chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.2
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Musculoskeletal stiffness, Opisthotonus, Pyrexia, Staring, Viral infection
Clinical narrative: After his 12 month shots, he lost all language and all eye contact and could not respond to any noise or even waving in front of his face. He still has no language and no receptive response. He has some eye contact but does not respond or react to people but is getting a little better at times. Called 911 and EMS came. Called because he was very hot with temperature of 106F and then 104F after trying warm towel and bathing in small tub of water but didn't work out. At ER he arched his head all the way back, was stiff and eyes rolled and looked very bad. The dx in ER was viral syndrome (fever of unknown origin) and possible seizure.  Diagnosed with Global Developmental Delay.
Age: 41.0
Sex: F
Vaccine: LYME
Symptoms: Chills, Dizziness, Headache, Hypotension, Immune system disorder
Clinical narrative: Pt developed a vise-like headache, nausea, photosensitivity, hypotension, shaking rigors and dizziness. Symptoms persisted for 4 hours. Pt was given Benadryl X 2 doses in office. Dx'd with depressed immune system.
Age: 41.0
Sex: F
Vaccine: LYME
Symptoms: Nausea, Photosensitivity reaction, Tremor
Clinical narrative: Pt developed a vise-like headache, nausea, photosensitivity, hypotension, shaking rigors and dizziness. Symptoms persisted for 4 hours. Pt was given Benadryl X 2 doses in office. Dx'd with depressed immune system.
Age: 1.3
Sex: M
Vaccine: IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: 24 hours after receiving the injection the patient has an area of erythema and edema the size of a lemon. The tissue is firm at the sight.
Age: 1.0
Sex: F
Vaccine: HEP, PNC
Symptoms: Convulsion
Clinical narrative: Post vax the patient had a seizure that lasted approximately 1 minute. No known temperature recorded.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Apnoea, Dyspnoea, Pyrexia
Clinical narrative: Post vax, the patient had brief apnea, trouble breathing and a temperature of 103-104F.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion
Clinical narrative: The patient had two seizures in the car on the way home from the clinic approximately 35 minutes after receiving vaccine.
Age: 4.8
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Headache, Nasal congestion, Oedema peripheral, Pyrexia, Rash
Clinical narrative: Post vax, on 08/01/2001 the patient started with a fever of 103F. The patient was treated with Advil. The patient also had a headache and congestion. On 08/03/2001 the patient had swollen feet and a rash. The patient was referred to a MD. The next day the rash was gone and the child was OK.
Age: 0.4
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Mother states patient has fever of 104F. The pediatrician did blood work and the results are pending.
Age: 1.0
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: The patient's injection site on his left thigh began swelling and turning red around midnight. The redness and swelling covered an area approximately 1 1/2"-2" in diameter. A rash was also starting, worsening with a fever around midnight. The patient was seen in the ER.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Anxiety, Bacterial infection, Blood cholesterol increased, Depression, Fatigue
Clinical narrative: Reportedly, within one week of the vaccination, the patient experienced head throbbing and pressure. The patient stated that her physician told her that her symptoms were not related to the vaccination. In late June 2000, the patient reportedly received her second injection. The patient stated that the head throbbing and pressure were ongoing at the time the second injection was administered. One week after the second injection, her symptoms increased in severity and the patient began to experience ringing in her ears. The patient also reported that she began experiencing exhaustion, extreme anxiety, depression, hypertension and elevated cholesterol. The patient stated that her blood pressure increased from 120/70 to 190/100. The patient's primary physician prescribed an antihypertensive medication which she took for 1 to 2 months. Reportedly, after this treatment, the patient's blood pressure returned to normal and the medication was discontinued. The patient's cholesterol increased from 180 to 268. The patient was treated with Lipitor for approximately 2 months, after which her cholesterol returned to 180. The patient was also treated with Xanax, which reportedly had no effect. The patient was seen by an ear specialist who made a diagnosis of tinnitus. This specialist declined to treat the patient. The patient was seen by a nutritionist, who reportedly treated the patient with herbs. There was no effect on her symptoms. The patient was seen by a neurologist who prescribed Paxil. The patient was seen by a gynecologist who prescribed Loestrin, Xanax and an unspecified medication for bloating. These medications reportedly had no effect. The patient was seen by a psychiatrist, who increased the Paxil dosage. This medication change had no effect. The patient was then seen by a homeopath whose conclusion was "bacteria in the system and either Lyme disease or a reaction to Lymerix". The patient was treated by stopping all medications and starting vitamin supplements to "detox the system". The patient stated that she felt somewhat better within 2 weeks. The patient was then seen by an infection control physician who found she had symptoms of Lyme, but that it could not be proven. The patient then returned to her primary physician, who reportedly informed her that her symptoms were without a doubt a reaction to the vaccine. As of 10/04/2001, the patient stated that the head throbbing and pressure, tinnitus, exhaustion, anxiety, and depression persisted, but have been milder since treatment by the homeopathic physician. The elevated cholesterol and hypertension had resolved.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Headache, Hypertension, Tinnitus
