chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased, Sleep disorder, White blood cell count increased
Clinical narrative: This case was reported by a physician and described the occurrence of anemia in a 48 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history was notable for good general health prior to the onset of these events.  The pt received injections of Engerix-B on 12/05/02, 01/14/03 and 06/03/03.  At an unspecified time after the third dose, the pt developed a fever of unknown origin, throbbing headaches, poor sleep, and fatigue.  She was seen by a physician.  Laboratory investigations revealed "mild" anemia, elevated white blood cell count, elevated sedimentation rate, elevated platelets, fibrinogen, and C-reactive protein.  The outcome of the events was unknown. The physician noted that the events jeopardized the patient. The events resolved on 23 September 2003. The physician considered the events to be possibly related to vaccination with Engerix-B
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver function test abnormal
Clinical narrative: This case was reported by a physician and described the occurrence of exacerbation of elevated liver function tests in an adult female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history included "elevated liver function tests (NOS)".  Her primary physician had confirmed that she could receive Engerix-B.  On 04/09/03, the pt received her first dose of Engerix-B (Lot # ENG5379A4).  At an unspecified time post-immunization, the pt went to her primary physician for a routine visit.  Laboratory evaluation revealed that her liver function tests had "risen higher".  The outcome of the event is unknown.  As per follow up report: this case was reported by a physician and described the occurrence of exacerbation of elevated alanine aminotransferase and aspartate aminotransferase in a 36 year old female patient. Alanine aminotransferase was elevated to 200 IU/L and aspartate aminotransferase was elevated to 115 IU/l. The immunization series with Engerix B was discontinued. On 08/29/2003, lab evaluation revealed that the events resolved. Alanine aminotransferase were normal at 32 IU/L and aspartate aminotransferase was normal at 15 IU/L. the physician considered the elevated liver enzymes to possibly be related to vaccination with Engerix B.
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described an adult pt who tested positive for hepatitis B surface antigen after receiving hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical condition was notable for renal failure (cause not reported) treated with hemodialysis.  On 10/06/03, the pt received the first dose of Engerix-B (either lot ENG5372A2 or Lot ENG5461A2).  On 10/09/03 a test for hepatitis B surface antigen was "positive".  The nurse considered the event to probably be related to the use of Engerix-B.  The nurse reported that "several" pt's experienced the same event, however, pt identifiers were not provided.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Dysgeusia, Mental retardation severity unspecified
Clinical narrative: This case was reported by a nurse and described the occurrence of confusion in a 32 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  On an unspecified date in September 2003, the pt received her first dose of Engerix-B (Lot # ENG5294B6).  She had no adverse events following the administration.  On 10/10/03, the pt received her second dose of Engerix-B (Lot # ENG5294B6).  A few hours later, she experienced confusion, a chlorine taste in her mouth, flushed feeling, and fuzzy mental status.  The events resolved.  The immunization series of Engerix-B was discontinued.  The nurse considered the events to be possibly related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse who experienced joint pain after she received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  At an unspecified time following an unspecified number of doses of Engerix-B, the pt experienced joint pain, neck stiffness and headache.  The events were unresolved as of 10/23/03.  Report received via manufacturer.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Skin burning sensation, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of urticaria in a 38 year old male who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  A physician or other health care professional has not verified this report.  The pt's medical history, concurrent conditions and concurrent medications were not reported.  On 09/24/2003 the pt received the first dose of Engerix-B (Lot ENG5387B6).  Approximately 10 days post-immunization, on 10/04/03, the pt experienced "burning muscle tissue" and rash.  The rash spread all over his body including his back and scalp.  The pt was evaluated by a physician who told the pt it was angioedema, but subsequently diagnosed urticaria. The pt was treated with oral ranitidine (Zantac) and oral diphenhydramine (Benadryl).  The events were unresolved as of 11/07/03.
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: This case was reported by a pharmacist and described an adult male pt who did not respond to hepatitis B vaccine recombinant (Engerix-B).  The pt's medical history, concurrent conditions and concurrent medications were not reported.  The pt was identified as "high-risk for hepatitis B."  The pharmacist stated that the pt had received "two full series" of Engerix-B and "has not responded."  The pharmacist clarified that the pt had received six adult doses and "his titers are still negative."
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a physician and described the occurrence of dry throat in a 22 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's past medical history included migraine.  The pt's concurrent medications were not reported.  On 10/31/2003 the pt received the 1st dose of Engerix-B.  Approximately 25 minutes later, the pt experienced a dry throat and developed a pruritic rash on the anterior chest.  The pt was treated with diphenhydramine hydrochloride followed by methylprednisolone sodium succinate ten minutes later.  The events resolved.  The reporting physician considered the events were probably related to vaccination with Engerix-B.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: This case was reported by a physician and described a 52 year old female pt who did not respond to immunization with hepatitis B vaccine (manufacturer unknown).  On unspecified dates, the pt received a series of six doses of hepatitis B vaccine (manufacturer unknown). Subsequently, on an unspecified date in 2003, a hepatitis B surface antibody titer was "negative".   As per follow up report: on 11/14/2003 and 12/18/2003, the patient received booster doses of Engerix B (lot ENG5394A2).
