chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Gave 0.25 cc Fluvirin instead of Fluzone in left thigh IM.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Severe tender and erythema of injection site.  No fever
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Rash, urticaria upper torso, arms and face.  Treatment BENADRYL 50 mg by mouth.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: Vaccine was given 10/9 at local grocery store.  Developed left arm pain 10/10 with swelling,myalgia, fever (started10/11) and left side trunk and left leg pain.  Seen 10/13 with persistent symptoms.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: 6 1/ 2 X 2 1/2 cm reaction on right deltoid.
Age: 41.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Urticaria
Clinical narrative: The pt calls today with a report of hives after receiving Menactra and Hepatitis B on 8/16/06.
Sex: M
Vaccine: ANTH, FLUX, HEP, SMALL, TYP
Symptoms: Abdominal pain, Back pain, Dyspnoea, Hypoaesthesia
Clinical narrative: Problem breathing while sleep, back pain, abdomen pain, numbness arms, legs.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Initial and follow up information has been received from a physician and a registered nurse in the physicians office concerning a pt (age and gender not reported) who on an unspecified date was vaccinated with  HPV rL1 6 11 16 18 VLP vaccine yeast. The physician reported that the pt experienced soreness, pain at injection site after receiving HPV. The registered nurse reported that she had spoken with the physician who felt that the soreness was not really a reaction or a problem. It was reported that the physician did not feel it was an adverse effect, just soreness at the injection site. At the time of this report, the outcome of the event was unk. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Pruritus genital, Vaginal infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with diabetes and no known adverse drug reactions or allergies reported. On 8/30/06, the pt was vaccinated IM with a 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653937/0637F). Concomitant therapy included insulin. On 9/9/06 the pt developed a yeast infection. It was reported that the pt had vaginal itching since receiving HPV It was reported that the pt underwent a vaginal swab which came back positive for yeast. The pt was being treated with Monistat. the pt was treated with the over the counter medication and was not required to follow up with the physician at this time. According to the licensed practical nurse, the physician did not feel that HPV was the cause of the yeast infection and that it was the pts mother who inquired about the event. At the time of this report, the pt had recovered from the yeast infection (date unk). No further information is available.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Infection, Injection site mass, Injection site reaction, Pruritus
Clinical narrative: Information has been received from a 42 year old female with hypersensitivity to SOMA and a history of two pregnancies, and two unspecified abortions who on 9/5/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (0.5ml). Concomitant therapy included Lasix and Wellbutrin. The pt reported that on 9/5/06 she developed an injection site reaction. The pt reported that the reaction was like straph infection and described the reaction as looking like and itching like a big mosquito bite. The pt had not yet contacted her physician. At the time of this report, the pt had not yet recovered from the injection site reaction. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Pain, Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse concerning a female pt who on an unspecified date was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently the pt experienced pain, numbness, and at tingly feeling all the way down to her fingertips. The events occurred in the arm in which the pt received the vaccination. Unspecified medical attention was sought. The pt subsequently recovered from the events. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 22 year old female pt who on 9/12/06 was vaccinated IM into the upper left buttock with a dose of GARDASIL, lot 653650/0702F. There was no concomitant medication. Approx one hour post vaccination the pt experienced numbness and tingling on the right side of her face. Medical attention was sought. No other symptoms were noted. As of the report date, the pt was recovering. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 10/13/2006.  Information has been received from a physician concerning a 22 year old female patient who on 12-SEP-2006 was vaccinated IM into the upper left buttock with a dose of GARDASIL lot #653650/0702F.  There was no concomitant medication.  Approximately one hour post vaccination the patient experienced numbness and tingling on the right side of her face.  Medical attention was sought.  No other symptoms were noted.  As of the report date, the patient was recovering.  Follow up information has been received concerning the 22 year old female with no medical history who on the morning of 12-SEP-2006 was vaccinated IM into the upper left buttock with her second dose of GARDASIL, lot #653650/0702F.  It was reported that right facial numbness developed within 1 hour after the injection.  No diagnostic/laboratory tests were performed.  The patient was reported to be recovered from right facial numbness.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Headache, Malaise, Mydriasis
