chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Skin disorder, Somnolence, Type 2 diabetes mellitus, Visual impairment
Clinical narrative: MUSCULAR PAIN SKIN RASH RED SKIN HIGH BLOOD PRESURE 11/13/06 Received medical records from VAMC which reveal patient experienced HTN, high cholesterol & high triglycerides, right knee & left shoulder pain, obesity, NIDDM. Per 60 day follow up: Muscle and joint pain, skin problems or rash, red skin, eye problems, memory problems, cramps leg and cramps arm, drowsiness, fatigue, headaches, appetite problems. Follow-up: Dry skin problems and rash. Red skin, vision problems, memory or brain problems, headache frequently, drowsiness, fatigue, muscle and joint paint, cramps in my legs and arms, appetite lost, diabetes, high blood pressure. After that vaccination I report this symptoms and I am not be the same person before this vaccination.
Age: 60.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Influenza like illness, Myalgia, Night sweats, Pain
Clinical narrative: High fever, severe muscle and body as a whole aches, night sweats, chills.  Full scale flu-like symptoms excepting respiratory.
Age: 60.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: High fever, severe muscle and body as a whole aches, night sweats, chills.  Full scale flu-like symptoms excepting respiratory.
Age: 31.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Convulsion
Clinical narrative: Reported on 10/10/06 that she had seizure (absence of reality) approximately one hour after having had vaccines of MMR and Fluzone. States she has had "controlled seizure disorder" on Depakote and has only had one other "seizure" episode.  She has had MMR and Td previously on the same day without problems. She stated she took Benadryl and then slept. She stated the following morning she awoke feeling much better. Has scheduled appt. with neurologist on 10/12/06 for regular annual visit.
Age: 65.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injection site vesicles, Rash erythematous
Clinical narrative: Patient describes a raised, itching, and blistering rash on right arm extending below vaccination site. Onset occured about 4 days after administration of vaccine. She was seen by her primary care MD who prescribed "Delavil" cream for the itching. Two-weeks post vaccine, she states rash "comes and goes" now.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling jittery, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Patient developed an immediate swelling at site of injection.  She did not report discomfort, just some stiffness.  Observed for 30 minutes, then patient felt jittery.  Observed for another 20 minutes and took a BP reading, which was 196/113.  Patient reported uncontrolled BP for the past week. Administered 25 mg diphenhydramine PO.  Swelling began to subside.
Age: 29.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Arthralgia, Asthenia, Dizziness, Hypoaesthesia, Joint stiffness
Clinical narrative: Patient states received MMR and Hep B vaccines on Oct 6, 2006.  In the next 48 hours her joints felt stiff, achy and she felt dizzy.  On Oct. 9 she began to have numbness entire length of left lower extremity, with her knee feeling weak.  She has a history of Multiple sclerosis with a remote episode in the past affecting the R lower extremity.  She is on no treatment for MS.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Skin nodule
Clinical narrative: Received IM Influenza vaccine 31 Oct 2003 to right deltoid w/mass and tenderness to site area. Approximately 01 Nov 2003 he noted slt tender mass rt supraclavicular area. Denies dental procedure, fever, chills, n/v, shortness of breath, cough, sore throat, dysphagia, smoking. DID have hx abd pain, loose stool prior to vac. HX HTN, lipomas, migraines. Seen by Surgery clinic and Occ health with dx enlarged rt supraclavicular node, poss hilar adenopathy rt upper lung field  11 Oct 2006: 1 Node still present @ 1/2-1cm size, mobile to mid subclavicular nodal region; mobile and non-tender.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 48 hours after vaccination, mother noticed edema and erythema at the vaccination site (left leg). No fever.
