chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Nerve injury, Pain, Rash erythematous
Clinical narrative: Information has been received from a 63 year old female consumer reporting on herself with drug reactions or allergies to clindamycin, penicillin and codeine and no pertinent medical history who on 29-JUN-2009, was vaccinated with a dose of ZOSTAVAX (Merck) administered into the back of her left arm (dose, route, lot number not reported). Concomitant therapy included hydrocodone and valacyclovir HCl. On approximately 04-MAY-2012, about three weeks ago, the patient was diagnosed as having shingles. The patient noticed the red spots up under her arm, across the breast and center back. It went from center front to center back. She felt like she had nerve damage. The patient thought if she had have been better informed, she would had gone to the physician sooner. Since the patient had the vaccine, she did not think she would get the shingles. If the patient did not start the medicine within 72 hours, she could get nerve damage. After the first week is scabbed up and dried over and then it felt like nerve damage. It still hurt a lot and the patient felt numbness down her whole arm and into her foot. As a treatment for shingles, the physician gave to the patient an antiviral and something for pain which caused her to vomit. At the time of the report the patient's outcome was recovering. No laboratory tests were performed. The patient sought medical attention. There was no PQC. Follow-up information has been received from physician who stated that the patient reported that she had shingles vaccine 3 years ago and developed shingles in May of 2012. The relatedness for the patient's shingles was not reported for ZOSTAVAX (Merck). Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Vomiting
Clinical narrative: Information has been received from a 63 year old female consumer reporting on herself with drug reactions or allergies to clindamycin, penicillin and codeine and no pertinent medical history who on 29-JUN-2009, was vaccinated with a dose of ZOSTAVAX (Merck) administered into the back of her left arm (dose, route, lot number not reported). Concomitant therapy included hydrocodone and valacyclovir HCl. On approximately 04-MAY-2012, about three weeks ago, the patient was diagnosed as having shingles. The patient noticed the red spots up under her arm, across the breast and center back. It went from center front to center back. She felt like she had nerve damage. The patient thought if she had have been better informed, she would had gone to the physician sooner. Since the patient had the vaccine, she did not think she would get the shingles. If the patient did not start the medicine within 72 hours, she could get nerve damage. After the first week is scabbed up and dried over and then it felt like nerve damage. It still hurt a lot and the patient felt numbness down her whole arm and into her foot. As a treatment for shingles, the physician gave to the patient an antiviral and something for pain which caused her to vomit. At the time of the report the patient's outcome was recovering. No laboratory tests were performed. The patient sought medical attention. There was no PQC. Follow-up information has been received from physician who stated that the patient reported that she had shingles vaccine 3 years ago and developed shingles in May of 2012. The relatedness for the patient's shingles was not reported for ZOSTAVAX (Merck). Additional information is not expected.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 years old patient. The patient was vaccinated with VARIVAX (dose, duration and lot number not provided) on unknown dates "last month", in June 2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients had injection site swelling as big as baseball. The patient had sought medical attention via calling the office and was given BENADRYL and ice for the adverse event. None laboratory diagnostics studies were performed. The outcome the patient's adverse events was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Lip swelling, Oedema peripheral