Clinical narrative: Reportedly, within one week of the vaccination, the patient experienced head throbbing and pressure. The patient stated that her physician told her that her symptoms were not related to the vaccination. In late June 2000, the patient reportedly received her second injection. The patient stated that the head throbbing and pressure were ongoing at the time the second injection was administered. One week after the second injection, her symptoms increased in severity and the patient began to experience ringing in her ears. The patient also reported that she began experiencing exhaustion, extreme anxiety, depression, hypertension and elevated cholesterol. The patient stated that her blood pressure increased from 120/70 to 190/100. The patient's primary physician prescribed an antihypertensive medication which she took for 1 to 2 months. Reportedly, after this treatment, the patient's blood pressure returned to normal and the medication was discontinued. The patient's cholesterol increased from 180 to 268. The patient was treated with Lipitor for approximately 2 months, after which her cholesterol returned to 180. The patient was also treated with Xanax, which reportedly had no effect. The patient was seen by an ear specialist who made a diagnosis of tinnitus. This specialist declined to treat the patient. The patient was seen by a nutritionist, who reportedly treated the patient with herbs. There was no effect on her symptoms. The patient was seen by a neurologist who prescribed Paxil. The patient was seen by a gynecologist who prescribed Loestrin, Xanax and an unspecified medication for bloating. These medications reportedly had no effect. The patient was seen by a psychiatrist, who increased the Paxil dosage. This medication change had no effect. The patient was then seen by a homeopath whose conclusion was "bacteria in the system and either Lyme disease or a reaction to Lymerix". The patient was treated by stopping all medications and starting vitamin supplements to "detox the system". The patient stated that she felt somewhat better within 2 weeks. The patient was then seen by an infection control physician who found she had symptoms of Lyme, but that it could not be proven. The patient then returned to her primary physician, who reportedly informed her that her symptoms were without a doubt a reaction to the vaccine. As of 10/04/2001, the patient stated that the head throbbing and pressure, tinnitus, exhaustion, anxiety, and depression persisted, but have been milder since treatment by the homeopathic physician. The elevated cholesterol and hypertension had resolved.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: The patient experienced cramps and diarrhea within the first 24 hours after the vaccination, lasting approximately 48 hours.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Child developed local reaction to flu vaccine beginning the following morning after injection. Reaction site increased in size to "baseball" size on deltoid. No symptoms of abscess. Child brought to office on third day after injection.  Follow up 10/25/2001: "Child had no other vaccines at this visit.  No other vaccines in prevous 4 weeks, on no medication, no history of previous adverse events."
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: On 10/16/2001 vaccine given, originally no reaction noted. On 10/17/2001 about 1/2 inch localized pink area with edema and slightly warm to touch. Warm compress applied.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Oedema, Vasodilation procedure
Clinical narrative: On 10/16/2001 vaccine given, originally no reaction noted. On 10/17/2001 about 1/2 inch localized pink area with edema and slightly warm to touch. Warm compress applied.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Oedema, Vasodilation procedure
Clinical narrative: On 10/16/2001, vaccine given, no reaction. On 10/17/2001 had a one and one-half inch red, slightly swollen and slightly warm reaction. Instructed to take Benadryl and put warm compresses. Did not do. On 10/18/2001 red area increased to about 2.5 inches of redness and slightly warm to touch. Instructed again to take Benadryl.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema
Clinical narrative: Originally had no reaction given on 10/16/01. On 10/17/01, area became red, swollen, warmth n4" in diameter. On 10/18/01 decreased redness and warmth putting Benadryl cream on left arm.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Given vaccine left deltoid, c/o itchiness, then became red, approximately 3" area of edema and warm to touch on 10/17/01. Reaction increased in size, approximately 6" red area, swollen and warm. Put cool - warm compresses and took Benadryl. On 10/18/01 decreased redness and warmth.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Vasodilation procedure
Clinical narrative: Given vaccine left deltoid, c/o itchiness, then became red, approximately 3" area of edema and warm to touch on 10/17/01. Reaction increased in size, approximately 6" red area, swollen and warm. Put cool - warm compresses and took Benadryl. On 10/18/01 decreased redness and warmth.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Cramps. Diarrhea, within 24 hours and lasted about 2 to 5 days.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Paraesthesia
Clinical narrative: Influenza administered right arm; 2 inch radius around shot, red blotched and hot with touch. Arm all the way to hand tingles (next day at 1600).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Nausea, Vomiting
Clinical narrative: Pt developed nausea vomiting SOB within 24 hours of receiving influenza shot
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Myalgia
Clinical narrative: Pt got myalgia, fever 24 ph after vaccine. By noct am, edema, erythema and warmth at injection site.   by 4-5 days.
Age: 27.0
Sex: F
Vaccine: FLU3, TD, TYP, YF
Symptoms: Oedema peripheral
Clinical narrative: The pt described sensation of B/L finger swelling and shaking. No erythema, edema or bruising noted at injection site. Symptoms abated.
