chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 15 month old patient who on 05-MAR-2012 was vaccinated with a dose of GARDASIL (lot# 671427/1217AA). The nurse mentioned that on 06-JUN-2012 the patient had outbreak of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow-up information received from registered nurse refers to a 15 months old male patient (child) with speech delay, hearing loss, colic and no illness of vaccination. On 05-MAR-2012 at 10:00 AM, the patient was vaccinated with the first dose of VARIVAX subcutaneously in right leg (dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 06-JUN-2012, the patient was seen in clinic, a rash described as "scattered macular and papular rash with a few vesicles mostly excoriated with trace crusting, rash spares face and palms, skin turgor within normal limits (WNL); diagnosed with varicella. No treatment information was reported. No testing was done. The outcome of patient's was recovered/resolved on 03-JUL-2012 ("no rash"). The relatedness for the patient's event was not reported for VARIVAX. Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash generalised, Rash macular, Rash papular, Rash pustular
Clinical narrative: Information has been received from a nurse concerning a 28 month old patient who on 20-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# 667920/0860Z). The nurse mentioned that on 18-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. A lot check has been initiated. Follow-up information has been received from a registered nurse refers to 24 months old (currently 30 months old) female patient with expressive language disorder and no illness at the time of vaccination. On 20-JAN-2012 at 17:00 PM, the patient was vaccinated with the second dose of VARIVAX (Merck) intramuscularly (IM) in right leg (dose not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-MAY-2012, the patient came to clinic with rash described as "generalized maculae, paulae, vesicles, pustules, rash more apparent on legs". Then on 18-MAY-2012, on follow-up visit the patient was diagnosed with varicella healing. No testing was done. No treatment information reported. The patient's outcome was recovered on 18-MAY-2012. The relatedness for the patient's events was not reported for VARIVAX. This was one of the several reports from the same source. Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 28 month old patient who on 20-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# 667920/0860Z). The nurse mentioned that on 18-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. A lot check has been initiated. Follow-up information has been received from a registered nurse refers to 24 months old (currently 30 months old) female patient with expressive language disorder and no illness at the time of vaccination. On 20-JAN-2012 at 17:00 PM, the patient was vaccinated with the second dose of VARIVAX (Merck) intramuscularly (IM) in right leg (dose not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-MAY-2012, the patient came to clinic with rash described as "generalized maculae, paulae, vesicles, pustules, rash more apparent on legs". Then on 18-MAY-2012, on follow-up visit the patient was diagnosed with varicella healing. No testing was done. No treatment information reported. The patient's outcome was recovered on 18-MAY-2012. The relatedness for the patient's events was not reported for VARIVAX. This was one of the several reports from the same source. Additional information is not expected.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Axillary mass, Blood test, Bronchitis, Erythema, Induration
Clinical narrative: This spontaneous report as received from a 73 years old female patient refers to herself with drug reactions/allergies of myacin drugs and most pain medications and with no pertinent medical history. The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified) on approximately 11-JUL-2012, "five weeks ago". No other co-suspects were reported. Concomitant medications included estradiol (reported as estrodial), PRILOSEC and naproxen. The patient reported that she experienced arm swelling, bronchitis and itchy, red, painful swelling the size of a softball where she received the ZOSTAVAX injection on approximately 11-JUL-2012, "about twelve hours after getting vaccine". Her muscles ached and she felt like she had the flu. She also experienced severe bronchitis. At the time of reporting the arm was the size of a golf ball and was red, with hard lumps underneath. The patient had sought unspecified medical attention. Lab diagnostics studies of blood test (type not specified) was performed with results not provided. Treatment of antibiotics was given for the AE for 10 days. The AE improved while on therapy. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Myalgia, Oedema peripheral
