chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HEP, TD
Symptoms: Chills, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: Immediately, post vax, became upset and saying "I'm gonna be sick". Cold, wet washcloth was applied to throat. She was pale, diaphoretic, BP 90/60, pulse 80. Transferred to hallway and laid down on exam table with feet elevated. BP 88/60, pulse 82, resp 16 and non-labored. Temp 97.9F. She remains pale, but is now shivering. Took a few small sips of apple juice and tolerated it well, denies nausea and states she is feeling better. Is now sitting up with legs dangling off side of table, denies dizziness, nausea and color is returning to normal. BP 104/64, pulse 84. She asked to go home. She was sent home with mother with instructions to observe and call us if she has any questions or concerns.
Age: 17.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Within 1-2 minutes, post vax, pt complained of feeling funny. His nurse observed pale, clammy skin. No LOC noted. BP 102/48. Moved to exam room table via wheelchair. Legs were elevated. BP 98/60, pulse 66, resp 18, regular and unlabored. Continued to monitor for 20-30 mnutes. BP monitored freqently. At 14:10, BP 104/70, pulse 60, resp 16, drinking orange juice and states he is feeling better. At 14:15, BP 100/68, sitting up with legs dangling, pulse 64, resp 16. At 14:20, BP 100/60, pulse 70, while standing up. Voices no complaints and color is returning to face. No sweating noted. States "I'm OK". Sent home with mother and instructed to let us know if he has any more problems.
Age: 11.0
Sex: M
Vaccine: DT, HEP
Symptoms: Eyelid oedema, Face oedema, Muscular weakness, Pain, Rash macular
Clinical narrative: About 30-40 minutes, post vax, pt's legs hurt and "felt weak". About 1-2 hours, post vax, had "bumps" on face and neck". About 18-20 hours, post vax, he had left side of face and left eyelid swollen. About 24-27 hours, post vax, both sides of face and both eyelids were swollen. RN called pt's doctor and symptoms reported on 7/28/00 at 13:45. Pt's parent called MD, also.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Urticaria
Clinical narrative: Mother of child reports he had hives about 21:30, post vax. No treatment.
Age: 16.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Face oedema, Hypoaesthesia oral
Clinical narrative: Mom called back about 3-4 hours, post vax, stating pt was complaining of facial numbness and mild swelling. No rash or respiratory distress per mom's report. Advised to give pt Benadryl and see PMD if no relief or improvement in 30-40 minutes or go to ER if she has any respiratory distress. Called on 7/18/00 and pt stated Benadryl was effective and had no further problems.
Age: 0.7
Sex: M
Vaccine: DTAP, IPV
Symptoms: Anorexia, Candidiasis, Irritability, Otitis media, Pyrexia
Clinical narrative: On 7/28/00, post vax, pt had a temperature of 104F (A) seen in ER and dx'd with bilateral OM. Pt fussy with decreased PO intake. Thrush. No rash or cough. Symptoms are still present.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Screaming
Clinical narrative: Crying X 4 hours, post vax.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 8 hours, post vax, pt's arm became painful, red and swollen which progressively increased from should to elbow.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt returned to MD's office at 18:25 with painful and swollen right arm from elbow to injection site. Pt treated with Benadryl IM and Augmentin and Motrin.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Oedema
Clinical narrative: The pt experienced redness/warmth over the left arm area about 12 hours with increased in redness and swelling until evaluated 36 hours later. Advised ice to area and hydrocortisone cream.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local swelling at site of injection with redness and tenderness (4.5cm X 3.5cm).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Hypersensitivity, Lethargy, Pyrexia, Vomiting
Clinical narrative: On 8/2/00 at 23:00, child vomited, had fever of 104F, headache and was very sleepy. Gave Motrin at 02:00 on 8/3/00 and she felt better. At 13:00 on 8/3/00, fever was 105F with headache and lethargy. Mom called Pediatrician who said it was a reaction and to call health dept.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Erythema, Irritability, Swelling, Urticaria
Clinical narrative: 10 minutes, post vax, pt's left leg was red from foot to groin, swollen with hives present. Had a few hives on abdomen and right leg. She was cranky. Epinephrine was given and sent to MD's office. Area "cleared up" in 10 minutes when he reached the office. Still had a few hives remaining; will see allergist.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Eczema, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Red  and swollen left anterior thigh that is warm to touch with a temperature of 38.1C (rectal). Treated with Keflex for 10 days.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Oedema genital, Orchitis
Clinical narrative: Complaint of swollen and painful testicles. Dx: orchitis
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Back pain, Difficulty in walking, Fasciitis, Neuralgia
