chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: From initial information received on 3/22/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 58 year old female patient received TD ADS ADULT vaccination, lot number U1017BA, administered IM in the left deltoid on 3/18/04. The next day, on 3/19/04, the patient phoned the reporter stating that the injection site was red and hot to the touch. She was seen in the physician's office on 3/22/04 and had a 9-15cm red, warm area at the injection site. Recovery status of the events is unknown. At the time of vaccination the patient was taking aspirin and conjugated estrogens. From additional information received on 8/30/04 from a health professional, it was reported that the patient recovered from these events. No further information is anticipated, this case is considered closed.
Age: 78.0
Sex: F
Vaccine: TD
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: From initial information received on 3/26/04 from a nurse regarding an adverse event occurring in the USA, it was reported that a 78 year old female patient received a TD ADS ADULT vaccination, lot number U1021AA, administered IM in the left deltoid on 3/18/04. At the time of vaccination the patient was taking Zestril, Lorazepam, Gas-X, and multivitamins. Seven days post immunization, the patient developed a red rash distal to the injection site radiating to her shoulder and elbow. She did not experience any respiratory distress. The patient was seen in the emergency room where a topical triamcinolone cream 1% was ordered four times a day. The patient's recovery status is unknown. From additional information received on 8/16/04 from the initial reporter, it was reported that the case was reviewed and the patient was contacted on 8/11/04. The patient stated that the hydrocortisone cream that was prescribed reduced the inflamed area, and within ten days the area was better with no untoward effects. No further information is anticipated, this case is considered closed.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Face oedema, Pyrexia, Urticaria
Clinical narrative: From initial information received on 4/15/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 14 year old female patient was administered a TD ADS ADULT booster dose, lot number U1014AA, administered in the left arm on 4/6/04 (route of administration not provided). Two days later the patient developed facial swelling, arthralgia, and a rash on arms and elbows. She also experienced fever, swelling of her lips, hives and rash. The patient called the doctor on 4/12/04 and upon examination on 4/14/04 she complained of a 101 degree F fever, lower lip swelling and generalized hives. The physician ordered Atarax. The rash was reported as persisting. From additional information received on 8/13/04 from the initial reporter, the route of vaccination was provided as IM. It was reported that the patient experienced an urticarial rash and the adverse event coding has been accordingly updated (hives and rash were changed to urticarial rash). The patient was seen by an allergy specialist on 4/22/04, who advised that the patient continue the Atarax. No labs were done at the specialist's office, however a CBC, metabolic panel, ANA, ESR, RF, urinalysis and C3 C4 complement were completed on an unspecified date and were within normal limits. On 5/10/04, the patient discontinued the Atarax and was started on Periactin 25mg three times per day, as her urticarial rash and swelling of body parts showed up in a limited way. Per the patient's parent, as of 5/9/04, the patient was free of rashes on Periactin and had no further episodes of rash or swelling. The patient recovered from the events. No further information is anticipated, this case is considered closed.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: From initial information received on 4/20/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 49 year old female patient received a dose of TD ADS ADULT, lot number U1018AA, administered IM in the deltoid. The following day, the patient experienced body aches as well as redness, swelling and soreness at the site of injection. Reportedly, the symptoms lasted one week and the patient recovered from these events. The reporter of this case is the same reporter of case 200401652. No further information is anticipated, this case is considered closed.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: From initial information received on 4/20/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 49 year old female patient received a dose of TD ADS ADULT, lot number U1018BA, administered IM in the deltoid on 2/13/04. The following day, on 2/14/04, the patient experienced swelling and redness at the injection site and could not lay on her arm. The symptoms resolved after persisting for seven days. The reporter of this case is the same reporter of case 200401651.
Age: 61.0
Sex: F
Vaccine: HEP, TD, HEP, TTOX
Symptoms: Oedema, Pruritus, Urticaria
Clinical narrative: From initial information received on 4/21/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 60 year old female patient received TD ADS ADULT vaccination, lot number U1021AA, administered IM in the left deltoid, and a first dose of ENGERIX B, lot number ENG5465A6, administered IM In the right deltoid on 4/6/04 at 11:00 AM. Four days later, on 4/10/04, the patient experienced urticaria, itching and swelling. She was treated with cortisone pills. The patient has not recovered from this event. From additional information received on 5/21/04, it was initially reported by a nurse that the patient experienced hives all over her body four days following the administration of the products. The patient was seen at a physician's office and treated with Medrol and Prednisone. The event improved, but it was not reported whether the patient recovered. The immunization series with ENGERIX B was discontinued. The nurse considered the hives to be possibly related to vaccination with ENGERIX B and tetanus toxoid. No other information was provided. From additional information received on 8/16/04 from the initial reporter, it was reported that the case was reviewed and there is no additional information available at this time.