Clinical narrative: This spontaneous report as received from a 65 years old female patient with declomycin allergy concerning herself. The patient was vaccinated with ZOSTAVAX (lot # was unknown) on 06-JUL-2012. By the Saturday on 07-JUL-2012 the patient noticed" red lump warm to the touch at the site of the injection". The patient stated Sunday on 08-JUL-2012 "after having a meal she noticed her lips had swelled up twice their sizes". The patient sought medical attention. Caller's HCP suggested her take BENADRYL for the itching and swelling of the lips and arm. The outcome of the AEs was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a 65 years old female patient with declomycin allergy concerning herself. The patient was vaccinated with ZOSTAVAX (lot # was unknown) on 06-JUL-2012. By the Saturday on 07-JUL-2012 the patient noticed" red lump warm to the touch at the site of the injection". The patient stated Sunday on 08-JUL-2012 "after having a meal she noticed her lips had swelled up twice their sizes". The patient sought medical attention. Caller's HCP suggested her take BENADRYL for the itching and swelling of the lips and arm. The outcome of the AEs was unknown. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 80 years old male patient. The patient was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX lot # (670980/0731AA), on 13-JUL-2012, which was reconstituted with expired diluents (Lot#G000186, exp: March 2012). There was no relevant laboratory data. The patient had not experienced any side effects after he had received ZOSTAVAX with an expired diluents. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a 28 years old female patient, who was vaccinated with the first dose of GARDASIL (lot# and dose not reported), intramuscularly in 2007. The patient was now 28 years old received the second dose in GARDASIL series (lot# and dose not reported), intramuscularly on 18-JUL-2012. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an unspecified number of patients who were vaccinated with a dose of ZOSTAVAX which was stored improperly. The pharmacist did not know the exact temperature the ZOSTAVAX could have been exposed to but stated it could have been elevated when it was dispensed as the temperature was not monitored in their freezer. In addition the ZOSTAVAX was stored in a dormitory style freezer. No adverse reactions reported. It was unknown of the patients sought medical attention. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Hypoaesthesia, Nuclear magnetic resonance imaging abnormal, Oedema peripheral, 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 15 years old female patient with no history and no previous illness was vaccinated IM in the right arm with the first dose of GARDASIL (lot # 672547/1745AA) on 17-APR-2012. There was no concomitant therapy. On 17-APR-2012, the patient was noticed edema and tingling of "pins and needles" of right arm. On 18-APR-2012 ("the following day") the symptoms had changed to include numbness of the entire right hand and loss of strength and sensation. The patient had a neurology appointment without definitive findings on 18-APR-2012, followed by an ultrasound and MRI significant for a blood clot, and details were not known at this time. She was treated and seen at Medical Center. As of this point, the patient had not recovered. The original reporting source was not provided. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Sensory loss, Thrombosis, Ultrasound scan abnormal
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 years old female patient with no history and no previous illness was vaccinated IM in the right arm with the first dose of GARDASIL (lot # 672547/1745AA) on 17-APR-2012. There was no concomitant therapy. On 17-APR-2012, the patient was noticed edema and tingling of "pins and needles" of right arm. On 18-APR-2012 ("the following day") the symptoms had changed to include numbness of the entire right hand and loss of strength and sensation. The patient had a neurology appointment without definitive findings on 18-APR-2012, followed by an ultrasound and MRI significant for a blood clot, and details were not known at this time. She was treated and seen at Medical Center. As of this point, the patient had not recovered. The original reporting source was not provided. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Laboratory test abnormal
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 male patient was vaccinated IM in the right arm with second dose of GARDASIL (lot # 671994/1537AA). Other suspect vaccine included ADAEL (lot # U3486AA, Dose 1) IM left deltoid muscle on 22-MAY-2012 and MENVEO (lot # M10032, Dose 1) IM left deltoid muscle on 22-MAY-2012. On 23-MAY-2012 the child developed reaction. Symptoms included pain, swelling, erythema of left deltoid muscle. Lab tests showed cellulitis left upper arm. The patient did not seek medical attention. The original reporting source was not provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unknown number of patients who were vaccinated with doses of GARDASIL (lot # not reported) that might have been improperly stored. No adverse effect 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.
