chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Oedema peripheral, Skin warm, Vaccine positive rechallenge
Clinical narrative: This is in follow-up to report (s) previously submitted on 11/14/2008. Information has been received from a healthcare worker concerning a 17 year old female with asthma who on 27 Aug 2008 was vaccinated with the first dose of GARDASIL intramuscularly. On 23-Oct-2008, the patient was vaccinated with the second dose of GARDASIL intramuscularly concomitant therapy included unspecified oral contraceptives. It was reported that one day after receiving her second dose, on 24-Oct-2008, the patient experienced an asthma attack. Prior to this, it had been 4 years since this patient had experienced an asthma attack. She was treated with an unspecified asthma inhaler. The patient also developed redness, swelling pain and warmth at the injection site after both of her immunization with GARDASIL. All these symptoms were greater after the second dose than the first dose. The onset date of these symptoms was unspecified. At the time of the report, the patient was recovering. The patient sought medical attention, by phone call. Follow up information received on 30-DEC-2009 stated that the patient's mom called and said that the patient has a reaction to the injection, her arm was swollen/warm to touch and she had an asthma attack. Patient has not had an attack for four years wasn't sure if it was related or not. Inhaler made patient feel better. Additional information is not expected.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a female who was vaccinated with a second dose of GARDASIL.  Secondary suspected therapy included INFLUENZA (unspecified).  The patient experienced vomiting 10 minutes after receiving GARDASIL and "flu" vaccination.  Medical attention was received in the office.  At the time of reporting, the outcome was unknown.   Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 22-AUG-2008 was vaccinated with first dose of GARDASIL (lot #660557/0072X) intramuscularly. Concomitant therapy included MENACTRA and atenolol. The patient experienced a headache that lasted for a period of three days after receiving the first dose of GARDASIL. On 25-AUGg-2008, the patient recovered from headache. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from a 22 year old female, who on February 2008 and April 2008, was vaccinated with the first and second doses, respectively, of GARDASIL. Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING). in April 2008, after receiving the second dose of GARDASIL, the patient went up to make her neck appointment and started to faint. So the office had her sat down in a chair and gave her some water. The patient reported that she started to lose consciousness, but never fully did, but she sat for 15 minutes and was able to leave the office after the 15 minutes. It was reported that the patient recovered. She was scheduled to get the third dose of GARDASIL in August 2008. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Headache
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 21 year old female who in April 2008 was vaccinated with a dose of GARDASIL, (unknown if 1st or 2nd dose). There was no concomitant medication. After receiving her first and second dose the patient experienced breathing difficulty, shortness of breath and severe headaches. The symptoms resolved by themselves 2 hours after the vaccinations. The patient has not received the third dose. Additional information has been requested. Follow up information received on 26-JAN-2009 stated that the patient came for a third dose of GARDASIL. Patient mentioned that she had some difficulty breathing and severe headache after her second dose. The reporter stated that the patient did not receive the third dose of GARDASIL. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning an approximately 14 year old patient who on an unspecified date was vaccinated with the first dose of GARDASIL. It was reported that after received the first dose of GARDASIL, in two instance, the patient experienced more of a general rash after getting vaccine. It was reported that the patient did not continue on with the series. So, the patient only received the first dose.  The patient's outcome was not reported. This is one of the two patients concerning the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Joint range of motion decreased, Neuropathy peripheral, Pain, Paraesthesia, Radiculopathy