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Hair disorder
Clinical narrative: This case was reported by a nurse and described a an adolescent female pt who experienced hair loss following immunization with hepatitis B vaccine (manufacturer unknown).  Family history was significant for hair loss in the pt's sister following receipt of hepatitis B vaccine.  On unspecified dates, the pt received an unspecified number of doses of hepatitis B vaccine (manufacturer unknown).  Subsequently, on an unspecified date, the pt experienced hair loss.  The hair loss resolved but the hair regrowth was different than prior to the hair loss.
Sex: M
Vaccine: HEP
Symptoms: Blood iron increased
Clinical narrative: This case was reported by a physician and described a male pt who experienced high iron following the completed immunization series to hepatitis B vaccine (unknown manufacturer).  On unspecified dates, the pt received a series of three doses of hepatitis B vaccine (lot numbers not specified).  At an unspecified time following the third dose of hepatitis B vaccine, the pt experienced high iron.  The physician stated that he never examined this pt directly, but heard this from one of his pt's who reported that, "he has a friend who developed a high iron after completing his hepatitis B vaccinations."
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Oedema
Clinical narrative: This case was reporter by a physician and described the occurence of upper arm swelling in a 6-year old male who received Hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The physician submitted this report directly to VAERS (212627).  The pt's medical history, concurrent conditions, and concurrent medications were not reported.  On 11/13/2003, the pt received the second dose of Hepatitis B vaccine to the arm and later the same day experienced swelling of the upper arm "from the shoulder to the elbow."  The event resolved the next day.  The reporter considered the event to be related to vaccination with Engerix-B.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: This case was reported by a nurse practitioner and described a 42 year old female pt who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On unspecified dates, the pt received two immunization series (six doses) of Engerix-B.  The nurse practitioner reported that the pt was informed after each series that "...they did not have any titer/protection."
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: This case was reported by a nurse and described a female pt who experienced hair loss following immunization with hepatitis B vaccine (manufacturer unknown).  Family history was significant for hair loss in the pt's sister following receipt of hepatitis B vaccine.  On unspecified dates, the pt received an unspecified number of doses of hepatitis B vaccine (manufacturer unknown).  Subsequently, on an unspecified date, the pt experienced hair loss.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described female pt who did not respond to the hepatitis B vaccine (unknown manufacturer).  The pt's medical history and concurrent medications were not reported. The nurse reported that the pt had received her vaccination series prior to 1999.  At an unspecified date in 2003, a hepatitis B surface antibody titer was "negative".  On follow-up received 12/10/03, the nurse reported the pt was determined to be "negative." The pt was also found to be pregnant and "on the advise of her physician declined the booster until a later date."  At the time of followup the pregnancy was ongoing.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Gait disturbance, Influenza like illness, Pain, Pyrexia
Clinical narrative: A pharmacist reported the occurrence of stumbling in an approximately 28 year old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  Additional information was received from the subject, who is a paramedic.  The subject claimed that he had a history of hepatitis, but pre-vaccination testing was negative for markers.  Concurrent medications were not reported.  On 07/31/1992, the subject received his first injection of Engerix-B.  That night, he developed flu-like symptoms, high fever, dizziness, stumbling and body aches.  He stated that he "felt like he was going to die".  The events were treated with paracetamol (Tylenol).  The events resolved by the evening of 08/01/1992.  The pharmacist reported that the subject received his second injection of Engerix-B as recommended by the emergency squad's assistant medical director, without adverse event.  The most recent information was received from the subject on 04/18/2003.  The subject stated that the events recurred after his second and third injections of Engerix-B, but with lessened intensity after each subsequent injection.  The events resolved after each injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion, Headache, Laboratory test abnormal, Petit mal epilepsy, Pyrexia
Clinical narrative: Approximately August 30, 2003 she developed absence seizures.  In October, 2003 she developed occasional tonic-clonic seizures.  She has been assessed by a pediatric neurologist, and the current diagnosis is atypical absence seizures.  She is taking Depakote. The medical records received on 2/11/04 state seizurre diagnosis was confirmed. Within 1-2 weeks after onset of AE (seizures) the child developed UTI, HA, fever, vomiting and vulvitis.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Urinary tract infection, Vomiting, Vulvovaginal disorder
Clinical narrative: Approximately August 30, 2003 she developed absence seizures.  In October, 2003 she developed occasional tonic-clonic seizures.  She has been assessed by a pediatric neurologist, and the current diagnosis is atypical absence seizures.  She is taking Depakote. The medical records received on 2/11/04 state seizurre diagnosis was confirmed. Within 1-2 weeks after onset of AE (seizures) the child developed UTI, HA, fever, vomiting and vulvitis.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Client states arm where vaccine was given began to get red and swollen and painful within 2-3 hours of vaccination.  States was worsening and swelling had almost triples in 24 hours after imm given.  Took Benadryl as prescribed x7da.  States swelling and redness had decreased after 4 doses, itched for several days after swelling gone
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Pruritus, Rash papular, Rash pustular
Clinical narrative: Developed multiple discrete pruritic, erythematous papules and pustules around hairline, on face, neck, back, and chest 17 days after Smallpox Vaccination.    Reports history of frequent folliculitis after shaving and haircuts.  No history of acne, herpes, or eczema.  Consulted with Dermatology Dept.   Final Assessment:  Likely Non-viral Pustulosis/Folliculitis No evidence of Vaccinia autoinoculation.  Tx:  Sx. treatment, No shaving, Warm Compresses
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: She received her vaccinations on 9/25/03 and passed away on 10/13/03. The autopsy report received on 1/29/04 states SIDS.
