chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Fatigue, Malaise, Neuritis, Vestibular disorder, Vomiting
Clinical narrative: My son is diagnosed with chronic fatigue syndrome which started acutely after after he recived HepB vaccine dose. He is profoundly disabled, he can't attend school or perform any age appropriate activites such as playing, reading, playing sports.Often he can't walk by himself and at times he even can't breath without difficulty. He is in a constant state of fatigue, maldie and brain fog. he requires around the clock care since the onset of his illness. Prior to the vaccination he was absolutely healthy, happy and bright little boy. His illness devastated the entire family physically, financially and morally. I am a mother and looking at my son suffer like he is suffering is riping my heart apart.No amount of medical intervention could provide cure or at least some relief.  Nurse follow up on 08/05/04 states: "Physician states in his progress note that Hep B was not necessary based on their office records. This would indicate that the Hep B in Box 13 was at least the 4th dose. However, a titer drawn on 2/28/2002, nearly 4 months s/p vaccination, was non-reactive. ADD: weakness; dizziness; vomiting ; vestibular neuronitis ; febrile illness ; pharyngitis-tonsillitis."
Age: 11.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Fatigue, Neuritis
Clinical narrative: My son is diagnosed with chronic fatigue syndrome which started acutely after after he recived HepB vaccine dose. He is profoundly disabled, he can't attend school or perform any age appropriate activites such as playing, reading, playing sports.Often he can't walk by himself and at times he even can't breath without difficulty. He is in a constant state of fatigue, maldie and brain fog. he requires around the clock care since the onset of his illness. Prior to the vaccination he was absolutely healthy, happy and bright little boy. His illness devastated the entire family physically, financially and morally. I am a mother and looking at my son suffer like he is suffering is riping my heart apart.No amount of medical intervention could provide cure or at least some relief.  Nurse follow up on 08/05/04 states: "Physician states in his progress note that Hep B was not necessary based on their office records. This would indicate that the Hep B in Box 13 was at least the 4th dose. However, a titer drawn on 2/28/2002, nearly 4 months s/p vaccination, was non-reactive. ADD: weakness; dizziness; vomiting ; vestibular neuronitis ; febrile illness ; pharyngitis-tonsillitis."
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Condition aggravated, Cough, Dyspnoea, Lung disorder
Clinical narrative: This subject is a 76 year old female who was admitted to the hospital with respiratory failure and COPD exacerbation while enrolled in a comparative randomized study of safety and immunogenocity of a non-adjuvanted respiratory syncytial virus vaccine versus an RSV vaccine adjuvanted with aluminum phosphate when administered concomitantly with a licensed influenza vaccine in high-risk adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was 10/29/03. The first dose was 10/17/02. Subject developed increasing shortness of breath over the last month and purulent sputum, fever, chills and cough over the last 2 weeks. Subject was taken to emergency by ambulance 93 days post immunization on 1/30/04 and admitted the same day with respiratory failure. Subject was placed on BiPAP, and treated with nebulizer treatments, Rocephin 1gm, Zithromax 500mg, Decadron 6mg IV, Prednisone 40mg BID, Vantin 200mg BID. A chest x-ray on 1/30/04 showed COPD and no pneumonia. EKG is normal. There is no history of chest pain. Subject had mild improvement, however her disease is severe with an FVC of approximately 0.5 liter. Seen in consultation with pulmonary and agreed that she is in end stage. Subject declined any further BiPAP and was discharge from the hospital to hospice 4 days later, 3 February 2004. Subject discontinued the study on 2/3/04. The respiratory failure and COPD exacerbation was reported by the investigator as not related to the study vaccine. Additional information received on 3/5/04: Subject was discharged from the hospital on 2/3/4 to hospice. Subject died in hospice on 2/17/04, 111 days post immunization. The death due to respiratory failure and COPD exacerbation was reported by the investigator as unrelated to the study vaccine. Follow up on 03/24/04: "Additional information received 03/18/04. Copy of death certificate: Cause of death: Advanced Chronic Obstructive Lung Disease. No autopsy performed."
