5/11 with persistent nausea and dizziness and continued limited range of motion. Her arm is sore all day; worse in am often not being used all night. On 5/15, the pt's palpitations stopped. On 5/16, the pt had nausea with dry heaves and lightheadness. On 5/18, pt developed sore, swollen glands in her neck. On 5/19, the swollen glands were worse, now including swelling under the tongue on the left side. Evaluated by dr due to inability to eat. Tongue was hard to manipulate without pain. Pt continues with symptoms.
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Oedema peripheral, Pain, Palpitations, Retching, Tongue oedema
Clinical narrative: Late in the evening post vax, the pt's arm became sore and swollen. By morning the swelling doubled in size. Very limited range of motion without discomfort. On 5/9, the pt had to leave work due to severe nausea, dizziness, palpitations, and limited arm movement. Pt was seen by a dr and dx with a severe reaction. Benadryl and Motrin taken per dr's request. Pt was also seen in the ER on 5/11 with persistent nausea and dizziness and continued limited range of motion. Her arm is sore all day; worse in am often not being used all night. On 5/15, the pt's palpitations stopped. On 5/16, the pt had nausea with dry heaves and lightheadness. On 5/18, pt developed sore, swollen glands in her neck. On 5/19, the swollen glands were worse, now including swelling under the tongue on the left side. Evaluated by dr due to inability to eat. Tongue was hard to manipulate without pain. Pt continues with symptoms.
Age: 35.0
Sex: F
Vaccine: LYME
Symptoms: Dizziness, Hypersensitivity, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Received vaccine in left arm and was sore 1st day. Late in the evening the arm became sore/swelling some. Took Tylenol. By the next AM, the swelling doubled in size and had very limited ROM, without discomfort. No redness at site, unable to lean or lay on arm. I had to leave work due to severe nausea, dizziness, palpitations and limited arm movement. Able to move arm but laterally abduction 2"-3" before pain won't allow me to move it any further. Examined by infection control MD who labeled me as severe reaction. Given Benadryl and Motrin. ER MD also saw me and symptoms had improved. On 17th, left arm still sore to touch and with movement. Glands in neck are sore and swollen. On 19th, glands worse. Under the tongue swollen on left side and also neck. By the 24th, able to swallow with minimal pain.
Age: 35.0
Sex: F
Vaccine: LYME
Symptoms: Lymphadenopathy, Nausea, Odynophagia, Palpitations, Tongue oedema
Clinical narrative: Received vaccine in left arm and was sore 1st day. Late in the evening the arm became sore/swelling some. Took Tylenol. By the next AM, the swelling doubled in size and had very limited ROM, without discomfort. No redness at site, unable to lean or lay on arm. I had to leave work due to severe nausea, dizziness, palpitations and limited arm movement. Able to move arm but laterally abduction 2"-3" before pain won't allow me to move it any further. Examined by infection control MD who labeled me as severe reaction. Given Benadryl and Motrin. ER MD also saw me and symptoms had improved. On 17th, left arm still sore to touch and with movement. Glands in neck are sore and swollen. On 19th, glands worse. Under the tongue swollen on left side and also neck. By the 24th, able to swallow with minimal pain.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Hypoaesthesia, Oedema, Pruritus, Rash
Clinical narrative: Pt experienced itchy red skin, swelling of arm, loss of feeling in arms (both). Entire body breaks out in bumps.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Localized pain and swelling that worsened at 48 hours, low-grade fever, chills, tenderness, heat and erythema. On day 3, 8" X 6' area but erythema and heat decreasing. This was the 4th dose.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Nausea
Clinical narrative: The pt experienced nausea, and headache upon waking the following morning after Anthrax shot.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Dizziness, Fatigue, Hypoaesthesia, Influenza like illness
Clinical narrative: Pt experienced a woozy feeling, dizziness, cold and flu type symptoms, extreme fatigue, parts of extremities falling asleep, joints sore.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Pharyngitis, Rhinitis
Clinical narrative: Pt experienced a woozy feeling, dizziness, cold and flu type symptoms, extreme fatigue, parts of extremities falling asleep, joints sore.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Ecchymosis, Myalgia, Paraesthesia, Peripheral coldness, Skin nodule
Clinical narrative: Pt experienced bruising, bumps, aching muscle, cool and tingling hands. Bruise was 7cm x 4.5cm with a nodule.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Erythema, Hyperhidrosis, Nausea, Oedema
Clinical narrative: Pt experienced excessive sweats, fevers (102.0), lightheadedness, nausea, dizziness, redness, edema for 5 hours.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Pt experienced excessive sweats, fevers (102.0), lightheadedness, nausea, dizziness, redness, edema for 5 hours.