Age: 61.0
Sex: F
Vaccine: HEP, TD, HEP, TTOX
Symptoms: Urticaria
Clinical narrative: From initial information received on 4/21/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 60 year old female patient received TD ADS ADULT vaccination, lot number U1021AA, administered IM in the left deltoid, and a first dose of ENGERIX B, lot number ENG5465A6, administered IM In the right deltoid on 4/6/04 at 11:00 AM. Four days later, on 4/10/04, the patient experienced urticaria, itching and swelling. She was treated with cortisone pills. The patient has not recovered from this event. From additional information received on 5/21/04, it was initially reported by a nurse that the patient experienced hives all over her body four days following the administration of the products. The patient was seen at a physician's office and treated with Medrol and Prednisone. The event improved, but it was not reported whether the patient recovered. The immunization series with ENGERIX B was discontinued. The nurse considered the hives to be possibly related to vaccination with ENGERIX B and tetanus toxoid. No other information was provided. From additional information received on 8/16/04 from the initial reporter, it was reported that the case was reviewed and there is no additional information available at this time.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: From initial information received on 5/25/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 23 year old female patient received a dose of TD ADS ADULT, lot number U1019AA, administered IM in the left deltoid on 5/14/04. That same day, the patient developed a local reaction of redness and warmth with the formation of a knot at the site of injection. The symptoms were treated with ice, mobility and Motrin and resolved within 24 hours. The reporter of this case is the same reporter of case 200402007. No further information is anticipated, this case is considered closed.
Age: 32.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: From initial info received on 5/25/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 13 year old female pt received a routine booster of TD ADS ADULT, lot U1019AA, IM, left deltoid and a dose of hepatitis B vaccine, lot 10035N83005, IM, right deltoid on 5/7/04. That same day, the pt experienced a local reaction of redness, warmth and a "knot" at the site of injection. It was not specified at which injection site the reaction occurred. The pt was treated with ice packs, Benadryl and Motrin and recovered from these events. From additional info received on 8/13/04 from a health care professional, it was reported that the pt had previously received 2 doses of TD ADS ADULT on unspecified dates. It was also reported that the pt developed the reaction of injection site redness, warmth and a "knot" on his left arm where the TD ADS ADULT was administered. Per the reporter, no other narrative is available at this time. No further info is anticipated. This case is considered closed.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: From initial info received on 5/26/04 from a physician's assistant regarding an adverse event occurring in the USA, it was reported that a 50 year old female pt received a dose of TD ADS ADULT, lot U1019AA, IM, in the left deltoid on 5/23/04. Within 6 hours, the pt's left deltoid area became red, swollen and tender to touch. She was seen 36 hours later, on 5/25/04, and given Benadryl, Motrin and cool compresses. The pt's recovery status was unknown at the time of the report.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: From initial info received on 6/15/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a cluster of 3 female pts (no specific pt identification provided), received TD ADS ADULT vaccination, lot U1184AA, on "variable" dates. The routes and sites of administration were not reported. Within 24 to 72 hours, after receiving the vaccines, the pts developed redness, swelling and tenderness at the injection site. The pts' recovery status was not reported.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: From initial info received on 6/16/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 42 year old female pt received a dose of TD ADS ADULT, lot U1022AA, in the left deltoid on 5/17/04. The route of administration was not reported. Three days later, on 5/20/04, the p'ts upper arm about her elbow became swollen, red, hot, hard and began itching. A physician in the hospital, where the pt works, evaluated the symptoms and prescribed Motrin, Benadryl and ice. Reportedly, the symptoms resolved after 1 week.