Age: 79.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: Had slight nausea on AM of 10/06 which progressively worsened and developed dizziness and diarrhea also. Still c/o symptoms today.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscle twitching, Paraesthesia
Clinical narrative: Received flu vaccine on 10/11 at 11:45am in employee health. received in right upper arm. developed numbness in right arm and fingers. then developed numbness in face with right side being greater than left several minutes after injection. right eye began to twitch for 30 minutes. pressure around right eye. numbness started to subside in about one hour but fingers and right side of face, especially under right eye, continues to feel numb and tingly. face and fingers remain to feel slightly numb and tingling several hours later. pressure continues around right eye with numbness under right eye several hours post injection.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Agitation, Asthenia, Chest pain, Chills
Clinical narrative: Received MMR on 9/26/2006.  Symptoms began one week ago.  During the past week, client has had 3 different episodes of chilling; also has had chest pain with in the past week, this was described as a dull ache with occasional sharp pain.  During this time, she has also complained of anterior and posterior back and lung pain.  During the past week, she has also noted some behavioral changes.  She described these changes as being agitated, along with being irritated to the point of paranoia.  She states she has had a heightened sense of awareness, has been overly irritated by things that should not have bothered her, and also complained of nervousness.  Within the past two days, she states she has had a headache and an overall sense of ill feeling.  On October 10, she states she developed symptoms of weakness, dizziness, and difficulty breathing.  The difficulty breathing and chest discomfort has continued throughout the day today, and she states she is slow, lethargic, and has to consciously form her words. Her temperature today was 98.7F.   Due to described symptoms of chest pain and difficulty breathing, was instructed to seek medical care.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Dyspnoea, Headache, Irritability, Lethargy
Clinical narrative: Received MMR on 9/26/2006.  Symptoms began one week ago.  During the past week, client has had 3 different episodes of chilling; also has had chest pain with in the past week, this was described as a dull ache with occasional sharp pain.  During this time, she has also complained of anterior and posterior back and lung pain.  During the past week, she has also noted some behavioral changes.  She described these changes as being agitated, along with being irritated to the point of paranoia.  She states she has had a heightened sense of awareness, has been overly irritated by things that should not have bothered her, and also complained of nervousness.  Within the past two days, she states she has had a headache and an overall sense of ill feeling.  On October 10, she states she developed symptoms of weakness, dizziness, and difficulty breathing.  The difficulty breathing and chest discomfort has continued throughout the day today, and she states she is slow, lethargic, and has to consciously form her words. Her temperature today was 98.7F.   Due to described symptoms of chest pain and difficulty breathing, was instructed to seek medical care.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Nervousness, Paranoia
Clinical narrative: Received MMR on 9/26/2006.  Symptoms began one week ago.  During the past week, client has had 3 different episodes of chilling; also has had chest pain with in the past week, this was described as a dull ache with occasional sharp pain.  During this time, she has also complained of anterior and posterior back and lung pain.  During the past week, she has also noted some behavioral changes.  She described these changes as being agitated, along with being irritated to the point of paranoia.  She states she has had a heightened sense of awareness, has been overly irritated by things that should not have bothered her, and also complained of nervousness.  Within the past two days, she states she has had a headache and an overall sense of ill feeling.  On October 10, she states she developed symptoms of weakness, dizziness, and difficulty breathing.  The difficulty breathing and chest discomfort has continued throughout the day today, and she states she is slow, lethargic, and has to consciously form her words. Her temperature today was 98.7F.   Due to described symptoms of chest pain and difficulty breathing, was instructed to seek medical care.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Tdap vaccine administered on 9/6/06 at approximately 4:00 PM.  Mother called the next day (9/7/2006) reporting a fever of 100.9 degrees and c/o stinging in her back and "nerve shocks" down both arms.  No pain, swelling, redness or tenderness at injection site.    9/8/2006 mother contacted their PA and reported above symptoms with pain in knees, back, palms of hands, ankles and legs.  PA phoned Health Department for recommendation.  9/11/06  Mom reports she is back to normal but requests that VAERS report be completed.  Fever broke 9/8/2006 about noon and other symptoms disappeared at that time as well.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE WAS RED, HOT, AND SWOLLEN. DAD NOTICED REACTION 1-2 DAYS AFTER INJECTION. RED, SWOLLEN AREA ABOUT 3" IN DIAMETER.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye discharge, Face oedema, Headache, Heart rate increased
Clinical narrative: Fever of 101.8, moderate muscle ache over entire body, headache, chills, red eyes (with some white-ish discharge), racing heart beat, swelling of face, fingers, injection site soreness, sore throat. Symptoms were extreme enough to force bed rest. Took Ibuprofen which eased the symptoms.  Most symptoms were gone by following morning except injection site soreness.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Ocular hyperaemia, Oedema peripheral, Pharyngolaryngeal pain
Clinical narrative: Fever of 101.8, moderate muscle ache over entire body, headache, chills, red eyes (with some white-ish discharge), racing heart beat, swelling of face, fingers, injection site soreness, sore throat. Symptoms were extreme enough to force bed rest. Took Ibuprofen which eased the symptoms.  Most symptoms were gone by following morning except injection site soreness.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever of 101.8, moderate muscle ache over entire body, headache, chills, red eyes (with some white-ish discharge), racing heart beat, swelling of face, fingers, injection site soreness, sore throat. Symptoms were extreme enough to force bed rest. Took Ibuprofen which eased the symptoms.  Most symptoms were gone by following morning except injection site soreness.
