chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal, Chills, Diarrhoea
Clinical narrative: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus antibody negative, Fatigue, Full blood count normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hysterectomy, Insomnia, Laboratory test, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Mean cell volume normal, Mean platelet volume normal, Myalgia, Nausea, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Platelet count normal, Protein total normal, Pyrexia, Red blood cell count normal, Vomiting
Clinical narrative: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count normal
Clinical narrative: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.
Age: 37.0
Sex: M
Vaccine: TYP, YF
Symptoms: Chest discomfort, Dyspnoea, Flushing, Lip swelling
Clinical narrative: Seriousness criteria: other-medically significant.  Initial report received on 08 January 2008 from a health care professional.  A 37-year-old male patient, with no known past medical history, had received a first dose, "right deltoid", subcutaneous injection of YF-VAX, lot number UF081AA, and a first dose, left deltoid, intramuscular injection of Typhim VI, lot number Z0922-2, on 04 January 2008.  Three hours post-vaccination, the patient experienced shortness of breath, chest tightness, facial flushing, and lip swelling.  He was transported to an emergency room and kept for several hours of observation.  Treatment included Benadryl.  The symptoms resolved, and the patient recovered.
Age: 1.8
Sex: M
Vaccine: DTAPHEPBIP, PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Child received Prevnar in right thigh on 1/14/08 and Pediarix left thigh at about 1000. At 1800 mother noted hives from head to toe. Gave child Benadryl. Hives were gone by am. On 1/15/08 left thigh was red and warm. On 1/16/08 thigh was red, warm, swollen and hard. Evaluated on 1/17/08. Mother had been giving the child Motrin without improvement. 1/17/08 8cm diameter of swelling, erythema and induration noted left thigh. Allergist gave mother Keflex. On 1/18/08 Mom stated redness and swelling were improved. On 1/22/08 all symptoms were resolved. Mother never gave the pt Keflex.
Age: 1.8
Sex: M
Vaccine: DTAPHEPBIP, PPV
Symptoms: Urticaria
Clinical narrative: Child received Prevnar in right thigh on 1/14/08 and Pediarix left thigh at about 1000. At 1800 mother noted hives from head to toe. Gave child Benadryl. Hives were gone by am. On 1/15/08 left thigh was red and warm. On 1/16/08 thigh was red, warm, swollen and hard. Evaluated on 1/17/08. Mother had been giving the child Motrin without improvement. 1/17/08 8cm diameter of swelling, erythema and induration noted left thigh. Allergist gave mother Keflex. On 1/18/08 Mom stated redness and swelling were improved. On 1/22/08 all symptoms were resolved. Mother never gave the pt Keflex.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitus at site left upper arm; Prevnar flu given 1/4/08; Admitted 1-15-08 -> 1-18-08 1/23/08-records received for DOS 1/15/08-ED report presented with C/O fever since night before. Temp 103.8. Left upper arm with tender induration 2cm in diameter on lateral aspect, no fluctutation. Right upper arm lateral aspect with needle mark and mild swelling, no redness no tenderness. Impression Arm abscess.   3/27/08-DC Summary received for DOS 1/15-1/18/08 DC DX: left arm cellulitis. leukocytosis. Fever.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Computerised tomogram, Feeling abnormal, Head injury, Loss of consciousness, Vomiting
Clinical narrative: Received vaccines, passed out while checking out and hit head on floor about 15 minutes later. Ice applied and observed x 20min. Did have brief LOC immediately after fall. Released to home, where began to experience episodes of vomiting and seemed "out of it" per dad about 1 1/2 after vaccine given. Sent per squad to MC-ER. Was evaluated and admitted. 2/4/08-records received for DOS 7/10-7/11/07-DC DX: Left frontal contusions secondary to fall. Experienced a vasovagal event after receiving vaccinations producing a fall to floor. Momentary loss of consciousness then recurrent emesis and confusion. C/O headache and waning nausea. Left-sided neck pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Herpes zoster, Insomnia, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: See accompanying form with course of events following Pneumovax injection.  In addition, patient reports 12/17/07 a spot on her back, not painful, looked like an insect bite, difficulty sleeping.  Later that day, c/o extreme pain under R shoulder blade which later spread to under R breast.  She had MRI scheduled with physician appointment.  On 12/18/07, seen by Dr. who diagnosed shingles, prescribed Valtrex.  Valtrex helped to improve sx.  She says that she has since recovered to about 90% with those sx.  She reports having a mild-moderate case of chickenpox as a child, approximately 8-9 yrs. of age.  She says that 4 other family members had chickenpox at same time.  She denies ever having shingles before.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: See accompanying form with course of events following Pneumovax injection.  In addition, patient reports 12/17/07 a spot on her back, not painful, looked like an insect bite, difficulty sleeping.  Later that day, c/o extreme pain under R shoulder blade which later spread to under R breast.  She had MRI scheduled with physician appointment.  On 12/18/07, seen by Dr. who diagnosed shingles, prescribed Valtrex.  Valtrex helped to improve sx.  She says that she has since recovered to about 90% with those sx.  She reports having a mild-moderate case of chickenpox as a child, approximately 8-9 yrs. of age.  She says that 4 other family members had chickenpox at same time.  She denies ever having shingles before.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Trigeminal neuralgia
Clinical narrative: Developed 4 spots on forehead that looked like Herpes Zoster.  Had received on 1/4 and dermatitis occurred on 1/12/08 in 1st bunch of trigeminal, no distribution.  HP obtained from patient a retired physician.
