chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a first dose of GARDASIL (lot number not provided) 0.5 ml intramuscular on an unknown date in 2008. No other co-suspects were reported. No concomitant medications were reported. The patient vaccinated with a second dose of GARDASIL (lot number not provided) on an unknown date in 2010 and came to the office on 02-AUG-2012 "today" for the third dose. It was unspecified if the patient had sought medical attention. No adverse effects reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report has been received from a consumer who was a 70 years old male patient with no drug allergy or pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX on 20-JUL-2012. Concomitant medications included: FLOMAX. On 22-JUL-2012 (reported as 2 days after vaccination) the patient developed what looked like a mosquito bite on his stomach and back. They itched. The patient went to the doctor who advised him he had shingles. They were just bumps now. The patient sought medical attention by visiting doctor and unspecified ointment and unspecified pain pill and valacyclovir were given for the treatment. And blood work yearly was performed. At the time of report, the patient was recovering. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of Pharmacy refers to an old male patient in his 60's. The patient was vaccinated SC. with ZOSTAVAX, 0.65 ml, on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist mentioned that the patient was "very muscular", so he was not able to administer the vaccine subcutaneously in the deltoid region of the upper arm, and the closest site he could find for subcutaneous injection was in the lower triceps region several inches above the elbow. No adverse event reported. It was unknown if the patient had sought medical attention. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dysgeusia, Headache
Clinical narrative: This spontaneous report has been received from a pharmacist refers to a 64 years old female patient with versed allergy and unspecified pertinent medical history who was vaccinated SC on the left arm with a 0.65 ml dose of ZOSTAVAX (lot # 672612/1653AA: Exp Date 21-JAN-2013) on 25-JUL-2012. There were some unspecified concomitant medications. On 25-JUlL-2012 the reporter stated that the patient had a monetary feeling of heaviness in her chest, a slight headache and a metallic taste in her mouth just after being vaccinated ZOSTAVAX. The pharmacist stated that they monitored the patient at the pharmacy for at least 18 minutes post vaccination. No treatment was given. Pharmacist stated that the patient told her she felt okay now. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 670616/0617AA) on 02-AUG-2012 after its expiration date. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient has sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age. The patient was vaccinated with the first, second and third 0.5ml dose of GARDASIL (Lot # and route not reported) respectively in May 2011, July 2011 and on 07-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was not known if the patient sought for medical attention. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age. On an unspecified date the patient were vaccinated with RECOMBIVAX HB which was improperly stored at various temperatures. No other co-suspects were reported. No concomitant medications were reported. It was unknown of the patients had sought medical attention. No adverse reaction reported. 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. This is one of several reports received from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age. On an unspecified date the patients were vaccinated with GARDASIL which was improperly stored at various temperatures. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patients had sought medical attention. No adverse reaction reported. 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. This is one of several reports received from the same source.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (L.P.N.) refers to unspecified patients. The patients were vaccinated with improperly stored VAQTA in May, 2011. It was reported that the first excursion occurred in May 2011 where VAQTA were exposed to 31 F for 4 hours and the second excursion occurred on 29-MAY-2012 where VAQTA were exposed to 30F for 12 hours. No adverse effects reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age. On an unspecified date the patients were vaccinated with ROTATEQ which was improperly stored at various temperatures. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patients had sought medical attention. No adverse reaction reported. 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. This is one of several reports received from the same source.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age. On an unspecified date the patients were vaccinated with MMR II which was exposed to 67F for 25 hours. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patients had sought medical attention. No adverse reaction reported. 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. This is one of several reports received from the same source.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rotavirus infection