Sex: F
Vaccine: RV5
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a female patient who was vaccinated with 2 doses of ROTATEQ (lot # not reported) when she was 2 months at the first dose and was 4 months old at the second dose. No other co-suspects were reported. No concomitant medications were reported. Nurse informed that after each dose, the patient developed symptoms of reflux disease. The patient did not finish the third dose in the series and the symptoms resolved after dosing. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist concerning that dialysis formulation of RECOMBIVAX HB (lot # 669494/0191AA) might have been administered to non-dialysis patients (hospital employees) inadvertently. Pharmacist reported that it may be about 5 employees who might have received dialysis formulation (40 mcg/ml) rather than regular adult formulation (10 mcg/ml). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Blood alcohol normal, Computerised tomogram normal, Disorientation, Full blood count normal, Gait disturbance
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 male patient was vaccinated with the first dose of GARDASIL (lot # 672233/1561AA) in right arm on 20-MAR-2012 (route unknown). Concomitant vaccine included: MENACTRA (lot # U4245BA) in right arm on 20-MAR-2012 (route unknown). On 22-MAR-2012, the patient experienced disorientation to person, time and place for 6 hours. The patient had difficulty in working and suffered a severe headache at onset of symptoms. The patient went to Emergency Room. Lab test included CBC, CT scan, U-tox, BA level, Chemistry, and the results were all normal. The outcome of patient was unknown. This report was considered to be non-serious. The original reporting source was not provided. Additional information is no expected.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Laboratory test normal, Toxicologic test 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 13 years old male patient was vaccinated with the first dose of GARDASIL (lot # 672233/1561AA) in right arm on 20-MAR-2012 (route unknown). Concomitant vaccine included: MENACTRA (lot # U4245BA) in right arm on 20-MAR-2012 (route unknown). On 22-MAR-2012, the patient experienced disorientation to person, time and place for 6 hours. The patient had difficulty in working and suffered a severe headache at onset of symptoms. The patient went to Emergency Room. Lab test included CBC, CT scan, U-tox, BA level, Chemistry, and the results were all normal. The outcome of patient was unknown. This report was considered to be non-serious. The original reporting source was not provided. Additional information is no expected.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Blood alcohol normal, Computerised tomogram normal, Disorientation, Full blood count normal, 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 male patient was vaccinated with the first dose of GARDASIL (lot # 672233/1561AA) in right arm on 20-MAR-2012 (route unknown). Concomitant vaccine included: MENACTRA (lot # U4245BA) in right arm on 20-MAR-2012 (route unknown). On 22-MAR-2012, the patient experienced disorientation to person, time and place for 6 hours. The patient had difficulty in working and suffered a severe headache at onset of symptoms. The patient went to Emergency Room. Lab test included CBC, CT scan, U-tox, BA level, Chemistry, and the results were all normal. The outcome of patient was unknown. This report was considered to be non-serious. The original reporting source was not provided. Additional information is no expected.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Impaired work ability, Laboratory test normal, Toxicologic test 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 13 years old male patient was vaccinated with the first dose of GARDASIL (lot # 672233/1561AA) in right arm on 20-MAR-2012 (route unknown). Concomitant vaccine included: MENACTRA (lot # U4245BA) in right arm on 20-MAR-2012 (route unknown). On 22-MAR-2012, the patient experienced disorientation to person, time and place for 6 hours. The patient had difficulty in working and suffered a severe headache at onset of symptoms. The patient went to Emergency Room. Lab test included CBC, CT scan, U-tox, BA level, Chemistry, and the results were all normal. The outcome of patient was unknown. This report was considered to be non-serious. The original reporting source was not provided. Additional information is no expected.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Muscle rigidity, Nausea, 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 18 years old female patient with no medical history and no illness at time of vaccination was vaccinated IM into right arm with lot # (670050/1229AA) dose 3 GARDASIL on 26-MAR-2012. The patient was also vaccinated IM into right arm with lot # (AHAVB541AA) dose 2 HAVRIX and into left arm with lot # (U4019AA) dose 2 MENACTRA and lot # (AC52B078BA) dose 1 BOOSTRIX on 26-MAR-2012. On 26-MAR-2012 patient's coloring turned pale; Patient fainted; patient became rigid and postured then began to slide down seat. Secured patient from sliding to ground. Applied cold compress to forehead and neck area. Fanned. Patient returned to consciousness and stated "I feel nauseous". Patient mother stated "I pass out frequently when I experience pain. Doctor told me I have vasovagal response. Guess she inherited it from me." Patient responsive and coloring returned to cheeks. Stated "not nauseous any more". Hydrated patient with fruit juice. Patient steady upon rising and ambulating. Left with mother. Upon interval review, loss of consciousness was considered to be medically significant. The original reporting source was not provided. The VAERS ID # is 453021-1. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