Age: 1.13
Sex: M
Vaccine: HIBV, MEA, PNC, VARCEL
Symptoms: Rash papular
Clinical narrative: Pt presents eleven days s/p varicella vaccination with a papular rash spinkled over the abdomen, back, face and into hair at nape. Rash was just emerging on legs. Pt was given BENADRYL .25 tsp q6-8 hours PRN itching.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: On 10/11/2006 at approximately 08:30 a.m, the above named employee received the Inactivated Influenza Vaccine (Right Deltoid) and a PPD SKIN Test (Left Arm).  She states that approx. 1 hour post vaccination she developed on LUE fine raised red rash on the LUE spreading to BUE's and back. Other symptoms include generalized pruritis.  Denies respiratory symptoms, Chest pains, or SOB at time of report.   10/11/06 Approx.12:00 Noon:  The employee  report that she recieved a Cortisone Injection from her treating physician for a plantar fascitis problem.  10/11/06 @ 16:30:  The employee presented to the Employee Health Office to report a possible vaccine adverse reaction to the flu shot based on the above symptomology reported.   - Employee self medicated with 2 Benadryl   (50mg total) with little relief at time of report.   -Employeee reports a history of multiple medical conditions.   -Denies adverse reactions with previous Flu vaccine given in 2005. - Employee was referred for further medial evaluation.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site oedema, Pyrexia
Clinical narrative: Fever, chills, swollen around injection Tylenol.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Erythema, Fatigue, Hangover, Headache
Clinical narrative: 5 hrs after receiving vaccine, pt experienced large reaction with red itchy raised lesion, followed by generalized itching (esp of scalp), fatigue, unarousable sleep for over 8 hours, hang over in am, Headache, nausea and muscle aches.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Myalgia, Nausea, Pruritus, Skin ulcer
Clinical narrative: 5 hrs after receiving vaccine, pt experienced large reaction with red itchy raised lesion, followed by generalized itching (esp of scalp), fatigue, unarousable sleep for over 8 hours, hang over in am, Headache, nausea and muscle aches.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Rash
Clinical narrative: The pt had an injection site reaction a red band went around her arm and she had a rash in her armpit. Also she had flu like reaction for 12 hrs (this was right arm), she took Benadryl and was fine her husband is MD.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Nonspecific reaction, Paraesthesia, Sensation of pressure, Sensory disturbance
Clinical narrative: 12 Hours after Menactra, pt developed a sensation of tightness over extremities (UE and LE) which developed over 3 days into weakness of B UE and LLE. She was evaluated by neurology who did not believe pt was CXN Gillian Barr. Symptoms revolved over 2 weeks. 01/09/07-records received and reviewed from Dr. for DOS 8/22/06-Impression: 12 hours after receiving meningitis vaccine developed tingling in her left foot and a pressure sensation in her left leg and then tingling in her arms. All of these symptoms have been transient. No evidence of GBS, the paresthesias may reflect a mild reaction to the meningitis vaccination in which these symptoms will probably melt away over the next week
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Warm, Red, Swollen area at site of vaccination.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Abnormal behaviour, Aggression, Antisocial behaviour, Autism, Cognitive disorder
Clinical narrative: This case was considered medically important (OMIC). Information (medical records) regarding Hib Titer vaccine was received from an attorney regards a male pt who received th fourth dose on 12/15/1992 and the first dose of MMR on that same Day. On 1/31/1997, at the age of 5 years old, the pt was diagnosed with pervasive developmental disorder and autism. Relevant medical history was not provided Indication for Hib titer vaccine was immunisation. Product was administered on 12/15/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Diphtheria and Tetanus Toxoids and Pertussis, Hep B vaccine, Poliomyelitis vaccine, MMR, Varicella, TD. Concomitant medications were not reported. On 1/31/97 the pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and autistic features (autism). It was noted that during observation, pt exhibited a lack of social interaction with peers, limited interaction with adult, echolalia, pronominal confusion, and inappropriate and restricted affect.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Constipation, Dermatitis atopic, Drug abuser, Drug toxicity, Emotional disorder
Clinical narrative: This case was considered medically important (OMIC). Information (medical records) regarding Hib Titer vaccine was received from an attorney regards a male pt who received th fourth dose on 12/15/1992 and the first dose of MMR on that same Day. On 1/31/1997, at the age of 5 years old, the pt was diagnosed with pervasive developmental disorder and autism. Relevant medical history was not provided Indication for Hib titer vaccine was immunisation. Product was administered on 12/15/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Diphtheria and Tetanus Toxoids and Pertussis, Hep B vaccine, Poliomyelitis vaccine, MMR, Varicella, TD. Concomitant medications were not reported. On 1/31/97 the pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and autistic features (autism). It was noted that during observation, pt exhibited a lack of social interaction with peers, limited interaction with adult, echolalia, pronominal confusion, and inappropriate and restricted affect.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Fall, Gastroenteritis, Haematoma, Hypersensitivity, Hypokinesia
