chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: MMR, MMRV
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Information has been received from the father of a 15 month old female who was vaccinated with ProQuad (Oka/Merck upgrade process) (Lot # "01434"). Subsequently the patient developed a "bad injection site reaction" and fever of 103 at day 9 post vaccination. The fever had to be controlled with acetaminophen (TYLENOL) or ibuprofen (MOTRIN) every 5 hours for almost 48 hours. It was reported that the child's fever had resolved. The injection site was still "looking bad" on day 12 postvaccination. Further information has been requested.  10/06/2007 This is in follow-up to report(s) previously submitted on 7/6/2007. Follow up information received from a licensed practical nurse indicated that on 08-APR-2007 the patient developed a maculopapular rash all over that was light red. There was also a bump around the injection site with increased redness. The patient had a fever of 102 to 103. The patient recovered on 10-APR-2007. No additional information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL, DTP, MMRV
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Information has been received from a physician concerning a 5 year old male, with no pertinent medical history, drug reactions or allergies, who on 10-MAY2007 was vaccinated with Proquad (Lot # 657297/0429U). Concomitant therapy that same day included diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid. On 10-MAY-2007 the physician was notified that the patient had developed a rash, fever, vomiting and seemed lethargic. The patient did not require treatment from the physician for his symptoms. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL, DTP, MMRV
Symptoms: Lethargy, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning a 5 year old male, with no pertinent medical history, drug reactions or allergies, who on 10-MAY2007 was vaccinated with Proquad (Lot # 657297/0429U). Concomitant therapy that same day included diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid. On 10-MAY-2007 the physician was notified that the patient had developed a rash, fever, vomiting and seemed lethargic. The patient did not require treatment from the physician for his symptoms. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC, HEPA, MMRV, PNC
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Information was received from a physician concerning a 12 month old male, with no known medical history or allergies, who was vaccinated on 12-APR-2007 with a 0.5 ml, SC first dose in the "right" of MMRV (lot number 656309/1393F). Concomitant vaccinations administered that day included a fourth dose of Prevnar (lot number BO8666B) and a first dose in the left deltoid of Havrix (lot number AHAVB143BA). There was no illness at the time of vaccination. It was reported that within 24 hours the patient developed urticaria. The patient was treated with oral diphenhydramine hydrochloride (BENADRYL). The symptoms have since resolved. It was reported that the patient's medical status is recovering. No product quality was involved. Additional information was received from the doctor who reported that on 12-APR-2007, a red rash developed within 12-24 hours. The patient went to the emergency department and received oral diphenhydramine hydrochloride (BENADRYL) and the rash got better. He was started on oral diphenhydramine hydrochloride (BENADRYL) and prednisolone and the rash resolved within a few hours. There was no reoccurrence. The patient recovered on 13-APR-2007. No further information is expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC, HEPA, MMRV, PNC
Symptoms: Urticaria
Clinical narrative: Information was received from a physician concerning a 12 month old male, with no known medical history or allergies, who was vaccinated on 12-APR-2007 with a 0.5 ml, SC first dose in the "right" of MMRV (lot number 656309/1393F). Concomitant vaccinations administered that day included a fourth dose of Prevnar (lot number BO8666B) and a first dose in the left deltoid of Havrix (lot number AHAVB143BA). There was no illness at the time of vaccination. It was reported that within 24 hours the patient developed urticaria. The patient was treated with oral diphenhydramine hydrochloride (BENADRYL). The symptoms have since resolved. It was reported that the patient's medical status is recovering. No product quality was involved. Additional information was received from the doctor who reported that on 12-APR-2007, a red rash developed within 12-24 hours. The patient went to the emergency department and received oral diphenhydramine hydrochloride (BENADRYL) and the rash got better. He was started on oral diphenhydramine hydrochloride (BENADRYL) and prednisolone and the rash resolved within a few hours. There was no reoccurrence. The patient recovered on 13-APR-2007. No further information is expected.
