chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia facial, Hypokinesia, Malaise, Musculoskeletal pain, Myalgia
Clinical narrative: Severe pain over entire body;Temperature of 102/103; Swelling and numbness of face,lips;Underwent blood exchange transfusion of 8 units of blood;developed pneumonia in right lung; chest tube inserted to remove fluid.  Muscle pain over back and shoulder, general malaise,face numbness and weakness continues to present;unable to resume normal activities. 60 day Follow-up Information 06-JUL-2006: Patient continues to experience pain in her left arm from the shoulder through the length of her arm. She also complains that her chin is still numb. The numbness has improved - originally her face from the jaws down and inclusive of the chin were numb.
Age: 22.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pneumonia, Swelling face
Clinical narrative: Severe pain over entire body;Temperature of 102/103; Swelling and numbness of face,lips;Underwent blood exchange transfusion of 8 units of blood;developed pneumonia in right lung; chest tube inserted to remove fluid.  Muscle pain over back and shoulder, general malaise,face numbness and weakness continues to present;unable to resume normal activities. 60 day Follow-up Information 06-JUL-2006: Patient continues to experience pain in her left arm from the shoulder through the length of her arm. She also complains that her chin is still numb. The numbness has improved - originally her face from the jaws down and inclusive of the chin were numb.
Age: 0.15
Sex: M
Vaccine: HEP, HIBV, IPV, PNC, HEP, HIBV, IPV, PNC
Symptoms: Coma, Hypotonia, Pallor
Clinical narrative: Information has been received from a health professional concerning a 55 day old male with no relevant past medical history who on 3/29/2006 was vaccinated IM in the right thigh with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). Concomitant therapy that day included a first dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) administered IM in the right thigh, a first dose of Hib conj vaccine (Tet toxoid) (ActHib) (Batch UE709A), and a first doe of HCPD15T IPV (patient was enrolled in a study of comparative Immunogenicity of different multivalent component pertussis vaccine formulations based on 5 component acellular pertussis vaccine in infants and toddlers. On 3/29/2006 the patient experienced an episode of not responding, was extremely pale, and had a loss of muscle tone, four hours post immunization. The patient had been taking a nap, and upon attempting to arouse him, the parent found that the patient was not responding, was extremely pale, and was experiencing a loss of muscle tone which lasted for 15 minutes. After the 15 minute period, the patient was back to normal, and he was taken to an ER for examination. He was noted to have a hypotonic hyporesponsive episode. Testing included an EKG and blood glucose which were normal. At the time of the report, the patient had recovered. The patient was discontinued from the trial on 3/29/2006. The event of hypotonic hyporesponsive episode was reported by the investigator to be related to hepatitis B virus vaccine rHBsAg (yeast), pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar), and the study vaccines of HCPD15T IPV and Hib conj vaccine (tet toxoid) (ActHib). The event was considered to be an other important medical event (OMIC). Other business partner numbers included 200600858.
Age: 0.15
Sex: M
Vaccine: HEP, HIBV, IPV, PNC, HEP, HIBV, IPV, PNC
Symptoms: Coma, Hypotonia, Pallor, Stupor
Clinical narrative: Information has been received from a health professional concerning a 55 day old male with no relevant past medical history who on 3/29/2006 was vaccinated IM in the right thigh with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). Concomitant therapy that day included a first dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) administered IM in the right thigh, a first dose of Hib conj vaccine (Tet toxoid) (ActHib) (Batch UE709A), and a first doe of HCPD15T IPV (patient was enrolled in a study of comparative Immunogenicity of different multivalent component pertussis vaccine formulations based on 5 component acellular pertussis vaccine in infants and toddlers. On 3/29/2006 the patient experienced an episode of not responding, was extremely pale, and had a loss of muscle tone, four hours post immunization. The patient had been taking a nap, and upon attempting to arouse him, the parent found that the patient was not responding, was extremely pale, and was experiencing a loss of muscle tone which lasted for 15 minutes. After the 15 minute period, the patient was back to normal, and he was taken to an ER for examination. He was noted to have a hypotonic hyporesponsive episode. Testing included an EKG and blood glucose which were normal. At the time of the report, the patient had recovered. The patient was discontinued from the trial on 3/29/2006. The event of hypotonic hyporesponsive episode was reported by the investigator to be related to hepatitis B virus vaccine rHBsAg (yeast), pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar), and the study vaccines of HCPD15T IPV and Hib conj vaccine (tet toxoid) (ActHib). The event was considered to be an other important medical event (OMIC). Other business partner numbers included 200600858.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Chills, Fatigue, Headache, Malaise
Clinical narrative: On the way home from receiving vaccine felt ill developed aches, chills, low grade fever and headache 2 hours after vaccine legs aches and back pain across the lower back,48 hours of headaches and fatigue, resolved by the next evening and well the 3rd day.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: On the way home from receiving vaccine felt ill developed aches, chills, low grade fever and headache 2 hours after vaccine legs aches and back pain across the lower back,48 hours of headaches and fatigue, resolved by the next evening and well the 3rd day.