Clinical narrative: This case was considered medically important (OMIC). Information (medical records) regarding Hib Titer vaccine was received from an attorney regards a male pt who received th fourth dose on 12/15/1992 and the first dose of MMR on that same Day. On 1/31/1997, at the age of 5 years old, the pt was diagnosed with pervasive developmental disorder and autism. Relevant medical history was not provided Indication for Hib titer vaccine was immunisation. Product was administered on 12/15/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Diphtheria and Tetanus Toxoids and Pertussis, Hep B vaccine, Poliomyelitis vaccine, MMR, Varicella, TD. Concomitant medications were not reported. On 1/31/97 the pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and autistic features (autism). It was noted that during observation, pt exhibited a lack of social interaction with peers, limited interaction with adult, echolalia, pronominal confusion, and inappropriate and restricted affect.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Injury, Mental impairment, Mental retardation severity unspecified, Otitis media, Pharyngitis
Clinical narrative: This case was considered medically important (OMIC). Information (medical records) regarding Hib Titer vaccine was received from an attorney regards a male pt who received th fourth dose on 12/15/1992 and the first dose of MMR on that same Day. On 1/31/1997, at the age of 5 years old, the pt was diagnosed with pervasive developmental disorder and autism. Relevant medical history was not provided Indication for Hib titer vaccine was immunisation. Product was administered on 12/15/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Diphtheria and Tetanus Toxoids and Pertussis, Hep B vaccine, Poliomyelitis vaccine, MMR, Varicella, TD. Concomitant medications were not reported. On 1/31/97 the pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and autistic features (autism). It was noted that during observation, pt exhibited a lack of social interaction with peers, limited interaction with adult, echolalia, pronominal confusion, and inappropriate and restricted affect.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Pigmentation disorder, Pityriasis rosea, Pollakiuria, Psychomotor hyperactivity, Rhinitis
Clinical narrative: This case was considered medically important (OMIC). Information (medical records) regarding Hib Titer vaccine was received from an attorney regards a male pt who received th fourth dose on 12/15/1992 and the first dose of MMR on that same Day. On 1/31/1997, at the age of 5 years old, the pt was diagnosed with pervasive developmental disorder and autism. Relevant medical history was not provided Indication for Hib titer vaccine was immunisation. Product was administered on 12/15/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Diphtheria and Tetanus Toxoids and Pertussis, Hep B vaccine, Poliomyelitis vaccine, MMR, Varicella, TD. Concomitant medications were not reported. On 1/31/97 the pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and autistic features (autism). It was noted that during observation, pt exhibited a lack of social interaction with peers, limited interaction with adult, echolalia, pronominal confusion, and inappropriate and restricted affect.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Rhinitis allergic, Speech disorder, Viral infection
Clinical narrative: This case was considered medically important (OMIC). Information (medical records) regarding Hib Titer vaccine was received from an attorney regards a male pt who received th fourth dose on 12/15/1992 and the first dose of MMR on that same Day. On 1/31/1997, at the age of 5 years old, the pt was diagnosed with pervasive developmental disorder and autism. Relevant medical history was not provided Indication for Hib titer vaccine was immunisation. Product was administered on 12/15/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Diphtheria and Tetanus Toxoids and Pertussis, Hep B vaccine, Poliomyelitis vaccine, MMR, Varicella, TD. Concomitant medications were not reported. On 1/31/97 the pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and autistic features (autism). It was noted that during observation, pt exhibited a lack of social interaction with peers, limited interaction with adult, echolalia, pronominal confusion, and inappropriate and restricted affect.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Abnormal behaviour, Antisocial behaviour, Autism, Confusional state, Echolalia
Clinical narrative: This case was considered medically important (OMIC). Information (medical records) regarding Hib Titer vaccine was received from an attorney regards a male pt who received th fourth dose on 12/15/1992 and the first dose of MMR on that same Day. On 1/31/1997, at the age of 5 years old, the pt was diagnosed with pervasive developmental disorder and autism. Relevant medical history was not provided Indication for Hib titer vaccine was immunisation. Product was administered on 12/15/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Diphtheria and Tetanus Toxoids and Pertussis, Hep B vaccine, Poliomyelitis vaccine, MMR, Varicella, TD. Concomitant medications were not reported. On 1/31/97 the pt was diagnosed with pervasive developmental disorder (autism spectrum disorder) and autistic features (autism). It was noted that during observation, pt exhibited a lack of social interaction with peers, limited interaction with adult, echolalia, pronominal confusion, and inappropriate and restricted affect.