Age: 1.7
Sex: M
Vaccine: DTAP, PPV
Symptoms: Diarrhoea, Lethargy, Pyrexia, Vomiting
Clinical narrative: Four days after given DTaP and Pneumococcal Conjugate child began vomiting and fever of 103, fifth day more vomiting & diarrhea with fever between 99 and 102, sixth was more vomiting with diarrhea, seventh, eighth day after shots more diarrhea and lethargy.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Instantly after receiving flu vaccine, patient developed a small rash on her chest.  Within minutes, rash disappeared, no other allergic symptoms.  No Treatment.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, High-pitched crying, Irritability
Clinical narrative: persistent high pitch cry and agitation for over 4 hours; irritable for 2 days
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Dysphonia, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: -Rash (Day after shot) -Hoarseness, cough (1-2 days after) -Fever (101.6 F; 10 days after) -Swollen Glands (7-10 days after)
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme from smallpox vaccine
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site warmth
Clinical narrative: 1-11-04 shot given @ 0830. Initial "bee sting" 1-12-04 3"x2" hot,red itchy site 1-13-04 4"x3" raised hot, red, itchy site with joint aches in rt shoulder and wrist. pain rt 4th & 5th digits to rt elbow. 1-14-04 5"x2" slightly hot, red and slightly indurated site. Less itchy.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 1-11-04 shot given @ 0830. Initial "bee sting" 1-12-04 3"x2" hot,red itchy site 1-13-04 4"x3" raised hot, red, itchy site with joint aches in rt shoulder and wrist. pain rt 4th & 5th digits to rt elbow. 1-14-04 5"x2" slightly hot, red and slightly indurated site. Less itchy.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Feeling cold, Flushing, Heart rate increased, Pyrexia
Clinical narrative: On the evening of November 24, 2003 client developed a fever of 102.6.  Initially noted clients faced flushed.  Complained of being cold.  No chills, or rash.  Physician called when fever 101.9.  Instructed by on call physician to administer Tylenol.  Client given Acetaminophen 1000mg.  Two hours after medicated, fever had increased to 102.6.  Called physician on call.  Continue to assess client.  If fever reached 103 client was to be seen in the Emergency Room at local hospital.  Other symptoms associated with fever increased respirations, B/P, and pulse rate.  Temperature when client was ready for sleep was 101.9.  Temperature in am 100.  Low grade fever of 99.4-99.8 until afternoon of November 25, 2003.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Respiratory rate increased
Clinical narrative: On the evening of November 24, 2003 client developed a fever of 102.6.  Initially noted clients faced flushed.  Complained of being cold.  No chills, or rash.  Physician called when fever 101.9.  Instructed by on call physician to administer Tylenol.  Client given Acetaminophen 1000mg.  Two hours after medicated, fever had increased to 102.6.  Called physician on call.  Continue to assess client.  If fever reached 103 client was to be seen in the Emergency Room at local hospital.  Other symptoms associated with fever increased respirations, B/P, and pulse rate.  Temperature when client was ready for sleep was 101.9.  Temperature in am 100.  Low grade fever of 99.4-99.8 until afternoon of November 25, 2003.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, chills, nausea, vomiting, malaise.
