chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Cellulitis, Erythema, Oedema
Clinical narrative: Patient received 7 vaccines in both arms on 4/27/2006.  His mother called the Call Center at 3PM on 4/28/2006 because of redness and swelling on both arms.  She was directed to take her son to the ER.  According to the mother the ER physician stated that patient had cellulitis of both arms due to the amount of vaccine given.  Patient was given a Rx of Augmentin.  ON 5/1/2006 Mom called the State Health Services (DSHS) to register a complaint.  DSHS directed her to contact VAERS and they contacted me on 5/2/2006.  I called Mom on 5/2/2006 and she gave me above information.  I contacted VAERS on 5/2/2006 and asked for a copy of the report. At this time, I have unable to secure an ER report.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Pyrexia, Rash macular, Urticaria
Clinical narrative: Rash on day # 5 after MMR Vaccine.  Reported rash was macular, urticarial in presentation. Fever on day 4 after MMR vaccine.
Sex: M
Vaccine: PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding her son who she described as borderline autistic. The patient received the Prevnar vaccine on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The child's mother described her son as borderline autistic (autism). The reporter declined to grant permission for follow up No additional information was available at the time of this report.
Age: 45.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Injection site infection, Injection site pain, Injection site swelling, Neuralgia, Skin burning sensation
Clinical narrative: Received call from pt stating that she received several immunization shots at health dept on 4/10/06 which were job related. She reports the onset of pain in left deltoid area on 4/13/06. She states that she initially thought that she slept on her arm the preceding night. She reports that the pain in the left deltoid area progressively worsened radiating down the left arm and also into her left shoulder and occipital region. She also reports a raised area the size of a peanut M&M appeared on her left upper arm. She states that the persistent pain in her left arm necessitated a call to her primary care physician, who advised ice to the area and to call on 4/19/06 if no improvement. States she did see Dr in the office and he felt that the injection hit a nerve or that the area was infected. States was given anti-inflammatory drug and antibiotic. States that she did refer to forms given at time of injections and did refer to them when pain started. She states that she is calling the health dept today for assistance in completing workers comp forms. Pt will present to health dept today to provide additional information so that a report can be completed. Chart reflects that pt was given first dose of Twinrix in the left deltoid and Typhim Vi in the right deltoid on 4/10/06. Now 4/21/06 pt can feel a difference in it, still pain, discomfort and burning but it is not as often. Pain goes all the way from left deltoid area to the occipital bone and then from left deltoid down arm and around elbow to left thumb. At this time pt's left deltoid is not red, not tender to touch or warm. There is no knots or anything palpable on her left arm where she describes that she had an M and M size lump on her arm. At this time she does not have a grimace on her face and she moved her left arm and left hand through all ROM as she gestured while talking. Physically she is about 5'3" tall and approx 250#. 5/8/06 To continue pt was advised on 4/21/06 to refer back to her private MD for any further vaccinations in this series. Pt asked if we could still fill out papers for workers compensation but that she did not have them with her this day (4/21/06). Pt was told that if she brought the forms we would fill out that we gave the Twinrix shot as per our health dept protocol and procedures. To date pt has not called or come back to the office.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash started 5/5
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass, Rash erythematous
Clinical narrative: Red rash, knot.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: 5x5 area of erythema and warmth around left biceps. Child not ill and area does not hurt.
Age: 42.0
Sex: U
Vaccine: TDAP
Symptoms: Chest pain, Drug interaction, Dyspnoea, Laboratory test abnormal, Nausea
Clinical narrative: 10/15 mins post vaccination experienced sudden onset of difficulty breathing followed by heaviness in chest then pain. Pain level fluctuates 2-3-5/10. Pain lasted 30 hours. Medical records state drug reaction, nausea, palpitaiton. msv
Age: 42.0
Sex: U
Vaccine: TDAP
Symptoms: Palpitations
Clinical narrative: 10/15 mins post vaccination experienced sudden onset of difficulty breathing followed by heaviness in chest then pain. Pain level fluctuates 2-3-5/10. Pain lasted 30 hours. Medical records state drug reaction, nausea, palpitaiton. msv
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cyanosis, Lethargy, Pallor
Clinical narrative: At home became pale, lethargic and lips turned gray to purple. EMTS called to home. Taken to hospital and admitted to Pediatric ICU.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Pt became short of breath and began to itch and rash. Sent to ER for treatment and evaluation.
Age: 0.45
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Crying, Irritability, Screaming, Somnolence
Clinical narrative: 2nd set, mother reported to physician that child was crying inconsolably after injections and was irritable and different for 7-10 days after. Her LOC was slightly drowsy all the time. She was eating and arousable but not the same. Dr will hold next pertussis injection. No problems w/ 1st set of immunizations.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site oedema
Clinical narrative: 10x9cm swelling with some extension to the knee from Dtap site.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Chills, Diarrhoea, Headache, Jaundice, Pyrexia
Clinical narrative: Pt c/o sudden onset of diarrhea severe headache and fever, chills. She was in bed most of the three days and she also developed jaundice. Symptoms resolved today (5/8/06).