Clinical narrative: This spontaneous report as received from a 73 years old female patient refers to herself with drug reactions/allergies of myacin drugs and most pain medications and with no pertinent medical history. The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified) on approximately 11-JUL-2012, "five weeks ago". No other co-suspects were reported. Concomitant medications included estradiol (reported as estrodial), PRILOSEC and naproxen. The patient reported that she experienced arm swelling, bronchitis and itchy, red, painful swelling the size of a softball where she received the ZOSTAVAX injection on approximately 11-JUL-2012, "about twelve hours after getting vaccine". Her muscles ached and she felt like she had the flu. She also experienced severe bronchitis. At the time of reporting the arm was the size of a golf ball and was red, with hard lumps underneath. The patient had sought unspecified medical attention. Lab diagnostics studies of blood test (type not specified) was performed with results not provided. Treatment of antibiotics was given for the AE for 10 days. The AE improved while on therapy. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a 73 years old female patient refers to herself with drug reactions/allergies of myacin drugs and most pain medications and with no pertinent medical history. The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified) on approximately 11-JUL-2012, "five weeks ago". No other co-suspects were reported. Concomitant medications included estradiol (reported as estrodial), PRILOSEC and naproxen. The patient reported that she experienced arm swelling, bronchitis and itchy, red, painful swelling the size of a softball where she received the ZOSTAVAX injection on approximately 11-JUL-2012, "about twelve hours after getting vaccine". Her muscles ached and she felt like she had the flu. She also experienced severe bronchitis. At the time of reporting the arm was the size of a golf ball and was red, with hard lumps underneath. The patient had sought unspecified medical attention. Lab diagnostics studies of blood test (type not specified) was performed with results not provided. Treatment of antibiotics was given for the AE for 10 days. The AE improved while on therapy. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unspecified date the patient was vaccinated with a dose of PNEUMOVAX23 (Lot#, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced tenderness at the injection site. The patient sought for unspecified medical attention. This is one of several reports received from a same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been receive from a pharmacist concerning a patient who on 11-JUL-2012 was inadvertently vaccinated with a subcutaneous single dose of ZOSTAVAX (lot # 671779/0169AE) that had been improperly stored. No adverse effects reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 14 years old female patient, who was vaccinated with the first dose of GARDASIL (lot # not reported), 0.5 ml, intramuscularly, on 23-MAR-2009 the second dose in June 2010 (lot # not reported), and the last dose in August 2011 (lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that in May 2012 the patient had joint pain in her right hip and left shoulder. At the time of the report the patient's outcome was unknown. The patient sought medical attention - "Went to pediatric rheumatologist told to take a non-steroidal anti-inflammatory". Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients who on on unknown dates might have received improperly stored ROTATEQ (dose and route not provided) (lot # 0059AE, expiration date on23-SEP-2013; lot # 1710AA, expiration date on 11-JUL-2013). The nurse sated that the vaccines were exposed to 47-48 F for 72 hours and 32 F for 24 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a office manager refers to a patient of unknown age. It was reported that the patient may have vaccinated with the third dose GARDASIL early. Vaccine lot #, route and date were unspecified. The patient was not experiencing any known symptoms. The outcome of patient was unspecified. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 37 years old female patient with idiopathic thrombocytopenic purpura and a platelet condition and with no drug reaction/allergy. The patient was vaccinated SC on left deltoid with the first dose, 0.5 ml VARIVAX on 26-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. In 2012 the patient developed shingles. No treatment information was reported. The patient had taken phone call for medical attention. The outcome of shingles was reported as recovering/resolving. Additional information is not expected.