Age: 1.2
Sex: F
Vaccine: MMRV, PNC, MMRV, PNC
Symptoms: Rash
Clinical narrative: Information has been received from a person working in a physician's office concerning a 14 month old female with no medical history and no allergies who on 03-MAY-2007 was vaccinated once with a 0.5 ml subcutaneous dose of MMRV (Lot # 657008/0229U). Concomitant vaccines administered included a dose of Prevnar. Concomitant drug therapy included a 10 day course of amoxicillin which started on 05-MAY-2007. On 13-MAY-2007 the patient developed a measles rash all over her body with a low grade fever. There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: MMRV, PNC, MMRV, PNC
Symptoms: Measles, Pyrexia
Clinical narrative: Information has been received from a person working in a physician's office concerning a 14 month old female with no medical history and no allergies who on 03-MAY-2007 was vaccinated once with a 0.5 ml subcutaneous dose of MMRV (Lot # 657008/0229U). Concomitant vaccines administered included a dose of Prevnar. Concomitant drug therapy included a 10 day course of amoxicillin which started on 05-MAY-2007. On 13-MAY-2007 the patient developed a measles rash all over her body with a low grade fever. There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC, HEP, MMRV, PNC
Symptoms: Injection site induration, Injection site swelling, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a patient who on 22-MAY-2007 was vaccinated with a dose of PROQUAD. On 22-MAY-207 after vaccination, the patient developed a local reaction before leaving the office. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source. This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a physician concerning a 24 month old female with no medical history or allergies who on 26-APR-2007 was vaccinated SC on left thigh with a first dose of PROQUAD (Lot # 656718/0167U). Concomitant therapy included a IM third dose on right thigh of PREVNAR (Lot # B08679E) and IM second dose of right thigh of hepatitis B virus vaccine (unspecified) (Lot # 1436F). There was no illness at the time of vaccination. On approximately 26-MAY-2007 after vaccination, the patient developed a local reaction before leaving the office. Unspecified medical attention was sought. At the time of the report, the patient had recovered. A product quality complaint was not involved. Additional information has been received from the physician who stated that patient had experienced induration and swelling of left leg. The patient was seen in clinic one month after vaccination. The findings were post inflammatory color changes. At the time of the report the patient had recovered. This is one of several reports received from the same source. No further information is expected.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC, HEP, MMRV, PNC
Symptoms: Local reaction
Clinical narrative: Information has been received from a physician concerning a patient who on 22-MAY-2007 was vaccinated with a dose of PROQUAD. On 22-MAY-207 after vaccination, the patient developed a local reaction before leaving the office. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source. This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a physician concerning a 24 month old female with no medical history or allergies who on 26-APR-2007 was vaccinated SC on left thigh with a first dose of PROQUAD (Lot # 656718/0167U). Concomitant therapy included a IM third dose on right thigh of PREVNAR (Lot # B08679E) and IM second dose of right thigh of hepatitis B virus vaccine (unspecified) (Lot # 1436F). There was no illness at the time of vaccination. On approximately 26-MAY-2007 after vaccination, the patient developed a local reaction before leaving the office. Unspecified medical attention was sought. At the time of the report, the patient had recovered. A product quality complaint was not involved. Additional information has been received from the physician who stated that patient had experienced induration and swelling of left leg. The patient was seen in clinic one month after vaccination. The findings were post inflammatory color changes. At the time of the report the patient had recovered. This is one of several reports received from the same source. No further information is expected.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAP, HEPA, MMRV
Symptoms: Immediate post-injection reaction, Induration, Injection site induration, Injection site urticaria, Urticaria
Clinical narrative: Information has been received from a physician concerning a patient who on 16-MAY-2007 was vaccinated with a dose of Proquad. It was reported that the patient developed a local reaction and returned to the office couple of days after vaccination. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source. Additional information has been received form the physician who stated that patient developed urticarical reaction at the injection site shortly after vaccination. The area was described as indurated. The patient was treated with BENADRYL. No further information is available.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, MMRV, DTAP, HEPA, MMRV
Symptoms: Injection site induration, Injection site urticaria, Local reaction, Urticaria
Clinical narrative: Information has been received from a physician concerning a patient who on 16-MAY-2007 was vaccinated with a dose of Proquad. It was reported that the patient developed a local reaction and returned to the office couple of days after vaccination. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source. Additional information has been received form the physician who stated that patient developed urticarical reaction at the injection site shortly after vaccination. The area was described as indurated. The patient was treated with BENADRYL. No further information is available.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 5 year old female with no medical history who on 14-MAY-2007 was vaccinated with a single dose of Proquad (Lot # 656643/0096U). On 14-MAY-2007 the patient developed a rash on her right arm at the injection site which was accompanied by redness, swelling and warmth. The nurse did not specify if the rash was a measles-like or varicella-like rash. Unspecified medical attention was sought. The patient was treated with BENADRYL and an ice pack for her arm. Subsequently, the patient recovered. NO product quality complaint was involved.