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: At site of injection pt had developed enlarging area of circumferential erythema, edema and pain. No ulceration. Reaction developed 24 hrs post vaccination. Pt was tx'd for cellulitis.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema, Irritability
Clinical narrative: Mother reports infants left upper thigh is warm, swollen and reddened. Sl. fever. Reports infant is irritable. Mother reports right thigh has a knot at injection site.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Mother reports infants left upper thigh is warm, swollen and reddened. Sl. fever. Reports infant is irritable. Mother reports right thigh has a knot at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Tenderness
Clinical narrative: Pt developed 15x20cm area of edema with tenderness/induration and red. Lasted 72 hrs on left thigh site of Dtap and IPV.
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability
Clinical narrative: Post Pediarix/HIB/Prevnar 3/7/06 with 20 h of marked fussiness and then fine.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Injection site hypersensitivity, Injection site warmth, Tension
Clinical narrative: Immunization given left shoulder on 5/2/06. On 5/3/06 entire area over deltoid is red, very tense, warm, non tender. On 5/4/06 area increased to include entire upper arm, from elbow to top of shoulder.
Age: 64.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Injection site hypersensitivity, Injection site warmth, Pruritus, Urticaria
Clinical narrative: Occurred approx 5 days after shots. Right deltoid had an irregular, oval shaped warm red area approx 4x3". Hive like changed over several days. Sometimes area had ridges on edge, sometimes not. Severe itching. Used cold compresses. Resolved over 5 day period.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Iz on 5/3/06; onset 5/4/06 redness; slightly increased on 5/5/06 8cm erythema surrounding centrally cleared IZ. (+) erythema, (+) /// but good Rom, no c/o pain. Treated: ice, ibuprofen, observe and recheck 5/8/06.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Nausea, Pain
Clinical narrative: Received TD 5/2/06. on 5/4/06 had pain across entire back. ON 5/6/06 had pain in thighs. On 5/9/06 had severe nausea.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Bacterial infection, Blister, Pruritus, Rash
Clinical narrative: PRESENTED  IN OFFICE WITH C/O ITCHING AND RASH. ON AMOXIL SUSP FOR STREP SINCE 05/05/2006.ONSET OF RASH LAST PM.WATERY BLISTERS COVERING ENTIRE BODY.>50POX ON DAY 2 OF BREAKOUT
Age: 19.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Urticaria
Clinical narrative: Reportedly developed urticaria one following immunization with DTaP and Hepatitis B vaccines.  Symptoms lasted approximately one hour.  Later in the evening after taking a hot bath, the rash returned.  She took Benadryl and the rash resolved 30 minutes later.  She had no facial swelling or airway involvement.  She has no known allergies.  She does describe a prior occurrence about one year ago.  No trigger was identified at the time.  She was referred to clinic for recommendations regarding further vaccinations.
Age: 1.07
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Lymphadenopathy, Pyrexia, Scrotal oedema
Clinical narrative: Fever 100.5, generalized lymphadenopathy with testicular swelling
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash erythematous, Rash pustular
Clinical narrative: devoloped rash (red, raised, with pustules)and severe itching 1-3 days after vaccine. She was treated by primary care physician 05-03-06 with Decadron and Benadryl.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema
Clinical narrative: SWELLING, REDNESS, 1.5 HOURS AFTER ADMINISTRATION.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, OPV, VARCEL
Symptoms: Abasia, Eye movement disorder, Tremor