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 18 years old female patient with no medical history and no illness at time of vaccination was vaccinated IM into right arm with lot # (670050/1229AA) dose 3 GARDASIL on 26-MAR-2012. The patient was also vaccinated IM into right arm with lot # (AHAVB541AA) dose 2 HAVRIX and into left arm with lot # (U4019AA) dose 2 MENACTRA and lot # (AC52B078BA) dose 1 BOOSTRIX on 26-MAR-2012. On 26-MAR-2012 patient's coloring turned pale; Patient fainted; patient became rigid and postured then began to slide down seat. Secured patient from sliding to ground. Applied cold compress to forehead and neck area. Fanned. Patient returned to consciousness and stated "I feel nauseous". Patient mother stated "I pass out frequently when I experience pain. Doctor told me I have vasovagal response. Guess she inherited it from me." Patient responsive and coloring returned to cheeks. Stated "not nauseous any more". Hydrated patient with fruit juice. Patient steady upon rising and ambulating. Left with mother. Upon interval review, loss of consciousness was considered to be medically significant. The original reporting source was not provided. The VAERS ID # is 453021-1. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Fall, Muscle rigidity, Nausea, Pallor, Posture abnormal
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 18 years old female patient with no medical history and no illness at time of vaccination was vaccinated IM into right arm with lot # (670050/1229AA) dose 3 GARDASIL on 26-MAR-2012. The patient was also vaccinated IM into right arm with lot # (AHAVB541AA) dose 2 HAVRIX and into left arm with lot # (U4019AA) dose 2 MENACTRA and lot # (AC52B078BA) dose 1 BOOSTRIX on 26-MAR-2012. On 26-MAR-2012 patient's coloring turned pale; Patient fainted; patient became rigid and postured then began to slide down seat. Secured patient from sliding to ground. Applied cold compress to forehead and neck area. Fanned. Patient returned to consciousness and stated "I feel nauseous". Patient mother stated "I pass out frequently when I experience pain. Doctor told me I have vasovagal response. Guess she inherited it from me." Patient responsive and coloring returned to cheeks. Stated "not nauseous any more". Hydrated patient with fruit juice. Patient steady upon rising and ambulating. Left with mother. Upon interval review, loss of consciousness was considered to be medically significant. The original reporting source was not provided. The VAERS ID # is 453021-1. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 years old male patient with a history allergic rhinitis, mild asthma and no previous illness who on 19-OCT-2012 was vaccinated IM with the first dose of GARDASIL lot # (666948/0886Z) into the right arm. Concomitant medications included benzoyl peroxide, tetracycline and clindamycin. On 23-OCT-2010, 5 days after onset of therapy, the patient experienced hives. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 453392. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Lymphadenopathy, Mononucleosis heterophile test negative, Pharyngeal erythema, Pharyngeal oedema
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with asthma and no previous illness on 11-APR-2012 was vaccinated in the left arm with dose 1 of GARDASIL (lot #, dose and route not reported). No other co-suspects were reported. Concomitant medications included: FLOVENT and "BYNABRILL". On 12-APR-2012 the patient experienced swollen glands in neck, tongue swelled, red swelled throat and trouble breathing. No treatment information was reported. The patient sought medical attention, and was checked for mononucleosis and streptococcus which came back negative. The outcome of the reported events was unknown. The relatedness the events was not provided for GARDASIL. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 453471. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test negative, Swollen tongue
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with asthma and no previous illness on 11-APR-2012 was vaccinated in the left arm with dose 1 of GARDASIL (lot #, dose and route not reported). No other co-suspects were reported. Concomitant medications included: FLOVENT and "BYNABRILL". On 12-APR-2012 the patient experienced swollen glands in neck, tongue swelled, red swelled throat and trouble breathing. No treatment information was reported. The patient sought medical attention, and was checked for mononucleosis and streptococcus which came back negative. The outcome of the reported events was unknown. The relatedness the events was not provided for GARDASIL. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 453471. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness
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. This spontaneous report as received from a regulatory authority refers to a 15 years old female patient. The patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced dizziness. No treatment information was reported. The outcome of dizziness is unknown. The relatedness for dizziness is unknown for GARDASIL. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus generalised
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient who experienced itching after a second dose of penicillin at age 5 and no pre-existing illness on 15-MAY-2012, was vaccinated IM in the left arm with the first dose of GARDASIL (lot # 671006/1291AA, exp 12-APR-2014). There was no concomitant medication. The patient's mother stated that the child had no reaction to previous vaccines. The patient was instructed to wait 15 minutes per manufacturer instructions. After 15 minutes, the patient complained of itching throughout body. No visible rash, denied difficulty breathing of swallowing. Supervisor notified that spoke with the patient's mother and instructed the supervisor to give 25 mg of BENADRYL orally. This was given at 9:30 am. The patient was observed for 30 minutes. She stated that she felt better. The patient's mother was instructed to observe the patient and if symptoms increased, to call for medical help. At the time of the report, the patient's outcome was unknown. This report was considered non serious with no conditions by the Agency. The original reporting source was not provided. The VAERS ID# is 455574-1. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Urticaria
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. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with anaemia and prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 18-MAY-2012. Other suspect therapies included VARIVAX (Merck) on 18-MAY-2012. Concomitant medications included: MENACTRA. On 19-MAY-2012 the patient experienced urticaria, 2 days after onset of therapy. No treatment information was reported. The outcome of urticaria was unknown. The relatedness for urticaria was unknown for VARIVAX (Merck) and GARDASIL. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Hypoaesthesia, 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 14 years old male patient with no medical history was vaccinated IM with dose 2 GARDASIL (lot # 671463/1359AA, IM, on left arm) on 25-MAY-2012.Other suspect  therapies included the second dose of VARIVAX (lot # 671027/1067AA, IM, on left arm) on 25-MAY-2012. No concomitant medications were reported. On 25-MAY-2012 the patient experienced feeling dizzy. At 9:30 AM the patient experienced shortness of breath and became diaphoretic. Doctor was called to exam patient at 9:25AM. The patient was pale and had weak pulse, vomiting once. No loss of consciousness. The patient was recovered progressively with good pulse. Nml. BP 100/70 after 15 minute. Patient initially stated numbness of left arm. The outcome of the other AEs were unknown. This reported was considered as no condition and non-serious. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Pulse pressure decreased, 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 14 years old male patient with no medical history was vaccinated IM with dose 2 GARDASIL (lot # 671463/1359AA, IM, on left arm) on 25-MAY-2012.Other suspect  therapies included the second dose of VARIVAX (lot # 671027/1067AA, IM, on left arm) on 25-MAY-2012. No concomitant medications were reported. On 25-MAY-2012 the patient experienced feeling dizzy. At 9:30 AM the patient experienced shortness of breath and became diaphoretic. Doctor was called to exam patient at 9:25AM. The patient was pale and had weak pulse, vomiting once. No loss of consciousness. The patient was recovered progressively with good pulse. Nml. BP 100/70 after 15 minute. Patient initially stated numbness of left arm. The outcome of the other AEs were unknown. This reported was considered as no condition and non-serious. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
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 medical history of unspecified neurological disorder and conductive hearing loss and no pre-existing illness was vaccinated on left arm with dose 1 GARDASIL (lot # 672834/0131AE) on 30-MAY-2012. Other suspect therapies included VAQTA (lot # 672840/0215AE, left arm, IM, dose 1) on 30-MAY-2012, MENACTRA (lot # U4257AA, dose 1, IM, on right arm) on 30-MAY-2012, ADACEL  (lot # C4023AA, dose 1, IM, on right arm) on 30-MAY-2012. Concomitant medications included DEPAKOTE ER). On 30-MAY-2012 the patient experienced right upper arm edema, redness and firm to touch. The outcome was unknown. The report was considered to be no conditions and non-serious. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
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 female patient of unknown age with previous illness of skin lesion of varicella was vaccinated with the first dose of GARDASIL on 24-MAY-2012. On 28-MAY-2012 the patient was vaccinated with the second dose of GARDASIL intramuscularly. There were no other medications. The patient was not experiencing any known symptoms. This was originally reported by a physician [manufacturer report #1206BOL000057].
