chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Oedema peripheral
Clinical narrative: 24 hours post vaccination site with redness & elongated lump. Temp to 101 degrees. Upper arm swollen from shoulder to elbow. On 8/15/12 (in Dr's office for a different issue) no redness. Afebrile but palpable elongated lump remains.
Age: 9.0
Sex: M
Vaccine: MMRV, TDAP, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Had localized erythema and induration.
Sex: U
Vaccine: MMR
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male child of unknown age with egg allergy. The patient was vaccinated with a dose of M-M-R II (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced "an allergic reaction", it was unknown what type of reaction. The patient was under another healthcare provider's care at the time of the reaction occurred which the reporter stated was awhile ago (unspecified date). No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of allergic reaction was reported as recovered. The relatedness for the reported event was unknown for M-M-R II. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Eye disorder, Headache, Ophthalmological examination normal, Pyrexia
Clinical narrative: This spontaneous report was received from a register nurse concerning a current 15 year old female patient with acne, who on 12-JUL-2010 was vaccinated with the first dose of GARDASIL, intramuscular, (lot # 666162/056Z). No other co-suspects were reported. Concomitant medications included minocycline. On 12-JUL-2010 the patient experienced fever, 1 day after onset of therapy, decrease energy, rash on the torso, forearms, and upper thigh, headache and right eye drooping. The patient was referred to an unspecified ophthalmologist who recorded a normal eye exam on 19-JUL-2010. On 19-JUL-2010, the patient recovered completely from the events. She had never received any other injections of GARDASIL. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a register nurse concerning a current 15 year old female patient with acne, who on 12-JUL-2010 was vaccinated with the first dose of GARDASIL, intramuscular, (lot # 666162/056Z). No other co-suspects were reported. Concomitant medications included minocycline. On 12-JUL-2010 the patient experienced fever, 1 day after onset of therapy, decrease energy, rash on the torso, forearms, and upper thigh, headache and right eye drooping. The patient was referred to an unspecified ophthalmologist who recorded a normal eye exam on 19-JUL-2010. On 19-JUL-2010, the patient recovered completely from the events. She had never received any other injections of GARDASIL. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Epistaxis
Clinical narrative: This spontaneous report as received from a mother refers to her 11 years old son with no drug allergy. The patient's medical history included attention deficit disorder (ADD). In about 2 months ago, approximately June 2012, the patient was vaccinated with GARDASIL (lot # not reported) intramuscular on his left arm. No other co-suspects were reported. Concomitant medications included: STRATTERA, In about 2 months ago, approximately June 2012, the patient experienced extremely bad nose bleeds on average of 3-4 times per day daily. The nose bleeds were randomly even waking him up and night and soaking through towels and pillows. The patient had sought unspecified medical attention and no laboratory performed. The outcome was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial information has been received from a pharmacist concerning a 74 year old male patient who on 17-APR-2012, was vaccinated with a dose of (Merck) (Lot # 671144/1269AA) that might have been exposed to a temperature excursion after the vaccine was transported back-and-forth between pharmacies packed in ice. The pharmacist stated that the patient did not receive any other vaccines on the same day that the ZOSTAVAX (Merck) was administered. The pharmacist also stated that the patient had not experienced any adverse events at that time. It was unknown if the patient sought medical attention. Follow-up information was received from pharmacist. On 17-APR-2012 at 11:30 AM, the patient was vaccinated with the second dose of ZOSTAVAX, subcutaneous (SC) (dose not reported) at pharmacy. No other co-suspects were reported. No concomitant medications were reported. No event occurred. This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 11 years old female patient with no drug reactions/allergies or pertinent medical history. The patient was vaccinated with  lot # (668051/0179AA) dose 1 GARDASIL on 08-JUN-2011 and lot # (0214AE, exp 13-OCT-2014) dose 2 on 30-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that a patient had an injection site reaction after her 2nd dose of GARDASIL. The reaction was a pruritic rash at the injection site which lasted 8 days and resolved without treatment. The rash looked like 10 poison ivy spots or pimples. The patient did not seek medical attention. No lab diagnostics studies performed. 