Clinical narrative: I had taken her to the Dr. because she was teething and pulling at her ears. Also Throwing up every once in a while. We arrived and fill in Dr. was seeing her. She determined that the patient had an DOUBLE EAR INFECTION.  It was then that she said that the patient was behind on 4 immunization shots. Then she asked me if she could go ahead and update her on all four of the shots. I looked at her puzzled and replied "If she has a double ear infection and is ill aren't you suppose to wait until the infection is gone?" she just said to me "Well that's only if she has a fever!" Two or Three times she assured me that it was normal for them to do so and so I agreed unwillingly. The Next Morning at 9:00am she woke up trembling, shaking, her eyes twitching backs and forth, and was unable to stand, walk or even crawl. She couldn't even control her arms good enough to pick up her food to feed herself.  Everything listed are everyday things that she performed all by herself on a daily basis. From that day forward each day we watched her regress all the way back to an infant, as far as her skills.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Abasia, Anorexia, Arthralgia, Arthritis, Hypokinesia
Clinical narrative: VACCINES WERE ADMINISTERED ON 3/24/06. ON 4/10/06 PT WAS SEEN WITH TONSILLITIS/PHARYNGITIS/ STOMATITIS, LOSS OF APPETITE, & A FINE MACULOPAPULAR ERYTHEMATOUS RASH.  A RAPID STREP & THROAT CULTURE WERE NEGATIVE. SHE WAS TREATED SYMPTOMATICALLY.  SHE WAS SEEN AGAIN ON 4/11/06 W/THE SAME S/S. SHE WAS SEEN AGAIN ON 4/12/06 WITH THE ADDITION OF ARTHRALGIA IN THE LEFT HIP & REFUSING TO BEAR WEIGHT.  SHE WAS DIAGNOSED WITH ARTHRALGIA OF THE LEFT HIP VS ARTHRITIS VS TENOSYNOVITIS VS FRACTURE.  X-RAYS REVEALED NO FRACTURES OR EVIDENCE OF SOFT TISSUE SWELLING.  SHE WAS TREATED SYMPTOMATICALLY & TO FOLLOW UP IN 24 HRS OR PRN. ON 4/13/06 SHE WAS FOUND TO HAVE IMPROVED SOMEWHAT THOUGH WAS STILL NOT WALKING. SHE WAS BEGINNING TO CRAWL & SIT AGAIN. ON 4/25/06 THE LEFT LEG APPEARED TO BE SOMEWHAT THINNER THAN THE RIGHT. SHE WOULD STAND ON THE RIGHT LEG WITH THE LEFT LEG FLEXED AT THE KNEE AND HIP JOINT WITH MINIMAL WEIGHT BEARING ON THE TOES.  THE RIGHT LEG IS MOVED MORE FREELY THAN THE LEFT.  LAB TESTS PERFORMED WERE ALL WNL WITH THE EXCEPTION OF A SLIGHTLY ELEVATED ESR (29 WITH THE NORMAL RANGE BEING 0-20).  A BONE SCAN WAS SCHEDULED. THE BONE SCAN PERFORMED ON 4/28/06 WAS INCONCLUSIVE W/THE RECOMMENDATION OF AN MRI.  THE INSURANCE DENIED THIS REQUEST & INSISTED THE PT BE SEEN BY AN ORTHOPEDIC. PT WAS SEEN ON 5/9/06 BY DR.  AT THIS POINT SHE WAS BEGINNING TO BEAR WEIGHT ON THE LEFT LEG & APPEARED TO BE IMPROVING, THOUGH NOT COMPLETELY BACK TO NORMAL. SHE IS SCHEDULED TO FOLLOW UP W/DR IN 3 WEEKS OR PRN.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Pharyngitis, Rash erythematous, Rash maculo-papular, Red blood cell sedimentation rate increased, Stomatitis
Clinical narrative: VACCINES WERE ADMINISTERED ON 3/24/06. ON 4/10/06 PT WAS SEEN WITH TONSILLITIS/PHARYNGITIS/ STOMATITIS, LOSS OF APPETITE, & A FINE MACULOPAPULAR ERYTHEMATOUS RASH.  A RAPID STREP & THROAT CULTURE WERE NEGATIVE. SHE WAS TREATED SYMPTOMATICALLY.  SHE WAS SEEN AGAIN ON 4/11/06 W/THE SAME S/S. SHE WAS SEEN AGAIN ON 4/12/06 WITH THE ADDITION OF ARTHRALGIA IN THE LEFT HIP & REFUSING TO BEAR WEIGHT.  SHE WAS DIAGNOSED WITH ARTHRALGIA OF THE LEFT HIP VS ARTHRITIS VS TENOSYNOVITIS VS FRACTURE.  X-RAYS REVEALED NO FRACTURES OR EVIDENCE OF SOFT TISSUE SWELLING.  SHE WAS TREATED SYMPTOMATICALLY & TO FOLLOW UP IN 24 HRS OR PRN. ON 4/13/06 SHE WAS FOUND TO HAVE IMPROVED SOMEWHAT THOUGH WAS STILL NOT WALKING. SHE WAS BEGINNING TO CRAWL & SIT AGAIN. ON 4/25/06 THE LEFT LEG APPEARED TO BE SOMEWHAT THINNER THAN THE RIGHT. SHE WOULD STAND ON THE RIGHT LEG WITH THE LEFT LEG FLEXED AT THE KNEE AND HIP JOINT WITH MINIMAL WEIGHT BEARING ON THE TOES.  THE RIGHT LEG IS MOVED MORE FREELY THAN THE LEFT.  LAB TESTS PERFORMED WERE ALL WNL WITH THE EXCEPTION OF A SLIGHTLY ELEVATED ESR (29 WITH THE NORMAL RANGE BEING 0-20).  A BONE SCAN WAS SCHEDULED. THE BONE SCAN PERFORMED ON 4/28/06 WAS INCONCLUSIVE W/THE RECOMMENDATION OF AN MRI.  THE INSURANCE DENIED THIS REQUEST & INSISTED THE PT BE SEEN BY AN ORTHOPEDIC. PT WAS SEEN ON 5/9/06 BY DR.  AT THIS POINT SHE WAS BEGINNING TO BEAR WEIGHT ON THE LEFT LEG & APPEARED TO BE IMPROVING, THOUGH NOT COMPLETELY BACK TO NORMAL. SHE IS SCHEDULED TO FOLLOW UP W/DR IN 3 WEEKS OR PRN.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Tenosynovitis, Tonsillitis