Clinical narrative: Information has been received from a nurse concerning a 13 year old female with no known allergies or drug reactions who on 20-FEB-2008 was vaccinated with the first dose of GARDASIL (lot no. 657736/0389U) IM, into the right arm and the first dose of MENACTRA (lot no 42421AA) IM, into the left arm. On 21-APR-2008, the patient was administered the second dose of GARDASIL (lot no. 657736/0389U) IM, into the right arm. In August 2008, the patient experienced shooting pain, paresthesia in both thighs and legs. The problem went from head, now range of motion in both hips decreased, especially the abdomen. The patient was diagnosed with neuropathy and radiculopathy. The patient also had entire body pain. On 08-OCT-2008, a thoracic and lumbar magnetic resonance imaging were performed (results not reported). On 06-SEP-2008, a complete blood cell count, a complete metabolic panel, serum C-reactive protein test and serum antinuclear antibodies test were performed (results no reported). Additional information has been requested.  2/24/09 Received vaccine records & PCP medical records of 9/4/08-1/30/2009. FINAL DX:adjustment disorder Records reveal patient experienced general body pain, chest pain, right shoulder pain.  Neuro exam WNL.  Referred for MRI of shoulder & spine & labs.  RTC 9/18 & had not been able to get MRI or labs done due to family & homeless developments as well as depression w/suicidal ideation.  Psych hospital admit & dx w/adjustment disorder.  Developed insomnia, pes plana, pharyngitis as well as continued psych & behavioral issues.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 11 year old female who was vaccinated  with two doses of GARDASIL.  There was no concomitant medication.  Subsequently, "one day after the second dose", the patient experienced severe leg pain and hurt to walk.  It was reported that the patient recovered, but no time to recovery reported.  This is one of several reports from the same source.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 14 year old female who was vaccinated with two doses of GARDASIL. There was no concomitant medication. Subsequently, "one day after the second dose", the patient's leg became aching, not debilitating. It was reported that the patient recovered, but no time to recovery reported. This is one of several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngitis streptococcal, Rash
Clinical narrative: Information has been received from a consumer concerning her daughter a 17 year old female who in June 2008 was vaccinated with the first dose of GARDASIL orally.  On an unspecified date, the patient was vaccinated with a second dose of GARDASIL.  Lot numbers were not available.   The  consumer reported that her daughter had strep throat twice during the time period between her first dose and second dose.  On an unspecified date, the patient experienced a severe rash all over her face and legs after receiving her second dose of GARDASIL.  The patient sought unspecified medical attention. On follow-up information, the patient's mother reported that she took unspecified steroids (manufacturer unknown) and other unspecified psoriasis medications (manufacturer unknown) but they did not help to clear up her rash.  An unspecified scrape test was performed but the results were not provided.  At the time of reporting the patient had not recovered.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with penicillin and amoxicillin allergy and no previous medical history reported, who on 25-FEB-2008, was vaccinated with the first dose of GARDASIL, 0.5 mL, injection. On 28-APR-2008 was vaccinated with the second dose, and on 03-SEP-2008 was vaccinated with the third dose. There was no concomitant medication. " One month ago" on approximately 28-SEP-2008, the patient experienced that falling after the third dose of GARDASIL, the patient was not recovered from hair falling. On an unspecified date a blood test was performed (result not provided). The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning her daughter who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL, 0.5ml intramuscularly. The nurse practitioner stated her daughter was tested positive for HPV on a PAP smear after completing the GARDASIL vaccine series, on an unspecified date. The patient was seen at the office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL 0.5ml, IM. The physician reported that the patient developed a severe rash on the left side of her body after administration of GARDASIL. She also developed a fever. At time of reporting, the patient had recovered. The patient sought medical attention via office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a female who in October 2008, was vaccinated with the first dose of GARDASIL 0.5 mL, injection and after that experienced itchiness at the injection site. The patient stated that "she won't be getting rest of doses". The patient was not recovered. The patient did not seek medical attention. No further information.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was intramuscularly vaccinated with the first 0.5ml dose of GARDASIL.   Concomitantly the patient was given Hepatitis A vaccine injection (manufacturer unknown).   A couple weeks later, the patient was admitted to the hospital for guillain-barrce syndrome on an unspecified date.  The duration of hospitalization was unknown, as well as the outcome.  The patient sought medical attention.   Additional information has been requested.  2/27/09 Received PCP medical records which included hospital & rehab hospital d/c summaries. FINAL DX: Guillain Barre syndrome; Miller Fisher variant Hospital admit 10/21-10/27/2008. Records reveal patient experienced progressive ascending bilateral LE tingling & weakness x 5 days, reduced oral intake, lump in throat, difficulty swallowing & walking, balance disturbance, speech alteration, HA & double vision.  Had been seen in PCP office & sent to hospital.  Had diarrheal illness approx 10/10.  Admitted PICU.  Neuro consult done.  Feeding tube inserted. Tx w/IVIG x 3, neurontin & pain meds.  Improved, diet advanced & transferred to inpatient rehab. where she continued to progress & d/c to home 11/15/08 w/Neuro f/u, rolling walker & outpatient PT/OT as well as homebound school.  4/13/09 Received additional hospital medical records of 10/21-27/2008.  No new information.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling
Clinical narrative: Information has been received from a 22 year old female patient with no known pertinent medical history, or no known drug reaction/allergies, who in July 2008, was vaccinated with first dose of GARDASIL vaccine. The consumer reported that three days after receiving the first dose of GARDASIL vaccine she developed swelling of both of her eyes. The swelling resolved one day later after vaccination. The patient sought medical attention by a phone call. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a Registered Nurse concerning a 26 year old female who on 02-OCT-2008 was vaccinated with the first dose of GARDASIL (660393/0067X). Concomitant therapy included TRI-SPRINTEC. Subsequently the patient developed tenderness at the injection site, as well as swelling and soreness. The patient returned to the office on 23-OCT-2009. There was bruising 4 inches below and anterior of the injection site. There was no masses, no redness and no induration. Tenderness was present. The patient was told to use hot compresses three times a day for 1 week and to call the office if her symptoms persisted. Follow up information received from the physician indicated that the female patient with no known allergies/drug reactions complained of persistent pain at the site of injection and bruising just below injection site which started on 02-OCT-2008 and lasted for six weeks. On approximately 16-NOV-2008, the patient recovered. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anger, Condition aggravated, Depression, Dizziness, Headache
Clinical narrative: Information has been received from a 21 year old female who received two dose of GARDASIL. She was supposed to get the third dose on 06-OCT-2008, she did not have insurance to pay for it so she did not get it. She started experiencing depression, dizziness and headache "around 19-OCT-2008". The patient mentioned that she had been sad previously after she gave birth to her child (14 months old); however, she was fine for a while and now the depression was back and it was much stronger. She felt angry and sad and wanted to be alone. The patient had the baby before starting the GARDASIL. At the time of reporting the patient was not recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician's assistant concerning a 21-26 year old female patient, who on unspecified dates, was vaccinated with a first and second dose of GARDASIL, and during the last week of September 2008 or the first week of October 2008, was vaccinated with the third dose of GARDASIL. The physician's assistant reported that the patient was seen about 2 weeks after the last GARDASIL vaccination for a different reason. During the visit, the patient reported that she developed numbness of the right foot from the arch to the ball of foot. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from an office manager concerning a 15 year old female, allergic to penicillin, who on 12-AUG-2008, was vaccinated with a first dose of GARDASIL (Lot # 660620/0571X), 0.5 ml. It was reported that the patient did not experience any adverse event on first dose. On 29-OCT-2008, the patient was vaccinated with a second dose of GARDASIL (Lot # 659184/0843X). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA) and vitamins (unspecified). The office manager reported that the patient fainted after getting the second dose of GARDASIL on 28-OCT-2008.The patient recovered the same date. No lab/ diagnostic tests were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse practitioner concerning a 12 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # not provided).  After getting first dose of GARDASIL, the patient developed rash on her whole body.  The patient sought medical attention.   At the time of reporting, the patient had recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a consumer who reported that she heard some girls experienced hair falling after getting a dose of GARDASIL vaccine.  was unknown if the patients sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma
Clinical narrative: Information has been received from physician concerning a 13 year old female patient with asthma who on 08-SEP-2008 was vaccinated with the first dose of GARDASIL vaccine (site and route not reported). No other vaccines were administered at this time. On 9-SEP-2008, the day after she received the vaccine, the patient went to the physician's office due to was the mother felt was an asthma attack. The patient was treated with levalbuterol and Orapred. The patient was not hospitalized. Additional information has been requested. Follow up information was received from a nurse who reported that they can not find any information about the patient. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 25 year old female who "recently" was vaccinate with the first dose of GARDASIL and fainted. The patient "came to" after she fainted the first time, and then fainted again while she was still in the office. This is one of several reports from same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no drug allergies or previous medical history reported, who on 26-AUG-2008, was vaccinated with the first dose of GARDASIL, 0.5 mL, IM, into the right deltoid,  and developed random joint swelling and a rash all over her body. The rash was flat and not raised. The patient had also started ethinyl estradiol (+) norethindrone acetate (LOESTRIN) during the same weeks as vaccination and within that same week her symptoms began. The patient discontinued ethinyl estradiol (+) norethindrone acetate (LOESTRIN),  and recovered within a week of stopping it. The patient did not notify the office until she went for second dose which had not been administered yet. The physician had not decided whether or not to continue the series. The patient did not seek medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Pain, Somnolence
Clinical narrative: Information has been received from a physician concerning her daughter an early 20's year old female who on 28-MAY-2008 was vaccinated with her first dose of GARDASIL injection (lot # 659657/1487U) and on 12-SEP-2008 received her second dose of GARDASIL injection (lot # 660553/0070X).  One day after receiving her first dose (on 29-MAY-2008) and her second dose (on 13-SEP-2008) the patient experienced a lot of body aches, sleepiness and decreased of alertness.  The symptoms lasted for 3 days.  Subsequently, the patient recovered from body aches, sleepiness and decrease of alertness and per physician "patient is fine now".  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine, Asthma, Dyspnoea, Hypersensitivity
Clinical narrative: Information has been provided from a physician's assistant concerning the daughter of a nurse who was vaccinated with the first doe of GARDASIL vaccine (dose and site not reported). It was reported that the patient developed an allergic reaction to the GARDASIL vaccine. The patient developed shortness of breath and asthmatic type symptoms. The patient did not "come in" for any additional follow-up or any medical treatment. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning an approximately 14 year old patient who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine. It was reported that after received the first dose of GARDASIL vaccine, in two instances, the patient experienced more of a general rash after getting vaccine. It was reported that the patient did not continued with the series. So, the patient only received the first dose. The patient's outcome was not reported. This is one of two patients concerning the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physical therapist concerning an unspecified number of patients, who on unspecified dates, were vaccinated with an unspecified dose of GARDASIL. The physical therapist stated the nurse from the department of health told him that irregular menstrual periods are commonly seen in patients who have received GARDASIL at the clinic.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 or 13 year old female patient who was intramuscularly vaccinated with the second dose of GARDASIL vaccine on unspecified date. In March  or April 2008, the patient experienced with urticaria all over her body within 24 hours of receiving GARDASIL vaccine and returned to the doctor's office for medical attention. There was no wheezing. Subsequently, the patient recovered on an unspecified date and there were no follow up visits. Additional information has been requested
Sex: F
Vaccine: HPV4, UNK
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a  Registered Nurse concerning a female who in October 2008 was vaccinated with a first dose of GARDASIL, single dose vial, in physician's office.  The patient experienced abdominal pain within 24 hours of receiving her first dose of GARDASIL.  Unspecified medical attention was sought.  At the time of reporting, the patient's outcome was unspecified.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who received GARDASIL (therapy date, route, site unknown) and fainted. The patient's medical history and concomitant therapy were unspecified. The patient did not seek medical attention. At the time of this report, the patient had recovered. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Information has been received from a 25 year old female with no medical history who on 15-SEP-2008 was vaccinated IM with the first dose of GARDASIL vaccine. Concomitant therapy included YAZ, within a week of getting the vaccine, patient experienced "a hard bump the size of a dime" at the injection site. At the time of this report, the patient was recovered. the reporter did not remember the date of recovery. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling
Clinical narrative: Information has been received from an Immunization Coordinator, concerning a female patient, who on an unknown date received the first dose of GARDASIL (lot number, route and injection site unknown).  It was reported that the patient's eyes "swelled shut" about three days after receiving the vaccine.  The patient sought unspecified medical attention.  At the time of reporting, the patient "is fine now".   Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Pigmentation disorder, Pruritus
Clinical narrative: Information has been received from a nurse, concerning a 12-year-old female patient with no known drug allergies, who on 22-AUG-2008, received the first dose of 0.5 ml, GARDASIL (lot# 659437/1266U, injection site unknown) via intramuscular route. On 23-AUG-2008, after the administration, the patient developed several red areas off to the side of the site of injection. According to the mother of the patient, " the areas initially looked like the skin had been burned, almost blister-like. The areas are extremely pruritic". On 30-OCT-2008, the patient was examined by her physician. It was noted that she now had a half-dollar size circle (34 mm by 30 mm) that was without pigmentation (very white). She also had two small red dots an a red area 5 cm by 4 cm to the left of thee white area. The red areas of skin were flattened. The patient stated that the areas never released fluid or became scabbed. At the time of reporting, the patient was not recovered from the events. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no medical history and no drug allergies who was vaccinated with a first dose of GARDASIL vaccine (lot # not reported) about a month ago, on approximately 30-SEP-2008. Concomitant therapy included CONCERTA. The patient experienced itchy rash/hives that mostly was localized on the legs about a month ago, on approximately 30-SEP-2008. The patient sought medical attention, and lab tests have not performed yet. The patient recovered on an unspecified date. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 08-SEP-2008 was vaccinated with GARDASIL vaccine 0.5ml. Second suspect therapy included VAQTA vaccine (inactive) (manufacture unknown) which was vaccinated at the same time. On 08-SEP-2008 the patient experienced syncope. The patient sought unspecified medical attention. On the same day, the patient recovered. Additional information has been requested
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with no pertinent medical history and no known drug allergies, who on 29-OCT-2008, was vaccinated with the first 0.5 ml dose of GARDASIL, IM, into her left arm (lot # 661764/0650X). Concomitant therapy included cetirizine hydrochloride (ZYRTEC). On 29-OCT-2008, the patient experienced severe joint and muscle pain. No lab diagnostics studies were performed. The patient sought unspecified medical attention, and the physician advised patient to take ibuprofen and to continue taking her cetirizine hydrochloride (ZYRTEC). At the time of reporting, the adverse events were ongoing. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL vaccine. The nurse practitioner stated the patient was tested positive for HPV on a Papanicolaou test (PAP smear) after completing the GARDASIL vaccine series, on an unspecified date. The patient was seen at the office. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test, Myalgia
Clinical narrative: Information has been received from a licensed  practical nurse concerning a 19 year old female with medical history unspecified who on an unspecified date was vaccinated with GARDASIL vaccine ( Lot#, route was not provided) (where in the series this dose was not known at the time of reporting. There was no concomitant medication. In September 2008, the patient developed muscle and joint pain. The patient had been seen by the physician. And she had blood work on 30-Oct-2008 (results were pending). The physician mentioned to the nurse a possible diagnosis of rheumatoid arthritis. At the time of reporting, the outcome was unknown. Additional information has been requested. 01/13/09 Reviewed Rheumatology medical records of 10/30-11/14/2008. FINAL DX: rheumaoid arthritis, seronegative. Records reveal patient experienced joint pain & swelling of multiple joints beginning 9/08 along with morning stiffness, bluish discoloration of fingers when cold, nose bleeds, .  Also had crepitus of TMJs, difficulty opening/closing mouth, spine pain & crepitus x 3-4 years.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Pain in extremity, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with no relevant medical history or allergies, who in November 2007, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported). In January 2008, the patient was vaccinated with a second dose of GARDASIL in arm (lot number and injection route not reported). There was no concomitant medication. Ten hours after the vaccination, the patient experienced vomiting every 15 minutes and pain in her back and legs. Unspecified medical attention was sought. The day after vaccination, the patient recovered from the events. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL vaccine, concerning a 15 year old female with no relevant medical history or allergies who on 16-MAR-2007 was vaccinated with a first dose of GARDASIL vaccine (lot number, injection site and route not reported). On 13-OCT-2008 the patient was vaccinated intramuscularly with a second dose of GARDASIL vaccine (lot umber and injection site not reported). There was no concomitant medication. On 13-OCT-2008 the patient experienced trace vaginal spotting. On 31-OCT-2008 the patient was determined to be pregnant by urine pregnancy test. The patient's LMP was 27-SEP-2008. Unspecified medical attention was sought. The outcome of the patient's experiences was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site irritation, Rash pruritic