Age: 0.4
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Hives developed the next morning after DTAP, IPV, PCV7, Rotateq administered. Also had pears for 1st time
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, VARCEL
Symptoms: Blood chloride decreased, Blood glucose increased, Febrile convulsion, Full blood count normal, Grand mal convulsion
Clinical narrative: Tonic clonic Sz activity with high fever to 102.4 degrees.  Spontaneous resolution with post-ictal state x7 20 mins.  Seen in ER, given Tylenol.  Was normal upon exam.  Normal in follow up exam.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, VARCEL
Symptoms: Influenza serology positive, Metabolic function test normal, Pyrexia, Renal function test normal
Clinical narrative: Tonic clonic Sz activity with high fever to 102.4 degrees.  Spontaneous resolution with post-ictal state x7 20 mins.  Seen in ER, given Tylenol.  Was normal upon exam.  Normal in follow up exam.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Induration, Oedema peripheral, Skin warm
Clinical narrative: 10x11cm, raised, in parts, with some induration; upper right arm - warm; Placed on Keflex 500g TID x 7Q
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dyskinesia, Febrile convulsion, Full blood count, Granulocyte count, Haematocrit normal
Clinical narrative: Seen 1/14/08 about 9AM, given vaccines, had slight fever at noon but eating fine & acting fine.  About 8PM being fed a bottle & had jerky movements & became unresponsive.  Seen at emergency room & Dx febrile seizure.  Temp 38.6 degrees.  Blood work & UA normal.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haemoglobin normal, Lymphocyte percentage, Platelet count normal, Pyrexia, Unresponsive to stimuli
Clinical narrative: Seen 1/14/08 about 9AM, given vaccines, had slight fever at noon but eating fine & acting fine.  About 8PM being fed a bottle & had jerky movements & became unresponsive.  Seen at emergency room & Dx febrile seizure.  Temp 38.6 degrees.  Blood work & UA normal.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urine analysis normal, White blood cell count normal
Clinical narrative: Seen 1/14/08 about 9AM, given vaccines, had slight fever at noon but eating fine & acting fine.  About 8PM being fed a bottle & had jerky movements & became unresponsive.  Seen at emergency room & Dx febrile seizure.  Temp 38.6 degrees.  Blood work & UA normal.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local reaction to varicella vaccine; right posterior arm had a silver dollar sized area of redness at injection site; no pain; afebrile;  was seen at PCP on 01/12/08 (3 days after vaccination)-- doctor suggested cool compresses and to watch for infection.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Bacillus infection, Blood culture positive, Influenza serology negative, Pyrexia, Respiratory syncytial virus infection
Clinical narrative: Suspect case of vaccine-associated Bacillus cereus infection in a newborn.  The initial blood culture (see below) was positive for B. cereus.  The infant had a severe, febrile respiratory illness, diagnosed as RSV, which required hospitalization at Medical Center.  An older sibling had RSV pneumonia in December.  The infant has recovered fully.  01/24/2008 MR received from CDC for ER admit 1/5-7/2008 with primary DX:  RSV Bronchiolitis.  Additional DX: UTI. Infant presented to ER with 2 day hx of fever with decrease po intake, decreased UO and increased respirations. (+) cough. On PE pt appeared sleepy and dehydrated (10%). Mildly increased WOB with minimal subcostal retractions and tracheal tugging. Otherwise WNL. Pt admitted and tx with IVF, nebs and abx.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Sick relative, Virus serology test