Age: 43.0
Sex: F
Vaccine: TD, TYP
Symptoms: Rash
Clinical narrative: From initial info received on 7/1/04 from an RN regarding an adverse event occurring in the USA, it was reported that a 43 year old female pt received a dose of TD ADS ADULT, lot U186AA, IM, in the left deltoid and a dose of Typhim VI, lot X0521, IM, in the right deltoid on 6/23/04. That same day, she also received a dose of Gamma Globulin, lot ISG158, IM, in the right deltoid. One day after receiving the products, on 6/24/04, the pt experienced small rash. She was given a Medrol pack on 6/25/04. The pt was evaluated by a physician on 6/30/04. At that time, the rash had improved, but began to resurface as the Medrol was decreased. The pt was schedule for a re-evaluation the following week. Her recovery status was reported as unknown. The lot number provided for TD ADS ADULT, does not match the mfr.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia
Clinical narrative: From initial info received on 7/9/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 36 year old female pt, who had stepped on a nail, received a dose of TD ADS ADULT, lot U0998AA, IM, in the left arm on 5/10/04. An unspecified amount of time after immunization, the pt started having arthralgia. Reportedly, she tried over the counter treatment. She was seen in the office on 7/2/04 and started on Vioxx. At the time of the report, the pt's recovery status was unknown.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: From initial info received on 7/16/04 from an RN regarding an adverse event occurring in the USA, it was reported that a 69 year old female pt received a dose of TD ADS ADULT, lot U1185AA, expiration date 3/15/06, administered in the right deltoid on 7/8/04. Route of administration was not reported. Eight days later, the pt developed a 3" circle on her right deltoid at the site of injection, which was red, swollen and hot. The pt requested that the nurse report this event. Pt's recovery status was not reported.
Age: 30.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: From initial info received on 7/28/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 30 year old male pt received a dose of TD ADS ADULT, lot U1278AA, in the right deltoid on 7/26/04. Route of administration was not reported. Approximately 24 hours post/vax, the pt developed generalized itchy urticaria described as red, raised patches. Reportedly, the pt was administered Keflex prescription at the time of immunization. He was seen by a doctor on 7/27/04 and given Benadryl, Zantac and a steroid pack. It was also reported that the pt might have received a booster of the vaccine in 1993. It was not reported whether the pt recovered from the event. From additional info received on 9/30/04 from a health care professional; the name of the county where the pt received the vaccination was provided as well as the amended name of the facility where it was administered. Reportedly, the pt recovered on 7/30/04 from the events. No further info is anticipated, this case is considered closed.
Sex: M
Vaccine: TD
Symptoms: Rash
Clinical narrative: From initial info received on 7/30/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a male pt (age unknown) received a TD ADS ADULT vaccination on an unspecified date. Lot number, route and site of administration were not reported. Unspecified time later, the pt developed a rash. No other info was reported. The pt's recovery was not reported.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: From initial info received on 8/13/04 from another mfr., a physician reported of an adverse event occurring in the USA. A 49 year old female pt received a TD ADS ADULT vaccination, lot U1019AA, route and site of administration not reported, on an unspecified date. On 4/16/04, the pt developed swelling down the arm, extreme induration and extreme warmth at the injection site. She was treated with prednisone, Allegra, ranitidine and ibuprofen. The pt improved after drug therapy and recovered from these events. From additional info received on 10/21/04 from the reporting physician, the pt's date of birth was provided. The pt was 48 years old at the time of the adverse events. The TD ADS ADULT vaccine was administered IM, in the left deltoid, on 4/14/04 at 11:00 AM. Two days later, on 4/16/04, the pt experienced the adverse events. No other info was provided. No further info is anticipated, this case is considered closed.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site induration, Injection site swelling
Clinical narrative: From initial information received on 08/13/2004 from another manufacturer from information reported to them by a physician regarding an adverse event occurring in the USA, it was reported that a 58 year old female patient received a tetanus booster, lot number SH1278A, route and site of administration not reported, on an unspecified date.  On 07/17/2004 the patient developed induration, swelling and extreme warmth at the injection site.  She was treated with prednisone, penicillin and Levaquin.  The patient improved after drug therapy and is recovering from these events.  From additional information received on 10/11/2004 from a physician, the patient's date of birth was provided.  According to the date of birth provided, the patient was 57 years old at the time of this event.  The patient received a 0.5ml dose of TD ADS Adult, lot number U1278AA, administered in the right arm on 07/16/2004 due to left facial abrasion and contusion.  The amount of previous doses was reported as unknown.  The patient has no known drug allergies.  Her pre-existing medical conditions include hypertension, which is treated with Diovan and Norvasc.  Per the reporter, the information has been reviewed and no further information is available at this time.