Clinical narrative: On 3/29/99, the pt received her 1st Lymerix. In April, 1999, the 2nd dose was given and some time after either the 1st or 2nd dose, she experienced mid to lower back pain (moderate to severe) and progressed quickly. In May, the pt reported she had a sudden onset of sciatic nerve pain which radiated down her left leg. She went to an othopod and had an MRI of her back which revealed "arthritis and inflammation". She had physical therapy until August, 1999. From July to August, 1999, she had a sudden onset of right heel pain and was dx'd with plantar fasciitis treated with supportive shoes and she was not to go barefoot. The back pain continued despite physical therapy. In 1/00, she saw a different orthopod and was noted to be "walking funny". Walking was painful, and she was prescribed Celebrex which relieved the pain and enabled her to walk better. A second MRI in 1/00, again showed inflammation and arthritis of her spine. In 3/00, the pt received the 3rd Lymerix. The most recent information received on 8/4/00 reports the pt's pain intensity increases with activity.  A follow up report received 2/2/2001 adds: This report was received from a pt and has been verified by the primary care physician. Concurrent medical conditions included a penicillin allergy, foot arthropathy, a narrowing of lumbar 5 and sacral 1 of back due to osteoarthritis, and hypercholesterolemia. Concurrent medications included atorvastatin (Lipitor) and estradiol (Estrace). On 03/29/1999 the pt received her 1st injection with Lymerix. On 04/26/1999 the 2nd dose was given.... Follow up from the primary care physician revealed confirmation of back pain and right heel pain only. These symptoms were not considered permanently disabling. To the reporting physician's knowledge, the joint complaints were not evaluated by a physician nor have any lab tests been performed for arthritis. The info received on 08/04/2000 reported the pt's pain and ability to walk has been manageable with the use of Celebrex but the pain intensity increases with activity. The plantar fasciitis "is not bad if she wears supportive shoes and has minimal intense activity when barefoot". The latest info on 10/17/2000 from the physician did not provide an outcome. The events of arthritis, inflammation, back pain, sciatic nerve pain, plantar fasciitis and heel pain do not meet ICH serious criteria but are being submitted as an expedite report by special FDA request per the 6/28/2000 letter.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Pain in extremity
Clinical narrative: On 3/29/99, the pt received her 1st Lymerix. In April, 1999, the 2nd dose was given and some time after either the 1st or 2nd dose, she experienced mid to lower back pain (moderate to severe) and progressed quickly. In May, the pt reported she had a sudden onset of sciatic nerve pain which radiated down her left leg. She went to an othopod and had an MRI of her back which revealed "arthritis and inflammation". She had physical therapy until August, 1999. From July to August, 1999, she had a sudden onset of right heel pain and was dx'd with plantar fasciitis treated with supportive shoes and she was not to go barefoot. The back pain continued despite physical therapy. In 1/00, she saw a different orthopod and was noted to be "walking funny". Walking was painful, and she was prescribed Celebrex which relieved the pain and enabled her to walk better. A second MRI in 1/00, again showed inflammation and arthritis of her spine. In 3/00, the pt received the 3rd Lymerix. The most recent information received on 8/4/00 reports the pt's pain intensity increases with activity.  A follow up report received 2/2/2001 adds: This report was received from a pt and has been verified by the primary care physician. Concurrent medical conditions included a penicillin allergy, foot arthropathy, a narrowing of lumbar 5 and sacral 1 of back due to osteoarthritis, and hypercholesterolemia. Concurrent medications included atorvastatin (Lipitor) and estradiol (Estrace). On 03/29/1999 the pt received her 1st injection with Lymerix. On 04/26/1999 the 2nd dose was given.... Follow up from the primary care physician revealed confirmation of back pain and right heel pain only. These symptoms were not considered permanently disabling. To the reporting physician's knowledge, the joint complaints were not evaluated by a physician nor have any lab tests been performed for arthritis. The info received on 08/04/2000 reported the pt's pain and ability to walk has been manageable with the use of Celebrex but the pain intensity increases with activity. The plantar fasciitis "is not bad if she wears supportive shoes and has minimal intense activity when barefoot". The latest info on 10/17/2000 from the physician did not provide an outcome. The events of arthritis, inflammation, back pain, sciatic nerve pain, plantar fasciitis and heel pain do not meet ICH serious criteria but are being submitted as an expedite report by special FDA request per the 6/28/2000 letter.
Age: 57.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Bone pain, Infection parasitic, Injection site erythema, Injection site pain
Clinical narrative: On 6/9/00, pt received her 1st Lymerix and subsequently, she had pain and redness at the injection site. Outcome: resolved. On 7/10/00, she had her 2nd shot and on 7/11/00, the pt had "extreme" muscle, joint, bone and skin pain. She is using codeine for sleep. She "may well have had a tick bite" and was started on Vibramycin X 3 weeks, starting on 7/25/00. The pt's husband, who is a doctor, reported that she may have gotten some phlebitis from the tick bite. She no longer had a visible bite mark. She had some calf tenderness, wore a TED, an elastic compression stocking, on that leg, and has been taking Motrin for the pain of Lyme disease. Joint complaints have not been evaluated by a physician. No arthritis lab work was done, or joint fluid obtained. The most recent information, received on 8/1/00, reports the outcome of the event as unresolved.