Age: 33.0
Sex: M
Vaccine: UNK
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt experienced an 100 x 200 mm area of erythema, edema and warmth to left upper arm to 8cm below elbow.  Pt was treated with Keflex.
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Headache
Clinical narrative: Pt had headache that lasted up to 1 hour; 1 day post vax.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Pt experienced a 33cm x 10 cm indurated erythematous lesion. Warm and tender to touch. Received Anthrax #6 on 4/29/00.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Skin ulcer
Clinical narrative: Pt received Anthrax #3 on 5/8/00. Pt now has large circular lesion extending below elbow. Lesion erythematous with very dark red bulls eye (1
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Inflammation, Pain, Pyrexia
Clinical narrative: Pt experienced inflammation, soreness, fever, and tiredness.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Hypokinesia, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Member with 26cm X 13cm erythematous induration extending below elbow on left arm, tenderness and warmth. Reports pain with movement.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Pain
Clinical narrative: Member with 26cm X 13cm erythematous induration extending below elbow on left arm, tenderness and warmth. Reports pain with movement.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Malaise
Clinical narrative: Pt experienced generalized malaise, reddened and swollen injection site with swelling down to the elbow (left). Pt lost one day of duty.
Age: 1.0
Sex: U
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: A nurse reported that a 1 year old child received the 2nd dose of Typhoid vaccine, USP. Heat Phenol Inactivated and subsequently, developed a fever and chills. The fever was "hard to handle with Tylenol." The reporter declined to provide further information and declined to grant permission for follow-up investigation.
Age: 1.0
Sex: U
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: A nurse reported that a 1 year old child received an injection of Typhoid Vaccine, USP, Heat Phenol Inactivated and subsequently, developed a fever and chills. The child was treated with Tylenol and recovered within 2 days. The reporter declined to provide further information and declined to grant permission for follow-up investigation.
Age: 52.0
Sex: F
Vaccine: TYP
Symptoms: Injection site erythema, Injection site oedema, Sensation of heaviness
Clinical narrative: A 52 year old female reported that, post vax, on 1/20/99, she subsequently, developed an injection site reaction characterized by redness and swelling the "size of a tennis ball". Her arm "felt heavy". She recovered within 24 hours.
Age: 0.9
Sex: F
Vaccine: TYP
Symptoms: Decreased appetite, Irritability, Lethargy, Pyrexia
Clinical narrative: A nurse reported that an 11 month old female received an injection of Typhoid Vaccine, USP, Heat Phenol, Inactivated on 2/8/99. That evening, the infant was cranky and developed a low-grade fever. The next day, she developed a fever of 103F, poor appetite, lethargy and "significant fussiness". She recovered after 2 or 3 days.
Age: 24.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: A physician reported that a 24 year old female received her 1st dose of Typhoid Vaccine, USP, Heat Phenol Inactivated, as well as Hep-A (manufacturer unknown) vaccine on 3/31/1999. Within 24 hours, she developed an injection site reaction characterized by redness, warmth, pain and swelling "the size of a baseball" at the site of Typhoid Vaccine administration.
Age: 3.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: A nurse reported that a 3 year old female, inadvertently, received 0.5 ml Typhoid Vaccine, USP, Heat Phenol Inactivated, on 5/26/1999, rather than 0.25 ml. When she returned to the clinic on 6/3/99, for her 2nd dose of vaccine, she was noted to have a temperature of 101F. She recovered within 24 hours.
Sex: M
Vaccine: TYP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: A nurse reported that a male, inadvertently, received a triple dose of Typhoid Vaccince, USP, Heat Phenol Inactivated, on 6/4/99 and subsequently, developed an injection site reaction, characterized by redness and soreness which persisted as of 6/10/99. This is 1 of 2 pt's from this facility who experienced this event following receipt of Typhoid Vaccine, USP, Heat Phenol Inactivated, lot 4988014.