Clinical narrative: Information has been received from a consumer concerning his 14 year old daughter with latex and a lot of other unspecified allergies who on unknown dates was vaccinated with two doses of GARDASIL vaccine in arm. There was no concomitant medication. "After the first dose" of GARDASIL vaccine, the patient experienced an itchy rash, the injection sites irritated and had pale spots. The caller thought his daughter might have and allergic reaction to GARDASIL vaccine because she had a lot of allergies. At the time of the report the patient received 2 doses already in both arms and arms had itchy rash now that was not going away. The patient sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Full blood count, Headache, Ophthalmological examination abnormal, Visual acuity reduced
Clinical narrative: Information has been received from a physician's nurse concerning a 13 year old female, who on 10-MAY-2008, received the first dose of GARDASIL (lot # 659180/17580), 0.5 ml, intramuscularly. Concomitant therapy included meningitis vaccine (manufacturer unspecified, lot # U2492AA). On 10-JUN-2008, the patient experienced joint pains, headache and decreased visual acuity. The patient returned for the second dose of GARDASIL (lot # 660393/0067X) on 21-JUL-2008. The patient was sent to an ophthalmologist, who diagnosed the decreased in visual acuity. The patient had a complete blood cell count (CBC) and x-ray test (results not provided). The patient would not be getting the third dose. It was not known if the adverse events had improved between the first and second dose of GARDASIL. At the time of the report, on 31-OCT-2008, the outcome of the patient was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray
Clinical narrative: Information has been received from a physician's nurse concerning a 13 year old female, who on 10-MAY-2008, received the first dose of GARDASIL (lot # 659180/17580), 0.5 ml, intramuscularly. Concomitant therapy included meningitis vaccine (manufacturer unspecified, lot # U2492AA). On 10-JUN-2008, the patient experienced joint pains, headache and decreased visual acuity. The patient returned for the second dose of GARDASIL (lot # 660393/0067X) on 21-JUL-2008. The patient was sent to an ophthalmologist, who diagnosed the decreased in visual acuity. The patient had a complete blood cell count (CBC) and x-ray test (results not provided). The patient would not be getting the third dose. It was not known if the adverse events had improved between the first and second dose of GARDASIL. At the time of the report, on 31-OCT-2008, the outcome of the patient was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who on 10-MAR-2008 was vaccinated with a first dose of GARDASIL vaccine (lot # 659653/1448U) and on 5-MAY-2008 was vaccinated with a second dose of GARDASIL vaccine (lot # 659653/1448U). Concomitant therapy included hormonal contraceptives (unspecified). On unspecified date the patient experienced arm numbness. The patient sought unspecified medical attention.  It is unknown if patient experienced the event after the first or second dose. At the time of reporting the patient's arm numbness persisted. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2008. Follow-up information was received from the nurse practitioner. It was reported that the patient was a female who was vaccinated with a first dose of GARDASIL vaccine intramuscularly into the left deltoid and with a second dose of GARDASIL vaccine intramuscularly into the right deltoid. The patient noted arm numbness after each injection and the affected area was from shoulder to elbow. At the time of reporting, the outcome was unknown. No further information was available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site movement impairment, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 23 year old female with allergies to erythromycin who was vaccinated with first, second, and third dose of GARDASIL on 29-APR-2008. 30-JUN-2008  and 29-OCT-2008 respectively. The third dose of GARDASIL (lot # was 661530/0575X) was IM, 0.5 ml. There was no concomitant medication. On 30-OCT-2008, the patient experienced an injection site reaction after her third dose of GARDASIL. The symptoms included 11 by 7 cm induration with pain and inability to lift her arm. The site was warm to the touch. She also reported stiffness in her fingers. At the time of the report, the patient was recovering. The physician saw the patient. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2008. Follow-up information has been received from a physician concerning a 23 year old female who was vaccinated with the third dose of GARDASIL in left upper arm. Concomitant medication included albuterol HFA inhaler. On 31-OCT-2008 (previously reported as 30-OCT-2008) the patient experienced adverse event after her third dose of GARDASIL. At the time of the report, the patient was recovered. The patient did not seek medical attention (previously reported the physician saw the patient). No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a 23 year old female with allergies to erythromycin who was vaccinated with first, second, and third dose of GARDASIL on 29-APR-2008. 30-JUN-2008  and 29-OCT-2008 respectively. The third dose of GARDASIL (lot # was 661530/0575X) was IM, 0.5 ml. There was no concomitant medication. On 30-OCT-2008, the patient experienced an injection site reaction after her third dose of GARDASIL. The symptoms included 11 by 7 cm induration with pain and inability to lift her arm. The site was warm to the touch. She also reported stiffness in her fingers. At the time of the report, the patient was recovering. The physician saw the patient. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2008. Follow-up information has been received from a physician concerning a 23 year old female who was vaccinated with the third dose of GARDASIL in left upper arm. Concomitant medication included albuterol HFA inhaler. On 31-OCT-2008 (previously reported as 30-OCT-2008) the patient experienced adverse event after her third dose of GARDASIL. At the time of the report, the patient was recovered. The patient did not seek medical attention (previously reported the physician saw the patient). No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dyspnoea, Influenza, Injection site pain, Myalgia
Clinical narrative: Information has been received from a physician concerning his 24 year old daughter who was vaccinated with the first dose of GARDASIL. Subsequently, the patient experienced general flu symptoms, but the adverse event had gone away. Several weeks ago, the patient received the second dose of GARDASIL. On approximately 27-OCT-2008 ("about 3 or 4 days ago"), the patient experienced arthralgia, myalgia, fever, and severe pain at the injection site. On 30-OCT-2008, the patient experienced having difficulty breathing with her asthma. The physician reported that the patient was not going to receive the third dosed of GARDASIL. At the time of reporting, the adverse events were ongoing. The patient sought medical attention via contacting physician. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning his 24 year old daughter who was vaccinated with the first dose of GARDASIL. Subsequently, the patient experienced general flu symptoms, but the adverse event had gone away. Several weeks ago, the patient received the second dose of GARDASIL. On approximately 27-OCT-2008 ("about 3 or 4 days ago"), the patient experienced arthralgia, myalgia, fever, and severe pain at the injection site. On 30-OCT-2008, the patient experienced having difficulty breathing with her asthma. The physician reported that the patient was not going to receive the third dosed of GARDASIL. At the time of reporting, the adverse events were ongoing. The patient sought medical attention via contacting physician. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old white female who on 23-OCT-2008 in the PM was vaccinated with GARDASIL IM in the right arm.  Concomitant therapy included INFLUENZA (unspecified) (manufacturer unspecified).  On 23-OCT-2008 the patient experienced vomited immediately after the injections.  The patient felt better afterwards.  At the time of the report, the patient was recovered.  No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Nausea, Pregnancy test negative
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 15-OCT-2008 was vaccinated with the second dose of GARDASIL vaccine, IM "single dose vial". The patient experienced nausea almost immediately after receiving her second dose of GARDASIL vaccine sometime around 15-OCT-2008. Physician reported that the patient's nausea "got progressively" for a couple of weeks after which it started to diminish. The patient sought medical attention. The pregnancy test was negative. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Medical device complication, No adverse event
Clinical narrative: Information has been received from a health professional regarding GARDASIL in a prefilled syringe (lot # 0947X).  It was reported that the prefilled syringe leaked at the hub.  The patient was able to receive the dose.  No AE reported.  The SR# is 1-3272605316.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on an unspecified dated was vaccinated with the first dose of GARDASIL vaccine. The physician reported that the patient fainted in the office after receiving vaccine. The outcome was unspecified. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL.  The patient fainted in the office after receiving the vaccine.   The outcome was unspecified.  This is one of several reports from the same source.  Additional information has been requested.