Age: 4.0
Sex: M
Vaccine: DTAP, HPV4, MMR, VARCEL, DTAP, HPV4, MMR, VARCEL, DTAP, HPV4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 4 year old son with asthma and no drug reactions or allergies, who on 11-JUN-2012 was inadvertently administered with GARDASIL (lot # not reported) at his physician's office. Concomitant therapy included albuterol. On 12-JUN-2012 the consumer noted that her son's arm was swollen and was hot and red, and he had a fever of 101F, and complained of a headache. The consumer also noted that she took her son to the physician's office on 13-JUN-2012. The patient was treated with TYLENOL. It was reported that no labs/diagnostics studies were performed. The present patient status was not recovered. Follow-up information was received from a physician concerning 4 year old male patient with no illness at the time of vaccination. Physician reported that on 11-JUN-2012 at 11:00 AM, the patient was vaccinated with the first dose of GARDASIL, intramuscularly in right arm, lot number 12714 (dose not reported). Other co-suspects medications included a second dose of VARIVAX (Merck) (lot number "0141AE") and a second dose of MMR II (lot number "1732AA") both administered on 11-JUN-2012 at 11:00 AM. Concomitant medication included a dose of INFANRIX administered on 11-JUN-2012 at 11:00 AM. Physician reported that on 12-JUN-2012 the patient experienced mild tenderness. Also reported that the patient recovered form "arm was swollen and was red, and he had a fever of 101F" and mild tenderness on 14-JUN-2012. The patient's outcome regarding to "arm was hot" was not reported. The relatedness for the patient's events was not reported for GARDASIL, VARIVAX (Merck) and a dose of MMR II. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, HPV4, MMR, VARCEL, DTAP, HPV4, MMR, VARCEL, DTAP, HPV4, MMR, VARCEL
Symptoms: Erythema, Headache, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Information has been received from a consumer concerning her 4 year old son with asthma and no drug reactions or allergies, who on 11-JUN-2012 was inadvertently administered with GARDASIL (lot # not reported) at his physician's office. Concomitant therapy included albuterol. On 12-JUN-2012 the consumer noted that her son's arm was swollen and was hot and red, and he had a fever of 101F, and complained of a headache. The consumer also noted that she took her son to the physician's office on 13-JUN-2012. The patient was treated with TYLENOL. It was reported that no labs/diagnostics studies were performed. The present patient status was not recovered. Follow-up information was received from a physician concerning 4 year old male patient with no illness at the time of vaccination. Physician reported that on 11-JUN-2012 at 11:00 AM, the patient was vaccinated with the first dose of GARDASIL, intramuscularly in right arm, lot number 12714 (dose not reported). Other co-suspects medications included a second dose of VARIVAX (Merck) (lot number "0141AE") and a second dose of MMR II (lot number "1732AA") both administered on 11-JUN-2012 at 11:00 AM. Concomitant medication included a dose of INFANRIX administered on 11-JUN-2012 at 11:00 AM. Physician reported that on 12-JUN-2012 the patient experienced mild tenderness. Also reported that the patient recovered form "arm was swollen and was red, and he had a fever of 101F" and mild tenderness on 14-JUN-2012. The patient's outcome regarding to "arm was hot" was not reported. The relatedness for the patient's events was not reported for GARDASIL, VARIVAX (Merck) and a dose of MMR II. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, HPV4, MMR, VARCEL, DTAP, HPV4, MMR, VARCEL, DTAP, HPV4, MMR, VARCEL
Symptoms: Tenderness
Clinical narrative: Information has been received from a consumer concerning her 4 year old son with asthma and no drug reactions or allergies, who on 11-JUN-2012 was inadvertently administered with GARDASIL (lot # not reported) at his physician's office. Concomitant therapy included albuterol. On 12-JUN-2012 the consumer noted that her son's arm was swollen and was hot and red, and he had a fever of 101F, and complained of a headache. The consumer also noted that she took her son to the physician's office on 13-JUN-2012. The patient was treated with TYLENOL. It was reported that no labs/diagnostics studies were performed. The present patient status was not recovered. Follow-up information was received from a physician concerning 4 year old male patient with no illness at the time of vaccination. Physician reported that on 11-JUN-2012 at 11:00 AM, the patient was vaccinated with the first dose of GARDASIL, intramuscularly in right arm, lot number 12714 (dose not reported). Other co-suspects medications included a second dose of VARIVAX (Merck) (lot number "0141AE") and a second dose of MMR II (lot number "1732AA") both administered on 11-JUN-2012 at 11:00 AM. Concomitant medication included a dose of INFANRIX administered on 11-JUN-2012 at 11:00 AM. Physician reported that on 12-JUN-2012 the patient experienced mild tenderness. Also reported that the patient recovered form "arm was swollen and was red, and he had a fever of 101F" and mild tenderness on 14-JUN-2012. The patient's outcome regarding to "arm was hot" was not reported. The relatedness for the patient's events was not reported for GARDASIL, VARIVAX (Merck) and a dose of MMR II. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disturbance in attention, Hypoaesthesia, Paralysis, Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 years old female patient with no previous illness and no medical history who was vaccinated with a second dose of GARDASIL, Left arm, IM (lot # 669285/0691AA) GARDASIL on 03-AUG-2011. No other co-suspects were reported. No concomitant medications were reported. It was reported that on approximately 08-AUG-2011 the patient had numbness in arms; 5-7 days after onset of therapy that lasted two weeks approximately until 22-AUG-2011. Patient had faint problems since; patient had concentration problems, photophobia, and headache. On 20-AUG-2012, the patient collapsed had complete paralysis and chest pain. The events mentioned above require ER visit caused hospitalization. The outcome of patient had numbness in arms, chest pain, patient had faint problems, headache, patient had concentration problems, photophobia and she had complete paralysis was reported as the patient was released to home in a stable condition. This report was considered serious, ER visit and hospitalized by the agency. The original reporting source was not provided. The VAERS ID# is 457525-1. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Disturbance in attention, Headache, Hypoaesthesia, Paralysis