Age: 13.0
Sex: M
Vaccine: TD
Symptoms: Myalgia, Pyrexia
Clinical narrative: From initial information received on 08/30/2004 from a physician regarding an adverse event occurring in the USA, it was reported that a 13 year old male patient received a TD ADS Adult vaccination, lot number U0844AA, administered intra-muscularly in the left arm on 08/27/2004.  Within 24 hours the patient developed a fever of 102 degrees and pain in all his extremities.  The events were reported to the physician by the patient's mother on 08/28/2004, and he was seen in the office on 08/30/2004.  The recovery status of the patient was not reported.  From additional information received on 10/04/2004 from the reporting physician, it was noted that the patient's muscle pain resolved after 5 days with no permanent sequelae.  The adverse event coding has been updated to change the event term of pain to muscle pain.  The reporter also provided additional information on 10/18/2004 regarding the event of fever.  It was reported that the patient recovered seven days later and became afebrile.  He was recovered from both of the reported adverse events.  No further information is anticipated, this case is considered closed.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site inflammation, Injection site swelling, Pyrexia
Clinical narrative: From initial information received on 08/31/2004 from a physician regarding an adverse event occurring in the USA, it was reported fever, injection site swelling, injection site inflammation, injection site induration.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: From initial information received on 09/30/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 49 year old female patient received a TD ADS adult vaccination, lot number U1347AA, administered in the left deltoid on 09/24/2004.  The route of administration was not reported.  The following day, on 09/25/2004, the patient developed a local reaction of redness and swelling measuring 3 x 3.5cm at the injection site.  The area was also warm and tender.  The patient was seen by a physician on 09/28/2004.  At the time of this report the patient had not recovered from these events.
Sex: U
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: From initial information received on 10/07/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a cluster of 5 patients received a dose of TD ADS Adult, lot number U1184AA, administered intramuscularly on an unspecified date.  Sites of administration were not reported, an unspecified amount of time later, four out of five patients developed local reactions.  The reporter did not know the details of the reactions.  It is unknown whether any of the patients recovered from these events.
Age: 58.0
Sex: M
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Pyrexia
Clinical narrative: From initial information received from a healthcare professional on 10/26/2004 regarding an adverse event occurring in the USA, it was reported that a 57 year old male patient received a TD ADS Adult vaccination, lot number U1282AA, administered intramuscularly in the left deltoid on 10/22/2004.  Reportedly within 24 hours the patient developed a large reddened area at the injection site that was warm to the touch.  The patient also had an oral temperature of 103 degrees.  No treatment was needed.  Reportedly the fever resolved but the redness persists.  Also, this patient had received a Fluzone vaccination on 10/15/2004, lot number, route and administration site not reported.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema
Clinical narrative: From initial information received on 11/01/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 61 year old female patient received a TD ADS Adult vaccination, lot number U1354AA, administered in the left deltoid on 10/20/2004.  The route of administration was not reported.  9 days later, on 10/29/2004, the patient developed a local reaction of redness, which measured 2 inches around the injection site.  The patient was seen by a physician, who prescribed a Medrol pack.  Per the reporter, the patient's recovery status is unknown.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: From initial information received on 11/08/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 40 year old female patient received a dose of TD ADS Adult, lot number U1281AA, administered in the left deltoid at 12:00PM on 11/06/2004.  The route of administration was not reported.  Later that same day, the patient developed a temperature ranging between 99 to 102 degrees and a local reaction of redness and swelling at the site of injection.  The patient did not require medical attention and she recovered from these events.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: From initial information received on 01/11/2005 from a pharmacist regarding an adverse event occurring in the USA, it was reported that a 25 year old female patient received a dose of TD ADS Adult, lot number U1280AA, administered intramuscularly in the left deltoid on 01/09/2005.  Two days later, the patient developed a local reaction of redness and soreness at the site of injection.  Reportedly, the patient experienced the soreness on movement.  It is unknown whether the patient recovered from these events.