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Productive cough, Pyrexia, Respiratory failure
Clinical narrative: This subject is a 76 year old female who was admitted to the hospital with respiratory failure and COPD exacerbation while enrolled in a comparative randomized study of safety and immunogenocity of a non-adjuvanted respiratory syncytial virus vaccine versus an RSV vaccine adjuvanted with aluminum phosphate when administered concomitantly with a licensed influenza vaccine in high-risk adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was 10/29/03. The first dose was 10/17/02. Subject developed increasing shortness of breath over the last month and purulent sputum, fever, chills and cough over the last 2 weeks. Subject was taken to emergency by ambulance 93 days post immunization on 1/30/04 and admitted the same day with respiratory failure. Subject was placed on BiPAP, and treated with nebulizer treatments, Rocephin 1gm, Zithromax 500mg, Decadron 6mg IV, Prednisone 40mg BID, Vantin 200mg BID. A chest x-ray on 1/30/04 showed COPD and no pneumonia. EKG is normal. There is no history of chest pain. Subject had mild improvement, however her disease is severe with an FVC of approximately 0.5 liter. Seen in consultation with pulmonary and agreed that she is in end stage. Subject declined any further BiPAP and was discharge from the hospital to hospice 4 days later, 3 February 2004. Subject discontinued the study on 2/3/04. The respiratory failure and COPD exacerbation was reported by the investigator as not related to the study vaccine. Additional information received on 3/5/04: Subject was discharged from the hospital on 2/3/4 to hospice. Subject died in hospice on 2/17/04, 111 days post immunization. The death due to respiratory failure and COPD exacerbation was reported by the investigator as unrelated to the study vaccine. Follow up on 03/24/04: "Additional information received 03/18/04. Copy of death certificate: Cause of death: Advanced Chronic Obstructive Lung Disease. No autopsy performed."
Age: 1.6
Sex: F
Vaccine: PNC
Symptoms: Drug ineffective, Sepsis
Clinical narrative: Follow-up info received from the physician provided pt info, medical history, vaccination dates, lot numbers and outcome. Information regarding Prevnar was received from a pediatrician regarding a 28 month old female who developed Streptococcus pneumoniae pneumonia and empyema. The pt received her second dose on 5/19/03 at 19 months of age. The child was hospitalized on 2/11/04 for Streptococcus pneumoniae pneumonia. The child subsequently devleoped an empyema that had to be evacuated thoracoscopically. The child was discharged after 13 days.
Age: 1.39
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Drug toxicity, Neurodevelopmental disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a 30 month old male pt who experienced neurodevelopmental injuries due to excessive doses of ethyl mercury. The pt received the fourth dose on 2/25/97, at 16 months of age. The pt also received the fourth dose of DTP/ DTaP on 2/25/97. The attorney alleges that the pt experienced neurodevelopemntal injuries caused by his exposure to excessive doses of ethyl mercury added to many of his pediatric vaccines. The multiple symptoms of the pt's injuries occurred and were first manifest by approximately April 1998. No additional info was available at the time of this report.
Sex: M
Vaccine: HIBV
Symptoms: Drug toxicity, Neurodevelopmental disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Heamophilus B conjugate vaccine was received from an attorney regarding a male pt who experienced mercury poisoning and neurodevelopmental injuries. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-containing vaccine (s), the child developed "severe" neurodevelopmental injuries of mercury poisoning. No additional info was available at the time of this report.
Sex: M
Vaccine: HIBV
Symptoms: Drug toxicity, Neurological symptom
Clinical narrative: This case was considered medically important (OMIC). Info regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male pt who experienced mercury poisoning and neurodevelopmental injuries. The pt received a dose on an unspecified date. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-containing vaccine (s), the child developed "severe" neurodevelopmental injuries of mercury poisoning. No additional info was available at the time of this report.
Sex: M
Vaccine: HIBV
Symptoms: Drug toxicity, Neurological symptom
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male pt who experienced mercury poisoning and neurodevelopmental injuries. The pt received a dose on an unspecified date. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-containing vaccine (s), the child developed "severe" neurodevleopmental injuries of mercury poisoning. No additional info was available at the time of this report.
Sex: M
Vaccine: HIBV
Symptoms: Drug toxicity, Neurological symptom
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate was received from an attorney regarding a male pt who experienced mercury poisoning and neurodevelopmental injuries. The pt received a dose on an unspecified date. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-containing vacine (s), the child developed "severe" neurodevelopmental injuries of mercury poisoning. No additional info was available at the time of this report.
Sex: M
Vaccine: HIBV
Symptoms: Drug toxicity, Neurological symptom
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male pt who experienced mercury poisoning and neurodevelopmental injuries. The pt received a dose on an unspecified date. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-contatining vaccne (s), the child developed "severe" neurodevelopmental injuries of mercury poisoning. No additional info was available at the time of this report.
Sex: M
Vaccine: HIBV
Symptoms: Drug toxicity, Neurological symptom
Clinical narrative: This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male pt who experienced mercury poisoning and neurodevelopmental injuries. The pt received a dose on an unspecified date. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-containing vaccine (s), the child developed "severe" neurodevelopomental injuries (neurological symptom) of mercury poisoning. No additional info was available at the time of this report.
