chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TD
Symptoms: Injection site reaction, Urticaria
Clinical narrative: A pharmacy technician reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated and subsequently developed generalized hives. The pt also developed an injection site reaction which the reporter did not describe. No further information was available at the date of this report. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 471638.
Age: 10.0
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: A mother reported that her 10 year old son received an injection of TD toxoids and immediately developed an injection site reaction characterized by a 4" wide area of induration and redness, lasting 1 week. The child subsequently, developed a hard nodule at the injection site. The mother reported that her son has "various unnamed allergies", possibly including eggs. The reporter declined to provide further information and declined to grant permission for follow-up investigation.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Myalgia
Clinical narrative: A physician reported that a female in her 60's with a history of arthritis, received an injection of TD Toxoids Adsorbed, Purogenated. She was receiving therapy with Mevacor at the time of the immunization. One to two days later, she developed myalgia of the proximal muscles in her extremities. She also developed an injection site reaction characterized by redness and tenderness.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injury, Nausea, Pruritus
Clinical narrative: A nurse reported that a 24 year old female sustained a puncture wound to her hand and received an injection of TD Toxoids Adsorbed, Purogenated on 5/27/00 as part of wound management. On 5/29/00, the pt developed a fever of 103F, hives on the back of her legs, nausea and vomiting, and a "severe" injection site reaction characterized by redness, swelling and itching. The pt was seen by the physician and treated with IM diphenhydramine and oral prednisone. This is 1 of 3 pts from this facility who had an adverse experience following receipt of this vaccine, lot 470536.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: A nurse reported that a 24 year old female sustained a puncture wound to her hand and received an injection of TD Toxoids Adsorbed, Purogenated on 5/27/00 as part of wound management. On 5/29/00, the pt developed a fever of 103F, hives on the back of her legs, nausea and vomiting, and a "severe" injection site reaction characterized by redness, swelling and itching. The pt was seen by the physician and treated with IM diphenhydramine and oral prednisone. This is 1 of 3 pts from this facility who had an adverse experience following receipt of this vaccine, lot 470536.
Sex: U
Vaccine: TD
Symptoms: Injection site abscess, Injection site induration, Injection site swelling
Clinical narrative: A pharmacist reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated and subsequently, developed a injection site reaction characterized by swelling and hardness and described as "looks like a boil". As of 6/11/00, the symptoms persisted. This is 1 of 3 pts from this facility who experienced this event following receipt of this vaccine, lot 471039. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is available.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A pharmacist reported that a 29 year old female received an injection of TD Adsorbed, Purogenated on 6/7/00. The pt received vaccine either from lot 462364 or 464259. She subsequently, developed an injection site reaction characterized by redness, swelling and pain. On 6/12/00, the pt was seen by the physician and the reaction had resolved by that date.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: A nurse reported that a 36 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 05/27/00. On 05/29/00, the patient developed a "severe"  injection site reaction characterized by pain, warmth, and swelling. The patient was seen by a physician and treated with Prednisone and a methylprednisolone pack. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Tetanus Diphtheria Toxoids Adsorbed, Purogenated lot # 470-536.
Age: 28.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: A nurse reported that a 28 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 05/27/00. On 05/29/00, the patient  developed a "severe" injection site reaction characterized by an area of redness, and induration measuring 2 inches by 1 inch. The patient was seen by the physician and treated with diphenhydramine, Prednisone, and Cephalexin. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Tetanus Diphtheria Toxoids Adsorbed, Purogenated lot # 470-536.
Age: 15.0
Sex: U
Vaccine: TD
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site oedema, Pain
Clinical narrative: A nurse reported that a 15  year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/09/00. The next day, the patient developed an injection site reaction characterized by erythema, and swelling. The patient also felt achy and light-headed. A few days later, the patient developed welts at the injection site. After the welts abated, the site became indurated. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Tetanus Diphtheria Toxoids Adsorbed, Purogenated lot # 468-868.
Age: 15.0
Sex: U
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: A nurse reported that a 15  year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/09/00. The next day, the patient developed an injection site reaction characterized by erythema, and swelling. The patient also felt achy and light-headed. A few days later, the patient developed welts at the injection site. After the welts abated, the site became indurated. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Tetanus Diphtheria Toxoids Adsorbed, Purogenated lot # 468-868.
Age: 39.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: A nurse reported that a 39 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/16/00 and subsequently developed an injection site reaction characterized by redness, warmth, and swelling. The reaction persisted for at least 1 week. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of 2 different lots of Tetanus Diphtheria Toxoids Adsorbed, Purogenated.
