chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 16 week old patient who on an unspecified date was vaccinated with a first dose of ROTATEQ vaccine live (human-bovine). It was noted that the office thought the patient had already received the 1st dose before 12 weeks of age, but he did not. It was noted that the patient was not experiencing any known symptoms. At the time of the report the patient's status was unknown. There were no product quality complaint involved. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 week old male patient who on 03-JUL-2008 was vaccinated orally with a first "one pouch" dose of ROTATEQ vaccine live (human-bovine). There were no adverse effects reported. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Follow-up information and vaccination administration records has been received from a licensed practical nurse concerning this 13 week old male infant who on 03-JUL-2008 was vaccinated orally with a 2ml dose of ROTATEQ vaccine live (human-bovine) (expiration date 11-SEP-2009). Concomitant vaccinations on the same day included a first  0.5ml dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (lot # AC14B046A) (expiration date 27-APR-2009) IM in the left thigh at 12:00 pm, a first 0.5cc dose of poliovirus virus vaccine inactivated (Vero) (IPOL) (lot # A0492) (expiration date 09-JUN-2009) SQ in the left thigh at 12:00 pm, a second 0.5cc dose of hepatitis B vaccine, recomb (MSD) (lot # 657607/1372U) IM in the right thigh at 12:00 pm and a first 0.5cc dose of PREVNAR vaccine (CRM197) (lot # C65931) IM in the right thigh. There was no illness at the time of vaccination or any adverse events following prior vaccinations. It was reported that the patient was seen as a new patient and noted to behind on his immunizations. The physician felt the patient could benefit from the ROTATEQ vaccine live (human-bovine) per his mother request. There was no adverse event reported. At the time of the report the patient's status was unknown. Additional information is not expected.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a paramedic concerning a patient who on an unspecified date was vaccinated with a first dose of ROTATEQ vaccine live (human-bovine) at 14 weeks of age. There was no adverse event reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Mucous stools
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with ROTATEQ vaccine live (human-bovine). It was reported at a lunch the representative had for the clinic the adverse events they had in general were one case of mucus in the stool. The week after the patient was administered with ROTATEQ vaccine live (human-bovine), the mother brought the child in with the mucus in the stool. At this time, it is unknown if the patient recovered. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Tongue black hairy
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 02-JUL-2008 was vaccinated with oral ROTATEQ vaccine live (human-bovine). Concomitant therapy included "other vaccines" (therapy unspecified). A phone call was received from the parent of the baby patient because the baby's tongue turned black after receiving ROTATEQ vaccine live (human-bovine) vaccine. Lot # was not available. Per nurse practitioner, the patient is now recovering. Unspecified medical attention was sought. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 16 week old patient with no known allergies who on an unspecified date was vaccinated orally with a first dose of ROTATEQ vaccine live (human-bovine). Subsequently, within 24 hours of vaccination the patient developed diarrhea. Unspecified medical attention was sought. There were no lab studies performed. It was noted that the physician has stopped the series. At the time of the report, the patient recovered on an unspecified date. There was no product quality complaint involved. No further information is available.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 16 week old female patient who on an unspecified date was vaccinated with a first dose of ROTATEQ vaccine live (human-bovine). Medical attention was sought in the office. It was noted that the patient did not experience any adverse effects. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old female infant with no known allergies who on 08-JUL-2008 was vaccinated orally with a third dose of 2ml of ROTATEQ vaccine live (human-bovine). It was noted that the child was administered the vaccination and vomited immediately afterward. Medical attention was sought in the office. It was unspecified if lab studies were performed. At the time of the report, the patient recovered on the same day. It was reported that the patient was "fine afterwards." There was no product quality complaint involved. No further information is available.