Age: 39.0
Sex: F
Vaccine: HEP, HEPA, IPV, TYP, YF
Symptoms: Pruritus, Urticaria
Clinical narrative: The pt's skin felt itchy all over the day after immunization, followed by scattered hives, which persisted into the second day post vax. When the client took Benadryl the discomfort was reduced and the client notified private provider.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The pt experienced redness, swelling from shoulder to fingers (about twice its normal size). This started approximately 1 day post vax lasting several days. Treated with hydrocortisone cream and elevation.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Post vax on 10/12/2001 the patient was feverish. The patient's left leg was red, indurated and sore. The pediatrician advised cold compresses, Tylenol, Advil and Benadryl. On 10/15/2001 the patient's leg is improved but still has a large hard area about 3" x 3".
Age: 1.0
Sex: M
Vaccine: DT, DTAP, HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash, Skin ulcer
Clinical narrative: Two days post vax, the patient developed a full body rash. The rash was bright pink with distinct lesions. The patient's mother reports the patient had a fever for 4 days.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Post vax on 07/19/2001 the patient experienced pain in her left arm. By 07/20/2001 the patient was unable to lift her arm above should level. There is no local redness or swelling. The patient has been seen by a chiropractor 6-7 times since August. The patient is being treated with exercises and heat. The patient feels the arm is worsening.
Age: 1.0
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Clumsiness, Vomiting
Clinical narrative: One month post vax the patient developed protracted emesis. There was no fever or rash. The patient became atoxic (clumsy) 3 days later. There was no evidence of Otitis Media when seen by the ENT. Symptoms resolved 09/30/2001 per mother.
Age: 1.3
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Nine days post vax, the patient developed a macular red rash. The rash has persisted for 3 days.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Contusion, Injection site swelling, Injection site warmth
Clinical narrative: Post vax the patient's left upper arm above the elbow is swollen and hot the touch. The area is starting to appear bruised. The patient is being treated with Tequin.
Age: 46.0
Sex: F
Vaccine: MMR, RAB
Symptoms: Eye swelling, Nasal congestion, Pruritus, Pyrexia, Rash
Clinical narrative: Post vax the patient developed itching with skin eruptions, hives, congestion, a temp of 100.1, swelling lips and swelling eyes. The patient was treated with Vistaril, SoluMedrol, Atarax, and Prednisone.
Age: 46.0
Sex: F
Vaccine: MMR, RAB
Symptoms: Swelling face, Urticaria
Clinical narrative: Post vax the patient developed itching with skin eruptions, hives, congestion, a temp of 100.1, swelling lips and swelling eyes. The patient was treated with Vistaril, SoluMedrol, Atarax, and Prednisone.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Post vax the patient had a severe local reaction, with swelling, erythematous, tender upper arm approximately 10x20cm. The patient was treated with diphenhydramine and NSAIDS.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Post vax, the patient complained of redness and soreness around the injection site.
Age: 6.0
Sex: F
Vaccine: DTAP, HBPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The patient was diagnosed with chickenpox on 10/15/2001. The patient received vaccine on 11/26/1996.
Age: 7.0
Sex: M
Vaccine: DTAP, OPV, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: On 10/11/2001 50 pox were noted on various body parts.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Feeling hot
Clinical narrative: The patient's left leg developed a large erythema area, warm to the touch due to vaccination.
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Rash maculo-papular
Clinical narrative: On 10/10 a rash was noted on the patient. On 10/11/2001 the rash increased with itchy eyes. The patient was treated with Benadryl. The patient was seen in the office which revealed red macular papular lesions on the face and trunk. On 10/12/2001 the rash was improved.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: The patient experienced generalized urticaria and pruritis for a 2 week period.
Age: 41.0
Sex: F
Vaccine: PNC
Symptoms: Injection site pain, Pyrexia, Urticaria
Clinical narrative: The patient experienced severe arm pain, hives and a fever one day after immunization, worsening the next day. The patient was treated with Medrol dose pack, Benadryl, Tylenol and cool compresses.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Application site reaction, Cellulitis, Injection site reaction
Clinical narrative: Patient complained via telephone on 08/30/2001, of a "large local reaction". The patient was advised to treat with an ice pack. The patient went to the ER on 09/02/2001 and was diagnosed with cellulitis. Augmentin was prescribed.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Arthritis, Joint swelling
Clinical narrative: The patient developed bilateral ankle effusions/arthritis, 2 days after vaccination.
Age: 55.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth, Musculoskeletal stiffness, Pruritus
Clinical narrative: The patient states his left arm started itching last night, then reddened and was warm. The patient's left arm now feels stiff.
Age: 19.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Dizziness
Clinical narrative: The patient complained of a "woozy feeling". When examined there were no signs of an allergic reaction. The "woozy feeling" abated with no treatment necessary.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Orchitis, Swelling, Tenderness
Clinical narrative: Post vax the patient experienced scrotal swelling and tenderness, possible orchitis.