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to an 8 weeks old patient. The patient was vaccinated orally with first dose of ROTATEQ on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced rotavirus. The patient went to the E/R. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a 61 years old female patient with no pertinent medical history and with no drug reaction or allergies. The patient was vaccinated subcutaneously in left arm with a dose of ZOSTAVAX (Lot # not reported) on 22-JUL-2012. There were no other co-suspects and concomitant medications. On 23-JUL-2012 the patient's left arm was "infected" as per what the nurse told her after getting the vaccine. Arm at injection site was red and had a bump 2" wide and 1" long. The patient sought for unspecified medical attention. No lab diagnostics studies performed. No treatment was given. At the time of this report the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age. On an unspecified date the patients were vaccinated with VARIVAX (Merck) which was improperly stored at various temperatures. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patients had sought medical attention. No adverse reaction reported. 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. This is one of several reports received from the same source.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received  from a registered nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced an adverse event. No treatment information was reported. The outcome of the adverse event was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Rash
Clinical narrative: This spontaneous report as received from a physician refers to himself, a 74 years old male with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported) on 26-JUL-2012. No other co-suspects were reported. Concomitant medications included RHINOCORT, omeprazole, FLOMAX, LIPITOR, hydrochlorothiazide, lisinopril, tamoxifen citrate, metoprolol, omega-3 and vitamin D. On 26-JUL-2012 the patient developed rash and bruising after receiving a dose of ZOSTAVAX. The rash and bruising appeared on the forearm below the injection site. The area of the rash was about 1 cm to 1/2 cm. The patient did not seek for medical attention. There were no lab diagnostic studies performed. No treatment was given. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 54 years old male patient with gout and hypertension. The patient was vaccinated with 3 doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (Lot #, dose and route not reported) on an unknown schedule at an unknown time. No other co-suspects were reported. No concomitant medications were reported. It was reported that now the patient had a hepatitis B titer of 7.1. The patient had seen in office for medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Hyperhidrosis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old male patient with no conditions and no history and no previous illness was vaccinated IM In the left arm with the second dose of GARDASIL (lot # 670049/1171AA, Exp on 11-NOV-2013) at approximately 3:50 PM for nursing visit on 29-MAY-2012. On 29-MAY-2012 the patient felt faint an dizzy 10 minutes after administration and fell to the floor - zero, no injuries sustained. Patient was sweating but denied LOC. Patient was brought back and allowed to lay down for 15 more minutes. The patient's vital signs (V/S) were taken an stable. The original reporting source was not provided. No further information is available.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old male patient. On 19-JUL-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot#not reported) that had been improperly stored at 50F for at least 24 hours. No other co-suspects were reported. The patient did not sought medical attention. No adverse event observed or reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to one of her 3 grandchildren of unknown age. It was reported that the patient may have received GARDASIL (lot # not reported) outside of the dosing schedule. The reporter was unaware of the dates when the patient received the GARDASIL injections. No adverse effect reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age, who is one of her grandchildren. It was reported that the patient may had received GARDASIL (lot # not reported) outside of the closing schedule. The reported was unaware