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 pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot# 670038/0761AA, expired date 09-APR-2012, dose and route not reported) on 02-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 effect reported. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 2 months old patient. The patient was vaccinated with dose 3 RECOMBIVAX HB on an unknown date (dose, route, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, a 3rd dose of RECOMBIVAX HB was administered during 2nd month. There was no adverse reaction. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to himself. The patient was vaccinated IM with single dose of ZOSTAVAX (lot# not reported) intramuscularly in the gluteus muscle in either February or March of 2012. No other co-suspects were reported. No adverse effects reported. No concomitant medications were reported. No treatment information was reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report received from an office manager who is also a medical assistant refers to a 74 years old female patient. The patient was inadvertently vaccinated with a dose of GARDASIL on 03-AUG-2012. No symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria chronic
Clinical narrative: This spontaneous report as received from a physician via representative refers to a 1 year old female patient with frequent outbreaks of hives. The patient was vaccinated with her first dose of M-M-R II (lot# not reported) on 06-JAN-1997 and first dose of VARIVAX (Merck) (lot# not reported) on 13-JAN-1997. The patient received her second dose of M-M-R II on 08-JAN-2001 and second dose of VARIVAX (Merck) on 17-JAN-2007. The patient had "chronic hives over the years" as well as additional unspecified "issues". The patient's mother believed that her multiple unspecified "issues" may be due to the improper spacing of her first dose of M-M-R II and VARIVAX (Merck). No concomitant medications were reported. The patient sought medical attention via physician consultation. At time of the report, the patient's outcome was unknown. Additional information has been requested..
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Back pain, Chest pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to his son a 20 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was intramuscularly vaccinated with 0.5 ml GARDASIL (Lot # and duration were unspecified) on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were used. The father of the patient reported that his son was experiencing chest pain and back pain on 09-AUG-2012, "the day after receiving GARDASIL". The patient had sought medical attention via contacting his father who was also a pharmacist. No lab diagnostics studies performed. Treatment of ADVIL was given for the AE. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
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 11 years old female patient with medical history of attention deficit/hyperactivity disorder (ADHD) and without illness at the time of vaccine treated intramuscularly into right arm with the third dose of GARDASIL (lot #: 672193/1524AA) on 29-FEB-2012. Concomitant therapy included CONCERTA. On the same day the patient experienced injection site red and itchy. There was no lab performed. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 450896-1.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, 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. A 15 years old female patient with no pertinent medical history and had toe fungus when vaccination who was vaccinated IM on the right arm with the second dose of GARDASIL (lot # 670049/1261AA; Exp Date 11-NOV-2013) on 21-FEB-2012. No other co-suspects were reported. No concomitant medications were reported. On 23-FEB-2012 the patient experienced itching. The patient went to emergency room for hives 48 hours after vaccine. Followed up office, the patient still had hives. The patient started prednisone, ranitidine and loratadine. BENADRYL was continued every 6 hours PRN increased itching. The outcome of the events was unknown. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
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 allergic to RYNATAN treated with the second dose of VARIVAX (Merck) given SC in the right arm on an unknown date. Concomitant medications included the first dose of ADACEL given IM in the right arm, the first dose of MENVEO given IM in the left arm and HAVRIX given IM in the left arm and the first dose of GARDASIL (lot #:666163/0661Z) given IM in the left arm. On day 2, in the right arm at varicella administration site, injection site turned "red" and raised slightly. It was warm to touch. The injection site size was about of 50 cent piece. The patient was administered TYLENOL and was compressed. No other symptoms reported. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 451269-1.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP, IPV, MMR
Symptoms: Erythema, Injection site reaction, Oedema peripheral, Type III immune complex mediated reaction