Clinical narrative: VACCINES WERE ADMINISTERED ON 3/24/06. ON 4/10/06 PT WAS SEEN WITH TONSILLITIS/PHARYNGITIS/ STOMATITIS, LOSS OF APPETITE, & A FINE MACULOPAPULAR ERYTHEMATOUS RASH.  A RAPID STREP & THROAT CULTURE WERE NEGATIVE. SHE WAS TREATED SYMPTOMATICALLY.  SHE WAS SEEN AGAIN ON 4/11/06 W/THE SAME S/S. SHE WAS SEEN AGAIN ON 4/12/06 WITH THE ADDITION OF ARTHRALGIA IN THE LEFT HIP & REFUSING TO BEAR WEIGHT.  SHE WAS DIAGNOSED WITH ARTHRALGIA OF THE LEFT HIP VS ARTHRITIS VS TENOSYNOVITIS VS FRACTURE.  X-RAYS REVEALED NO FRACTURES OR EVIDENCE OF SOFT TISSUE SWELLING.  SHE WAS TREATED SYMPTOMATICALLY & TO FOLLOW UP IN 24 HRS OR PRN. ON 4/13/06 SHE WAS FOUND TO HAVE IMPROVED SOMEWHAT THOUGH WAS STILL NOT WALKING. SHE WAS BEGINNING TO CRAWL & SIT AGAIN. ON 4/25/06 THE LEFT LEG APPEARED TO BE SOMEWHAT THINNER THAN THE RIGHT. SHE WOULD STAND ON THE RIGHT LEG WITH THE LEFT LEG FLEXED AT THE KNEE AND HIP JOINT WITH MINIMAL WEIGHT BEARING ON THE TOES.  THE RIGHT LEG IS MOVED MORE FREELY THAN THE LEFT.  LAB TESTS PERFORMED WERE ALL WNL WITH THE EXCEPTION OF A SLIGHTLY ELEVATED ESR (29 WITH THE NORMAL RANGE BEING 0-20).  A BONE SCAN WAS SCHEDULED. THE BONE SCAN PERFORMED ON 4/28/06 WAS INCONCLUSIVE W/THE RECOMMENDATION OF AN MRI.  THE INSURANCE DENIED THIS REQUEST & INSISTED THE PT BE SEEN BY AN ORTHOPEDIC. PT WAS SEEN ON 5/9/06 BY DR.  AT THIS POINT SHE WAS BEGINNING TO BEAR WEIGHT ON THE LEFT LEG & APPEARED TO BE IMPROVING, THOUGH NOT COMPLETELY BACK TO NORMAL. SHE IS SCHEDULED TO FOLLOW UP W/DR IN 3 WEEKS OR PRN.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Hyperhidrosis, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Pain at injection site Diaphoresis, no fever chills body aches headache stiff neck upset stomach/nausea
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pain, Stomach discomfort
Clinical narrative: Pain at injection site Diaphoresis, no fever chills body aches headache stiff neck upset stomach/nausea
Age: 0.22
Sex: F
Vaccine: DTAP
Symptoms: Anorexia, Convulsion, Crying, Laboratory test abnormal, Lethargy
Clinical narrative: Fever to 104, 3hrs after vaccination in physicians office: 12 hours after vaccination had tonic-clonic generalized seizure then lethargic with decrease oral intake: Neurology consult suspencts reaction to pertusis portion of vaccine 5/30/06 Received medical records from hospital which reveal patient experienced inconsolable screaming and febrile seizures 1 day after vaccination.  WBC 17,800, Temp 100.8. All cultures were neg & no further seizure activity noted.  Family hx of seizures in father & paternal grandmother (both related totraumatic brain injury).  Ped neuro recommended witholding further pertussis.  d/c home on 5/4/06 6/19/06 Records received from PCP whicl reveal patient had well child visit on day of vaccination/ss
Age: 0.22
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Screaming
Clinical narrative: Fever to 104, 3hrs after vaccination in physicians office: 12 hours after vaccination had tonic-clonic generalized seizure then lethargic with decrease oral intake: Neurology consult suspencts reaction to pertusis portion of vaccine 5/30/06 Received medical records from hospital which reveal patient experienced inconsolable screaming and febrile seizures 1 day after vaccination.  WBC 17,800, Temp 100.8. All cultures were neg & no further seizure activity noted.  Family hx of seizures in father & paternal grandmother (both related totraumatic brain injury).  Ped neuro recommended witholding further pertussis.  d/c home on 5/4/06 6/19/06 Records received from PCP whicl reveal patient had well child visit on day of vaccination/ss
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Dizziness, which started about 1pm (vaccination was given about 11:45 am, Mon. May 8, 2006. Very worrisome as I had to be very careful when I walked for fear of falling. Serious condition until about 3am Wednesday morn. Then sort of became light-headed throughout rest of Wednesday. It appears to be wearing off now(Wed. evening @ 6:30 pm).