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: A nurse reported that a female, inadvertently, received a triple dose of Typhoid Vaccine, USP, Heat Phenol Inactivated, on 6/4/99, and subsequently, developed an injection site reaction characterized by redness and soreness which persisted as ot 6/10/99. This is 1 of 2 pt's from this facility to experience this event following receipt of this vaccine, lot 4988014.
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported that a female pt received an injection of Typhoid Vaccine, USP, Heat Phenol Inactivated, on 6/21/99 and immediately, felt lightheaded. The pt also developed an injection site reaction characterized by swelling and "3 by 5" area of redness as well as fatigue. As of 6/24/99, the light-headedness and fatigue had resolved, but the injection site symptoms persisted.
Age: 47.0
Sex: M
Vaccine: HEPA, TTOX, TYP
Symptoms: Injection site erythema, Injection site oedema, Movement disorder
Clinical narrative: A nurse reported that a 47 year old male received an injection of Typhoid, USP, Heat Phenol Inactivated, Hep-A and tetanus toxoid vaccines on 6/18/99, and subsequently, developed a "severe" injection site reaction at the site of the Typhoid injection characterized by redness and swelling. The pt was unable to use that arm for 1 week; he recovered without treatment.
Sex: U
Vaccine: TYP, TYP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported that a pt received an injection of Typhoid Vaccine, Heat Phenol Inactivated and developed cellulitis at the site of the injection. The pt was treated with dicloxacillin and recovered. This is 1 of several pts from this facility who had an adverse experience following receipt of Typhoid Vaccine, USP, Heat Phenol Inactivated, lot 4998088.
Sex: U
Vaccine: TYP, TYP
Symptoms: Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: A nurse reported that a pt received Typhoid Vaccine, USP, Heat Phenol Inactivated and within 1 to 2 days, post vax, developed fever and an injection site reaction characterized by a tender and swollen arm. The pt was prescribed an oral antibiotic. No further information was available at the date of this report. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when indentifying information is provided.
Age: 2.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: The same day post vax, the pt developed welts over the entire body.
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Injection site pain
Clinical narrative: Post vax, the pt experienced pain at the injection site.
Age: 46.0
Sex: M
Vaccine: TYP
Symptoms: Hypoacusis, Pyrexia
Clinical narrative: Next day post vax, the pt developed a fever. He recovered. On 9/4/99, he experienced a feeling of hearing loss as though his right ear was clogged.
Age: 0.2
Sex: F
Vaccine: DTP
Symptoms: Cerebral palsy, Convulsion, Hypersensitivity
Clinical narrative: The mother of a female reported that he daughter received in injection of DTP in 1988 at the age of 2 months. By 5 months of age, the infant had developed seizures. She was seen by the physician, who reportedly dx an allergic reaction to the Pertussis component of the DTP vaccine. The child was treated with Phenobarbital "for months". In addition, a dx of cerebral palsy was made.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Petechiae, Pruritus, Thrombocytopenia, Thrombocytopenic purpura
Clinical narrative: On 5/29, presented with progressive petechial and purpuric lesion over course of one day-seen in ER. Dx of ITP.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying
Clinical narrative: Inconsolable crying following vaccines lasting for 6 hours. Admitted for observation.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site oedema, Vasodilation procedure
Clinical narrative: Two days post vax, the pt developed an injection site reaction characterized by an area of warmth and swelling measuring 5.5 cm in diameter. The pt recovered.
Age: 0.2
Sex: F
Vaccine: DTP, HIBV, IPV, RV, DTP, HIBV, IPV, RV, DTP, HIBV, IPV, RV
Symptoms: Abdominal pain, Agitation, Gastrointestinal disorder, Gastrointestinal haemorrhage, Melaena
Clinical narrative: A mother reported that her 2 month old daughter received Rota Shield, Hib-Titer, IPV and DTP in July, 99. At 4 months of age, the infant developed loose, bloody stools, decreased appetite and nasal congestion. She was seen b the physician who has attempted to rule out food allergies and GERD. Additional information received 10/18/99 from the mother indicated the infant was still experiencing cramping "with eating, blood in stools and decreased appetite. The infant is still being seen by a gastroenterologist. Further information received on 10/25/99 indicates the infant developed vomiting, cramping, crying, irregular bowel movements with change in color from brown to black to very dark green and congestion in her throat. The pediatrician changed the infants formula, the infant continued to vomit, experience sharp pains and gastroenterologist noted covert blood in her stool and indicated that it was possible to have a partial intussusception which could create symptoms of reflux. The infant was prescribed Tagamet. An allergy test for milk, rice, soy and wheat performed by the allergist was neg.