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 environmental allergies, allergy to peanuts and prophylaxis and medical history included asthma, eczema and adverse event while on Polio and MMR (manufacturer unknown). On 08-FEB-2011, the patient was vaccinated with dose of GARDASIL (Lot #, dose and route not reported). Secondary suspect therapies included Hepatitis A vaccine, inactivated (manufacturer unknown), the first dose of BOOSTRIX (C3489AA, intramuscular on right arm) and the first dose of MENACTRA (U3518AA, intramuscular on right arm), which were given on the same day. Concomitant medications included ADVAIR, albuterol, FLONASE, CLARITIN and EPIPEN. On an unspecified amount of time later the same day, the patient experienced injection site reaction, oedema peripheral, arthus reaction of swelling and redness of the right upper arm down to the elbow. According to the reporter the patient had a "similar reaction" after she had received an IPOL and MMR vaccine (manufacturer). The patient also had to be revaccinated after having DTaP vaccine when she was five year old because it was thought that the vaccine had been "unstable" from being too cold. At the time of reporting, the outcome was unknown. The patient pervious developed adverse event who on MMR (manufacturer) (MARRS # 1207USA012147). The original reporting source was a health care professional. The VAERS ID # 451776-1.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Oedema peripheral, Type III immune complex mediated reaction
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 environmental allergies, allergy to peanuts and prophylaxis and medical history included asthma, eczema and adverse event while on Polio and MMR (manufacturer unknown). On 08-FEB-2011, the patient was vaccinated with dose of GARDASIL (Lot #, dose and route not reported). Secondary suspect therapies included Hepatitis A vaccine, inactivated (manufacturer unknown), the first dose of BOOSTRIX (C3489AA, intramuscular on right arm) and the first dose of MENACTRA (U3518AA, intramuscular on right arm), which were given on the same day. Concomitant medications included ADVAIR, albuterol, FLONASE, CLARITIN and EPIPEN. On an unspecified amount of time later the same day, the patient experienced injection site reaction, oedema peripheral, arthus reaction of swelling and redness of the right upper arm down to the elbow. According to the reporter the patient had a "similar reaction" after she had received an IPOL and MMR vaccine (manufacturer). The patient also had to be revaccinated after having DTaP vaccine when she was five year old because it was thought that the vaccine had been "unstable" from being too cold. At the time of reporting, the outcome was unknown. The patient pervious developed adverse event who on MMR (manufacturer) (MARRS # 1207USA012147). The original reporting source was a health care professional. The VAERS ID # 451776-1.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP, IPV, MMR
Symptoms: Injection site erythema, Oedema peripheral, Type III immune complex mediated reaction
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 environmental allergies, allergy to peanuts and prophylaxis and medical history included asthma, eczema and adverse event while on Polio and MMR (manufacturer unknown). On 08-FEB-2011, the patient was vaccinated with dose of GARDASIL (Lot #, dose and route not reported). Secondary suspect therapies included Hepatitis A vaccine, inactivated (manufacturer unknown), the first dose of BOOSTRIX (C3489AA, intramuscular on right arm) and the first dose of MENACTRA (U3518AA, intramuscular on right arm), which were given on the same day. Concomitant medications included ADVAIR, albuterol, FLONASE, CLARITIN and EPIPEN. On an unspecified amount of time later the same day, the patient experienced injection site reaction, oedema peripheral, arthus reaction of swelling and redness of the right upper arm down to the elbow. According to the reporter the patient had a "similar reaction" after she had received an IPOL and MMR vaccine (manufacturer). The patient also had to be revaccinated after having DTaP vaccine when she was five year old because it was thought that the vaccine had been "unstable" from being too cold. At the time of reporting, the outcome was unknown. The patient pervious developed adverse event who on MMR (manufacturer) (MARRS # 1207USA012147). The original reporting source was a health care professional. The VAERS ID # 451776-1.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypersensitivity, Vaccination site swelling, Vaccination site 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. On 19-MAR-2012, a 12 year old male with no pre-existing illness and no medical history was vaccinated with the third dose of GARDASIL (lot # 670049/1261AA) into the left arm. On 19-MAR-2012, the patient experienced local allergic reaction, swelling and urticarial rash surrounding vaccination, 7 cm diameter within 30 minutes of vaccination. At the time of report, the patient's outcome was unknown. The adverse events were considered to be no conditions, not serious. No further information is available. The original reporting source was not provided. The VAERS ID # is 452702.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypersensitivity, Urticaria, Vaccination site reaction, Vaccination site swelling
