chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Rash, Serum sickness
Clinical narrative: Serum sickness syndrome; rash with pruritus and some swelling in hands. We identified this reaction through retro-spectrum chart review as part of the hospital's program. It may have already been reported to you. Also diagnosed with tinea pedis, Neutropenia, lymphocytopenia, Eosinophilia, anemia
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Admitted to hospital on 12/6/00 with cellulitis to left arm which was red and swollen with tenderness.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blood creatinine increased, Blood urea increased, Bone disorder, CSF test abnormal
Clinical narrative: Guillain-Barre Syndrome and later developed acute renal failure; started as pain in feet and legs. Admitted to the hospital on 12/26/00. Received IVIG  and IV contrast which may be related to acute renal failure. Per F/U 5/1/01: BP 220/100. During her stay in the hospital, she gradually became weak and worse. Attempts to insert an IV line were made, but it was unsuccessful anf for this reason, we had asked MD to see her to insert a Port-A-Cath which was performed on 12/27/00. The pt was then given 8mg of Globulin, immunogloblin, 17 grams daily for 5 days over 16 hours. However, this was discontinued on 12/30/00 after 4 dosages, after she developed an elevated BUN and creatininie who had a history of was felt to be secondary to the immunoglobulin. Because of this, we had asked MD to see her who then started her on short-term dialysis. Slowly and gradually the rhythm failure improved. She remained stable and was then transferred to the skilled nursing facility on 1/16/01. Impression: Guillain-Barre syndrome, improving; Acute renal failure, transient secondary to the immunoglobulin therapy; hypertension.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Hypertension, Lung disorder, Nuclear magnetic resonance imaging brain abnormal, Pain
Clinical narrative: Guillain-Barre Syndrome and later developed acute renal failure; started as pain in feet and legs. Admitted to the hospital on 12/26/00. Received IVIG  and IV contrast which may be related to acute renal failure. Per F/U 5/1/01: BP 220/100. During her stay in the hospital, she gradually became weak and worse. Attempts to insert an IV line were made, but it was unsuccessful anf for this reason, we had asked MD to see her to insert a Port-A-Cath which was performed on 12/27/00. The pt was then given 8mg of Globulin, immunogloblin, 17 grams daily for 5 days over 16 hours. However, this was discontinued on 12/30/00 after 4 dosages, after she developed an elevated BUN and creatininie who had a history of was felt to be secondary to the immunoglobulin. Because of this, we had asked MD to see her who then started her on short-term dialysis. Slowly and gradually the rhythm failure improved. She remained stable and was then transferred to the skilled nursing facility on 1/16/01. Impression: Guillain-Barre syndrome, improving; Acute renal failure, transient secondary to the immunoglobulin therapy; hypertension.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Renal failure acute
Clinical narrative: Guillain-Barre Syndrome and later developed acute renal failure; started as pain in feet and legs. Admitted to the hospital on 12/26/00. Received IVIG  and IV contrast which may be related to acute renal failure. Per F/U 5/1/01: BP 220/100. During her stay in the hospital, she gradually became weak and worse. Attempts to insert an IV line were made, but it was unsuccessful anf for this reason, we had asked MD to see her to insert a Port-A-Cath which was performed on 12/27/00. The pt was then given 8mg of Globulin, immunogloblin, 17 grams daily for 5 days over 16 hours. However, this was discontinued on 12/30/00 after 4 dosages, after she developed an elevated BUN and creatininie who had a history of was felt to be secondary to the immunoglobulin. Because of this, we had asked MD to see her who then started her on short-term dialysis. Slowly and gradually the rhythm failure improved. She remained stable and was then transferred to the skilled nursing facility on 1/16/01. Impression: Guillain-Barre syndrome, improving; Acute renal failure, transient secondary to the immunoglobulin therapy; hypertension.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure decreased, Dehydration, Dyspnoea, Fatigue
Clinical narrative: The morning after the injection, the pt complained of fever 100F, aches, chills and felt stiff. The next day, he had fever, was pale and weak, so went to the doctor. He was hydrated with a pint of fluids and given Tylenol. Pulse was rapid. Had a low-grade fever for the rest of the week. On 12/18/00, went to the doctor. Pulse 190, low BP. Was sent to the hospital and put in ICU for 2 days, then sent home on Coumadin, Digoxin and Cardizem. (Did not have difficulty breathing). He is feeling better and has an appointment in 2 months. 60 day follow up states patient has shortness of breath and gets tired more easily. Per review of Hospital D/C Summary add diagnosis of 2:1 AV Block./awb
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Musculoskeletal stiffness, Pain, Pallor, Pyrexia
Clinical narrative: The morning after the injection, the pt complained of fever 100F, aches, chills and felt stiff. The next day, he had fever, was pale and weak, so went to the doctor. He was hydrated with a pint of fluids and given Tylenol. Pulse was rapid. Had a low-grade fever for the rest of the week. On 12/18/00, went to the doctor. Pulse 190, low BP. Was sent to the hospital and put in ICU for 2 days, then sent home on Coumadin, Digoxin and Cardizem. (Did not have difficulty breathing). He is feeling better and has an appointment in 2 months. 60 day follow up states patient has shortness of breath and gets tired more easily. Per review of Hospital D/C Summary add diagnosis of 2:1 AV Block./awb
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Somnolence
Clinical narrative: The patient had his vaccines on 12/20/00.  He slept a lot for approximately 2 days, since then more subdued.  The patient used to talk more, and laugh more now he requires stimulation to laugh.  The patient is quiet unless he is hungry, needs a diaper change, or is stimulated by the mom, he was always easy going but now more so. No virus in the house.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Abdominal pain, Injection site pain, Pyrexia