Age: 1.39
Sex: F
Vaccine: PNC
Symptoms: Angioneurotic oedema, Oedema, Urticaria
Clinical narrative: Angioedema, Urticaria, Swollen
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Sister had break through varicella rash on 4-23-06 - had been imm. on 02-25-00.  Broke out in a few spots on 04-27-06.
Age: 1.48
Sex: M
Vaccine: DTAP, IPV
Symptoms: Eye movement disorder
Clinical narrative: Within 3 hours of the shot, my son began having intermittent eye rolling which look like it was without control.  The eye rolling got worse over the next week.  We took him to a pediatric neurologist 10 days later who did an EEG.  At the time he had no sign of permanent damage, she suggested following up with a longer test if the symptoms continued.
Age: 62.0
Sex: F
Vaccine: HEPAB, MNQ, TYP, YF
Symptoms: Medication error
Clinical narrative: None.  Only issue is discovering that patient had received a dose of Menactra when she is older than the stated criteria.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Nasal congestion, Pyrexia, Viral infection
Clinical narrative: High fever 104-105 rash 4 days after high fever (twin sib had febrile seizure above twin admitted due to high temp, similar symptoms. 6/8/06 Received medical records from hospital which reveal patient experienced Temp 104.9 with no seizures.  Twin sibling also admitted  but with febrile seizures.  Patient's exam while hospitalized revealed seizures, congested nasopharynx. Final dx: viral syndrome/ss
Age: 15.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Electrocardiogram abnormal, Erythema, Pruritus, Rash, Stomach discomfort
Clinical narrative: S/S began 4/21 c/o pruritus, then rash, red, then hives. DR prescribed Prednisone 20mg and Hydrocortisone 1% cream. Today 4/26 stomach upset.
Age: 15.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: S/S began 4/21 c/o pruritus, then rash, red, then hives. DR prescribed Prednisone 20mg and Hydrocortisone 1% cream. Today 4/26 stomach upset.
Sex: F
Vaccine: MNQ
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Developed painful red arm, got worse the next day, took Benadryl and it made it less tight. 11 x 11cm slight redness, slight warmth but predominately induration, got better on 4/17/06 no more redness, pain or soreness.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Rash, Urticaria
Clinical narrative: Varivax reaction noted above injection site with in 1-2 minutes wheal, warm indurated area about 1 inch in length. Right thigh vaccine given Varivax, Ice applied to site. RX given for Benadryl elixir 3/4 tsp PO Q 6 hours. Clarinex 1mg 2.5ml given PO. Spoke with Mom 4/26/06. Rash resolved follow up appt 1 week.
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site oedema, Injection site rash, Skin ulcer, Tenderness
Clinical narrative: Rash on left arm with swelling and tenderness (cellulitis) 4 x 6cm oral lesion.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Flushing, Pruritus, Urticaria
Clinical narrative: Tickly throat, itching all over, stomach pain, flushed, urticarial rash over trunk, arms, legs 40 mg Benadryl 1116 Zantac 75mg 1130 EPI JR 1202 V/S Q 10 mins. Discharged Home 1520.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on body, Benadryl/Aveeno.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: 04/21/2006 9cm oval redness left deltoid with slight induration. Noticed redness and swelling 4/20/06 am circled redness increased on 4/21/06.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Rash started 4/20/06 pm no itchy, temp 99 <100 ac, approx 6/10 spots DX Chicken pox , DX by Dr 4/22/06
Age: 1.02
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Pruritus, Rash, Skin ulcer, Viral infection
Clinical narrative: 04/21/06 child came home from a camp out. Had bumps on her. On exam had a few typical bug bites but had about 26 lesions that appeared to be varicella. No fever, Lesions on trunk, buttock and legs. Spoke to mom this am 4/24/06 child seems fine. No more lesions. No change in the rash from Friday 4/21/06. Taking Benadryl for itching.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Atypical VZV, lesions ^30.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Eye oedema, Rash
Clinical narrative: Sudden onset diffuse rash all over body with in 5 minutes, eyes swelling, 911 called. Benadryl 25mg IM RUQ given at 11am rash cleared somewhat and send to ER via ambulance.