Age: 0.57
Sex: M
Vaccine: DTP, HEP, HIBV
Symptoms: Drug toxicity, Neurological symptom
Clinical narrative: Information has been received regarding a case in litigation concerning a 30 month old male who on 10/6/95, 12/6/95 and 5/1/96 and vaccinated with a first, second and third dose of hep B virus vaccine, respectively. On 12/6/95, 2/16/95, 5/1/96 and 2/25/97 the pt was vaccinated with a first, second, third and fourth dose of DTP and a first, second, third and fourth dose of Hib conj vaccine, respectively. It is alleged that as a result of the mercury overdose the pt sustained via these thimerosal-containing vaccines, the pt suffered severe neurodevelopmental injuries. The multiple symptoms of the pt's injuries occurred and were first manifested by approximately April 1998. Upon internal review, severe neurodevelopmental injuries and mercury overdose were considered to be other important medical events (OMIC). No further info is available.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Anaphylactic reaction, Choking, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: 10-15 minutes after innoculation, patient experienced lightheadedness, SOB, choking sensation, diaphoresis. Relieved with 25mg IM Benadryl, then 25mg IV Benadryl. Reviewed e-mail update from reporter on 3/16/04. Final diagnosis was anaphylaxis.
Age: 1.2
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Dyspnoea, Febrile convulsion, Injury, Rash vesicular, Rhinitis
Clinical narrative: Complex febrile seizures-1 episode generalized tonic clonic seizure lasting approximately 35 min associated vesculated rash all over. Review of hospital records. Please add INJURY ACCID, RHINITIS, and DYSPNEA.
Sex: U
Vaccine: ANTH
Symptoms: Erythema, Oedema, Skin irritation
Clinical narrative: Pt presented to clinic with complaint of redness and swelling over weekend, received vaccine (Anthrax) on 27 Feb 04. Presented on 01 Mar 04. No evidence of Allergic reaction. Pt with local irritation/reaction. Not a true adverse event but patient wanted it documented in record.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Abasia, Dyspnoea, Erythema, Pain, Urticaria
Clinical narrative: Mother came into WIC office with child at approx. 1:00 pm. Child was covered in hives, face, ears and back were red. Mother stated that the child had trouble breathing at home. In the office the child was breathing okay. Referred the child to the physician's office (2 blocks away)  right away. Later in the evening, after the office was closed, the child's mother called the immunization clerk at home. The child's mother stated the child could not walk and that it looked like he was in a lot of pain. Mother also states that the child will not let her touch the injection sites (given in his legs) because of the pain. Immunization clerk instructed the mother to take the child to the emergency room. Called residence at 8:35 am 3/9/04 and there was no answer. Will continue to follow up.
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Fatigue, Myalgia, Night sweats
Clinical narrative: Night sweats first 3 nights after vaccine "extreme fatigue" day after vaccine to present muscle pain since day after vaccine MD diagnosis "arthritis-type vaccine reaction".
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Face oedema, Mydriasis, Pyrexia
Clinical narrative: Child developed fever up to 102 degrees ax. left side of face was swollen. Left pupil more dilated than right pupil saw MD who stated this was not a vaccine related event.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Swelling, pain and redness at Td inj. site.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Skin nodule
Clinical narrative: Developed small non tender nodes rt post auricular, left anterior cervical and left occipital 2 days ago.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site pain, Oedema
Clinical narrative: Mother noticed redness, edema to right thigh 12 hours after admin. of vaccine, pt complained of pain/discomfort to site. Tylenol/Benadryl prescribed by doctor during office visit.
Age: 1.97
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Injection site infection, Injection site mass, Injection site oedema
Clinical narrative: 2/27/04 Phone call. Mom noticed large lump in left thigh, swelling around thigh reddened and warm to touch. No fever went to doctor. Diagnosed as infection at the site. Prescribed Z-Pac. Follow-up report: 2/27/04 Initial report of localized swelling at injection site treatment with Zithromax. 2/28/04 continued swelling, redness, heat to left thigh. Taken to ER. Site measured at 10 cm x 11 cm. Admitted for IV antibiotics. Child doing well active, continue with small lump at injection site. Discoloration to affected site. No other complaints.  Follow up 05/10/2004 Telephone call from pt mother. Family has been on holiday for the past 2 1/2 weeks. Follow up call on child: pt is doing great. She continues with discoloration at indentation surrounding the site, and a lump at the injection site. No other c/o. No difficulties with activities. Information from Annual Follow-up report states , Mother states, "Completely recovered," 4/19/05.
Age: 1.97
Sex: F
Vaccine: DTAP
Symptoms: Skin discolouration, Skin nodule
Clinical narrative: 2/27/04 Phone call. Mom noticed large lump in left thigh, swelling around thigh reddened and warm to touch. No fever went to doctor. Diagnosed as infection at the site. Prescribed Z-Pac. Follow-up report: 2/27/04 Initial report of localized swelling at injection site treatment with Zithromax. 2/28/04 continued swelling, redness, heat to left thigh. Taken to ER. Site measured at 10 cm x 11 cm. Admitted for IV antibiotics. Child doing well active, continue with small lump at injection site. Discoloration to affected site. No other complaints.  Follow up 05/10/2004 Telephone call from pt mother. Family has been on holiday for the past 2 1/2 weeks. Follow up call on child: pt is doing great. She continues with discoloration at indentation surrounding the site, and a lump at the injection site. No other c/o. No difficulties with activities. Information from Annual Follow-up report states , Mother states, "Completely recovered," 4/19/05.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Rash erythematous
Clinical narrative: DTAP, polio and MMR given 3-1-04. Evening of 3-2-04. Mom noticed 4 inch circumference raised red hot area on deltoid right arm.