of the dates when the patient received the GARDASIL injections. No adverse effect reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, FLUX, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Muscular weakness, Myelitis transverse, Paraesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old female patient with no known allergies and mild viral infection was vaccinated in the right arm with a dose of GARDASIL (lot # 669308/0636AA) on 05-JAN-2012. Concomitant vaccine included ADACEL (lot# C3989AA) in the left arm, fluocinolone acetonide (FLUZON, lot# UT441AA) in the left arm and MENACTRA (lot# U4243AA) in the left arm. Following vaccinations, the patient experienced acute right leg weakness and bilateral leg "parathesis." The patient was diagnosed with transverse myelitis. At the time of the report, the condition persisted but had improved as of 09-FEB-2012. The patient sought medical attention via Emergency Room visit. The agency felt that all the events were non-serious. The original reporting source was provided by a health care professional. The VAERS ID # is 451480-3. This report was related to reports with VAERS# 451480-1 and 451480-2. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient was vaccinated intramuscularly into left arm with the second dose of GARDASIL (lot #: 669795/1317AA) on 20-MAR-2012. On the same day, the patient was vaccinated IM into right arm with the first dose of MENACTRA (Lot#U3848AA). On 21-MAR-2012, 1 day after vaccination, the patient complained of itching and redness on left deltoid. No warmth, tenderness, induration. Area was outlined in pen RTC in 2 days. On 23-MAR-2012 area of redness increased slightly. ATARAX was given for the AE. At time of the report, the patient's outcome was unknown. The list indicated that all events were non-serious and required no ER/doctor visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 452886.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Amenorrhoea
Clinical narrative: Report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 years old female patient no preexisting illness and no pertinent medical history who on 20-JUN-2010, was vaccinated IM in the left arm with the third dose of GARDASIL (lot # not provided). There was no concomitant medication. It was reported that on 20-JUN-2010, the patient developed amenorrhoea, so that at the time of reporting she had not gotten her period in almost two years. This report was considered non serious with not conditions by the Agency. The original reporting source was not provided. The VAERS ID# is 453646-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female patient with none pertinent medical history, treated with the second dose of GARDASIL (lot # reported as 0692AA) intramuscularly on the left arm on 13-APR-2012 experienced dizziness and presyncope on the same date. It was reported that dizziness appeared 2 1/2 hours after vaccine and what sounds like near-syncope also appeared at that time. The patient's symptoms lasted about 15 minutes then she returned to baseline. Whether the patient sought for medical attention was not reported. The original reporting source was not provided. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Body temperature increased, Chills, Diarrhoea, Heart rate increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient was vaccinated GARDASIL (lot# reported as 668985/0690AA) of intramuscular into right arm with the second dose on 18-APR-2012. The patient have no medical history and previous illness. No other co-suspects were reported. Concomitant medications included: SRONYX and oral contraceptive. On 19-APR-2012 the patient experienced temperature 102-103 x3-4 hrs, joint pain, muscle aches, chills, rapid heart rate, nausea/vomiting/diarrhea s/s lasted 3-4 hrs. The outcome was unknown. The listing indicated that the events as nonserious. No further information is available. The original reporting source was not provided. The VAERS ID # is 454016-1.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient was vaccinated GARDASIL (lot# reported as 668985/0690AA) of intramuscular into right arm with the second dose on 18-APR-2012. The patient have no medical history and previous illness. No other co-suspects were reported. Concomitant medications included: SRONYX and oral contraceptive. On 19-APR-2012 the patient experienced temperature 102-103 x3-4 hrs, joint pain, muscle aches, chills, rapid heart rate, nausea/vomiting/diarrhea s/s lasted 3-4 hrs. The outcome was unknown. The listing indicated that the events as nonserious. No further information is available. The original reporting source was not provided. The VAERS ID # is 454016-1.