Age: 1.0
Sex: M
Vaccine: HBHEPB, IPV, MMRV, PNC, MMRV
Symptoms: Rash, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 1 year old male with no known allergies and a history of umbilical hernia who on 21-MAY-2007 was vaccinated SC in the right leg with a 0.5 ml dose of MMRV (lot 3 655842/1330F). Concomitant therapy included sodium fluoride (+) vitamins (unspecified) (POLY-VI-FLOR DROPS). On 21-MAY-2007 the patient developed a rash all over his body. The patient's parents took him to the ER and he was to follow up in the office on 22-MAY-2007. There were no lab tests performed. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HBHEPB, IPV, MMRV, PNC, MMRV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 1 year old male with no known allergies and a history of umbilical hernia who on 21-MAY-2007 was vaccinated SC in the right leg with a 0.5 ml dose of MMRV (lot 3 655842/1330F). Concomitant therapy included sodium fluoride (+) vitamins (unspecified) (POLY-VI-FLOR DROPS). On 21-MAY-2007 the patient developed a rash all over his body. The patient's parents took him to the ER and he was to follow up in the office on 22-MAY-2007. There were no lab tests performed. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, DTPIPV, MMRV
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male who on 03-MAY-2007 was vaccinated with ProQuad (Lot # 656307/1391F). Concomitant therapy that same day included DTaP-IPV, administered in the "same arm". On 04-MAY-2007 the patient developed a fever of 100.4, with redness and swelling in the arm. The patient was given diphenhydramine hydrochloride and ibuprofen for comfort. The arm continued to worsen, and the patient was seen in the emergency room on 5 MAY 2007. The patient was afebrile, with swelling in the arm from the Deltoid to elbow area. The patient was diagnosed with cellulitis, placed on amoxicillin (+) clavulanate potassium and sent home. At the time of reporting the patient was recovering. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007.  Information has been received from a registered nurse concerning a 4-year-old male on 03-MAY-2007 was vaccinated with PROQUAD (Merck) (Lot # 656307/1391F).  Secondary suspect therapy that same day included DTAP-IPV administered in the "same arm".  On 04-MAY-2007 the patient developed a fever of 100.4 celcius, with redness and swelling in the arm.  The patient was given diphenhydramine hydrochloride and IBUPROFEN for comfort.  The arm continued to worsen, and the patient was seen in the emergency room on 5 MAY 2007.  The patient was afebrile, with swelling in the arm from the deltoid to elbow are.  The patient was diagnosed with cellulitis, placed on amoxicillin (+) clavulanate potassium and sent home.  At the time of reporting the patient was recovering.  There was no product quality complaint.  Follow up information received on 07-Jun-2007 states that the patient is a male who has an allergy to oxybenzone, a medical history of respiratory syncytial virus infection and a concurrent condition of asthma who on 03-May-2007 at 4:08 pm, was vaccinated subcutaneously with his firs dose of PROQUAD (Merck) (lot# 556307/1391F).  He was seen in the office on 05-May-2007 by another doctor and diagnosed with cellulitis of the left arm.  The patient did not have any complaints of pain.  The are was warm to touch, swollen, red and hard.  He had a temperature of 100.4 celcius.  The patient was given AUGMENTIN 400 milligrams/5 milliliters (400 mg amoxicillin/57.0 mg clavulanic acid) - 4 milliliters by mouth twice a day - 100 milliliters dispenser taken until gone.  Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, DTPIPV, MMRV
Symptoms: Pyrexia, Skin tightness
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male who on 03-MAY-2007 was vaccinated with ProQuad (Lot # 656307/1391F). Concomitant therapy that same day included DTaP-IPV, administered in the "same arm". On 04-MAY-2007 the patient developed a fever of 100.4, with redness and swelling in the arm. The patient was given diphenhydramine hydrochloride and ibuprofen for comfort. The arm continued to worsen, and the patient was seen in the emergency room on 5 MAY 2007. The patient was afebrile, with swelling in the arm from the Deltoid to elbow area. The patient was diagnosed with cellulitis, placed on amoxicillin (+) clavulanate potassium and sent home. At the time of reporting the patient was recovering. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007.  Information has been received from a registered nurse concerning a 4-year-old male on 03-MAY-2007 was vaccinated with PROQUAD (Merck) (Lot # 656307/1391F).  Secondary suspect therapy that same day included DTAP-IPV administered in the "same arm".  On 04-MAY-2007 the patient developed a fever of 100.4 celcius, with redness and swelling in the arm.  The patient was given diphenhydramine hydrochloride and IBUPROFEN for comfort.  The arm continued to worsen, and the patient was seen in the emergency room on 5 MAY 2007.  The patient was afebrile, with swelling in the arm from the deltoid to elbow are.  The patient was diagnosed with cellulitis, placed on amoxicillin (+) clavulanate potassium and sent home.  At the time of reporting the patient was recovering.  There was no product quality complaint.  Follow up information received on 07-Jun-2007 states that the patient is a male who has an allergy to oxybenzone, a medical history of respiratory syncytial virus infection and a concurrent condition of asthma who on 03-May-2007 at 4:08 pm, was vaccinated subcutaneously with his firs dose of PROQUAD (Merck) (lot# 556307/1391F).  