Clinical narrative: The patient has pain in the injection site, questionable abdominal pain, and a fever of 103.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Anorexia, Injection site erythema, Injection site induration, Injection site inflammation, Injection site nodule
Clinical narrative: The patient became red and inflamed at the site of the injection, it also felt hard to touch.  There was a hard knot that lasted 3 weeks even though the redness diminished in 36 hours. The patient's appetite was diminished and he was a bit listless for about 72 hours.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Listless
Clinical narrative: The patient became red and inflamed at the site of the injection, it also felt hard to touch.  There was a hard knot that lasted 3 weeks even though the redness diminished in 36 hours. The patient's appetite was diminished and he was a bit listless for about 72 hours.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cellulitis, Injection site reaction, Injection site swelling
Clinical narrative: The patient had swelling, and cellulitis at the site of injection (DTaP and Hib given in that leg). Treated with Keflex, and cool compresses. Recheck in 5 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site reaction, Urticaria
Clinical narrative: The patient has 1 1/4 by 2 3/4 inch resolving hive in the left deltoid area, it first appeared approximately 48 hours after DTaP, IPV, MMR, and Prevnar vaccines.  The hive occurred over DTap, and IPV site. No other symptoms.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: The patient had a localized reaction with a 20 minute induration, larger erythema with pruritus.
Age: 52.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Injection site reaction, Oedema peripheral
Clinical narrative: The patient had a shot on 02/18/1999, then on 02/19/1999 she still had pain in her left knee with a lot of swelling. The patient reported to the doctor 03/01/1999, was treated with Relafen. The patient then went to the orthopedist 03/10/1999 and got a second shot, on 03/18/1999 she reacted again.  The patient went back to the doctor on 04/15/1999, and the rheumatologist on 05/07/1999, she was treated with Relafen and Ultram. The patient has pain and intermittent swelling to this day.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site nodule, Tenderness
Clinical narrative: The patient had a hard, tender, knot appear at the injection site that has moved to the back of the deltoid area.  It is now less tender and some what smaller after the patient took several doses of Benadryl over the past 4 days and Hydrocortisone cream.  Zero redness was noted.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Gastritis, Pyrexia
Clinical narrative: The patient states that approximately 24 hours after receiving the Flu vaccine he began having abdominal cramping. The cramping became severe  so he went to his PDM. He was diagnosed with viral gastritis.  He is now on bedrest, clear fluids and meds for relief of symptoms, and he continues to have a low grade temperature. He has a follow up appointment on 12/21/00.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing, Urticaria
Clinical narrative: The patient received a vaccine and seven days after receiving it the patient began sneezing and developed a hive on her wrist.  By midnight she had hives all over her whole body so she took Benadryl. The patient then developed more hives, so she went to see her doctor; where she was treated this was 25 hours after she received her vaccine. The patient went to the ER 35 hours after receiving the vaccine to be treated because the hives continued to develop. The patient was treated with Benadryl, Solu-Medrol, Zantac, Epinephrine, Albuterol nebulized inhalation, Prednisone, Ranitidine, and Zyrtec.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: The patient developed a cough, redness, swelling and soreness at the site of the injection on 11/17/00 in the PM. The patient was seen by his family physician who prescribed cough medicine with codeine. The patient states the cough was somewhat alleviated but still complains of soreness and achiness in left arm to date.  He has trouble lifting and or reaching. Pain in the shoulder still 12/29/00.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: The patient had soreness in his arm that soon after developed into pain in the upper arm especially when raising his arm.  A small knot still present at the site. No systemic symptoms. Plans to see PMD if no improvement.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: The patient had a fever of 102.4, swollen (the size of an orange), hard, hot, painful injection site. The patient also had achiness and feeling "wiped out." On 12/7/00 the fever was 99.6 this morning "feeling better". On 12/11/00 the patient recovered.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: The patient had a fever of 102.4, swollen (the size of an orange), hard, hot, painful injection site. The patient also had achiness and feeling "wiped out." On 12/7/00 the fever was 99.6 this morning "feeling better". On 12/11/00 the patient recovered.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Injection site pain, Injection site warmth, Oedema, Syncope
Clinical narrative: The patient had severe pain in the right arm about three hours after an injection. On 12/22/00 the patient fainted in the store. Arlington EMS was called they checked the patient out and then the patient went home, and notified her doctor that the pain continued.  By 10 PM on 12/22/00 the patient arm from elbow almost to the shoulder, was so swollen, difficult to get shirt off. Arm also had become very warm and purple color. Swelling worse the next day. Swelling and soreness finally over on 12/27/000.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: The patient had an allergic reaction at the injection site within 48 hrs.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Headache, Pain, Vomiting
Clinical narrative: The patient had diarrhea, vomiting, severe chills, headache and whole body aching all afternoon and all night on 12/07/00. The next day all of the symptoms were gone.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: The patient developed a rash from her shoulder on up, following vaccination on 12/18/00. The patient saw her PCP 12/19/00, she was treated with Benadryl.  The rash increased to the trunk area through out the day, no trouble breathing, no hospitalization.
