chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, Injection site oedema, Medication error
Clinical narrative: Information has been received from a health professional concerning a 12 month old female with a penicillin allergy and no other medical history who on 6/21/06 in the PM was vaccinated IM previously reported S IV in the right thigh with a first doe of MMR II/Varicella vaccine (lot #652233/0844R). There was no concomitant medications. There was no illness at the time of vaccination. On 6/22/06 the pt developed right thigh swelling. It was previously reported there was no adverse event. Unspecified medical attention was sought. No lab test were performed. The pts outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Viral infection
Clinical narrative: Information has been received form a physician concerning a child who was vaccinated with a dose of MMR II/Varicella vaccine on an unspecified date. Subsequently the pt developed chicken pox. Unspecified medical attention was sought. No other information has been provided. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Erythema, Hypersensitivity, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old pt who on an unspecified date was vaccinated with a dose of MMR II/Varicella vaccine. Subsequently a couple of days after vaccination the pt broke out in an allergic type reaction with reddish bumps all over the body. The physician reported it was like a measles type rash. At the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Hypersensitivity, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a pt between 12-15 months of age who on an unspecified date was vaccinated with a dose of MMR II/Varicella vaccine. Subsequently, the pt broke out in an allergic type, measles rash all over the body. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a male pt with no past medical history or allergies who 6/26/06 was vaccinated SC with a 0.5ml first dose of MMR II/Varicella vaccine (lot 652328/0956R). There was not concomitant medication. Subsequently, on 6/28/06, two days after vaccination, the pt developed a rash and fever. Unspecified medical attention was sought there were no labs performed. At the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a female pt who on 6/28/06 was vaccinated with a dose of MMR II/Varicella vaccine (lot 652328/0956R). Subsequently, on 7/2/06, four days after vaccination, the pt developed a fever. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male pt who on 6/22/06 was vaccinated with a dose of MMR II/Varicella vaccine (lot 652328/0956R). Subsequently, on 7/4/06, 12 days after vaccination, the pt developed a rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male pt who on 6/23/06 was vaccinated with a dose of MMR II/Varicella vaccine (lot 652328/0956R). Subsequently, on 7/6/06, thirteen days after vaccination, the pt developed a rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a female pt who on 6/28/06 was vaccinated with a dose of MMR II/Varicella vaccine (lot 652328/0956R). Subsequently, on 7/11/06, thirteen days after vaccination, the pt developed a rash and fever. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a female pt who on 6/16/06 was vaccinated with a dose of MMR II/Varicella vaccine (lot 652678/1135R). Subsequently, on 6/28/06, the pt developed a breakthrough case of chicken pox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male who on 4/14/06 was vaccinated in the right leg with a first dose of MMR II/Varicella vaccine. (lot 652233/0844R). There was no concomitant illness at the time of vaccination. On 4/22/06, eight days after vaccination, the pt developed a fever and a rash on the trunk, extremities and face. Subsequently, the pt recovered. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male who on 4/17/06 was vaccinated in the left thigh with a first dose of MMR II/Varicella vaccine. (lot 652234/0951R). There was no illness at the time of vaccination. On 4/24/06, seven days after vaccination, the pt developed a rash on the trunk, extremities, welts on and off for thirteen days all over his body and fever. Subsequently, the pt recovered. There was no quality complaint involved. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMRV, PNC
Symptoms: Erythema, Feeling hot, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no known allergies and sinusitis who on 29-JUN-2006 was vaccinated SC in the left thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot # 651813/0770R). Concomitant therapy included amoxicillin. Concomitant vaccination included a fourth dose of Prevnar (lot # B08655A) IM in the right thigh. On 08-JUL-2006 the patient developed a rash all over body, a measles-like rash with flat lesions which were bright red and hot to the touch but "not".  Additional information indicated that on 08-JUL-2006 the patient woke up with a rash that spread to his entire body. The rash was consistent with a measles vaccine rash. On 12-JUL-2006, "two days off the amoxicillin", the patient's cough worsened. The patient was started on Augmentin and her rash initially worsened becoming red, hot, raised and pruritic, the improved. On 20-JUL-2006 the patient recovered. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a women in a physician's office concerning a 12 month old female with no medical history who on 31-MAY-2006 was vaccinated in the right thigh with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (Lot # 652328/0956R). There was no illness at the time of vaccination. The woman reported that on 12-JUN-2006, 12 days post vaccination, the patient developed a rash on her arms and legs characterized by 25-30 pinpoint lesions. It was unknown if medical attention was sought and no laboratory/diagnostic tests were performed. Subsequently, the patient's rash resolved. This is a consolidation of two reports concerning the same patient. No further information is available.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from woman in a physician's office concerning a 12 month old female with no medical history or allergies who on 05-JUN-2006 was vaccinated in the left thigh with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (Lot #652328/0956R). There was no illness at the time of vaccination. The woman reported that on 16-JUN-2006, the patient developed a fine pinpoint rash on her chest, neck and arms consisting of 50 lesions. The patient was afebrile. Medical attention was not sought and no laboratory/diagnostic tests were performed. Subsequently, the patient's rash resolved. There was no product quality complaint involved. This is a consolidation of two reports concerning the same patient. No further information is available.