He was seen in the office on 05-May-2007 by another doctor and diagnosed with cellulitis of the left arm.  The patient did not have any complaints of pain.  The are was warm to touch, swollen, red and hard.  He had a temperature of 100.4 celcius.  The patient was given AUGMENTIN 400 milligrams/5 milliliters (400 mg amoxicillin/57.0 mg clavulanic acid) - 4 milliliters by mouth twice a day - 100 milliliters dispenser taken until gone.  Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, DTPIPV, MMRV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male who on 03-MAY-2007 was vaccinated with ProQuad (Lot # 656307/1391F). Concomitant therapy that same day included DTaP-IPV, administered in the "same arm". On 04-MAY-2007 the patient developed a fever of 100.4, with redness and swelling in the arm. The patient was given diphenhydramine hydrochloride and ibuprofen for comfort. The arm continued to worsen, and the patient was seen in the emergency room on 5 MAY 2007. The patient was afebrile, with swelling in the arm from the Deltoid to elbow area. The patient was diagnosed with cellulitis, placed on amoxicillin (+) clavulanate potassium and sent home. At the time of reporting the patient was recovering. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007.  Information has been received from a registered nurse concerning a 4-year-old male on 03-MAY-2007 was vaccinated with PROQUAD (Merck) (Lot # 656307/1391F).  Secondary suspect therapy that same day included DTAP-IPV administered in the "same arm".  On 04-MAY-2007 the patient developed a fever of 100.4 celcius, with redness and swelling in the arm.  The patient was given diphenhydramine hydrochloride and IBUPROFEN for comfort.  The arm continued to worsen, and the patient was seen in the emergency room on 5 MAY 2007.  The patient was afebrile, with swelling in the arm from the deltoid to elbow are.  The patient was diagnosed with cellulitis, placed on amoxicillin (+) clavulanate potassium and sent home.  At the time of reporting the patient was recovering.  There was no product quality complaint.  Follow up information received on 07-Jun-2007 states that the patient is a male who has an allergy to oxybenzone, a medical history of respiratory syncytial virus infection and a concurrent condition of asthma who on 03-May-2007 at 4:08 pm, was vaccinated subcutaneously with his firs dose of PROQUAD (Merck) (lot# 556307/1391F).  He was seen in the office on 05-May-2007 by another doctor and diagnosed with cellulitis of the left arm.  The patient did not have any complaints of pain.  The are was warm to touch, swollen, red and hard.  He had a temperature of 100.4 celcius.  The patient was given AUGMENTIN 400 milligrams/5 milliliters (400 mg amoxicillin/57.0 mg clavulanic acid) - 4 milliliters by mouth twice a day - 100 milliliters dispenser taken until gone.  Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV, DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth, Pain
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 5 year 4 month old female who on 29-MAY-2007 was vaccinated in the right tricep with a subcutaneous injection of "one dose" of Proquad. Concomitant vaccination included a dose in the right deltoid of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 31-MAY-2007 the patient experienced injection site rash, which was "red, hot to touch, and swollen". The patient complained of a lot of discomfort. It is reported that there were more than "10, clear fluid-filled blisters around the injection site that was 5-6 millimeters in diameter". The patient was given MOTRIN, antibiotics and steroids on 01-JUN-2007. The blisters began to pop by 02-Jun-2007. By 05-Jun-2007 the blisters began to dry out and scab over and the patient's arm was cool to touch. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV, DTAP, MMRV
Symptoms: Discomfort, Injection site erythema, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 5 year 4 month old female who on 29-MAY-2007 was vaccinated in the right tricep with a subcutaneous injection of "one dose" of Proquad. Concomitant vaccination included a dose in the right deltoid of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 31-MAY-2007 the patient experienced injection site rash, which was "red, hot to touch, and swollen". The patient complained of a lot of discomfort. It is reported that there were more than "10, clear fluid-filled blisters around the injection site that was 5-6 millimeters in diameter". The patient was given MOTRIN, antibiotics and steroids on 01-JUN-2007. The blisters began to pop by 02-Jun-2007. By 05-Jun-2007 the blisters began to dry out and scab over and the patient's arm was cool to touch. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV, DTAP, MMRV
Symptoms: Injection site warmth, Scab
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 5 year 4 month old female who on 29-MAY-2007 was vaccinated in the right tricep with a subcutaneous injection of "one dose" of Proquad. Concomitant vaccination included a dose in the right deltoid of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 31-MAY-2007 the patient experienced injection site rash, which was "red, hot to touch, and swollen". The patient complained of a lot of discomfort. It is reported that there were more than "10, clear fluid-filled blisters around the injection site that was 5-6 millimeters in diameter". The patient was given MOTRIN, antibiotics and steroids on 01-JUN-2007. The blisters began to pop by 02-Jun-2007. By 05-Jun-2007 the blisters began to dry out and scab over and the patient's arm was cool to touch. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 5-year-old male who on 23-MAY-2007 at 1:45 pm was vaccinated with a first dose of MMRV (lot # 656550/1531F). On 24-MAY-2007, at 8:30 PM, the patient's left leg had a 1 1/2 inch raised hard knot which looked like a golf ball under the skin that was very red and itchy. The patient went to the doctor's office on 25-MAY-2007 and was told to keep ice on it. The dad applied 1% hydrocortisone cream for the itching. On 29-MAY-2007 it was marble sized with bruising and tender but improving. Subsequently, on an unspecified date, the patient recovered. It is unspecified if a product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Contusion, Erythema, Induration, Pruritus, Tenderness