Age: 10.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Rash
Clinical narrative: Child broke out in a rash from his knees down. No fever or other signs and symptoms. Took child to PMD, who gave Rx for prednisone. Pt broke out on entire body with rash within 24 hours. On 10/2/00, child was ok.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left arm tender with mild swelling.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Hypoaesthesia, Joint stiffness, Nasal congestion
Clinical narrative: Pt has had stiffness and pain in all of his joints since receiving the 1st Hep-B injection. Has not seen MD. Encouraged him to see MD. He also had numbness then a few days later, he had sniffles. 2nd injection not given.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: 1 week, post vax, she has pain in her left arm. Pain if felt during any movement of her arm. Pain is present even when arm is still, it is exacerbated with movement. Not tender to touch.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Injection site mass, Injection site pain, Pain
Clinical narrative: Large lump, sore arm, shooting pains.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever, swelling is not yet recovered.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Influenza like illness, Oedema peripheral, Pallor, Rash, Vomiting
Clinical narrative: Rash on chest, neck and right side; pallor; swelling of hands at 13:35; emesis at 14:00; flu-like symptoms for 24 hours, post vax.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: 2 days, post vax, there was a hard, reddened area 2 3/4" X 3". Temperature spiked to 102.3F, 37 hours, post vax.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral
Clinical narrative: States right leg, from knee to groin area, is swollen approx. 2 X larger than normal. No increased erythema or induration noted. Doesn't appear to cause problems with walking. Swelling noted on 12/7/00 PM.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Anorexia, Diarrhoea, Headache, Injection site erythema, Myalgia
Clinical narrative: Fever of 103F, palpitations, diarrhea, muscle pain, headache, anorexia, redness at the site of injection.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Palpitations, Pyrexia
Clinical narrative: Fever of 103F, palpitations, diarrhea, muscle pain, headache, anorexia, redness at the site of injection.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: Severe headache, tiredness, dizzy, short of breath at times, heart palpitations, weakness and nausea.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Palpitations
Clinical narrative: Severe headache, tiredness, dizzy, short of breath at times, heart palpitations, weakness and nausea.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Pt states it started as a 15cm "lump" and continued to spread. Today, pt has a 60mm X 60mm red, raised circle, warm to touch. PA examined pt's circle area with pen and instructed to RTC on 1/5/01 for evaluation. Pt to apply ice prn and take Benadryl as directed.
Age: 4.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Developed chickenpox lesions all over the face, back, trunk and in genital area. Px: oatmeal baths and Benadryl; had immunization on 8/5/97.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Localized erythema, edema and tenderness lasting 3-4 days, relieved by warm compresses and ibuprofen. Saw doctor and return visit on 12/22/00.
Sex: U
Vaccine: OPV
Symptoms: Unevaluable event
Clinical narrative: A pharmacist reported that several pt's received an expired dose of Orimune between 7/5/00 and 7/31/00. The onset of unspecified adverse events occurred within the same time frame. The Orimune expired 7/1/00. As of 8/24/00 no further information was available. Additional reports will be generated.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Autism, Croup infectious, Drug interaction, Purpura, Pyrexia
Clinical narrative: "A mother reported that her 6 month old son received Hib-Titer, Orimune and Tripedia vaccines on 4/15/93. On 4/25/93, the infant developed a fever of 104F and a viral croup. He was hospitalized. Subsequently, he developed a bleeding rash on his cheeks and was reportedly dx'd with autism. The mother attributed these events to the vaccines he received since the age of 4 months. She also believes preservative thimerosal is related to the development of autism."
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Viral infection
Clinical narrative: "A mother reported that her 6 month old son received Hib-Titer, Orimune and Tripedia vaccines on 4/15/93. On 4/25/93, the infant developed a fever of 104F and a viral croup. He was hospitalized. Subsequently, he developed a bleeding rash on his cheeks and was reportedly dx'd with autism. The mother attributed these events to the vaccines he received since the age of 4 months. She also believes preservative thimerosal is related to the development of autism."