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with syncope, anxiety and no known allergies reported. On 9/11/06, the pt was vaccinated IM with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0702F). Concomitant therapy included Lexapro, Wellbutrin, Klonopin, Nicomide, and Zithromax. On 9/12/06 when the pt woke up, she complained of her pupils being dilated, a headache, light headed and reported that she feels like something in not quite right. It was reported that it was unknown if the pt had eaten that day. The pt sought unspecified medical attention. At the time of this report, the pt had not recovered from the events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a pharmacy intern concerning a female who on 9/12/06 the pt experienced nausea and vomiting. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unk. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Unintended pregnancy, Viral infection
Clinical narrative: Information has been received through the pregnancy registry from a nurse practitioner concerning a 15 year old female with no known drug allergies, and with depression who on 8/31/06 at 3:00pm was vaccinated IM in the right deltoid with the first dose of GARDASIL (lot 653937/0637F). Illnesses at the time of vaccination included flu symptoms and a breast lump. Concomitant therapy included Zoloft. Other vaccinations given on 9/6/06 included Tdap. On 9/6/06 the pt was seen at her physician with a complaint of continued viral illness. It was reported that the pt was aware that she was pregnant but did not disclose this information to her health care provider until after vaccination. A urine pregnancy test was performed and found to be positive. The pt was advised no to receive the second dose of HPV. At the time of this report, the outcome of the viral illness and vaccine exposure during pregnancy was not known. Follow-up information has been received from the patient's OB-GYN. A nurse reported that the patient was last seen at 28 weeks gestation on 12-JAN-2007. At that time, she was transfered to the department of maternal-fetal medicine at a local hospital. A nurse at the maternal-fetal medicine department reported that the patient delivered via vaginal delivery a "healthy baby boy but had gastroschisis". The baby was born on 07-APR-2007 and APGAR scores were 8 and 9 at one and five minutes, respectively. The nurse was unable to provide the infant's birhtweight and indicated that infants born with this congenital anomaly are generally hospitalized for 12 weks. The nurse could not confirm when and if thin infant had been discharged from the hospital. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a female patient who on 11-SEP-2006 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The physician reported that within 24 hours of receiving the vaccine the patient developed a maculo papular rash all over the body. Medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a nurse practioner concerning her 20 year old daughter who on an unspecified date was vaccinated with 0.5 mL of HPV rL1 6111618 VLP vaccine (yeast). It was reported that "right after she got it", the patient developed severe arm pain (date unknown). The patient sought unspecified medical attention. At the time of this report, the patient was recovering from the event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician concerning a 20 year old female patient with sulfonamide allergy who on 12-SEP-2006 at 13:45 p.m. was vaccinated IM in the left deltoid with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), lot #653650/0641. Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+) norethindrone acetate (MICROGESTIN FE). On the early morning of 13-SEP-2006 the patient developed a fever to 103.6 degrees F, and generalized body aches. Medical attention was sought. On 18-SEP-2006, the patient recovered. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Malaise, Syncope
Clinical narrative: Information has been received from a nurse practioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, the patient fainted post vaccination. She stated that it "felt like the medicine traveled through my system at time of injection". Subsequently, the patient recovered from the syncope and abnormal feeling. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional has been requested. 01/05/2007 Information has been received from a nurse practitioner concerning a 22 year old female patient who on 06-SEP-2006 at 14:00 was vaccinated with the first dose of GARDASIL (Lot# 653650/0640F). Subsequently, the patient fainted 30 minutes post vaccination. She stated that it "felt like the medicine traveled through my system at time of injection". Subsequently, the patient recovered from the syncope and abnormal feeling. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink(soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Dizziness, Fatigue, Fatigue, Headache
Clinical narrative: Information has been received from a 28 year old female patient with epilepsy, asthma and an allergy to carbamazepine (TEGRETOL) who on 18-SEP-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included escitalopram oxalate (LEXAPRO), lorazepam, "lomectol," zolpidem tartrate (AMBIEN), and fluticasone propionate (FLOVENT). The patient stated that since her vaccination she has been experiencing dizzy, tired, has headaches and felt nauseous. No medical attention was sought. As of the report date the patient has not recovered. Additional information has been requested. 01/05/2007 Follow up information has been received from a physician concerning the patient with a seizure disorder who on 18-SEP-2006 at 9:50 a.m. received her second dose of GARDASIL, lot # 653937/0637F, in the left deltoid. The physician reported that the patient complained of right lower quadrant pain and mild nausea after receiving the vaccine. A pelvic sonogram was performed to rule out ovarian cyst. The patient had not yet recovered. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Ultrasound pelvis