Age: 0.04
Sex: M
Vaccine: HEP
Symptoms: Headache, Lethargy, Pain, Pyrexia, Vomiting
Clinical narrative: Fever 102, headache, lethargy, emesis, body aches. Tylenol, Motrin.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Received the meningitis vaccine on Monday, June 6, 2005 at approx. 11:00 a.m. She experienced tenderness in the sight of the injection.  On Tuesday, June 7,2005 she complained of a headache and stomach-ache, she had a fever of 102.8 degrees. These symptoms lasted all day and throughout the night.  On Wednesday, June 8,2005 she awoke feeling fine, but by noon of that day she was running a fever of 102.6, had a headache,and was extremely tired. This lasted for the rest of the day and evening. Thurdsay morning, she was fine, no fever. Approx. 7:00 p.m. she complained of being very tired - again a fever or 102 degrees.  The same on Friday - she was fine during the day but about 7:00 p.m. she ran a fever of 101 degrees.  Saturday, June 11,2005 awoke feeling fine but at approx 9:30 a.m. she complained of an itching feeling on her back.  She had a terrible red, hot raised rash all over her back, chest, neck and behind her ears. Benadryl has been given - the rash seems to fade and the itching subsides only to return every 4 hours.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Received the meningitis vaccine on Monday, June 6, 2005 at approx. 11:00 a.m. She experienced tenderness in the sight of the injection.  On Tuesday, June 7,2005 she complained of a headache and stomach-ache, she had a fever of 102.8 degrees. These symptoms lasted all day and throughout the night.  On Wednesday, June 8,2005 she awoke feeling fine, but by noon of that day she was running a fever of 102.6, had a headache,and was extremely tired. This lasted for the rest of the day and evening. Thurdsay morning, she was fine, no fever. Approx. 7:00 p.m. she complained of being very tired - again a fever or 102 degrees.  The same on Friday - she was fine during the day but about 7:00 p.m. she ran a fever of 101 degrees.  Saturday, June 11,2005 awoke feeling fine but at approx 9:30 a.m. she complained of an itching feeling on her back.  She had a terrible red, hot raised rash all over her back, chest, neck and behind her ears. Benadryl has been given - the rash seems to fade and the itching subsides only to return every 4 hours.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: DTaP given June 10.  24 hours later T 104.7ºF 36 hrs later T 105.6ºF.  Vomited while riding in car at 24 hrs.  No headache or meningismus.  Fever controlled with Tylenol and sponging.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Autism, Injection site rash, Lethargy, Pyrexia, Speech disorder
Clinical narrative: Vaccinations occurred in the AM.  I had to wake her up from a 5 hour nap.  She had high fever-105, totally lethargic and a red rash at shot site. She did not respond to us.  We rushed her to the ER.  Where they administered Motrin and watched her until fever went down. (ER doctor said to us- that next time she gets her shots space them out and half dosage). Sent home after couple of hours. Fever broke the next day, but she was a shell of the girl she had been days before. 2 weeks later-stopped talking.
Age: 8.0
Sex: M
Vaccine: IPV
Symptoms: Abasia, Asthenia, Eczema, Fatigue, Headache
Clinical narrative: Two weeks post IPV, high fever, headache. This subsided and then returned a couple days later. When the fever left, a flat rash appeared over most of his body especially chest. He was unable to walk without assistance, but could crawl. He was weak, fatigued. The fatigue gradually went away and slowly he was able to regain full use of his legs. However, since this incidence (4 years ago) he continues to have periods of leg weakness and fatigue. This is also accompanied at times with leg pain. Where he had the injection (buttock site) he also had a long and narrow branch or line of red inflamed area. Though this did not appear until significantly later; months after the IPV shot. It was approximately 1/4 to 1/2 inch wide and 6 inches long. It was diagnosed as eczema. It was present for at least a month. Initially the doctor diagnosed it as shingles, however, our son had none of the other symptoms that occur with this. Our doctors have told us that there never has been a recorded reaction to the IPV. Also, the fact that his fever was 2 weeks post inoculation there could be no association. We are very frustrated. I have repeatedly asked about the possibility of a reaction to the IPV and all doctors have just shrugged this off. To my amazement they haven't even charted my concerns with this. My son looks healthy; he just gets as he says it "tired legs". The doctors look at him and treat this as if it is just a common cold. He has been treated at a hospital, has had every x-ray possible and many blood tests. I keep hoping he will out grow this, but it has now been four years and my hope is fading. When he exerts himself continually, then the leg weakness/pain/fatigue return with vengeance. Exerting himself continually would be like playing at the playground for a couple of hours and then playing soccer. He becomes very frustrated at times that he can't run. He must, at these times, use much energy and upper arm movement to help compensate or just sit, rest and watch his friends play. As for the initial illness four years ago (my son calls it the fever, where he couldn't walk), I called the doctor during that time period. He told me not to be concerned that most children can't walk after a high fever because they are weak. I believed him. I didn't realize I could fill this form out myself until yesterday. I asked my doctor to fill this form out. He didn't feel there was a correlation with the IPV and he has never documented any of my concerns. We are so frustrated. How come no one listens? I want to report this. Yes, my child did have a reaction to the IPV. My son said to me yesterday, "Mom, maybe I'll just always have wobbly legs." I had to turn and walk away because I didn't want him to see me cry.