Age: 0.75
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 months old patient. The patient was vaccinated with a dose of VAQTA (Lot # not reported) on an unspecified date, "a few months ago". No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with an expired GARDASIL (lot # 663452/0671Y, Expire date 18-SEP-2012) (vaccination site unknown) on 02-AUG-2012. This was the patient first dose. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unknown number of patients who on an unknown dates were vaccinated with doses of PNEUMOVAX 23 (doses, routes and lot number not reported) which were stored at lower than recommended temperatures on multiple occasions. No adverse effect reported. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. The health care professional contacted during telephone follow-up could not supply the following information: patients names, dates of birth, dates of vaccination/therapy, dose number, lot number, date of event, healthcare provider name and contact information. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site warmth, Oedema peripheral
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 13 years old female patient with no drug reactions or allergies or pertinent medical history who was vaccinated intra muscular (IM) with the first dose, 0.5 ml GARDASIL (lot # not reported) on 01-JUN-2012. There were no concomitant therapies. The nurse, reported that a female patient was administered her first dose of GARDASIL on 01-JUN-2012 and later the same evening experienced arm swelling "the size of a softball" and injection site area was hot to the touch. The patient's outcome for arm swelling "the size of a softball" and injection site area was hot to the touch was reported as recovered, "3 or 4 days after initial reaction". The patient did not seek medical attention. No treatment for the adverse event was given. Laboratory and diagnostics were not performed. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Testicular pain, Testicular swelling
Clinical narrative: This spontaneous report was received from an unspecified reporter refers to a 10 year old (reported also as 11 year old) male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with a dose of GARDASIL (number of dose, dose, route and lot # not reported) on 08-JUN-2012. There was no concomitant medication. On 20-JUL-2012 the patient experienced swelling and pain in 1 testicle. No treatment was given for adverse event. At the time of the report patient's state was not reported. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 62 years old female patient with no pertinent medical history and no drug reaction/allergies. The patient was vaccinated with ZOSTAVAX (Lot#Exp, dose/frequency, dose number and therapy route were unspecified) in November-2011. No other co-suspects were reported. No concomitant medications were taken. It was reported that on 16-JUL-2012 the patient was diagnosed with shingles. The patient had sought medical attention via office visit. No lab diagnostics studies performed. No treatment information was reported. The outcome was unknown when reporting. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Contusion
Clinical narrative: This spontaneous report as received from a consumer refers her cousin, a 23 years old female with no medical history or allergies who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. No concomitant medications were reported. While on PNEUMOVAX 23 the patient's arm developed a bruise. No treatment was given. No lab studies were performed. The bruise was all gone now. Additional information is not expected.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash erythematous, Ulcer, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 14 month old patient who on 19-APR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 670169/1574AA). The nurse mentioned that on 14-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. The follow up information has been received from a registered nurse refers to a 14 months (reported also as 1 year old) old male patient. The patient's medical history included eczema. Current conditions included hearing problems and cleft palate cleft lip bilateral, completed and none illness at the time of the vaccination. The patient was vaccinated subcutaneously in left leg with a first dose of VARIVAX, (dose not reported; lot # (670169/1574AA) on 19-APR-2012. It was reported that on 14-JUN-2012 the patient came to the clinic with rash described as "multiple erythematous patches with vesicles, have localized over knees and elbows. All stages of vesicles were present from ulcers to fresh blisters." The patient was diagnosed with the varicella. No lab tests were performed. The patient's recovered from varicella on 02-JUL-2012. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Lymphadenopathy, X-ray
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with 0.5 ml GARDASIL (lot # unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient experienced an unspecified adverse event with her supraclavicular lymph node about a week after getting GARDASIL. The patient also was experiencing an unspecified concomitant illness at that time. X-rays and complete blood count were performed (no results were reported). No treatment information was reported. The outcome of the events were unknown. The patient had sought unspecified medical attention. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Facial pain, Rash, Tenderness