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pneumonia, Sepsis
Clinical narrative: "A territory representative reported that a 2 month old infant received an injection of Prevnar and subsequently, developed pneumococcal sepsis. The infant was hospitalized and recovered. From follow-up information received from the physician on 11/22/00, it indicated that a 2 month old male received Prevnar, Acel-Imune, Hib-Titer, IPV and Recombivax HB vaccines on 8/21/00. On 10/12/00, the infant developed pneumococcal sepsis.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Pneumonia, Sepsis
Clinical narrative: "A territory representative reported that a 2 month old infant received an injection of Prevnar and subsequently, developed pneumococcal sepsis. The infant was hospitalized and recovered. From follow-up information received from the physician on 11/22/00, it indicated that a 2 month old male received Prevnar, Acel-Imune, Hib-Titer, IPV and Recombivax HB vaccines on 8/21/00. On 10/12/00, the infant developed pneumococcal sepsis.
Age: 15.0
Sex: M
Vaccine: HEP, TD
Symptoms: Asthenia, Convulsion, Fatigue, Syncope
Clinical narrative: Approx. 10 minutes, post vax, client had a syncopal episode with seizure-like activity, as reported by mother. Episode lasted approx. 30 seconds. Sequela from event included weakness, fatigue for 3 days, so far. Encouraged mother to take client in to see primary physician.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Hypertension, Injection site erythema
Clinical narrative: Information has been received from a physician's office and an ER concerning a white 67 year old female who was vaccinated with pneumococcal vaccine 23 polyvalent, IM in the left deltoid. The ER reports the pt received "Flu with pneumonia shot to left arm," however, the administering doctor's office does not mention the pt receiving a flu vaccine. On 10/21/00, the pt had redness, pain and swelling of the left arm. On 10/22/00, the pt presented to the ER with complaints of redness and swelling distal to the injection site. On exam, the pt's left arm was red and swollen. The pt reported that the onset was "a few days after deltoid injection". The ER physician noted that the pt's left arm had a puncture wound over the deltoid with "small" ecchymosis and the distal portion of the arm was well demarcated with erythema and increased warmth. The ER physician reported there was not any signs of lymphangitis or adenopathy. The pt was treated in the ER with Rocephin IM and no reaction noted. The pt was prescribed Augmentin 875mg po twice a day. The condition has resolved as per the pt's family physician's office. Upon internal review cellulitis was determined to be an "Other Medical Event". Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician's office and an ER concerning a white 67 year old female who was vaccinated with pneumococcal vaccine 23 polyvalent, IM in the left deltoid. The ER reports the pt received "Flu with pneumonia shot to left arm," however, the administering doctor's office does not mention the pt receiving a flu vaccine. On 10/21/00, the pt had redness, pain and swelling of the left arm. On 10/22/00, the pt presented to the ER with complaints of redness and swelling distal to the injection site. On exam, the pt's left arm was red and swollen. The pt reported that the onset was "a few days after deltoid injection". The ER physician noted that the pt's left arm had a puncture wound over the deltoid with "small" ecchymosis and the distal portion of the arm was well demarcated with erythema and increased warmth. The ER physician reported there was not any signs of lymphangitis or adenopathy. The pt was treated in the ER with Rocephin IM and no reaction noted. The pt was prescribed Augmentin 875mg po twice a day. The condition has resolved as per the pt's family physician's office. Upon internal review cellulitis was determined to be an "Other Medical Event". Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: HEP, IPV, PNC, HEP, IPV, PNC
Symptoms: Decreased appetite, Hyperexplexia, Irritability, Staring, Strabismus
Clinical narrative: "A physician reported that a 1 month old male received Prevnar, Recombivax-HB and IPV vaccines on 10/2/00. Post vax, he developed irritability, decreased oral intake, spitting up and strange episodes of not focusing and unusual startling and looking to his right side. He was transferred to the ER at a university medical center for further evaluation and was admitted to the pediatric neurology unit.
Age: 0.08
Sex: M
Vaccine: HEP, IPV, PNC, HEP, IPV, PNC
Symptoms: Vomiting
Clinical narrative: "A physician reported that a 1 month old male received Prevnar, Recombivax-HB and IPV vaccines on 10/2/00. Post vax, he developed irritability, decreased oral intake, spitting up and strange episodes of not focusing and unusual startling and looking to his right side. He was transferred to the ER at a university medical center for further evaluation and was admitted to the pediatric neurology unit.
Age: 0.08
Sex: M
Vaccine: HEP, IPV, PNC, HEP, IPV, PNC
Symptoms: Anorexia, Dyskinesia, Hyperexplexia, Impetigo, Irritability
Clinical narrative: "A physician reported that a 1 month old male received Prevnar, Recombivax-HB and IPV vaccines on 10/2/00. Post vax, he developed irritability, decreased oral intake, spitting up and strange episodes of not focusing and unusual startling and looking to his right side. He was transferred to the ER at a university medical center for further evaluation and was admitted to the pediatric neurology unit.