Age: 1.42
Sex: M
Vaccine: HEP, HEP, HIBV, MMR
Symptoms: Autism, Bronchitis, Conjunctivitis, Cough, Gastroenteritis
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib injection (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 12/17/1999 along with the second dose of Hep B vaccine (manufacturer unk) and the first dose of MMR (manufacturer unk) at the age of 17 months. On 4/6/00, at the age of 20 months, the pt experienced pervasive development disorder. On 7/26/01, at the age of 3 years, the pt was diagnosed with autism. The pt has a past history of ear infection (one at 1 year of age and several by 4/6/00). Indication for Hib was immunization. Product was administered on 12/17/1999. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DPT, Polio, Hep B, Varicella and Prevnar. Concomitant medications were not reported. On 12/17/1999, the pt received the third dose of Hib vaccine along with other childhood vaccine. On 3/17/00, physician notes had a question mark about combining words, suggesting some delay of speech at the time. On 4/6/00 physician notes reported that the pt said DaDa and MaMa then stopped speaking and said E all day. The physician also noted that the child would play only with adults. The physicians impression was pervasive development disorder (autism spectrum disorder). Treatment included Nystatin. On 7/26/2001, the child was diagnosed with autism. It was unknown if the pt recovered from the events.
Age: 1.42
Sex: M
Vaccine: HEP, HEP, HIBV, MMR
Symptoms: Hypoacusis, Lymphocytosis, Mental retardation severity unspecified, Nasopharyngitis, Otitis media
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib injection (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 12/17/1999 along with the second dose of Hep B vaccine (manufacturer unk) and the first dose of MMR (manufacturer unk) at the age of 17 months. On 4/6/00, at the age of 20 months, the pt experienced pervasive development disorder. On 7/26/01, at the age of 3 years, the pt was diagnosed with autism. The pt has a past history of ear infection (one at 1 year of age and several by 4/6/00). Indication for Hib was immunization. Product was administered on 12/17/1999. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DPT, Polio, Hep B, Varicella and Prevnar. Concomitant medications were not reported. On 12/17/1999, the pt received the third dose of Hib vaccine along with other childhood vaccine. On 3/17/00, physician notes had a question mark about combining words, suggesting some delay of speech at the time. On 4/6/00 physician notes reported that the pt said DaDa and MaMa then stopped speaking and said E all day. The physician also noted that the child would play only with adults. The physicians impression was pervasive development disorder (autism spectrum disorder). Treatment included Nystatin. On 7/26/2001, the child was diagnosed with autism. It was unknown if the pt recovered from the events.
Age: 1.42
Sex: M
Vaccine: HEP, HEP, HIBV, MMR
Symptoms: Pharyngitis, Pyrexia, Rash, Rash papular, Rhinitis
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib injection (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 12/17/1999 along with the second dose of Hep B vaccine (manufacturer unk) and the first dose of MMR (manufacturer unk) at the age of 17 months. On 4/6/00, at the age of 20 months, the pt experienced pervasive development disorder. On 7/26/01, at the age of 3 years, the pt was diagnosed with autism. The pt has a past history of ear infection (one at 1 year of age and several by 4/6/00). Indication for Hib was immunization. Product was administered on 12/17/1999. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DPT, Polio, Hep B, Varicella and Prevnar. Concomitant medications were not reported. On 12/17/1999, the pt received the third dose of Hib vaccine along with other childhood vaccine. On 3/17/00, physician notes had a question mark about combining words, suggesting some delay of speech at the time. On 4/6/00 physician notes reported that the pt said DaDa and MaMa then stopped speaking and said E all day. The physician also noted that the child would play only with adults. The physicians impression was pervasive development disorder (autism spectrum disorder). Treatment included Nystatin. On 7/26/2001, the child was diagnosed with autism. It was unknown if the pt recovered from the events.
Age: 1.42
Sex: M
Vaccine: HEP, HEP, HIBV, MMR
Symptoms: Rhinitis allergic, Sinusitis, Somnolence, Tonsillitis, Upper respiratory tract infection
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib injection (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 12/17/1999 along with the second dose of Hep B vaccine (manufacturer unk) and the first dose of MMR (manufacturer unk) at the age of 17 months. On 4/6/00, at the age of 20 months, the pt experienced pervasive development disorder. On 7/26/01, at the age of 3 years, the pt was diagnosed with autism. The pt has a past history of ear infection (one at 1 year of age and several by 4/6/00). Indication for Hib was immunization. Product was administered on 12/17/1999. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DPT, Polio, Hep B, Varicella and Prevnar. Concomitant medications were not reported. On 12/17/1999, the pt received the third dose of Hib vaccine along with other childhood vaccine. On 3/17/00, physician notes had a question mark about combining words, suggesting some delay of speech at the time. On 4/6/00 physician notes reported that the pt said DaDa and MaMa then stopped speaking and said E all day. The physician also noted that the child would play only with adults. The physicians impression was pervasive development disorder (autism spectrum disorder). Treatment included Nystatin. On 7/26/2001, the child was diagnosed with autism. It was unknown if the pt recovered from the events.