Age: 0.2
Sex: F
Vaccine: DTP, HIBV, IPV, RV, DTP, HIBV, IPV, RV, DTP, HIBV, IPV, RV
Symptoms: Nervousness, Small for dates baby, Vomiting
Clinical narrative: A mother reported that her 2 month old daughter received Rota Shield, Hib-Titer, IPV and DTP in July, 99. At 4 months of age, the infant developed loose, bloody stools, decreased appetite and nasal congestion. She was seen b the physician who has attempted to rule out food allergies and GERD. Additional information received 10/18/99 from the mother indicated the infant was still experiencing cramping "with eating, blood in stools and decreased appetite. The infant is still being seen by a gastroenterologist. Further information received on 10/25/99 indicates the infant developed vomiting, cramping, crying, irregular bowel movements with change in color from brown to black to very dark green and congestion in her throat. The pediatrician changed the infants formula, the infant continued to vomit, experience sharp pains and gastroenterologist noted covert blood in her stool and indicated that it was possible to have a partial intussusception which could create symptoms of reflux. The infant was prescribed Tagamet. An allergy test for milk, rice, soy and wheat performed by the allergist was neg.
Age: 0.2
Sex: F
Vaccine: DTP, HIBV, IPV, RV, DTP, HIBV, IPV, RV, DTP, HIBV, IPV, RV
Symptoms: Abdominal pain, Anorexia, Diarrhoea, Gastrointestinal disorder, Gastrointestinal haemorrhage
Clinical narrative: A mother reported that her 2 month old daughter received Rota Shield, Hib-Titer, IPV and DTP in July, 99. At 4 months of age, the infant developed loose, bloody stools, decreased appetite and nasal congestion. She was seen b the physician who has attempted to rule out food allergies and GERD. Additional information received 10/18/99 from the mother indicated the infant was still experiencing cramping "with eating, blood in stools and decreased appetite. The infant is still being seen by a gastroenterologist. Further information received on 10/25/99 indicates the infant developed vomiting, cramping, crying, irregular bowel movements with change in color from brown to black to very dark green and congestion in her throat. The pediatrician changed the infants formula, the infant continued to vomit, experience sharp pains and gastroenterologist noted covert blood in her stool and indicated that it was possible to have a partial intussusception which could create symptoms of reflux. The infant was prescribed Tagamet. An allergy test for milk, rice, soy and wheat performed by the allergist was neg.
Age: 0.2
Sex: F
Vaccine: DTP, HIBV, IPV, RV, DTP, HIBV, IPV, RV, DTP, HIBV, IPV, RV
Symptoms: Melaena, Rhinitis, Vomiting
Clinical narrative: A mother reported that her 2 month old daughter received Rota Shield, Hib-Titer, IPV and DTP in July, 99. At 4 months of age, the infant developed loose, bloody stools, decreased appetite and nasal congestion. She was seen b the physician who has attempted to rule out food allergies and GERD. Additional information received 10/18/99 from the mother indicated the infant was still experiencing cramping "with eating, blood in stools and decreased appetite. The infant is still being seen by a gastroenterologist. Further information received on 10/25/99 indicates the infant developed vomiting, cramping, crying, irregular bowel movements with change in color from brown to black to very dark green and congestion in her throat. The pediatrician changed the infants formula, the infant continued to vomit, experience sharp pains and gastroenterologist noted covert blood in her stool and indicated that it was possible to have a partial intussusception which could create symptoms of reflux. The infant was prescribed Tagamet. An allergy test for milk, rice, soy and wheat performed by the allergist was neg.
Age: 29.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Nausea, Vomiting
Clinical narrative: Subsequently post vax, the pt developed nausea and vomiting. The reporter indicated that another pt experienced this event; however, he/she is not presently identifiable.
Age: 52.0
Sex: F
Vaccine: TYP
Symptoms: Hypoacusis
Clinical narrative: On 9/4/99, the pt experienced a feeling of hearing loss, as though her ear was clogged.
Sex: U
Vaccine: TYP
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Subsequently post vax, the pt developed an injection site reaction characterized by redness, swelling, and pain. The symptoms resolved within 4 to 5 days.