Age: 1.67
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site vesicles, Oedema
Clinical narrative: Pt. seen for 20 mo. physical examination received DTaP- IPV-Hep B Temp 101 that night-next day right deltoid with large confluent area of erythema, mild edema and warmth, 3 tiny vesicles at site of Band-Aid. Diagnosed probable early cellulitis/ localized reaction to DTaP/IPV. Prescribed Augmentin- Benadryl- Cool Compress.
Age: 1.67
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Pyrexia
Clinical narrative: Pt. seen for 20 mo. physical examination received DTaP- IPV-Hep B Temp 101 that night-next day right deltoid with large confluent area of erythema, mild edema and warmth, 3 tiny vesicles at site of Band-Aid. Diagnosed probable early cellulitis/ localized reaction to DTaP/IPV. Prescribed Augmentin- Benadryl- Cool Compress.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Facial rash, torso blotchy approx. 10 min. No difficulty breathing. No acute distress.
Age: 9.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Drug ineffective, Infection
Clinical narrative: Varicella 8 yr after administration of Varivax. 2-29-04 vesicles started on face and chest. 3-5-04 approx. 15 crusted or semi crusted vesicles.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Arthritis
Clinical narrative: Painful shoulder arthritis within hours- lasted a week and was treated with subacromial injection of Celestone 1cc. Follow up on 04/21/04: reporter does not have any new information.
Age: 1.08
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Erythema, Oedema
Clinical narrative: Arms Edema- Red
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Prolonged crying - No other visible signs. BMP, CBC, Bld culture done.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, HEPA
Symptoms: Oedema
Clinical narrative: Right deltoid swelling.
Age: 6.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: 7 1/2 x 7 cm non indurated redness on left deltoid, surrounding DTaP and MMR vaccine site plus itching. Treated with Zyrtec and cool compresses.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling, redness at injection site.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Erythema, Infection
Clinical narrative: Child broke out with scattered erythema papulo-vesicular lesions scattered on face, trunk, right hand - Benadryl.
Age: 1.78
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling, redness at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anorexia, Listless, Oedema, Pain, Pruritus
Clinical narrative: Patient had DTaP yesterday and started complaining last night that his right leg hurt and itched- this am, the right thigh was swollen and edematous with a macular pink rash down the front of the thigh - there is no fever- the pt is listless and doesn't want to eat.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash macular
Clinical narrative: Patient had DTaP yesterday and started complaining last night that his right leg hurt and itched- this am, the right thigh was swollen and edematous with a macular pink rash down the front of the thigh - there is no fever- the pt is listless and doesn't want to eat.
Age: 65.0
Sex: M
Vaccine: TTOX
Symptoms: Erythema, Myalgia, Oedema
Clinical narrative: Redness, swelling and soreness extending from deltoid to elbow, right arm.
Age: 36.0
Sex: U
Vaccine: ANTH, SMALL
Symptoms: Chills, Erythema, Fatigue, Pyrexia, Skin nodule
Clinical narrative: #1 Anthrax- Fatigue, chills, subjective fever for 5 days, local nodule. #2 Anthrax- Local nodule only. #3 Anthrax- Large local reaction with approximately 10 cm erythema.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Balance disorder, Coma, Convulsion, Loss of consciousness
Clinical narrative: Due to a change of school, our son had gone to his doctor's for a physical. Doctor physician assistant took our son's vitals and then the doctor proceeded with the examination. At the end of the examination, Doctor stated that he was due for a tetanus shot, and we asked the P.A. if the shot had a mercury derivative as a preservative. We were informed, after the P.A. went to check, that it did not contain any mercury derivative. It was further explained that only the MMR had a mercury derivative, but that it had been discontinued. After conferring between ourselves, my husband gave permission for the shot. Our son took the injection well, without the normal fighting and need for restraint, got dressed, and we left the examination room. While I waited at the receptionist's window to receive requested medical records, approximately thirty-five feet from the examination room, the receptionist and I heard a noise and turned to see my son collapsing into my husband. At first, my husband thought he was just giving him a hug, but our son continued to lean into my husband and fell to the floor. Our son lay on the floor for about five minutes; his body twitching as if in a seizure for about one minute. We have seen seizures prior to this having family members with epilepsy, and immediately informed the office personnel, only to be told that he was not having a seizure and that the doctor was coming. Once the trembling had ceased, we called his name and patted his face, but he remained unresponsive. It was another minute until he said he was alright in reply to our questions and thirty seconds longer for him to be able to move. Our son tried to roll onto his side in order to sit up, but he was not able to do it, so he laid there an additional minute. He again tried to sit up, and being able to, tried immediately to stand up, but was too weak and unstable, which caused him to fall back down. Five minutes after he lost consciousness, his father carried him back to the examining room. Doctor said, after checking him over, that the reaction was no big deal, that it happens all the time, and that our son would be fine. The doctor elevated his feet, had him resting, and under observation for another ten minutes before he felt secure enough to release him.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Muscle twitching, Tremor