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 years old female patient with no previous illness and no medical history who was vaccinated with a second dose of GARDASIL, Left arm, IM (lot # 669285/0691AA) GARDASIL on 03-AUG-2011. No other co-suspects were reported. No concomitant medications were reported. It was reported that on approximately 08-AUG-2011 the patient had numbness in arms; 5-7 days after onset of therapy that lasted two weeks approximately until 22-AUG-2011. Patient had faint problems since; patient had concentration problems, photophobia, and headache. On 20-AUG-2012, the patient collapsed had complete paralysis and chest pain. The events mentioned above require ER visit caused hospitalization. The outcome of patient had numbness in arms, chest pain, patient had faint problems, headache, patient had concentration problems, photophobia and she had complete paralysis was reported as the patient was released to home in a stable condition. This report was considered serious, ER visit and hospitalized by the agency. The original reporting source was not provided. The VAERS ID# is 457525-1. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Photophobia, Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 years old female patient with no previous illness and no medical history who was vaccinated with a second dose of GARDASIL, Left arm, IM (lot # 669285/0691AA) GARDASIL on 03-AUG-2011. No other co-suspects were reported. No concomitant medications were reported. It was reported that on approximately 08-AUG-2011 the patient had numbness in arms; 5-7 days after onset of therapy that lasted two weeks approximately until 22-AUG-2011. Patient had faint problems since; patient had concentration problems, photophobia, and headache. On 20-AUG-2012, the patient collapsed had complete paralysis and chest pain. The events mentioned above require ER visit caused hospitalization. The outcome of patient had numbness in arms, chest pain, patient had faint problems, headache, patient had concentration problems, photophobia and she had complete paralysis was reported as the patient was released to home in a stable condition. This report was considered serious, ER visit and hospitalized by the agency. The original reporting source was not provided. The VAERS ID# is 457525-1. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: DTAP, HEPA, HPV4, DTAP, HEPA, HPV4
Symptoms: Oedema peripheral
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 years old male patient on 13-JUN-2012 was vaccinated IM with dose 1 GARDASIL (lot # reported as 1696AA) into the right arm. Concomitant vaccines given on the same day included the first IM dose of DAPTACEL (lot # C3974AA) into the right arm and the second IM dose of HAVRIX (lot # 0271AE) into the left arm. On 13-JUN-2012, the patient's right arm swelled up to the size of a half dollar the first day of injection, two days later on 15-JUN-2012, the patient had swelling the size of a baseball. No other symptoms were noted. Patient was not in distress. The patient was advised to ice the area and taken ibuprofen scheduled 3 times a day for the next two days as well as take ZYRTEC 10 mg once daily for 3 days. At the time of the report, the patient's outcome was unknown. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457547. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Contusion, Epistaxis, Full blood count abnormal, Idiopathic thrombocytopenic purpura, Petechiae
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old male patient with no previous illness who was vaccinated with a second dose of GARDASIL (lot # 672834/0131AE), IM, Left arm, on 14-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 18-JUN-2012, the patient experienced epistaxis, bruising, petechia clinical history and complete blood count (CBC) results consistent with Idiopathic thrombocytopenic purpura (ITP) (medically significant, upon internal review), 35 days after onset of therapy. No treatment information was reported. The outcome of complete blood count (CBC) results consistent with Idiopathic thrombocytopenic purpura (ITP), bruising, petechia clinical history and epistaxis was unknown. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457749-1. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 years old male patient with no medical history and no previous illness who on 20-JUN-2012 was vaccinated with a dose of GARDASIL (lot #, dose and site of administration were not reported). No other co-suspects were reported. No concomitant medications were reported. On 20-JUN-2012, the patient experienced fainting. No treatment information was reported. At the time of the report, the patient's outcome was unknown. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457799. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 years old female patient (retired teacher). The patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported, Lot# 0564AE during verification process) on left arm on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 15-JUL-2012 the patient experienced quarter size red spot at injection site. No treatment information was reported. The outcome of adverse events was unknown. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 years old female patient (retired teacher). The patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported, Lot# 0564AE during verification process) on left arm on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 15-JUL-2012 the patient experienced quarter size red spot at injection site. No treatment information was reported. The outcome of adverse events was unknown. Additional information is not expected.