Age: 8.0
Sex: M
Vaccine: IPV
Symptoms: Herpes zoster, Pain, Pyrexia, Rash, Skin striae
Clinical narrative: Two weeks post IPV, high fever, headache. This subsided and then returned a couple days later. When the fever left, a flat rash appeared over most of his body especially chest. He was unable to walk without assistance, but could crawl. He was weak, fatigued. The fatigue gradually went away and slowly he was able to regain full use of his legs. However, since this incidence (4 years ago) he continues to have periods of leg weakness and fatigue. This is also accompanied at times with leg pain. Where he had the injection (buttock site) he also had a long and narrow branch or line of red inflamed area. Though this did not appear until significantly later; months after the IPV shot. It was approximately 1/4 to 1/2 inch wide and 6 inches long. It was diagnosed as eczema. It was present for at least a month. Initially the doctor diagnosed it as shingles, however, our son had none of the other symptoms that occur with this. Our doctors have told us that there never has been a recorded reaction to the IPV. Also, the fact that his fever was 2 weeks post inoculation there could be no association. We are very frustrated. I have repeatedly asked about the possibility of a reaction to the IPV and all doctors have just shrugged this off. To my amazement they haven't even charted my concerns with this. My son looks healthy; he just gets as he says it "tired legs". The doctors look at him and treat this as if it is just a common cold. He has been treated at a hospital, has had every x-ray possible and many blood tests. I keep hoping he will out grow this, but it has now been four years and my hope is fading. When he exerts himself continually, then the leg weakness/pain/fatigue return with vengeance. Exerting himself continually would be like playing at the playground for a couple of hours and then playing soccer. He becomes very frustrated at times that he can't run. He must, at these times, use much energy and upper arm movement to help compensate or just sit, rest and watch his friends play. As for the initial illness four years ago (my son calls it the fever, where he couldn't walk), I called the doctor during that time period. He told me not to be concerned that most children can't walk after a high fever because they are weak. I believed him. I didn't realize I could fill this form out myself until yesterday. I asked my doctor to fill this form out. He didn't feel there was a correlation with the IPV and he has never documented any of my concerns. We are so frustrated. How come no one listens? I want to report this. Yes, my child did have a reaction to the IPV. My son said to me yesterday, "Mom, maybe I'll just always have wobbly legs." I had to turn and walk away because I didn't want him to see me cry.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HEP, PNC
Symptoms: Crying
Clinical narrative: Fussy, irritable, crying.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HEP, PNC
Symptoms: Crying, Irritability
Clinical narrative: Fussy, irritable, crying.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Mental retardation severity unspecified
Clinical narrative: Information has been received from a registered school nurse concerning a female who was vaccinated with a dose of MMR. It was reported that the nurse received a phone call from a student's parent and during their conversation, the parent stated that he had heard about a girl that received the vaccine and didn't develop right. The girl's outcome was unknown. No product quality complaint was involved. Follow up information noted that the caller stated that a friend of his was vaccinated with MMR and was later retarded at the age of 11 from the shot. Upon internal review, retarded was considered an other important medical event (OMIC). No further information is expected.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cough, Dysphonia, Dyspnoea, Hypoxia, Laboratory test abnormal
Clinical narrative: Initial and follow up information has been received from a director of nursing at a nursing facility concerning a 86 year old female patient with dementia, asthma, and insulin-dependent diabetes mellitus who on 3/26/05 at 10:45 PM was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot # 650087/0815P). The patient had no acute illness at the time of vaccination. The director of nursing previously reported that there had been a viral infection at the nursing facility that had affected approximately 33% of the residents occurring at the same time pneumococcal 23v polysaccharide was administered. On 3/29/05, the patient developed a non-productive cough and hoarseness. On 3/31/05, the patient developed fever (laboratory value not provided), wheezing, and was diagnosed with an upper respiratory infection (previously reported as respiratory distress). The patient was treated at the nursing facility with nebulizer treatments, unspecified medications and oxygen. An influenza swab taken was negative. As of 4/8/05, the patient recovered from the upper respiratory infection. The director of nursing considered the upper respiratory infection to be an other important medical event (OMIC). No further information is available.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Upper respiratory tract infection, Wheezing
Clinical narrative: Initial and follow up information has been received from a director of nursing at a nursing facility concerning a 86 year old female patient with dementia, asthma, and insulin-dependent diabetes mellitus who on 3/26/05 at 10:45 PM was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot # 650087/0815P). The patient had no acute illness at the time of vaccination. The director of nursing previously reported that there had been a viral infection at the nursing facility that had affected approximately 33% of the residents occurring at the same time pneumococcal 23v polysaccharide was administered. On 3/29/05, the patient developed a non-productive cough and hoarseness. On 3/31/05, the patient developed fever (laboratory value not provided), wheezing, and was diagnosed with an upper respiratory infection (previously reported as respiratory distress). The patient was treated at the nursing facility with nebulizer treatments, unspecified medications and oxygen. An influenza swab taken was negative. As of 4/8/05, the patient recovered from the upper respiratory infection. The director of nursing considered the upper respiratory infection to be an other important medical event (OMIC). No further information is available.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Upper respiratory tract infection
Clinical narrative: Initial and follow up information has been received from a director of nursing at a nursing facility concerning a 86 year old female patient with dementia, asthma, and insulin-dependent diabetes mellitus who on 3/26/05 at 10:45 PM was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot # 650087/0815P). The patient had no acute illness at the time of vaccination. The director of nursing previously reported that there had been a viral infection at the nursing facility that had affected approximately 33% of the residents occurring at the same time pneumococcal 23v polysaccharide was administered. On 3/29/05, the patient developed a non-productive cough and hoarseness. On 3/31/05, the patient developed fever (laboratory value not provided), wheezing, and was diagnosed with an upper respiratory infection (previously reported as respiratory distress). The patient was treated at the nursing facility with nebulizer treatments, unspecified medications and oxygen. An influenza swab taken was negative. As of 4/8/05, the patient recovered from the upper respiratory infection. The director of nursing considered the upper respiratory infection to be an other important medical event (OMIC). No further information is available.