Age: 1.1
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: Patient came in to office today with light case of chicken pox.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Ecchymosis, Laboratory test abnormal, Purpura, Thrombocytopenic purpura
Clinical narrative: first, let me say I do not know if my problem definetly occured due to the Flu shot I received.  Until receiving this years Flu shot I had never before participated in the Flu vaccination program.  Approx. 3 weeks after the shot was administered I contracted ITP. Idiopathic Thrombocytopenic Purpura. My blood platelets were found to be extremely low. According to the Dr. they were at 4000. I spent 3 days in hospital until the Platelets were brought back up to normal capacity. One month prior to receiving the Flu shot my blood platelet count was at 230,000. While in the hospital, Gamma Globulin and Steroids were used to as treatment.                    Have asked Doctor to provide:  1. Name of Vaccine 2. Manufacturer 3. Lot Number 4. Date Flu shot given. The discharge summary received on 3/23/04 states bruises and purpura.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Convulsion, Salivary hypersecretion, Tremor, Urinary incontinence
Clinical narrative: Client received vaccine Hep A, Hep B & Td booster. Client passed out about 5 min after receiving vaccines. She started having a seizure, shaking, foaming @ the mouth & urinated on herself. O2 per face mask. Client transfered via ambulance to hospital.
Age: 60.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Difficulty in walking, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient was given a flu shot in the community. The onset of Guillain Barre Syndrome began the following day. Two weeks later, patient admitted to ICU and IVIG administered for two days. Patient improved.
Age: 60.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient was given a flu shot in the community. The onset of Guillain Barre Syndrome began the following day. Two weeks later, patient admitted to ICU and IVIG administered for two days. Patient improved.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV
Symptoms: Supraventricular tachycardia
Clinical narrative: It was reported that a 4 month old female pt received IPOL and ActHIB, and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and HEPATITIS B VACCINE and administration info not provided, two years ago. An unspecified amount of time later (reported as two years ago) the pt deveoped supraventricular tachycardia which lasted for four days. The pt reported that the supraventricular tachycardia is controlled today by medicine (unspecified). It was reported that the pt did not recover from these events. From additional information received on 20/Jan/2004 from Merck (WAES0401USA01072), it was reported that the event was reported by a health care professional and that the event of supraventricular tachycardia occurred in approximately December 2001. The supraventricular tachycardia was considered to be disabling. The patient has not recovered. No other information was reported. Follow up on 06/25/04 states: "From additional information received on 06/21/04 from the responsible physician, it was reported that the pt was not their health center pt. She was seen in another clinic by a different physician. The reporter that has been provided has no address or phone number available. No other information was provided. No further information is anticipated, this case is considered closed." Supraventricular tachycardia was considered to be disabling.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Eye pain, Headache, Injection site inflammation, Optic neuritis, Vision blurred
Clinical narrative: Strong pain in the eye from the front to the posterior part of the head.  Blurry vision, very strong pain.  Went to various specialists fo the eye and an MRI was done.  She was hospitalized for a great inflammation of the optic nerve.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Bradycardia, Cyanosis, Depressed level of consciousness, Encephalopathy
Clinical narrative: Patient was more lethargic after Hepatitis B vaccine given; trouble latching on to feed, sleeping more, found limp and cyanotic by parents. Unable to arouse but had weak heart rate at 60. Patient intubated and then on vent. Almost immediately extubated but unable to maintain respirations on his own. Increasing respiratory problems over next few days. Had to remain on ventilator. Patient with pooling of secretions. Patient became hypertolic. Hospital records received on 1/22/04 states acute life threatening event, metabolic acidosis , and encephalopathy. The hospital discharge summary received on 2/19/04 states GERD and chronic resp. failure.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Gastrointestinal disorder, Hypotonia, Lethargy, Metabolic acidosis, Respiratory distress
Clinical narrative: Patient was more lethargic after Hepatitis B vaccine given; trouble latching on to feed, sleeping more, found limp and cyanotic by parents. Unable to arouse but had weak heart rate at 60. Patient intubated and then on vent. Almost immediately extubated but unable to maintain respirations on his own. Increasing respiratory problems over next few days. Had to remain on ventilator. Patient with pooling of secretions. Patient became hypertolic. Hospital records received on 1/22/04 states acute life threatening event, metabolic acidosis , and encephalopathy. The hospital discharge summary received on 2/19/04 states GERD and chronic resp. failure.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Salivary hypersecretion, Somnolence
Clinical narrative: Patient was more lethargic after Hepatitis B vaccine given; trouble latching on to feed, sleeping more, found limp and cyanotic by parents. Unable to arouse but had weak heart rate at 60. Patient intubated and then on vent. Almost immediately extubated but unable to maintain respirations on his own. Increasing respiratory problems over next few days. Had to remain on ventilator. Patient with pooling of secretions. Patient became hypertolic. Hospital records received on 1/22/04 states acute life threatening event, metabolic acidosis , and encephalopathy. The hospital discharge summary received on 2/19/04 states GERD and chronic resp. failure.