Sex: M
Vaccine: TYP
Symptoms: Injection site oedema
Clinical narrative: Subsequently post vax, the pt developed swelling at the injection site that extended from his shoulder to his elbow.
Age: 24.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Same day post vax, the pt developed an injection site reaction characterized by swelling, redness, and pain. Within the next two weeks, her entire arm began to swell. The pt recovered.
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, IPV, TYP
Symptoms: Injection site hypersensitivity, Pyrexia, Vasodilation procedure
Clinical narrative: Same day post vax, the pt developed a fever and an injection site reaction characterized by a 5 cm by 6 cm area of redness and warmth. The pt recovered within 36 hours.
Sex: F
Vaccine: TYP
Symptoms: Diverticulitis, Injection site hypersensitivity, Injection site pain, Malaise
Clinical narrative: Within 24 hours post vax, the pt developed redness and tenderness at the injection site. 48 hours after the injection she experienced malaise. She reports that her diverticulitis got better following the injection but now has worsened.
Sex: M
Vaccine: TYP
Symptoms: Feeling abnormal
Clinical narrative: Same day post vax, the pt felt crummy.
Age: 39.0
Sex: F
Vaccine: MMR, OPV, TYP, MMR, OPV, TYP
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: A 39 year old female reported that she received the Typhoid vaccine, Orimune vaccine, and MMR vaccine on 5/5/99. Within 12 hours she developed a 5 inch area of redness, hardness and pain at the site of the Typhoid vaccine. She also developed a fever of 99.0. She recovered within 5 days.
Age: 39.0
Sex: F
Vaccine: MMR, OPV, TYP, MMR, OPV, TYP
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: A 39 year old female reported that she received the Typhoid vaccine, Orimune vaccine, and MMR vaccine on 5/5/99. Within 12 hours she developed a 5 inch area of redness, hardness and pain at the site of the Typhoid vaccine. She also developed a fever of 99.0. She recovered within 5 days.
Age: 39.0
Sex: F
Vaccine: MMR, OPV, TYP, MMR, OPV, TYP
Symptoms: Pyrexia
Clinical narrative: A 39 year old female reported that she received the Typhoid vaccine, Orimune vaccine, and MMR vaccine on 5/5/99. Within 12 hours she developed a 5 inch area of redness, hardness and pain at the site of the Typhoid vaccine. She also developed a fever of 99.0. She recovered within 5 days.
Sex: U
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: Post vax, the pt developed a fever. The pt recovered. This is one of several pts from this facility who had an adverse experience following vax.
Sex: U
Vaccine: TYP
Symptoms: Malaise
Clinical narrative: Post vax, the pt developed malaise. The pt recovered. This is 1 of 2 pts from this facility who experienced this event following receipt of vax.
Sex: U
Vaccine: TYP
Symptoms: Injection site reaction
Clinical narrative: Post vax, the pt experienced an injection site reaction. The pt recovered. This is one of several pts from this facility to experience an injection site reaction following receipt of vax.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Injection site hypersensitivity
Clinical narrative: Subsequently post vax, the pt developed an area of redness at the injection site, measuring 5 cm. The pt recovered.
Sex: U
Vaccine: TYP
Symptoms: Injection site reaction
Clinical narrative: Subsequently post vax, the pt developed a serious injection site reaction. The reporter stated that 6 pts, out of 15 vaccinees, experienced this event following receipt of vax.
Age: 1.5
Sex: F
Vaccine: DTAP, OPV, VARCEL, DTAP, OPV, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: A nurse reported an 18 month old female received Acel-Imune on 8/25/99 and subsequently developed an injection site reaction characterized by a 7 cm x 8 cm area of redness, swelling and warmth. The child was treated with Keflex. This is 1 of 2 pt's from this facility who developed an injection site reaction following receipt of Acel-Imune.
Age: 1.5
Sex: F
Vaccine: DTAP, OPV, VARCEL, DTAP, OPV, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported an 18 month old female received Acel-Imune on 8/25/99 and subsequently developed an injection site reaction characterized by a 7 cm x 8 cm area of redness, swelling and warmth. The child was treated with Keflex. This is 1 of 2 pt's from this facility who developed an injection site reaction following receipt of Acel-Imune.