Age: 1.16
Sex: F
Vaccine: MMRV
Symptoms: Blister, Erythema, Rash, Rash papular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 14-month-old female with no medical history who on 08-JUN-2006 was vaccinated SC in the left thigh with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (Lot#651812/0769R). There was no illness at the time of vaccination. The physician reported that on approximately 13-JUN-2006 the patient developed a blistery rash which subsequently resolved. On 05-JUL-2006 the patient developed papules, which increased in number by 07-JUL-2006. On that same day, the patient was seen by the physician. At the same time she had papules and vesicles with an erythematous base typical of wild type varicella. The physician felt that the patient had been exposed to wild type varicella shortly before or after vaccination. On 12-JUL-2006, the patient was seen by another physician who confirmed she had resolving varicella and gave her some samples of Cedax to cover for possible secondary infection and noted that she has passed the contagious phase. The patient's wild type varicella was diagnosed clinically as no diagnostic work up (no titers drawn) was done to confirm the diagnosis. As of 18-JUL-2006, the patient's wild type varicella was noted to be resolved. The physician thought the patient's current case of chickenpox was wild type and due to breakthrough and was not related to vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (Lot#651812/0769R) and was unsure if the patient's previous "blistery" rash was due to the vaccine but suspected it was. No further information is available.
Age: 1.04
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Eye swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning her 12 month old female daughter with no known allergies or medical history, who on 10-Jul-2006 at approximately 09:00 was vaccinated SC in the left thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#652329/1130R).  Concomitant vaccination included a first dose of hepatitis A vaccine (inactive) (lot#653144/0602F) IM in the left thigh, and a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot#B08651F) IM in the right thigh.  There was no illness at the time of vaccination.  On 10 Jul 2006, approximately 8-9 hours after vaccination the patient developed hives, which was also described as a urticartial rash.  She then had significant eye swelling which responded to diphenhydramine hydrochloride (BENADRYL).  The patient was treated with scheduled diphenhydramine hydrochloride (BENADRL0 four days.  The patient's rash resumed for an additional two days 24 hours after the diphenhydramine hydrochloride (BENADRYL) was discontinued.  On 17 Jul 2006 the patient recovered.  There was no product quality complaint involved.  Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a patient who in "which the last month" in July 2006, was vaccinated with a SC 0.5 ml dose of of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  In July 2006, the patient developed a measles like rash.  Medical attention was sought.  subsequently, the patient recovered on an unspecified date.  There was no product quality complaint involved.  Additional information  has been requested.
Age: 1.28
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a physician concerning a 15 month old patient with no past medical history who on 28-Jul-2006 was vaccinated with a 0.5 ml dose of of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  On 30-Jul-2006 the patient developed a rash at the injection site which spread to the patient's torso.  Unspecified medical attention was sought.  At the time of this report the patient had not recovered.  There was no product quality complaint involved.  1/5/10 follow up - injection site rash.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMRV
Symptoms: Abdominal pain upper, Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on an unspecified date was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  Concomitant vaccination included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified) and poliovirus vaccine (manufacturer unspecified).  Shortly after vaccination, the patient developed a stomach ache, her arms and legs became puffy and she developed hives on her arms and legs.  The patient returned to the office and was treated with diphenhydramine hydrochloride (BENADRYL).  At the time of the report the patient was recovering.  There was no product quality complaint involved. Additional information requested.