Age: 1.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Pyrexia, Subcutaneous nodule
Clinical narrative: On 10/10/2001 the patient developed a low grade fever with inguinal nodes. On 10/11/2001 follow up by phone, the patient is doing better, the fever is down, but the patient still has inguinal nodes.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abnormal behaviour, Aggression
Clinical narrative: Three hours post vax, the patient began not focusing at preschool, not listening, standing up and throwing chairs, screaming, and running around the room yelling.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles, Otitis media
Clinical narrative: A few days after receiving vaccination, the patient's mother noted a small area of redness and vesicles around the injection site. When examined in office, the patient had a 2" area of erythema, indurated, tender with papules. The patient also had otitis media. The patient was treated with Bactroban and Benadryl.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: A few days after receiving vaccination, the patient's mother noted a small area of redness and vesicles around the injection site. When examined in office, the patient had a 2" area of erythema, indurated, tender with papules. The patient also had otitis media. The patient was treated with Bactroban and Benadryl.
Age: 0.2
Sex: M
Vaccine: HEPA, DTAP, HEP, HIBV, MMR, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: A nurse reported that a 2 month old infant received an injection of Prevnar (1st dose). Approx. 30 minutes, post vax, the pt experienced anaphylactic shock. The infant was hospitalized and placed on a respirator. The reporter did indicate that the infant also received "other routine childhood immunizations at the same visit"; however, they were not specified. No further information was available at the time of this report. F/U information received on 10/26/01, from the reporter, indicated that the infant was a 2 month old male who received his 2nd doses of Prevnar, Hib-Titer, DTAP, IPV and Hep-B vaccines on 10/10/01. Within a "few" minutes after immunization, the infant became lethargic and apneic. He was seen in an ER and subsequently hospitalized. A blood culture "found evidence of 2 viruses, including paravirus". The reported stated that "it is felt that this was the cause of the reaction". The infant also experienced his 1st injections of Prevnar, Hib-Titer, DTAP, IPV and Hep-B vaccines on 9/20/01. Information regarding this event has been forwarded to the manufacturer of the IPB vaccine. Additional FOLLOW-UP information receivedon 11/05/2001 indicated that the infant received his second dose of Prevnar, along with IPV, Infanrix, and Act Hib vaccines on 10/10/2001 FOLLOW-UP information received on 12/04/2001 from the physician indicated that the infant experienced the events approximately 3 to 4 hours post-vaccination. The infant recovered.
Age: 0.2
Sex: M
Vaccine: HEPA, DTAP, HEP, HIBV, MMR, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Vomiting
Clinical narrative: A nurse reported that a 2 month old infant received an injection of Prevnar (1st dose). Approx. 30 minutes, post vax, the pt experienced anaphylactic shock. The infant was hospitalized and placed on a respirator. The reporter did indicate that the infant also received "other routine childhood immunizations at the same visit"; however, they were not specified. No further information was available at the time of this report. F/U information received on 10/26/01, from the reporter, indicated that the infant was a 2 month old male who received his 2nd doses of Prevnar, Hib-Titer, DTAP, IPV and Hep-B vaccines on 10/10/01. Within a "few" minutes after immunization, the infant became lethargic and apneic. He was seen in an ER and subsequently hospitalized. A blood culture "found evidence of 2 viruses, including paravirus". The reported stated that "it is felt that this was the cause of the reaction". The infant also experienced his 1st injections of Prevnar, Hib-Titer, DTAP, IPV and Hep-B vaccines on 9/20/01. Information regarding this event has been forwarded to the manufacturer of the IPB vaccine. Additional FOLLOW-UP information receivedon 11/05/2001 indicated that the infant received his second dose of Prevnar, along with IPV, Infanrix, and Act Hib vaccines on 10/10/2001 FOLLOW-UP information received on 12/04/2001 from the physician indicated that the infant experienced the events approximately 3 to 4 hours post-vaccination. The infant recovered.
Age: 0.2
Sex: M
Vaccine: HEPA, DTAP, HEP, HIBV, MMR, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Anaphylactic shock, Apnoea, Hypoxia, Lethargy, Viral infection
Clinical narrative: A nurse reported that a 2 month old infant received an injection of Prevnar (1st dose). Approx. 30 minutes, post vax, the pt experienced anaphylactic shock. The infant was hospitalized and placed on a respirator. The reporter did indicate that the infant also received "other routine childhood immunizations at the same visit"; however, they were not specified. No further information was available at the time of this report. F/U information received on 10/26/01, from the reporter, indicated that the infant was a 2 month old male who received his 2nd doses of Prevnar, Hib-Titer, DTAP, IPV and Hep-B vaccines on 10/10/01. Within a "few" minutes after immunization, the infant became lethargic and apneic. He was seen in an ER and subsequently hospitalized. A blood culture "found evidence of 2 viruses, including paravirus". The reported stated that "it is felt that this was the cause of the reaction". The infant also experienced his 1st injections of Prevnar, Hib-Titer, DTAP, IPV and Hep-B vaccines on 9/20/01. Information regarding this event has been forwarded to the manufacturer of the IPB vaccine. Additional FOLLOW-UP information receivedon 11/05/2001 indicated that the infant received his second dose of Prevnar, along with IPV, Infanrix, and Act Hib vaccines on 10/10/2001 FOLLOW-UP information received on 12/04/2001 from the physician indicated that the infant experienced the events approximately 3 to 4 hours post-vaccination. The infant recovered.