Age: 1.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt received vaccinations on 8/25/99, and that evening, developed an injection site reaction characterized by swelling, redness and warmth at the site. The physician noted that this event was related to Acel-Imune. IPV and Comvax were administered in the opposite arm. The pt recovered. This is 1 of 5 pt from this facility who experienced an adverse event following receipt of Acel-Imune.
Age: 5.0
Sex: M
Vaccine: DTAP, OPV
Symptoms: Injection site erythema
Clinical narrative: A nurse reported that a 5 year old male received an injection of Acel-Imune on 8/24/99 and subsequently developed a 5 cm x 3 cm area of redness at the injeciton site. the child was treated with warm soaks and Tylenol. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Acel-Imune lot # 464304.
Sex: U
Vaccine: DTAP
Symptoms: Injection site nodule
Clinical narrative: A physician reported that an infant revceived Acel-Imune vaccine and subsequently developed a nodule at the injection site. MANUFACTURERS COMMENT: The reporter indicated that 2 pt's experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Sex: U
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema
Clinical narrative: A physician reported that an infant received Acel-Imune, IPV and Comvax on 8/25/99. That evening the infant developed an injection site reaction characterized by a red mark at the injection site. The MD noted that this event was related to Acel-Imune.  IPV and Comvax were administered in the opposite arm. This is 1 of 5 pts from this facility who had an adverse event following receipt of Acel-Imune. The reported indicated that 5 pts experienced an adverse event; however, only 4 pts have been identified. Additional information received on 11/23/99 from the MD indicated that the infant recovered.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: A physician reported that a 4 month old female received Acel-Imune, IPV and Comvax on 8/24/99 and that same day, developed "knots" and an injection site reaction characterized by redness and warmth at the site. The physician noted that this event was related to Acel-Imune; IPV and Comvax were administered in the opposite arm. The infant recovered. This is 1 of 5 pts from this facility who had an adverse experienced following receipt of Acel-Imune. MANUFACTURER'S COMMENT: The reporter indicate that 5 pts experienced an adverse event; however, only 4 pts have been identified. An additional report will be generated when identifying iformation is provided.
Age: 5.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: A physician reported that a 5 1/2 year old male received Acel-Imune, IPV and Comvax on 8/25/99 and that evening developed "knots" and an injection site reaction characterized by redness and warmth at the site. The physician noted that this event was related to Acel-Imune; IPV and Comvax were administered in the opposite arm. The pt recovered. This is 1 of 5 pts from this facility who had an adverse experienced following receipt of Acel-Imune. MANUFACTURER'S COMMENT: The reporter indicate that 5 pts experienced an adverse event; however, only 4 pts have been identified. An additional report will be generated when identifying information is provided.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: A physician reported that a 2 month old male received Acel-Imune, IPV and Comvax on 8/24/99 and that same day, developed "knots" and an injection site reaction characterized by redness and warmth at the site. The physician noted that this event was related to Acel-Imune; IPV and Comvax were administered in the opposite arm. The infant recovered. This is 1 of 5 pts from this facility who had an adverse experienced following receipt of Acel-Imune. MANUFACTURER'S COMMENT: The reporter indicates that 5 pts experienced an adverse event; however, only 4 pts have been identified. An additional report will be generated when identifying information is provided.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Injection site mass, Injection site oedema
Clinical narrative: A nurse reported that a 15 month old male received his fourth dose of Hib-Titer on 8/26/99. Within 24 hours he developed an injection site reaction characterized by an area which enlarged rapidly, and became hard and swollen, The child was taken to the ER but not admitted. No further information was available at the date of this report.
Age: 1.25
Sex: M
Vaccine: HBPV, HIBV
Symptoms: Injection site oedema, Injection site rash, Injection site urticaria
Clinical narrative: A physician has reported that a 15 month old male received hi fourth dose of Hib-Titer Vaccine on 8/28/99. That day, he developed a 2-2.5 cm area around the injection site characterized by urticaria and a rash. On 9/29/00, the injection site was more swollen. The physician prescribed Benadryl and the symptoms abated. Follow-up information received form the physician on 11/22/99, indicated that the infant had recovered.
Age: 1.25
Sex: M
Vaccine: HBPV, HIBV
Symptoms: Injection site rash, Injection site reaction
Clinical narrative: A physician reported that a male pt received his third dose of Hib-Titer and subsequently developed an injection site reaction. No further details were available at the date of this report. Follow-up information received from the physician on 11/22/99 indicated that the pt had a rash at the injection site. He recovered.