Clinical narrative: Due to a change of school, our son had gone to his doctor's for a physical. Doctor physician assistant took our son's vitals and then the doctor proceeded with the examination. At the end of the examination, Doctor stated that he was due for a tetanus shot, and we asked the P.A. if the shot had a mercury derivative as a preservative. We were informed, after the P.A. went to check, that it did not contain any mercury derivative. It was further explained that only the MMR had a mercury derivative, but that it had been discontinued. After conferring between ourselves, my husband gave permission for the shot. Our son took the injection well, without the normal fighting and need for restraint, got dressed, and we left the examination room. While I waited at the receptionist's window to receive requested medical records, approximately thirty-five feet from the examination room, the receptionist and I heard a noise and turned to see my son collapsing into my husband. At first, my husband thought he was just giving him a hug, but our son continued to lean into my husband and fell to the floor. Our son lay on the floor for about five minutes; his body twitching as if in a seizure for about one minute. We have seen seizures prior to this having family members with epilepsy, and immediately informed the office personnel, only to be told that he was not having a seizure and that the doctor was coming. Once the trembling had ceased, we called his name and patted his face, but he remained unresponsive. It was another minute until he said he was alright in reply to our questions and thirty seconds longer for him to be able to move. Our son tried to roll onto his side in order to sit up, but he was not able to do it, so he laid there an additional minute. He again tried to sit up, and being able to, tried immediately to stand up, but was too weak and unstable, which caused him to fall back down. Five minutes after he lost consciousness, his father carried him back to the examining room. Doctor said, after checking him over, that the reaction was no big deal, that it happens all the time, and that our son would be fine. The doctor elevated his feet, had him resting, and under observation for another ten minutes before he felt secure enough to release him.
Age: 1.67
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Difficulty in walking, Erythema, Irritability, Oedema, Pyrexia
Clinical narrative: Fever 104 degrees. Rash- Flat red dots on back and chest this AM 6-7 raised bumps on back red with white center 5 legs red and swollen. Fussy. Won't walk but can walk.
Age: 1.67
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Fever 104 degrees. Rash- Flat red dots on back and chest this AM 6-7 raised bumps on back red with white center 5 legs red and swollen. Fussy. Won't walk but can walk.
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site oedema
Clinical narrative: Swelling at injection site.
Age: 4.92
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Skin nodule, Tenderness
Clinical narrative: DTaP test; this am noted redness increasing in size and tenderness. No fever. Right upper arm with puncture area of redness below/around it. 4x4 cm, warm, indurated. No ax nodes.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin reaction
Clinical narrative: Local skin reaction.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pyrexia
Clinical narrative: Fever, papular/vesicular eruption.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Skin nodule
Clinical narrative: Left deltoid erythema and induration 4-5 cm.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Diarrhoea, Haematochezia, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Rash where shot was given left thigh, 2.5 cm diameter with induration and erythema. Generalized maculopapular eruption on trunk. Associated with diarrhea and bleeding of blood in stool.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Rash maculo-papular
Clinical narrative: Rash where shot was given left thigh, 2.5 cm diameter with induration and erythema. Generalized maculopapular eruption on trunk. Associated with diarrhea and bleeding of blood in stool.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site induration, Pyrexia, Skin ulcer
Clinical narrative: ~1 day post #3 Anthrax Vax.  Pt developed large 150mm indurated, pyretic lesion over injection sight that extended to elbow.  Resolved with oral Prednisone and topical Timovate.  Pt had prior reactions to previous 2 doses only marked less severe.