Age: 0.16
Sex: F
Vaccine: RV5, UNK
Symptoms: Underdose, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 58 day old female patient who on 10-JUL-2008 was vaccinated with an incomplete first dose of ROTATEQ vaccine live (human-bovine), oral, (lot number and dose not provided) due to vomiting 5 minutes after administration of the dose. Concomitant therapy included additional unspecified vaccines given on 10-JUL-2008. The patient completely recovered while in the office. Additional information has been requested. 12/03/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Follow up information received on 19-SEP-2008 from the physician stated that there were no known adverse reactions. No further information available.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 24 hour old female who on 02-NOV-2007, 03-MAR-2008 and 12-MAY-2008 was vaccinated po with the first, second and third 2.0 ml doses respectively of ROTATEQ vaccine live (human-bovine) (first dose lot #656392/0239U), second dose lot # 659772/1636U and third dose lot #660376/0019X). There was no illness at the time of vaccination. On approximately 12-MAY-2008 the patient developed diarrhea which lasted 6 to 7 days after receiving the third vaccine dose. It was reported that the patient recovered from the diarrhea. Unspecified medial attention was sought. Diarrhea for 6 to7 days was considered to be an other important medial event. Follow-up information was received from a registered nurse (RN) who reported that the patient received the first dose of ROTATEQ vaccine live (human-bovine) (lot # 656392/239U) on 02-JAN-2008 (previously reported as 02-NOV-2008). On 29-MAY-2008 (previously reported as approximately 12-MAY-2008) the patient experienced diarrhea for about 6 days and vomiting (duration unspecified). The patient was seen in the ER on 01-JUN-2008, a stool sample collected was positive for Rotavirus. The patient was seen in the office on 02-JUN-2008. The patient was reported as recovered (date unspecified). The event is no longer considered serious by the reporter. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a 5 week old patient who was vaccinated with ROTATEQ vaccine live (human-bovine) (date, dose unspecified). No adverse effect reported. It is unknown if medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test
Clinical narrative: Information has been received from a physician concerning a patient,  who is a twin, who on 02-JUL-2008 was vaccinated with an oral first dose of ROTATEQ vaccine live (human-bovine). Within days of receiving the vaccination the twin experienced severe diarrhea, approximately 10 times per day. The physician reported that the twin was being  tested for rotavirus (no information was provided). No lot number was provided. No product complaint was involved. This is one of two reports form the same source. The patient's twin was administered an oral first dose of ROTATEQ vaccine live (human-bovine) and had a similar experience (WAES# 0807USA03987). Additional information has been requested
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Bronchiolitis, Ear infection, Inappropriate schedule of drug administration, Reflux oesophagitis
Clinical narrative: Information has been received concerning a male who on 03-APR-2008 was vaccinated with ROTATEQ vaccine live (human-bovine) (Lot # reported as 660289/1888U). Concomitant therapy included PREVNAR vaccine (CRM197) and diphtheria toxoid (+) hepatitis B virus vaccine  rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX). The patient received the first dose of ROTATEQ vaccine live (human-bovine) (Lot # reported a 0301X) was received on 08-JUL-2008 also out of recommended age. The patient has problems with reflux, bronchiolitis and ear infection but they are not believed to be related to ROTATEQ vaccine live (human-bovine) since they started before the patient received the vaccine. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Infectious mononucleosis, Malaise, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a public health nurse concerning her daughter a 19 year old female patient with no known allergies who on last summer (2007), was vaccinated with the first dose of GARDASIL vaccine (yeast). On last fall (2007), was vaccinated with the second dose of GARDASIL vaccine (yeast). In February 2008, was vaccinated with the third dose of GARDASIL vaccine (yeast). In January 2008, the patient was diagnosed with mononucleosis and was treated with (3 MEDROL dose pack). The patient's mononucleosis persisted. Nurse states that her daughter was not on any medication when the third dose of GARDASIL vaccine (yeast) was administered. The patient had muscle aches and pains on both arms and legs, had been tired, fatigued and generally feels unwell. Nurse states she thought these symptoms were lingering due to mononucleosis, but is not sure now. At the time of reporting the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a mother who called to say her daughter received a dose of GARDASIL vaccine (yeast) a couple of months prior to the 18-JUL-2008 report date, and experienced muscle pain. The patient did not seek medical attention. The mother said she would call back if they found out this was caused by GARDASIL vaccine (yeast). At the time of report, the patient was recovering. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning her 16 year old daughter who was vaccinated with the complete series of GARDASIL vaccine (yeast). A week and a half after each dose, the patient started having fainting spells. The patient was rushed to the emergency room about five times. No lab diagnostic studies were performed. It was said she was having these spells for about a year. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL vaccine (yeast) injection, Lot # not provided. Subsequently the patient became pale and slumped over for about 10 seconds. The patient did not lose consciousness. No further information was provided. At the time of the report, the patient recovered. The patient sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Nausea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient who 14-DEC-2007 and on 07-MAR-2008 was vaccinated with the first and second dose of GARDASIL vaccine (yeast) respectively. There was no concomitant medication. The registered nurse reported that within 24 hours of vaccination with the first dose of GARDASIL vaccine (yeast) on 14-DEC-2007, the patient developed a fever of 101 degrees F, nausea and flu like symptoms. It was unclear how long the fever, nausea and flu like symptoms lasted. The patient recovered. On 07-MAR-2008, the same night after the second vaccination with GARDASIL vaccine (yeast), the patient developed a fever of 102 degrees F, nausea and flu like symptoms that lasted for "several days". On an unspecified date, the patient recovered. It was not specified if the patient sought for medical attention. There was no product quality complaint. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Back pain, Dysuria, Fatigue, Headache
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with sulfonamide allergy and no relevant medical history who on 03-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). There was no concomitant medication. On 13-JUL-2008 the patient experienced stomach cramps, back pain, extreme fatigue, pain upon urination, headaches and irregular menstrual cycles. Unspecified medical attention was sought. The patient's events persisted. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular, Urine analysis normal
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with sulfonamide allergy and no relevant medical history who on 03-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). There was no concomitant medication. On 13-JUL-2008 the patient experienced stomach cramps, back pain, extreme fatigue, pain upon urination, headaches and irregular menstrual cycles. Unspecified medical attention was sought. The patient's events persisted. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 female who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 24-JUN-2008 the patient experienced faint after vaccination. The patient then revived and then fainted again within a short time while still in office. The patient recovered from faint after vaccination before leaving the office on 24-JUN-2008. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Hypotension, Syncope, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 17-JUL-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 658219/0755U). After receiving the second dose the patient fainted in the parking lot of the physician's office. The patient was taken back to the office for observation. Subsequently, on the same day, the patient was recovered. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Initial information has been received from a physician and follow-up information was received from a medical assistant concerning a 16 year old female with no known allergies who on 17-JUL-2008 at 11:15 AM was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot no. 658219/0755U) into the left arm. After receiving the second dose, at 11:45 AM, the patient fainted in the parking lot of the physician's office. The patient was taken back to the office for observation. The patient experienced vasovagal syncope, very lightheaded and low blood pressure. After 15 minutes, the patient was stable but she was tired when she left the office. Subsequently, on the same day, the patient was recovered. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who on unspecified dates was vaccinated with 2 doses of GARDASIL vaccine (yeast). After the first vaccination, the patient developed yeast infection. After the second vaccination the patient developed another yeast infection. As of 18-JUL-2008, the patient was not recovered. The patient saw a doctor. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on 25-JUL-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast). The nurse reported that on 30-JUL-2008, "today", the mother called the office and reported that her daughter had been nauseous since receiving the first dose. At the time of this report, the patient was still nauseous. The patient's mother called the office to seek unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Fatigue, Pain, Rash
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no relevant medical history or allergies who on 28-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 29-JUL-2008, also reported as "24 hours after vaccination" the patient developed fatigue and a rash on the palms of the hands and the soles of the feet. On 30-JUL-2008, the patient sought treatment with an urgent care provider rather than the provider who administered the vaccine. The rash was described as "little reddened spots that were almost raised and similar in look to that of a hands foot and mouth disease rash". The rash was painful and did not itch. The physician planed to prescribe unspecified anti-inflammatory pain medication for the symptoms. At the time of reporting, the patient's events persisted. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: DTP, HPV4