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: Pt states sudden onset of abdominal pain 4.5 hrs after initial capsule.
Age: 1.33
Sex: M
Vaccine: DTAP, MMR
Symptoms: Decreased appetite, Dehydration, Irritability, Otitis media, Pyrexia
Clinical narrative: 48 hours after shot MMR, pt with temp 102, fussy, decreased appetite and fluid intake. Seen at office. Child irritable, temp 100.9, not toxic, right OM noted and treated.
Age: 0.97
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood sodium increased, Convulsion, Pyrexia
Clinical narrative: Vaccines administered at primary care office on 4/26/06. The next day, he spiked a fever to 105.3 and had a generalized seizure which lasted approximately 30-45 minutes and was stopped by administration of Valium in the Emergency room.  He returned to baseline by the next morning (approx 12 hours later).  He is currently being monitored in the hospital without any further sequelae.  Of note, he also has symptoms of a viral URI and a right otitis media (TM is bulging and non-mobile on exam).
Age: 1.52
Sex: F
Vaccine: DTAPH, HEP, HEPA, MMRV, PNC
Symptoms: Fatigue, Pyrexia, Rash, Urticaria
Clinical narrative: Mother reports hives on thighs and arms 5 days after receiving Dtap/Hib, Prevnar,Hep B, ProQuad, Hep A.  Mother also reported fever on and off for 2 weeks (highest temp 104), and last week child developed a round, raised, lacy rash on trunk of body. Mom took child to the Clinic for the hives, child was prescribed Benadryl.  Mom spoke to doctor's office, who stated child is OK- to keep child hydrated and give Tylenol for temp.  Mom stated that child is AA&O x3, no seizures, no screaming, behavior OK, tired with fever, resting often.  Asked mom if she had any questions.  Discussed "normal" side effects of live vaccines, reviewed/reminded mom of the MMR and Varicella VIS forms.
Age: 73.0
Sex: F
Vaccine: DTAP, PPV, TDAP
Symptoms: Headache, Injury, Pharyngitis, Rhinitis, Syncope
Clinical narrative: On the evening of the date of injection she reported she was asleep and woke up and wandered to her restroom where she felt weak, fainted and fell and hit her head on the tile.  She had a headache and also reports vomiting, she said the injection site was sore for 2 days, she also developed a chest cold and says she has always been healthy and has not had a cold for years. Improved now.
Age: 73.0
Sex: F
Vaccine: DTAP, PPV, TDAP
Symptoms: Vomiting
Clinical narrative: On the evening of the date of injection she reported she was asleep and woke up and wandered to her restroom where she felt weak, fainted and fell and hit her head on the tile.  She had a headache and also reports vomiting, she said the injection site was sore for 2 days, she also developed a chest cold and says she has always been healthy and has not had a cold for years. Improved now.
Age: 73.0
Sex: F
Vaccine: DTAP, PPV, TDAP
Symptoms: Cough, Malaise, Syncope, Vomiting
Clinical narrative: On the evening of the date of injection she reported she was asleep and woke up and wandered to her restroom where she felt weak, fainted and fell and hit her head on the tile.  She had a headache and also reports vomiting, she said the injection site was sore for 2 days, she also developed a chest cold and says she has always been healthy and has not had a cold for years. Improved now.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Autism, Gait disturbance, Hypokinesia, Neurodevelopmental disorder, Pyrexia
Clinical narrative: Rectal temperature 101 F, exessive sleepiness, decreases responsiveness for about 24 p/vax, mom had to wake the child up for feedings. No appetite changes. Developmental delays showed up later in life. Child started sitting up at 9.5 months, walked on toes holding on furniture, started walking alone at 18 months, currently shows most significant delays in social interaction, speech and language skills. At age 2 years 5 months 8 days had developmental evaluation and met criteria for a diagnosis of autism.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Somnolence, Speech disorder
Clinical narrative: Rectal temperature 101 F, exessive sleepiness, decreases responsiveness for about 24 p/vax, mom had to wake the child up for feedings. No appetite changes. Developmental delays showed up later in life. Child started sitting up at 9.5 months, walked on toes holding on furniture, started walking alone at 18 months, currently shows most significant delays in social interaction, speech and language skills. At age 2 years 5 months 8 days had developmental evaluation and met criteria for a diagnosis of autism.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus, Pyrexia, Urticaria
Clinical narrative: 4/20/06 Noticed redness at injection site. 4/26/06 Woke up with hives 3" X 2" at injection site with itching and lo grade fever.  Presented at ER, sent home with advil and benedryl and reassurance. Mother c/o "this is a bad reaction and wants VAERS filled out" 4/28/06 Public Health notified by parent.  I counseled parent on local effects of 4th DTap injection site reactions.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blood pressure increased, Dyspnoea, Erythema, Face oedema, Oedema peripheral
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from the patients parents on 4/18/2006. A four year old male patient, with possible allergies, had received, on 8/4/2005, an injection of IPOL, lot number X12402, and injection of MMR vaccine, lot number 0348P, and an injection of Infanrix, lot number AC14B002AA. Routes and sites of administration were not provided. Fifteen minutes post vaccination, the patients face, lips and palms of his hands became swollen and red. He also experienced difficulty breathing and elevated blood pressure. He was examined by a physician and treated with steroids. At the time of this report, the patient had recovered from the event.