Age: 1.42
Sex: M
Vaccine: HEP, HEP, HIBV, MMR
Symptoms: Antisocial behaviour, Autism, Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Medical records regarding Hib injection (manufacturer unk) were received from an attorney regarding a male pt who received the third dose on 12/17/1999 along with the second dose of Hep B vaccine (manufacturer unk) and the first dose of MMR (manufacturer unk) at the age of 17 months. On 4/6/00, at the age of 20 months, the pt experienced pervasive development disorder. On 7/26/01, at the age of 3 years, the pt was diagnosed with autism. The pt has a past history of ear infection (one at 1 year of age and several by 4/6/00). Indication for Hib was immunization. Product was administered on 12/17/1999. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included DPT, Polio, Hep B, Varicella and Prevnar. Concomitant medications were not reported. On 12/17/1999, the pt received the third dose of Hib vaccine along with other childhood vaccine. On 3/17/00, physician notes had a question mark about combining words, suggesting some delay of speech at the time. On 4/6/00 physician notes reported that the pt said DaDa and MaMa then stopped speaking and said E all day. The physician also noted that the child would play only with adults. The physicians impression was pervasive development disorder (autism spectrum disorder). Treatment included Nystatin. On 7/26/2001, the child was diagnosed with autism. It was unknown if the pt recovered from the events.
Age: 3.0
Sex: M
Vaccine: HIBV, DTP, HIBV
Symptoms: Abdominal pain upper, Abnormal behaviour, Acarodermatitis, Autism, Cough
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine manfacturer unk, was received from an attorney regarding a 7 year old male pt who developed autism, moderate mental retardation and pervasive development disorder. The pt received the first dose on 5/5/1992. The pts concurrent illness includes austic like tendencies. Indication for Hib vaccine was immunisation. Product was administered on 5/5/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, Oral polio, MMR and Hep B vaccine. Concomitant medications were not reported. Medical records have been received from an attorney regarding a pt who was diagnosed with austic disorder and moderate mental retardation on 5/7/1996. The child had previously experienced austic like tendencies at five years of age. On 3/30/2000 the pt was additionally diagnosed with pervasive developmental disorder (autism spectrum disorder). Diagnostic studies were suggested at the time. The pt was treated with Ritalin. The outcome is unk. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HIBV, DTP, HIBV
Symptoms: Drug toxicity, Hypersensitivity, Injury, Lymphadenitis, Mental retardation severity unspecified
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine manfacturer unk, was received from an attorney regarding a 7 year old male pt who developed autism, moderate mental retardation and pervasive development disorder. The pt received the first dose on 5/5/1992. The pts concurrent illness includes austic like tendencies. Indication for Hib vaccine was immunisation. Product was administered on 5/5/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, Oral polio, MMR and Hep B vaccine. Concomitant medications were not reported. Medical records have been received from an attorney regarding a pt who was diagnosed with austic disorder and moderate mental retardation on 5/7/1996. The child had previously experienced austic like tendencies at five years of age. On 3/30/2000 the pt was additionally diagnosed with pervasive developmental disorder (autism spectrum disorder). Diagnostic studies were suggested at the time. The pt was treated with Ritalin. The outcome is unk. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HIBV, DTP, HIBV
Symptoms: Metal poisoning, Nervous system disorder, Neurodevelopmental disorder, Screaming, Stomatitis
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine manfacturer unk, was received from an attorney regarding a 7 year old male pt who developed autism, moderate mental retardation and pervasive development disorder. The pt received the first dose on 5/5/1992. The pts concurrent illness includes austic like tendencies. Indication for Hib vaccine was immunisation. Product was administered on 5/5/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, Oral polio, MMR and Hep B vaccine. Concomitant medications were not reported. Medical records have been received from an attorney regarding a pt who was diagnosed with austic disorder and moderate mental retardation on 5/7/1996. The child had previously experienced austic like tendencies at five years of age. On 3/30/2000 the pt was additionally diagnosed with pervasive developmental disorder (autism spectrum disorder). Diagnostic studies were suggested at the time. The pt was treated with Ritalin. The outcome is unk. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HIBV, DTP, HIBV
Symptoms: Stomatitis, Upper respiratory tract infection, Wheezing
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine manfacturer unk, was received from an attorney regarding a 7 year old male pt who developed autism, moderate mental retardation and pervasive development disorder. The pt received the first dose on 5/5/1992. The pts concurrent illness includes austic like tendencies. Indication for Hib vaccine was immunisation. Product was administered on 5/5/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, Oral polio, MMR and Hep B vaccine. Concomitant medications were not reported. Medical records have been received from an attorney regarding a pt who was diagnosed with austic disorder and moderate mental retardation on 5/7/1996. The child had previously experienced austic like tendencies at five years of age. On 3/30/2000 the pt was additionally diagnosed with pervasive developmental disorder (autism spectrum disorder). Diagnostic studies were suggested at the time. The pt was treated with Ritalin. The outcome is unk. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HIBV, DTP, HIBV