Age: 5.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Brain oedema, Headache, Hernia, Lethargy, Pyrexia
Clinical narrative: MMR #2 given on 8/8/01. The pt died on 8/18/01. I do not have the medical records to reconstruct the course of events leading up to her death.
Age: 5.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Viral infection
Clinical narrative: MMR #2 given on 8/8/01. The pt died on 8/18/01. I do not have the medical records to reconstruct the course of events leading up to her death.
Age: 5.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Headache, Hernia, Lethargy, Pyrexia
Clinical narrative: MMR #2 given on 8/8/01. The pt died on 8/18/01. I do not have the medical records to reconstruct the course of events leading up to her death.
Age: 5.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Unevaluable event
Clinical narrative: MMR #2 given on 8/8/01. The pt died on 8/18/01. I do not have the medical records to reconstruct the course of events leading up to her death.
Age: 0.18
Sex: F
Vaccine: DTAP, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion
Clinical narrative: On 9/25/01, the pt's grandmother called stating that infant had received her 1st set of shots on 9/19/01 and had a seizure on 9/20/01. She was admitted to the hospital on 9/20/01 and then transferred to another medical center on 9/22/01 and was admitted for tests. The infant was discharged on phenobarbital.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Apnoea, Feeling abnormal, Tremor
Clinical narrative: A few hours after receiving vaccines the patient had an episode of apnea with pallor and shaking of 15-30 seconds. The patient seemed "out of it".
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Apnoea, Malaise, Pallor, Tremor
Clinical narrative: A few hours after receiving vaccines the patient had an episode of apnea with pallor and shaking of 15-30 seconds. The patient seemed "out of it".
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Apnoea, Diarrhoea, Fatigue, Meningitis, Mouth haemorrhage
Clinical narrative: Unsure if related to vaccines. Mother reports fever, being more tired than usual and 3 or 4 episodes of diarrhea on 10/16/01. Dad checked on infant in evening and found him not breathing and noticed blood from mouth. Mother was at work. Infant was alone in parents bed. COD as per autopsy report: Lymphoplasmacytic Meningitis.
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Unsure if related to vaccines. Mother reports fever, being more tired than usual and 3 or 4 episodes of diarrhea on 10/16/01. Dad checked on infant in evening and found him not breathing and noticed blood from mouth. Mother was at work. Infant was alone in parents bed. COD as per autopsy report: Lymphoplasmacytic Meningitis.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Bacterial infection, Laboratory test abnormal, Nausea, Vomiting
Clinical narrative: Information has been received concerning a 30 year old white wife who on 7/2/00 was vaccinated with 1 dose of varicella virus vaccine live (site unknown). On 9/6/00, it was confirmed that she is 9 1/2 weeks pregnant (LMP: 7/5/00). Follow-up information from the consumer noted that the pt had the baby on 4/8/01. Additional information received from the consumer noted that the pt had been tested for varicella antibodies before vaccination in 2000 and the results were negative. In approx. 9/00, the pt developed nausea and was started on therapy with metoclopramide hydrochloride (Reglan) 10mg, the number of doses taken was noted to be "at first 5 and then 2". The metoclopramide hydrochloride (Reglan) was stopped on 4/8/01. On an unknown date, the pt had a positive test for alpha fetoprotein. At "around 20 weeks" the pt had the amniocentesis done that was normal. The amniocentesis was performed because the pt had the positive alpha fetoprotein test and then had the test retaken and had a negative test result. It was noted that the pt delivered pre-term at less than 37 weeks gestation on 4/8/01, a normal male weighing 4 lbs and 11.6 oz. The pt did not have any complications during labor/delivery and there were no concurrent medical conditions. The pt did not have a local reaction at the vaccination site and there were no symptoms of varicella or herpes zoster. Follow-up information from the pt's medical records noted that the pt was hospitalized twice for hyperemesis and treatment with unspecified medications (dates not specified). The pt's LMP was noted to be 7/23/00 (previously reported as 7/5/00) with an EDD of 4/30/01. On 2/26/01 and 3/12/01 it was noted that the pt was "doing well". It was noted on an unspecified date, that the pt was to start "NST" regarding an increased alpha fetoprotein test early in pregnancy. No further information is available. A follow up report received 12/27/2001 adds: Follow-up info from an office manager in a physician's office stated that their records do not indicate that the pt received (varicella virus vaccine live) under their care but it had been reported by another physician earlier in the pregnancy as the pt transferred to this office late in the pregnancy. It was confirmed that the hyperemesis had resolved as the pt had delivered. No further info is available.