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Dizziness, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient with attention deficit disorder and no preexisting illnesses was vaccinated with a dose 1 of GARDASIL (lot # 672233/1561AA), unknown route into the left arm on 02-APR-2012, No other co-suspects were reported. Concomitant medications included: RITALIN LA. It was reported that on 02-APR-2012, the patient experienced severe stomach pain, knee weakness, nausea, knee pain, headache and dizziness. No treatment information was reported. The outcome of the events mentioned above was unknown. No laboratories were performed. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID # is 454512-1. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient with attention deficit disorder and no preexisting illnesses was vaccinated with a dose 1 of GARDASIL (lot # 672233/1561AA), unknown route into the left arm on 02-APR-2012, No other co-suspects were reported. Concomitant medications included: RITALIN LA. It was reported that on 02-APR-2012, the patient experienced severe stomach pain, knee weakness, nausea, knee pain, headache and dizziness. No treatment information was reported. The outcome of the events mentioned above was unknown. No laboratories were performed. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID # is 454512-1. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Chest pain, Dyspnoea, Full blood count, Metabolic function test, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old male patient with no medical history and no previous illnesses was vaccinated on 26-APR-2012 with the third dose of GARDASIL (lot # 0636AA), in the right arm (route and dose not reported). Concomitant vaccine given on the same date included the first dose of HAVRIX, (lot # AHAVB550CA), in the right arm (route not reported). On 26-APR-2012, the patient presented with pale skin, chest pain and shortness of breath (SOB). Laboratory test performed included CBC (complete blood count) and Comprehensive Metabolic Panel (CMP), no results were reported. At the time of the report, patient's outcome for all the events was unknown. This report was considered non-serious by the agency, it required ER/doctor visit. The original reporting source was not provided. The VAERS ID # is 454913. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Burning sensation, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 22 years old female patient with no medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated with lot # (666163/0664Z) dose 1 GARDASIL (dose not reported) on 26-APR-2012. No other co-suspects and no concomitant medications were reported. It was reported that the patient came back to the office 1 1/2 weeks later and reported that rash started on 27-APR-2012 soon after receiving vaccine. The patient had papular rash to entire face, erythematous, complaining of itching and burning and had progressively gotten worse over the past 1 1/2 weeks. The patient denied any other new products or food that may have caused reaction. No treatment information was reported. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 455465. No information is available.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Back pain, Blood count normal, Ear pain, Epstein-Barr virus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with no pertinent medical history was vaccinated in gluteous maxima with the second dose of GARDASIL (lot # 672652/0022AE) on 19-APR-2012. Concomitant medications included: NUVARING. The patient experienced arthralgia, back pain, ear pain, fatigue, grip strength decreased, headache, hypoaesthesia, lymphadenopathy, muscular weakness, oropharyngeal pain, pain in extremity, paraesthesia and rash. On 25-APR-2012 she experienced swollen glands in back of neck. On 25-APR-2012 she saw doctor and started Amoxicillin (1000 mg, bid). On 01-MAY-2012 she experienced extreme fatigue, body aches, sore throat, face rash. She started on prednisolone. On 03-MAY-2012 she experienced severe headaches. On 05-MAY-2012 she experienced numbness and tingling in right arm. On 06-MAY-2012 she experienced numbness and tingling in both arms. On 08-MAY-2012 she experienced numbness and tingling in left leg. Sharp shooting head pained, right hand weak. Swollen glands gone. On 11-MAY-2012 all numbness and tingling gone. Left arm and left leg (knee) weak. No grip in left hand. On 01-JUN-2012 she still had body aches in feet, ankle, fingers, knees, wrists, fingers, legs and back. Her left knee and left hand was still weak. The patient still got shooting pains in head. By mid afternoon extreme fatigue set in. She was still having shooting head pains and headaches. Left hand and knee still weak and ache. Left wrist and elbow ached and throbbed. Occasional ear pained. Lower back pained. Overall body ached. The patient complained of arms and legs tingling when she waked up in the morning. There was no illness at the time of vaccination. The patient required an emergency room visit and the agency considered the events were non-serious. The lab data included: nuclear magnetic resonance imaging (MRI) of neck and head were normal; hepatitis test was normal; monocyte count (mono) was normal; blood count (blood ct) was normal; Guillain barre was normal; epstein barr was normal; liver function test (liver Ct.) was high. No further information is available. The original reporting source was not provided. The VAERS ID # 456913.