Sex: M
Vaccine: MMRV
Symptoms: Abnormal behaviour
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Subsequently the patient began "acting different" than his first visit.  Unspecified medical attention was sought.  There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a license practical nurse concerning a 12 month old male who was vaccinated SQ with 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Subsequently the patient experienced rash.  The patients' outcome was not reported. Additional information has been requested.
Age: 1.06
Sex: F
Vaccine: MMRV
Symptoms: Pruritus, Pyrexia, Rash maculo-papular, Skin ulcer, Urticaria
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 13 month old female with no known history and allergies who on 20-Jul-2006 was vaccinated with SQ with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#654042/0663F).  There was no concomitant medication.  The patient was seen in the office on 02 Aug 2006 with fever and maculopapular rash on trunk and hands.  She was seen again on 08-Aug-2006 with itching, urticaria and a lesion under her eye.  The patient was treated with diphenhydramine hcl (BENADRYL), CETAPHIL CREAM, and hydrocortisone cream 2.5%.  The patient's fever, maculopapular rash, itching, urticaria and lesion under eye persisted.  Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a physician and an other health professional concerning the physician's 2 year old son who on 04-Aug-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#654042/0663F).  On 04-Aug-2006 the patient experienced an injection site rash and out of the normal swelling.  Redness was also noted.  Subsequently, the patient recovered.  Medical attention was not sought. No additional information is expected.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a physician and an other health professional concerning a 2 year old male who on 03-Aug-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#654042/0663F).  On 03-Aug-2006 the patient experienced an injection site rash and out of the normal swelling.  Redness was also noted.  Subsequently, that recovered.  Medical attention was not sought.  No additional information is expected.
Age: 1.04
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a "12-15" month old patient who was vaccinated with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Subsequently the patient developed a high a high fever.  Medical attention was sought.  The patient's outcome was not reported. There was no product quality complaint involved.  Additional information has been requested. 01/05/2007 This is in follow-up to report(s) submitted on 10/6/2006. Information has been received from a physician concerning a 12 month old male patient with a penicillin allergy who was vaccinated on 15-MAY-2006 in the right thigh with a 0.5 mL first dose of PROQUAD (Oka/Merck upgrade process) (lot # 652332/1122R). Subsequently the patient developed a high fever with a rectal temperature of 105 degrees. Medical attention was sought. Additional information was received from a registered nurse who reported that the patient's fever was controlled with a tepid bath, MOTRIN and TYLENOL. The patient's outcome was recovered on 19-MAY-2006. There was no product quality complaint involved. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old male with no known history or allergies who on 08-May-2006 was vaccinated with a 0.5 ml SC dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#651815/0950R). There was no concomitant medication.  On 18-Aug-2006 the patient developed a fever of 99.7 F and about 50 lesions on the sides of his trunk.  He was seen in the office for breakthrough varicella.  Medical attention was sought.  No treatment was reported.  At the time of the report the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning her 1 year old daughter who on an unspecified date was vaccinated SC with a single 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Ten days after vaccination, the patient developed 25-300 skin lesions.  She also had a low grade temperature.  No further information was available.  There was no product quality complaint involved.  The patient is one of triplets whose sisters (WAES#0608USA05091 and 0608usa05188) also had adverse experiences after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.   Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, IPV, MMRV
Symptoms: Premature baby, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning her 1 year old daughter who on an unspecified date was vaccinated SC with a single 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live. Subsequently the patient developed a low grade fever. The patient is one of triplets whose sisters (WAES0608USA05091 and 0608USA05187) have also had adverse experiences after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live. Additional information has been requested. 01/05/2007 This is in follow-up to report(s) previously submitted on 10/06/2006. Information has been received from a registered nurse concerning her 1 year old daughter who was delivered prematurely at 31 weeks gestation, who on 26-JUL-2006 was vaccinated SC with a single 0.5 ml dose of PROQUAD (Oka/Merck upgrade process). Concomitant vaccination included a dose of HAVRIX and a dose of poliovirus vaccine inactivated (unspecified) (manufacturer unspecified). Subsequently the patient developed a low grade fever. The patient recovered "a couple of days after onset". The patient is one of triplets whose sisters (WAES # 0608USA05091 and 0608USA05187) have also had adverse experiences after vaccination with PROQUAD (Oka/Merck upgrade process). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on 14-Aug-2006 was vaccinated with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  The morning of 22 Aug 2006 the patient's mother called the office to report that her daughter had a rash on her torso.  Unspecified medical attention was sought.  At the time of the report the patient had not yet recovered.  There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Subsequently the patient developed a high fever.  It was reported if medical attention was sought.  The patient's outcome was not reported.  There was no product quality complaint involved.  Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 15-AUG-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live. Subsequently, the patient developed a rash all over his body. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: Information has been received concerning a male described as "fairly healthy" with no significant medial history with a birth twin and a history childhood illnesses such as colds and ear infections who on 24-Jul-2006 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Subsequently the patient developed several "bumps" on back of neck for which he was seen in the emergency room.  These had not developed into anything more at present, however, they are continuing to monitor the patient closely.  At this point, there was no other case information or specimens available for this patient.  The patients twin sister (WAES#0608USA02545) experienced an adverse event after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician and a woman in a physician's office concerning a female who on 08-Aug-2006 at 10:50 am was vaccinated in the left thigh a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#653466/0466O).  Subsequently, 16 days after the vaccination, on 24-Aug-2006 at 09:00 am, the patient developed a generalized rash on her face, body and extremities.  It was unknown if medical attention was sought.  No outcome was reported.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Info has been received from a physician concerning a pt who was vaccinated with a dose of MMR (+) varicella virus. Subsequently, the pt developed a fever greater that 101. Additional info has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Agitation, Crying
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on 28 Aug 2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  On 28-Aug-2006, after the dose was given, the patient started crying excessively. Unspecified medical attention was sought and the patient recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Information has been received from a physician concerning a 19 year old female who in early August 2006, was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml).  The physician reported that at the time of vaccination, the patient experienced injection site pain.  The patient later experienced decreased range of motion in the arm she received the vaccination.  It was reported that the patient's arm hurt when she raised it above her head.  At the time of this report, the patient's injection site pain, decreased range of motion in arm pain persisted.  Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a nurse concerning a female who on 01 Sep 2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702P).  The nurse reported that she was very unhappy with the syringe.  The nurse reported that she "had received no instructions, and upon using the syringe for the first time, the safety device activated as soon as she pushed all the way down on the plunger, and it hit the patient in the arm".  The nurse also reported that she had not read the product insert prior to administering the vaccine, as it was not available in the carton, and as soon as she administered the full dose of vaccine, she immediately let go of the plunger.  She also reported that "it was loud, which scared the patient, and the needle coil sprang out and hurt the patient.  The patient was kept in the office longer than normal since the coil hit the patient against her arm and hurt her.  Unspecified medical attention was sought.  The nurse was able to administer the entire dose of vaccine.  On 05-Sep-2006 the patient had recovered.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injury, Medical device complication, Medication error, Scratch
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history or drug reaction/allergies, who on 8/31/06 was vaccinated IM with a pre filled syringe HPV rL1 6 11 16 18 VLP vaccine yeast (lot 654540/0800F). There was no concomitant therapy. The medical assistant reported that the spring action activated so forceful the needle and spring popped out of the clients left arm and scratched her. It was reported that all the vaccine was administered and that the pts left arm was washed with soap and water. She also reported that the pt did not bleed. No further details were provided. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 10/6/2006.  Initial and follow-up information has been received from a medical assistant concerning a 23 year old white female with no partinent medical history of drug reactions/allergies, who on 31-AUG-2006 at 2:00 PM was vaccinated intramuscularly in the left deltoid with the first dose of a pre-filled syringe of GARDASIL (Lot # 654540/0800F).  