Sex: F
Vaccine: DTP, IPV, PNC
Symptoms: Laboratory test abnormal, Pneumonia
Clinical narrative: A physician reported that a female child received Prevnar vaccine and subsequently, developed a positive blood culture. Additional vaccines received included DTP and Poliomyelitis vaccine inactivated. The child was admitted to the hospital. The physician stated that the child was treated with an injection of ceftriaxone sodium (Rocephin) in their office. No additional information was available as of the date of this report.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Cyanosis, Eye movement disorder, Febrile convulsion, Hypotonia, Staring
Clinical narrative: This information was received from a consumer concerning his 13 month old son who was vaccinated with a dose of MMRII, IM, on an unspecified date. On 9/7/01, the child's father alleged that the following events were associated with the use of ibuprofen (Children's Motrin). On an unspecified date, 4 minutes after the ibuprofen was given for fever of 104.3F, his son sat up in his crib, began staring blankly and his eyes rolled back and to the right. The father reported that his son was not convulsing and that he rushed the child to the closest medical facility, while reporting the events to the physician, the child remained in a trance, lifeless and developed cyanosis of the lips, genitals and extremities. The child was immediately treated with oxygen, turned pink and began crying. The father reported that no additional treatment was given and the child was discharged after being stabilized, once the fever improved. According to the parent's report, the physician attributed the event (75%) to a ibuprofen allergy and (25%) to the fever. The following day, the child was taken to the doctor, who reportedly believed that the event was a delayed reaction to vaccination with MMRII, received 3 weeks prior, since there was no increase in his WBC. The child was also taken to a neurologist who performed an EEG and could not attribute the event to ibuprofen or MMRII. The father reported that the neurologist classified the event as a febrile seizure. Subsequently, the pt recovered. Febrile seizure and cyanosis were considered to be "Other Important Medical Events". Additional information is not expected.
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Drooling, Eye movement disorder, Febrile convulsion, Hypotonia, Nasal congestion
Clinical narrative: Information has been received from a health professional concerning a 17 month old female who on 9/26/01 was vaccinated with a dose of MMRII (lot 639621/0899L). On 10/4/01, the pt developed a fever of 103.4F, followed by a febrile seizure. The child was taken to the ER. It was reported that she also had "increased respirations, wheezing and congestion, dx'd as secondary to fever". She had a 2nd febrile seizure in the ER. The child was treated with Rocephin. She was admitted to the hospital for less than 24 hours and was discharged on the afternoon of 10/5/01. That day, the pt's mother reported to the doctor's office that the child was "doing well". Additional information has been requested. F/U information received on 11/15/01, from an MA indicated that the vaccination was the pt's 1st dose and that the dose had been administered SC, in the left arm. It was reported that the adverse event onset date was 10/3/01 (also reported as 10/4/01). On 10/4/01, the pt's mother called into the physician's office thinking that the pt had respiratory syncytial virus (RSV). She reported that the pt's sibling had RSV. The pt's mother reported that the child was resting comfortably but in the car, the pt's eyes rolled back, she drooled, her body went limp and she had no body jerks. Medical records received indicated that on 10/4/01, the pt experienced contractions and had a respiratory rate of 40 when asleep. It was reported that the pt's temperature was 103-104F. The pt was treated at an urgent care facility. Motrin was administered and it was reported that the pt improved. A physician reported that the pt's CBC was 12K and that the blood cultures were pending. No distress was noted and a respiratory rate of 30 was recorded. The pt was given Rocephin IM and sent home. The pt was scheduled for a follow-up visit. On 10/5/01, it was reported that the pt was admitted to the hospital on 10/4/01 where a fever of 103.4F was noted. Another seizure occurred while the pt was hospitalized. It was noted that the pt's dx of high fever was secondary to the therapy with MMRII. It was reported that the pt had received a 2nd injection of Rocephin and that her fever decreased, she was alert and she had a normal respiratory rate. It was noted that the pt was to be transferred. It was reported that the pt's experience was resolving on 10/5/01 and that she recovered from her experience on an unspecified date. No further information is available.
Age: 1.4
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Respiratory rate increased, Wheezing
Clinical narrative: Information has been received from a health professional concerning a 17 month old female who on 9/26/01 was vaccinated with a dose of MMRII (lot 639621/0899L). On 10/4/01, the pt developed a fever of 103.4F, followed by a febrile seizure. The child was taken to the ER. It was reported that she also had "increased respirations, wheezing and congestion, dx'd as secondary to fever". She had a 2nd febrile seizure in the ER. The child was treated with Rocephin. She was admitted to the hospital for less than 24 hours and was discharged on the afternoon of 10/5/01. That day, the pt's mother reported to the doctor's office that the child was "doing well". Additional information has been requested. F/U information received on 11/15/01, from an MA indicated that the vaccination was the pt's 1st dose and that the dose had been administered SC, in the left arm. It was reported that the adverse event onset date was 10/3/01 (also reported as 10/4/01). On 10/4/01, the pt's mother called into the physician's office thinking that the pt had respiratory syncytial virus (RSV). She reported that the pt's sibling had RSV. The pt's mother reported that the child was resting comfortably but in the car, the pt's eyes rolled back, she drooled, her body went limp and she had no body jerks. Medical records received indicated that on 10/4/01, the pt experienced contractions and had a respiratory rate of 40 when asleep. It was reported that the pt's temperature was 103-104F. The pt was treated at an urgent care facility. Motrin was administered and it was reported that the pt improved. A physician reported that the pt's CBC was 12K and that the blood cultures were pending. No distress was noted and a respiratory rate of 30 was recorded. The pt was given Rocephin IM and sent home. The pt was scheduled for a follow-up visit. On 10/5/01, it was reported that the pt was admitted to the hospital on 10/4/01 where a fever of 103.4F was noted. Another seizure occurred while the pt was hospitalized. It was noted that the pt's dx of high fever was secondary to the therapy with MMRII. It was reported that the pt had received a 2nd injection of Rocephin and that her fever decreased, she was alert and she had a normal respiratory rate. It was noted that the pt was to be transferred. It was reported that the pt's experience was resolving on 10/5/01 and that she recovered from her experience on an unspecified date. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a male pt who was vaccinated with Hep-B vaccine recombinant (yeast) and experienced autism. Unspecified medical attention was sought. No further information was provided. Upon internal review Autism was considered an "Other Important Medical Event". Additional information has been requested.