Sex: U
Vaccine: PPV, PPV
Symptoms: Cough, Dysphonia, Dyspnoea, Hypoxia, Laboratory test abnormal
Clinical narrative: Initial information has been received from a director of nursing at a nursing facility concerning two patients (age and sex not specified) who on an unspecified date in approximately March 2005 were vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 650087/0815P). The director of nursing previously reported that there had been a viral infection at the nursing facility that had affected approximately 33% of the residents occurring at the same time pneumococcal 23v polysaccharide was administered. In approximately March 2005 the patients developed signs and symptoms of an upper respiratory infection that affected the other residents. The director of nursing considered the upper respiratory infection to be an other important medical event (OMIC). No further information is available.
Sex: U
Vaccine: PPV, PPV
Symptoms: Pyrexia, Upper respiratory tract infection, Wheezing
Clinical narrative: Initial information has been received from a director of nursing at a nursing facility concerning two patients (age and sex not specified) who on an unspecified date in approximately March 2005 were vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 650087/0815P). The director of nursing previously reported that there had been a viral infection at the nursing facility that had affected approximately 33% of the residents occurring at the same time pneumococcal 23v polysaccharide was administered. In approximately March 2005 the patients developed signs and symptoms of an upper respiratory infection that affected the other residents. The director of nursing considered the upper respiratory infection to be an other important medical event (OMIC). No further information is available.
Sex: U
Vaccine: PPV, PPV
Symptoms: Upper respiratory tract infection
Clinical narrative: Initial information has been received from a director of nursing at a nursing facility concerning two patients (age and sex not specified) who on an unspecified date in approximately March 2005 were vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 650087/0815P). The director of nursing previously reported that there had been a viral infection at the nursing facility that had affected approximately 33% of the residents occurring at the same time pneumococcal 23v polysaccharide was administered. In approximately March 2005 the patients developed signs and symptoms of an upper respiratory infection that affected the other residents. The director of nursing considered the upper respiratory infection to be an other important medical event (OMIC). No further information is available.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Petechiae, Pneumonia, Pulmonary oedema, Viral infection
Clinical narrative: Imm on 5/12/05 Infant deceased 5/16/05 after sleeping, father reported he had fed infant, laid down to sleep checking on infant later found not breathing by father, CPR until EMS arrived at scene. Autopsy Report received which stated patient experienced pneumonitis, viral infection, petechiae and pulmonary edema.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus, Rash
Clinical narrative: Patient developed widespread rash on 4/13/05 which looked target-like. Rash was pruritic and covered entire body to include palms, soles and chin.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Fracture, Sudden infant death syndrome
Clinical narrative: Death ruled SIDS but was 6 days after vaccines. Received Autopsy Report which revealed COD as undetermined; manner of death undetermined.  Patient found supine cosleeping with twin sibling.  Found 4 healing rib fractures which ME ruled as resulting from excessive force precluding SIDS.
Age: 72.0
Sex: M
Vaccine: HEPA, IPV, TD, YF
Symptoms: Dizziness, Fall, Infection
Clinical narrative: Pt c/o dizziness 6/3/05. He fell several times, wife discovered him after he had fell, he was admitted to medical center. MD unsure, could be related to yellow fever vaccine or infection. Pt consented to given phone numbers.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Medication error
Clinical narrative: Manf syringes have peel off labels to affix to the paper chart to document vaccine admin. Over 40 expired vaccines (Pediarix) were administered, nurses didn't take time to read the labels, they just stuck them to the chart documentation forms (could have easily been wrong vaccine, too).