Age: 23.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: A nurse reported that a 23 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/18/00 and subsequently developed an injection site reaction characterized by redness, warmth, and swelling. The reaction persisted for at least 1 week. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of 2 different lots of Tetanus Diphtheria Toxoids Adsorbed, Purogenated.
Age: 66.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: A nurse reported that a 66 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/14/00 and subsequently developed and injection site reaction characterized by redness, warmth, and swelling. The reaction persisted for at least 1 week. This is 1 of 3 patients from this facility who developed an injection site reaction following the receipt of 2 different lots of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: A nurse reported that a 76 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 07/06/00, and subsequently developed an injection site reaction characterized by redness, soreness, and warmth. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated lot #471-637.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: A nurse reported that a 73 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 07/03/00. On 07/06/00, she developed an injection site reaction characterized by soreness, swelling, redness, and warmth. A diagnosis of cellulitis was made. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated lot # 471-637.
Sex: F
Vaccine: TD
Symptoms: Hypersensitivity
Clinical narrative: A physician reported that a female received Tetanus and Diphtheria Toxoids Adsorbed and subsequently, developed a "severe" allergic reaction. No further information was available as of 07/11/00. Additional information received on 08/28/00 from the reporting physician, indicated that the event had occurred "many years ago" and no further information was available.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: A nurse reported that a 16 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/28/00. On 07/01/00, he developed an injection site reaction characterized by redness, swelling, and pain. She was treated with Ibuprofen, diphenhydramine, an antibiotic, and application of ice. As of 07/13/00, the patient had improved.
Age: 64.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site reaction
Clinical narrative: A purchasing agent reported that a 64 year old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated and subsequently developed an injection site reaction. The patient was seen in the ER and recovered. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids lot # 470-531.
Age: 11.0
Sex: M
Vaccine: DT, HEP
Symptoms: Injection site erythema, Rash
Clinical narrative: A nurse reported that an 11 year old male received Tetanus and Diphtheria Toxoids Adsorbed, Purogenated and Engerix-B vaccines on 08/04/00. On 08/06/00, he developed a rash on both hands and a 3 to 4 inch area of redness at the site of Tetanus and Diphtheria Toxoids administration. He was noted to be improving on 08/08/00. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated. A copy of this report has been forwarded to SKB, manufacturer of Engerix-B.
Age: 14.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema
Clinical narrative: A nurse reported that a 14 year old patient received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 08/04/00. On 08/06/00, the patient developed redness at the injection site. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus Diphtheria Toxoids adsorbed, Purogenated.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site necrosis, Injection site pain
Clinical narrative: A nurse reported that a 35 year old female received an injection of TD Adsorbed, Purogenated on 7/19/00. On 7/24/00, she developed swelling at the injection site which extended to involve her entire upper arm. On exam at hospital, she had morbid erythema and induration and tenderness at the injection site, just inferior to the deltoid muscle, questionable subcutaneous tissue.  She was hospitalized on 7/22/00 and treated with IV antibiotics (Rocephin one ram IV q 24 hours. Cool compresses were applied to the arm and she was placed on Naprosyn 500 bid and given Stadol for pain. Her dx was cellulitis at the injection site with fat necrosis. She also, had a fever. She recovered and was discharged on 7/24/00. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of TD lot 470536; the other 2 events were non-serious.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: A nurse reported that a 35 year old female received an injection of TD Adsorbed, Purogenated on 7/19/00. On 7/24/00, she developed swelling at the injection site which extended to involve her entire upper arm. On exam at hospital, she had morbid erythema and induration and tenderness at the injection site, just inferior to the deltoid muscle, questionable subcutaneous tissue.  She was hospitalized on 7/22/00 and treated with IV antibiotics (Rocephin one ram IV q 24 hours. Cool compresses were applied to the arm and she was placed on Naprosyn 500 bid and given Stadol for pain. Her dx was cellulitis at the injection site with fat necrosis. She also, had a fever. She recovered and was discharged on 7/24/00. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of TD lot 470536; the other 2 events were non-serious.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction, Injury