Age: 17.0
Sex: F
Vaccine: LYME
Symptoms: Abnormal behaviour, Arthralgia, Asthenia, Balance disorder, Chills
Clinical narrative: This case was reported by a lawyer and described the occurrence of loss of concentration in a 17 yr old female pt who received Lyme disease vaccine recombinant OspA (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received LYMErix. At an unknown time after receiving Lymerix, the pt experienced fatigue, migraine headaches, myalgias, arthralgias, dizziness, gait disturbances, insomnia, numbness, loss of concentration, cognitive problems and fibromyalgia type symptoms with a SPECT (single photon emission computerized tomography) scan showing focally diminished cortical brain activity. Time to onset, treatment, and outcome were not reported. In a Statement of Injuries, the subject's attorney alleged that the subject suffers and has suffered from arthralgias myalgias, fatigue, headaches, swollen joints, loss of concentration, cognitive problems, difficulty breathing, vision problems, tinnitus, fever, chills, difficulty walking, difficulty writing, dizziness, flu-like symptoms, rashes, tingling, stiffness, weakness, balance problems, sleep problems, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and increased ability to participate in recreational activities. Future expedited reports for this Lymerix case shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily revoked license.
Age: 17.0
Sex: F
Vaccine: LYME
Symptoms: Cognitive disorder, Difficulty in walking, Disturbance in attention, Dizziness, Dysgraphia
Clinical narrative: This case was reported by a lawyer and described the occurrence of loss of concentration in a 17 yr old female pt who received Lyme disease vaccine recombinant OspA (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received LYMErix. At an unknown time after receiving Lymerix, the pt experienced fatigue, migraine headaches, myalgias, arthralgias, dizziness, gait disturbances, insomnia, numbness, loss of concentration, cognitive problems and fibromyalgia type symptoms with a SPECT (single photon emission computerized tomography) scan showing focally diminished cortical brain activity. Time to onset, treatment, and outcome were not reported. In a Statement of Injuries, the subject's attorney alleged that the subject suffers and has suffered from arthralgias myalgias, fatigue, headaches, swollen joints, loss of concentration, cognitive problems, difficulty breathing, vision problems, tinnitus, fever, chills, difficulty walking, difficulty writing, dizziness, flu-like symptoms, rashes, tingling, stiffness, weakness, balance problems, sleep problems, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and increased ability to participate in recreational activities. Future expedited reports for this Lymerix case shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily revoked license.
Age: 17.0
Sex: F
Vaccine: LYME
Symptoms: Dyspnoea, Fatigue, Gastrointestinal disorder, Headache, Immune system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of loss of concentration in a 17 yr old female pt who received Lyme disease vaccine recombinant OspA (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received LYMErix. At an unknown time after receiving Lymerix, the pt experienced fatigue, migraine headaches, myalgias, arthralgias, dizziness, gait disturbances, insomnia, numbness, loss of concentration, cognitive problems and fibromyalgia type symptoms with a SPECT (single photon emission computerized tomography) scan showing focally diminished cortical brain activity. Time to onset, treatment, and outcome were not reported. In a Statement of Injuries, the subject's attorney alleged that the subject suffers and has suffered from arthralgias myalgias, fatigue, headaches, swollen joints, loss of concentration, cognitive problems, difficulty breathing, vision problems, tinnitus, fever, chills, difficulty walking, difficulty writing, dizziness, flu-like symptoms, rashes, tingling, stiffness, weakness, balance problems, sleep problems, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and increased ability to participate in recreational activities. Future expedited reports for this Lymerix case shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily revoked license.
Age: 17.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Joint swelling, Musculoskeletal stiffness, Myalgia, Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of loss of concentration in a 17 yr old female pt who received Lyme disease vaccine recombinant OspA (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received LYMErix. At an unknown time after receiving Lymerix, the pt experienced fatigue, migraine headaches, myalgias, arthralgias, dizziness, gait disturbances, insomnia, numbness, loss of concentration, cognitive problems and fibromyalgia type symptoms with a SPECT (single photon emission computerized tomography) scan showing focally diminished cortical brain activity. Time to onset, treatment, and outcome were not reported. In a Statement of Injuries, the subject's attorney alleged that the subject suffers and has suffered from arthralgias myalgias, fatigue, headaches, swollen joints, loss of concentration, cognitive problems, difficulty breathing, vision problems, tinnitus, fever, chills, difficulty walking, difficulty writing, dizziness, flu-like symptoms, rashes, tingling, stiffness, weakness, balance problems, sleep problems, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and increased ability to participate in recreational activities. Future expedited reports for this Lymerix case shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily revoked license.