Age: 4.5
Sex: F
Vaccine: DT, HEP, HIBV, MMR, VARCEL
Symptoms: Bacterial infection, Cellulitis, Injection site erythema, Injection site swelling, Lymphopenia
Clinical narrative: Pt developed left arm cellulitis that needed hospital admission with IV antibiotics, 2 days after vaccine administration. The pt had redness and swelling of left upper arm 1 day, post vax. Pt was treated with IV nafcillin on admission. Cefuroxine added to regimen after swelling was noted to increase on 10/15/01. Surgery consult was obtained; nafcillin discontinued; IV clindamycin and vancomysin started with gradual decrease in swelling and erythema with peeling of areas in left upper arm. Seen by Dermatologist on 10/16/01.
Age: 4.5
Sex: F
Vaccine: DT, HEP, HIBV, MMR, VARCEL
Symptoms: Skin exfoliation, Toxic epidermal necrolysis, White blood cell count increased
Clinical narrative: Pt developed left arm cellulitis that needed hospital admission with IV antibiotics, 2 days after vaccine administration. The pt had redness and swelling of left upper arm 1 day, post vax. Pt was treated with IV nafcillin on admission. Cefuroxine added to regimen after swelling was noted to increase on 10/15/01. Surgery consult was obtained; nafcillin discontinued; IV clindamycin and vancomysin started with gradual decrease in swelling and erythema with peeling of areas in left upper arm. Seen by Dermatologist on 10/16/01.
Age: 15.0
Sex: M
Vaccine: HEP, IPV, MMR, HEP, IPV, MMR
Symptoms: Petechiae
Clinical narrative: Pt developed petechiae on buccal mucosa, trunk and extremities. Referred to ER for evaluation.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema multiforme, Laboratory test abnormal
Clinical narrative: Pt presented on 9/24/01 with erythema multiforme. He was admitted to the hospital on 9/25/01 and placed on IV Solu-Medrol. He was discharged home on 9/27/01 with no rash.
Age: 0.1
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash
Clinical narrative: Two days post vax, the patient developed a reddish brown sandpaper-like rash on bilateral anterior thighs. The patient had no other problems and the rash did not seem to bother him.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Abnormal behaviour, Pyrexia
Clinical narrative: Mother states rectal temp of patient at home is 103F. The patient's temp at the dr's office is 100.8F. The patient's mother states the patient was "acting funny" after getting immunizations. The patient was sent to the hospital for lab work. Over the counter meds were used to reduce the fever.
Age: 1.6
Sex: M
Vaccine: DTAP, PNC
Symptoms: Urticaria
Clinical narrative: Post vax the patient broke out with hives on his arms, chest and back. The patient was treated with epinephrine.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Agitation, Irritability
Clinical narrative: Post vax the patient was unconsolable, crying, and irritable for approximately 4 hours.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Dyskinesia, Irritability
Clinical narrative: The day after vaccination the patient was irritable with myoclonic jerks. The patient was treated with Tylenol and Phenobarbitol.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Injection site rash
Clinical narrative: The patient was seen in the Urgent Care Dept for a rash at the injection site. The patient still had the rash 4 months after the injection, but much less severe. No treatment was received.
Age: 0.5
Sex: F
Vaccine: DTAP, HBPV, PNC
Symptoms: Cold sweat, Coma, Convulsion
Clinical narrative: The patient had a possible seizure. The patient's mother states the child is unresponsive with cool clammy skin.
Age: 0.1
Sex: F
Vaccine: DTAP, HBPV, IPV, PNC
Symptoms: Agitation, Coma, Opisthotonus, Screaming, Somnolence
Clinical narrative: Post vax the patient was unconsolable, screaming for 2-2 1/2 hours then arching, unresponsive, staring for 20 minutes than asleep for 6 hours. Then back to her previous good state of health.