Clinical narrative: A nurse reported that a 41 year old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 06/30/00 as part of wound management following a cat bite. The patient also received therapy with Amoxicillin / Clavulanate. On 07/06/00, the patient was seen by the physician, who diagnosed cellulitis at the Tetanus and Diphtheria Toxoids injection site. The patient was hospitalized. Follow up info received 08/02/00 indicated that the patient recovered. MANUFACTURER'S COMMENT: On the following up, the reporter indicated that 2 additional patients developed cellulitis following receipt of Tetanus and Diphtheria Toxoids adsorbed, Purogenated; however, the report did not identify these patients. Neither of them was hospitalized.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Child was at Disneyland with family; paramedics were called. The child died. This is a coroner case. No other details are available to us at this time.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction, Injection site vesicles, Skin ulcer
Clinical narrative: This child had cellulitis on his right leg 4 inches in diameter. Also with an area of ulceration and blister on the center.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: This patient had multiple joint pain in Dec 00. Diagnosed with rheumatoid arthritis after the 4th Anthrax injection.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Alopecia, Arthralgia, Cognitive disorder, Difficulty in walking, Extensor plantar response
Clinical narrative: The pt experienced worsening fatigue, frequent sore throats with elevated temps from 99-100, very sore joints especially knees, blurred vision in right eye. Onset within 10 days post vax. The pt also experienced difficulty walking, unable to continue working. Treatment was rest. The pt also had severe headaches.Doc 197456 received on 08/15/2001,reports the followings: frequent infections, severe cognitive impairment, transient memory loss and forgetfulness. Abnormal EEG and sleep study. Paraesthesias plus babinski's. Hypersomnia alternating with insomnia. Low endurance threshold, exercise intolerance, muscle cramps, restless leg syndrome. Migraines. Athralgias. 8 years of positive mononuclosis (Mono Spots), elevated EBV titers. Debilitating exhaustion. No signs of recovery, completely disabled after vaccination injuries. The annual follow-up states "activity intolerance, cognitive dysfunction, muscle twitching and cramping, frequent infections, insomnia and sleep deprivation, exhaustion. Unable to sit upright or stand for more than 0-6 hours per 24 hrs, freq episodes of having to lay flat numbness in extremities, osteoporosis, alopecia. This was "mandatory" vaccine for employment purposes. At the time of this vaccination the pt complained of being unwell since the hep B vaccine received 3 months earlier 9/19/91. The pt's health declined significantly after receiving this vaccine.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Headache, Infection, Insomnia, Memory impairment
Clinical narrative: The pt experienced worsening fatigue, frequent sore throats with elevated temps from 99-100, very sore joints especially knees, blurred vision in right eye. Onset within 10 days post vax. The pt also experienced difficulty walking, unable to continue working. Treatment was rest. The pt also had severe headaches.Doc 197456 received on 08/15/2001,reports the followings: frequent infections, severe cognitive impairment, transient memory loss and forgetfulness. Abnormal EEG and sleep study. Paraesthesias plus babinski's. Hypersomnia alternating with insomnia. Low endurance threshold, exercise intolerance, muscle cramps, restless leg syndrome. Migraines. Athralgias. 8 years of positive mononuclosis (Mono Spots), elevated EBV titers. Debilitating exhaustion. No signs of recovery, completely disabled after vaccination injuries. The annual follow-up states "activity intolerance, cognitive dysfunction, muscle twitching and cramping, frequent infections, insomnia and sleep deprivation, exhaustion. Unable to sit upright or stand for more than 0-6 hours per 24 hrs, freq episodes of having to lay flat numbness in extremities, osteoporosis, alopecia. This was "mandatory" vaccine for employment purposes. At the time of this vaccination the pt complained of being unwell since the hep B vaccine received 3 months earlier 9/19/91. The pt's health declined significantly after receiving this vaccine.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Muscle spasms, Muscle twitching, Osteoporosis, Paraesthesia, Pharyngolaryngeal pain
Clinical narrative: The pt experienced worsening fatigue, frequent sore throats with elevated temps from 99-100, very sore joints especially knees, blurred vision in right eye. Onset within 10 days post vax. The pt also experienced difficulty walking, unable to continue working. Treatment was rest. The pt also had severe headaches.Doc 197456 received on 08/15/2001,reports the followings: frequent infections, severe cognitive impairment, transient memory loss and forgetfulness. Abnormal EEG and sleep study. Paraesthesias plus babinski's. Hypersomnia alternating with insomnia. Low endurance threshold, exercise intolerance, muscle cramps, restless leg syndrome. Migraines. Athralgias. 8 years of positive mononuclosis (Mono Spots), elevated EBV titers. Debilitating exhaustion. No signs of recovery, completely disabled after vaccination injuries. The annual follow-up states "activity intolerance, cognitive dysfunction, muscle twitching and cramping, frequent infections, insomnia and sleep deprivation, exhaustion. Unable to sit upright or stand for more than 0-6 hours per 24 hrs, freq episodes of having to lay flat numbness in extremities, osteoporosis, alopecia. This was "mandatory" vaccine for employment purposes. At the time of this vaccination the pt complained of being unwell since the hep B vaccine received 3 months earlier 9/19/91. The pt's health declined significantly after receiving this vaccine.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Restless legs syndrome, Viral infection, Vision blurred