Age: 17.0
Sex: F
Vaccine: LYME
Symptoms: Paraesthesia, Pyrexia, Rash, Rheumatoid arthritis, Sleep disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of loss of concentration in a 17 yr old female pt who received Lyme disease vaccine recombinant OspA (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received LYMErix. At an unknown time after receiving Lymerix, the pt experienced fatigue, migraine headaches, myalgias, arthralgias, dizziness, gait disturbances, insomnia, numbness, loss of concentration, cognitive problems and fibromyalgia type symptoms with a SPECT (single photon emission computerized tomography) scan showing focally diminished cortical brain activity. Time to onset, treatment, and outcome were not reported. In a Statement of Injuries, the subject's attorney alleged that the subject suffers and has suffered from arthralgias myalgias, fatigue, headaches, swollen joints, loss of concentration, cognitive problems, difficulty breathing, vision problems, tinnitus, fever, chills, difficulty walking, difficulty writing, dizziness, flu-like symptoms, rashes, tingling, stiffness, weakness, balance problems, sleep problems, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and increased ability to participate in recreational activities. Future expedited reports for this Lymerix case shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily revoked license.
Age: 17.0
Sex: F
Vaccine: LYME
Symptoms: Tinnitus, Visual disturbance
Clinical narrative: This case was reported by a lawyer and described the occurrence of loss of concentration in a 17 yr old female pt who received Lyme disease vaccine recombinant OspA (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received LYMErix. At an unknown time after receiving Lymerix, the pt experienced fatigue, migraine headaches, myalgias, arthralgias, dizziness, gait disturbances, insomnia, numbness, loss of concentration, cognitive problems and fibromyalgia type symptoms with a SPECT (single photon emission computerized tomography) scan showing focally diminished cortical brain activity. Time to onset, treatment, and outcome were not reported. In a Statement of Injuries, the subject's attorney alleged that the subject suffers and has suffered from arthralgias myalgias, fatigue, headaches, swollen joints, loss of concentration, cognitive problems, difficulty breathing, vision problems, tinnitus, fever, chills, difficulty walking, difficulty writing, dizziness, flu-like symptoms, rashes, tingling, stiffness, weakness, balance problems, sleep problems, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and increased ability to participate in recreational activities. Future expedited reports for this Lymerix case shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily revoked license.
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Abnormal behaviour, Amnesia, Arthralgia, Autoimmune disorder, Cognitive disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of short term memory loss in a 58 yr old male pt who received Lyme disease vaccine recombinant injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received Lymerix. At an unknown time after receiving Lymerix, the pt experienced severe joint pain, fatigue, tingling, mental confusion, short term memory loss, and fibromyalgia type symptoms. Time to onset, treatment and outcome were not reported. in a statement of Injuries, the subject's attorney allege that the subject suffers and has suffered from pain and swelling in his joints, fatigue, rashes, tingling in extremities, headaches, muscle pain and weakness, cognitive problems,  loss of weight, sleep disturbances, gastrointestinal problems, urinary problems, sensitivity to light and noise, hearing loss, reproductive disturbances, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reported to be caused by vaccination with Lymerix. Future expedited reports for this Lymerix case shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily revoked license.
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Confusional state, Fatigue, Fibromyalgia, Gastrointestinal disorder, Headache
Clinical narrative: This case was reported by a lawyer and described the occurrence of short term memory loss in a 58 yr old male pt who received Lyme disease vaccine recombinant injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received Lymerix. At an unknown time after receiving Lymerix, the pt experienced severe joint pain, fatigue, tingling, mental confusion, short term memory loss, and fibromyalgia type symptoms. Time to onset, treatment and outcome were not reported. in a statement of Injuries, the subject's attorney allege that the subject suffers and has suffered from pain and swelling in his joints, fatigue, rashes, tingling in extremities, headaches, muscle pain and weakness, cognitive problems,  loss of weight, sleep disturbances, gastrointestinal problems, urinary problems, sensitivity to light and noise, hearing loss, reproductive disturbances, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reported to be caused by vaccination with Lymerix. Future expedited reports for this Lymerix case shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily revoked license.
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Hypoacusis, Joint swelling, Muscular weakness, Myalgia, Paraesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of short term memory loss in a 58 yr old male pt who received Lyme disease vaccine recombinant injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received Lymerix. At an unknown time after receiving Lymerix, the pt experienced severe joint pain, fatigue, tingling, mental confusion, short term memory loss, and fibromyalgia type symptoms. Time to onset, treatment and outcome were not reported. in a statement of Injuries, the subject's attorney allege that the subject suffers and has suffered from pain and swelling in his joints, fatigue, rashes, tingling in extremities, headaches, muscle pain and weakness, cognitive problems,  loss of weight, sleep disturbances, gastrointestinal problems, urinary problems, sensitivity to light and noise, hearing loss, reproductive disturbances, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reported to be caused by vaccination with Lymerix. Future expedited reports for this Lymerix case shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily revoked license.