Clinical narrative: Information has been received from a 28 year old female patient with epilepsy, asthma and an allergy to carbamazepine (TEGRETOL) who on 18-SEP-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included escitalopram oxalate (LEXAPRO), lorazepam, "lomectol," zolpidem tartrate (AMBIEN), and fluticasone propionate (FLOVENT). The patient stated that since her vaccination she has been experiencing dizzy, tired, has headaches and felt nauseous. No medical attention was sought. As of the report date the patient has not recovered. Additional information has been requested. 01/05/2007 Follow up information has been received from a physician concerning the patient with a seizure disorder who on 18-SEP-2006 at 9:50 a.m. received her second dose of GARDASIL, lot # 653937/0637F, in the left deltoid. The physician reported that the patient complained of right lower quadrant pain and mild nausea after receiving the vaccine. A pelvic sonogram was performed to rule out ovarian cyst. The patient had not yet recovered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient with sulfonamide allergy who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced a fever for four days. Unspecified medical attention was sought. No further details were provided. Additional information has been requested. This is a follow-up to report (s).  Information has been received from a physician concerning his 19 year old daughter with a sulfonamide allergy and no other pertinent medical history reported.  In August 2006, the patient was vaccinated with the first dose of GARDASIL by another health care professional.  Concomitant therapy included EFFEXOR.  In approximately August 2006, "about 4 days after being vaccinated", the patient developed a primary herpetic gingivostomatitis on her lips.  The patient sought unspecified medical attention.  All symptoms had resolved.  At the time of this report.  The patient had recovered from the event (date unknown).  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no history of varicella virus vaccine live vaccination and an unknown history of varicella, who on 11-SEP-2006 was vaccinated intramuscularly with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. The physician reported that on 12-SEP-2006 "the next day, the patient developed a low grade fever and a vesicular rash on her neck and shoulders of about 15-20 lesions." The patient was treated with acetaminophen (TYLENOL). All of her symptoms resolved within 3-4 days (approximately 15-SEP-2006). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold. No other problems were noted with the administration. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 25 year old female with connective tissue disorder, thrombocytopenia, depression and allergy to ZITHROMAX who on 20-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) IM in the deltoid described as "pre-filled syringe one time." Concomitant therapy included escitalopram oxalate (LEXAPRO) and methylphenidate HCl (RITALIN). On 21-SEP-2006 the patient experienced fever of 100 degrees F. The patient sought unspecified medical attention. The patient's fever of 100 degrees F. persisted. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 18-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced injection site reaction. The patient sought unspecified medical attention. Injection site reaction persists. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 25 year old female who on 01-SEP-2006 was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 08-SEP-2006, one week after vaccination, the patient developed "small bumps under her skin" at the injection site. The patient sought unspecified medical attention. Subsequently, the patient fully recovered.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on an unknown date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). Subsequently, the patient developed "swelling feet" for an unspecified amount of time after receiving the injection. At the time of this report the patient was recovering. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). Subsequently, the patient experienced burning and pain at the injection site. Unspecified medical attention was sought. It was unknown at the time of the report if the patient had recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning his "around 18" year old daughter who was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included a dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX). Subsequently, the patient experienced numbness in her arms and lower extremities. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested. 01/05/2007 Information has been received from a physician and health professional concerning an 18 year old female student with no medical history or allergies, who on 15-AUG-2006 at 09:00 was vaccinated IM into the right arm with a 0.5 ml first dose of GARDASIL (lot# 653650/0641F). Concomitant therapy included a first IM dose into the left arm of ADACEL (batch # C2151AC) and TUBERSOL (batch#C2250AB). On 15-AUG-2006 at 12:00, the patient experienced numbness in her arms and lower extremities. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On 21-AUG-2006, the patient recovered completely. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 26 year old female with a penicillin allergy who on 25-SEP-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Immediately post-vaccination, the patient experienced hives. The patient was treated with oral diphenhydramine hydrochloride (BENADRYL) and symptoms lessened. No diagnostic studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 22-SEP-2006 was vaccinated IM with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. On 22-SEP-2006 the patient developed swollen lymph nodes in the neck and groin, swelling at injection site and low grade fever. The patient sought unspecified medical attention. It was reported that the patient was recovering. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Neurological examination, Pain, Pallor