Clinical narrative: The pt experienced worsening fatigue, frequent sore throats with elevated temps from 99-100, very sore joints especially knees, blurred vision in right eye. Onset within 10 days post vax. The pt also experienced difficulty walking, unable to continue working. Treatment was rest. The pt also had severe headaches.Doc 197456 received on 08/15/2001,reports the followings: frequent infections, severe cognitive impairment, transient memory loss and forgetfulness. Abnormal EEG and sleep study. Paraesthesias plus babinski's. Hypersomnia alternating with insomnia. Low endurance threshold, exercise intolerance, muscle cramps, restless leg syndrome. Migraines. Athralgias. 8 years of positive mononuclosis (Mono Spots), elevated EBV titers. Debilitating exhaustion. No signs of recovery, completely disabled after vaccination injuries. The annual follow-up states "activity intolerance, cognitive dysfunction, muscle twitching and cramping, frequent infections, insomnia and sleep deprivation, exhaustion. Unable to sit upright or stand for more than 0-6 hours per 24 hrs, freq episodes of having to lay flat numbness in extremities, osteoporosis, alopecia. This was "mandatory" vaccine for employment purposes. At the time of this vaccination the pt complained of being unwell since the hep B vaccine received 3 months earlier 9/19/91. The pt's health declined significantly after receiving this vaccine.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: The pt experienced a seizure immediately following MMR vax at the age of 1.2 years of age. Hospitalization after valium administration.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: The pt experienced a pinpoint rash on trunk starting evening of 5/9/01. Fever starting on 5/10/01.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Agitation, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: The pt was up all night with leg pain from the Prevnar vaccine. The leg was swollen and the pt had a high fever, was crying, won't walk on leg, just lying down. Site doesn't really look too red.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: The pt experienced erythema and firmness at the site the evening of the vax. Returned to the office with increasing erythema.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Agitation, Crying, Feeling hot
Clinical narrative: Mom called stating the child received immunizations and that night woke up at 1:30 am crying  and has not stopped. When asked stated warm, but was unaware of temp. Stated very warm last night. Pt is receiving Tylenol.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Dyskinesia
Clinical narrative: Mother noted intermittent head shaking and head jerking, starting 2 days, post vax. At first occurred multiple times a day, for a few seconds, then gradually became less frequent and occurred about 2 X a day, especially when tired. Resolved after a few months. ? involuntary. Reaction brought to my attention at 2 year visit and it had resolved.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia
Clinical narrative: On an unspecified date, the pt received a dose of Lymerix; it is not known whether the pt had received prior injections of Lymerix. Reportedly, after a "few" months, the vaccinee developed "severe joint and muscle pain and stiffness". The physician "did not give me any further shots." Reportedly, the physician treated the pt with ibuprofen 400mg three times daily. As of 5/15/01, the adverse events were unresolved.
Age: 38.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: "Two years ago", in 5/99, the vaccinee received her 1st dose of Lymerix, without adverse event. "One month later", in 6/99, she received her 2nd dose of Lymerix. "Two months later", in 8/99, the pt experienced joint pain in her neck, spine, wrists, feet, hips and shoulders. A doctor visit was required. The pt stated that her physician had suggested that she had osteoarthritis. X-rays were performed. The pt spoke with the radiologist, who reportedly told her that she did not have osteoarthritis. Multiple sets of unspecified lab tests were performed, and the pt stated that they all came back "unremarkable." As of 5/16/01, the outcome of the event is unresolved. The follow-up states that she had arthralgia in the knees in 1995. At that time her Lyme titer was negative. There was no illness at the time of vaccination. The vaccinee's mother had osteoarthritis in her fifties. On 05/18/1999, she received her second dose of LYMErix. Five months later on 10/05/1999, the vaccinee experienced joint pain in her hands, neck, spine, wrists,feet, hips, and shoulders. The pt was treated on 11/22/1999 with aspirin, ibuprofen and glucosamine/chondroitin. The LYMErix immunizatin series was discontinued due to the adverse event. The reporting physician stated that the adverse event was mild in intensity and was possibly related to LYMErix. However, he reported that it could also be associated with the pt's family history of osteoarthritis. As of 06/22/2001, the event was ongoing.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The pt experienced a red patch at the injection site. Had also complained of arm pain 6 hours post vax.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Coordination abnormal, Hypotonia, Injection site erythema, Injection site pain
Clinical narrative: 1cm local reaction with red erythema and central pallor and pain. Altered mental status and ataxia and weakness, irritable and floppy. Referred for urgent neurology consult. Throat culture was negative.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Mental impairment
Clinical narrative: 1cm local reaction with red erythema and central pallor and pain. Altered mental status and ataxia and weakness, irritable and floppy. Referred for urgent neurology consult. Throat culture was negative.