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Cognitive disorder, Difficulty in walking, Dysgraphia, Gastrointestinal disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of difficulty writing in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, burning in hands and feet, difficulty walking, hip pain, rashes, difficulty writing, gastrointestinal problems, tingling in her hands, feet, arms, and toes, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Immune system disorder, Nervous system disorder, Paraesthesia, Rash, Rheumatoid factor
Clinical narrative: This case was reported by a lawyer and described the occurrence of difficulty writing in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, burning in hands and feet, difficulty walking, hip pain, rashes, difficulty writing, gastrointestinal problems, tingling in her hands, feet, arms, and toes, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Skin burning sensation
Clinical narrative: This case was reported by a lawyer and described the occurrence of difficulty writing in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, burning in hands and feet, difficulty walking, hip pain, rashes, difficulty writing, gastrointestinal problems, tingling in her hands, feet, arms, and toes, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Cognitive disorder, Dizziness, Fatigue
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, dizziness, cognitive problems, insomnia, rashes, tingling in body, memory loss, headaches, migraines, tinnitus, sensitivity to light, gastrointestinal problems, all over itching, mental fog, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Gastrointestinal disorder, Headache, Immune system disorder, Insomnia, Mental impairment
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, dizziness, cognitive problems, insomnia, rashes, tingling in body, memory loss, headaches, migraines, tinnitus, sensitivity to light, gastrointestinal problems, all over itching, mental fog, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Migraine, Nervous system disorder, Paraesthesia, Pruritus, Rash
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, dizziness, cognitive problems, insomnia, rashes, tingling in body, memory loss, headaches, migraines, tinnitus, sensitivity to light, gastrointestinal problems, all over itching, mental fog, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Rheumatoid factor, Sensory disturbance, Tinnitus
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, dizziness, cognitive problems, insomnia, rashes, tingling in body, memory loss, headaches, migraines, tinnitus, sensitivity to light, gastrointestinal problems, all over itching, mental fog, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Age: 1.49
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Convulsion, Irritability
Clinical narrative: Generalized tonic-clonic seizure 4/25/06 X 2. Work-up in ER negative. Medical record state irritable, droopy, diarrhea, vomiting, cough. msv
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Agitation, Cellulitis, Crying, Injection site erythema, Injection site oedema
Clinical narrative: Pt received Dtap and IPV in left arm for 4 yr boosters. MMR in right arm. When he woke up this morning he was crying, will not let anyone touch left arm. It is red, swollen and tight. Required Ceftriaxone IM and Tx in office for cellulitis and PO antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site pain
Clinical narrative: Pt received Dtap and IPV in left arm for 4 yr boosters. MMR in right arm. When he woke up this morning he was crying, will not let anyone touch left arm. It is red, swollen and tight. Required Ceftriaxone IM and Tx in office for cellulitis and PO antibiotics.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Redness, swelling and warmth to touch right deltoid x 2 days has been given Ibuprofen Q 6 hrs as comfort measures. Seen MD 4/28/06 prescription given for Keflex BID x 10 days. Cold compresses pm to right arm.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Agitation, Crying, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: 04/25/06 red and hot to touch. 04/26/06 swelling to below elbow with pain with blister like sores around site of varicella injection, crying with pain took to ER, given cream to put on blisters. 4/27/06 improved. 4/28/06 no open blisters, swelling resolved, remains red and some pain.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site reaction, Injection site vesicles, Injection site warmth
Clinical narrative: 04/25/06 red and hot to touch. 04/26/06 swelling to below elbow with pain with blister like sores around site of varicella injection, crying with pain took to ER, given cream to put on blisters. 4/27/06 improved. 4/28/06 no open blisters, swelling resolved, remains red and some pain.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Face oedema, Nausea
Clinical narrative: Inoc. 4/18/06: pt left work with pain in shoulder (front and back) weak and nausea. 4/19/2006 continued weakness and nausea, lightheaded and dizzy. 4/20/06 upper lip swollen until 4/21/06 even after 2 Benadryl. Saw Dr 4/26/06.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration
Clinical narrative: <5 min O/P IM injection, induration and erythema spread to 5.5cm x 4cm with central hematoma of 1.5 x 1cm2 (despite cool compress).