Age: 0.08
Sex: M
Vaccine: HEP, IPV, PNC, HEP, IPV, PNC
Symptoms: Staring, Stupor, Visual disturbance, Vomiting
Clinical narrative: "A physician reported that a 1 month old male received Prevnar, Recombivax-HB and IPV vaccines on 10/2/00. Post vax, he developed irritability, decreased oral intake, spitting up and strange episodes of not focusing and unusual startling and looking to his right side. He was transferred to the ER at a university medical center for further evaluation and was admitted to the pediatric neurology unit.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Wegener's granulomatosis
Clinical narrative: clinical diagnosis - Gullian Barre of lower extremities. The follow-up states that a dignosis of Wegener's granulometosis was made.
Age: 52.0
Sex: U
Vaccine: FLUX
Symptoms: Back pain, Cartilage development disorder
Clinical narrative: Pt complained of LBP beginning 3 hours, post vax. No fever, rashes, nausea or vomiting or other myalgias. No radiation of pain, no bowel/bladder or other weaknesses.
Age: 12.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Coma, Crying, Dyspnoea, Hypotonia
Clinical narrative: The pt had her 1st injection of Engerix-B on 6/1/00 and her 2nd on 7/6/00 with no adverse experiences following either of these 2 injections. She received her 3rd injection of Engerix-B on 12/12/00 and she reportedly took 1 tablet of Tylenol to prevent local soreness. She was well until approx. 02:00 on 12/15/00, when her parents reported hearing "a funny noise" coming from her room. Her father found her lying in bed, breathing, but unresponsive to verbal stimuli; her eyes were "half open". The pt then stopped breathing and her parents began CPR and summoned EMS. At the hospital, she was pronounced dead on arrival. An autopsy reportedly, did not reveal a cause of death, although toxicology results were pending as of 1/4/01. The reporter considers the death to be unrelated to Engerix-B. The reporter stated that the pt's 13 year old brother received 3 injections of Engerix-B on the same dates, and from the same lots, as his sister. The brother had no adverse experiences, post vax, of any on the injections. He continued to be well as of 1/4/01.
Age: 12.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Apnoea, Coma, Staring
Clinical narrative: The pt had her 1st injection of Engerix-B on 6/1/00 and her 2nd on 7/6/00 with no adverse experiences following either of these 2 injections. She received her 3rd injection of Engerix-B on 12/12/00 and she reportedly took 1 tablet of Tylenol to prevent local soreness. She was well until approx. 02:00 on 12/15/00, when her parents reported hearing "a funny noise" coming from her room. Her father found her lying in bed, breathing, but unresponsive to verbal stimuli; her eyes were "half open". The pt then stopped breathing and her parents began CPR and summoned EMS. At the hospital, she was pronounced dead on arrival. An autopsy reportedly, did not reveal a cause of death, although toxicology results were pending as of 1/4/01. The reporter considers the death to be unrelated to Engerix-B. The reporter stated that the pt's 13 year old brother received 3 injections of Engerix-B on the same dates, and from the same lots, as his sister. The brother had no adverse experiences, post vax, of any on the injections. He continued to be well as of 1/4/01.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Asthma
Clinical narrative: Information has been received from a health professional concerning a 30 year old female who was inadvertently vaccinated with a double dose of pneumococcal vaccine 23 (1ml). Subsequently, the pt experienced a severe asthma attack. She was referred to the ER for treatment. The pneumococcal vaccine 23 polyvalent had expired in May 2000. The severe asthma attack was considered a "Significant Medical Event".
Age: 1.08
Sex: M
Vaccine: IPV, MMR
Symptoms: Contusion, Difficulty in walking, Epistaxis, Erythema, Gingival bleeding
Clinical narrative: The pt was hospitalized for thrombocytopenia, platelets were 14,000 on admission. Was re-hospitalized for platelets below 50,000. Per F/U 6/21/01: The mother had taken the pt to the doctor on 8/8/00, after noticing that the pt had a bruise on his chest that was increasing in size. She did not know how the bruise began. She stated that she had put him to sleep on 8/7/00 and when he woke up, she noticed the bruise. The pt has a history of bruising easily beginning at 6 months of age. The mother states that the pt is very active, plays hard and gets bruised easily. In the past month, she has also noticed that the pt has had epistaxis X 2 and in the past few days, he had a small amount of bleeding from his gums. The pt is twin number 1 of a pair and his sister has not had any similar problems. The pt has never seen a specialist regarding his bruises. He had no hematemesis, no hematuria and no blood in his stools. The mother also states that the pt has had 18 ear infections in the past year. He was not treated with PE tubes for these infections. His twin also had recurrent ear infections but not as many. Prior to admission, the pt had no fever, nausea or vomiting and no rhinorrhea or cough. On exam: The pt had a erythematous, papular rash present over perianal area surrounding buttocks. Skin with multiple bruises in different stages of healing and petechiae on the chest and face. Per mother, he was having more difficulty walking than usual. After IV IP, the pt responded to IV IG and after approx. 20 hours, platelets came on up. The pt should follow-up in Hematology Clinic and also be seen immediately and have is platelets checked, if he has further brusising and bleeding.