Age: 22.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dizziness, Paraesthesia, Pruritus, Swelling face
Clinical narrative: Lips got swollen and "itchy" and "tingles"; felt a little "dizzy".
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm and tender mass, 8cm raised by 1cm on lateral right arm by 3rd day, post vax.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Chickenpox, despite vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red and warm left shoulder with 5-7cm of erythema.
Age: 1.25
Sex: M
Vaccine: HEP, HIBV, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: 4 1/2" X 4" local reaction which mom noticed on 5/23/01 at 08:30.
Age: 1.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Bronchitis, Grunting, Injection site reaction, Pyrexia, Rash macular
Clinical narrative: Night of vaccines, 5/16/01, spiked a fever to 103.4F and developed "grunty" breathing. Had a red, blotchy rash on body. Was seen in ER that night and dx'd with bronchitis and given IM Rocephin. Seen by PMD on 5/17/01 and was told it was "moderate reaction" to pertussis. Mother said he was better by 5/17/01.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR
Symptoms: Pyrexia
Clinical narrative: Fever 11 days, post vax.
Age: 82.0
Sex: F
Vaccine: TD
Symptoms: Hypertension, Hypotension, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: One week, post vax, site erythemic induration and area measured in size to about 8cm in diameter, was very itchy and warm to touch. Rx'd Biaxin 500 mg BID x 7 days, Benadryl cream, Zyrtec 10mg and ice pack. Vital signs on 5/15/01, BP 172/100; HR-64; Afebrile; RR-16.
Age: 82.0
Sex: F
Vaccine: TD
Symptoms: Pruritus
Clinical narrative: One week, post vax, site erythemic induration and area measured in size to about 8cm in diameter, was very itchy and warm to touch. Rx'd Biaxin 500 mg BID x 7 days, Benadryl cream, Zyrtec 10mg and ice pack. Vital signs on 5/15/01, BP 172/100; HR-64; Afebrile; RR-16.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: At 14:48, left deltoid area reddened and swollen to approx. 10cm X 10cm and warm. Temperature 36C.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Pruritus, Rash macular
Clinical narrative: Erythematous, macular rash, itchy and warm. Tx: Augmentin and Benadryl.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site swelling, Rash macular
Clinical narrative: Swelling from of right leg from hip to knee; botchy red area on upper thigh, not directly around injection site.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: Fever up to 104.3" on days 7 & 8, post vax.
Age: 1.94
Sex: F
Vaccine: MMR
Symptoms: Cyanosis, Hypotension, Hypotonia, Lethargy, Pallor
Clinical narrative: Child became pale and limp at 14:59. Had cyanosis of lips with wheezing at 15:00. Epinephrine .3cc, SC, LL and Benadryl 12.5mg, IM, RL given at 15:00. 911 called with laying down child on floor and checking respirations. At 15:00, R-24; P-110 and BP 70/30. Lethargic response to verbal stimuli, expiratory wheezing heard bilaterally per stethoscope; paramedic here and assisted to lay seat. Pulse Ox-98% on room air. Sent to hospital via ambulance. Was transferred to another hospital for 23 hours of observation to her pulmonary management. Discharged on 5/2/01 from hospital.
Age: 1.94
Sex: F
Vaccine: MMR
Symptoms: Wheezing
Clinical narrative: Child became pale and limp at 14:59. Had cyanosis of lips with wheezing at 15:00. Epinephrine .3cc, SC, LL and Benadryl 12.5mg, IM, RL given at 15:00. 911 called with laying down child on floor and checking respirations. At 15:00, R-24; P-110 and BP 70/30. Lethargic response to verbal stimuli, expiratory wheezing heard bilaterally per stethoscope; paramedic here and assisted to lay seat. Pulse Ox-98% on room air. Sent to hospital via ambulance. Was transferred to another hospital for 23 hours of observation to her pulmonary management. Discharged on 5/2/01 from hospital.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Mother states the child had diarrhea prior to vaccine. Vaccine was given on 4/20/01 at 15:00. The child was fine initially following vax. At 03:00 AM woke with hives and at 4:00 am the child was brought to the ER where the MD related the symptoms to Prevnar vax.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site oedema
Clinical narrative: The pt experienced extreme swelling around the site of vax on right leg.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, PNC
Symptoms: Fatigue, Irritability, Rash
Clinical narrative: The pt began with dime sized red rash on both legs on 5/5/01. By 5/6/01 the pt had a rash covering both thighs with a little on her face. The pt was very cranky and tired. The doctor suggested Benadryl. The pt was given Benadryl and symptoms faded gradually.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: The pt experienced red, tender palpable induration at the injection site.