Age: 44.0
Sex: M
Vaccine: FLUX, TYP, UNK
Symptoms: Chills, Fatigue, Hyperhidrosis, Influenza like illness, Tremor
Clinical narrative: Flu like symptoms, chills, shakes, sweats. Run down feeling, tired. Treatment, motrin, tylenol
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Abscess, Blister, Laboratory test abnormal, Skin ulcer
Clinical narrative: This is a 21-year-old who received his primary hepatitis B vaccination on 02/03/03. Approximately 1 week later he reports the development of a single "pustule/bump" on his right anterior lateral abdominal area. He did not seek care because he thought that it would to away. He states that it soon became a hole "the size of the end of a Q-tip". He reports that it drained "yellow, green and bloody" pus, but denies any odor to the drainage. On 03/25/03 he sought care at the medical department. Doctor referred him to the emergency department for further evaluation and treatment.  The client was evaluated in the Emergency Department (ED). An incision and drainage procedure was performed on the abscess. He was instructed to pack the wound twice a day with iodophor gauze. He completed the procedure as instructed for 7 to 10 days. He states that the abscess healed without further complication.  On 17 June 2003 the client received his second hepatitis B vaccination. As before, within one week he developed a single pustule/bump on his right upper lateral buttock. He states that he can touch both areas by spreading his hand and reaching from thumb to pink between the two lesion sites. He reports that the pustule progressed, as previously, however this time he did not wait to seek care. The abscess required incision and drainage (I&D), which was done on 30 June 2003. Like before the abscess healed after the I&D procedure without further complication.  The client states that he had never before, or since these two occurrences developed pustules or abscesses. He is a volunteer on a search and rescue team and is concerned that he may not be hepatitis B immune. His other concern is if he continues and takes the third hepatitis B vaccination that he will again develop another abscess. He also states that he did not change detergents, softners, personal hygiene products, living environment or work environment.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Swelling
Clinical narrative: LEG WAS SWOLLEN AND RED. WAS STARTED ON ANTIBOTICS.
Age: 39.0
Sex: M
Vaccine: TYP
Symptoms: Hypersensitivity, Rash, Sunburn
Clinical narrative: 0840-Received Typhoid Immunization 0910-Developed a rash in mouth 0910-Rash, hypersensativity, feels like sunburn all over. 1300- Present at ER for treatment
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Rash, Swelling
Clinical narrative: 0.5 ml prefilled pneumovax vaccine (23 valent) given to pt on 3/9/04. Administered to Right deltoid. Returned to office on 3/10 with swollen R deltoid, red rash and discomfort. Seen by doctor.
Age: 3.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Malaise
Clinical narrative: Pt had localized red/endurated reaction appro. 14 cm at injectoin site without abcess. Generalized althragia and malaise.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Infantile spasms, Sleep disorder
Clinical narrative: 02-20-04 Mother reported sleep disturbance onset day vaccine rec'd and continued daily. Episodes of 'sporatic movement/seizures' onset evening of 02-17-04. ER visit 02-18. Seen by private physician 02-19. Referred to neurologist; seen 02-23. Dx of Infantile Spasms.  Medications prescribed: Topamax, B6 - 200mg daily
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: SWELLING/REDNESS/PRURITUS OF LT ARM 2 DAYS AFTER VACCINATION.  REDNESS AND SWELLING EXTENDED TO FOREARM
Age: 0.3
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Apnoea, Depressed level of consciousness
Clinical narrative: Approximately 2 hours after vaccinations were given, infant became apneic and unarousable.  The Infant required intubation.  Medical record on 04/30/04 states no new information.
Age: 46.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Muscular weakness, Myalgia
Clinical narrative: sore muscles, joint pain, muscle weakness
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 6 month old male who experienced SIDS. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Additional suspect medication included Haemophilus B vaccine and DTaP-Poliomyelitis. Concomitant medications were not reported. On 2/10/04, the infant died. The cause of death was reported as sudden infant death syndrome. This is 1 of 2 infants from this facility who experienced this event following receipt of Prevnar, lot 495161. No additional information was available at the time of this report. Information regarding this event has been forwarded to manufacturer. Information on the circumstances surrounding the patient's death and family history was unavailable. An autopsy was performed, results were requested, but "were not expected for several months" at the time of reporting.
Age: 32.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Rash papular, Skin ulcer
Clinical narrative: Screen for MMR/varicella neg antibody Rubella/Varicella given vaccines MMR Varivax same day patient noted eruption 2/4/04 with predomal sign body aches headache. Returned to office 2/6/04 pink papular/macular rash trunk area.