Age: 1.2
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Cough, Dermatitis bullous, Infection, Laboratory test abnormal, Pneumonia
Clinical narrative: Admission history and physical for 8/28/03, sates that pt had a well-baby's visit on August and at which time he received his 1 year old shots. Presented today in the pediatric clinic with an increase cough and a four day history of 30-35 varicella lesions. The lesions on the trunk are crusted. Dx'ed varicella and probable varicella pneumonia.
Age: 1.2
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Admission history and physical for 8/28/03, sates that pt had a well-baby's visit on August and at which time he received his 1 year old shots. Presented today in the pediatric clinic with an increase cough and a four day history of 30-35 varicella lesions. The lesions on the trunk are crusted. Dx'ed varicella and probable varicella pneumonia.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema, Pain, Tenderness
Clinical narrative: Swelling, redness, tenderness, pain left axillary lymph nodes and spread to entire left pectoralis and upper left chest area. Developed initially 2 days after vaccine, progressed for 4 days.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral, Pain
Clinical narrative: Awoke with pain and swelling in arm 12-16 hours later.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Vomiting
Clinical narrative: Received vaccine in AM after night shift, slept. On waking, fell x2 due to dizziness (like room spinning). Subsided, then vomiting next day due to extreme dizziness (had to hold on to things to walk). Less severe as time passes. Taking Antivert and exercises prescribed by neurologist.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Decreased appetite, Dyspnoea, Irritability, Pyrexia, Urticaria
Clinical narrative: Mom reports infant had immunizations approx 3-4 PM at HD. Infant started getting fussy and had a low grade fever approx 10 AM. Mom reports by 2 PM infant had hives all over her body and difficulty with breathing so mom took infant to ER. Baby had temp of 101 and was vomiting. Baby was at ER 6 hours after 10 PM. Mom states baby got PO Benadryl and oral pedialyte. No IV. Mom states infant has been referred to a pediatric allergist on 3/8/04 to rule out egg allergy per mom. The medical record received on 2/2/04 states decreased appetite.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: Mom reports infant had immunizations approx 3-4 PM at HD. Infant started getting fussy and had a low grade fever approx 10 AM. Mom reports by 2 PM infant had hives all over her body and difficulty with breathing so mom took infant to ER. Baby had temp of 101 and was vomiting. Baby was at ER 6 hours after 10 PM. Mom states baby got PO Benadryl and oral pedialyte. No IV. Mom states infant has been referred to a pediatric allergist on 3/8/04 to rule out egg allergy per mom. The medical record received on 2/2/04 states decreased appetite.
Age: 41.0
Sex: F
Vaccine: ANTH
Symptoms: Shoulder pain
Clinical narrative: Pain in my shoulder since receiving my Anthrax shot #3. Pain if I try to lift my body with my arm or sleep on it in bed.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Urticaria following AVA #2
Age: 1.42
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site induration
Clinical narrative: 10 x 10cm area induration and erythema on left anterior thigh. Non-tender. No fever or systemic symptoms. Slight limp.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling, erythema, right thigh 2 x 1".
Age: 1.25
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Abnormal behaviour, Muscle twitching, Pyrexia
Clinical narrative: Fever developed shortly after receiving vaccine. Mother reports "spacey" behavior following by twitching of the arms.
Age: 0.83
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Oedema peripheral
Clinical narrative: Pt received DPT #2, IPV #2, HIB #2, Hep B #3, Prevnar #2 on 9/10/03. Left leg swollen with knot and red at injection site. Hib #2, Hep B #3 given in left leg.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Erythema, swelling, sore to touch left leg. Keflex given for cellulitis. Tylenol and war compress for comfort.
Age: 1.58
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Had WCE 1/7, developed temp 102 at 2 PM 1/7, increased to 104, irritable.
Age: 1.25
Sex: M
Vaccine: DTAPH, MMR, PNC
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever (T increase to 104) on 1/3. T ranged 101-104 1/4-1/6. 1/6 developed red raised rash on face which spread to all body parts over the next day. Seen in clinic on 1/7/04.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Mild varicella.
Age: 22.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Pallor
Clinical narrative: Donor stated feeling dizzy and faint within seconds of receiving tetanus shot. Pt appeared pale during reaction. Ice packs applied to neck region. About 200cc PO fluids given. Pt reported feeling better within 3-5 minutes.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Child had probable chickenpox, approx 8-9 spots, low grade temp, lasting 4-5 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: 6 x 5.5 urticaria reaction left thigh.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Induration, swelling and redness at injection site and asthmatic bronchitis requiring hospitalization.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hypersensitivity, Hypotension, Somnolence, Urticaria
Clinical narrative: Pt had completed his 5 year old well checkup on 1/9/04 about 4:30 PM, had his 5 year old shots and went home. But within about 15 minutes Mom called to report allergic reaction and returned at about 4:50 PM. Pt had hives, mild hypotension and somnolence. No wheeze or hypoxemla. Given 0.2mg Epi subcutaneous and responded well, within 1 hour, back to normal. No further reaction.