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. On 19-MAR-2012, a 12 year old male with no pre-existing illness and no medical history was vaccinated with the third dose of GARDASIL (lot # 670049/1261AA) into the left arm. On 19-MAR-2012, the patient experienced local allergic reaction, swelling and urticarial rash surrounding vaccination, 7 cm diameter within 30 minutes of vaccination. At the time of report, the patient's outcome was unknown. The adverse events were considered to be no conditions, not serious. No further information is available. The original reporting source was not provided. The VAERS ID # is 452702.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Hypoaesthesia, Presyncope
Clinical narrative: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 12 years old female patient was vaccinated IM into left arm with a dose of GARDASIL (lot # 1009AA) on 02-APR-2012. No othe co-suspects were reported. The patient was also vaccinated IM into right arm with a dose of MENACTRA (lot # U4055BA) and a dose of ADACEL (lot # 4137AA) on 02-APR-2012, respectively. On 02-APR-2012 the patient experienced presyncope and numbness of arm. The outcome of presyncope and numbness in arm was unknown. The original reporting source was not provided. The VAERS ID # is 452969-1. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dyspnoea, Lymphadenopathy, Mononucleosis heterophile test negative, Pharyngeal erythema, Pharyngeal 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. A 1312 old female patient with was vaccinated on 11-APR-2012 with the first dose of GARDASIL, (lot # 1537AA), I.M, in the left arm (dose not reported). Concomitant medication included albuterol sulfate. On 12-APR-2012, the patient's mother reported the patient woke up with sore throat, ear pain. On Saturday she was having breathing difficulty. On Monday (16-APR-2012 through 18-APR-2012) she started having red, swollen eyes. Mom took her on 14-APR-2012 to an urgent care facility. They told mom she was having a reaction to the GARDASIL. They gave her steroids on 18-APR-2012, They brought her to see doctor. He didn't feel her symptoms were related to the GARDASIL. He diagnosed her with conjunctivitis, pharyngitis, viral syndrome like adenovirus. Laboratory tests were performed: Monospot and strep screen, both were negative. At the time of the report, patient's outcome for adenovirus infection, conjunctivitis, dyspnoea, ear pain, eye swelling, ocular hyperaemia, oropharyngeal pain pharyngitis, vaccination complication, and viral infection was not reported. This report was considered non-serious by the agency, it required ER visit. The original reporting source was the patient's mother. The VAERS ID # is 453741-2. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Streptococcus test negative, Swollen tongue
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 1312 old female patient with was vaccinated on 11-APR-2012 with the first dose of GARDASIL, (lot # 1537AA), I.M, in the left arm (dose not reported). Concomitant medication included albuterol sulfate. On 12-APR-2012, the patient's mother reported the patient woke up with sore throat, ear pain. On Saturday she was having breathing difficulty. On Monday (16-APR-2012 through 18-APR-2012) she started having red, swollen eyes. Mom took her on 14-APR-2012 to an urgent care facility. They told mom she was having a reaction to the GARDASIL. They gave her steroids on 18-APR-2012, They brought her to see doctor. He didn't feel her symptoms were related to the GARDASIL. He diagnosed her with conjunctivitis, pharyngitis, viral syndrome like adenovirus. Laboratory tests were performed: Monospot and strep screen, both were negative. At the time of the report, patient's outcome for adenovirus infection, conjunctivitis, dyspnoea, ear pain, eye swelling, ocular hyperaemia, oropharyngeal pain pharyngitis, vaccination complication, and viral infection was not reported. This report was considered non-serious by the agency, it required ER visit. The original reporting source was the patient's mother. The VAERS ID # is 453741-2. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Adenovirus infection, Conjunctivitis, Dyspnoea, Ear pain, Eye swelling