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Photophobia, Rash, Sleep disorder, Urine analysis abnormal, Weight decreased
Clinical narrative: This case was reported by a lawyer and described the occurrence of short term memory loss in a 58 yr old male pt who received Lyme disease vaccine recombinant injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received Lymerix. At an unknown time after receiving Lymerix, the pt experienced severe joint pain, fatigue, tingling, mental confusion, short term memory loss, and fibromyalgia type symptoms. Time to onset, treatment and outcome were not reported. in a statement of Injuries, the subject's attorney allege that the subject suffers and has suffered from pain and swelling in his joints, fatigue, rashes, tingling in extremities, headaches, muscle pain and weakness, cognitive problems,  loss of weight, sleep disturbances, gastrointestinal problems, urinary problems, sensitivity to light and noise, hearing loss, reproductive disturbances, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reported to be caused by vaccination with Lymerix. Future expedited reports for this Lymerix case shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily revoked license.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Erythema, Irritability
Clinical narrative: Information has been received from a woman working in a physicians office concerning a 15 month old male with gastroesophageal reflux disease, Pierre Robin Sequence, for which he has a gastrostomy tub, and an allergy to bananas, who on 4/19/2006, at 100:00am, was vaccinated with a 0.5ml, one time, subcutaneous dose in the left anterior thigh of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella Virus Vaccine live (upgrade process) (lot 651814/0771R). Concomitant therapy included metoclopramide hydrochloride Reglan and lansoprazole Prevacid, 15 mg. There was no illness at the time of vaccination and no adverse events following prior vaccination. On 4/19/2006, within 60 minutes of the vaccination, at approximately 11:00am, the patient experienced fussing and diffuse erythema all over his body. The patient returned to the office at noon. The patient was treated with dexamethasone MSD, 5mg, intramuscular and diphenhydramine hydrochloride (Benadryl) 12.5 mg per teaspoon, 3/4 teaspoonful, oral administration. It was noted that the patients symptoms resolved the same day and was considered recovered. It was noted that the patient has never had eggs. No product quality complaint was involved. No other information was provided. The patients reaction were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Agitation, Crying, Erythema
Clinical narrative: Information has been received from a woman working in a physicians office concerning a 15 month old male with gastroesophageal reflux disease, Pierre Robin Sequence, for which he has a gastrostomy tub, and an allergy to bananas, who on 4/19/2006, at 100:00am, was vaccinated with a 0.5ml, one time, subcutaneous dose in the left anterior thigh of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella Virus Vaccine live (upgrade process) (lot 651814/0771R). Concomitant therapy included metoclopramide hydrochloride Reglan and lansoprazole Prevacid, 15 mg. There was no illness at the time of vaccination and no adverse events following prior vaccination. On 4/19/2006, within 60 minutes of the vaccination, at approximately 11:00am, the patient experienced fussing and diffuse erythema all over his body. The patient returned to the office at noon. The patient was treated with dexamethasone MSD, 5mg, intramuscular and diphenhydramine hydrochloride (Benadryl) 12.5 mg per teaspoon, 3/4 teaspoonful, oral administration. It was noted that the patients symptoms resolved the same day and was considered recovered. It was noted that the patient has never had eggs. No product quality complaint was involved. No other information was provided. The patients reaction were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Pt went through ER on 4/27/2006.  Dx c seizure disorder & transferred to Hospital
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Crying, Pyrexia, Screaming, Vaccination complication
Clinical narrative: Initial report received on 4/27/2006 from a health care provider. A two month old female patient, had received her first intramuscular dose of ActHib, lot number UE868AA, SA lot number Z0450-2, in the right thigh, a first  intramuscular dose of Daptacel, lot number C2406AA, in the left thigh, a first subcutaneous dose of IPOL, lot number X1050, in the left thigh, and a first administration route not reported for Prevnar, lot number 817697K, in the right thigh on 4/17/2006 at approximately 10:30 am. 150 minutes post immunization, at 1:00pm on 4/17/2006, it was reported that the patient cried and screamed for two hours, would not feed, and had a low grade temperature of 99.9 deg F. She was admitted to the hospital for one day, and subsequently recovered. The patient had previously received a second intramuscular dose per reporter of hepatitis B vaccine lot number 0505R, in the left thigh on 2/15/2006. She did not have an adverse effect following this vaccination. The reporter for this case is the same as for cases 200600951 and 200600952.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Crying, Pyrexia, Screaming
Clinical narrative: Initial report received on 4/27/2006 from a health care provider. A two month old female patient, had received her first intramuscular dose of ActHib, lot number UE868AA, SA lot number Z0450-2, in the right thigh, a first  intramuscular dose of Daptacel, lot number C2406AA, in the left thigh, a first subcutaneous dose of IPOL, lot number X1050, in the left thigh, and a first administration route not reported for Prevnar, lot number 817697K, in the right thigh on 4/17/2006 at approximately 10:30 am. 150 minutes post immunization, at 1:00pm on 4/17/2006, it was reported that the patient cried and screamed for two hours, would not feed, and had a low grade temperature of 99.9 deg F. She was admitted to the hospital for one day, and subsequently recovered. The patient had previously received a second intramuscular dose per reporter of hepatitis B vaccine lot number 0505R, in the left thigh on 2/15/2006. She did not have an adverse effect following this vaccination. The reporter for this case is the same as for cases 200600951 and 200600952.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Crying, Screaming, Vaccination complication
Clinical narrative: A two month old male patient, had received his first intra muscular dose of ActHib, lot number UE858AA (SA lot number Z0450-2), in the right thigh, a first intra muscular dose of Daptacel, lot number C2406AA, in the left high, a first subcutaneous dose of IPOL, lot number X1050, in the left thigh, and a first intramuscular dose of Prevnar, lot number 8176971K, in the right thigh on 4/26/2006 at 10:30am. 90 minutes post immunization, the patient started crying. The mother called the nurse, and reported that the patient had cried for three hours and would not nurse. The event was described as strange crying. The patient was evaluated by the physician, and admitted to the hospital overnight for close observation. The patients recovery status was not reported. The reporter for this case is the same as for cases 200600951, and 200600953.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Crying, Screaming
Clinical narrative: A two month old male patient, had received his first intra muscular dose of ActHib, lot number UE858AA (SA lot number Z0450-2), in the right thigh, a first intra muscular dose of Daptacel, lot number C2406AA, in the left high, a first subcutaneous dose of IPOL, lot number X1050, in the left thigh, and a first intramuscular dose of Prevnar, lot number 8176971K, in the right thigh on 4/26/2006 at 10:30am. 90 minutes post immunization, the patient started crying. The mother called the nurse, and reported that the patient had cried for three hours and would not nurse. The event was described as strange crying. The patient was evaluated by the physician, and admitted to the hospital overnight for close observation. The patients recovery status was not reported. The reporter for this case is the same as for cases 200600951, and 200600953.