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Grip strength decreased, Headache, Hepatic enzyme increased, Hypoaesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with no pertinent medical history was vaccinated in gluteous maxima with the second dose of GARDASIL (lot # 672652/0022AE) on 19-APR-2012. Concomitant medications included: NUVARING. The patient experienced arthralgia, back pain, ear pain, fatigue, grip strength decreased, headache, hypoaesthesia, lymphadenopathy, muscular weakness, oropharyngeal pain, pain in extremity, paraesthesia and rash. On 25-APR-2012 she experienced swollen glands in back of neck. On 25-APR-2012 she saw doctor and started Amoxicillin (1000 mg, bid). On 01-MAY-2012 she experienced extreme fatigue, body aches, sore throat, face rash. She started on prednisolone. On 03-MAY-2012 she experienced severe headaches. On 05-MAY-2012 she experienced numbness and tingling in right arm. On 06-MAY-2012 she experienced numbness and tingling in both arms. On 08-MAY-2012 she experienced numbness and tingling in left leg. Sharp shooting head pained, right hand weak. Swollen glands gone. On 11-MAY-2012 all numbness and tingling gone. Left arm and left leg (knee) weak. No grip in left hand. On 01-JUN-2012 she still had body aches in feet, ankle, fingers, knees, wrists, fingers, legs and back. Her left knee and left hand was still weak. The patient still got shooting pains in head. By mid afternoon extreme fatigue set in. She was still having shooting head pains and headaches. Left hand and knee still weak and ache. Left wrist and elbow ached and throbbed. Occasional ear pained. Lower back pained. Overall body ached. The patient complained of arms and legs tingling when she waked up in the morning. There was no illness at the time of vaccination. The patient required an emergency room visit and the agency considered the events were non-serious. The lab data included: nuclear magnetic resonance imaging (MRI) of neck and head were normal; hepatitis test was normal; monocyte count (mono) was normal; blood count (blood ct) was normal; Guillain barre was normal; epstein barr was normal; liver function test (liver Ct.) was high. No further information is available. The original reporting source was not provided. The VAERS ID # 456913.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test normal, Lymphadenopathy, Mononucleosis heterophile test negative, Muscular weakness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with no pertinent medical history was vaccinated in gluteous maxima with the second dose of GARDASIL (lot # 672652/0022AE) on 19-APR-2012. Concomitant medications included: NUVARING. The patient experienced arthralgia, back pain, ear pain, fatigue, grip strength decreased, headache, hypoaesthesia, lymphadenopathy, muscular weakness, oropharyngeal pain, pain in extremity, paraesthesia and rash. On 25-APR-2012 she experienced swollen glands in back of neck. On 25-APR-2012 she saw doctor and started Amoxicillin (1000 mg, bid). On 01-MAY-2012 she experienced extreme fatigue, body aches, sore throat, face rash. She started on prednisolone. On 03-MAY-2012 she experienced severe headaches. On 05-MAY-2012 she experienced numbness and tingling in right arm. On 06-MAY-2012 she experienced numbness and tingling in both arms. On 08-MAY-2012 she experienced numbness and tingling in left leg. Sharp shooting head pained, right hand weak. Swollen glands gone. On 11-MAY-2012 all numbness and tingling gone. Left arm and left leg (knee) weak. No grip in left hand. On 01-JUN-2012 she still had body aches in feet, ankle, fingers, knees, wrists, fingers, legs and back. Her left knee and left hand was still weak. The patient still got shooting pains in head. By mid afternoon extreme fatigue set in. She was still having shooting head pains and headaches. Left hand and knee still weak and ache. Left wrist and elbow ached and throbbed. Occasional ear pained. Lower back pained. Overall body ached. The patient complained of arms and legs tingling when she waked up in the morning. There was no illness at the time of vaccination. The patient required an emergency room visit and the agency considered the events were non-serious. The lab data included: nuclear magnetic resonance imaging (MRI) of neck and head were normal; hepatitis test was normal; monocyte count (mono) was normal; blood count (blood ct) was normal; Guillain barre was normal; epstein barr was normal; liver function test (liver Ct.) was high. No further information is available. The original reporting source was not provided. The VAERS ID # 456913.