Age: 1.4
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt experienced swelling to the right thigh following vax. The area was warm to the touch, with erythema. The child walks stiffly on right leg. The reaction occurred 24 hours post vax.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: The mother called and stated the are on right lower thigh was red, and sore on 5/2/01. Feels warm to the touch, states child not eating as well and was somewhat fussy. The pt has several bumps at the injection site.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability
Clinical narrative: The mother called and stated the are on right lower thigh was red, and sore on 5/2/01. Feels warm to the touch, states child not eating as well and was somewhat fussy. The pt has several bumps at the injection site.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Injection site oedema, Injection site pain, Lymph node pain, Myalgia
Clinical narrative: The pt experienced flu like symptoms, sore muscles and mild fever, mild swelling, soreness in glands under jaw. Swelling and soreness in the arm.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: The pt experienced flu like symptoms, sore muscles and mild fever, mild swelling, soreness in glands under jaw. Swelling and soreness in the arm.
Age: 14.0
Sex: M
Vaccine: DT
Symptoms: Pruritus, Rash
Clinical narrative: The pt experienced a rash 1-2 hours post vax. Small dots, very itchy. Rash still present on 5/14/01.
Age: 64.0
Sex: F
Vaccine: HEPA, IPV, TD, TYP
Symptoms: Injection site erythema, Injection site oedema, Pruritus, Pyrexia, Urticaria
Clinical narrative: The pt experienced redness, swelling in the left deltoid 1.5 days post vax. 8 days later the pt experienced a "huge welt" 5 1/2"x6 1/2" in diameter accompanied with 99.6 temp and itching. The pt went to the ER and received IV antibiotics and oral Cipro.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Rash, Respiratory distress, Urticaria
Clinical narrative: Rash, hives, mild respiratory, red and raised area at MMR site.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Developed 1 spot on leg on 5/15/01, spread overnight. Seen today, 5/17/01, in office with multiple vesicles on back, stomach and legs.
Age: 3.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness of right arm noted during 1st 24 hours, post vax.
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Anorexia, Dizziness, Injection site reaction, Pruritus
Clinical narrative: Dizziness, injection site itchy and loss of appetite. Treated with Keflex 500mg and Prednisone 10mg.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cough, Headache, Injection site pain, Pain
Clinical narrative: Pt received Pneumococcal 23 in AM of 5/7/01 and that evening, she developed shaking-chills, body aches, headache and discomfort at injection site. On 5/8/01, she was seen and evaluated by NP who ordered CXR for her cough and this was negative. She was started on Biaxin XL 500mg, 2 tabs together for 7 days. She was cautioned to return to office if symptoms exacerbate and redness increases over 1 cm, over the next 48 hours. She returned to office on 5/9/01 and was seen by physician who ordered labs, started her on Dicloxacillin and ordered injection of Rocephin. She was to monitor symptoms and report to ER if the symptoms got worse or higher temperatures. We telephoned her each day, to monitor her progress. Addendum: On 5/14/01, she returns to office with her daughter and her arm looks much better, only small area of hardness at injection site.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Pt received Pneumococcal 23 in AM of 5/7/01 and that evening, she developed shaking-chills, body aches, headache and discomfort at injection site. On 5/8/01, she was seen and evaluated by NP who ordered CXR for her cough and this was negative. She was started on Biaxin XL 500mg, 2 tabs together for 7 days. She was cautioned to return to office if symptoms exacerbate and redness increases over 1 cm, over the next 48 hours. She returned to office on 5/9/01 and was seen by physician who ordered labs, started her on Dicloxacillin and ordered injection of Rocephin. She was to monitor symptoms and report to ER if the symptoms got worse or higher temperatures. We telephoned her each day, to monitor her progress. Addendum: On 5/14/01, she returns to office with her daughter and her arm looks much better, only small area of hardness at injection site.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Injection site mass, Injection site oedema
Clinical narrative: Mother called on 5/4/01 concerned due to large "knots" at the injection site. The largest is the size of an egg. Was told to call MD. On 5/9/01, spoke with the father and father states the swelling has gone down.
Age: 39.0
Sex: U
Vaccine: ANTH, ANTH
Symptoms: Amnesia, Arthralgia, Cardiac flutter, Chest pain, Diarrhoea
Clinical narrative: Documentation is in my medical records at AFB; dizziness, nodules at site of shot (itch), heart seems to slow and skip occasionally and memory loss.  Follow up:  Patient has not recovered from adverse event.  Itching at site of injection, dizziness, heart flutters, occasional loss of consiousness, (pass out if get up to quick).  Memory loos, vision correction - good thing.  Patient has been evaluated by a physician or health care provider.  Patient did not receive any further shots since the reported event.  "I'm not sure what that means."