There was no concomitant therapy and no illnesses at time of vaccination.  The medical assistant reported that "when the needle safety device was activated, it came down so forceful that the needle and syringe popped out of the client's left arm, struck the patient, and scratched her."  The reporter stated that the "syringe deployed as it should have, but was unexpected" by the health care provider.  It was reported that the plunger was released before removing the needle from the arm of the patient.  The reporter stated that there was no damage noted to the syringe.  It was reported that all of the vaccine was administered and that the patient's left arm was washed with soap and water and a bandaid was placed over the puncture site and scratch.  The reporter also stated that the patient did not bleed and taht there was no adverse reaction to the patient.  The patient subsequently recovered.  No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a female pt (age not provided) who on approx 8/22/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot not provided). The nurse reported that a day and half after receiving the vaccine, on approx 8/23/06 the pt developed what appeared to be hives. Unspecified medical attention was sought. Subsequently, the p0t recovered from the hives. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of 0.5 ml of HPV rL1 6 11 16 18 VLP vaccine yeast. It was reported that the pt fainted after the injection (date unk). The pt sought unspecified medical attention. AT the time of this report, the pt had recovered from the event (date unk). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning her 13 year old daughter who on approx 8/16/06, (also reported as within the past 2-3 weeks) was vaccinated with a 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine yeast. the physician reported that her daughter experienced soreness at injection site for a couple of days after receiving HPV vaccine. The pt sought unspecified medical attention. At the time of this report, the outcome of the event was unk. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Dysgeusia, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 27 year old female with no pertinent medical history or drug reactions. allergies, who on 9/7/06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653736/0689F). Concomitant therapy included ethinyl Estradiol norgestimate (Ortho Tri Cyclen). On 9/7/06, immediately after receiving the vaccine, the pt experienced a metallic taste in her mouth, nausea and sweating. The nurse had the pt lay down for a little while and the pt started to feel better. No further details were provided. At the time of this report, the pt was recovering. Additional information has been requested.
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast (0.5ml). Concomitant therapy included Dtap. The day after vaccination with HPV the pt developed a blotchy rash which lasted for three days (site of rash not specified). It was also reported that the pt experienced a fever with a temp between 99 and 103 degrees during the same three day period. Unspecified medical attention was sought. At the time of this report, the pt was recovering from the rash and fever. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoxia
Clinical narrative: Initial and follow up information has been received from a physician concerning a female pt (age not reported) who on an unspecified date, in the morning, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (date unknown). It was reported that the pt felt dizzy and was administered oxygen. The pt was observed for 30 minutes (previously reported that the pt had not eaten anything. At the time of this report, the pt had recovered from the events (date unk). The physician assessed the events as non serious and reported that she was unsure of the causality of the events. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Initial and follow up information has been received from a physician concerning a female pt (age not reported) who on an unspecified date, in the morning, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently, the pt fainted after receiving HPV vaccine (date unk). It was reported that the pt felt dizzy and was kept for observation (previously reported that the pt had no eaten anything). At the time of this report, the pt had recovered from the events (date unk). The physician assessed the events as non serious and reported that she was unsure of the causality of the events. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Aphthous stomatitis, Herpes simplex, Malaise, Myalgia
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history and no allergies, who on 8/30/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. On 9/2/06 the pt developed a canker sore on her lip and sore throat. On 9/6/06 she experienced nausea, vomiting, malaise, a temperature of 102F and developed a herpetic ulcerative ring on her left ring finger. It was also reported that the pt experienced myalgia. Unspecified medical attention was sought/ Subsequently, it was reported on 9/8/06 that the symptoms were subsiding, the lesion on the pts lip had crusted and her temp was 98.9F. 01/05/2007 Follow up information received stated that on 02-SEP-2006 the patient also developed gastrointestinal upset. Lab work completed on 13-SEP-06 included positive cultures for Herpes simplex type 1 isolated in oral swab and on the patients finger. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pharyngolaryngeal pain, Pyrexia, Skin ulcer, Vomiting