Age: 1.08
Sex: M
Vaccine: IPV, MMR
Symptoms: Petechiae, Rash papular, Thrombocytopenia
Clinical narrative: The pt was hospitalized for thrombocytopenia, platelets were 14,000 on admission. Was re-hospitalized for platelets below 50,000. Per F/U 6/21/01: The mother had taken the pt to the doctor on 8/8/00, after noticing that the pt had a bruise on his chest that was increasing in size. She did not know how the bruise began. She stated that she had put him to sleep on 8/7/00 and when he woke up, she noticed the bruise. The pt has a history of bruising easily beginning at 6 months of age. The mother states that the pt is very active, plays hard and gets bruised easily. In the past month, she has also noticed that the pt has had epistaxis X 2 and in the past few days, he had a small amount of bleeding from his gums. The pt is twin number 1 of a pair and his sister has not had any similar problems. The pt has never seen a specialist regarding his bruises. He had no hematemesis, no hematuria and no blood in his stools. The mother also states that the pt has had 18 ear infections in the past year. He was not treated with PE tubes for these infections. His twin also had recurrent ear infections but not as many. Prior to admission, the pt had no fever, nausea or vomiting and no rhinorrhea or cough. On exam: The pt had a erythematous, papular rash present over perianal area surrounding buttocks. Skin with multiple bruises in different stages of healing and petechiae on the chest and face. Per mother, he was having more difficulty walking than usual. After IV IP, the pt responded to IV IG and after approx. 20 hours, platelets came on up. The pt should follow-up in Hematology Clinic and also be seen immediately and have is platelets checked, if he has further brusising and bleeding.
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hearing impaired
Clinical narrative: "A territory representative reported that an infant received Prevnar, Acel-Imune, Hib-Titer and IPOL vaccines on 8/29/00. Approx. 24 to 36 hours, post vax, the parents observed that the infant no longer responded to noise. No further information was available at the date of this report."
Age: 1.25
Sex: F
Vaccine: IPV, PNC, IPV, PNC
Symptoms: Convulsion, Tremor
Clinical narrative: "A mother reported that her 15 month old daughter received Prevnar and IPV vaccines on 10/20/00. On 10/30/00, the child experienced a 'seizure type episode'. Approx. 4 hours later, she had 'unexplained tremors' while in an ER. Convulsion is considered to be "Medically Important".
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Hypertension, Injection site erythema, Injection site swelling, Joint stiffness, Pain
Clinical narrative: Post vax, of my 1st Lymerix shot, I experienced significant redness and swelling at the injection site which lasted about 3 days. More importantly, I began to experience joint stiffness and pain in my hands, shortly thereafter. Prior to the shot, I had not had any such problems. I assumed the stiffness was temporary and therefore, had the 2nd shot on 6/11/99. The joint stiffness, inflammation and pain in my hands continued to increase. Eventually, I was referred to a rheumatologist who thinks I have some type of rheumatoid arthritis (even though the symptoms only began days after the 1st Lymerix shot) and started me on NSAIDS. The NSAIDS caused a rise in my blood pressure to the point that I had to start taking medication for that, too. I know that the Lymerix triggered some type of auto-immune reaction!
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: Post vax, of my 1st Lymerix shot, I experienced significant redness and swelling at the injection site which lasted about 3 days. More importantly, I began to experience joint stiffness and pain in my hands, shortly thereafter. Prior to the shot, I had not had any such problems. I assumed the stiffness was temporary and therefore, had the 2nd shot on 6/11/99. The joint stiffness, inflammation and pain in my hands continued to increase. Eventually, I was referred to a rheumatologist who thinks I have some type of rheumatoid arthritis (even though the symptoms only began days after the 1st Lymerix shot) and started me on NSAIDS. The NSAIDS caused a rise in my blood pressure to the point that I had to start taking medication for that, too. I know that the Lymerix triggered some type of auto-immune reaction!