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Information has been received from an office manager concerning an 18 year old female who on 27-JUL-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). After receiving the first dose, the patient's arm was sore. On 29-JUL-2008 the patient came back to the office and was vaccinated with the second dose of GARDASIL vaccine (yeast), which was almost a year later. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On the same day, after receiving the second dose, the patient was a little dizzy so she waited for a while until she felt better. The patient was fully recovered on that day. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female with no pertinent medical history or drug reactions or allergies who on 01-NOV-2006 was vaccinated with the first dose of GARDSIL vaccine (yeast) (lot no. 653978/0955F). On 11-JAN-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot no. 654389/0961F). On an unspecified date, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). On 30-JUL-2008 the patient was vaccinated intramuscularly with the fourth 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659962/1740U) and experienced a sore arm (which arm unspecified). There was no concomitant medication. It was not documented in the patient's record that a third dose was given however the mother of the patient insist she had received the third dose. At the time of this report, the patient was recovering from a sore arm. The patient sought unspecified medical attention in the office. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician's assistant concerning a patient who in approximately January 2008, "7 months ago", was vaccinated with the first dose of GARDASIL vaccine (yeast). On the same day, "shortly after the first dose was given", the patient developed a "knot" at the injection site. The patient had since been given the next 2 doses and had not reported any adverse reactions. On an unspecified date the patient recovered from a "knot" at the injection site. The patient contacted the physician's office and sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a bachelor of science in nursing concerning a 16 year old female with no pertinent medical history and codeine allergy who on 14-DEC-2006 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5 ml IM (lot # 654885/1424F). Concomitant therapy included SUDAFED and DELSYM. On 14-DEC-2006 the patient experienced injection site reaction, arm red, swollen and warm from shoulder to the elbow for 5 days after the injection. Subsequently, the patient recovered from injection site reaction, arm red, swollen and warm from shoulder to the elbow. The patient did not contact the physician at the time of the events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her daughter a 15 year old female who on 29-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). On approximately 29-JUL-2008 the patient experienced a little bit of swelling at the injection site after getting the shot. The patient's a little bit of swelling at the injection site persisted. The patient did not seek medical attention. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Nausea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient who on 07-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 659182/1757U) 0.5ml intramuscularly. On 14-JUL-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot # 660389/1968U) 0.5ml intramuscularly. Concomitant therapy included YAZ. The nurse reported that the patient developed dizziness, nausea, some shortness of breath and heaviness in her chest after the first two doses of HPV vaccine. The nurse reported that the symptoms were worse after the second dose. The patient was observed in the office for 20 minutes after the vaccination and then was discharged home when all symptoms resolved. At the time of the report, the patient had recovered. The patient sought medical attention. Additional information has been requested. This is in follow-up to report (s) perviously submitted on 8/14/2008. No futher information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female patient who in July 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) for HPV prevention. The physician reported that the patient was experiencing persistent arm pain, "shooting pains in the shoulder" for about a month after receiving her first dose of HPV vaccine in July 2008. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, DNA antibody positive, Rectal haemorrhage, Systemic lupus erythematosus
Clinical narrative: Information has been received from a physician's nurse concerning a 14 year old female who on 10-MAR-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast) (Lot # 659435/1265U). There was no concomitant medication. The reporter heard that the patient was very sick and had an autoimmune disorder. It was unclear if the patient was hospitalized. The physician in the case had not been contacted by the patient's mother at the time of the report. The patient's autoimmune disorder persisted. The patient sought unspecified medical attention. Additional information has been requested. In follow-up a physician reported that the patient had several months pf heaby periods, developed rectal bleeding and bruising. The patient was diagnosed with idiopathic thrombocytopenic purpura and ulcerative colitis. It was also reported the patient developed an unspecified auto-immune disease. She received two units of packed red blood cells and multiple treatments with REMICADE and globulin, immune. The patient required emergency room visit and was hospitalized for 3 days. It was unknown if the patient recovered. It was noted that the patient continued on "aspirin cd" and oral conctraceptives. In follow-up a physician reported that the patient was diagnosed with autoimmune disorder. The specialist that the patient was seeing and the reporting physician did not feel that GARDASIL vaccine had anything to did the patient's condition. No further information is available since the physician stated that he already completed the forms and doesn't wish to receive anymore forms.  