Age: 39.0
Sex: U
Vaccine: ANTH, ANTH
Symptoms: Dizziness, Dry skin, Ear disorder, Hypoaesthesia, Hypothyroidism
Clinical narrative: Documentation is in my medical records at AFB; dizziness, nodules at site of shot (itch), heart seems to slow and skip occasionally and memory loss.  Follow up:  Patient has not recovered from adverse event.  Itching at site of injection, dizziness, heart flutters, occasional loss of consiousness, (pass out if get up to quick).  Memory loos, vision correction - good thing.  Patient has been evaluated by a physician or health care provider.  Patient did not receive any further shots since the reported event.  "I'm not sure what that means."
Age: 39.0
Sex: U
Vaccine: ANTH, ANTH
Symptoms: Injection site rash, Lethargy, Loss of consciousness, Muscular weakness, Pruritus
Clinical narrative: Documentation is in my medical records at AFB; dizziness, nodules at site of shot (itch), heart seems to slow and skip occasionally and memory loss.  Follow up:  Patient has not recovered from adverse event.  Itching at site of injection, dizziness, heart flutters, occasional loss of consiousness, (pass out if get up to quick).  Memory loos, vision correction - good thing.  Patient has been evaluated by a physician or health care provider.  Patient did not receive any further shots since the reported event.  "I'm not sure what that means."
Age: 39.0
Sex: U
Vaccine: ANTH, ANTH
Symptoms: Skin atrophy, Vertigo
Clinical narrative: Documentation is in my medical records at AFB; dizziness, nodules at site of shot (itch), heart seems to slow and skip occasionally and memory loss.  Follow up:  Patient has not recovered from adverse event.  Itching at site of injection, dizziness, heart flutters, occasional loss of consiousness, (pass out if get up to quick).  Memory loos, vision correction - good thing.  Patient has been evaluated by a physician or health care provider.  Patient did not receive any further shots since the reported event.  "I'm not sure what that means."
Age: 39.0
Sex: U
Vaccine: ANTH, ANTH
Symptoms: Amnesia, Dizziness, Heart rate irregular, Injection site mass, Pruritus
Clinical narrative: Documentation is in my medical records at AFB; dizziness, nodules at site of shot (itch), heart seems to slow and skip occasionally and memory loss.  Follow up:  Patient has not recovered from adverse event.  Itching at site of injection, dizziness, heart flutters, occasional loss of consiousness, (pass out if get up to quick).  Memory loos, vision correction - good thing.  Patient has been evaluated by a physician or health care provider.  Patient did not receive any further shots since the reported event.  "I'm not sure what that means."
Age: 61.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: Pain in knees and surrounding tissue, then to ankles with tingling and burning sensation. Has progressed to hips, elbows, wrist and base of neck. More frequent headaches. Treated with Celebrex and then Vioxx.
Age: 61.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Headache, Paraesthesia
Clinical narrative: Pain in knees and surrounding tissue, then to ankles with tingling and burning sensation. Has progressed to hips, elbows, wrist and base of neck. More frequent headaches. Treated with Celebrex and then Vioxx.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Cerebellar ataxia, Difficulty in walking, Nervous system disorder, Strabismus, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no significant medical history and no immunosuppression or recent exposure to varicella or other viruses. It was also noted that no one in the patient's household was reported to be ill in recent weeks. On 04/18/2001, the patient was vaccinated with the 1st dose of Varicella Vaccine Live (site unk). Concomitant therapy included the 1st dose of MMR, the 4th dose of HIB conjugate vaccine (UNK), and the 4th dose of Hepatitis B vaccine recombinant (UNK), and the 4th dose of streptococcus pneumoniae vaccine (Prevnar). On approximately 05/05/01, 17 days post-vaccination, the patient developed a "wide-base gait". The child had difficulty standing (he was previously able to stand unassisted). The patient had to hold onto a wall in order to stand. The symptoms persisted for several days and the patient was taken to the ER on approximately 05/06/01 and was examined by a neurologist. The patient had an MRI (w/o contrast) of the brain, which was negative. The patient was sent home form the ER the same day. The following morning, the symptoms persisted, and the parents of the patient also reported a "ptosis of the right eyelid" as well as "deviation of the right pupil". The patient was returned to the ER and admitted to the hospital. The patient was hospitalized for approximately a day and a half, and had another MRI of the brain, with contrast, which was again Neg. A lumbar puncture was also performed and a specimen has been submitted for PCR analysis. The patient was discharged from the hospital on 05/09/01. A definitive diagnosis was never made, though the ataxia was felt to be related to an undiagnosed viral infection. Additional info has been requested. Follow-up on 05/19/2001 reported the pt was very much improved. The physician stated that the child was still "wobbly" however a full recovery was expected. Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Balance disorder, Coordination abnormal, Eyelid ptosis, Gait disturbance, Strabismus