Age: 0.1
Sex: F
Vaccine: DTAP, HBPV, IPV, PNC
Symptoms: Staring
Clinical narrative: Post vax the patient was unconsolable, screaming for 2-2 1/2 hours then arching, unresponsive, staring for 20 minutes than asleep for 6 hours. Then back to her previous good state of health.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Post vax, the patient developed a hive type rash, mainly on his arms and a little on his legs. The patient was treated with Benadryl.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Pt developed pain, redness and heat that measured 4 1/2" by 3 1/2", at the injection site. Pt was given Diprolene cream to help with itching.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Diarrhoea, Fatigue, Headache
Clinical narrative: Employee called on 10/15/01 to report that at 23:00 that evening, post vax, he developed a headache, lower back and knee "joint" pain. The following day, pot vax, on 10/10/01, he had a low-grade fever of 100F, muscle aches, felt very fatigued and experienced diarrhea. On 10/11/01, muscle aches improved, no diarrhea but had malaise. He took 1000mg Tylenol. On 10/12/01, myalgia was gone, had no diarrhea, no fever but felt tired. On 10/13/01, he felt fine.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Employee called on 10/15/01 to report that at 23:00 that evening, post vax, he developed a headache, lower back and knee "joint" pain. The following day, pot vax, on 10/10/01, he had a low-grade fever of 100F, muscle aches, felt very fatigued and experienced diarrhea. On 10/11/01, muscle aches improved, no diarrhea but had malaise. He took 1000mg Tylenol. On 10/12/01, myalgia was gone, had no diarrhea, no fever but felt tired. On 10/13/01, he felt fine.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood pressure increased, Headache, Hypoventilation, Injection site pain
Clinical narrative: Reported to Employee Health office at 12:45, indicating that she did not "feel well" since receiving the flu shot this morning. Complained of onset of "headache" and pain in the right side of her neck radiating down her back. She rated pain as a "5" on pain scale of 0-10. BP-120/72; P-70; R-16; temperature 98.2F. Injection given in left deltoid. There was no redness, swelling or warmth although she reports it does feel "sore". Physician notified and she was given Motrin 400mg po at 12:55. On 10/18/01, no further complaints, it was resolved.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Reported to Employee Health office at 12:45, indicating that she did not "feel well" since receiving the flu shot this morning. Complained of onset of "headache" and pain in the right side of her neck radiating down her back. She rated pain as a "5" on pain scale of 0-10. BP-120/72; P-70; R-16; temperature 98.2F. Injection given in left deltoid. There was no redness, swelling or warmth although she reports it does feel "sore". Physician notified and she was given Motrin 400mg po at 12:55. On 10/18/01, no further complaints, it was resolved.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Swelling face
Clinical narrative: Swollen upper lip, edema and redness at injection site. 6X10 cus. A follow up report received 11/01/2001 adds: Reporter gave additional time line info; pt seen at local ER on 10/14/01 where she was given Decadron and Depomedrol; she was checked in the office on the 15th with some improvement. Office personnel saw her in passing today and she looks well.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema
Clinical narrative: Local redness and edema at site of injection. A follow up report received 10/25/2001 adds: Reporter states Pt was treated with Augmentin and problem cleared within a few days.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site swelling
Clinical narrative: Left arm with raised area at ? site injection below bruised in about a 12 inch area running down arm also yellowish area.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Insomnia, Pain
Clinical narrative: Symptoms started 13:30 PM, unable to raise right arm. Swollen right arm. Aching on back on right arm. When arrived home after work applied ice. Then went to heat during night. Unable to sleep, taking Advil, rated pain as 9 on scale 1 to 10. Advil doesn't relieve pain. Advised to check with her doctor. 10/17/01, spoke with pt, she did not go to doctor. Pain decreased with ice, heat, Aleve, back at work. A follow up report received 10/25/2001 adds: Pt was very clear she had much improved overnight when reporter had called day after injection given.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Reported onset of headache about 10-15 minutes after injection given. Also complained of arm "aching" and pain down right arm. Rated pain as a "5" on pain scale of 0 to 10. Took 2 Motrin around 9 am which has helped the headache and sore arm. Right deltoid area with swelling, redness and warmth. Physician follow up call "no headache, arm just sore", but better.
Age: 10.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Post vax, the patient developed pain, itching, swelling and heat at the injection site. The patient had vesicles, numerous clumps, at the injection site. The patient had a fever off and on and complained of over all body aches and pains and nausea.
Age: 10.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Nausea, Pain, Pruritus, Pyrexia
Clinical narrative: Post vax, the patient developed pain, itching, swelling and heat at the injection site. The patient had vesicles, numerous clumps, at the injection site. The patient had a fever off and on and complained of over all body aches and pains and nausea.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Post vax, the patient developed swelling and erythema of the left deltoid region approximately 3"x3" in size.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Fatigue, Pruritus
Clinical narrative: Post vax, on 10/09/2001 the patient broke out with 50 pox. By 10/15/2001 she had 150 pox. The patient complained of being tired and itchy. No other symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: The patient developed swelling to the left upper arm after vaccination. The mother used a cool compress and Tylenol as directed.