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Angioneurotic oedema, Asthma, Joint swelling, Laryngeal oedema, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning a 36 year old white female who in July 2000, was vaccinated with varicella virus vaccine live. Four weeks later, the pt experienced angioedema and hives. It was reported that since that time, each week on the same day of the week, Thursday, the pt experienced hives. It was noted that since approx. 10/00, the pt has also experienced slight laryngeal edema. Also, it was reported that the pt feels that since the vaccination in July 2000, she has experienced an increase in her "mild asthma". Unspecified medical attention was sought. Follow-up information from the physician, indicated that the pt was vaccinated with the 1st dose of varicella on 7/20/00. It was reported that there was no illnesses at the time of vaccination. On 8/20/00, the pt developed generalized hives, lip angioedema, ankle and shoulder swelling, and a mild worsening of asthma. No improvement was seen with aggressive antihistamine therapy. The pt developed laryngeal edema and was placed on oral steroids with good response. The physician considered the events life threatening and "Other Medical Events". As of 11/14/00, the pt recovered from the events. No further details were provided.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 36 year old white female who in July 2000, was vaccinated with varicella virus vaccine live. Four weeks later, the pt experienced angioedema and hives. It was reported that since that time, each week on the same day of the week, Thursday, the pt experienced hives. It was noted that since approx. 10/00, the pt has also experienced slight laryngeal edema. Also, it was reported that the pt feels that since the vaccination in July 2000, she has experienced an increase in her "mild asthma". Unspecified medical attention was sought. Follow-up information from the physician, indicated that the pt was vaccinated with the 1st dose of varicella on 7/20/00. It was reported that there was no illnesses at the time of vaccination. On 8/20/00, the pt developed generalized hives, lip angioedema, ankle and shoulder swelling, and a mild worsening of asthma. No improvement was seen with aggressive antihistamine therapy. The pt developed laryngeal edema and was placed on oral steroids with good response. The physician considered the events life threatening and "Other Medical Events". As of 11/14/00, the pt recovered from the events. No further details were provided.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Eye disorder, Feeling hot, Hearing impaired, Nervous system disorder, Otitis media
Clinical narrative: Information has been received from a consumer concerning an approx. 1 year old male, with no known drug allergies and a history of three tympanic membrance surgeries, tonsillectomy and adenoidectomy, who in approx. 9/98, was vaccinated with MMR II. The pt's mother reported that the night of the vaccination, she woke up to the child making a strange humming sound. She reported that she went to the crib and the child looked swollen and was hot to the touch. The pt's mother took a rectal temperature and the result was 105.8F. She bathed him in tepid water and gave the child Tylenol. The pt's mother took him to the physician, who did not feel the events were vaccine related. Later that evening, it was reported that the child developed a 'measles-like rash' that went away within a couple of hours. The child had computed axial tomography scan in November 2000  that showed "hypoplasmia (organ not specified) and other significant abnormalities" on the right side only (pre-existing conditions)(follow-up in process). The report mentioned possible old injury or insult. The patient can not hear with the right ear and is losing his eyesight It was reported that the patient is always sick upon internal review the patient's experience were determined to be Other Medical Events. FOLLOW-UP information, the physician reported that the patient was vaccinated with measles virus vaccine live (-) mumps virus vaccine live (-) rubella virus vaccine live (second generation) on 10/02.1998. Concomitant vaccination on 10/02/1998 included varicella virus vaccine live. Patient also received tuberculin purified protein deriative (PPD) on 10/02/1998. The physician reported that the patient was seen in the clinic on 10/07/1998 with low grade fever (T. 99.6/Tympanic) and was diagnosed with bilateral otitis media (BOM), tonsillitis and rash (? post vaccination vs. viral). A complete blood count (CBC) was done and was consistent with a viral infection.  Chest x-ray was negative. The physician stated "I don't feel there was any adverse reaction". Additional information has been requested. In follow-up, the physician reported tha the pt was vaccinated with MMR on 10/02/1998. Concominant vaccination on 10/02/1998 icluded varicella virus vaccine. Pt also received tuberculin purified protein derivative on 10/02/1998. The physician reported that the pt was seen in the clinic on 10/07/1998 with low grade fever (99.6 deg. F) and was diagnosed with bilateral otitis media, tonsillitus and rash post vaccination. A complete blood count CBC was done and was consistent with a viral infection. Chest x-ray was negative. Antistreptolysin 0 titer, blood culture and Epstein Barr virus titers were negative. The physician stated, "I don't feel there was any adverse reaction." Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular, Swelling, Tonsillitis
Clinical narrative: Information has been received from a consumer concerning an approx. 1 year old male, with no known drug allergies and a history of three tympanic membrance surgeries, tonsillectomy and adenoidectomy, who in approx. 9/98, was vaccinated with MMR II. The pt's mother reported that the night of the vaccination, she woke up to the child making a strange humming sound. She reported that she went to the crib and the child looked swollen and was hot to the touch. The pt's mother took a rectal temperature and the result was 105.8F. She bathed him in tepid water and gave the child Tylenol. The pt's mother took him to the physician, who did not feel the events were vaccine related. Later that evening, it was reported that the child developed a 'measles-like rash' that went away within a couple of hours. The child had computed axial tomography scan in November 2000  that showed "hypoplasmia (organ not specified) and other significant abnormalities" on the right side only (pre-existing conditions)(follow-up in process). The report mentioned possible old injury or insult. The patient can not hear with the right ear and is losing his eyesight It was reported that the patient is always sick upon internal review the patient's experience were determined to be Other Medical Events. FOLLOW-UP information, the physician reported that the patient was vaccinated with measles virus vaccine live (-) mumps virus vaccine live (-) rubella virus vaccine live (second generation) on 10/02.1998. Concomitant vaccination on 10/02/1998 included varicella virus vaccine live. Patient also received tuberculin purified protein deriative (PPD) on 10/02/1998. The physician reported that the patient was seen in the clinic on 10/07/1998 with low grade fever (T. 99.6/Tympanic) and was diagnosed with bilateral otitis media (BOM), tonsillitis and rash (? post vaccination vs. viral). A complete blood count (CBC) was done and was consistent with a viral infection.  