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient between the age of 15 to 18 who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 658556/1060U). Subsequently, the patient complained of stinging. It was noted that the stinging was only for a moment and resolved quickly. The reporter felt that the stinging could be from the vaccine being cold.Approximately 10 minutes post vaccination, the patient got pale, lightheaded and passed out. Unspecified medical attention was sought. It was reported that the patient rested and a neurological check was performed. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician's office concerning a female patient was was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The reporter indicated that using the prefilled syringe was "painful and startling" to the patient. Her outcome was not reported. A product quality complaint was not involved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a 27 year old female with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 27-SEP-2006, the patient was vaccinated with 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included unspecified hormonal contraceptives (reported as "birth control"). On 28-SEP-2006, the patient developed red, itchy and swollen hands and feet. The patient sought unspecified medical attention. At the time of this report the patient was recovering from the events. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: Information has been received from the mother of a female patient in her "early 20's" with no relevant medical history who on 25-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 mL). There was no concomitant medication. On 25-SEP-2006, the patient experienced "a lot of pain and nausea." The pain was described as a stinging feeling when the medication was being injected. The patient subsequently recovered from the pain and nausea one hour after vaccination. Medical attention was not sought. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Medication error, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with mild cervical dysplasia with colposcopy and no known allergies or adverse drug reactions reported. On 26-SEP-2006, the patient was vaccinated with the first dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication reported. It was reported that the pre-filled syringe had been stored at 34F. On 26-SEP-2006 the patient developed severe pain during administration with lightheadedness and dizziness. The patient was laid on the exam table and given ibuprofen (MOTRIN) for pain. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the events. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female who in 2006 (date not reported) was vaccinated with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The nurse reported having "the syringe jam and could not administer the vaccine." The vaccine was given using a second syringe. The nurse also reported that the patient experienced "muscle pain in her arm, the arm of the jammed syringe." At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who in September 2006 was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently in September 2006 the patient developed 102 degree temperature and chills. Medical attention was sought. The patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from an LPN concerning a female patient who was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced pain in her arm in excess of 5 days. There was no swelling or rash, only the pain. Medical attention was sought. The pain was reported to have improved on therapy. It was unknown whether this was an injection site reaction. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced pain, numbness, and a tingly feeling all the way down to her fingertips. The events occurred in the arm in which the patient received the vaccination. Unspecified medical attention was sought. The patient subsequently recovered from the events. Additional information has been sought.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Within 1 to 2 days after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast), the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. Information has been received from physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated GARDASIL. Within 1 to 2 days after receiving GARDASIL, the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. Upon review of the file. WAES #0610USA00860 has been found to be a duplicate oWAES #0610USA01164. Therefore, WAES #0610USA00860 is being deleted from our files on GARDASIL.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Body temperature increased, Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient who on an unspecified date was vaccinated IM with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Within one to two days after administration, the patient developed headache and fever. No medical attention was sought. Her outcome was not reported. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 10/13/2006.  Information has been received from a physician concerning a 11 year old female patient who on an unspecified date was vaccinated IM with her first dose of GARDASIL.  Within one to two days after administration, the patient developed headache and fever.  No medical attention was sought.  Her outcome was not reported.  