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 1312 old female patient with was vaccinated on 11-APR-2012 with the first dose of GARDASIL, (lot # 1537AA), I.M, in the left arm (dose not reported). Concomitant medication included albuterol sulfate. On 12-APR-2012, the patient's mother reported the patient woke up with sore throat, ear pain. On Saturday she was having breathing difficulty. On Monday (16-APR-2012 through 18-APR-2012) she started having red, swollen eyes. Mom took her on 14-APR-2012 to an urgent care facility. They told mom she was having a reaction to the GARDASIL. They gave her steroids on 18-APR-2012, They brought her to see doctor. He didn't feel her symptoms were related to the GARDASIL. He diagnosed her with conjunctivitis, pharyngitis, viral syndrome like adenovirus. Laboratory tests were performed: Monospot and strep screen, both were negative. At the time of the report, patient's outcome for adenovirus infection, conjunctivitis, dyspnoea, ear pain, eye swelling, ocular hyperaemia, oropharyngeal pain pharyngitis, vaccination complication, and viral infection was not reported. This report was considered non-serious by the agency, it required ER visit. The original reporting source was the patient's mother. The VAERS ID # is 453741-2. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Mononucleosis heterophile test negative, Ocular hyperaemia, Oropharyngeal pain, Pharyngitis, Streptococcus 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 1312 old female patient with was vaccinated on 11-APR-2012 with the first dose of GARDASIL, (lot # 1537AA), I.M, in the left arm (dose not reported). Concomitant medication included albuterol sulfate. On 12-APR-2012, the patient's mother reported the patient woke up with sore throat, ear pain. On Saturday she was having breathing difficulty. On Monday (16-APR-2012 through 18-APR-2012) she started having red, swollen eyes. Mom took her on 14-APR-2012 to an urgent care facility. They told mom she was having a reaction to the GARDASIL. They gave her steroids on 18-APR-2012, They brought her to see doctor. He didn't feel her symptoms were related to the GARDASIL. He diagnosed her with conjunctivitis, pharyngitis, viral syndrome like adenovirus. Laboratory tests were performed: Monospot and strep screen, both were negative. At the time of the report, patient's outcome for adenovirus infection, conjunctivitis, dyspnoea, ear pain, eye swelling, ocular hyperaemia, oropharyngeal pain pharyngitis, vaccination complication, and viral infection was not reported. This report was considered non-serious by the agency, it required ER visit. The original reporting source was the patient's mother. The VAERS ID # is 453741-2. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vaccination complication, Viral infection
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 1312 old female patient with was vaccinated on 11-APR-2012 with the first dose of GARDASIL, (lot # 1537AA), I.M, in the left arm (dose not reported). Concomitant medication included albuterol sulfate. On 12-APR-2012, the patient's mother reported the patient woke up with sore throat, ear pain. On Saturday she was having breathing difficulty. On Monday (16-APR-2012 through 18-APR-2012) she started having red, swollen eyes. Mom took her on 14-APR-2012 to an urgent care facility. They told mom she was having a reaction to the GARDASIL. They gave her steroids on 18-APR-2012, They brought her to see doctor. He didn't feel her symptoms were related to the GARDASIL. He diagnosed her with conjunctivitis, pharyngitis, viral syndrome like adenovirus. Laboratory tests were performed: Monospot and strep screen, both were negative. At the time of the report, patient's outcome for adenovirus infection, conjunctivitis, dyspnoea, ear pain, eye swelling, ocular hyperaemia, oropharyngeal pain pharyngitis, vaccination complication, and viral infection was not reported. This report was considered non-serious by the agency, it required ER visit. The original reporting source was the patient's mother. The VAERS ID # is 453741-2. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Adenovirus infection, Adenovirus test, Conjunctivitis, Dyspnoea, Ear pain
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 1312 old female patient with was vaccinated on 11-APR-2012 with the first dose of GARDASIL, (lot # 1537AA), I.M, in the left arm (dose not reported). Concomitant medication included albuterol sulfate. On 12-APR-2012, the patient's mother reported the patient woke up with sore throat, ear pain. On Saturday she was having breathing difficulty. On Monday (16-APR-2012 through 18-APR-2012) she started having red, swollen eyes. Mom took her on 14-APR-2012 to an urgent care facility. They told mom she was having a reaction to the GARDASIL. They gave her steroids on 18-APR-2012, They brought her to see doctor. He didn't feel her symptoms were related to the GARDASIL. He diagnosed her with conjunctivitis, pharyngitis, viral syndrome like adenovirus. Laboratory tests were performed: Monospot and strep screen, both were negative. At the time of the report, patient's outcome for adenovirus infection, conjunctivitis, dyspnoea, ear pain, eye swelling, ocular hyperaemia, oropharyngeal pain pharyngitis, vaccination complication, and viral infection was not reported. This report was considered non-serious by the agency, it required ER visit. The original reporting source was the patient's mother. The VAERS ID # is 453741-2. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Eye swelling, Mononucleosis heterophile test negative, Ocular hyperaemia, Oropharyngeal pain, Pharyngitis