Symptoms: Autism, Laboratory test abnormal, Mental retardation severity unspecified
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine manfacturer unk, was received from an attorney regarding a 7 year old male pt who developed autism, moderate mental retardation and pervasive development disorder. The pt received the first dose on 5/5/1992. The pts concurrent illness includes austic like tendencies. Indication for Hib vaccine was immunisation. Product was administered on 5/5/1992. Dose regimen was 1 dose 1 time per day. Additional suspect medication included DPT, Oral polio, MMR and Hep B vaccine. Concomitant medications were not reported. Medical records have been received from an attorney regarding a pt who was diagnosed with austic disorder and moderate mental retardation on 5/7/1996. The child had previously experienced austic like tendencies at five years of age. On 3/30/2000 the pt was additionally diagnosed with pervasive developmental disorder (autism spectrum disorder). Diagnostic studies were suggested at the time. The pt was treated with Ritalin. The outcome is unk. No additional information was available at the time of this report.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Erythema, Injection site cellulitis, Injection site swelling, Lymphocyte percentage decreased
Clinical narrative: 10/06/2006 vaccine DTaP administered 10/07/2006 reported to ED C/O swollen, painful rt arm, red at injection site. PT also had fever 100.2 in ED at 2107. 10/08/2006 Returned to Ed worse, additional, not generalized malaise. Admitted to hospital at 1610.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Malaise, Neutrophil count increased, Neutrophil percentage, White blood cell count increased
Clinical narrative: 10/06/2006 vaccine DTaP administered 10/07/2006 reported to ED C/O swollen, painful rt arm, red at injection site. PT also had fever 100.2 in ED at 2107. 10/08/2006 Returned to Ed worse, additional, not generalized malaise. Admitted to hospital at 1610.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Laboratory test abnormal, Malaise
Clinical narrative: 10/06/2006 vaccine DTaP administered 10/07/2006 reported to ED C/O swollen, painful rt arm, red at injection site. PT also had fever 100.2 in ED at 2107. 10/08/2006 Returned to Ed worse, additional, not generalized malaise. Admitted to hospital at 1610.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: 10/06/2006 vaccine DTaP administered 10/07/2006 reported to ED C/O swollen, painful rt arm, red at injection site. PT also had fever 100.2 in ED at 2107. 10/08/2006 Returned to Ed worse, additional, not generalized malaise. Admitted to hospital at 1610.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site erythema, Injection site oedema, Skin discolouration
Clinical narrative: Within an hour after tetanus shot, the arm became black, blue, red and was very sore and swollen spreading down and around the arm. Went to PCP on 7/24 and she noted the adverse reaction and upon recommendation. I went to DR (allergy specialist) to see if it was an allergic reaction. Dr noted that the reaction was due to tetanus protein and an awakening of antibodies already in my body. An increase of headaches was also noted at this time.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Bacterial infection, CSF test abnormal, Musculoskeletal stiffness, Myalgia, Petechiae
Clinical narrative: Initial report received on 9/29/06 from a health care professional. An 18 year old pt, with an unk past medical history, had received a left deltoid dose of Menomune, lot number UE493AA on 2/20/06. The route of administration was not reported. On 9/23/06, 214 days post immunization, the pt developed petechiae on his hands and feet, and had a fever of 103 deg F. Treatment received was not reported. Three days later, he was admitted to the hospital with myalgia, stiff neck and continued petechiae on his hands and feet. The pt had a positive CSF for Neisseria, and results of group strain were expected in a week. At the time of this report, the pt was stabilizing and was moved from the ICU ped unit. The pt has not recovered from these adverse events.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Pyrexia
Clinical narrative: Initial report received on 9/29/06 from a health care professional. An 18 year old pt, with an unk past medical history, had received a left deltoid dose of Menomune, lot number UE493AA on 2/20/06. The route of administration was not reported. On 9/23/06, 214 days post immunization, the pt developed petechiae on his hands and feet, and had a fever of 103 deg F. Treatment received was not reported. Three days later, he was admitted to the hospital with myalgia, stiff neck and continued petechiae on his hands and feet. The pt had a positive CSF for Neisseria, and results of group strain were expected in a week. At the time of this report, the pt was stabilizing and was moved from the ICU ped unit. The pt has not recovered from these adverse events.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoacusis, Loss of consciousness, Vertigo, Vomiting