Clinical narrative: Suspect case of vaccine-associated Bacillus cereus infection in a newborn.  The initial blood culture (see below) was positive for B. cereus.  The infant had a severe, febrile respiratory illness, diagnosed as RSV, which required hospitalization at Medical Center.  An older sibling had RSV pneumonia in December.  The infant has recovered fully.  01/24/2008 MR received from CDC for ER admit 1/5-7/2008 with primary DX:  RSV Bronchiolitis.  Additional DX: UTI. Infant presented to ER with 2 day hx of fever with decrease po intake, decreased UO and increased respirations. (+) cough. On PE pt appeared sleepy and dehydrated (10%). Mildly increased WOB with minimal subcostal retractions and tracheal tugging. Otherwise WNL. Pt admitted and tx with IVF, nebs and abx.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory tract infection, Sick relative, Virus serology test
Clinical narrative: Suspect case of vaccine-associated Bacillus cereus infection in a newborn.  The initial blood culture (see below) was positive for B. cereus.  The infant had a severe, febrile respiratory illness, diagnosed as RSV, which required hospitalization at Medical Center.  An older sibling had RSV pneumonia in December.  The infant has recovered fully.  01/24/2008 MR received from CDC for ER admit 1/5-7/2008 with primary DX:  RSV Bronchiolitis.  Additional DX: UTI. Infant presented to ER with 2 day hx of fever with decrease po intake, decreased UO and increased respirations. (+) cough. On PE pt appeared sleepy and dehydrated (10%). Mildly increased WOB with minimal subcostal retractions and tracheal tugging. Otherwise WNL. Pt admitted and tx with IVF, nebs and abx.
Age: 36.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Muscular weakness, Oral herpes, Pain in extremity, Trismus
Clinical narrative: Approx 10 days after injection of MMR noticed an ache in base of R metacarpal joint. That week the ache and weakness spread through R hand and by 1/15 was in both hands/wrists. Also developed cold sores (first in a long time) at lower lip edge. Still c/o pain and weakness in both hands, unable to open a jar. No treatment.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: High-pitched crying
Clinical narrative: Mom reported to physician child had high pitch cry lasting longer than 3 hours.  Family using Tylenol and cool compresses.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: PATIENT CAME IN FOR HER 4 YEAR VACCINES.  RECEIVED DTAP, HEPA, IPV, MMR, & VARIVAX.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Patient's provider called County Health and Human Services to report that patient came in 10 days after receiving MMR, and had a rash along with a low grade fever. MMR administered was Merck Lot number 0279U.
Age: 1.16
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Body temperature increased, Fatigue, Irritability, Nasal congestion, Rash
Clinical narrative: Pt had vaccines administered 01-08-08. Became congested with runny nose approx 1 week later. On 01-19-08 pt became more fussy and tired and developed a rash over bilateral upper extremities and across trunk. Pt taken to Stat Care 01-20-08 and was diagnosed with "Viral Exanthem." Family was instructed to keep pt out of child care for up to 1 week while rash still visible. Also instructed to administer infant Tylenol or Motrin as needed. Pt developed low-grade temperature of 100.0F on 01-21-08. Rash still present at this time.