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 5-year-old male who on 23-MAY-2007 at 1:45 pm was vaccinated with a first dose of MMRV (lot # 656550/1531F). On 24-MAY-2007, at 8:30 PM, the patient's left leg had a 1 1/2 inch raised hard knot which looked like a golf ball under the skin that was very red and itchy. The patient went to the doctor's office on 25-MAY-2007 and was told to keep ice on it. The dad applied 1% hydrocortisone cream for the itching. On 29-MAY-2007 it was marble sized with bruising and tender but improving. Subsequently, on an unspecified date, the patient recovered. It is unspecified if a product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Information has been received concerning a 16 year old female who on 30-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included Varivax, Vaqta, tuberculin purified protein derivative and Menactra. On 30-MAY-2007 the patient received the above vaccines without complaints or symptoms. She stood and walked out of room with mother. The patient turned to ask a question, at that time her eyes closed and her body went limp. She was aided to the floor without injury. She opened her eyes and spoke appropriately. Her legs were elevated for 15 minutes, BP 88/54. The patient then sat on a chair, never pale or diaphoretic. After 10-15 minutes the patient walked out of the office with her mother. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Blood pressure decreased, Hypotonia
Clinical narrative: Information has been received concerning a 16 year old female who on 30-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included Varivax, Vaqta, tuberculin purified protein derivative and Menactra. On 30-MAY-2007 the patient received the above vaccines without complaints or symptoms. She stood and walked out of room with mother. The patient turned to ask a question, at that time her eyes closed and her body went limp. She was aided to the floor without injury. She opened her eyes and spoke appropriately. Her legs were elevated for 15 minutes, BP 88/54. The patient then sat on a chair, never pale or diaphoretic. After 10-15 minutes the patient walked out of the office with her mother. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy, Pain, Pruritus, Wrong technique in drug usage process
Clinical narrative: This is in follow-up to report (s) previously submitted on 7/6/2007. Information has been received from a physician concerning a 19 year old female who was vaccinated with GARDASIL. It was reported that the patient received her first dose of GARDASIL (from an other physician than the one who reported it) in her right lower back. As a result of this incorrect administration, the patient experienced painful itching in the lymph nodes and in the groin area 1-2 days after the vaccination. Medical attention was sought. Patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. In follow up information it was reorted that on 07-MAY-2007, following week patient noticed enlarged lympnodes in right groin. It was painful to walk and some itching that area. Patient was seen at doctor for this on 14-May-2007 and was advised to monitor over next few weeks for increased sign and symptoms. The patient recovered within approximately 2-6 weeks. No further problems. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Incorrect route of drug administration, Pain, Pruritus
Clinical narrative: This is in follow-up to report (s) previously submitted on 7/6/2007. Information has been received from a physician concerning a 19 year old female who was vaccinated with GARDASIL. It was reported that the patient received her first dose of GARDASIL (from an other physician than the one who reported it) in her right lower back. As a result of this incorrect administration, the patient experienced painful itching in the lymph nodes and in the groin area 1-2 days after the vaccination. Medical attention was sought. Patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. In follow up information it was reorted that on 07-MAY-2007, following week patient noticed enlarged lympnodes in right groin. It was painful to walk and some itching that area. Patient was seen at doctor for this on 14-May-2007 and was advised to monitor over next few weeks for increased sign and symptoms. The patient recovered within approximately 2-6 weeks. No further problems. Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: MMRV, MMR, MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 11-MAY-2007 was vaccinated SC on left arm with a 0.5 ml dose of PROQUAD (Lot # 657185/0301U) instead of a dose of MMR II and a dose of VARIVAX. It was noted to be human error, not product confusion. The patient was not experiencing any known symptoms. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007. Information has been received from a registered nurse concerning a 37 years old femal patient who on 11-MAY-2007 at 10:00 AM was vaccinated IM on left arm with a 0.5 ml dose of MMR.