Age: 0.6
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: Mother states spit up feeding later on evening after injection.  Not vomiting, is taking fluids.  Both thighs, no swelling, no redness at site of injection.  NO fever.  Is drinking well, states did spit up 2 times after 1st time the following day.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Laboratory test abnormal, Lethargy, Pyrexia, Vomiting
Clinical narrative: Pt presented to ER with vomiting and fever (100.8), lethargic per mother.  Pt received Motrin and Tigan supp.  Pt return to ER later with focal seizure activity per mother.  MD to rule out febrile seizures vs MMR reaction.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pneumonia, Pyrexia, Skin discolouration
Clinical narrative: MD reported on 10/21/03 that pt got hepatitis A vaccine on 02/20/03, and PPD the same day.  9 hours later pt was found in car seat with his head hanging out with temperature 102.8F and black lips.  Pt was taken to ER.  Follow up on 02/27/03.  Pt was seen by MD on 10/20/03.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema multiforme, Pyrexia, Rash, Stevens-Johnson syndrome
Clinical narrative: A report was received from a health care professional on 1/8/04 concerning a 78 year old male vaccinee who developed a rash and fever and was diagnosed with Stevens Johnson Syndrome on 11/02/2003 and hospitalized on the same day, after receiving Fluvirin vaccine on 10/29/03. Concomitant medications included phenytoin, amlopidine besilate and lisinopril which were commenced two months prior to hospitalization. On 11/02/03, the vaccinee, who is a lung cancer patient, developed a rash, fever, and was admitted to hospital on the same day and diagnosed with Stevens Johnson Syndrome. Skin biopsy results of the left chest were determined to be consistent with erythema multiforme. The vaccinee also experienced erythema of the conjuctiva and erythema with palmar involvement. The vaccinnee was treated with topical and systemic corticosteroids. The vaccinee recovered and was discharged from hospital on approximately 11/11/03. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up on 04/29/04 states: "Further information was received from a health care professional indicating that the vaccinee experienced erythema multiforme and erythema with palmar involvement on 10/30/03.  On 11/03/03 the vaccineee underwent a skin biopsy on 0.4cm of a conical piece of skin of the left chest, which was consistent with erythema multiforme.  The epidermis revealed minimal spongiosis, necrotic keratinocies, exocytosis and focal vasuolar degeneration in the basal cell layer. On 10/29/03 the vaccinee visited a center and the attending physician reported that he had a superficial skin reaction on his scalp due to radiation therapy. The vaccinee has no known allergies. The vaccinee has a medical history of non-small cell lung cancer-metastatic lung adenocarcinoma with metastases in the brain and adrenal glands. A brain lesion was subsequently diagnosed in Sept 03. The vaccinee also has a  history of seizure, hypertension and coronary artery disease and underwent CABG surgery on an unspecified date. The vaccine had a radiation therapy with palliation of the brain metastasec from 10/03/03 -010/24/03.  Concomitant medication included phenytoin sodium for seizure, dexamathosone and bran metastases, simvastatin, acetylealicyclic acid for coronary artery disease and trazodone.  The vaccinee's dermatologist was consulted and he was treated with hydrocortisone cream to be administered twice a day to the face.  The vaccinee was also treated with an increase of dexamethalosone, dexamethssone eye drops and cefatolin. Phenytoin was discontinued. The reporter has assessed the relation ship of the vaccinee to the erythema multiforme with palmar involvement and fever as possible, although stating that the vaccinee was also taking phenytoin sodium at the time of the event. Follow up pending." Follow up on 05/17/04 states: "No new information at this time."