10/20/08-records received-4/30/08-C/O irregular and excessive menstruation. Pt got her period for first time in December and skipped 3 months until April. Presented to ED on 5/10-5/13/08- DC DX: ITP and GI bleed. C/O feeling tired, weak, fever spiked to 102.2 nasal congestion, cough, sore throat. Petechial rash. Bloody stool 2 days ago. Weight loss.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Headache, Loss of consciousness, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a 16 year old female who in May 2008, complete her series of GARDASIL vaccine (yeast). In 2008, the patient experienced chest pain and she also had pressure in her head that caused blacking out. The patient had no problems when the series of GARDASIL vaccine (yeast) was completed. An MRI was performed (results not reported). At the time of this report, the patient was recovering. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL vaccine (yeast) INJ. After receiving GARDASIL vaccine (yeast), the patient experienced a dizzy episode. At the time of the reporting the patient had recovered. The patient sought unspecified medical attention. No additional information is available.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 29-JUL-2008 was vaccinated with a dose of GARDASIL vaccine (yeast) 0.5 ml (route and administration site not reported). Other suspect therapy included varicella virus vaccine live (Oka/Merck) (MSD) (duration and dose not reported) and hepatitis A virus vaccine inactivated (manufacturer unknown). Other concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). After she received the dose of GARDASIL vaccine (yeast), she fainted. It was mentioned that the patient had not eaten most of the day. The patient sought medical attention in the office at time. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Full blood count normal, Joint swelling, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on 04-JAN-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 657006/0188U) IM, on 19-MAR-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot # 659657/1487U) IM and on 09-JUL-2008, was vaccinated with the third dose GARDASIL vaccine (yeast) (lot # 660553/0070X) IM. The nurse reported the patient developed hives, arthralgia and swollen knees and ankles after administration of her first dose of HPV vaccine in January-2008. The patient experienced the symptoms intermittently through receiving her HPV vaccine series. Medical attention was sought. The laboratory diagnostics studies performed were sedimentation rate, CBC and rheumatoid factor were negative. The patient's hives and arthralgia and swollen knees and ankles persisted. The patient is being treated with ibuprofen (motrin) and cetirizine (Zyrtec). Additional information has been requested.  10/08/2008 PCP office records received. 13 yr WCC 1/4/08.  PE WNL except nevus noted on neck, wart on finger. Seen 5/19/08 for worsening joint pain, constant x 2 weeks-5 months duration. Pain ankles, knees, hips and back. One time ankle swelling. Sent for labs. DX: Joint pain-unspecified. Seen 7/9/08 for spreading rash and joint pain. PE (+) for wheal and flare lesion on knee and shoulder. Pediatric Rheumatology consult 8/21/08 with Impression: Arthralgia associated with mild joint hypermobility. Urticaria. Pt reports transient joint swelling as well. Tx with Aleve.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on 04-JAN-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 657006/0188U) IM, on 19-MAR-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot # 659657/1487U) IM and on 09-JUL-2008, was vaccinated with the third dose GARDASIL vaccine (yeast) (lot # 660553/0070X) IM. The nurse reported the patient developed hives, arthralgia and swollen knees and ankles after administration of her first dose of HPV vaccine in January-2008. The patient experienced the symptoms intermittently through receiving her HPV vaccine series. Medical attention was sought. The laboratory diagnostics studies performed were sedimentation rate, CBC and rheumatoid factor were negative. The patient's hives and arthralgia and swollen knees and ankles persisted. The patient is being treated with ibuprofen (motrin) and cetirizine (Zyrtec). Additional information has been requested.  10/08/2008 PCP office records received. 13 yr WCC 1/4/08.  PE WNL except nevus noted on neck, wart on finger. Seen 5/19/08 for worsening joint pain, constant x 2 weeks-5 months duration. Pain ankles, knees, hips and back. One time ankle swelling. Sent for labs. DX: Joint pain-unspecified. Seen 7/9/08 for spreading rash and joint pain. PE (+) for wheal and flare lesion on knee and shoulder. Pediatric Rheumatology consult 8/21/08 with Impression: Arthralgia associated with mild joint hypermobility. Urticaria. Pt reports transient joint swelling as well. Tx with Aleve.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal
Clinical narrative: Information has been received from a registered nurse concerning a female with a history of seizure who was vaccinated with GARDASIL vaccine (yeast). The registered nurse reported that a patient's family is reporting a patient has been feeling "funny" since she was given GARDASIL vaccine (yeast). The patient was given 2 doses so far but the third dose will not be given due to the patient feeling "funny". The patient sought medical attention, by calling the physician office. There was no product quality complaint. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female who in April 2008, was vaccinated with a first dose of GARDASIL vaccine (yeast). No adverse reaction was reported. In July 2008, the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot #660620/0571X). In July 2008, after the vaccination, the patient "held her head and fainted". Medical attention was sought, the patient spoke to medical assistant. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who on 30-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). According to the nurse, the patient had no symptoms when she left the office after vaccination. On 31-JUL-2008 the patient experienced dizzy and fell in her closet when she woke up at 4:00 AM. Unspecified medical attention was sought. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Headache, Injection site pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a 26 year old female with an allergy to amoxicillin who on 30-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5ml and on 30-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast). After the first dose of vaccination the patient experienced a sore arm, headache and pain at the injection site. The AE went away in one day. After the second dose of the vaccination, the patient experienced the same AE and also burning and sting. After 2 days the patient was still in pain. The patient sought unspecified medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a 26 year old female with an allergy to amoxicillin who on 30-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5ml and on 30-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast). After the first dose of vaccination the patient experienced a sore arm, headache and pain at the injection site. The AE went away in one day. After the second dose of the vaccination, the patient experienced the same AE and also burning and sting. After 2 days the patient was still in pain. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Nausea, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced nausea and fever. As of 31-JUL-2008 the patient had not gotten her period yet. The patient's nausea and fever persisted. The patient didn't seek medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis contact, Injection site erythema, Rash pruritic
Clinical narrative: Information has been received from a registered pharmacist concerning her 22 year old daughter with a lobster allergy and a history of a tonsillectomy 5 years ago and chickenpox in childhood who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5ml IM. Concomitant therapy included YAZ. Subsequently, not long after vaccination, the patient experienced "a little" redness at the injection site which resolved on its own. One week after the vaccination (on approximately 27-MAY-2008) the patient developed a "rash". The patient also developed poison ivy at the time. The "rash" had persisted since that time. The rash looked like tiny hives that itch, no drainage noted. The patient had seen her primary physician and a dermatologist. The patient was prescribed 2 courses of MEDROL dose pack and multiple creams that have been resolved the rash. The rash had completely resolved and then come back again. The location of the rash changed each time it returned. It has been located on her arms, legs, knees, and thighs at different times. The dermatologist stated that it may be caused from a virus or nerves. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 16 year old female with no medical history or no drug allergies who on 25-JUL-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot # 660391/0063X). There was no concomitant medication. On 25-JUL-2008 the patient experienced an allergic reaction. The patient had pain and swelling at injection site. The patient then developed hives and fever. The patient saw the physician to seek medical attention. On an unspecified date, several days later, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no relevant medical history and no drug allergy who on 29-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (dose, route and site of administration and lot number not reported). There was no illness at the time of vaccination. The second suspect therapy included varicella virus vaccine live (lot number not reported). Other concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and hepatitis A vaccine (inactive) (HAVRIX). The patient developed dizziness and nausea while getting into the car to leave the physician's office. The patient sought medical attention and was taken back into the office to observe. Subsequently the symptoms resolved. The patient recovered from dizziness and nausea and was as discharged home. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with epilepsy and no known allergies who on 28-MAY-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659653/1448U). Concomitant therapy included CARBATROL and ASTELIN. A few days after her second vaccination, the patient developed some mental confusion that lasted several days. On an unspecified date, the patient recovered from mental confusion. The patient sought unspecified medical attention at routine office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Visual disturbance