Clinical narrative: This spontaneous report as received from an approximately 73 years old male patient with high blood pressure and cholesterol. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant medications included Lisinopril, Clonidine, Hydrochlorothiazide and Simvastatin (manufacturer unknown). In 2010, months after the ZOSTAVAX injection was given he stated perhaps 2009 or 2010, he noticed both sides of his face starting to feel a painful burning sensation and spots by left eye, lower left ear that was very sensitive to the touch which has not subsided and was still experiencing. The patient sought unspecified medical attention. The patient received prescribed gaspentin 600mg three times a day. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash pustular, Scab, Scarlet fever, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 47 month old patient who on 06-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (lot# 663710/0219Y). The nurse mentioned that on 22-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow-up information was received from a registered nurse who stated that the 3 year old female patient with precocious sexual development and puberty diagnosed early and wheezing and no illness at time of vaccination on 06-JUL-2009, was vaccinated SQ in the left leg with the first dose of VARIVAX (Merck) (lot# 663710/0219Y). The nurse reported that the patient went to the clinic for a rash. The mother stated that the day after initial rash visit (the patient was diagnosed with scarlet fever). The patient developed multiple vesicles and pustules, localized on genitals, arms and legs. The provider described "multiple scabs on genital, arms and legs". The patient was diagnosed with varicella. The patient did not have any testing done. On 13-JUN-2012, the patient recovered from varicella. A lot check has been initiated. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus generalised, Rash, White blood cell count decreased
Clinical narrative: Information has been received from the pharmacist and from the 79 year old female patient, with no drug reaction/allergies and no pertinent medical history, who on 11-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 671075/1197AA, Expiration date 25-OCT-2012, diluent lot number is H001976, diluent expiration date February 2014) (dose and route not reported). The patient also called to add information that she took an unspecified blood pressure pill. The pharmacist reported that on 11-JUN-2012, after receiving the ZOSTAVAX (Merck) the patient developed redness and swelling at the injection site along and itchiness all over the body. The patient sought medical attention by called the pharmacist. TYLENOL as the treatment was given. No lab diagnostics studies were performed. At the time of reporting the patient's outcome was not reported. Follow-up information was received from a physician who stated that the 79 year old retired female patient with Ca colon at time of vaccination, who on 11-JUN-2012, was vaccinated IM in the left deltoid with the first dose of ZOSTAVAX at 10:00 am. On 12-JUN-2012, the patient experienced rash on left arm, leg and chest. The patient also experienced pruritus that continued to present. The patient was treated with BENADRYL and CLARITIN and it helped. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age who an unspecified dates was vaccinated with, second 0.5 ml GARDASIL on unspecified date. A nurse, reported that a patient did not received his third dose of GARDASIL (route and lot # not reported) on time and at the time of the report the patient was in the office for receive it. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter. The patient was vaccinated IM with the first and second dose of 0.5 ml GARDASIL in June 2011 and on 08-AUG-2012 separately. Now, she did not known if she would get the third dose or if she must start the series of shots all over again. It was unknown if the patient sought medical attention or not. No adverse reactions reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. No concomitant medications were reported. The pharmacist reported that on 04-AUG-2012, an unspecified patient received a dose of ZOSTAVAX that expired on 03-JUL-2012 (dose, route and lot # not reported). He did not know if the patient experienced any adverse effects. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site reaction
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 62 years old female patient with no pertinent medical history and no drug reactions or allergies who on 06-JUL-2012, was vaccinated with a dose of ZOSTAVAX (lot # 672868/0239AE, Exp. Date: 26-APR-2012) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as a red area (no rash) with a "knot" (hard area) at the injection site. The pharmacist did not know the time of development of the injection site reaction other than it occurred shortly after the ZOSTAVAX was administered. No lab diagnostics studies were performed. Ice or cold compresses were given as a treatment for the experience. At the time of the report, the patient had not recovered. The patient sought medical attention by contacting the pharmacist. The relatedness for red area at injection site and "knot" hard area at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a physician concerning a patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that another unspecified physician reported to him that an unspecified patient broke out in a rash all over their body about 14 days after receiving ZOSTAVAX. The patient contacted the physician. The outcome of rash all over the body was unknown. The relatedness for rash all over the body was unknown for ZOSTAVAX. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Information has been received from a registered pharmacist concerning a 61 year-old male patient with an allergy to tetanus toxoids and history of respiratory problems. On 08-SEP-2011, the patient was vaccinated with ZOSTAVAX (Merck) (lot # 670542/0619AA; expiration 26-JUL-2012), 0.65 ml, subcutaneously (LPLA). No other vaccines were administered at the time of the ZOSTAVAX (Merck). Post injection, the patient developed Bells Palsy. The patient's physician was notified. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Chest pain, Nausea, Paraesthesia