Age: 57.0
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Myalgia, Phlebitis
Clinical narrative: On 6/9/00, pt received her 1st Lymerix and subsequently, she had pain and redness at the injection site. Outcome: resolved. On 7/10/00, she had her 2nd shot and on 7/11/00, the pt had "extreme" muscle, joint, bone and skin pain. She is using codeine for sleep. She "may well have had a tick bite" and was started on Vibramycin X 3 weeks, starting on 7/25/00. The pt's husband, who is a doctor, reported that she may have gotten some phlebitis from the tick bite. She no longer had a visible bite mark. She had some calf tenderness, wore a TED, an elastic compression stocking, on that leg, and has been taking Motrin for the pain of Lyme disease. Joint complaints have not been evaluated by a physician. No arthritis lab work was done, or joint fluid obtained. The most recent information, received on 8/1/00, reports the outcome of the event as unresolved.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Asthenia, Dystonia, Nausea, Somnolence, Vomiting
Clinical narrative: On 5/15/00, the pt received her 1st Lymerix shot with no reported events. On 6/15/00, 2 to 3 hours, post vax, the pt had severe nausea and vomiting, a feeling of generalized weakness and "needed to sleep." She reported "feeling funny" until she went to sleep. The responsible physician initially reported that the symptoms were attributed to a dystonic reaction; however, this dx was not confirmed on follow-up. The events resolved after the vaccinee vomited and rested.
Age: 67.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Fatigue, Influenza like illness, Joint stiffness
Clinical narrative: In 1996, the pt was enrolled in Lyme protocol 008 and was randomized to the placebo arm. The pt was, subsequently, enrolled in Lyme protocol 013 and received 3 injections of Lymerix on 4/10/97, 5/6/97 and 4/13/98. Per the study investigator, the pt informed the site that she was a bicyclist. During the study, 1 day post vax 2nd shot, she reported experiencing moderate fever and chills which resolved in 1 day. On 8/1/97, the pt reported having a permanent pacemaker inserted for a pre-existing cardiac arrhythmia. All events were noted not to be related to Lymerix. The pt's last study date of contact was 5/22/98 and there were no complaints reported on her follow-yp contacts. Per the pt, on 7/31/00, she experienced flu-like symptoms (consisting of achiness, chills, fatigue and sleepiness) within "hours" of each injection of Lyme vaccine during protocol 013. The symptoms were "milder" after the 3rd injection. All events after each injection resolved within "hours" without treatment or sequela. Toward the "end of 1997", vaccinee noticed stiffness as "arthritic pain" which required no treatment and physician was consulted. By the den of 1998, the pt had bilateral knee stiffness that was more intense and frequent. She was examined by an orhopedist in 2/00 who saw no swelling or warmth of joints. She received bilateral cortisone injections which were effective for a short time only. The events are currently ongoing.
Age: 67.0
Sex: F
Vaccine: LYME
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: In 1996, the pt was enrolled in Lyme protocol 008 and was randomized to the placebo arm. The pt was, subsequently, enrolled in Lyme protocol 013 and received 3 injections of Lymerix on 4/10/97, 5/6/97 and 4/13/98. Per the study investigator, the pt informed the site that she was a bicyclist. During the study, 1 day post vax 2nd shot, she reported experiencing moderate fever and chills which resolved in 1 day. On 8/1/97, the pt reported having a permanent pacemaker inserted for a pre-existing cardiac arrhythmia. All events were noted not to be related to Lymerix. The pt's last study date of contact was 5/22/98 and there were no complaints reported on her follow-yp contacts. Per the pt, on 7/31/00, she experienced flu-like symptoms (consisting of achiness, chills, fatigue and sleepiness) within "hours" of each injection of Lyme vaccine during protocol 013. The symptoms were "milder" after the 3rd injection. All events after each injection resolved within "hours" without treatment or sequela. Toward the "end of 1997", vaccinee noticed stiffness as "arthritic pain" which required no treatment and physician was consulted. By the den of 1998, the pt had bilateral knee stiffness that was more intense and frequent. She was examined by an orhopedist in 2/00 who saw no swelling or warmth of joints. She received bilateral cortisone injections which were effective for a short time only. The events are currently ongoing.
Age: 71.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Asthma, Back pain, Cough, Fatigue
Clinical narrative: The pt enrolled in Lyme protocol 013 and received 3 Lymerix shots on 4/10/97, 5/6/97 and 4/13/98. No adverse events were recorded on the case report form for the vaccines. The pt's last study date of contact was 5/22/98. For the investigator, there were no complaints reported on his follow-up. Per the pt, on 7/31/00, on an unspecified date, he developed a cough and was treated with Claritin. His cough increased, so he was seen by an allergist who dx'd him with "adult asthma" at the end of 1997 or early 1998. The pt reported that "he saw another doctor who prescribed 3 inhalers (2 for regular use) and 1 for (emergency use). After the 3rd shot of Lymerix, in the end of 1998, he developed lower back pain, intermittent swollen finger joints, finger stiffness and fatigue. The events were described as occurring fairly constantly with varying intensity. In 1/00, the pt saw an allergist and, since he had not improved, he adjusted his medication. Investigator indicated, pt also reported to her in 8/00 that he had bilateral knee pain and stiffness, starting in 1/98. He reported his joint complaints have not been evaluated by a physician. The events are currently ongoing. He stated that he planned to make an appointment with a rheumatologist in "the near future."