Age: 33.0
Sex: M
Vaccine: DTAP, MEN, MNQ, TDAP
Symptoms: Asthenia, Back pain, Discomfort, Headache, Hypoaesthesia
Clinical narrative: After received vaccine became light-headed, faintness, complained of numbness, tingling in both arms, back of neck and upper spine. Later that evening was taken to ER and sent home. Later (date unknown) was taken to Urgent Care and given steroids. 8/7/12 had MRI of head/spine ordered by PMD. No results.
Age: 33.0
Sex: M
Vaccine: DTAP, MEN, MNQ, TDAP
Symptoms: Neck pain, Paraesthesia, Vision blurred
Clinical narrative: After received vaccine became light-headed, faintness, complained of numbness, tingling in both arms, back of neck and upper spine. Later that evening was taken to ER and sent home. Later (date unknown) was taken to Urgent Care and given steroids. 8/7/12 had MRI of head/spine ordered by PMD. No results.
Age: 33.0
Sex: M
Vaccine: DTAP, MEN, MNQ, TDAP
Symptoms: Dizziness, Hypoaesthesia, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: After received vaccine became light-headed, faintness, complained of numbness, tingling in both arms, back of neck and upper spine. Later that evening was taken to ER and sent home. Later (date unknown) was taken to Urgent Care and given steroids. 8/7/12 had MRI of head/spine ordered by PMD. No results.
Age: 33.0
Sex: M
Vaccine: DTAP, MEN, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: After received vaccine became light-headed, faintness, complained of numbness, tingling in both arms, back of neck and upper spine. Later that evening was taken to ER and sent home. Later (date unknown) was taken to Urgent Care and given steroids. 8/7/12 had MRI of head/spine ordered by PMD. No results.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Malaise, Myalgia, Pyrexia
Clinical narrative: Initial report was received from a health care professional on 25 July 2012. A 35-year-old female patient had received an injection of ADACEL, lot number C4188AA (route, site and date of administration not reported) and less than 24 hours later experienced a fever of 104 degrees Fahrenheit (40 degrees Celsius), myalgias and malaise. The patient was seen in the emergency department (ED) and treated. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Initial report was received from a health care professional on 25 July 2012. A 35-year-old female patient had received an injection of ADACEL, lot number C4188AA (route, site and date of administration not reported) and less than 24 hours later experienced a fever of 104 degrees Fahrenheit (40 degrees Celsius), myalgias and malaise. The patient was seen in the emergency department (ED) and treated. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Burning sensation, Chills, Dizziness
Clinical narrative: Joint aching, weakness, fatigue, nausea, body burning up and cold at the same time, teeth chattering, eyes burning up, dizziness, headache, sweaty. 2 days since, symptoms still present, but less severe.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Eye irritation, Fatigue, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Joint aching, weakness, fatigue, nausea, body burning up and cold at the same time, teeth chattering, eyes burning up, dizziness, headache, sweaty. 2 days since, symptoms still present, but less severe.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Joint aching, weakness, fatigue, nausea, body burning up and cold at the same time, teeth chattering, eyes burning up, dizziness, headache, sweaty. 2 days since, symptoms still present, but less severe.