Follow up information has been received regarding the 11 year old white female with no medical history who at 2:30 p.m. on 19-SEP-2006 was vaccinated in the right arm with her first dose of GARDASIL, lot #653735/0688F.  She received her first dose of ADACEL in the left arm at the same time.  At 7:00 p.m. on the same day, she developed a headache.  She woke up during the night with severe headache.  Fever was approximately 101-102.  On the afternoon of 20-SEP-2006 she was better and able to attend school.  It was reported that she recovered from headache and fever on the afternoon of 20-SEP-2006.  Additional information is not expected. This is a consolidation of two reportes concerning the same patient. WAES #0160USA00860 was previously submitted on 13-OCT-2006.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with GARDASIL. Within 1 to 2 days after receiving GARDASIL, the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/13/2006. Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with GARDASIL. Within 1 to 2 days after receiving GARDASIL, the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. Upon review of the file, WAES #0610USA01349 has been found to be a duplicate of WAES #0610USA03614. Therefore, WAES #0610USAUSA01349 is being deleted from our files on GARDASIL.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Within 1 to 2 days after receiving HPV rL1 6 11 16 18 VLP vaccine (yeast), the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. Upon review of the file, WAES #0610USA0135 has been found to be a duplicate of WAES #0610USA03615. Therefore, WAES # 0610USA0135 is being delated from our files on GRDASIL.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 25 year old female who on 01-SEP-2006 was vaccinated IM with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 08-SEP-2006, one week after vaccination, the patient developed "small bumps under her skin" at the injection site. The patient sought unspecified medical attention. Subsequently, the patient fully recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, the patient developed headache and fever. Her outcome was not reported. Additional information has been requested. This is a consolidation of two reports concerning the same patient. WAES# 0610USA01349 was previously submitted on 13-Oct-2006.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Body temperature normal, Eye pain, Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL.  Subsequently, the patient developed headache and fever.  Her outcome was not reported.  Additional information has been requested.  Follow up information has been received concerning the patient with no medical history who on 27-SEP-2006 at 2:00 p.m. received her first dose of GARDASIL, lot #653735/0688F, in the right arm.  On 28-SEP-2006 at 8:00 a.m. the patient developed headache and fever (approximeately 100 oral temperature).  The patient complained of headache pain behind eyes that was relieved by ADVIL.  It was reported that on 29-SEP-2006 she recovered.  Additional information is not expected. This is a consolidation of two reports concerning the same patient. WAES # 0610USA01350 was previously submitted on 13-OCT-2006.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. The patient had to lie down for a short time period until the pain subsided. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning a female between the ages of 14 to 21 years old who was vaccinated IM into the deltoid region with a first 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced extreme pain during injection. No medical attention was sought. About 15 to 20 minutes after injection, the patient was improving. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. She stated that it "felt like the medicine traveled through my system at time of injection." Subsequently, the patient recovered from the syncope and abnormal feeling. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. Subsequently, the patient recovered from the syncope. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis from site, arm clean to breast bone.
Age: 46.0
Sex: U
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Blood cholesterol increased, Blood triglycerides increased, Headache
Clinical narrative: Headache frequently, joint pain, disorder, anxiety nasal allergy, eyes allergy, itching, back pain
Age: 46.0
Sex: U
Vaccine: ANTH
Symptoms: Hypersensitivity, Lacrimation increased, Pruritus, Rhinorrhoea
Clinical narrative: Headache frequently, joint pain, disorder, anxiety nasal allergy, eyes allergy, itching, back pain
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia
Clinical narrative: Pain in joints.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Pain, Pruritus
Clinical narrative: Itchy my whole body, body aches and joint, bumps full of pus and once explode leave scars.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Urticaria with erythematous streaks, swelling of entire thigh, right circumference 3 cm > left.
Age: 1.26
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: 24 hrs after MMRV was administered, pt developed hives.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Pyrexia, Tremor
Clinical narrative: Fever, shaking, (+) tenderness on the injection site and erythematic nodule.
Age: 16.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Began 10/8/06; high fever (103), achy body, a lot of pain in (L) deltoid, difficult to use (L) arm. Pt took ibuprofen/Tylenol and symptoms resolved on their own.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Hyperhidrosis, Injection site pain, Joint range of motion decreased
Clinical narrative: 3 hrs after shot (pneumonia), I developed severe pain in upper arm, sweating and faintness, severe pain, unable to raise arm for 2 days! Still sore!