Age: 0.6
Sex: M
Vaccine: HIBV, PNC, UNK
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever began Thursday but was gone in a couple of days. On Saturday vomiting and diarrhea began; the vomiting lasted for a couple of days. Pt still has diarrhea (explosive one) so gets covered from head to toe. His diarrhea is getting better.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site warmth, Oedema
Clinical narrative: Left deltoid red, hot to touch, painful, very swollen. Child seems fine otherwise mother states he's eating and sleeping fine, playful. Mother worried will take to pediatrician for review.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinitis allergic
Clinical narrative: Increased symptoms of seasonal rhinitis every year after receiving FluMist vaccine. Treatment with Perscription Zyrtec effective.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, VARCEL, MMR
Symptoms: Joint swelling, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 5 year old female, with no medical history and no allergies, who on 1/13/06 was vaccinated with a 0.5ml SC dose of MMR (lot # 649654/0235R). There was no concomitant medication. About two weeks later, on 1/27/06, the patient developed a generalized macular erythematous rash on her trunk and legs and swelling of her knees and ankles. The patient was treated with prednisone and diphenhydramine hydrochloride. All symptoms fully resolved about one month post onset. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. The patient's reactions were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, VARCEL, MMR
Symptoms: Joint swelling, Rash erythematous, Rash macular
Clinical narrative: Information has been received from a physician concerning a 5 year old female, with no medical history and no allergies, who on 1/13/06 was vaccinated with a 0.5ml SC dose of MMR (lot # 649654/0235R). There was no concomitant medication. About two weeks later, on 1/27/06, the patient developed a generalized macular erythematous rash on her trunk and legs and swelling of her knees and ankles. The patient was treated with prednisone and diphenhydramine hydrochloride. All symptoms fully resolved about one month post onset. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. The patient's reactions were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site hypersensitivity, Injection site pain, Pruritus, Rash
Clinical narrative: Initial report received on 4/5/2006 from a physician. A 42 year old female patient with a history of costal chondritis, and who was taking Ibuprofen and Benadryl at the time of the vaccination, had received her first intra muscular dose of Adacel, lot number C2340AA, in the right arm, on 3/17/2006. On that same day, at an unspecified time, the patient developed itching. 48 hours later, she developed a rash in the chest, neck and arms. She was evaluated by her physician the following day and was prescribed a Medrol dose pack. Per the reporter, no testing was completed to determine the cause of the adverse events. The patients recovery status was reported as recovered. Seriousness Criteria other medically significant (OMIC). 4/13/2006 due to medical evaluation of this case, it has been upgraded to serious.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Initial report received on 4/5/2006 from a physician. A 42 year old female patient with a history of costal chondritis, and who was taking Ibuprofen and Benadryl at the time of the vaccination, had received her first intra muscular dose of Adacel, lot number C2340AA, in the right arm, on 3/17/2006. On that same day, at an unspecified time, the patient developed itching. 48 hours later, she developed a rash in the chest, neck and arms. She was evaluated by her physician the following day and was prescribed a Medrol dose pack. Per the reporter, no testing was completed to determine the cause of the adverse events. The patients recovery status was reported as recovered. Seriousness Criteria other medically significant (OMIC). 4/13/2006 due to medical evaluation of this case, it has been upgraded to serious.
Age: 0.19
Sex: M
Vaccine: 6VAX-F, HEP, PNC
Symptoms: Dermatitis atopic, Pruritus
Clinical narrative: Total body outbreak accompanied with oozing and excessive itching three weeks after initial vaccination. First diagnosis was atopic dermentitis, treated with atopic cortizone creams, which were unaffective. Total duration of symptoms three months and counting.  Skin is still oozing toxins with accompanied with excessive itching. Scheduled to see dermatologist 5-2-06.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Low grade fever, severe arthralgias (no arthritis), Dizziness, fatigue, headache, treated symptomatically.