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with no pertinent medical history was vaccinated in gluteous maxima with the second dose of GARDASIL (lot # 672652/0022AE) on 19-APR-2012. Concomitant medications included: NUVARING. The patient experienced arthralgia, back pain, ear pain, fatigue, grip strength decreased, headache, hypoaesthesia, lymphadenopathy, muscular weakness, oropharyngeal pain, pain in extremity, paraesthesia and rash. On 25-APR-2012 she experienced swollen glands in back of neck. On 25-APR-2012 she saw doctor and started Amoxicillin (1000 mg, bid). On 01-MAY-2012 she experienced extreme fatigue, body aches, sore throat, face rash. She started on prednisolone. On 03-MAY-2012 she experienced severe headaches. On 05-MAY-2012 she experienced numbness and tingling in right arm. On 06-MAY-2012 she experienced numbness and tingling in both arms. On 08-MAY-2012 she experienced numbness and tingling in left leg. Sharp shooting head pained, right hand weak. Swollen glands gone. On 11-MAY-2012 all numbness and tingling gone. Left arm and left leg (knee) weak. No grip in left hand. On 01-JUN-2012 she still had body aches in feet, ankle, fingers, knees, wrists, fingers, legs and back. Her left knee and left hand was still weak. The patient still got shooting pains in head. By mid afternoon extreme fatigue set in. She was still having shooting head pains and headaches. Left hand and knee still weak and ache. Left wrist and elbow ached and throbbed. Occasional ear pained. Lower back pained. Overall body ached. The patient complained of arms and legs tingling when she waked up in the morning. There was no illness at the time of vaccination. The patient required an emergency room visit and the agency considered the events were non-serious. The lab data included: nuclear magnetic resonance imaging (MRI) of neck and head were normal; hepatitis test was normal; monocyte count (mono) was normal; blood count (blood ct) was normal; Guillain barre was normal; epstein barr was normal; liver function test (liver Ct.) was high. No further information is available. The original reporting source was not provided. The VAERS ID # 456913.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Viral test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with no pertinent medical history was vaccinated in gluteous maxima with the second dose of GARDASIL (lot # 672652/0022AE) on 19-APR-2012. Concomitant medications included: NUVARING. The patient experienced arthralgia, back pain, ear pain, fatigue, grip strength decreased, headache, hypoaesthesia, lymphadenopathy, muscular weakness, oropharyngeal pain, pain in extremity, paraesthesia and rash. On 25-APR-2012 she experienced swollen glands in back of neck. On 25-APR-2012 she saw doctor and started Amoxicillin (1000 mg, bid). On 01-MAY-2012 she experienced extreme fatigue, body aches, sore throat, face rash. She started on prednisolone. On 03-MAY-2012 she experienced severe headaches. On 05-MAY-2012 she experienced numbness and tingling in right arm. On 06-MAY-2012 she experienced numbness and tingling in both arms. On 08-MAY-2012 she experienced numbness and tingling in left leg. Sharp shooting head pained, right hand weak. Swollen glands gone. On 11-MAY-2012 all numbness and tingling gone. Left arm and left leg (knee) weak. No grip in left hand. On 01-JUN-2012 she still had body aches in feet, ankle, fingers, knees, wrists, fingers, legs and back. Her left knee and left hand was still weak. The patient still got shooting pains in head. By mid afternoon extreme fatigue set in. She was still having shooting head pains and headaches. Left hand and knee still weak and ache. Left wrist and elbow ached and throbbed. Occasional ear pained. Lower back pained. Overall body ached. The patient complained of arms and legs tingling when she waked up in the morning. There was no illness at the time of vaccination. The patient required an emergency room visit and the agency considered the events were non-serious. The lab data included: nuclear magnetic resonance imaging (MRI) of neck and head were normal; hepatitis test was normal; monocyte count (mono) was normal; blood count (blood ct) was normal; Guillain barre was normal; epstein barr was normal; liver function test (liver Ct.) was high. No further information is available. The original reporting source was not provided. The VAERS ID # 456913.