Sex: U
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: Decavac the new Diphtheria tetanus come in a lovely prefilled syringe with a rubber leurlock tip. This tip fits right over a clave or other type of needless IV system. The syringe and the clave adapter connect and can be connected to the IV tubing we use. Nowhere on the syringe is the warning not for IV use or for IM use only. This is another accident waiting to happen. Our temp fix for this is to put each syringe in a bag labeled IM use only. We are getting syringe labels printed that say IM use only and put them on individual syringes. Apparently these labels do not exist commercially so we are having a custom print job done.
Sex: U
Vaccine: DTAP
Symptoms: Injection site pain, Medication error
Clinical narrative: When ordering tetanus diphtheria toxoids (adult) from the computer system a technician ordered tetanus diphtheria acellular pertussis (pediatric) vaccines. The error is easy to make because 15 vaccine products appear beginning with the Tetanus and 6 appear beginning with Diphtheria. The wrong product was dispensed as floor stock to an outpatient clinic and mistakenly administered to several adults. The logo on the two vaccine packages is similar but the products are clearly labeled. Only one of 36 outpatients who received the wrong product had a possible reaction, local area soreness. The soreness was temporary. The problems is how similar products look on ordering screens. Stock bin for Tetanus diphtheria toxoids had been labeled with the wrong drug label rather than with a bar-coded shelf label that is standard practice for formulary drugs. Pharmacists now double check floor stock requests for accuracy and appropriateness for intended use. Correct bar code label has been placed on shelf bin. Pharmacist must approve any non formulary product ordered. Pharmacists and nurses have been inserviced on vaccines and checking procedures.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site pain, Petechiae, Synovitis
Clinical narrative: My daughter received pneumonia vaccine which resulted in petechiae several hours later. ER visit. After administration 1 yr later she was unable to bear weight on her leg. After consulting the pediatrician the next day she was diagnosed w/ synovitis, she was in severe pain, unable to move leg.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Employee tested negative for varicella titer on pre-employment 10/28/04. Responded on 12/7/04 for Varivax series. Given 1st injection 12/7/04 R deltoid. Employee broke out with chicken pox on 12/20/04 on face, chest, back (scalp).
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Asthenia, Disorientation, Face oedema, Vomiting
Clinical narrative: About 10 minutes after injections, vomiting, facial swelling, disorientation and weakness.
Age: 8.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dizziness, Heart rate decreased, Hypotonia, Hypoventilation, Nausea
Clinical narrative: Patient given PPD then Hep A. After Hep A, said she was dizzy. Patient then said she felt ok. Hep B given. Patient became limp, pale; said she felt like vomiting. Taken to lie down. Pulse weak, patient pale, shallow respiration, yawning. Elevated legs; no improvement. Pulse 44, BP 93/41 at 10:08. At 10:10, Pulse 120, weak. Gave Epi Pen Jr and called 911. Patient cleared by by MD per telephone call to ER from EMS and said to have vagal reaction. Released to home. EMS arrived at 10:15.
Age: 8.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pallor, Yawning
Clinical narrative: Patient given PPD then Hep A. After Hep A, said she was dizzy. Patient then said she felt ok. Hep B given. Patient became limp, pale; said she felt like vomiting. Taken to lie down. Pulse weak, patient pale, shallow respiration, yawning. Elevated legs; no improvement. Pulse 44, BP 93/41 at 10:08. At 10:10, Pulse 120, weak. Gave Epi Pen Jr and called 911. Patient cleared by by MD per telephone call to ER from EMS and said to have vagal reaction. Released to home. EMS arrived at 10:15.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Redness at site of injection on left deltoid, extending to elbow. Hot to touch. No rash/difficulty breathing. Enc. Children's Benadryl. Enc to see MD if problems persist/worsen.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Inconsolable screaming and crying for 4 hours immediately after vaccine administration.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis left upper extremity
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site warmth, Tenderness
Clinical narrative: Right leg with 4cm circular area of redness, induration, 1 vesicle-blister noted, warm, tender.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: One day after vaccines, had high fever and self-limited febrile seizure.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling to Right upper leg. Treated with Rx: Augmentin 500BID x10
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Diarrhoea, Oedema, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, diarrhea, swelling of fundus (soft spot) head.
Age: 1.57
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Chicken pox
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Feeling hot, Injection site oedema
Clinical narrative: Swollen R deltoid area and warm to the touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Pruritus
Clinical narrative: Client in 2 days after vaccine administration, right arm, site of Dtap (Daptacel), red, swollen, from shoulder to antecubital, mother states arm was more swollen day after vaccination but today is more red than swollen, itching also.