Age: 71.0
Sex: M
Vaccine: LYME
Symptoms: Joint stiffness, Oedema peripheral
Clinical narrative: The pt enrolled in Lyme protocol 013 and received 3 Lymerix shots on 4/10/97, 5/6/97 and 4/13/98. No adverse events were recorded on the case report form for the vaccines. The pt's last study date of contact was 5/22/98. For the investigator, there were no complaints reported on his follow-up. Per the pt, on 7/31/00, on an unspecified date, he developed a cough and was treated with Claritin. His cough increased, so he was seen by an allergist who dx'd him with "adult asthma" at the end of 1997 or early 1998. The pt reported that "he saw another doctor who prescribed 3 inhalers (2 for regular use) and 1 for (emergency use). After the 3rd shot of Lymerix, in the end of 1998, he developed lower back pain, intermittent swollen finger joints, finger stiffness and fatigue. The events were described as occurring fairly constantly with varying intensity. In 1/00, the pt saw an allergist and, since he had not improved, he adjusted his medication. Investigator indicated, pt also reported to her in 8/00 that he had bilateral knee pain and stiffness, starting in 1/98. He reported his joint complaints have not been evaluated by a physician. The events are currently ongoing. He stated that he planned to make an appointment with a rheumatologist in "the near future."
Age: 1.25
Sex: M
Vaccine: DTPHIB, HEP, OPV
Symptoms: Abnormal behaviour, Aphasia, Drug effect increased, Neurodevelopmental disorder
Clinical narrative: Cumulative thimerosol, resulting in mercury induced developmental delay. Chelation therapy DMSA 100mg X 3. The annual follow-up states that the pt is still exhibiting autistic like behaviors and is nerologically damaged. He is still non-verbal and still is developmentally delayed.
Age: 0.3
Sex: M
Vaccine: HBHEPB
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema
Clinical narrative: On 8/1/00, within 1-2 hours, post vax, the pt experienced a large local reaction in left leg, consisting of erythema and edema of the entire leg. The pt was taken back to the physician's office where he was administered Benadryl. Within 15 minutes, most of the swelling had gone down and within 30 minutes it was back to normal. The pt was also ordered Tylenol and the physician consulted with an allergist and other pediatricians. Additionally, it was noted that the pt had been pulling himself and using the leg to bear weight and was not doing so as of 8/2/00. Upon internal review, the pt's experiences were considered to be "Other Medical Events". Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Abnormal behaviour, Autism, Balance disorder, Hypersensitivity, Screaming
Clinical narrative: Approximately 2 days post vax, this pt cried hysterically for approximately 2 days. He was seen by doctors who said he "was fine." The reporter stated that he "was not fine because he was losing his balance a lot and banging his head on the floor. They examined him and said he was fine. As the weeks continued all these behaviors continued." The reporter stated that she took him to a neurologist who dxed him as PDD/Autism. The neurologist suggested that the pt be put in a program for these types of conditions. The reporter stated "my son was fine before he took this vax." She also reported that the pt was seen by an allergist who did a blood test and the "MMR came out with a positive reaction." The reporter stated, "My son is allergic to the vax" and the allergist confirmed that he is allergic to MMR." The reporter also stated that the doctor gave her a letter stating that her son should not received the vax again. "He is improving with the program. He still loses his balance but it was worse before, his speech is okay and his hearing is fine." The reporter consulted another physician and told that the child would always have PPD/Autism. The reporter wanted "people to know that the vax could cause this." She also stated that her son cried hysterically for 4-6 months and could not stop. Upon medical review this is considered to be an "other medical event." FU indicates diagnosis to be autism.
Age: 1.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Dementia, Ecchymosis, Injury
Clinical narrative: Approximately 2 days post vax, this pt cried hysterically for approximately 2 days. He was seen by doctors who said he "was fine." The reporter stated that he "was not fine because he was losing his balance a lot and banging his head on the floor. They examined him and said he was fine. As the weeks continued all these behaviors continued." The reporter stated that she took him to a neurologist who dxed him as PDD/Autism. The neurologist suggested that the pt be put in a program for these types of conditions. The reporter stated "my son was fine before he took this vax." She also reported that the pt was seen by an allergist who did a blood test and the "MMR came out with a positive reaction." The reporter stated, "My son is allergic to the vax" and the allergist confirmed that he is allergic to MMR." The reporter also stated that the doctor gave her a letter stating that her son should not received the vax again. "He is improving with the program. He still loses his balance but it was worse before, his speech is okay and his hearing is fine." The reporter consulted another physician and told that the child would always have PPD/Autism. The reporter wanted "people to know that the vax could cause this." She also stated that her son cried hysterically for 4-6 months and could not stop. Upon medical review this is considered to be an "other medical event." FU indicates diagnosis to be autism.