Age: 35.0
Sex: M
Vaccine: ANTH, HEPAB
Symptoms: Arthralgia, Blister, Fatigue
Clinical narrative: day after recieving shot got little blisters pop up on chest. was very fatigued and severe joint pain. no treatment
Sex: M
Vaccine: PNC
Symptoms: Blood culture positive, Brain abscess, CSF culture positive, Convulsion, Meningitis pneumococcal
Clinical narrative: Information regarding Prevnar was received from a Pediatrician regarding a 2-month-old male patient who received a first dose on 21-May-2007. On 31-May-2007, the patient was hospitalized with pneumococcal meningitis, pneumococcal bacteremia and brain abscesses. On 31-MAY-2007, the patient was hospitalized with pneumococcal meningitis and pneumococcal bacteremia. On 01-Jun-2007, a spinal and blood culture were performed which revealed streptococcus pneumoniae, serotype not reported. During the patient's hospitalization (Jun-2007), the reporter noted that as a result of meningitis the patient experienced several convulsions and also developed brain abscesses. Due to the location in the brain, the abscesses were not cultured. Treatment included intravenous vancomycin and Rocephin. On 02-Jul- 2007, the patient's condition was improved and he was discharged to home to continue intravenous antibiotics. On 08-Jul-2007, the child developed a fever (temperature not specified), an was re-admitted to the hospital. As of 09-Jul-2007, the patient remained hospitalized, his outcome was not available. CSF results (results: streptococcus pneumoniae, serotype unknown) and blood culture (results: streptococcus pneumoniae, serotype unknown) were done on 01-Jun-2007. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Pneumococcal bacteraemia, Pneumonia pneumococcal, Pyrexia
Clinical narrative: Information regarding Prevnar was received from a Pediatrician regarding a 2-month-old male patient who received a first dose on 21-May-2007. On 31-May-2007, the patient was hospitalized with pneumococcal meningitis, pneumococcal bacteremia and brain abscesses. On 31-MAY-2007, the patient was hospitalized with pneumococcal meningitis and pneumococcal bacteremia. On 01-Jun-2007, a spinal and blood culture were performed which revealed streptococcus pneumoniae, serotype not reported. During the patient's hospitalization (Jun-2007), the reporter noted that as a result of meningitis the patient experienced several convulsions and also developed brain abscesses. Due to the location in the brain, the abscesses were not cultured. Treatment included intravenous vancomycin and Rocephin. On 02-Jul- 2007, the patient's condition was improved and he was discharged to home to continue intravenous antibiotics. On 08-Jul-2007, the child developed a fever (temperature not specified), an was re-admitted to the hospital. As of 09-Jul-2007, the patient remained hospitalized, his outcome was not available. CSF results (results: streptococcus pneumoniae, serotype unknown) and blood culture (results: streptococcus pneumoniae, serotype unknown) were done on 01-Jun-2007. No additional information was available at the time of this report.