Age: 32.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Headache, Pain, Rash maculo-papular
Clinical narrative: Screen for MMR/varicella neg antibody Rubella/Varicella given vaccines MMR Varivax same day patient noted eruption 2/4/04 with predomal sign body aches headache. Returned to office 2/6/04 pink papular/macular rash trunk area.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Hypotension, Rash, Somnolence, Syncope
Clinical narrative: From initial information received on 3/3/04 from a registered nurse, regarding an adverse event occurring in the USA, it was reported that a 4 year old female patient received a fourth dose of IPOL, lot number X0316-2, administered SC in the left arm; a fifth dose of TRIPEDIA, lot number U1257CA, administered IM in the left thigh; and a second dose of MMR, lot number 0822N, administered SC in the right arm, on 3/1/04 at 12:00 PM. Fifteen minutes later the child complained of abdominal pain. A nurse first observed the child on the bathroom floor, where the mother had placed her. The child had an apparent syncopal episode and was taken to an examination room for observation. She experienced episodes of tachycardia and hypotension. At 12:23 PM, her blood pressure was 81/53 and her pulse was 126. At 12:30 her blood pressure was 93/56 and her pulse was 121. At 12:38 PM, her blood pressure was 96/61 and her pulse was 111. At approximately 12:55 PM, the child began to develop urticaria. She was given Benadryl 1.5 teaspoons at 12:55 PM and epinephrine 0.18 mg. SC at 1:00 PM. The child was then transported by ambulance to the hospital and was hospitalized for one day. The patient reportedly did recover from this event. Follow up on 03/23/04 states: From additional information received on 03/15/04 from manufacturer, it was reported by a health care professional that the pt has no relevant medical history, no known allergies or previous reactions and was well at the time of vaccination. Approximately five minutes post vaccination (also reported as fifteen minutes post vaccination), the pt began complaining of stomach pains. The pt's mother took her to the bathroom. Shortly thereafter another nurse noticed that the pt was lying on the bathroom floor. The pt was taken to a treatment room. The pt developed syncope, tachycardia, hypotension, and urticaria. No respiratory distress was noted. The pt was transported by ambulance to the hospital and was hospitalized overnight. She was released the next day and "appeared to be fine". The nurse reported that as far as she knew the pt had recovered." From additional information received on 20/Apr/2004 from the patient's physician, it was reported that the patient was on no other medication at the time of vaccine administration. The patient received intravenous Solu-Medrol and intravenous Benadryl in the Emergency Room at 1:45 PM. The physician also reported that she reported this adverse event previously to VAERS and manufacturer. Additional patient information was provided such as the patient's address and telephone number. The physician stated "Reviewed 12/Apr/2004, form complete and no additiional medical information at this time."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Tachycardia, Urticaria
Clinical narrative: From initial information received on 3/3/04 from a registered nurse, regarding an adverse event occurring in the USA, it was reported that a 4 year old female patient received a fourth dose of IPOL, lot number X0316-2, administered SC in the left arm; a fifth dose of TRIPEDIA, lot number U1257CA, administered IM in the left thigh; and a second dose of MMR, lot number 0822N, administered SC in the right arm, on 3/1/04 at 12:00 PM. Fifteen minutes later the child complained of abdominal pain. A nurse first observed the child on the bathroom floor, where the mother had placed her. The child had an apparent syncopal episode and was taken to an examination room for observation. She experienced episodes of tachycardia and hypotension. At 12:23 PM, her blood pressure was 81/53 and her pulse was 126. At 12:30 her blood pressure was 93/56 and her pulse was 121. At 12:38 PM, her blood pressure was 96/61 and her pulse was 111. At approximately 12:55 PM, the child began to develop urticaria. She was given Benadryl 1.5 teaspoons at 12:55 PM and epinephrine 0.18 mg. SC at 1:00 PM. The child was then transported by ambulance to the hospital and was hospitalized for one day. The patient reportedly did recover from this event. Follow up on 03/23/04 states: From additional information received on 03/15/04 from manufacturer, it was reported by a health care professional that the pt has no relevant medical history, no known allergies or previous reactions and was well at the time of vaccination. Approximately five minutes post vaccination (also reported as fifteen minutes post vaccination), the pt began complaining of stomach pains. The pt's mother took her to the bathroom. Shortly thereafter another nurse noticed that the pt was lying on the bathroom floor. The pt was taken to a treatment room. The pt developed syncope, tachycardia, hypotension, and urticaria. No respiratory distress was noted. The pt was transported by ambulance to the hospital and was hospitalized overnight. She was released the next day and "appeared to be fine". The nurse reported that as far as she knew the pt had recovered." From additional information received on 20/Apr/2004 from the patient's physician, it was reported that the patient was on no other medication at the time of vaccine administration. The patient received intravenous Solu-Medrol and intravenous Benadryl in the Emergency Room at 1:45 PM. The physician also reported that she reported this adverse event previously to VAERS and manufacturer. Additional patient information was provided such as the patient's address and telephone number. The physician stated "Reviewed 12/Apr/2004, form complete and no additiional medical information at this time."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abdominal pain, Hypotension, Syncope, Tachycardia, Urticaria