Age: 1.16
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Rhinorrhoea, Viral rash
Clinical narrative: Pt had vaccines administered 01-08-08. Became congested with runny nose approx 1 week later. On 01-19-08 pt became more fussy and tired and developed a rash over bilateral upper extremities and across trunk. Pt taken to Stat Care 01-20-08 and was diagnosed with "Viral Exanthem." Family was instructed to keep pt out of child care for up to 1 week while rash still visible. Also instructed to administer infant Tylenol or Motrin as needed. Pt developed low-grade temperature of 100.0F on 01-21-08. Rash still present at this time.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pain, Pain in extremity
Clinical narrative: Received Tetanus and Diphtheria vaccine (Td) on 09/08/07 in left arm. My regular physician was not working that Saturday, so I saw this physician.  The vaccine was given to me because of a cat bite on right finger with possible infection. (The cat is mine and is healthy and has had all shots and vet care.) I had a knot at site and soreness immediately after shot was given. Within 1 week I developed a deep aching, sharp pain in upper arm at area of injection.  It has not gone away, but became worse.  I have lost full movement of arm as a result of deep pain and arm will not move high above head and am unable to reach around to back.  Arm stops at a certain point and cannot move any further.  I cannot use force with this arm, like pushing movements, side pushing movement because of deep pain and deep pain experienced if arm is jerked around.  Manual pushing and rubbing on spot causes deep pain also.  I reported to nurse on 10/19/07. Dr. was not in on the day I called, so I left a message with this nurse. She said if it does not go away to come in to have it looked at, but I felt there was nothing that could be done about it. So I have not gone into the doctor's office.  I certainly do not want pain medication.  I doubt that would help anyway.  Simple Tylenol or ibuprofen does not help pain. The pain can be so severe, it takes my breath away and lasts for up to 1-2 minutes.  When arm is at rest I do not feel pain, just a very mild aching feeling. I experience different levels of pain depending on the type of arm movement I do.  I cannot put my coat on with this arm 1st, because I cannot move it back enough to get the other arm in the sleeve.  I must always put my coat on with the other arm first, ever since this vaccine.  It has been 4 months since vaccine was given.  How long does this pain last and will it ever go away or is this a permanent problem for me.  Please advise.
Sex: U
Vaccine: MNQ, VARCEL
Symptoms: Injection site induration, Injection site inflammation, Injection site warmth, Limb discomfort, Pyrexia
Clinical narrative: Soreness in arm shortly after receipt of injection.  Soreness increased throughout the evening.  Next morning injection site inflamed and hot the touch; hard knot at injection site.  Evening of second day fever of 101 degrees.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: 3rd dose of HPV given to otherwise healthy 17 y/o female, L deltoid. Patient notes mild pharyngitis at time of injection, recovering from a previous URI.  Gradual onset over the following 24 hours of pain, swelling, erythema, and warmth at injection site, approx 7 cm wide and 15 cm long heading distally. Also notes deep-seated pain in forearm but CR < 2 sec, sensation/strength intact.  Patient has been icing and there has been some improvement.  Motrin, Benadryl, ice x 48 hours was prescribed.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: We received on 16 JAN 2008 via agency from a consumer the following information: A 28-year-old female patient, born on 22 JAN 1979, was vaccinated IM with 0.5 ml Fluvirin, batch no. unknown, on 14 NOV 2007.  At 12-13 weeks gestational age caller discovered via ultrasound that she had miscarried on 08 JAN 2008.  Company assessment: seriousness criterion: medically significant.  Causality: insufficient date (the amount of data is insufficient to finally assess causality as information about the pregnancy is missing).  Expectedness assessment according to product information: Miscarriage is unexpected, drug exposure during pregnancy is expected after vaccination with Fluvirin.  On a case level, the case is considered unexpected.  No change in benefit-risk-ratio.  No measures necessary.  No.: NA08-00183.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: We received on 16 JAN 2008 via local agency, from a consumer the following information: Consumer left voice mail stating that she received vaccine in November. She wants to report an adverse event that she had her colleague (see case no. MA2008-0051) experienced. No additional information left with message. Addendum: On 16 JAN 2008 we received the following information: A 31-year-old female patient, born on 02 APR 1976 was vaccinated i.m. with 0.5 ml Fluvirin, batch no. unknown, on 14 NOV 2007. At 9 weeks gestational age caller discovered that she had miscarried on 29 NOV 2007. Company assessment: Seriousness criterion: medically significant. Causality: insufficient data (the amount of data is insufficient to finally assess causality as information about the pregnancy is missing). Expectedness assessment according to agency and local product information: Miscarriage is unexpected drug exposure during pregnancy is expected after vaccination with Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. Local agency no.: NA08-00160
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot
Clinical narrative: DL got "hot" after HPV vaccine injection; dizzy Did not Lose consciousness "Always feels this way when blood drawn"
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Inappropriate schedule of drug administration, Inappropriate schedule of drug administration, Malaise
Clinical narrative: Administration error. FDA approved ZOSTAVAX vax for 60 years old persons. Patient is 54. The day after vaccination pt was feeling well for 24 hours. After 24 hours pt. was tired, malaise feeling following vaccination. Patient taled to ER Director to explain her situation. She asked the Dr if she could have the ZOSTAVAX vaccine under the age of 60 years he approved the vaccine for economic reasons. Pt. also mentioned to him that she had chicken pox as a child and exposure in health care practice.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Exposure to communicable disease, Fatigue, Inappropriate schedule of drug administration, Stomach discomfort
Clinical narrative: Administration error. FDA approved ZOSTAVAX vax for 60 years old persons. Patient is 54. The day after vaccination pt was feeling well for 24 hours. After 24 hours pt. was tired, malaise feeling following vaccination. Patient taled to ER Director to explain her situation. She asked the Dr if she could have the ZOSTAVAX vaccine under the age of 60 years he approved the vaccine for economic reasons. Pt. also mentioned to him that she had chicken pox as a child and exposure in health care practice.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Oedema peripheral
Clinical narrative: Left thigh swollen and red from toe up above hip,Lasted 2 1/2 hours - resolved with Ice and Bath
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: Patient seen in clinic 1-20-08. Right Thigh with oval Area of inflammation at injection site.