Age: 0.99
Sex: F
Vaccine: MEA, VARCEL
Symptoms: Injection site induration, Injection site vesicles
Clinical narrative: 2.5 x 2.0 cm local induration with hard vesicle no sign of infection. not tender to touch
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Injection area (RD) turned red, swollen and lg lump approx 3"x3" circular appeared 24 hrs later.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Tremor
Clinical narrative: About 8-9 hours after receiving the 2nd in series, she awoke at about 01:30 AM with pain in R arm (where injected) from wrist to shoulder. She also experienced about 10 minutes of shaking with no L.O.C. Resolved and no further symptoms. (No problems 24 hours after 3rd.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspnoea, Nausea
Clinical narrative: Received Yellow Fever vaccine 4/21/06. Felt ill. 4/22/06. Nausea, vomiting, diarrhea, weakness, SOB and dizziness; advised to go to ER - declined. Given IV fluids. Had U/A and blood work drawn.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Vomiting
Clinical narrative: Received Yellow Fever vaccine 4/21/06. Felt ill. 4/22/06. Nausea, vomiting, diarrhea, weakness, SOB and dizziness; advised to go to ER - declined. Given IV fluids. Had U/A and blood work drawn.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Cardiomegaly, Cerebral ischaemia, Encephalopathy, Hepatic necrosis
Clinical narrative: Child developed fever early morning of Monday 11/7/06, then status epilepticus. Was brought to ER, was intubated and ventilated. Suffered hypoxic insult. Died 11/8/06. 7/6/06 Received medical records & autopsy report from hospital which reveal COD as status epilepticus with subsequent severe hypoxic/ischemic encephalopathy; cerebral edema with bilateral cerebellar tonsillar herniation; subdural hematoma, small, right lateral cerebellum & asthma (by clinical history).  Stated that status epilepticus possibly related to URI (MRSA).  Temp max 105.8
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoxia, Pneumonia, Pyrexia, Status epilepticus, Subdural haematoma
Clinical narrative: Child developed fever early morning of Monday 11/7/06, then status epilepticus. Was brought to ER, was intubated and ventilated. Suffered hypoxic insult. Died 11/8/06. 7/6/06 Received medical records & autopsy report from hospital which reveal COD as status epilepticus with subsequent severe hypoxic/ischemic encephalopathy; cerebral edema with bilateral cerebellar tonsillar herniation; subdural hematoma, small, right lateral cerebellum & asthma (by clinical history).  Stated that status epilepticus possibly related to URI (MRSA).  Temp max 105.8
Age: 13.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Asthenia, Hyporeflexia, Pain, Tremor
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 4/19/2006 from a physician. A 13 year old female patient with no reported illnesses, pre existing medical conditions, or use of other medications, had received an administration of Menactra, lot number U2003AA, in the right deltoid, and an administration of Decavac, lot number U1619BA, in the left deltoid in 4/11/2006. The route of administration was not reported for either vaccine. 24 hours post immunization, the patient experienced severe pain in her arms bilaterally, generalized aches, bilateral leg weakness, and shakiness. She was taken to the ER where laboratory data was collected, and the results were within normal limits. She was released the same day. The patient was seen by her physician on 4/19/2006 and at that time, she was still shaky when walking, and continued with generalized weakness that was accompanied by absent bilateral ankle/plantar reflexes. Per the reporter, no foot drop was present. The patient had not recovered from these events at the time of this report.