Age: 0.9
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious, spontaneous report of administration of FLUMIST to a eleven-month-old female infant was received from a health professional. There was no adverse event associated with this medication error; treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post marketing. Commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature, Heart rate decreased, Malaise, Oxygen saturation normal, Rash erythematous
Clinical narrative: Flu shot 10/28. Not feeling well just after getting flu shot. Fine red itchy rash all over body which developed yesterday. Reports throat is itchy but able to swallow with no difficulty. Symptoms: Skin rash, Treatment Drugs used: DIPHENHYDRAMINE dose 25 units: MG Freq: PRN Route; PO, HYDROCORTISONE dose: Units: Freq: PRN Route: TOP
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Rash generalised, Rash pruritic, Respiratory rate, Throat irritation, Weight
Clinical narrative: Flu shot 10/28. Not feeling well just after getting flu shot. Fine red itchy rash all over body which developed yesterday. Reports throat is itchy but able to swallow with no difficulty. Symptoms: Skin rash, Treatment Drugs used: DIPHENHYDRAMINE dose 25 units: MG Freq: PRN Route; PO, HYDROCORTISONE dose: Units: Freq: PRN Route: TOP
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Pt called office stated he was feeling nauseous and had vomited. Stated he received Flu vaccine before and had no issues. Called pt at 14:55 to check on him - he was at work, stated nausea and sweating decreased, he took Tylenol and axixity decreased. Stated he would se how he felt tomorrow morning.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Slightly swollen, warm, red area approximately 3" X 1/2" @ injection site over the weekend is improving without Rx.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Medical device complication
Clinical narrative: When administered FLUMIST to Pt little or no solution came out prior to removal of clip on the plunger. When inserted into other nostril it seemed all or most of the solution was administered at that time. This happened w/2 different nurses and when one was practiced on.
Age: 65.0
Sex: F
Vaccine: DTAP, FLU3, PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event reported by patient from DTAP administration.
Age: 0.3
Sex: M
Vaccine: HIBV
Symptoms: Cough, Erythema, Lethargy, Rash, Rash macular
Clinical narrative: Reddened arms and legs. Small dots around month, rash back of neck, coughing, more lethargic than usual.
Age: 2.6
Sex: F
Vaccine: HEP, HEPA, PNC, VARCEL
Symptoms: Rash papular
Clinical narrative: Pink papular
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Immunization given 11/6/08, very painful arm during night w/ rash. AM pt noted hot to touch. Evaluated by MD on 11/7/08- erythema, heat, swelling, tenderness at injection site and distally down right arm. Temperature 36.4. 11/10/08 Pt reports much better.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: Immunization given 11/6/08, very painful arm during night w/ rash. AM pt noted hot to touch. Evaluated by MD on 11/7/08- erythema, heat, swelling, tenderness at injection site and distally down right arm. Temperature 36.4. 11/10/08 Pt reports much better.
Sex: U
Vaccine: PPV
Symptoms: Chest X-ray, Pneumonia, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a patient with diabetes, cirrhosis, hypertension and hyperlipidaemia and no allergies, who on 06-NOV-2008 or 07-NOV-2008, was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23 (lot # 662599/1076X). Concomitant therapy included INSULIN R, LIPITOR and Lisinopril. On 10-NOV-2008 the patient went to the ER and was hospitalized for pneumonia. Laboratory diagnostics includes a white blood cell count of 39,000 and a chest x-ray. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: This serious case was received from a physician on 06 November 2008, and represents a cluster of "six or seven patients". SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A physician reported that "five or six" employees at a local hospital had experienced Bell's Palsy within two weeks of receiving FLUZONE SV (lot numbers, date of administration, and patient details not provided). Additionally, the physician reported that at least one employee at another local facility had also experienced Bell's Palsy. The physician, who was a pediatrician, had not seen any cases of Bell's Palsy in her own practice. Outcome was unknown. Documents held by sender: None.
Sex: M
Vaccine: FLUX
Symptoms: Convulsion, Malaise
Clinical narrative: Initial report received from another manufacturer on 06 November 2008 who received the report from a healthcare professional. An unidentified male patient (age not reported) had received a flu vaccine (trade name, manufacturer, lot number not reported) and "became very ill" and convulsions. The patient sought medical attention. No additional information is available. Documents held by sender: None.