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 18 years old female patient with no known medical history or pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with lot # (670049/1171AA) of GARDASIL (dose not reported) on 06-APR-2012. Other suspect therapies included a dose of VARIVAX (Merck) (lot # 1248AA) (dose not reported) subcutaneously in the left arm, on 06-APR-2012 and a dose of VAQTA (lot # 672221/1586AA) (dose not reported) intramuscularly in the right arm, on 06-APR-2012. Concomitant medications included a dose of BOOSTRIX (lot # AC52B080DA) and a dose of MENACTRA (lot # U4053AA). On 06-APR-2012, 10 minutes post vaccination the patient complained of nausea, chest pain and tingling in arms. There was no loss of consciousness. Vitals were taken (results not provided) and ice was applied to neck, rescue was called. The patient was sent to hospital by ambulance. The patient was alert and responsive, oriented x 3. No treatment information was reported. The outcome of chest pain, tingling in arms and complaining of nausea was unknown. The relatedness for the reported events was not provided for GARDASIL, VARIVAX and VAQTA. 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 453139-1. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Arthralgia, Dizziness, Dyspnoea, Fatigue
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female patient with no previous illness and no medical history was vaccinated with dose 2 of GARDASIL on 23-FEB-2012. It was reported that she experienced the following: severe headaches, nausea, dizziness, joints hurt, muscles felt weak, swollen lymph nodes in her throat, hard to breathe, extreme fatigue, gastrointestinal problems, shaking, anxiety and afraid to sleep. It was noted that she has been to the emergency room twice and her pediatrician several times. Blood work to test for mono and thyroid issues all of which were negative. Her symptoms got worse after the second dose that was given on 23-FEB-2012. The consumer noted she did not relate the shot to illness first time until second shot was given and she got worse and worse. The consumer stated do not give this shot to anymore young girls; it is causing major health problems and death. There have been over 8000 complaints and over 35 deaths (MARRS# 1208USA009902). No treatment information was reported. The outcome of the events mentioned above was unknown. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# 453638-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fear, Gastrointestinal disorder, Headache, Lymphadenopathy, Mononucleosis heterophile test negative
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female patient with no previous illness and no medical history was vaccinated with dose 2 of GARDASIL on 23-FEB-2012. It was reported that she experienced the following: severe headaches, nausea, dizziness, joints hurt, muscles felt weak, swollen lymph nodes in her throat, hard to breathe, extreme fatigue, gastrointestinal problems, shaking, anxiety and afraid to sleep. It was noted that she has been to the emergency room twice and her pediatrician several times. Blood work to test for mono and thyroid issues all of which were negative. Her symptoms got worse after the second dose that was given on 23-FEB-2012. The consumer noted she did not relate the shot to illness first time until second shot was given and she got worse and worse. The consumer stated do not give this shot to anymore young girls; it is causing major health problems and death. There have been over 8000 complaints and over 35 deaths (MARRS# 1208USA009902). No treatment information was reported. The outcome of the events mentioned above was unknown. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# 453638-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Nausea, Thyroid function test normal, Tremor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female patient with no previous illness and no medical history was vaccinated with dose 2 of GARDASIL on 23-FEB-2012. It was reported that she experienced the following: severe headaches, nausea, dizziness, joints hurt, muscles felt weak, swollen lymph nodes in her throat, hard to breathe, extreme fatigue, gastrointestinal problems, shaking, anxiety and afraid to sleep. It was noted that she has been to the emergency room twice and her pediatrician several times. Blood work to test for mono and thyroid issues all of which were negative. Her symptoms got worse after the second dose that was given on 23-FEB-2012. The consumer noted she did not relate the shot to illness first time until second shot was given and she got worse and worse. The consumer stated do not give this shot to anymore young girls; it is causing major health problems and death. There have been over 8000 complaints and over 35 deaths (MARRS# 1208USA009902). No treatment information was reported. The outcome of the events mentioned above was unknown. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# 453638-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gastrointestinal disorder, Headache, Insomnia, Laboratory test normal, Lymphadenopathy