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Dyspnoea
Clinical narrative: "Difficulty breathing". Two 25mg Benadryl.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Coma, Irritability, Pyrexia
Clinical narrative: This case was reported by a lawyer and described the occurrence of death in a 34 day old female pt who received hep B vaccine recombinant (Engerix B). A physician or other health care professional has not verified this report. The pt's past medical history was notable for premature birth at 36 weeks gestation and a birth weight of 1.76 kilograms. The pt had no illnesses at the time of administration of Engerix B and was not receiving any concurrent medications. On 4/19/01, the pt received the first dose of Meningococcal polysaccharide vaccine. On 5/4/01, the pt received the first dose of Engerix B. On 5/5/01, the pt experienced fever and irritability and became unresponsive. She was taken to a hospital "where efforts to revive her were unsuccessful." The pt expired on 5/5/01, "within 24 hrs of receiving the vaccination." The cause of death was not reported. It is unknown whether an autopsy was performed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: From faxed correspondence received at AP Inc, on 09/26/02, it was reported that on 09/17/02 a 4 year old male child was vaccinated with Tripedia (Lot # U0549BA), IPOL (Lot # U1428), MMR (Merck), and Tubersol 5 TU (Lot # C0986AB). The next day pt developed injection site redness, swelling and tenderness.  Parent was advised to give Tylenol or Motrin and apply ice pack compresses to the area. It was not reported whether the pt recovered.  See case # U2002-00967, U2002-00969 and U2002-00970 with same reporter.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain
Clinical narrative: From initial correspondence received at manufacturer on 01/08/03, it was reported that a 5 year old female was vaccinated with Tripedia, Lot # U0848AA, given IM in the left deltoid on 01/05/03.  In the morning of the following day, pt experienced bright redness of left upper arm, a bright red patch that extended down her arm about 5-6 inches along with swelling.  Area felt warm and sore on 01/06/03. Pt had a stitch above eyebrow at the time of vaccination and is scheduled on 01/08/03 with her physician for removal of stitches.  Pt was not taking any other medication and has no previous medical history.  No diagnostic tests/laboratory data were done.  Pt recovery status is unknown.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Injection site inflammation
Clinical narrative: From telephone contact received at AP, Inc on 09/13/2002, it was reported that a 4 year old female vaccinated with IPOL (Lot # U0422) and Tripedia (Lot # U0549DA) on 09/04/02 in the left deltoid.  The pt developed inflammation and induration at the injection site.  She was evaluated by the physician and treated with motrin, benadryl and compresses.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: From initial information received on 05/09/03 from a RN regarding an adverse event occurring in USA, it was reported that a four year old male patient received a Tripedia vaccination, lot # U0851DA, administered IM in the left arm, an IPOL vaccination, Lot # W0704, administered SC in the right arm, and an MMR vaccination manufactured by Merck, Lot # 1015M, administered IM in the right arm on 05/06/03.  Sometime between 05/06/03 and 05/07/03, the pt developed swelling in the left arm with erythema and warmth 11 centimeters by six centimeters. The pt's recovery status was reported as "in process." The reporter of this case is the same reporter of cases 2003-01232 and 2003-01233.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Contusion, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: From initial information received on 06/05/03 from a health care professional, regarding an adverse event occurring in the US, it was reported that a 5 year old female pt received her sixth dose of Tripedia, Lot # U0850AA, given IM in the left arm on 05/13/03.  The following evening, approximately at 20:00, the parent stated that the pt's left arm became bruised, red, hot, hard and swollen. the swelling and induration occurred from the shoulder down to the elbow and most of the way around the arm.  The pt was taken to the ER on 05/15/2003 at 12:00 and placed on Augmentin and Benadryl for possible cellulitis. The pt had a follow-up visit with a private physician at 14:00.  A fever was denied. The pt was to continue with the antibiotics and have the size of the swelling monitored. the pt was taken to the ER again, on 05/17/03 to be evaluated for any improvements. The bruising and administration site were still noticable but the remainder of the symptoms had resolved, according to the follow-up made on 05/21/03.  This case is from the same facility as case: 2003-01053.
Age: 0.9
Sex: M
Vaccine: HIBV
Symptoms: Asthma, Bacterial infection, Conjunctivitis, Drug ineffective, Heart rate increased
Clinical narrative: Information regarding Haemophilus influenzae type B conjugate vaccine, was received from a published literature article. The article discusses that the elimination of Haemophilus influenzae type B disease may be achievable as a result of the use of Haemophilus influenzae type B vaccines since 1987. The authors specifically focus on 3 cases of Hib bacteremia over a 12 month period (October 1999-September 2000), providing insight into the kinds of cases that may still occur in the haemophilus influenzae type B vaccine era. Only 2 of the 3 patients mentioned had received the vaccination. This report concerns an 11 month old male, who was immunized with a Haemophilus influenzae type B conjugate vaccine at 3, 5 and 11 months of age (last dose was 6 days prior to admission), who developed haemophilus bacteremia and respiratory syncytial virus. The pt presented to a hospital in respiratory distress. Physical examination revealed a pulse of 217 beats/minute and temp of 39.7 deg C. Oxygen saturation was 73% on room air. Chest auscultation revealed wheezing and retractions were apparent. Bilateral conjunctival injection was present. A chest x-ray demonstrated bilateral parenchymal infiltrates with hyperinflation of the lung fields. A nasopharyngeal washing yielded respiratory syncytial virus (RSV) antigen. The child was hospitalized and treated with ceftriaxone and azithromycin. The next day, Haemophilus influenzae type B ausceptible to ampicillin, was isolated from a blood culture. Examination of cerebral spinal fluid (CSF) was normal. The pt was prescribed a 10-day course of ceftriaxone, and recovered without sequelae. The authors stated that this case was atypical because most reported cases of Haemophilus influenzae type B occur in children who have not been vaccinated. As was established with this child, the receipt of Haemophilus influenzae type B vaccine is not always sufficient to protect from bacteremia even after the third or fourth dose. The authors concluded that the occurrence of this case "suggests that despite an effective immunization program, the organism must still be circulating. If we are to achieve the goal of elimination of invasive Hib disease, additional strategies may be required." See related case(s): HQWYE238012JAN04. No additional info was available at the date of this report.