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Anorexia, Irritability, Pyrexia, Rash
Clinical narrative: "Acting funny since shots". Fever up to 104.2, irritability, loss of appetite, rash on forehead. Symptoms still present.
Age: 1.3
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever yesterday after immunizations and in following AM was given Motrin at 07:15 AM followed by seizure. Taken to ER. Given Tylenol Supp. in ER.
Age: 15.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Local cellulitis at site of Varivax. Pt being treated for presumed infectious cellulitis.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Chicken pox lesions 50-100.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Adult Hep B vaccine to pt for 1st dose no reactions.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Hep B vaccine given adult dose no reaction from pt.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Injection site warmth, Swelling
Clinical narrative: Severe local reaction with redness (10c X 12c) indurate, warm and red with localized swelling on left leg.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Adult dose Hepatitis B given. No reaction.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Patient got varicella after receiving Varivax vaccine.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Started with rash on trunk, groin, hairline.  Spreading and now has approximately 25-30 papules.  To give BENADRYL and use Calamine lotion.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Nausea, Swelling, Vomiting
Clinical narrative: Had arm swelling, nausea and diarrhea and vomiting onset a few hours after vaccine given.  Seen in emergency room and given BENADRYL, COMPAZINE, Imodium and MOTRIN, then discharged.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Patient still had outbreak of Varicella after receiving Varivax vaccine.
Age: 1.23
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash macular
Clinical narrative: 2 days after MMR injection-fever and localized reaction. 8 days after MMR injection-macular rash covering trunk and head, arms some legs.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site warmth, Pruritus, Rash, Tremor
Clinical narrative: 9/22: developed rash on low back; 9/23 headaches; 9/24 extremely hot, whole body shaky; 9/25 headaches; 9/27 10:30 pm extremely itchy, red bumps all over body.  Felt hot and shaky.  Took BENADRYL, itched for 2 hours, headache all nos.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pruritus, Pyrexia, Rash
Clinical narrative: Patient developed generalized rash, itchy and erythema onset with chills, fever sore arm
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Infection, Injection site warmth, Swelling
Clinical narrative: Left arm swollen and hot 3x arm on right side. Started about fist size and moved about 2inches up and down arm.  Took to emergency room Sunday and doctor said it was an infection.
Age: 3.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Large red are left thigh 10 cm diameter.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: developed varicella 10/15/06.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Chills, Fatigue, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient woke up 10/3 at 730 am feeling really tired. Later had chills, body ache and temperature 101.  Arm swollen golf ball size at injection site.  Saw FNP associated with her work place and sent home 1/2 day from work.  Feeling better 10/4 and 10/5 but not 100%.
Age: 1.01
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Varicella disease despite vaccination.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a 28 year old female who on approximately 26-AUG-2006 was vaccinated intramuscularly in her right buttocks with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). On approximately 27-AUG-2006 the patient developed a painful lump in the area of her injection site. She stated "there is a ball inside my skin and it still occasionally hurts." Subsequently, unspecified medical attention was sought. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a 28 year old female who on approximately 26-AUG-2006 was vaccinated intramuscularly in her right buttocks with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). On approximately 27-AUG-2006 the patient developed a painful lump in the area of her injection site. She stated "there is a ball inside my skin and it still occasionally hurts." Subsequently, unspecified medical attention was sought. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Dyskinesia, Pain, Pyrexia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 10/6/06 from the pts parent. A five month old infant, with no significant past medial history, had received a first dose of Hib vaccine, a first dose of Pediarix vaccine and a first dose of Pneumococcal vaccine on 6/10/06. The trade names, manufacturers names, routes and sites of administration were not reported for the above mentioned vaccines. Approx nine hours post immunization, the pt experienced muscle twitching, a rigid body, excessive crying and a fever of 101.0 to 102.0 degrees F. The mother contacted the physician office after hours and spoke with the physician on call, and per the instructions of the physician there was no need for the pt to be medically evaluated at the physicians office, or referred to the ER. Per the mother the symptoms lasted four to five days. The mother stated the pt was developmentally on track and was diagnosed with lockjaw. Per the mother, the pt recovered from these adverse events.