Clinical narrative: From initial information received on 3/3/04 from a registered nurse, regarding an adverse event occurring in the USA, it was reported that a 4 year old female patient received a fourth dose of IPOL, lot number X0316-2, administered SC in the left arm; a fifth dose of TRIPEDIA, lot number U1257CA, administered IM in the left thigh; and a second dose of MMR, lot number 0822N, administered SC in the right arm, on 3/1/04 at 12:00 PM. Fifteen minutes later the child complained of abdominal pain. A nurse first observed the child on the bathroom floor, where the mother had placed her. The child had an apparent syncopal episode and was taken to an examination room for observation. She experienced episodes of tachycardia and hypotension. At 12:23 PM, her blood pressure was 81/53 and her pulse was 126. At 12:30 her blood pressure was 93/56 and her pulse was 121. At 12:38 PM, her blood pressure was 96/61 and her pulse was 111. At approximately 12:55 PM, the child began to develop urticaria. She was given Benadryl 1.5 teaspoons at 12:55 PM and epinephrine 0.18 mg. SC at 1:00 PM. The child was then transported by ambulance to the hospital and was hospitalized for one day. The patient reportedly did recover from this event. Follow up on 03/23/04 states: From additional information received on 03/15/04 from manufacturer, it was reported by a health care professional that the pt has no relevant medical history, no known allergies or previous reactions and was well at the time of vaccination. Approximately five minutes post vaccination (also reported as fifteen minutes post vaccination), the pt began complaining of stomach pains. The pt's mother took her to the bathroom. Shortly thereafter another nurse noticed that the pt was lying on the bathroom floor. The pt was taken to a treatment room. The pt developed syncope, tachycardia, hypotension, and urticaria. No respiratory distress was noted. The pt was transported by ambulance to the hospital and was hospitalized overnight. She was released the next day and "appeared to be fine". The nurse reported that as far as she knew the pt had recovered." From additional information received on 20/Apr/2004 from the patient's physician, it was reported that the patient was on no other medication at the time of vaccine administration. The patient received intravenous Solu-Medrol and intravenous Benadryl in the Emergency Room at 1:45 PM. The physician also reported that she reported this adverse event previously to VAERS and manufacturer. Additional patient information was provided such as the patient's address and telephone number. The physician stated "Reviewed 12/Apr/2004, form complete and no additiional medical information at this time."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Hypotension, Syncope, Tachycardia, Urticaria
Clinical narrative: From initial information received on 3/3/04 from a registered nurse, regarding an adverse event occurring in the USA, it was reported that a 4 year old female patient received a fourth dose of IPOL, lot number X0316-2, administered SC in the left arm; a fifth dose of TRIPEDIA, lot number U1257CA, administered IM in the left thigh; and a second dose of MMR, lot number 0822N, administered SC in the right arm, on 3/1/04 at 12:00 PM. Fifteen minutes later the child complained of abdominal pain. A nurse first observed the child on the bathroom floor, where the mother had placed her. The child had an apparent syncopal episode and was taken to an examination room for observation. She experienced episodes of tachycardia and hypotension. At 12:23 PM, her blood pressure was 81/53 and her pulse was 126. At 12:30 her blood pressure was 93/56 and her pulse was 121. At 12:38 PM, her blood pressure was 96/61 and her pulse was 111. At approximately 12:55 PM, the child began to develop urticaria. She was given Benadryl 1.5 teaspoons at 12:55 PM and epinephrine 0.18 mg. SC at 1:00 PM. The child was then transported by ambulance to the hospital and was hospitalized for one day. The patient reportedly did recover from this event. Follow up on 03/23/04 states: From additional information received on 03/15/04 from manufacturer, it was reported by a health care professional that the pt has no relevant medical history, no known allergies or previous reactions and was well at the time of vaccination. Approximately five minutes post vaccination (also reported as fifteen minutes post vaccination), the pt began complaining of stomach pains. The pt's mother took her to the bathroom. Shortly thereafter another nurse noticed that the pt was lying on the bathroom floor. The pt was taken to a treatment room. The pt developed syncope, tachycardia, hypotension, and urticaria. No respiratory distress was noted. The pt was transported by ambulance to the hospital and was hospitalized overnight. She was released the next day and "appeared to be fine". The nurse reported that as far as she knew the pt had recovered." From additional information received on 20/Apr/2004 from the patient's physician, it was reported that the patient was on no other medication at the time of vaccine administration. The patient received intravenous Solu-Medrol and intravenous Benadryl in the Emergency Room at 1:45 PM. The physician also reported that she reported this adverse event previously to VAERS and manufacturer. Additional patient information was provided such as the patient's address and telephone number. The physician stated "Reviewed 12/Apr/2004, form complete and no additiional medical information at this time."
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Coma, Sudden infant death syndrome
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 2 month old male who experienced SIDS. At 2 months of age, the infant received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Additional suspect medication included Pediarix and haemophilus B vaccine. Concomitant medications were not reported. On 2/28/04, the infant died. The cause of death was reported as sudden infant death syndrome. This is one of two infants from this facility who experienced this event following receipt of Prevnar lot 495161. Information regarding this event has been forwarded to the manufacturer of Pediarix. No additional information was available at the time of this report.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 2 month old male who experienced SIDS. At 2 months of age, the infant received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Additional suspect medication included Pediarix and haemophilus B vaccine. Concomitant medications were not reported. On 2/28/04, the infant died. The cause of death was reported as sudden infant death syndrome. This is one of two infants from this facility who experienced this event following receipt of Prevnar lot 495161. Information regarding this event has been forwarded to the manufacturer of Pediarix. No additional information was available at the time of this report.