Chest x-ray was negative. The physician stated "I don't feel there was any adverse reaction". Additional information has been requested. In follow-up, the physician reported tha the pt was vaccinated with MMR on 10/02/1998. Concominant vaccination on 10/02/1998 icluded varicella virus vaccine. Pt also received tuberculin purified protein derivative on 10/02/1998. The physician reported that the pt was seen in the clinic on 10/07/1998 with low grade fever (99.6 deg. F) and was diagnosed with bilateral otitis media, tonsillitus and rash post vaccination. A complete blood count CBC was done and was consistent with a viral infection. Chest x-ray was negative. Antistreptolysin 0 titer, blood culture and Epstein Barr virus titers were negative. The physician stated, "I don't feel there was any adverse reaction." Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a consumer concerning an approx. 1 year old male, with no known drug allergies and a history of three tympanic membrance surgeries, tonsillectomy and adenoidectomy, who in approx. 9/98, was vaccinated with MMR II. The pt's mother reported that the night of the vaccination, she woke up to the child making a strange humming sound. She reported that she went to the crib and the child looked swollen and was hot to the touch. The pt's mother took a rectal temperature and the result was 105.8F. She bathed him in tepid water and gave the child Tylenol. The pt's mother took him to the physician, who did not feel the events were vaccine related. Later that evening, it was reported that the child developed a 'measles-like rash' that went away within a couple of hours. The child had computed axial tomography scan in November 2000  that showed "hypoplasmia (organ not specified) and other significant abnormalities" on the right side only (pre-existing conditions)(follow-up in process). The report mentioned possible old injury or insult. The patient can not hear with the right ear and is losing his eyesight It was reported that the patient is always sick upon internal review the patient's experience were determined to be Other Medical Events. FOLLOW-UP information, the physician reported that the patient was vaccinated with measles virus vaccine live (-) mumps virus vaccine live (-) rubella virus vaccine live (second generation) on 10/02.1998. Concomitant vaccination on 10/02/1998 included varicella virus vaccine live. Patient also received tuberculin purified protein deriative (PPD) on 10/02/1998. The physician reported that the patient was seen in the clinic on 10/07/1998 with low grade fever (T. 99.6/Tympanic) and was diagnosed with bilateral otitis media (BOM), tonsillitis and rash (? post vaccination vs. viral). A complete blood count (CBC) was done and was consistent with a viral infection.  Chest x-ray was negative. The physician stated "I don't feel there was any adverse reaction". Additional information has been requested. In follow-up, the physician reported tha the pt was vaccinated with MMR on 10/02/1998. Concominant vaccination on 10/02/1998 icluded varicella virus vaccine. Pt also received tuberculin purified protein derivative on 10/02/1998. The physician reported that the pt was seen in the clinic on 10/07/1998 with low grade fever (99.6 deg. F) and was diagnosed with bilateral otitis media, tonsillitus and rash post vaccination. A complete blood count CBC was done and was consistent with a viral infection. Chest x-ray was negative. Antistreptolysin 0 titer, blood culture and Epstein Barr virus titers were negative. The physician stated, "I don't feel there was any adverse reaction." Additional info has been requested.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Hyperhidrosis, Hypersensitivity, Visual disturbance
Clinical narrative: Information has been received from an RN concerning a 26 year old male that while hospitalized for a splenectomy in 1996, was vaccinated with pneumococcal vaccine 23 polyvalent. Approx. 30 seconds later, the pt experienced a drenching sweat and visual disturbances. The pt was treated with Benadryl therapy. The physician felt that the pt had an allergic reaction due to the phenol component in pneumococcal vaccine 23 polyvalent. Upon internal review, drug allergy, was determined to be an "Other Medical Event". Additional information has been requested. In F/U the Physician reported that the pt's experience was reported to him by the pt and the event happened in another state and not at this physician's office. Further information is not expected. The code of drug allergy has been changed to anaphylaxis, a labeled event. Therefore, this report is no longer meets the criteria for expediated submission.
Sex: U
Vaccine: VARCEL
Symptoms: Brain oedema, Convulsion
Clinical narrative: Information has been received from an LVN concerning a child who in approx. June, 1999, was vaccinated with varicella virus vaccine live. Subsequently, the pt experienced seizure and brain swelling and was hospitalized. A brain biopsy was scheduled to determine course of treatment, therapy and cause. It was reported that the pt's mother was told that the pt's experience was related to therapy with varicella virus vaccine live. Additional information has been requested. Further FU: the physician's office reported that the child was not one of their patients.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: The pt experienced a "large tight knot" at the site. The pt was seen by her physician. The are from the deltoid to mid humerus with induration, erythema that blanches to pressure and pain. The diagnosis was possible cellulitis. The pt's physician prescribed Cefzil for seven days and ice to the area for two to three days. The next day improvement was noted. Upon internal review induration,erythema and possible cellulitis was determined to be "other medical events". Additional information has been requested.