Clinical narrative: Information has been received from an investigator concerning a 70 year old male who entered a study, title as stated above. On 7/3/06 the pt was vaccinated SC in the deltoid region of the arm with a .065 ml dose of Varicella Zoster virus vaccine live. On approx 7/10/06, one week after vaccination, the pt was vaccinated with travel immunizations which included Hep A, typhoid vaccine and DPT. It was reported that the pt has been instructed not to receive any other vaccinations within one month of receiving varicella zoster virus vaccine live. About 48 hours after receiving the travel immunization, on 7/12/06, the pt developed vomiting, vertigo and passed out while at home. The vertigo was severe enough of the pt, who is a dentist, to cancel his appointments. The pt reported that he went to his primary physician on 7/17/06 and was determined to have hearing loss. The reporting investigator felt that hearing loss, vomiting and vertigo were possibly related to vaccination with varicella zoster virus vaccine live. Hearing loss, vomiting and vertigo were considered to be other important medical events (OMIC). Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a health care worker concerning a female who on 9/25/06 was SC, vaccinated with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (Lot 651400/0618F). The vaccine was given concomitantly with a tetanus shot (manufacturer unk) in the other arm. The pt experienced severe pain in the arm she received the Pneumococcal 23v polysaccharide vaccine, and a welt at the injection site. The pt went to the ER, and was given Demerol, which was considered by the reporter to be an intervention. The pt was not admitted the hospital. At the time of the report, the pt was recovering. The reporter considered the pts severe pain and a welt at the injection site to be other important medical events (OMIC). In follow up it was reported that the pharmacist requested a lot check for Pneumococcal 23v polysaccharide vaccine lot 651400/0618F. The pharmacist wanted to know if there have been other adverse events reports with this vaccine. The pharmacist will await the results of the lot check before vaccinating any more clients with Pneumococcal 23v polysaccharide vaccine that was left over from this lot. A lot check of concern has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red, swollen, warm to touch (area around injection site).
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt received flu vaccine in RD IM on 10/02/06. Right arm sore since then. Advised pt to put ice on it and take Tylenol. Go to private DR if not better. Pt to call Dr today.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Rash
Clinical narrative: TC per mom Tdap is only new vaccination client received on 9/27. By evening client had developed a fine rash on ant post torso described as prickly heat type of rash. By morning rash was more extensive over torso. No other s/s.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Headache, Muscle disorder, Myalgia, Nausea
Clinical narrative: Pain muscular, headache, nausea, heat muscular, for more information see anexo.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 4x3" redness and swelling secondary to histamine reaction.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Urticaria at site of MMR and Varivax immediately after administration. Given Benadryl in office, urticaria resolved within minutes of administration.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Pt developed chicken pox and low grade fever at age 10 years, Had Varivax at age 15 months. Disease uncomplicated.
Age: 1.63
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Injection site oedema, Oedema, Skin ulcer
Clinical narrative: Localized swelling at site of injection. Given Dytan for swelling 9/22/06. 9/30/06 lesion on trunk swell an red. Given cortisone injection, 10/03/06 lesion also on arms and legs.
Sex: F
Vaccine: MU, RUB
Symptoms: Medication error
Clinical narrative: Rubella vaccine ordered on pt and mumps vaccine was loaded into Pyxis by pharmacy. Nurse removed dose and administered to pt.
Age: 1.74
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh red, swollen at site, warm to touch, hard and tender to touch.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Discomfort, Fatigue, Headache, Hot flush
Clinical narrative: Initially, I experienced only the expected side effects of the vaccine (e.g., slight discomfort at the location of the vaccine, slight achiness).  However, approx. 8 hours later, I began to experience significant pain in my arms and additional pain (not as severe) throughout my entire upper body.  The pain was so severe in the arms, that I was unable to lift them above my waist.  My neck was also quite stiff (it hurt to move it and I had a pounding headache.  Shortly thereafter I became nauseous, got freezing cold and began to shake uncontrollably.  The shaking continued on and off for about 45 minutes, but the movement from very cold to very hot, nausea, stiffness and headache continued throughout the night.  I was also unable to sleep.    The following day, I was still unable to move my arms without extreme discomfort and remained nauseous, fatigued and feverish through out the day.  By the second day after the shot, movement in my arms was restored, but the nausea and fatique continued, although to a lesser degree.  It is now the third day after the shot and the only remaining symptoms are slight achiness, nausea and soreness at the injection site (i.e., the expected symptoms).  I should note 3 facts:  (1) I had received the vaccine without incident approx. 5 1/2 years prior to this injection;  (2) I received the flu shot at the same time; (3) I had an allergy shot the prior Monday (could not find this listed in the pull down menu in no. 14)