Age: 1.04
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: Urticaria, started <24 hours after vaccine administration.  treated with benadryl.
Age: 0.58
Sex: M
Vaccine: DT
Symptoms: Fontanelle bulging, Irritability, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Seriousness criteria other medically significant (OMIC). From initial information received on 4/27/2006 from a literature report, it was reported that a 7 month old male patient, who as 5 months of age had received budging fontanelle and fever following second dose of diphtheria tetanus pertussis vaccine DTP 2, and second dose of trivalent oral poliovirus vaccine OPV 2, received diphtheria tetanus vaccine DT 3. The manufacturer, route and site of administration were not reported for either vaccine. On day post immunization, the patient was found to have bulging fontanelle and fever. He did not require hospitalization and his physical exam was normal. No CBC or lumbar puncture for CSF was complete. The patient recovered one day after the onset of the adverse events. Reportedly there were no conditions ore exposure EG steroids that could have explained the event of bulging fontanelle. Subsequent followup determined that the patient was normal neurologically and developmentally. The reporter for this case is the same as for cases 200600970 to 200600976, 200600979, and 200600980.
Age: 0.58
Sex: M
Vaccine: DT
Symptoms: Fontanelle bulging, Irritability, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Seriousness criteria other medically significant (OMIC). From initial information received on 4/27/2006 from a literature report, it was reported that a 7 month old male patient, who as 5 months of age had received budging fontanelle and fever 1 day post immunization with third dose of diphtheria tetanus pertussis vaccine DTP 3, the manufacturer, route and site of administration were not reported. The same patient had bulging fontanelle and irritability at 3 months of age following first dose of diphtheria tetanus pertussis vaccine DTP 1, and a first dose of trivalent oral poliovirus vaccine IPV 1, and had a repeated such occurrence accompanied by fever at 5 months of age (after administration of diphtheria tetanus vaccine DT 1, and a second dose of trivalent oral poliovirus vaccine OPV 2. The patient did not require hospitalization and his physical exam was normal. No CBC or lumbar puncture for CSF was complete. The patient recovered one day after the onset of the adverse events. Reportedly there were no conditions or exposure EG steroids that could have explained the event of bulging fontanelle. Subsequent followup determined that the patient was normal neurologically and developmentally. Case 200600973 captures the patients events at 5 months of age.  The reporter of this event is the same as for cases 200600970 to 200600976, 200600979.
Age: 0.42
Sex: M
Vaccine: DTP, OPV
Symptoms: Fontanelle bulging, Irritability, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Seriousness criteria other medically significant (OMIC). From initial information received on 4/27/2006 from a literature report, it was reported that a 5 month old male patient, who at 3 months of age had received budging fontanelle and irritability following first dose of diphtheria tetanus pertussis vaccine DTP 1, and first dose of trivalent oral poliovirus vaccine OPV 1, administration, received diphtheria tetanus vaccine DT 1, and a second dose of trivalent oral poliovirus vaccine OPV 2. The manufacturer, route and sites of administration were not reported for either vaccine. One day post immunization, the patient was found to have bulging fontanelle, irritability and fever. He did not require hospitalization, and did not have a CBC or lumbar puncture for CSF completed. His physical exam was normal, and he recovered one day after the onset of the adverse events. The patient subsequently received a second dose of DT 2 at age seven month and again experienced a bulging fontanelle without any associated symptoms. Reportedly there were no conditions or exposures eg steroids that could have explained the event of bulging fontanelle. Subsequent follow up determined that the patient was normal neurologically and developmentally. Case 200600970 captures the patients event at 3 months of age. The reporter of this event is the same as for cases 200600970 to 200600976, case 200600980 and 200601056.