Age: 1.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Aphasia, Balance disorder, Crying, Irritability, Pain
Clinical narrative: Approximately 2 days post vax, this pt cried hysterically for approximately 2 days. He was seen by doctors who said he "was fine." The reporter stated that he "was not fine because he was losing his balance a lot and banging his head on the floor. They examined him and said he was fine. As the weeks continued all these behaviors continued." The reporter stated that she took him to a neurologist who dxed him as PDD/Autism. The neurologist suggested that the pt be put in a program for these types of conditions. The reporter stated "my son was fine before he took this vax." She also reported that the pt was seen by an allergist who did a blood test and the "MMR came out with a positive reaction." The reporter stated, "My son is allergic to the vax" and the allergist confirmed that he is allergic to MMR." The reporter also stated that the doctor gave her a letter stating that her son should not received the vax again. "He is improving with the program. He still loses his balance but it was worse before, his speech is okay and his hearing is fine." The reporter consulted another physician and told that the child would always have PPD/Autism. The reporter wanted "people to know that the vax could cause this." She also stated that her son cried hysterically for 4-6 months and could not stop. Upon medical review this is considered to be an "other medical event." FU indicates diagnosis to be autism.
Age: 1.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Pyrexia, Screaming
Clinical narrative: Approximately 2 days post vax, this pt cried hysterically for approximately 2 days. He was seen by doctors who said he "was fine." The reporter stated that he "was not fine because he was losing his balance a lot and banging his head on the floor. They examined him and said he was fine. As the weeks continued all these behaviors continued." The reporter stated that she took him to a neurologist who dxed him as PDD/Autism. The neurologist suggested that the pt be put in a program for these types of conditions. The reporter stated "my son was fine before he took this vax." She also reported that the pt was seen by an allergist who did a blood test and the "MMR came out with a positive reaction." The reporter stated, "My son is allergic to the vax" and the allergist confirmed that he is allergic to MMR." The reporter also stated that the doctor gave her a letter stating that her son should not received the vax again. "He is improving with the program. He still loses his balance but it was worse before, his speech is okay and his hearing is fine." The reporter consulted another physician and told that the child would always have PPD/Autism. The reporter wanted "people to know that the vax could cause this." She also stated that her son cried hysterically for 4-6 months and could not stop. Upon medical review this is considered to be an "other medical event." FU indicates diagnosis to be autism.
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Drug ineffective, Infection, Pneumonia
Clinical narrative: Post 3rd vax, this pt experienced pneumonia. An unspecified specimen revealed Haemophilus influenzae type B. The pt's outcome was reported as yes.
Age: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Drug ineffective, Infection
Clinical narrative: Post 4th vax, this pt experienced bacteremia. This was reported as "vaccine failure." Blood specimen was positive for Haemophilus influenzae type B. Outcome of pt was reported as "yes."  Follow up information received on 11/13/2000: "Information has been received concerning a 56 month old male who on 04/28/1992, 09/30/1992, 03/05/1993 and 06/07/1993 was vaccinated with the first, second, third and fourth doses of haemophilus b conjugate vaccine (manufacturer unknown).  Subsequently the patient experienced bacteremia.  This was reported as "vaccine failure".  This was considered a significant medical event.  A blood specimen was positive for Haemophilus influenzae type b.  The outcome status was reported as "yes".  Sixteen other patients were reported with adverse events following vaccination with haemophilus b conjugate vaccine: WAES: 00072311, 00072312, 00072313, 00072314, 00072315, 00072316, 00072317, 00072318, 00072319, 00072320, 00072321, 00072322, 00072323, 00072325, 00072326, and 00072327.  Additional information has been received from a published abstract titled "Haemophilus influenzae invasive disease among children aged <5 years--epidemiology in the United States.  1994-1999" From the 34th National Immunization Conference on Vaccine Preventable Diseases (WAES # 00102472); abstract is attached.