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Grip strength decreased, Headache, Hepatitis viral test, Hypoaesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with no pertinent medical history was vaccinated in gluteous maxima with the second dose of GARDASIL (lot # 672652/0022AE) on 19-APR-2012. Concomitant medications included: NUVARING. The patient experienced arthralgia, back pain, ear pain, fatigue, grip strength decreased, headache, hypoaesthesia, lymphadenopathy, muscular weakness, oropharyngeal pain, pain in extremity, paraesthesia and rash. On 25-APR-2012 she experienced swollen glands in back of neck. On 25-APR-2012 she saw doctor and started Amoxicillin (1000 mg, bid). On 01-MAY-2012 she experienced extreme fatigue, body aches, sore throat, face rash. She started on prednisolone. On 03-MAY-2012 she experienced severe headaches. On 05-MAY-2012 she experienced numbness and tingling in right arm. On 06-MAY-2012 she experienced numbness and tingling in both arms. On 08-MAY-2012 she experienced numbness and tingling in left leg. Sharp shooting head pained, right hand weak. Swollen glands gone. On 11-MAY-2012 all numbness and tingling gone. Left arm and left leg (knee) weak. No grip in left hand. On 01-JUN-2012 she still had body aches in feet, ankle, fingers, knees, wrists, fingers, legs and back. Her left knee and left hand was still weak. The patient still got shooting pains in head. By mid afternoon extreme fatigue set in. She was still having shooting head pains and headaches. Left hand and knee still weak and ache. Left wrist and elbow ached and throbbed. Occasional ear pained. Lower back pained. Overall body ached. The patient complained of arms and legs tingling when she waked up in the morning. There was no illness at the time of vaccination. The patient required an emergency room visit and the agency considered the events were non-serious. The lab data included: nuclear magnetic resonance imaging (MRI) of neck and head were normal; hepatitis test was normal; monocyte count (mono) was normal; blood count (blood ct) was normal; Guillain barre was normal; epstein barr was normal; liver function test (liver Ct.) was high. No further information is available. The original reporting source was not provided. The VAERS ID # 456913.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Liver function test abnormal, Lymphadenopathy, Monocyte count normal, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with no pertinent medical history was vaccinated in gluteous maxima with the second dose of GARDASIL (lot # 672652/0022AE) on 19-APR-2012. Concomitant medications included: NUVARING. The patient experienced arthralgia, back pain, ear pain, fatigue, grip strength decreased, headache, hypoaesthesia, lymphadenopathy, muscular weakness, oropharyngeal pain, pain in extremity, paraesthesia and rash. On 25-APR-2012 she experienced swollen glands in back of neck. On 25-APR-2012 she saw doctor and started Amoxicillin (1000 mg, bid). On 01-MAY-2012 she experienced extreme fatigue, body aches, sore throat, face rash. She started on prednisolone. On 03-MAY-2012 she experienced severe headaches. On 05-MAY-2012 she experienced numbness and tingling in right arm. On 06-MAY-2012 she experienced numbness and tingling in both arms. On 08-MAY-2012 she experienced numbness and tingling in left leg. Sharp shooting head pained, right hand weak. Swollen glands gone. On 11-MAY-2012 all numbness and tingling gone. Left arm and left leg (knee) weak. No grip in left hand. On 01-JUN-2012 she still had body aches in feet, ankle, fingers, knees, wrists, fingers, legs and back. Her left knee and left hand was still weak. The patient still got shooting pains in head. By mid afternoon extreme fatigue set in. She was still having shooting head pains and headaches. Left hand and knee still weak and ache. Left wrist and elbow ached and throbbed. Occasional ear pained. Lower back pained. Overall body ached. The patient complained of arms and legs tingling when she waked up in the morning. There was no illness at the time of vaccination. The patient required an emergency room visit and the agency considered the events were non-serious. The lab data included: nuclear magnetic resonance imaging (MRI) of neck and head were normal; hepatitis test was normal; monocyte count (mono) was normal; blood count (blood ct) was normal; Guillain barre was normal; epstein barr was normal; liver function test (liver Ct.) was high. No further information is available. The original reporting source was not provided. The VAERS ID # 456913.