Age: 0.4
Sex: M
Vaccine: HBPV, HIBV
Symptoms: Agitation, Decreased appetite, Injection site pain, Insomnia
Clinical narrative: A mother reported that her 3 month old son received his second injection of Hib-Titer vaccine on 9/10/99. 4 1/2 hours later, he woke from his nap screaming. She stated that the upper left thigh where he was given the injection was so painful, he would not let her touch it. She feels that the pain in  his leg "may have been due to the injection technique". She brought her son to the MD"s office. He was seen by the physician and administered Tylenol and sent home. That evening the child was up the entire night. His sleeplessness continued for 72 hours but is back to normal. The child has had a decreased appetite since vaccination that persisted as of 10/12/99. Additional information received from the physician on 1/6/00 indicated that the child was crying and irritable following immunization. He was brought back to the office where a diagnosis of pain from immunization was made. He was treated with Tylenol and had "significant improvement". He recovered.
Age: 0.2
Sex: F
Vaccine: DTP, HBPV, HIBV, HIBV
Symptoms: Screaming, Tremor
Clinical narrative: A parent reported that her 2 month old daughter received poliomyelitis, DTP, and Hib vaccines and subsequently experienced shaking and uncontrollable crying for 24 hours. MANUFACTURERS COMMENT: The lot number for Hib vaccine was reported as M650SH, this is not a valid Lederle lot number. This report was received form Merck.
Age: 0.4
Sex: F
Vaccine: RV
Symptoms: Lethargy, Vomiting
Clinical narrative: A physician reported that a 5 or 6 month old infant received Rota Shield and subsequently became lethargic and vomited 1 to 2 weeks following receipt of the vaccine. The infant was hospitalized. Abdominal x-ray was neg. The infant was discharged from the hospital. No further information was available at the date of this report.   Follow up information received form the physician indicated that the infant recovered.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV, HEP, HIBV, IPV, RV, DTAP, HEP, HIBV, IPV
Symptoms: Grand mal convulsion, Staring
Clinical narrative: A father reported that his 2 month old daughter received Rota Shield, Hib-Titer, Tripedia, Engerix B and IPV on 6/23/99. In 10/99 she experienced a grand mal seizure and a petit mal seizure. She was seen by a MD who prescribed phenobarbital. The caller reportes that the infant develops a "blank look" on her face at times. This event is considered medically important.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV, HEP, HIBV, IPV, RV, DTAP, HEP, HIBV, IPV
Symptoms: Convulsion, Grand mal convulsion, Staring
Clinical narrative: A father reported that his 2 month old daughter received Rota Shield, Hib-Titer, Tripedia, Engerix B and IPV on 6/23/99. In 10/99 she experienced a grand mal seizure and a petit mal seizure. She was seen by a MD who prescribed phenobarbital. The caller reportes that the infant develops a "blank look" on her face at times. This event is considered medically important.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, RV
Symptoms: Agitation, Irritability, Vomiting, Weight decreased
Clinical narrative: A physician reported that a 5 month old male received Rota Shield, Tripedia, IPV and Hib vaccines on 6/15/99. On 6/18/99 he developed severe irritability crying and vomiting. By 6/25/99, the mother reported that the infant had lost 1/2 lb. The reporter declined to provide additional information.  From additional correspondence received on 01/24/00, it was reported; "My 'report' of this incident was in the form of a query about possible adverse actions to the vaccine, Rota-shield. I was investigating a complaint received by a peer review committee against a physician who had administered the vaccine. I had no direct knowledge to the case and informed the clerk who requested the information. The details of the complaint against the physician and the identifies of the individuals involved is confidential. I have no further information on this situation." From following correspondence received on 08/06/01, it was reported that the patient's recovery status is unknown. No further information available regarding this patient or this case. This case is closed.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, RV
Symptoms: Constipation, Diarrhoea
Clinical narrative: The mother of a 2 month old male reported that her son received his first dose of Rota Shield, as well as Hib, DtaP and IPV vaccines on 8/25/99. Within a "few" days, the infant developed "runny stools". He also developed constipation for 4 days, however the runny stools continued. The mother notified the MD, no treatment was prescribed.