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: Drug ineffective, Infection
Clinical narrative: Post 3rd dose in series, this child experienced bacteremia. Unspecified blood work was positive for Haemophilus influenzae type B. Vax failure was noted.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site hypersensitivity, Pneumonia, Pyrexia, Sinusitis, Vasodilation procedure
Clinical narrative: Mother reported approximately 3x5 inch area of redness and increased warmth at DTaP injection site (left thigh) on 06/15/2000. No other problems until late evening of 06/19 when child was taken to ER with elevated temperature of 105. Dxed with Pneumonia. Prescribed Erythromycin and Albuterol. Saw pediatrician for follow-up on 06/20. On 06/21 had elevated temperature and vomiting and was seen by pediatrician again and was dxed with sinusitis. Antibiotic changed to Augmentin. On 06/23 infant had 104 F after Tylenol and tepid bath and was taken to ER where admitted. Dxed with pneumonia and/or sinusitis. Discharged on 06/25.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR
Symptoms: Vomiting
Clinical narrative: Mother reported approximately 3x5 inch area of redness and increased warmth at DTaP injection site (left thigh) on 06/15/2000. No other problems until late evening of 06/19 when child was taken to ER with elevated temperature of 105. Dxed with Pneumonia. Prescribed Erythromycin and Albuterol. Saw pediatrician for follow-up on 06/20. On 06/21 had elevated temperature and vomiting and was seen by pediatrician again and was dxed with sinusitis. Antibiotic changed to Augmentin. On 06/23 infant had 104 F after Tylenol and tepid bath and was taken to ER where admitted. Dxed with pneumonia and/or sinusitis. Discharged on 06/25.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Amnesia, Encephalitis, Grand mal convulsion, Infection
Clinical narrative: Permanently disabled, on social security disability. Hepatitis B Viral encephalitis - sequela post vax. Developed loss of short term memory and some long term memory. Also, developed grand mal seizures.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Abasia, Arthropathy, Bacterial infection, Night sweats, Palpitations
Clinical narrative: I became immobilized, couldn't walk or stand, high fever, night sweats, all joints affected, in wheelchair/ walker for 1.5 months, palpitations. The annual follow-up states that he still has "flat feet" little ankle motion during the morning hours and some night sweats and others.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Pyrexia
Clinical narrative: I became immobilized, couldn't walk or stand, high fever, night sweats, all joints affected, in wheelchair/ walker for 1.5 months, palpitations. The annual follow-up states that he still has "flat feet" little ankle motion during the morning hours and some night sweats and others.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Bone disorder, Joint stiffness, Joint swelling
Clinical narrative: Third day post 3rd vax, this pt experienced fever. Fourth day he was very sore, stiff and couldn't turn neck. Knees stiff and swollen, aching. Physician prescribed Celebrex. Later requested X-rays. Osteoarthritis dxed.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Musculoskeletal stiffness, Nuchal rigidity, Pain, Pyrexia
Clinical narrative: Third day post 3rd vax, this pt experienced fever. Fourth day he was very sore, stiff and couldn't turn neck. Knees stiff and swollen, aching. Physician prescribed Celebrex. Later requested X-rays. Osteoarthritis dxed.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Abdominal pain, Anorexia, Dehydration, Irritability, Pyrexia
Clinical narrative: Irritability for 4 days. Vomiting, dehydration, requiring IV rehydration. Abdominal tenderness. Conducted test resulting in nml findings. Fever of greater than 101 for 24 hours. Anorexia for 48 hours. No reaction at injection site.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Vomiting
Clinical narrative: Irritability for 4 days. Vomiting, dehydration, requiring IV rehydration. Abdominal tenderness. Conducted test resulting in nml findings. Fever of greater than 101 for 24 hours. Anorexia for 48 hours. No reaction at injection site.
Age: 1.9
Sex: F
Vaccine: PNC
Symptoms: Irritability, Leukocytosis, Otitis media, Pyrexia
Clinical narrative: One day post vax, the pt experienced a fever. Otitis media was dx in the ER two days post vax. However a high fever to 105 and irritability developed prompting another ER visit. On 8/6/00, Otitis had completely resolved. Rocephin was given. By 8/7/00, symptoms have mostly resolved.
Age: 1.25
Sex: M
Vaccine: IPV, PNC
Symptoms: Erythema, Rash macular
Clinical narrative: The pt experienced redness and blotchiness all over body. This began on the leg less than 24 hours post vax. In 24 hours the redness and blotchiness was all over the body. No local swelling, no fever and pt was not uncomfortable.
Age: 32.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Joint aches, especially, wrists, knees, shoulders, neck and hips.
Age: 49.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt received his 5th Anthrax on 8/5/00 and noted redness and swelling to below the elbow in the right arm with minimal pain.
Age: 49.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Feeling hot, Injection site erythema, Pruritus
Clinical narrative: Pt received his 5th Anthrax on 8/5/00 and noted redness and swelling to below the elbow in the right arm with minimal pain.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: The pt experienced cellulitis at the left deltoid with redness and pain. The pt was prescribed Keflex but didn't improve.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Injection site abscess
Clinical narrative: The pt experienced an abscess at the site requiring incision and drainage.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The pt experienced 7 to 8 cm redness/swelling at the site of injection.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: The pt experienced swollen upper right arm from deltoid to mid arm, which was hot to the touch.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Left leg swollen from to hip.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt experienced a swollen left arm with redness and warmth to the touch from shoulder to elbow.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Myalgia
Clinical narrative: The pt experienced two full weeks of extreme soreness as if the muscle had been both pulled and pummelled.
Age: 34.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Dysgeusia, Hypertension, Paraesthesia
Clinical narrative: The pt experienced a "funny taste" in mouth, tingling and numbness in hands. Pt was given Benadryl and after 5 minutes the numbness was better and no tingling. Vitals improved 30 minutes after onset. Pt states had not eaten today. Coke offered to pt and she improved.
Age: 34.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Dysgeusia, Hypoaesthesia
Clinical narrative: The pt experienced a "funny taste" in mouth, tingling and numbness in hands. Pt was given Benadryl and after 5 minutes the numbness was better and no tingling. Vitals improved 30 minutes after onset. Pt states had not eaten today. Coke offered to pt and she improved.
Age: 1.3
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Erythema multiforme
Clinical narrative: The pt experienced erythema multiforme which began 5 days post vax. No other identifiable cause of erythema multiforme.