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female patient with no previous illness and no medical history was vaccinated with dose 2 of GARDASIL on 23-FEB-2012. It was reported that she experienced the following: severe headaches, nausea, dizziness, joints hurt, muscles felt weak, swollen lymph nodes in her throat, hard to breathe, extreme fatigue, gastrointestinal problems, shaking, anxiety and afraid to sleep. It was noted that she has been to the emergency room twice and her pediatrician several times. Blood work to test for mono and thyroid issues all of which were negative. Her symptoms got worse after the second dose that was given on 23-FEB-2012. The consumer noted she did not relate the shot to illness first time until second shot was given and she got worse and worse. The consumer stated do not give this shot to anymore young girls; it is causing major health problems and death. There have been over 8000 complaints and over 35 deaths (MARRS# 1208USA009902). No treatment information was reported. The outcome of the events mentioned above was unknown. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# 453638-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mononucleosis heterophile test negative, Muscular weakness, Nausea, Thyroid function test normal, Tremor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female patient with no previous illness and no medical history was vaccinated with dose 2 of GARDASIL on 23-FEB-2012. It was reported that she experienced the following: severe headaches, nausea, dizziness, joints hurt, muscles felt weak, swollen lymph nodes in her throat, hard to breathe, extreme fatigue, gastrointestinal problems, shaking, anxiety and afraid to sleep. It was noted that she has been to the emergency room twice and her pediatrician several times. Blood work to test for mono and thyroid issues all of which were negative. Her symptoms got worse after the second dose that was given on 23-FEB-2012. The consumer noted she did not relate the shot to illness first time until second shot was given and she got worse and worse. The consumer stated do not give this shot to anymore young girls; it is causing major health problems and death. There have been over 8000 complaints and over 35 deaths (MARRS# 1208USA009902). No treatment information was reported. The outcome of the events mentioned above was unknown. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# 453638-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Affect lability, Crying, Disturbance in attention, Feeling hot
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 17 years old female patient with scoliosis. The patient was vaccinated intramuscularly in the left arm with lot # (0022AC) dose 1 of GARDASIL (dose not reported) on 24-APR-2012. No other co-suspects were reported. Concomitant medications included: tuberculin purified protein derivative (PPD). On 25-APR-2012 the patient began to feet hot, became emotionally unstable about 22 hours after vaccine lasting 24 hours. The patient also had trouble focusing. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provided for GARDASIL. 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 454474-1. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Affect lability, Feeling hot, Vision blurred
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 17 years old female patient with scoliosis. The patient was vaccinated intramuscularly in the left arm with lot # (0022AC) dose 1 of GARDASIL (dose not reported) on 24-APR-2012. No other co-suspects were reported. Concomitant medications included: tuberculin purified protein derivative (PPD). On 25-APR-2012 the patient began to feet hot, became emotionally unstable about 22 hours after vaccine lasting 24 hours. The patient also had trouble focusing. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provided for GARDASIL. 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 454474-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
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 14 years old female patient with no previous medical history or pre-existing illness at the time of vaccination. The patient was vaccinated in the left arm with lot # (668554/0306AA) dose 1 of GARDASIL (dose and route not reported) on 16-APR-2012. Other suspect therapies included dose 2 of VARIVAX (Merck) (lot # 1376AA) (dose and route not reported) in the left arm, on 16-APR-2012. Concomitant medications included: 1 dose of VAQTA (lot # 672220/1416AA) (dose and route not reported), in the right arm on 16-APR-2012. On 18-APR-2012 the patient presented to office with complaints of pain, erythema and warmth of injection site left arm. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provided for GARDASIL and VARIVAX (Merck). This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 454610-1. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Crying, Emotional disorder, Feeling abnormal, Grip strength decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no pre existing illness and no medical history was vaccinated with a dose 1 GARDASIL, Lot # (672547/1745AA), left arm, IM on 23-APR-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 23-APR-2012, a few hours after GARDASIL patient was in school and developed, incontrollable shaking, laughing, then crying, then curled up in a ball on the floor, patient had no control over her emotions x 45 min, the patient's dad observed this behavior, next day on 24-APR-2012, patient felt like "in a fog" again felt "shaky" and unable to hold a pencil, also developed headache lasting until 25-APR-2012. The patient "today" felt within the normal limits. There were no labs performed. This report was considered not serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 454755-1. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Inappropriate affect, 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. A 15 year old female patient with no pre existing illness and no medical history was vaccinated with a dose 1 GARDASIL, Lot # (672547/1745AA), left arm, IM on 23-APR-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 23-APR-2012, a few hours after GARDASIL patient was in school and developed, incontrollable shaking, laughing, then crying, then curled up in a ball on the floor, patient had no control over her emotions x 45 min, the patient's dad observed this behavior, next day on 24-APR-2012, patient felt like "in a fog" again felt "shaky" and unable to hold a pencil, also developed headache lasting until 25-APR-2012. The patient "today" felt within the normal limits. There were no labs performed. This report was considered not serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 454755-1. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Crying, Feeling abnormal, Grip strength decreased, 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 15 year old female patient with no pre existing illness and no medical history was vaccinated with a dose 1 GARDASIL, Lot # (672547/1745AA), left arm, IM on 23-APR-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 23-APR-2012, a few hours after GARDASIL patient was in school and developed, incontrollable shaking, laughing, then crying, then curled up in a ball on the floor, patient had no control over her emotions x 45 min, the patient's dad observed this behavior, next day on 24-APR-2012, patient felt like "in a fog" again felt "shaky" and unable to hold a pencil, also developed headache lasting until 25-APR-2012. The patient "today" felt within the normal limits. There were no labs performed. This report was considered not serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 454755-1. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Inappropriate affect, Posture abnormal, 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. A 15 year old female patient with no pre existing illness and no medical history was vaccinated with a dose 1 GARDASIL, Lot # (672547/1745AA), left arm, IM on 23-APR-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 23-APR-2012, a few hours after GARDASIL patient was in school and developed, incontrollable shaking, laughing, then crying, then curled up in a ball on the floor, patient had no control over her emotions x 45 min, the patient's dad observed this behavior, next day on 24-APR-2012, patient felt like "in a fog" again felt "shaky" and unable to hold a pencil, also developed headache lasting until 25-APR-2012. The patient "today" felt within the normal limits. There were no labs performed. This report was considered not serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 454755-1. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Presyncope, Tremor
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, it was unknown if the patient had any pre-existing illness at the time of vaccination. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on 20-MAR-2012. No other co-suspects were reported. Concomitant medications included: a dose of MENVEO (lot # A10130/X10130X expiry date 01-FEB-2013). There was no other concomitant medications. It was reported that on 20-MAR-2012 the patient became shaky after getting the shots and experienced a near fainting episode. No treatment information was reported. The outcome of became shaky after getting the shots and near fainting episode was reported as complete recovery of the patient on 20-MAR-2012. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 454834-1. No further information is available.
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Human chorionic gonadotropin positive, Menstruation irregular, Pregnancy
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 29 year old female patient of unknown age with not pre-existing illnesses, irregular menses, Gastroesophageal reflux disease (GERD), seasonal allergies (self diagnosed), benzoyl peroxide and mint/ginger allergies, family risk factor: Cousin (male; mother's brother's son) with "whole in heart" repaired as an adult with a pertinent medical history/past surgical history of 1 normal vaginal delivery, C-section (due to recent diagnosis of Human papilloma virus (HPV) and Herpes simplex virus (HSVII) without maternal or infant complications, loop electrosurgical excision procedure (LEEP) in October 2009, 1 therapeutic abortion, ovarian cyst drained in 1998 and pyelonephritis who was vaccinated with dose 1 of GARDASIL lot # (668819/0477AA), Left arm (unknown route and dose) on 17-MAR-2012. NO other co-suspects were reported. Concomitant medications included: anthrax vaccine. The patient was in none other medications. On 13-APR-2012 patient was given "TAD" orders off the ship on 13-APR-2012. On 24-APR-2012 a Human chorionic gonadotropin urine hCG (qualitative) was performed which resulted positive. Subsequently, the patient became pregnant with a LMP (light) that was sometime between of 25-FEB-2012 and an EDD of 01-DEC-2012. It was reported that on 12-APR-2012 the patient experienced menstruation irregular, patient used condoms for birth control (not consistently). Patient was demonstrated how to perform a home pregnancy test for a friend which was positive. The patient repeated the home pregnancy test 4 more times which were all positive. Patient contacted the center on 19-APR-2012 and desired pregnancy follow-up. The outcome of the events mentioned above 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 454843-1. Additional information is not expected.