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a female who on 16-JUN-2008 was vaccinated with a dose of GARDASIL vaccine (yeast). "This week", on approximately 28-JUL-2008 the patient went to emergency room with visual disturbances. The patient was not hospitalized. At the time of the report, it was unknown if the patient had recovered from visual disturbances. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 37 year old female healthcare worker who "a couple of weeks ago", in approximately July 2008, was vaccinated with a first dose of GARDASIL vaccine (yeast). Subsequently, the patient developed a tender "knot" at the injection site. At the time of this report, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: Information has been received from a physician concerning his daughter a female with no pertinent medical history who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient experienced ringing in her ears after vaccination. On an unspecified date, the patient recovered from ringing in her ears. The reporter felt that ringing in the patient's ears was not related to therapy with GARDASIL vaccine (yeast). The MRI was performed. The patient sought medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Depression, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient experienced fever and depression after vaccination. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 24-JUL-2008 the patient experienced nausea, vomiting and tiredness after received the vaccine. The patient's nausea and vomiting and tiredness persisted. No further information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Dyspnoea, Painful respiration, Rash
Clinical narrative: Information has been received from a physician assistant concerning a 20 year old white female student patient who on 25-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660555/0279X) IM in her right arm. Concomitant therapy included YAZ. On 26-JUL-2008, the patient experienced shortness of breath, pain in back lung area with deep breath, rash on lower extremities, after administration of her first dose of GARDASIL vaccine. The patient recovered from shortness of breath, pain upon deep breaths and rash, in less than 48 hours. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 30-NOV-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 30-NOV-2007, the patient experienced syncopal episode. The patient finish her series and receive her third dose of GARDASIL vaccine, on 21-APR-2008. On approximately 21-JUL-2008 the patient has another dizzy, clammy feeling episode. The grandmother who reported this to the physician mentioned it was her third episode already. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a female who on unspecified dates was vaccinated with the first and second doses of GARDASIL vaccine (yeast). In May 2008, the patient was vaccinated with a third dose of GARDASIL vaccine (yeast), 0.5 mL, IM, and developed nausea. The patient sought medical attention at the office. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Immediate post-injection reaction, No reaction on previous exposure to drug, Visual disturbance
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female who on 30-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) IM. On 31-JUL-2008 the patient received the second dose of GARDASIL vaccine (yeast) IM and 5-10 minutes after injection was given, she felt dizzy and fell on ground. She could only see black, but was talking to nurse the entire time. Oxygen was given and patient rested. She was discharged home with her mother. On 31-JUL-2008, the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Malaise, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant vaccination included diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (DTAP-IPV) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). After vaccination, the patient fainted (outcome unknown). Patient's mother called the doctor's office on 31-JUL-2008 stating her daughter was not feeling well, not feeling like herself and was lethargic. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent medical history who on 31-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). The physician reported that on 31-JUL-2008 a patient fainted after she received her first and only dose of GARDASIL vaccine (yeast). The patient woke up after few seconds. Recovered 31-JUL-2008. The patient had not eaten anything prior the vaccination. The patient sought medical attention, she was seen by the physician. There was no product quality complaint. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a teenage girl believed to be 17 year old who on an unknown date was vaccinated with GARDASIL vaccine (yeast). The physician reported that a patient developed severe headaches after received GARDASIL vaccine (yeast). The patient is currently seeing a neurologist (name unspecified) and taking NEURONTIN for the headaches. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician's office manager concerning a female who on 20-MAY-2008 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast). There was no concomitant medication. The patient felt dizzy afterwards, however that went away. On 22-JUL-2008 the patient was vaccinated intramuscularly with the second dose of GARDASIL vaccine (yeast) and has been dizzy ever since. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) (lot number not provided) and fainted. The patient outcome was unknown. This is one of the several reports received from the same source. Additional information has been requested.