Age: 0.33
Sex: F
Vaccine: HIBV, IPV, TD, VARCEL
Symptoms: Autism, Medication error, Speech disorder
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from another manufacturer, report number HQWYE555005MAY, on 4/17/2006. A 16 month old female patient, with a family history of a sister with autism post immunization, had received on 5/18/2000, an intramuscular, second dose injection of IPOL, lot number unknown, an intramuscular, second dose injection of Hib Titer vaccine, lot number unknown and intramuscular, second dose injection of Diphtheria and tetanus toxoids absorbed, purogenated, lot number unknown. Approximately 13 months post vaccination, in June 2001, the patient experienced receptive language and speech delays. By early 2004, the patient was diagnosed with autism. Per the reporter, the patient is receiving therapy to improve her skills. The case was considered medically important by the reporter. At the time of this report, the patients recovery status was unknown. Vaccination, received on 7/18/2000, included intramuscular third dose injection of Hib titer vaccine, lot number unknown, an intramuscular, third dose injection of Diphtheria and tetanus toxoids absorbed purogenated, lot number unknown and an intramuscular first dose injection of Hepatitis B vaccine, lot number unknown. Vaccination received on 10/19/2000 included an intramuscular second dose injection of Hepatitis B vaccine, manufacturer unknown lot number unknown. Vaccination, received on 1/26/2001 included intramuscular injection of Varivax, lot number unknown. Vaccinations received on 5/4/2001 included an intramuscular fourth dose injection of Hib Titer vaccine, lot number 560753A, an intramuscular third dose injection of Hepatitis B vaccine manufacturer unknown, lot number unknown, and intramuscular first dose injection of MMR vaccine lot number unknown.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Mother of the patient mentions high fever, diarrheas, edema on right thigh and redness. Fever was 38.5 deg C during the first 24 hours fluctuation.
Age: 1.01
Sex: M
Vaccine: MMR, IPV, MMR
Symptoms: Cough, Febrile convulsion, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Info has been received from a certified medical assistant concerning a 12 month old male with no allergies or pertinent medical history, who on 4/4/06, was vaccinated SQ, in the left thigh with 0.5 ml dose of MMRII (lot No 650350/0970R). On 4/19/06, the pt was taken to the ER due to fever of 103.5, pulse 160 and a febrile seizure at home. It was reported that the pt also had a febrile seizure enroute to the hospital. Prior to ER, the pt had been having a runny nose and slight cough. He was given ibuprofen and acetaminophen (Tylenol) at the ER and his temperature dropped to 100.1. A CBC, BNF and blood culture were done and it was reported that the blood work was "essentially normal". On 4/21/06, the pt woke up with a rash on his head and body, no fever was present, at that time. No further info was available at the time of this report. The reporter considered the pt's experiences to be other important medical events. Additional info has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, IPV, MMR
Symptoms: Cough, Febrile convulsion, Heart rate increased, Pyrexia, Rash
Clinical narrative: Info has been received from a certified medical assistant concerning a 12 month old male with no allergies or pertinent medical history, who on 4/4/06, was vaccinated SQ, in the left thigh with 0.5 ml dose of MMRII (lot No 650350/0970R). On 4/19/06, the pt was taken to the ER due to fever of 103.5, pulse 160 and a febrile seizure at home. It was reported that the pt also had a febrile seizure enroute to the hospital. Prior to ER, the pt had been having a runny nose and slight cough. He was given ibuprofen and acetaminophen (Tylenol) at the ER and his temperature dropped to 100.1. A CBC, BNF and blood culture were done and it was reported that the blood work was "essentially normal". On 4/21/06, the pt woke up with a rash on his head and body, no fever was present, at that time. No further info was available at the time of this report. The reporter considered the pt's experiences to be other important medical events. Additional info has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, IPV, MMR
Symptoms: Rhinorrhoea
Clinical narrative: Info has been received from a certified medical assistant concerning a 12 month old male with no allergies or pertinent medical history, who on 4/4/06, was vaccinated SQ, in the left thigh with 0.5 ml dose of MMRII (lot No 650350/0970R). On 4/19/06, the pt was taken to the ER due to fever of 103.5, pulse 160 and a febrile seizure at home. It was reported that the pt also had a febrile seizure enroute to the hospital. Prior to ER, the pt had been having a runny nose and slight cough. He was given ibuprofen and acetaminophen (Tylenol) at the ER and his temperature dropped to 100.1. A CBC, BNF and blood culture were done and it was reported that the blood work was "essentially normal". On 4/21/06, the pt woke up with a rash on his head and body, no fever was present, at that time. No further info was available at the time of this report. The reporter considered the pt's experiences to be other important medical events. Additional info has been requested.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Dysphagia, Laboratory test abnormal, Oedema, Unintended pregnancy