Age: 1.2
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC
Symptoms: Body temperature increased, Computerised tomogram, Convulsion, Crying
Clinical narrative: On 1/12/08 patient presented to the ER with seizure lasting 45 min.  Fever at the time before seizure started was 103.5 rectally.  CT scan was negative.  Chest x-ray was negative.  From the time of discharge 1/12/08 - 1/16/08 baby cried/screamed almost all the time.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: Raised Reddened Skin. area measurers 7x6 cm right deltoid Little pain, warm to Touch, very Itchy, Had Dtap, Flu, Varicella in that arm.
Age: 76.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Oedema peripheral
Clinical narrative: Shingles outbreak.  Received vaccine in left arm 1/10/08.  Several days later noted swollen LU in right axilla, followed by outbreak in T1 distributor (right side).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: CP 2 days after Gardasil
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm red, swollen, hot to touch, non tender around injection shot. Rx - Keflex.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Leg - red and blotchy - gave Benadryl, no resp difficulty.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain
Clinical narrative: Chest pain 2 days after HPV # 1
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Received vaccine at 0730. At 200 H/A started, then nausea/vomiting, fever/chills, myalgia, fatigue, tingly/prickly skin. Multiple episodes of emesis overnight. Temp 38 degrees at 0830 1/15. Sx gradually decreased around 1400 on 1/15.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Received vaccine at 0730. At 200 H/A started, then nausea/vomiting, fever/chills, myalgia, fatigue, tingly/prickly skin. Multiple episodes of emesis overnight. Temp 38 degrees at 0830 1/15. Sx gradually decreased around 1400 on 1/15.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Contusion, Erythema, Excoriation, Oedema peripheral, Pyrexia
Clinical narrative: Left upper arm very swollen, red, warm with presence of bruising under (L) deltoid area and excoriations from scratching arm. Mother stated that her daughter spiked a fever of 103 axillary on 1/17/08 at 3 AM and was given Tylenol. Client was referred to pediatrician to r/o infection or other problems.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Left upper arm very swollen, red, warm with presence of bruising under (L) deltoid area and excoriations from scratching arm. Mother stated that her daughter spiked a fever of 103 axillary on 1/17/08 at 3 AM and was given Tylenol. Client was referred to pediatrician to r/o infection or other problems.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Breast pain, Breast swelling, Nipple pain
Clinical narrative: Patient presents to clinic complaint of left sided soreness under arm and left breast and nipple soreness and swelling since 1/3/08. Observed left nipple soreness. Patient guarding during palpation of breast and under arm. Denies nipple discharge.
Age: 1.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Auricular swelling, Erythema, Eye swelling, Lip swelling, Pharyngeal oedema
Clinical narrative: Given immunizations on 12/17/07, parent states child's lips, eye, ears, and throat began to swell approximately 4 hrs after immun. She sates red rash on body and face. Take to ER, was given a steroid shot and Benadryl. Stayed for 4 hrs before being released once swelling and rash started to subside.