Sex: F
Vaccine: RV5
Symptoms: Cough, Haematemesis, Haematochezia, Occult blood positive, Retching
Clinical narrative: Information has been received from a registered nurse (RN) concerning a female who was vaccinated PO with a dose of Rotateq (Lot# 656390/0239U). The RN reported that the patient subsequently gagged and coughed after the vaccine was administered. Unspecified medical attention was sought. Approximately 30 minutes after vaccination, the patient vomited blood. A guaiac test in the office was also positive for blood. No other symptoms or episodes of vomiting were reported. At the time of this report, the outcome was unknown. Upon internal review guaiac test positive for blood was determined to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Entire body rash ---> Sent to ED
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Arm red and swollen
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Local reaction, itch, swelling, red
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Ecchymosis, Pain
Clinical narrative: LUE ecchymosis, body aches
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass
Clinical narrative: Left axillary nodes resolved 5/24/07
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature, Injection site pain, Swelling
Clinical narrative: Site pain, swelling, temp
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, site pain
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Left deltoid swelling
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Chills
Clinical narrative: Right arm - systemic Rxn, chills abd pain
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Lymphadenopathy
Clinical narrative: Chills, lymphadenopathy
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: LUE cellulitis large on antibiotic resolved 6/4/07
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Red/firm tender area at the inj site
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: RUE cellulitis
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Left axilla lymphadenopathy
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: Left deltoid pain, swelling resolved 5/9/07
Sex: M
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Right jaw swelling, resolved 5/11/07.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Left arm pain, swelling
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Right arm cellulitis
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Left arm pain
Sex: F
Vaccine: MNQ, TD
Symptoms: Swelling face
Clinical narrative: 8:30 a.m. received Menactra IM RA and Td IM RA. Patient reports the left side of her face feels swollen and left jaw beginning at 2:00 p.m. Denies wheezing denies, itching denies shortness of breath, denies swelling around eyes and or mouth.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Tic
Clinical narrative: Simple motor tic- shrugging shoulder, persistent x 1 month, 1st noted approximately 2d after Gardasil vaccine.
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Mother and daughter, both had Twinrix# 1 on 7/6/07. Next day, both had headache, nausea, diarrhea, achy muscles, slightly better by 7/10 but still achy with headache.
Age: 21.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Phone call 7/10/07 from patient's mother - she and patient both had Twinrix #1 on 7/6/07. Next day both had headache, nausea, diarrhea, and achy muscles, slightly better by 7/10. (7/10/07 slightly better but still achy with headache).
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Rash pruritic
Clinical narrative: Developed itchy , bumpy red spots 3-4 on each lower buttocks.
Age: 23.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: Patient received Tdap Ipol on 6/11/07. Pt received MMR on 6/15/07. Her mother in law called office on 7/11/07 to report a positive pregnancy test. This would be pregnancy within 28 days of vaccination.
Sex: U
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: unknown
Age: 1.0
Sex: F
Vaccine: HEPA, MM, PNC, VARCEL
Symptoms: Vomiting
Clinical narrative: Per mom approx 10 minutes after imms child started vomiting every 20-30 minutes. No wet diapers for 7 hours. Stopped vomiting after 8 hours. Referred to ER for evaluation. Given Tylenol suppository in ER triage. Left ER AMA before seeing doctor. The following day child had no further vomiting , eating okay, acting normal, t-98.9ax.
Age: 60.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Asthenia, Dysphonia, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: swelling, redness, itching at injection site, headache, fever and hoarseness and weakness.    Shingles Vaccine
Age: 60.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: swelling, redness, itching at injection site, headache, fever and hoarseness and weakness.    Shingles Vaccine
Age: 85.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient ssays she broke out with hives approx 2 hrs after receiveing vaccine. Seen by doctor and given Prednoisone and antihistamines
Age: 85.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient ssays she broke out with hives approx 2 hrs after receiveing vaccine. Seen by doctor and given Prednoisone and antihistamines
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, Redness and tenderness at site about 5 inches in diameter.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Angioedema, Erythema, Rash erythematous, Rash generalised, Rash macular
Clinical narrative: 5/29/07 infant received first set of immunizations. well exam-noting improved eczema with vaseline ointment and occ. 1% hydrocortisone cream.  On 5/30/07 Father and grandmother took the child to an urgent care center c/o "rash all over."  Rash was described as diffuse erythematous macular rash with a significant amount of erythema on the feet and in the lower extremities with angioedema that was present. No other abnormalities reported.  Paternal grandmother thought she noticed increase redness and hive looking areas on chest the evening of his immunizations (5/29) but did not report.