Age: 1.2
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Screaming
Clinical narrative: Mother states the child woke up at 11:30 PM on 8/6/00 crying. Me had a fever of 103, motrin was given. He cried all night until 6:00 am. No other symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: The pt experienced 8 x 4 1/2 cm erythema on the left deltoid.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Two days post vax, the pt complained of redness and warmth in right upper arm from shoulder to above elbow. Most tender at shot site. Advised to use warm packs to area for 2-4 days.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Approximately 4 days post vax, the pt complained of redness and warmth on left lower deltoid area. The site was not raised. Approximate sized of an adult fist. No medical treatment was sought. The pt also experienced pain to the area. Suggested treatment of hot/moist pack to the site for 2-4 days for 20 minutes. Also educated client on signs of infection.
Age: 0.6
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Crying, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 4 hours post vax, the pt woke up screaming unconsolably with bilateral lower leg redness, heat and possibly swelling. The pt was rushed to ER. Crying and redness resolved in approximately 15-30 minutes.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: 45 minutes post vax, the pt complained of generalized itching.
Age: 1.4
Sex: F
Vaccine: DTP, HIBV, MMR
Symptoms: Diarrhoea, Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Swollen, reddened area around injection site of left thigh. Also, fever and diarrhea.
Age: 1.4
Sex: F
Vaccine: DTP, HIBV, MMR
Symptoms: Diarrhoea, Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Swollen, reddened area around left thigh. Also, fever and diarrhea
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Severe local allergic reaction with 5 x 6 area of erythema.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Erythema nodosum, Injection site oedema, Lymphadenopathy, Pyrexia
Clinical narrative: Pt developed localized swelling at vaccine site one day post vax. The pt then developed bilateral axillary adenopathy, low grade fever, and non specific rash of all extremities. Pt subsequently developed erythema nodosum.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Itching and rash developed hours after vax. Resolved within 4-6 hours with antihistamines.
Age: 20.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fatigue, Lymphadenopathy, Vaccine positive rechallenge, Vision blurred
Clinical narrative: Shortly after receiving vax, the pt experienced blurred vision in left eye. Later complained of fatigue and lymph involvement.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site swelling
Clinical narrative: 14 x 20 cm raised, red, swollen area covering right upper thigh. Treated with Keflex.
Age: 1.0
Sex: F
Vaccine: HEP, PNC, VARCEL
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever > 39C, decreased appetite and irritable.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Pt reported she broke out in a rash and had sores all over which lasted 2 or more weeks.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Same day post vax, the pt was pale and diaphoretic.
Age: 0.7
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Hypertension, Injection site mass, Pyrexia
Clinical narrative: Same day post vax, the pt developed a temperature of 102 and a knot on left thigh. On 7/21/00, the pt had temperature of 103 and hypertension. Given Tylenol and Motrin. On 7/22/00, the pt's temperature was 104. He was taken to ER and treated with Tylenol.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Back pain, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Next day post vax, the pt awoke with nausea, chills, headache, low back pain, and fever. Medicated with Tylenol.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Otitis media, Pyrexia, Rash
Clinical narrative: Post vax, the pt started having fever. Mom used Tylenol and fever decreased. Also, he had a lacy looking rash on his trunk, feet, legs,arms, and some on face. On 6/16, he had a fever of 104 and was taken to ER. He was dx with an ear infection and started on Amoxicillin. On 6/17 and 6/18, fever and rash continued and child cried almost all the time; did not eat or sleep well.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site hypersensitivity, Injection site pain, Myalgia, Pain
Clinical narrative: Erythematous papule at site, less than 24 hours post vax, muscle aches, chills, myalgia, pain in entire arm at first then just upper arm. Pt recovering at time of report.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Nausea, Pyrexia, Urticaria, Vomiting
Clinical narrative: Mother called clinic stating child has had temperature of 103, nausea, vomiting, and hives since 06/30/2000. Instructed mother to take child  in for treatment and notify clinic when she has returned from doctors office.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Contusion, Ecchymosis, Erythema, Injection site infection
Clinical narrative: Developed redness, swelling, and bruising the day of injection. On 07/15, developed pain from shoulder to wrist. Developed red streak of redness down arm. Seen at ER and given Cephalexin 500 mg for 3 days for infection at injection site. 07/21, improved with only bruising at injection site.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Pain, Swelling
Clinical narrative: Developed redness, swelling, and bruising the day of injection. On 07/15, developed pain from shoulder to wrist. Developed red streak of redness down arm. Seen at ER and given Cephalexin 500 mg for 3 days for infection at injection site. 07/21, improved with only bruising at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Coma, Lethargy
Clinical narrative: Pt became unresponsive after leaving health department according to his mother. She brought him back and he was very lethargic. The physician evaluated him and within 10 minutes he was fully responsive.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Facial palsy
Clinical narrative: On 7/24/00, the family noticed the pt's right side of face not moving when child smiled. Saw physician on 7/25/00 and dx with Bell's Palsy.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Injection site hypersensitivity, Pruritus
Clinical narrative: 03/31/00 Pt received TD on the upper left arm during routine physical. On the 3rd day post vax, this pt experienced redness and itchiness at the site. Subsequently a rash developed around the area. The pt had scratched the area and "maybe infected it" according to his grandmother. 04/03 pt returned to the clinic for follow up and informed the physician's assistant that he thought he may have had a reaction to the vax. Hydrocortisone cream was prescribed.