Age: 1.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash generalised
Clinical narrative: Given immunizations on 12/17/07, parent states child's lips, eye, ears, and throat began to swell approximately 4 hrs after immun. She sates red rash on body and face. Take to ER, was given a steroid shot and Benadryl. Stayed for 4 hrs before being released once swelling and rash started to subside.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Rash pruritic
Clinical narrative: Pt states she gets nervous and breaks out into hives after shots, pt did not have hives but an itchy rash after a meningococcal vaccine.  Benadryl 25 mg po given and it resolved.
Age: 9.0
Sex: M
Vaccine: FLUN3, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema at sight of injection 2-2 1/2 inches. Slight induration and tender, no fluctuations, 3 days after Varivax. Afebrile
Age: 50.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fall, Palpitations
Clinical narrative: Pt. stated that she got "very dizzy" the next day to the point of falling over.  Her heart started racing & she called 911.  Paramedics gave her a clean bill of health & didn't need to be taken to E.R.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, PPV, TDAP
Symptoms: Body temperature increased, Erythema, Injected limb mobility decreased, Oedema, Pruritus
Clinical narrative: (R) arm, edema, red, warm, peeling - 2" from site of injection down to elbow. Could not straighten arm out. T 99, was itchy. Was put on antibiotic, was to call/come back PRN.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, PPV, TDAP
Symptoms: Skin exfoliation, Skin warm
Clinical narrative: (R) arm, edema, red, warm, peeling - 2" from site of injection down to elbow. Could not straighten arm out. T 99, was itchy. Was put on antibiotic, was to call/come back PRN.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash generalised
Clinical narrative: Received HPV #2 (GARASIL) on 11/28/07 at approximately 0800 hrs. Itchy, generalized rash started in afternoon, covering entire body. Mom gave "some pills" to stop rash. Rash resolved that evening.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pruritus, Injection site rash
Clinical narrative: Local 4x6 cm pink mildly pruritic rash at injection site left deltoid within 15 minutes.  Resolved completely within several hours.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Parent previously declined administration of Rotateq vaccine at 2 and 4 mos. Physicals 1st dose of this vaccine given at 6 months of age contrary to manufacturer's recommendation. No side effects/problems/adverse reactions reported by parent.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cough, Diarrhoea, Vomiting
Clinical narrative: 2 days after vaccines administered, pt. developed cough, vomiting & diarrhea persisting until at least 1/16/08.
Age: 1.06
Sex: F
Vaccine: DTAP, HEPA, HPV4, PNC, VARCEL, DTAP, HEPA, HPV4, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 12 month old received a Gardasil vaccine that is not indicated for this age group. No adverse reaction noted, seen in office 1/17/08 for recheck.
Age: 1.06
Sex: F
Vaccine: DTAP, HEPA, HPV4, PNC, VARCEL, DTAP, HEPA, HPV4, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, Inappropriate schedule of drug administration, Injection site swelling, Medication error, Pyrexia
Clinical narrative: 12 month old received a Gardasil vaccine that is not indicated for this age group. No adverse reaction noted, seen in office 1/17/08 for recheck.
Age: 1.06
Sex: F
Vaccine: DTAP, HEPA, HPV4, PNC, VARCEL, DTAP, HEPA, HPV4, PNC, VARCEL
Symptoms: Swelling, Wrong drug administered
Clinical narrative: 12 month old received a Gardasil vaccine that is not indicated for this age group. No adverse reaction noted, seen in office 1/17/08 for recheck.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abscess, Culture negative, Injection site abscess
Clinical narrative: Sterile abscess left thigh 1 month post vaccination
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Abscess, Culture, Injection site abscess
Clinical narrative: Steril abscess (L) thigh one month post vaccination
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Culture negative, Injection site abscess sterile
Clinical narrative: Sterile abscess 1 month post vaccination L thigh.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: C/O itching (L) anterior arm below elbow. Approximately 1hr 15 minutes after receiving injection. No rash, swelling or discoloration noted. Redness not as signs of scratching at site. Ice pk applied with relief noted. Injection site no visible signs. Only slight redness where band aid was.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Rash Hives on 1/14/08
Age: 15.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Injection site erythema
Clinical narrative: Redness around site.  Instructed to give Tylenol or Motrin for pain.  Ice pack (PRN) (baseball size).  Pt. (request same arm).  Called 1-16-08, no redness.