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 1312 old female patient with was vaccinated on 11-APR-2012 with the first dose of GARDASIL, (lot # 1537AA), I.M, in the left arm (dose not reported). Concomitant medication included albuterol sulfate. On 12-APR-2012, the patient's mother reported the patient woke up with sore throat, ear pain. On Saturday she was having breathing difficulty. On Monday (16-APR-2012 through 18-APR-2012) she started having red, swollen eyes. Mom took her on 14-APR-2012 to an urgent care facility. They told mom she was having a reaction to the GARDASIL. They gave her steroids on 18-APR-2012, They brought her to see doctor. He didn't feel her symptoms were related to the GARDASIL. He diagnosed her with conjunctivitis, pharyngitis, viral syndrome like adenovirus. Laboratory tests were performed: Monospot and strep screen, both were negative. At the time of the report, patient's outcome for adenovirus infection, conjunctivitis, dyspnoea, ear pain, eye swelling, ocular hyperaemia, oropharyngeal pain pharyngitis, vaccination complication, and viral infection was not reported. This report was considered non-serious by the agency, it required ER visit. The original reporting source was the patient's mother. The VAERS ID # is 453741-2. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Streptococcus test negative, Vaccination complication, Viral infection
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 1312 old female patient with was vaccinated on 11-APR-2012 with the first dose of GARDASIL, (lot # 1537AA), I.M, in the left arm (dose not reported). Concomitant medication included albuterol sulfate. On 12-APR-2012, the patient's mother reported the patient woke up with sore throat, ear pain. On Saturday she was having breathing difficulty. On Monday (16-APR-2012 through 18-APR-2012) she started having red, swollen eyes. Mom took her on 14-APR-2012 to an urgent care facility. They told mom she was having a reaction to the GARDASIL. They gave her steroids on 18-APR-2012, They brought her to see doctor. He didn't feel her symptoms were related to the GARDASIL. He diagnosed her with conjunctivitis, pharyngitis, viral syndrome like adenovirus. Laboratory tests were performed: Monospot and strep screen, both were negative. At the time of the report, patient's outcome for adenovirus infection, conjunctivitis, dyspnoea, ear pain, eye swelling, ocular hyperaemia, oropharyngeal pain pharyngitis, vaccination complication, and viral infection was not reported. This report was considered non-serious by the agency, it required ER visit. The original reporting source was the patient's mother. The VAERS ID # is 453741-2. No further information is available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPATYP, HPV4
Symptoms: Eye swelling, Hypersensitivity, Lip swelling, Oedema mouth, Oedema peripheral
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 years old female patient with no previous illness on 13-DEC-2011 was vaccinated IM with the dose 3 GARDASIL (dose not reported, lot # 1569Z) onto left arm and dose 2 HEPATYRIX (dose not reported, lot # AHAVB481AB) IM onto left arm. On 16-APR-2012, grandmother reported allergic reaction after 13-DEC-2011 vaccines and stated that student had swelling of the lips, mouth, eyes and left arm, also reported hives to the body. Family did not seek treatment for symptoms. Family was unable to recall how long symptoms lasted. All AEs were assessed as non serious. The patient had no conditions. Outcome was unknown at the time of reporting. No further information is available. The original reporting source was provided by the patient's grandmother. The VAERS ID # is 453793.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPATYP, HPV4
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. A 16 years old female patient with no previous illness on 13-DEC-2011 was vaccinated IM with the dose 3 GARDASIL (dose not reported, lot # 1569Z) onto left arm and dose 2 HEPATYRIX (dose not reported, lot # AHAVB481AB) IM onto left arm. On 16-APR-2012, grandmother reported allergic reaction after 13-DEC-2011 vaccines and stated that student had swelling of the lips, mouth, eyes and left arm, also reported hives to the body. Family did not seek treatment for symptoms. Family was unable to recall how long symptoms lasted. All AEs were assessed as non serious. The patient had no conditions. Outcome was unknown at the time of reporting. No further information is available. The original reporting source was provided by the patient's grandmother. The VAERS ID # is 453793.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Haematemesis, 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 16 years old male patient with allergic to bee sting who on 11-APR-2012, about 5pm, was vaccinated with the third dose of GARDASIL (lot # 672547/1745AA, intramuscular on left arm, dose not reported). On 12-APR-2012, patient awoke early morning with nausea/dry-heaving followed by spitting up scant amount of blood x 1. Temp approx 100-101 degrees. Patient was given aspirin x 1 by father. The patient felt decreased energy and appetite as of 9:15 AM 12-APR-2012. At the time of reporting, the outcomes were unknown. The original reporting source was unknown. The VAERS ID# 453811. It was reported that the patient's experience was considered non-serious.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Retching