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Paraesthesia, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with no pertinent medical history was vaccinated in gluteous maxima with the second dose of GARDASIL (lot # 672652/0022AE) on 19-APR-2012. Concomitant medications included: NUVARING. The patient experienced arthralgia, back pain, ear pain, fatigue, grip strength decreased, headache, hypoaesthesia, lymphadenopathy, muscular weakness, oropharyngeal pain, pain in extremity, paraesthesia and rash. On 25-APR-2012 she experienced swollen glands in back of neck. On 25-APR-2012 she saw doctor and started Amoxicillin (1000 mg, bid). On 01-MAY-2012 she experienced extreme fatigue, body aches, sore throat, face rash. She started on prednisolone. On 03-MAY-2012 she experienced severe headaches. On 05-MAY-2012 she experienced numbness and tingling in right arm. On 06-MAY-2012 she experienced numbness and tingling in both arms. On 08-MAY-2012 she experienced numbness and tingling in left leg. Sharp shooting head pained, right hand weak. Swollen glands gone. On 11-MAY-2012 all numbness and tingling gone. Left arm and left leg (knee) weak. No grip in left hand. On 01-JUN-2012 she still had body aches in feet, ankle, fingers, knees, wrists, fingers, legs and back. Her left knee and left hand was still weak. The patient still got shooting pains in head. By mid afternoon extreme fatigue set in. She was still having shooting head pains and headaches. Left hand and knee still weak and ache. Left wrist and elbow ached and throbbed. Occasional ear pained. Lower back pained. Overall body ached. The patient complained of arms and legs tingling when she waked up in the morning. There was no illness at the time of vaccination. The patient required an emergency room visit and the agency considered the events were non-serious. The lab data included: nuclear magnetic resonance imaging (MRI) of neck and head were normal; hepatitis test was normal; monocyte count (mono) was normal; blood count (blood ct) was normal; Guillain barre was normal; epstein barr was normal; liver function test (liver Ct.) was high. No further information is available. The original reporting source was not provided. The VAERS ID # 456913.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Viral test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with no pertinent medical history was vaccinated in gluteous maxima with the second dose of GARDASIL (lot # 672652/0022AE) on 19-APR-2012. Concomitant medications included: NUVARING. The patient experienced arthralgia, back pain, ear pain, fatigue, grip strength decreased, headache, hypoaesthesia, lymphadenopathy, muscular weakness, oropharyngeal pain, pain in extremity, paraesthesia and rash. On 25-APR-2012 she experienced swollen glands in back of neck. On 25-APR-2012 she saw doctor and started Amoxicillin (1000 mg, bid). On 01-MAY-2012 she experienced extreme fatigue, body aches, sore throat, face rash. She started on prednisolone. On 03-MAY-2012 she experienced severe headaches. On 05-MAY-2012 she experienced numbness and tingling in right arm. On 06-MAY-2012 she experienced numbness and tingling in both arms. On 08-MAY-2012 she experienced numbness and tingling in left leg. Sharp shooting head pained, right hand weak. Swollen glands gone. On 11-MAY-2012 all numbness and tingling gone. Left arm and left leg (knee) weak. No grip in left hand. On 01-JUN-2012 she still had body aches in feet, ankle, fingers, knees, wrists, fingers, legs and back. Her left knee and left hand was still weak. The patient still got shooting pains in head. By mid afternoon extreme fatigue set in. She was still having shooting head pains and headaches. Left hand and knee still weak and ache. Left wrist and elbow ached and throbbed. Occasional ear pained. Lower back pained. Overall body ached. The patient complained of arms and legs tingling when she waked up in the morning. There was no illness at the time of vaccination. The patient required an emergency room visit and the agency considered the events were non-serious. The lab data included: nuclear magnetic resonance imaging (MRI) of neck and head were normal; hepatitis test was normal; monocyte count (mono) was normal; blood count (blood ct) was normal; Guillain barre was normal; epstein barr was normal; liver function test (liver Ct.) was high. No further information is available. The original reporting source was not provided. The VAERS ID # 456913.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Fall, Head injury, Injury, Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old female patient with depression and no previous illness who on  12-JUN-2012 was vaccinated IM with the third dose of GARDASIL into the left arm (lot # 670049/1261AA). No other co-suspects were reported. Concomitant vaccine given IM on the same day included the second dose of HAVRIX (lot # AHAVB541CA) into the right arm. Concomitant therapy included PROZAC. On 12-JUN-2012, the patient experienced nasal trauma, minor head injury and syncopal episode causing fall. No treatment information was reported. At the time of the report, the patient's outcome was not reported. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 457427. Additional information is not expected.