Age: 0.9
Sex: M
Vaccine: HIBV
Symptoms: Hypoventilation, Laboratory test abnormal, Pyrexia, Respiratory distress, Respiratory syncytial virus infection
Clinical narrative: Information regarding Haemophilus influenzae type B conjugate vaccine, was received from a published literature article. The article discusses that the elimination of Haemophilus influenzae type B disease may be achievable as a result of the use of Haemophilus influenzae type B vaccines since 1987. The authors specifically focus on 3 cases of Hib bacteremia over a 12 month period (October 1999-September 2000), providing insight into the kinds of cases that may still occur in the haemophilus influenzae type B vaccine era. Only 2 of the 3 patients mentioned had received the vaccination. This report concerns an 11 month old male, who was immunized with a Haemophilus influenzae type B conjugate vaccine at 3, 5 and 11 months of age (last dose was 6 days prior to admission), who developed haemophilus bacteremia and respiratory syncytial virus. The pt presented to a hospital in respiratory distress. Physical examination revealed a pulse of 217 beats/minute and temp of 39.7 deg C. Oxygen saturation was 73% on room air. Chest auscultation revealed wheezing and retractions were apparent. Bilateral conjunctival injection was present. A chest x-ray demonstrated bilateral parenchymal infiltrates with hyperinflation of the lung fields. A nasopharyngeal washing yielded respiratory syncytial virus (RSV) antigen. The child was hospitalized and treated with ceftriaxone and azithromycin. The next day, Haemophilus influenzae type B ausceptible to ampicillin, was isolated from a blood culture. Examination of cerebral spinal fluid (CSF) was normal. The pt was prescribed a 10-day course of ceftriaxone, and recovered without sequelae. The authors stated that this case was atypical because most reported cases of Haemophilus influenzae type B occur in children who have not been vaccinated. As was established with this child, the receipt of Haemophilus influenzae type B vaccine is not always sufficient to protect from bacteremia even after the third or fourth dose. The authors concluded that the occurrence of this case "suggests that despite an effective immunization program, the organism must still be circulating. If we are to achieve the goal of elimination of invasive Hib disease, additional strategies may be required." See related case(s): HQWYE238012JAN04. No additional info was available at the date of this report.
Age: 0.9
Sex: M
Vaccine: HIBV
Symptoms: Respiratory tract infection, Sepsis, Viral infection
Clinical narrative: Information regarding Haemophilus influenzae type B conjugate vaccine, was received from a published literature article. The article discusses that the elimination of Haemophilus influenzae type B disease may be achievable as a result of the use of Haemophilus influenzae type B vaccines since 1987. The authors specifically focus on 3 cases of Hib bacteremia over a 12 month period (October 1999-September 2000), providing insight into the kinds of cases that may still occur in the haemophilus influenzae type B vaccine era. Only 2 of the 3 patients mentioned had received the vaccination. This report concerns an 11 month old male, who was immunized with a Haemophilus influenzae type B conjugate vaccine at 3, 5 and 11 months of age (last dose was 6 days prior to admission), who developed haemophilus bacteremia and respiratory syncytial virus. The pt presented to a hospital in respiratory distress. Physical examination revealed a pulse of 217 beats/minute and temp of 39.7 deg C. Oxygen saturation was 73% on room air. Chest auscultation revealed wheezing and retractions were apparent. Bilateral conjunctival injection was present. A chest x-ray demonstrated bilateral parenchymal infiltrates with hyperinflation of the lung fields. A nasopharyngeal washing yielded respiratory syncytial virus (RSV) antigen. The child was hospitalized and treated with ceftriaxone and azithromycin. The next day, Haemophilus influenzae type B ausceptible to ampicillin, was isolated from a blood culture. Examination of cerebral spinal fluid (CSF) was normal. The pt was prescribed a 10-day course of ceftriaxone, and recovered without sequelae. The authors stated that this case was atypical because most reported cases of Haemophilus influenzae type B occur in children who have not been vaccinated. As was established with this child, the receipt of Haemophilus influenzae type B vaccine is not always sufficient to protect from bacteremia even after the third or fourth dose. The authors concluded that the occurrence of this case "suggests that despite an effective immunization program, the organism must still be circulating. If we are to achieve the goal of elimination of invasive Hib disease, additional strategies may be required." See related case(s): HQWYE238012JAN04. No additional info was available at the date of this report.