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no significant medical history and no immunosuppression or recent exposure to varicella or other viruses. It was also noted that no one in the patient's household was reported to be ill in recent weeks. On 04/18/2001, the patient was vaccinated with the 1st dose of Varicella Vaccine Live (site unk). Concomitant therapy included the 1st dose of MMR, the 4th dose of HIB conjugate vaccine (UNK), and the 4th dose of Hepatitis B vaccine recombinant (UNK), and the 4th dose of streptococcus pneumoniae vaccine (Prevnar). On approximately 05/05/01, 17 days post-vaccination, the patient developed a "wide-base gait". The child had difficulty standing (he was previously able to stand unassisted). The patient had to hold onto a wall in order to stand. The symptoms persisted for several days and the patient was taken to the ER on approximately 05/06/01 and was examined by a neurologist. The patient had an MRI (w/o contrast) of the brain, which was negative. The patient was sent home form the ER the same day. The following morning, the symptoms persisted, and the parents of the patient also reported a "ptosis of the right eyelid" as well as "deviation of the right pupil". The patient was returned to the ER and admitted to the hospital. The patient was hospitalized for approximately a day and a half, and had another MRI of the brain, with contrast, which was again Neg. A lumbar puncture was also performed and a specimen has been submitted for PCR analysis. The patient was discharged from the hospital on 05/09/01. A definitive diagnosis was never made, though the ataxia was felt to be related to an undiagnosed viral infection. Additional info has been requested. Follow-up on 05/19/2001 reported the pt was very much improved. The physician stated that the child was still "wobbly" however a full recovery was expected. Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no significant medical history and no immunosuppression or recent exposure to varicella or other viruses. It was also noted that no one in the patient's household was reported to be ill in recent weeks. On 04/18/2001, the patient was vaccinated with the 1st dose of Varicella Vaccine Live (site unk). Concomitant therapy included the 1st dose of MMR, the 4th dose of HIB conjugate vaccine (UNK), and the 4th dose of Hepatitis B vaccine recombinant (UNK), and the 4th dose of streptococcus pneumoniae vaccine (Prevnar). On approximately 05/05/01, 17 days post-vaccination, the patient developed a "wide-base gait". The child had difficulty standing (he was previously able to stand unassisted). The patient had to hold onto a wall in order to stand. The symptoms persisted for several days and the patient was taken to the ER on approximately 05/06/01 and was examined by a neurologist. The patient had an MRI (w/o contrast) of the brain, which was negative. The patient was sent home form the ER the same day. The following morning, the symptoms persisted, and the parents of the patient also reported a "ptosis of the right eyelid" as well as "deviation of the right pupil". The patient was returned to the ER and admitted to the hospital. The patient was hospitalized for approximately a day and a half, and had another MRI of the brain, with contrast, which was again Neg. A lumbar puncture was also performed and a specimen has been submitted for PCR analysis. The patient was discharged from the hospital on 05/09/01. A definitive diagnosis was never made, though the ataxia was felt to be related to an undiagnosed viral infection. Additional info has been requested. Follow-up on 05/19/2001 reported the pt was very much improved. The physician stated that the child was still "wobbly" however a full recovery was expected. Additional info has been requested.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Bacterial infection, Sepsis, Sudden infant death syndrome, Unevaluable event
Clinical narrative: This patient was seen on 05/04/2001 for a well physical exam. The patient was given Hep B vaccine # 1 on 05/04/01. The Health Bureau was notified on 05/07/01 at 8 AM that the involved child had expired over the weekend. Autopsy states cause of death as sudden death in infancy. Autopsy also showed E. Coli septicemia.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Obstructive airways disorder
Clinical narrative: Information has been received from an investigator regarding a 76 year old male who received a dose of Influenza virus vaccine trivalent, types A & B, live cold-adapted (frozen formulation) on 11/10/98 as a part of the study, a Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Efficacy of Protection From Natural Influenza Virus Infection of Influenza Virus Vaccine Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) and Inactivated Influenza Virus Vaccine in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Field Trial". On 11/16/98, the patient developed an exacerbation of chronic obstructive pulmonary disease. He recovered by 12/01/98. The investigator considered the exacerbation of chronic obstructive pulmonary disease (unexpected per the investigator brochure) to be medically important and "possibly" related to study vaccine administration. The medical monitor's assessment was unknown.