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 years old male patient with allergic to bee sting who on 11-APR-2012, about 5pm, was vaccinated with the third dose of GARDASIL (lot # 672547/1745AA, intramuscular on left arm, dose not reported). On 12-APR-2012, patient awoke early morning with nausea/dry-heaving followed by spitting up scant amount of blood x 1. Temp approx 100-101 degrees. Patient was given aspirin x 1 by father. The patient felt decreased energy and appetite as of 9:15 AM 12-APR-2012. At the time of reporting, the outcomes were unknown. The original reporting source was unknown. The VAERS ID# 453811. It was reported that the patient's experience was considered non-serious.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Haemoptysis, 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 16 years old male patient with allergic to bee sting who on 11-APR-2012, about 5pm, was vaccinated with the third dose of GARDASIL (lot # 672547/1745AA, intramuscular on left arm, dose not reported). On 12-APR-2012, patient awoke early morning with nausea/dry-heaving followed by spitting up scant amount of blood x 1. Temp approx 100-101 degrees. Patient was given aspirin x 1 by father. The patient felt decreased energy and appetite as of 9:15 AM 12-APR-2012. At the time of reporting, the outcomes were unknown. The original reporting source was unknown. The VAERS ID# 453811. It was reported that the patient's experience was considered non-serious.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal discomfort, Asthenia, Body temperature increased, 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. On 15-DEC-2011, a 12 year old female with no know relevant medical history and pre-existing illness was vaccinated intramuscularly with a second dose of GARDASIL (Lot# 671994/1537AA) in her left arm. On 15-DEC-2011 the patient experienced bleeding at site, headache, dizzy, upset stomach, temperature 99-100. Headache and low energy level for approximately 2 weeks. Final outcome was not reported. The original reporting source was not provided. The VAERS ID # 453939-1. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site haemorrhage
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. On 15-DEC-2011, a 12 year old female with no know relevant medical history and pre-existing illness was vaccinated intramuscularly with a second dose of GARDASIL (Lot# 671994/1537AA) in her left arm. On 15-DEC-2011 the patient experienced bleeding at site, headache, dizzy, upset stomach, temperature 99-100. Headache and low energy level for approximately 2 weeks. Final outcome was not reported. The original reporting source was not provided. The VAERS ID # 453939-1. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Purpura, Rash
Clinical narrative: This report was identified from a line listing on the request by the company from the FDA under the Freedom of Information Act, a 11 years old female patient with no medical history vaccinated with lot # (670049/1171AA) dose 3 GARDASIL at right arm on 20-MAR-2012. There was no concomitant therapy. On 23-MAR-2012 the patient experienced a rash on feet and palpable purpuric, she also developed on palpable bump on breast but not purpuric. The outcome of a rash on feet and purpura was unknown. No further information was available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Breast mass, Palpable purpura, Rash
Clinical narrative: This report was identified from a line listing on the request by the company from the FDA under the Freedom of Information Act, a 11 years old female patient with no medical history vaccinated with lot # (670049/1171AA) dose 3 GARDASIL at right arm on 20-MAR-2012. There was no concomitant therapy. On 23-MAR-2012 the patient experienced a rash on feet and palpable purpuric, she also developed on palpable bump on breast but not purpuric. The outcome of a rash on feet and purpura was unknown. No further information was available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, 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 refers to a 15 years old female patient. The patient was vaccinated in left arm with the first dose of GARDASIL (lot # 668261/1397AA) on 21-APR-2012. On 21-APR-2012 the patient experienced dizziness and pallor 10 minutes after vaccination. The adverse events were considered to be non-serious. If the patient sought medical attention or not was unknown. No lab data was reported. The outcome of pallor and dizziness was unknown. Additional information is not expected. The original reporting source was not provided. The VAERS ID # is 454237-1.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Hypersensitivity, Injection site pruritus, Injection site reaction, Injection site swelling