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history and no allergies, who on 8/30/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. On 9/2/06 the pt developed a canker sore on her lip and sore throat. On 9/6/06 she experienced nausea, vomiting, malaise, a temperature of 102F and developed a herpetic ulcerative ring on her left ring finger. It was also reported that the pt experienced myalgia. Unspecified medical attention was sought/ Subsequently, it was reported on 9/8/06 that the symptoms were subsiding, the lesion on the pts lip had crusted and her temp was 98.9F. 01/05/2007 Follow up information received stated that on 02-SEP-2006 the patient also developed gastrointestinal upset. Lab work completed on 13-SEP-06 included positive cultures for Herpes simplex type 1 isolated in oral swab and on the patients finger. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Skin discolouration, Sunburn
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 year old female with no pertinent medical history and no known allergies or adverse drug reactions reported. On 9/5/06, the pt was vaccinated IM with one dose of HPV rL1 6 11 16 18 VLP vaccine yeast. Concomitant therapy included Ortho Tri Cyclen. It was reported that the pt woke up the next morning and her skin was pink from head to toe. There was no rash, no pain, no itching, no swelling and no hives. It was reported that her only symptom was a sunburn like appearance to her skin. the pt sought unspecified medical attention. On 9/7/06 in the evening, the color began to subside. As of 9/8/06 her skin was reported as looks better and the pt was noted as recovering. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Choking, Cough, Injection site erythema, Injection site induration
Clinical narrative: 10/3/06-9AM-vaccine given (Tdap-Adacel). 10/4/06 and 10/5/06-Slight redness, swelling. Ice to site per pt. 10/6/06-c/o general weakness; injection site with induration, heat, swelling and noticed slight itchiness at site-continued to ice. 10/7/06-Increased weakness, fatigue; "choking" sensation and coughing with eating and drinking; no hives; noticed area of induration on same arm; the area of erythema was now about 70mm X 50mm at the injection site. A second wheal or indurated area appeared on 10/7/06 and a third on 10/9/06. The symptoms of "choking" continued until 10/10/06 when she reported to E Health. House physician assessed and treated her with Prednisone and Benadryl po. 10/11/06=Recheck in EH, no visible erythema, small dime-sized area of induration on palpation at injection site. Choking sensation is resolved. States she has received TD in the past without incident. Advised to notify PMD of event. Will need MD's advice regarding future doses of TD.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 10/3/06-9AM-vaccine given (Tdap-Adacel). 10/4/06 and 10/5/06-Slight redness, swelling. Ice to site per pt. 10/6/06-c/o general weakness; injection site with induration, heat, swelling and noticed slight itchiness at site-continued to ice. 10/7/06-Increased weakness, fatigue; "choking" sensation and coughing with eating and drinking; no hives; noticed area of induration on same arm; the area of erythema was now about 70mm X 50mm at the injection site. A second wheal or indurated area appeared on 10/7/06 and a third on 10/9/06. The symptoms of "choking" continued until 10/10/06 when she reported to E Health. House physician assessed and treated her with Prednisone and Benadryl po. 10/11/06=Recheck in EH, no visible erythema, small dime-sized area of induration on palpation at injection site. Choking sensation is resolved. States she has received TD in the past without incident. Advised to notify PMD of event. Will need MD's advice regarding future doses of TD.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling and hard lump at injection site. Pt is to be given 1/3 to 1/2 tsp liquid Benadryl q 4=6 hrs prn and to return to clinic if not better in 2 days.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Left humerus warm to the touch and swollen from shoulder to elbow. Improved sx next day. Reported by patient.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Rash papular, Rash vesicular
Clinical narrative: Low grade fever, and generalized, papular and vesicular rash on erythematous bases. some scabby.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm is pinkish-red/swollen from shoulder to elbow. Normal range of motion. Neuro-vascular intact. TX: Benadryl 3/4 5 po q 8 hrs X 3 days. Ice pack prn; Motrin 1 1/2 t po q 8hrs X 3 days. Follow-up not complete.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Injection site pain, Injection site swelling, Irritability
Clinical narrative: Extreme irritability. At site of injection of right thigh, with tenderness and swelling (severely tender), lasting 2-3 days.
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Severe muscle (deltoid) pain, weakness, unable to lift over head or lie on arm, 7 days after immunization. On-going. Referred to PCP.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: Indurated area left deltoid 5x6 cm with erythema, blanching.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash x 2 days. Calamine lotion PRN OTC Benadryl Q6 PRN, fluids.