Clinical narrative: Info has been received from a physician concerning a female pt with no allergies or medical history, who on 10/21/98, was vaccinated with a third dose of MMRII. Concomitant therapy included prenatal vitamins (unspecified). On approximately 4/28/06, the pt was seen by the physician due to her neck area being swollen. She had no fever or sore throat. Just swelling. She was unable to eat or drink and was hospitalized on 3/28/06. She had antibody liters drawn before admission to the hospital. A rubeola titer was less than 0.9, a mumps titer was less than 0.8, and a rubella titer was less than 0.8. At the time of the report, the pt was recovering. A product complaint was not involved. At the time of the report, the pt was 34 years old and pregnant at 30 weeks gestation. Swollen neck area, unable to eat or drink, rubeola titer less than 0.9, mumps titer less than 0.8, and rubella titer less than 0.8, were considered to be other important medical events by the reporter. Additional info has been requested.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain, Dermatitis, Dyspnoea, Flushing, Hypoxia
Clinical narrative: Sore throat, difficulty breathing, flushed, abdominal cramping, mild stridor. Tx Oxygen, Albuterol Tx 05 + 3cc saline, Epinephrine SQ R thigh 0.2cc Solumedrol 40mg IM right thigh 25-30mg by EMS. Admitted ICU on 4/7/06 discharged 4/8/06. 06/08/06-received 6 page medical records to include pediatric intensivist note dates 04/07/06-No respiratory distress or urticarial rash noted. Past medical history significant for surgically corrected congenital heart disease (dextrocardia with multiple holes in the heart) as an infant. Current medications none. No known medication allergy, no history of reactive airway disease. O2 sat on admission 97% on RA. Atrophic dermatitis noted but no other rash noted TMs clear. No facial or lip edema. Pharynx clear. Sinus rhythm with grade 2/6 systolic murmur. Normal neuro exam. Assessment: immunization reaction-doubt anaphylaxis. Admit for observation. RX with oral Benadryl and Decadron.  Impression on CXR: dextrocardia, close clinical and historic correlation is recommended to evaluate for congenital heart disease.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Pharyngolaryngeal pain, Stridor
Clinical narrative: Sore throat, difficulty breathing, flushed, abdominal cramping, mild stridor. Tx Oxygen, Albuterol Tx 05 + 3cc saline, Epinephrine SQ R thigh 0.2cc Solumedrol 40mg IM right thigh 25-30mg by EMS. Admitted ICU on 4/7/06 discharged 4/8/06. 06/08/06-received 6 page medical records to include pediatric intensivist note dates 04/07/06-No respiratory distress or urticarial rash noted. Past medical history significant for surgically corrected congenital heart disease (dextrocardia with multiple holes in the heart) as an infant. Current medications none. No known medication allergy, no history of reactive airway disease. O2 sat on admission 97% on RA. Atrophic dermatitis noted but no other rash noted TMs clear. No facial or lip edema. Pharynx clear. Sinus rhythm with grade 2/6 systolic murmur. Normal neuro exam. Assessment: immunization reaction-doubt anaphylaxis. Admit for observation. RX with oral Benadryl and Decadron.  Impression on CXR: dextrocardia, close clinical and historic correlation is recommended to evaluate for congenital heart disease.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain, Chills, Diarrhoea
Clinical narrative: Chills and abd pain, diarrhea after receiving vaccine. Treated in Emergency only. No additional symptoms per mother.
Age: 1.36
Sex: M
Vaccine: DTAP, MMRV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Papular macular exanthem face, abd, extremities, fever 38C, palm and soles involved.
Age: 1.91
Sex: F
Vaccine: FLU3
Symptoms: Rash papular
Clinical narrative: Reported by child's grandmother when contacted (to recall child for flu vaccine 2nd dose), that child had developed rash 2 days after 1st few vaccine ///. Rash described as looking like water blisters under skin. No itching. Rash covered abdomen from below breast nipples to above navel. Rash lasted 7-8 days. No other effects. Child taken to physician who recommended child not receive flu vaccine dose No. 2. Note: Health department was not notified of child's rash until 3/1/06. Nurse made numerous calls over 4 wk period trying to reach grandparent to get info needed to file Vaers report.
Age: 3.0
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Contacted by father "after hours" who left description of adverse reaction on 4/25/06. Home visit made by public health nurse (vaccine administered) on 4/26/06 AM. Patient outside playing. Mother showed PHN right arm. Elbow to shoulder area swollen 1 1/2 X 2 X normal size. Area hard, warm, red and painful with 2-3 inch area /// injection site blistered. Mother had placed warm compresses. Physician notified. On 4/26/06, physician presented Zithromax. Physician agreed to make home visit.
Age: 4.0
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Contacted by father after hours who left on voice mail a description of reaction on 4/25/06. Home visa made by public health nurse (vaccine administrator) on 4/26/06 AM. Pt inside with mother. R arm affected elbow to shoulder about 1 1/2 times normal; warm, hard, red, painful to touch with slightly blistered area. Physician informed. 4/26/06, Physician presented Zithromax. Physician to make home visit.