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 11 years old male patient with no pre-existing illness. The patient was vaccinated intramuscularly with lot # (672232/1495AA) dose 3 of GARDASIL (dose not reported) on 19-APR-2012. No co-suspect medications were reported. Concomitant vaccines included: the first dose of MENACTRA (lot # U4039AA) (dose not reported) on 19-APR-2012. On 20-APR-2012 the patient's left arm was swollen, red and itchy at injection site. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provided for GARDASIL. This report was considered no conditions and non serious by the agency. The original reporting source was not provided. The VAERS ID# is 454622. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
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 11 years old male patient with no pre-existing illness. The patient was vaccinated intramuscularly with lot # (672232/1495AA) dose 3 of GARDASIL (dose not reported) on 19-APR-2012. No co-suspect medications were reported. Concomitant vaccines included: the first dose of MENACTRA (lot # U4039AA) (dose not reported) on 19-APR-2012. On 20-APR-2012 the patient's left arm was swollen, red and itchy at injection site. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provided for GARDASIL. This report was considered no conditions and non serious by the agency. The original reporting source was not provided. The VAERS ID# is 454622. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Electrocardiogram, Haematocrit, Haemoglobin, 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. This spontaneous report as received from a regulatory authority refers to a 14 years old female patient. The patient was vaccinated in the left arm lot # (672652/0022AE) with dose 1 of GARDASIL (dose and route not reported) on 07-MAY-2012. No other co-suspects and no concomitant medications were reported. On 07-MAY-2012 the patient experienced dizziness and headache that started 10 minutes after vaccine. No treatment information was reported. The outcome of headache and dizziness was unknown. The relatedness for the reported events was not provided for GARDASIL. The original reporting source was not provided. The VAERS ID # is 455334.  This report was considered non serious by the agency. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metabolic function test
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 14 years old female patient. The patient was vaccinated in the left arm lot # (672652/0022AE) with dose 1 of GARDASIL (dose and route not reported) on 07-MAY-2012. No other co-suspects and no concomitant medications were reported. On 07-MAY-2012 the patient experienced dizziness and headache that started 10 minutes after vaccine. No treatment information was reported. The outcome of headache and dizziness was unknown. The relatedness for the reported events was not provided for GARDASIL. The original reporting source was not provided. The VAERS ID # is 455334.  This report was considered non serious by the agency. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test normal, Dizziness, Electrocardiogram 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. This spontaneous report as received from a regulatory authority refers to a 14 years old female patient. The patient was vaccinated in the left arm lot # (672652/0022AE) with dose 1 of GARDASIL (dose and route not reported) on 07-MAY-2012. No other co-suspects and no concomitant medications were reported. On 07-MAY-2012 the patient experienced dizziness and headache that started 10 minutes after vaccine. No treatment information was reported. The outcome of headache and dizziness was unknown. The relatedness for the reported events was not provided for GARDASIL. The original reporting source was not provided. The VAERS ID # is 455334.  This report was considered non serious by the agency. Additional information is not expected.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dizziness, Pallor, Tremor
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 patient with allergic rhinitis, poor appetite and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly with lot # (671994/1537AA) dose 1 of GARDASIL (dose not reported) on 15-MAY-2012. No other co-suspects were reported. Concomitant medications included dose 1 of MENACTRA (lot # H4030AA) IM and dose 1 of Tdap (lot # U4106BA) IM. No other concomitant medications were reported. On 15-MAY-2012 a few minutes after GARDASIL the patient felt faint became pale and shaky, the patient was given cake and was laid down, vitals remained good. The episode passed in about 10 minutes. No treatment information was reported. The outcome of shaky, felt faint and became pale was reported as recovered/resolved. The relatedness for the reported events was not provided for GARDASIL. The original reporting source was not provided. The VAERS ID # is 456039. This report was considered non serious and no conditions by the agency. Additional information is not expected.