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Right upper out arm area swollen around injection site 4x3 reddened and induration, no c/o pain.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Within 24 hours left upper arm was big and warm minimal pain, today warmer to touch, no fever, soft to touch non tender, full range of motion surrounded all upper arm.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cough, Erythema, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Vaccine given 9/29/06 and nurse noted almost immediate induration on the left leg. Pt returned following day with temp 100.2, 102 at daycare. Left leg was erythematous with two nodules at each site. Pharynx was erythematous. Nodules were quite tender. Pt otherwise normal. AUGMENTIN started. Following day, decreased erythema, induration , tenderness. Throat still erythematous. Fever gone. Called 10/5/06 pd did develop slight cough, rhinorrhea, leg completely normal.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rhinorrhoea, Tenderness
Clinical narrative: Vaccine given 9/29/06 and nurse noted almost immediate induration on the left leg. Pt returned following day with temp 100.2, 102 at daycare. Left leg was erythematous with two nodules at each site. Pharynx was erythematous. Nodules were quite tender. Pt otherwise normal. AUGMENTIN started. Following day, decreased erythema, induration , tenderness. Throat still erythematous. Fever gone. Called 10/5/06 pd did develop slight cough, rhinorrhea, leg completely normal.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Swelling at injection site right arm, circling around arm and moving up toward shoulder. Reddened with heat disbursement.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: Due to physician oversight (myself), pt inadvertently received an extra dose of Menactra today. After nnk you. shot given, noticed it was given in Nov of 2005. There were no reactions. However inadvertent extra vaccine dose was given ( patient had menactra a year ago.) Per National Immunization Program representive, I was told I need to send a vares form to describe error. Tha
Age: 79.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Cellulitis, Eosinophilia, Hypersensitivity, Injection site erythema
Clinical narrative: 2 days after vaccine administration (in anticipation of international travel) pt noticed erythema of left arm around elbow on left side. Evaluated in clinic started on Diclonicillin in case of cellulitis and Benadryl in chase of allergy. Area progressed 1 day later, increased EOS, preformed allergic reaction type.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Tenderness
Clinical narrative: Large 15cm hot tender red zone over injection site on ant thigh.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Lymphadenopathy, Rash
Clinical narrative: 10/27/2006 generalized rash began on face and progressed throughout body. Enlarged lymph nodes and painful joints. Saw Dr on 6/28/06 no treatment.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Blood cholesterol increased, Blood triglycerides increased, Dry skin, Erythema
Clinical narrative: MUSCULAR PAIN SKIN RASH RED SKIN HIGH BLOOD PRESURE 11/13/06 Received medical records from VAMC which reveal patient experienced HTN, high cholesterol & high triglycerides, right knee & left shoulder pain, obesity, NIDDM. Per 60 day follow up: Muscle and joint pain, skin problems or rash, red skin, eye problems, memory problems, cramps leg and cramps arm, drowsiness, fatigue, headaches, appetite problems. Follow-up: Dry skin problems and rash. Red skin, vision problems, memory or brain problems, headache frequently, drowsiness, fatigue, muscle and joint paint, cramps in my legs and arms, appetite lost, diabetes, high blood pressure. After that vaccination I report this symptoms and I am not be the same person before this vaccination.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Eye disorder, Fatigue, Headache, Hypertension
Clinical narrative: MUSCULAR PAIN SKIN RASH RED SKIN HIGH BLOOD PRESURE 11/13/06 Received medical records from VAMC which reveal patient experienced HTN, high cholesterol & high triglycerides, right knee & left shoulder pain, obesity, NIDDM. Per 60 day follow up: Muscle and joint pain, skin problems or rash, red skin, eye problems, memory problems, cramps leg and cramps arm, drowsiness, fatigue, headaches, appetite problems. Follow-up: Dry skin problems and rash. Red skin, vision problems, memory or brain problems, headache frequently, drowsiness, fatigue, muscle and joint paint, cramps in my legs and arms, appetite lost, diabetes, high blood pressure. After that vaccination I report this symptoms and I am not be the same person before this vaccination.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Memory impairment, Muscle spasms, Musculoskeletal pain, Myalgia, Rash
Clinical narrative: MUSCULAR PAIN SKIN RASH RED SKIN HIGH BLOOD PRESURE 11/13/06 Received medical records from VAMC which reveal patient experienced HTN, high cholesterol & high triglycerides, right knee & left shoulder pain, obesity, NIDDM. Per 60 day follow up: Muscle and joint pain, skin problems or rash, red skin, eye problems, memory problems, cramps leg and cramps arm, drowsiness, fatigue, headaches, appetite problems. Follow-up: Dry skin problems and rash. Red skin, vision problems, memory or brain problems, headache frequently, drowsiness, fatigue, muscle and joint paint, cramps in my legs and arms, appetite lost, diabetes, high blood pressure. After that vaccination I report this symptoms and I am not be the same person before this vaccination.