Age: 18.0
Sex: F
Vaccine: DTOX
Symptoms: Cold compress therapy, Injection site erythema, Injection site swelling
Clinical narrative: Pt came in for swelling and redness form a Td injection on her left deltoid she received on 7-11-2007. It was red and very sore to the touch. Ptdid not have any fever. She was treated with an antibotic Bactrim  DS and to apply cool comopress to affected area and we will see the pt back at our office on 7-18-2007.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Grand mal convulsion, Pyrexia
Clinical narrative: had brief tonic-clonic febrile seizures (all less than 5 minutes) x 3 the night following the administration of one year old shots.  Called 911 and told they were febrile seizures.  Subsequently saw our office and referred for evaluation to ED.  Had CXR and urine which were both negative.  Continued to have fevers to 105 for 3 days after shot administration.  Given atypical nature of seizures, will consult pediatric neurology.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Activities of daily living impaired, Arthralgia, Fatigue, Oral herpes, Pyrexia
Clinical narrative: States she never "felt well" after receiving vaccine but at approx 1 week, on 7/11/07, she was complaining of severe joint pain that was debilitating enough that she could not work, mild rash, fever at night, fever blister on lip, fatigue.  She was seen in our ED on 7/12/07 and advised to remain home and rest for 1 week.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: States she never "felt well" after receiving vaccine but at approx 1 week, on 7/11/07, she was complaining of severe joint pain that was debilitating enough that she could not work, mild rash, fever at night, fever blister on lip, fatigue.  She was seen in our ED on 7/12/07 and advised to remain home and rest for 1 week.
Age: 57.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Cellulitis
Clinical narrative: Developed cellulitis left upper arm 12 days after receiving IPV and Pneumonia Vaccine.  Was Rx'd with antibiotics and a steroid injection.  Felt better after about 4-5 days.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Cold compress therapy, Erythema, Injection site swelling
Clinical narrative: Pneumovax 0.5 ml Im x 1 given on 3/30/07 at 1400.  Pt developed redness, swelling of upper arm after vaccine given.  At 2258, documented temps of 101.5, chills noted.  Cooling measures provided, typlenol 650mg given. AT 2357 pt given ice packs, cooling blankets, cool washcloth.  7/17/07 Received hospital records which reveal patient experienced post radical prostatectomy stress incontinence & had artificial urinary sphincter placed some time ago which had now malfunctioned.  Admitted for surgery for that problem from 3/27-4/6/07.  Found to have low grade infection within scrotum at time of surgery & all components were removed.  Had fever & wound cellulitis post operatively & was taken back to OR for I&D of scrotum.  Wound c/s (+) for morganella & acinetobacter & was treated w/IV antibiotics.  Defervesced & wound progressed well.  D/C to home w/open wound care, Foley catheter & continued oral antibiotics.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Pneumovax 0.5 ml Im x 1 given on 3/30/07 at 1400.  Pt developed redness, swelling of upper arm after vaccine given.  At 2258, documented temps of 101.5, chills noted.  Cooling measures provided, typlenol 650mg given. AT 2357 pt given ice packs, cooling blankets, cool washcloth.  7/17/07 Received hospital records which reveal patient experienced post radical prostatectomy stress incontinence & had artificial urinary sphincter placed some time ago which had now malfunctioned.  Admitted for surgery for that problem from 3/27-4/6/07.  Found to have low grade infection within scrotum at time of surgery & all components were removed.  Had fever & wound cellulitis post operatively & was taken back to OR for I&D of scrotum.  Wound c/s (+) for morganella & acinetobacter & was treated w/IV antibiotics.  Defervesced & wound progressed well.  D/C to home w/open wound care, Foley catheter & continued oral antibiotics.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Irritability
Clinical narrative: Elevated Temperture to 104.6  within 4 hours following injuections.  Temperature did not go below 102 with acatamenophen(q4 hrs)and tepid baths for 16 hours. Child became very irritable, no vomiting, seizures, or lethery. Temp resolved on the way to the doctor's office.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth of entire upper arm beginning shortly after injection and persisting 2 days after injection
Age: 0.1
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Angiogram, Convulsion, Dyskinesia, Dyspnoea, Electroencephalogram
Clinical narrative: About 3 days after receiving his 2 month immunizations our son woke up from sleep gasping for air, very stiff and acting scared. This lasted a few minutes before he just "snapped out of it" ate, and went back to sleep. The next morning we called our doctor because my husband and I believed he'd had a possible seizure. We'd noticed a few jerky movements but since it was so late at night and the lights were off it was hard to tell for sure. We did bring him in to our doctor who did not think it was a seizure. Since then he has been diagnosed with a Generalized Seizure Disorder.