Age: 1.7
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Approximately one month post vax, this pt experienced rash (06/24), fever of 101 F (06/26). He was taken to the pediatric ER (06/27) and dxed with possible reaction from vax. CBC was conducted. No abnormalities were detected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Slight rash on face, onset began 06/25, ten days post vax. Upon exam it appeared as scattered pox marks on face and body. She was happy and playful despite rash and appeared to be feeling well at time of examination.
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Received vax on 02/21/00. Eight days post vax, she developed a runny nose which stopped 03/04. Fever of 101 F for three to four days then returned to nml.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Agitation, Anorexia, Rash maculo-papular
Clinical narrative: Approximately twelve days post vax, this pt became very cranky. She was crying with less intake of food. On 06/07, she had a non-itching maculopapula rash which started from her chest then to her abdomen and spread all over her body. 06/09 she returned to clinic.  06/16, rash became more extensive and she returned again to the pediatric clinic. No medication was administered. Follow up occurred on 06/19 where mother was advised to administer Benadryl if itching occurred. She subsequently recovered.
Age: 1.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site mass, Vasodilation procedure
Clinical narrative: Induration and erythema at IM injection site approximately 4.5 to 5 cm. Also increased warmth.
Age: 0.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Crying
Clinical narrative: Seven days post vax, child seemed constantly inconsolable from 6:00 AM to 5:00 PM. It was different than a cry, no tears. Then he sleep for 2 hours. He re-started screaming from 9:00 to 10:00 PM. Then I gave him chamomile homeopathic and he slept ok. Woke up at 6:00 AM, screaming again for 15 minutes and resolved.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour, Agitation, Personality disorder
Clinical narrative: Two and a half to three weeks post vax, this pt began head banging with screaming especially when tired. Parent saw marked personality change. This lasted for about 3 weeks and stopped. No medical treatment sought during this time.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Dermatitis bullous, Pyrexia, Rash
Clinical narrative: Nine days post vax, this pt developed low grade fever at about 8:00 PM. Rash began the following morning at 10:00 with 4 to 5 spots. Four days later, 4 to 5 more pox spots broke. All spots scabbed and healed within 2 weeks. Child ran fever for 3 days.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Nine days post vax, this pt developed low grade fever at about 8:00 PM. Rash began the following morning at 10:00 with 4 to 5 spots. Four days later, 4 to 5 more pox spots broke. All spots scabbed and healed within 2 weeks. Child ran fever for 3 days.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: Erythema and mild induration at vax site immediately post IZ. Given ice pack at site. Approximately 15 minutes post vax, decreased induration, still with mild erythema.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Pt received IPV and MMR in left leg on 08/07/2000. Both appeared red and with mild swelling within 26 hours.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Diarrhoea, Influenza like illness, Pain
Clinical narrative: Flu like, pain and achiness through out whole body, especially in joints, diarrhea - all lasting for 4 days then tappering off slowly over the next 3 to 4 days.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Urticaria
Clinical narrative: One day post vax, this pt returned to office with raised, irregular lesions on face, trunk, and proximal extremities . Hep B is the only vax not previously received. Dxed with urticaria.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Two day inflammation on muscle in left arm. Pain is on shoulder also with pain and burning.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Infection, Swelling
Clinical narrative: IZ received on 07/27. Pt went on vacation and returned to clinic on 08/07. Her arm was swollen, looked infected, consequently she was referred to physician. Spoke with mother and pt over the phone. She received antibiotics and was doing well.
Age: 21.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Headache, Nausea, Pharyngolaryngeal pain
Clinical narrative: Sore throat, headache, nausea, weakness.
Age: 11.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Facial palsy, Hypoaesthesia, Ophthalmoplegia, Paraesthesia oral
Clinical narrative: Numbness under right eye, eye won't close. Mouth is drawn, right side pulls to left. Physician feels this is a reaction to vax. Bell's Palsy. At the time of this report, his condition was unchanged.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: On 11/22/99, the pt experienced one mark on her wrist and five on her face. They looked like little whitehead marks. One was scabbed. She thought the first one was a bug bite. She experienced the most marks on 11/29/99.
Age: 0.5
Sex: M
Vaccine: DTP, HEP, HIBV
Symptoms: Convulsion, Pyrexia, Screaming
Clinical narrative: It was reported that a 6 month old male received DTP, ACTHIB and Recombivax-HB at 11:00 AM on 8/10/99. "Within a few hours, post vax, he developed a fever to 103F, crying nonstop (several hours), and reported an episode, thought to be seizure activity. Evaluated on-site by EMS and local ER. Evaluated again in our office, 3 days from vaccine administration." Reportedly, the pt recovered from this experience.